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Incidence of Exacerbations and Hospitalizations Is Reduced and Time to Exacerbations Is Prolonged with Mometasone Furoate Dry Powder Inhaler Versus Beclomethasone Dipropionate Hydrofluoroalkane Aerosol in Patients with Mild Asthma 轻度哮喘患者糠酸莫米松干粉吸入器与二丙酸倍氯米松氢氟烷烃气雾剂的急性发作和住院发生率降低,急性发作时间延长
Pub Date : 2010-12-01 DOI: 10.1016/j.ehrm.2010.08.001
Prakash Navaratnam RPh, MPH, PhD , Eduardo Urdaneta MD , John McLaughlin MSPH , Howard S. Friedman PhD, MMS

Objective

To compare the incidence and time to onset of exacerbations among mild asthmatic non-controller-naive patients who began treatment with mometasone furoate via a dry powder inhaler (MF-DPI) or a beclomethasone dipropionate-hydrofluoroalkane (BDP-HFA) aerosol inhaler.

Study Design

An administrative claims database was retrospectively examined from January 1, 2005 through June 30, 2008. Patients with mild asthma aged 12-65 years who were US residents and enrolled in their health plan for ≥1 year before and after the index date for MF-DPI or BDP-HFA treatment initiation were included (n = 1273 matched patients per cohort). Primary evaluations included the incidence of and time to any asthma exacerbations and several asthma exacerbation subtypes. Multivariate generalized linear regression modeling analyses were used to compare the postindex incidence of exacerbations between cohorts. Cox regression analyses were conducted to control for the impact of input variables and evaluate the time to exacerbations.

Results

Significantly fewer MF-DPI patients experienced an exacerbation compared with BDP-HFA patients (9.7% vs 11.5%, respectively; P = .0002). At all time points examined, fewer MF-DPI patients compared with BDP-HFA patients experienced any exacerbation or an exacerbation requiring inpatient hospitalization. The difference between cohorts in the incidence of inpatient exacerbations increased over time. MF-DPI patients experienced prolonged time to any asthma exacerbation (hazard ratio = 0.77; P = .0414) or exacerbations requiring inpatient hospitalization (hazard ratio = 0.51; P = .0191) compared with BDP-HFA patients.

Conclusion

These analyses suggest that patients (previously receiving asthma-related therapy) with mild asthma receiving MF-DPI are at lower risk for asthma exacerbations compared with those receiving BDP-HFA.

目的比较经干粉吸入器(MF-DPI)或双丙酸倍氯米松-氢氟烷烃(BDP-HFA)气溶胶吸入器开始使用糠酸莫米松治疗的轻度哮喘非控制者患者的急性发作发生率和发作时间。研究设计对2005年1月1日至2008年6月30日的行政索赔数据库进行回顾性检查。纳入在MF-DPI或BDP-HFA治疗起始指标日期前后参加健康计划≥1年的12-65岁美国居民轻度哮喘患者(每个队列n = 1273名匹配患者)。初步评估包括任何哮喘加重和几种哮喘加重亚型的发生率和时间。采用多元广义线性回归模型分析比较各队列间指数后加重发生率。进行Cox回归分析以控制输入变量的影响并评估到恶化的时间。结果:与BDP-HFA患者相比,MF-DPI患者的病情加重明显减少(分别为9.7%和11.5%;p = 0.0002)。在所有检查的时间点,与BDP-HFA患者相比,MF-DPI患者出现任何恶化或需要住院治疗的恶化。随着时间的推移,住院患者病情恶化发生率在队列之间的差异越来越大。MF-DPI患者哮喘发作时间延长(风险比= 0.77;P = 0.0414)或病情加重需要住院治疗(风险比= 0.51;P = 0.0191),与BDP-HFA患者相比。结论这些分析表明,与接受BDP-HFA治疗的患者相比,接受MF-DPI治疗的轻度哮喘患者哮喘加重的风险较低。
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引用次数: 1
An Editorial 一篇社论
Pub Date : 2010-12-01 DOI: 10.1016/j.ehrm.2010.09.001
Bryan R. Luce PhD, MBA (Associate Editor, Health Policy and Comparative Effectiveness)
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引用次数: 0
Development and Analysis of Item Response Theory-based Short-form Depression Severity Scales Based on the HDRS and MADRS 基于项目反应理论的基于HDRS和MADRS的短格式抑郁严重程度量表的编制与分析
Pub Date : 2010-12-01 DOI: 10.1016/j.ehrm.2009.11.001
Dennis A. Revicki PhD , Wen-Hung Chen PhD , Lori Frank PhD , Douglas Feltner MD , Robert Morlock PhD

Objectives

The Hamilton Depression Rating Scale (HDRS) is the most frequently used primary endpoint for antidepressant clinical trials. This study developed and evaluated the psychometric characteristics of 3 item response theory (IRT)-based short-form depression severity scales based on combinations of the HDRS and Montgomery-Asberg Depression Rating Scale (MADRS) items.

Study Design

A secondary analysis was completed using data from 1027 subjects with major depressive disorder participating in 2 antidepressant clinical trials. Data were collected using the HDRS and MADRS throughout the 6-week clinical trials. Maier, Bech, and Gibbons brief depression scales were calculated based on the HDRS.

Results

Three short-form depression severity (DS) scales were developed based on clinician recommendations and IRT analyses, (DS-1, 7 items; DS-2, 8 items; DS-3, 10 items). Internal consistency reliability of the short forms was 0.87 to 0.93. DS were more reliable across the range of the depression than the HDRS or MADRS. The DS scales were correlated 0.27 to 0.29 with HDRS, 0.55 to 0.85 with MADRS, and −0.25 to −0.34 with Quality of Enjoyment and Satisfaction Questionnaire scores at baseline. In 1 clinical trial, none of the depression outcome measures demonstrated statistically significant differences between the paroxetine and placebo groups. In the second clinical trial, there were significant between-group differences in DS-1 (P = .004; ES = 0.46), DS-2 (P <.001; ES = 0.59), DS-3 (P <.001; ES = 0.63), Bech (P = .007; ES = 0.43), Maier (P = .009; ES = 0.41), Gibbon (P = .003; ES = 0.47), HDRS (P = .007; ES = 0.43), and MADRS (P = .001; ES = 0.54) scores.

Conclusions

The IRT-based short-form depression measures were reliable, valid, and responsive in patients with major depressive disorder. Effect sizes were comparable or better to other depression severity scales.

汉密尔顿抑郁评定量表(HDRS)是抗抑郁药物临床试验中最常用的主要终点。本研究开发并评估了基于3项反应理论(IRT)的短格式抑郁严重程度量表的心理测量特征,该量表是基于HDRS和Montgomery-Asberg抑郁评定量表(MADRS)项目的组合。研究设计:采用1027名重度抑郁症患者参与2项抗抑郁药物临床试验的数据进行二次分析。在为期6周的临床试验中,使用HDRS和MADRS收集数据。Maier, Bech和Gibbons简要抑郁量表是基于HDRS计算的。结果根据临床医师建议和IRT分析,编制了3份简易抑郁严重程度量表(DS- 1,7项;DS-2, 8项;DS-3, 10项)。短表的内部一致性信度为0.87 ~ 0.93。在整个抑郁范围内,DS比HDRS或MADRS更可靠。DS量表与HDRS的相关性为0.27 ~ 0.29,与MADRS的相关性为0.55 ~ 0.85,与享受质量和满意度问卷基线得分的相关性为- 0.25 ~ - 0.34。在一项临床试验中,帕罗西汀组和安慰剂组之间没有抑郁结果测量显示统计学上的显著差异。在第二次临床试验中,DS-1组间差异有统计学意义(P = 0.004;ES = 0.46), DS-2 (P < 0.001;ES = 0.59), DS-3 (P <.001;ES = 0.63), Bech (P = .007;ES = 0.43), Maier (P = 0.009;ES = 0.41), Gibbon (P = 0.003;Es = 0.47), HDRS (p = 0.007;ES = 0.43), MADRS (P = .001;ES = 0.54)评分。结论基于irt的短格式抑郁测量在重度抑郁症患者中是可靠、有效和有效的。效应大小与其他抑郁严重程度量表相当或更好。
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引用次数: 3
Understanding Brain Damage and Sleep Apnea: A Review 理解脑损伤和睡眠呼吸暂停:综述
Pub Date : 2010-12-01 DOI: 10.1016/j.ehrm.2010.09.004
Susan Zafarlotfi PhD , Mohammed Quadri , Jacob Borodovsky

Sleep disturbances affect practically every segment of society, permeating across all ethnic, socioeconomic, and age groups. According to the American Academy of Sleep Medicine, there are more than 90 different sleep disorders. One of the most commonly diagnosed sleep disorders is sleep apnea. There are 3 types of sleep apnea: central, mixed, and obstructive sleep apnea (OSA). Sleep-disordered breathing is extremely prevalent in the brain-injured patient population. OSA is the most common type of apnea and is easily alleviated with continuous positive airway pressure. However, if left untreated, OSA can induce and exacerbate cognitive deficits and other metabolic disorders. It has been established that OSA is a risk factor for cerebrovascular accidents and cardiovascular outcomes. Patients with brain injury have existing lesions that are exposed to episodic/intermittent hypoxia if accompanied by OSA. The ubiquitous nature of OSA poses a threat to brain-injured patients, and treatment of sleep apnea is warranted to avoid further complications that might prolong recovery and time in rehabilitation. The purpose of this article is to increase awareness among physicians in order to improve the management of patients with brain injury and OSA. We will review the current concepts, prevalence, and ramifications of sleep apnea in brain-injured patients and their cognitive function.

睡眠障碍几乎影响到社会的每一个部分,渗透到所有种族、社会经济和年龄群体。根据美国睡眠医学学会的数据,有90多种不同的睡眠障碍。最常见的睡眠障碍之一是睡眠呼吸暂停。睡眠呼吸暂停有三种类型:中枢性、混合性和阻塞性睡眠呼吸暂停(OSA)。睡眠呼吸障碍在脑损伤患者中极为普遍。阻塞性睡眠呼吸暂停是最常见的呼吸暂停类型,通过持续气道正压很容易缓解。然而,如果不及时治疗,OSA会诱发并加剧认知缺陷和其他代谢紊乱。已经确定OSA是脑血管意外和心血管结局的危险因素。脑损伤患者存在病变,如果伴有OSA,则暴露于发作性/间歇性缺氧。阻塞性睡眠呼吸暂停的普遍性对脑损伤患者构成了威胁,治疗睡眠呼吸暂停是必要的,以避免可能延长恢复和康复时间的进一步并发症。本文的目的是提高医生对脑损伤和阻塞性睡眠呼吸暂停的认识,以改善对患者的管理。我们将回顾当前的概念,患病率和脑损伤患者的睡眠呼吸暂停及其认知功能的后果。
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引用次数: 4
Variations in CRC Screening Practice: Would This Patient Be Screened? CRC筛查实践的变化:该患者会被筛查吗?
Pub Date : 2010-12-01 DOI: 10.1016/j.ehrm.2010.09.002
Sarah B. Wackerbarth PhD , Yelena N. Tarasenko MPH, MPA , Jennifer M. Joyce MD , Steven A. Haist MD, MS, FACP

Purpose

Screening rates for colorectal cancer (CRC) in the United States were below the goal of 50% outlined in Healthy People 2010. Physician recommendation is an important predictor of patient compliance. We compared physician CRC screening decision processes (as depicted in decision trees) and examined how variations in decision processes affected decision outcomes. Further, we examined whether those variations could be attributed to physicians’ characteristics and guidelines’ utilization.

Methods

We conducted semi-structured interviews with primary care physicians, developed decision trees, compared trees, used trees to predict the recommendation for 8 sample patients, and used regression analysis to identify predictors of variation.

Results

Most of the physicians (77.3%) self-reported following clinical guidelines for CRC screening. Physicians considered an average of 5.9 decision criteria (range 2-12) in making their screening recommendations. Frequently cited criteria included patient age and family history. We documented variation for 3 of 8 sample patients. Regression analysis indicated that complexity of decision process, gender, age, and experience of physicians contributed to recommendations on screening. In addition, the self-report adherence to guidelines did not influence whether a physician would recommend CRC screening.

Conclusions

This study supports the notion that variation in practice is a function of decision processes. Therefore, studying decision processes may facilitate efforts to improve patient outcomes.

目的:美国结直肠癌(CRC)的筛查率低于《健康人》2010年概述的50%的目标。医生推荐是患者依从性的重要预测指标。我们比较了医生CRC筛查的决策过程(如决策树所示),并检查了决策过程的变化如何影响决策结果。进一步,我们检查了这些变化是否可以归因于医生的特点和指南的使用。方法对初级保健医生进行半结构化访谈,制定决策树,比较树,使用树预测8例样本患者的推荐,并使用回归分析确定变异的预测因子。结果77.3%的医生自我报告遵循了CRC筛查的临床指南。医生在提出筛查建议时平均考虑了5.9个决策标准(范围2-12)。常被引用的标准包括患者年龄和家族史。我们记录了8例样本患者中3例的变异。回归分析表明,决策过程的复杂性、性别、年龄和医生的经验对筛查建议有影响。此外,自我报告对指南的依从性并不影响医生是否会推荐CRC筛查。结论:本研究支持实践中的变化是决策过程的函数这一观点。因此,研究决策过程可能有助于改善患者的预后。
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引用次数: 0
Transcultural and Measurement Evaluation of the Asthma Quality-of-Life Questionnaire 哮喘生活质量问卷的跨文化及测量评估
Pub Date : 2010-12-01 DOI: 10.1016/j.ehrm.2010.09.003
Angela E. Williams BSc , Lydiane Agier MSc , Ingela Wiklund PhD , Lucy Frith MSc , Nadeem Gul MSc , Elizabeth Juniper MSc F

Objective

This analysis compared Asthma Quality-of-Life Questionnaire (AQLQ) data from across 16 countries (17 languages) to evaluate suitability to combine data in analyses.

Study Design

AQLQ data from the Gaining Optimal Asthma Control study was used for the analyses; 1832 patients had an overall AQLQ score at baseline and week 12. The original North American English version, for Canadian patients only, was the reference language (RL). AQLQ scores range from 1-7, where a high score indicates no impairment. Values within 0.5 of the RL were considered comparable.

Results

The number of patients varied from 27 (Canadian French) to 257 (Mandarin Chinese). Mean age ranged from 27.6 (Spain Spanish) to 52.9 years (Norway Norwegian). Mean overall AQLQ score (SD) at baseline in the RL was 4.59 (0.94). All but 3 languages reported scores within 0.5 of the RL. Mean change from baseline in the overall AQLQ score in the RL was 0.89 (1.06). Baseline overall AQLQ scores were all within 0.5 of the RL. Cronbach alpha ranged from 0.93 to 0.97 (RL 0.94). Correlation with baseline Asthma Control Questionnaire (ACQ) and the forced expiratory volume in 1 second (FEV1) ranged from −0.76 to −0.58 (RL −0.69) and −0.02 to 0.41 (RL 0.08), respectively. Similarly, correlations with change from baseline for ACQ and FEV1 ranged from −0.83 to −0.61 (RL −0.77) and −0.11 to 0.56 (RL 0.03). Effect sizes were all >0.50, ranging from 0.59 (Norway Norwegian) to 1.10 (New Zealand English) (RL 0.85).

Conclusions

The finding that internal consistency, construct validity, and responsiveness were demonstrated across languages and similar to the RL supports the combining of data for analyses.

目的本分析比较了来自16个国家(17种语言)的哮喘生活质量问卷(AQLQ)数据,以评估数据合并分析的适用性。研究设计:采用获得最佳哮喘控制研究的aqlq数据进行分析;1832例患者在基线和第12周时有总体AQLQ评分。最初的北美英语版本仅供加拿大患者使用,是参考语言(RL)。AQLQ得分在1-7分之间,得分高表示没有损伤。在RL的0.5以内的值被认为具有可比性。结果患者数量从27例(加拿大法语)到257例(普通话)不等。平均年龄为27.6岁(西班牙西班牙语)至52.9岁(挪威挪威语)。RL基线时平均AQLQ总分(SD)为4.59分(0.94分)。除了3种语言外,所有语言的分数都在RL的0.5以内。RL中AQLQ总分与基线相比的平均变化为0.89(1.06)。基线总体AQLQ得分均在RL的0.5以内。Cronbach alpha为0.93 ~ 0.97 (RL 0.94)。与基线哮喘控制问卷(ACQ)和1秒用力呼气量(FEV1)的相关性分别为- 0.76 ~ - 0.58 (RL - 0.69)和- 0.02 ~ 0.41 (RL 0.08)。同样,ACQ和FEV1与基线变化的相关性范围为- 0.83至- 0.61 (RL为- 0.77)和- 0.11至0.56 (RL为0.03)。效应量均为>0.50,范围从0.59(挪威挪威语)到1.10(新西兰英语)(RL 0.85)。结论内部一致性、构念效度和响应性在不同语言中都得到了证明,这一发现与RL相似,为数据的合并分析提供了支持。
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引用次数: 3
Readability and Missing Data Rates in CAHPS 2.0 Medicare Survey in African American and White Medicare Respondents CAHPS 2.0在非裔美国人和白人医疗保险调查对象中的可读性和数据缺失率
Pub Date : 2010-07-01 DOI: 10.1016/j.ehrm.2010.03.001
Marie Ngetiko Fongwa RN, MPH, PhD , Claude M. Setodji PhD , Sylvia H. Paz PhD , Leo S. Morales MD, PhD , W.N. Steers PhD , Ron D. Hays PhD

Purpose

To examine associations between readability of survey items and missing data rates in a sample of white and African-American Medicare enrollees in managed care plans.

Methods

Consumer Assessment of Healthcare Provider and Systems (CAHPS) 2.0 health plan survey data collected from 139,284 respondents (127,524 whites and 11,760 African Americans) in 321 health plans. Product-moment correlations were computed between Flesch-Kincaid (F-K) readability estimates and the CAHPS item-missing data rates.

Results

F-K reading levels for items ranged from 4.8 to 17.7 with a mean of 8.9 across items. Missing data rates ranged from 1% to 10%, with African Americans having significantly higher missing data rates. Correlations between missing data rates and item-level readability were statistically significant for whites (r = 0.33, P = .0515) and African Americans (r = 0.37, P = .0284).

Conclusions

The significant associations between missing data rates and item-level readability estimates indicate that the completion of survey items varies by their readability. Enhancing the readability of survey items can improve the inclusion of survey data collected from different respondents.

目的研究管理式医疗计划中白人和非裔美国医疗保险参保人样本中调查项目的可读性与数据缺失率之间的关系。方法采用消费者医疗服务提供者和系统评估(CAHPS) 2.0健康计划调查数据,收集321个健康计划的139284名受访者(127524名白人和11760名非裔美国人)。计算Flesch-Kincaid (F-K)可读性估计与CAHPS项目缺失数据率之间的积矩相关性。结果f - k阅读水平在4.8 - 17.7之间,平均8.9。数据丢失率从1%到10%不等,非裔美国人的数据丢失率要高得多。在白人(r = 0.33, P = .0515)和非裔美国人(r = 0.37, P = .0284)中,缺失数据率与项目水平可读性之间的相关性具有统计学意义。结论数据缺失率与项目可读性之间的显著关联表明,调查项目的完成程度因其可读性而异。提高调查项目的可读性可以提高从不同受访者收集的调查数据的包容性。
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引用次数: 7
The Effect of the Vermont Diabetes Information System on Inpatient and Emergency Department Use: Results from a Randomized Trial 佛蒙特州糖尿病信息系统对住院和急诊科使用的影响:一项随机试验的结果
Pub Date : 2010-07-01 DOI: 10.1016/j.ehrm.2010.03.002
Shamima Khan MBA, PhD , Charles D. MacLean MDCM , Benjamin Littenberg MD

Objective

To describe the effect of the Vermont Diabetes Information System (VDIS) on hospital and emergency department use.

Data Source

Statewide discharge database.

Study Design

Randomized controlled trial of a decision support system for 7412 adults with diabetes and their 64 primary care providers.

Data Collection/Data Extraction

Charges and dates for hospital admissions and emergency department care in Vermont during an average of 32 months of observation. Data from New York hospitals were not available.

Results

Patients randomized to VDIS were admitted to the hospital less often than control subjects (0.17 admissions vs 0.20; P = .01) and generated lower hospital charges ($3113 vs $3480; P = .019). VDIS patients also had lower emergency department utilization (0.27 visits vs 0.36; P <.0001) and charges ($304 vs $414; P <.0001). The intervention was particularly effective in men and in older subjects.

Conclusions

Despite data limitations that tended to reduce the apparent effect of the system, this randomized, controlled trial showed that VDIS reduces hospitalization and emergency department utilization and expenses.

目的探讨佛蒙特州糖尿病信息系统(VDIS)在医院和急诊科的应用效果。数据源全州排放数据库。研究设计:对7412名成年糖尿病患者及其64名初级保健提供者进行决策支持系统的随机对照试验。数据收集/数据提取佛蒙特州平均32个月观察期间住院和急诊护理的费用和日期。纽约医院的数据无法获得。结果随机分配到VDIS组的患者入院次数低于对照组(0.17次vs 0.20次;P = 0.01),并产生较低的医院费用(3113美元对3480美元;p = .019)。VDIS患者急诊科使用率也较低(0.27次vs 0.36次;P < 0.0001)和收费(304美元vs 414美元;P & lt;。)。这种干预对男性和老年受试者尤其有效。结论:尽管数据限制可能会降低该系统的明显效果,但这项随机对照试验表明,VDIS降低了住院和急诊科的使用率和费用。
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引用次数: 24
Preferences of Patients and Oncologists for Advanced Ovarian Cancer Treatment-Related Health States 晚期卵巢癌患者和肿瘤学家对治疗相关健康状态的偏好
Pub Date : 2010-07-01 DOI: 10.1016/j.ehrm.2010.02.001
Lisa M. Hess PhD , Daniel C. Malone PhD , Pamela G. Reed PhD , Grant Skrepnek PhD , Karen Weihs MD

Purpose

The purpose of this study was to compare expected utility preferences of various health outcomes of chemotherapy treatment among ovarian-cancer patients receiving chemotherapy, ovarian cancer patients who were post-treatment (eg, under surveillance), and oncologists who treat this disease.

Methods

Participants were asked to score 6 hypothetical ovarian cancer treatment-related health states using both a rating scale and the standard gamble. Scores were obtained in the range of 0.0 (death) to 1.0 (perfect health) for each hypothetical health state, with a difference of 0.10 being practically meaningful, and were analyzed by analysis of variance.

Results

Seventy-five eligible participants were included in this study (41 ovarian-cancer patients and 34 oncologists). Patients and physicians reported similar responses in the rating scale exercise (F = 0.854, P = .43). However, when the health states were presented with an element of uncertainty via the standard gamble exercise, patients who were under surveillance reported significantly different expected utilities of the health states from physicians and from patients who were receiving treatment, demonstrating greater risk aversion than the other groups (F = 4.270, P = .018).

Conclusions

This study suggests that there are significant differences in expected utility preferences among patients who are under surveillance as opposed to oncologists or patients receiving treatment, despite similarities in rating scale values. These findings suggest a need to further evaluate these differences in expected utility preferences in the context of decision in the setting of recurrent disease, where a patient under surveillance must make decisions related to re-initiation of therapy at a time when her preferences are likely to significantly differ from those of oncologists.

目的本研究的目的是比较接受化疗的卵巢癌患者、治疗后(如在监测下)的卵巢癌患者和治疗该疾病的肿瘤学家对化疗各种健康结果的预期效用偏好。方法要求参与者使用评定量表和标准赌博对6种假设的卵巢癌治疗相关健康状态进行评分。每个假设健康状态的得分范围为0.0(死亡)至1.0(完全健康),差异为0.10为有实际意义,并通过方差分析进行分析。结果本研究纳入75名符合条件的参与者(41名卵巢癌患者和34名肿瘤学家)。患者和医生在评定量表运动中报告的反应相似(F = 0.854, P = 0.43)。然而,当健康状态通过标准赌博练习呈现不确定因素时,接受监测的患者报告的健康状态预期效用与医生和接受治疗的患者显著不同,表现出比其他组更大的风险厌恶(F = 4.270, P = 0.018)。本研究表明,尽管评分量表值相似,但在接受监测的患者与肿瘤学家或接受治疗的患者之间,预期效用偏好存在显著差异。这些发现表明,有必要进一步评估在复发性疾病决策背景下预期效用偏好的差异,在这种情况下,接受监测的患者必须在她的偏好可能与肿瘤学家的偏好显著不同的时候做出与重新开始治疗相关的决定。
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引用次数: 6
The Momentum for Health Outcomes Research in Medicine 医学健康结果研究的势头
Pub Date : 2010-07-01 DOI: 10.1016/j.ehrm.2010.07.001
Donald E. Stull PhD (Editor-in-Chief)
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引用次数: 0
期刊
Health outcomes research in medicine
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