Health outcomes research in medicine最新文献

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The Relationship of Opioid Analgesia to Quality of Life in an Adult Sickle Cell Population 成人镰状细胞患者阿片类镇痛与生活质量的关系

Health outcomes research in medicine

Pub Date : 2010-07-01 DOI: 10.1016/j.ehrm.2010.04.002

Soheir S. Adam MD, Marilyn J. Telen MD, Charles R. Jonassaint PhD, Laura M. De Castro MD, Jude C. Jonassaint RN

Background

Pain is a limiting factor in the daily life activities of sickle cell disease (SCD) patients. Although opioid analgesics are widely used, to date there have been no studies on the relationship of daily opioid use to quality of life (QoL) measures in this population.

Objective

To determine the relationship of opioid analgesia to QoL in adults with SCD.

Design

There were 185 outpatients with various SCD genotypes evaluated. Data were collected by patient interviews as well as review of medical records. QoL as determined by the Medical Outcome Study 36-item Short Form Survey (SF-36) was the main outcome measured.

Results

QoL outcomes were not lower in the classically more severe homozygous SS individuals when compared with the heterozygous SC patients. However, SF-36 scores were significantly lower in individuals using opioids daily compared with those who did not, in all age groups and for all diagnoses. When controlling for hydroxyurea use, the negative association between opioid use and QoL scores remained unchanged. QoL scores were significantly higher in those who were either on no medications or on hydroxyurea alone, as compared with those who were on opioids alone or on hydroxyurea and opioids concurrently. Disease severity scores were not different between medication groups.

Conclusions

SCD patients on daily opioids had poorer QoL scores than those who were not on opioids, independent of disease severity. Hydroxyurea had a positive impact on QoL, although that effect was not observed in patients also using chronic opioids. Prospective studies are needed to define the relationship of opioid use to QoL and the significance of the interaction of both drugs in SCD.

背景:疼痛是镰状细胞病(SCD)患者日常生活活动的限制因素。尽管阿片类镇痛药被广泛使用，但迄今为止，还没有关于阿片类药物每日使用与这一人群生活质量(QoL)测量之间关系的研究。目的探讨成人SCD患者阿片类镇痛与生活质量的关系。设计对185例不同SCD基因型的门诊患者进行评估。数据是通过与患者面谈以及查阅医疗记录收集的。医学结果研究36项简短问卷调查(SF-36)确定的生活质量是测量的主要结果。结果典型重度纯合子SS患者的生活质量不低于杂合子SC患者。然而，在所有年龄组和所有诊断中，每天使用阿片类药物的个体的SF-36评分明显低于不使用阿片类药物的个体。在控制羟基脲使用时，阿片类药物使用与生活质量评分之间的负相关关系保持不变。与单独使用阿片类药物或同时使用羟基脲和阿片类药物的患者相比，不使用药物或单独使用羟基脲的患者的生活质量评分明显更高。不同用药组的疾病严重程度评分无差异。结论与疾病严重程度无关，每日服用阿片类药物的scd患者的生活质量评分较不服用阿片类药物的患者差。羟基脲对生活质量有积极影响，尽管在同时使用慢性阿片类药物的患者中没有观察到这种影响。需要前瞻性研究来确定阿片类药物使用与生活质量的关系以及两种药物在SCD中的相互作用的意义。

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引用次数: 5

COPD and Asthma Fatigue Scale (CAFS): Development and Psychometric Assessment 慢性阻塞性肺病和哮喘疲劳量表(CAFS):发展和心理测量评估

Health outcomes research in medicine

Pub Date : 2010-07-01 DOI: 10.1016/j.ehrm.2010.06.001

Dennis A. Revicki PhD , David M. Meads MSc , Stephen P. McKenna PhD , Rupert Gale MA , G. Alistair Glendenning MSc , Robin F. Pokrzywinski MHA

Objectives

Patients with respiratory diseases report significant fatigue, but few measures have been developed to assess respiratory disease-related fatigue in patients with either asthma or chronic obstructive pulmonary disease (COPD). This study developed and evaluated the psychometric characteristics of the COPD and Asthma Fatigue Scale (CAFS), a respiratory disease-targeted scale.

Study Design

Patient qualitative data (focus groups and individual interviews) with COPD and asthma patients were used to generate the CAFS. An observational study involving patients with asthma or COPD from the US and UK was then conducted to assess the psychometric qualities of the CAFS. COPD patients completed the St. George’s Respiratory Questionnaire, asthma patients completed the Asthma Quality of Life Questionnaire, and selected clinical severity measures were collected for all patients.

Results

Qualitative data were obtained from 78 patients with COPD and 84 with asthma. The observational study included 311 patients with COPD and 324 with asthma. The final 12-item CAFS was confirmed based on factor and item analyses. Internal consistency was 0.95 (both groups) and test-retest reliability was 0.82 and 0.84 (COPD and asthma, respectively). In COPD patients, CAFS scores were significantly correlated with St. George’s Respiratory Questionnaire scores (P <.0001); mean CAFS scores varied significantly by disease severity, exacerbations, and health status (P ≤.0014). In asthma patients, CAFS scores were significantly correlated with Asthma Quality of Life Questionnaire scores (P <.0001); mean CAFS scores varied significantly by disease severity, exacerbations, and health status (all P ≤.0024).

Conclusions

The CAFS was developed using systematic qualitative and psychometric methods and is a reliable and valid measure of fatigue in asthma or COPD patients.

呼吸系统疾病患者报告明显的疲劳，但很少有措施来评估哮喘或慢性阻塞性肺疾病(COPD)患者的呼吸系统疾病相关疲劳。本研究开发并评估了慢性阻塞性肺病和哮喘疲劳量表(CAFS)的心理测量特征，这是一种针对呼吸系统疾病的量表。研究设计使用COPD和哮喘患者的定性数据(焦点小组和个人访谈)来生成CAFS。一项涉及美国和英国哮喘或慢性阻塞性肺病患者的观察性研究随后进行，以评估CAFS的心理测量质量。COPD患者填写St. George’s Respiratory Questionnaire，哮喘患者填写asthma Quality of Life Questionnaire，收集所有患者的选定临床严重程度测量值。结果78例COPD患者和84例哮喘患者获得了定性数据。这项观察性研究包括311名COPD患者和324名哮喘患者。通过因子分析和项目分析，确定了最终的12项CAFS。内部一致性为0.95(两组)，重测信度分别为0.82和0.84 (COPD和哮喘)。在COPD患者中，CAFS评分与圣乔治呼吸问卷评分显著相关(P <.0001);CAFS平均评分因疾病严重程度、恶化程度和健康状况而有显著差异(P≤0.0014)。在哮喘患者中，CAFS评分与哮喘生活质量问卷评分显著相关(P <.0001);CAFS平均评分因疾病严重程度、恶化情况和健康状况而有显著差异(P≤0.0024)。结论CAFS采用系统的定性和心理测量方法，是一种可靠、有效的哮喘或COPD患者疲劳测量方法。

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引用次数: 19

Validation of the Modified Brief Pain Inventory-Exploratory Form in Surgery Patients 改良的简易疼痛调查表-探查表在外科患者中的验证

Health outcomes research in medicine

Pub Date : 2010-07-01 DOI: 10.1016/j.ehrm.2010.04.001

Wen-Hung Chen PhD , Kitty S. Chan PhD , Tong J. Gan MD , Connie Chen PharmD , Mani Lakshminarayanan PhD , Dennis A. Revicki PhD

Objective

An exploratory version of the Modified Brief Pain Inventory (mBPI-e) to measure acute post-operative pain, with new items on coughing, breathing, and concentration, was examined for their measurement properties.

Study Design

This is a secondary study using data from two randomized clinical trials: general surgery trial (N=1050) and coronary artery bypass graft (CABG) surgery trial (N=1636). The measurements used in the two trials were: 1) mBPI-e; 2) clinician and patient global evaluations of medications; and 3) pain intensity diary. The mBPI-e and pain intensity were collected for 10 days. Clinician and patient global evaluations of medication were collected twice. The analyses conducted were: 1) exploratory factor analysis (EFA); 2) confirmatory factor analysis (CFA); 3) item response theory (IRT); 4) internal consistency; 5) test-retest reliability; 6) concurrent validity; 7) known-group validity; and 8) responsiveness.

Results

Pain severity, pain interference, and coughing and breathing factors were identified. Pain severity and pain interference subscale scores were constructed for mBPI-e. IRT analyses showed all items exhibited good item characteristics. Internal consistency was 0.85 for severity and 0.87 for interference. Test-retest reliability was 0.81 for severity and 0.71 for interference. Both severity and interference scores were correlated with diary-based pain intensity ratings (P <.0001). Mean severity and interference scores varied by physician and patient global ratings (P <.05). Severity and interference scores were responsive to changes in pain diary scores and physician global ratings (P <.001). There were no substantive differences in reliability or validity for sub-samples of surgery patients.

Conclusions

The original BPI has been used in clinical studies, and the mBPI has demonstrated good reliability and validity in CABG patients. Based on this study, the mBPI-e has also demonstrated good reliability and validity for assessing postoperative acute pain in CABG and general surgery patients.

目的探讨改进的简易疼痛量表(mBPI-e)在增加咳嗽、呼吸、注意力集中等项目后，测量急性术后疼痛的性能。这是一项二级研究，数据来自两项随机临床试验:普通外科试验(N=1050)和冠状动脉旁路移植术(CABG)手术试验(N=1636)。两项试验中使用的测量方法为:1)mBPI-e;2)临床医生和患者对药物的整体评价;3)疼痛强度日记。连续10 d采集mBPI-e和疼痛强度。收集两次临床医生和患者对药物的总体评价。分析方法:1)探索性因子分析(EFA);2)验证性因子分析(CFA);项目反应理论(IRT);4)内部一致性;5)重测信度;6)同时有效;7)已知组效度;还有反应能力。结果确定了西班牙严重程度、疼痛干扰、咳嗽和呼吸因素。对mBPI-e进行疼痛严重程度和疼痛干扰分量表评分。IRT分析显示所有项目都表现出良好的项目特征。内部一致性的严重性为0.85，干扰为0.87。严重性的重测信度为0.81，干扰的重测信度为0.71。严重程度和干扰评分均与基于日记的疼痛强度评分相关(P <.0001)。平均严重程度和干扰评分因医生和患者总体评分而异(P < 0.05)。严重程度和干扰评分对疼痛日记评分和医生总体评分的变化有反应(P <.001)。手术患者的子样本在信度和效度上没有实质性差异。结论原始BPI已用于临床研究，mBPI在CABG患者中表现出良好的信度和效度。基于本研究，mBPI-e在评估CABG和普外科患者术后急性疼痛方面也显示出良好的信度和效度。

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引用次数: 3

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