Patient-reported outcome

患者报告的结果
  • 文章类型: Journal Article
    慢性咳嗽,持续超过8周的咳嗽,包括难治性慢性咳嗽(RCC)和原因不明的慢性咳嗽(UCC)。需要通过患者报告结果(PRO)来更好地了解对患者最重要的慢性咳嗽影响。19项莱斯特咳嗽问卷(LCQ),现有的慢性咳嗽的PRO措施,评估咳嗽对身体的影响,心理,和社会领域。然而,LCQ在RCC/UCC患者中评估这些概念的内容效度尚未确定.
    评估LCQ在RCC/UCC患者中的内容效度。
    横截面,定性访谈研究。
    首先,评估了先前完成的RCC/UCC成人(N=30)的定性访谈结果,并将其映射到LCQ概念.接下来,临床咳嗽专家审查了每个LCQ项目,并评估了其概念对RCC/UCC患者的重要性。最后,在患有RCC/UCC(N=20)的成年人中进行了半结构化访谈,包括概念启发和认知汇报,以引出一组全面的参与者经验,并评估在该人群中使用LCQ的适当性.
    过去和现在的定性访谈报告的概念包括在所有LCQ项目中,LCQ评估了大多数报告为“最麻烦”的影响。在目前的研究中,所有参与者均表示,减少咳嗽频率将是一个重要的治疗目标.在认知汇报期间,每个LCQ项目都得到70%的参与者的认可。此外,参与者通常能够理解,召回,并为每个LCQ项目选择一个响应。所有参与者和临床专家都表示LCQ是适当的,并评估了与RCC/UCC患者最相关的影响。
    我们的发现支持LCQ的内容有效性,并证明该措施适合目的,并且包括RCC/UCC成人的重要咳嗽影响。
    UNASSIGNED: Chronic cough, a cough lasting >8 weeks, includes refractory chronic cough (RCC) and unexplained chronic cough (UCC). Patient-reported outcome (PRO) measures are needed to better understand chronic cough impacts that matter most to patients. The 19-item Leicester Cough Questionnaire (LCQ), an existing PRO measure of chronic cough, assesses impacts of cough across physical, psychological, and social domains. However, the content validity of the LCQ evaluating these concepts in patients with RCC/UCC had not been established.
    UNASSIGNED: To evaluate the content validity of the LCQ in patients with RCC/UCC.
    UNASSIGNED: A cross-sectional, qualitative interview study.
    UNASSIGNED: First, previously completed qualitative interview results in adults with RCC/UCC (N = 30) were evaluated and mapped to LCQ concepts. Next, a clinical cough expert reviewed each LCQ item and assessed the salience of its concepts for patients with RCC/UCC. Finally, semistructured interviews-including both concept elicitation and cognitive debriefing-were conducted in adults with RCC/UCC (N = 20) to elicit a comprehensive set of participant experiences and to assess the appropriateness of using the LCQ in this population.
    UNASSIGNED: Concepts reported in the past and present qualitative interviews were included across all LCQ items, and most impacts reported to be the \"most bothersome\" were assessed in the LCQ. In the current study, all participants indicated that reduced cough frequency would be an important treatment target. During cognitive debriefing, each LCQ item was endorsed by ⩾70% of participants. Additionally, participants were generally able to understand, recall, and select a response for each LCQ item. All participants and the clinical expert indicated that the LCQ was appropriate and assessed the impacts most relevant to patients with RCC/UCC.
    UNASSIGNED: Our findings support the content validity of the LCQ and demonstrate that this measure is fit-for-purpose and includes important cough impacts in adults with RCC/UCC.
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  • 文章类型: Journal Article
    背景:计算机自适应测试(CAT)是减少时间的有效方法,重复冗余,和回应负担,并已被用于衡量许多疾病的结果。这项研究旨在开发和验证针对慢性阻塞性肺疾病(COPD)患者报告的综合疾病特异性CAT结果测量。
    方法:使用项目反应理论分析改良的COPD患者报告结果量表(mCOPD-PRO)中项目的区分度和难度。然后是最初的项目,项目选择方法,能力估计方法,并根据协奏曲平台进一步设定了停止标准以形成CAT。最后,信度和效度得到验证。
    结果:项目区分范围为1.05至2.71,项目难度范围为-3.08至3.65。使用随机方法,CAT的测量可靠性范围为0.910至0.922,而使用最大Fisher信息(MFI)方法的范围为0.910至0.924。内容有效性良好。CAT和COPD评估测试的θ与采用随机方法的改良医学研究理事会呼吸困难量表评分之间的相关系数分别为0.628和0.540(P<0.001;P<0.001)。而MFI法分别为0.347和0.328(P=0.007;P=0.010)。使用随机方法对大约11个项目(平均减少59.3%)进行了测试,而使用MFI方法平均约有7个项目(减少74.1%)。随机法检测CAT与mCOPD-PRO总分θ的相关系数为0.919(P<0.001),而MFI方法为0.760(P<0.001)。
    结论:COPD患者报告的综合疾病特异性CAT结果测量具有良好的心理测量学特性,它可以提供有效的,准确,和用户友好的测量患者报告的COPD的结果。
    BACKGROUND: Computerized adaptive testing (CAT) is an effective way to reduce time, repetitious redundancy, and respond burden, and has been used to measure outcomes in many diseases. This study aimed to develop and validate a comprehensive disease-specific CAT for chronic obstructive pulmonary disease (COPD) patient-reported outcome measurement.
    METHODS: The discrimination and difficulty of the items from the modified patient-reported outcome scale for COPD (mCOPD-PRO) were analyzed using item response theory. Then the initial item, item selection method, ability estimation method, and stopping criteria were further set based on Concerto platform to form the CAT. Finally, the reliability and validity were validated.
    RESULTS: The item discrimination ranged from 1.05 to 2.71, and the item difficulty ranged from - 3.08 to 3.65. The measurement reliability of the CAT ranged from 0.910 to 0.922 using random method, while that ranged from 0.910 to 0.924 using maximum Fisher information (MFI) method. The content validity was good. The correlation coefficient between theta of the CAT and COPD assessment test and modified Medical Research Council dyspnea scale scores using random method was 0.628 and 0.540 (P < 0.001; P < 0.001) respectively, while that using MFI method was 0.347 and 0.328 (P = 0.007; P = 0.010) respectively. About 11 items (reducing by 59.3%) on average were tested using random method, while about seven items (reducing by 74.1%) on average using MFI method. The correlation coefficient between theta of the CAT and mCOPD-PRO total scores using random method was 0.919 (P < 0.001), while that using MFI method was 0.760 (P < 0.001).
    CONCLUSIONS: The comprehensive disease-specific CAT for COPD patient-reported outcome measurement is well developed with good psychometric properties, which can provide an efficient, accurate, and user-friendly measurement for patient-reported outcome of COPD.
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  • 文章类型: Journal Article
    背景:缺乏关于孤立的脊柱损伤后业余运动员恢复运动和患者报告结果测量(PROM)的信息。
    方法:在18至60岁的业余运动员中进行单中心队列研究,其中包括孤立的脊柱损伤;通过电话访谈和标准化的PROM(简短表格36,Oswestry和颈部残疾指数,运动恐惧症的坦帕量表,医院焦虑抑郁量表,疼痛视觉模拟量表)。使用Wilcoxon符号秩检验对PROM的潜在影响因素进行了双变量分析。P值<0.05被认为是统计学上显著的。
    结果:在80名参与者中,78%(n=62)在随访中活跃于运动。PROM比年龄调整后的普通人群描述的要差一点。更好的PROM与达到运动中的主观伤害前表现水平有一致的关联,虽然损伤严重程度和手术或保守治疗与PROM没有一致的关联。
    结论:大多数业余运动员在脊柱损伤后恢复运动。更好的结果与个人恢复运动和主观表现水平有关,虽然损伤严重程度和手术或保守治疗与PROM没有一致的关联,强调病人教育的重要性,康复,和鼓励。
    BACKGROUND: There is a lack of information on return to sport and patient-reported outcome measures (PROMs) in amateur athletes after isolated spine injuries.
    METHODS: A single-center cohort study in amateur athletes aged 18 to 60 with isolated spine injuries; clinical data collection and follow-up via telephone interview and standardized PROMs (Short-Form 36, Oswestry and Neck Disability Index, Tampa Scale of Kinesiophobia, Hospital Anxiety and Depression Scale, Pain Visual Analog Scale). Bivariate analyses of potential influencing factors on PROMs were conducted using the Wilcoxon Signed-Rank Test. p-values < 0.05 were considered statistically significant.
    RESULTS: Out of the 80 included participants, 78% (n = 62) were active in sport at follow-up. PROMs were slightly worse than those described for the age-adjusted general population. There were consistent associations of better PROMs with having reached the subjective preinjury level of performance in sport, while injury severity and surgical or conservative therapy did not show consistent associations with PROMs.
    CONCLUSIONS: Most amateur athletes resume their sports activity after a spine injury. Better outcomes are associated with individuals\' resumption of sport and subjective level of performance, while injury severity and surgical or conservative therapy do not show consistent associations with PROMs, highlighting the importance of patient education, rehabilitation, and encouragement.
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  • 文章类型: Journal Article
    肿瘤整形手术已成为手术方案的重要组成部分,为乳腺癌患者提供肿瘤安全和美观的结果。比较肿瘤整形和重建乳房手术的数据有限。这项研究旨在评估我们的肿瘤增生和重建手术患者队列中患者报告的结果(PRO)。
    接受肿瘤整形手术的患者,包括由一名外科医生立即重建,在2010年至2018年期间,我们联系了参与这项研究。总的来说,157例患者符合纳入标准。54个患者数据集用于统计评估。身体形象量表(BIS)和BreastQ问卷用于测量主观PRO得分,使用乳房分析工具(BAT)拍摄照片以客观地测量对称性。根据Tübingen分类将患者分为三组(第1组:Tübingen3-4(n=16),组2:图宾根5(n=26),组3:乳房重建/Tübingen6(n=12)。
    第1组的平均年龄为53.5岁,第2组的平均年龄为51.4岁,第3组的平均年龄为46.8岁。平均随访62.9±35.82个月。第3组的BIS(3.92±1.73)明显优于第1组和第2组(7.69±4.48和4.81±3.41,p=0.016)。使用BAT测量的对称性仅显示出有利于重建的趋势(p=0.12)。BreastQ项目“性幸福感”在肿瘤性乳房缩小手术中明显更好(p=0.036)。
    乳房再造手术后BIS比肿瘤整形手术后更好。在经验丰富的乳房护理单位重建乳房手术提供了很高的患者满意度和高质量的生活。
    UNASSIGNED: Oncoplastic surgery has become an important part of the surgical repertoire to offer both oncologically safe and aesthetically pleasing results in patients with breast cancer. Data comparing oncoplastic and reconstructive breast surgeries are limited. This study aimed to assess patient-reported outcomes (PRO) in our cohort of oncoplastic and reconstructively operated patients.
    UNASSIGNED: Patients who underwent oncoplastic surgery, including immediate reconstruction by a single surgeon, between 2010 and 2018 were contacted to participate in this study. In total, 157 patients fulfilled the inclusion criteria. 54 patient data sets were used for statistical evaluation. Body Image Scale (BIS) and BreastQ questionnaires were used to measure subjective PRO scores, and pictures were taken to objectively measure symmetry using the Breast Analyzing Tool (BAT). Patients were divided into three groups according to the Tübingen classification (group 1: Tübingen 3-4 (n = 16), group 2: Tübingen 5 (n = 26), group 3: Breast Reconstruction/Tübingen 6 (n = 12]).
    UNASSIGNED: The mean age was 53.5 for group 1, 51.4 for group 2 and 46.8 for group 3. The mean follow-up was 62.9 ± 35.82 months. BIS was significantly better in group 3 (3.92 ± 1.73) than in group 1 and 2 (7.69 ± 4.48 and 4.81 ± 3.41, p = 0.016). Symmetry measured using BAT showed only a trend favoring reconstruction (p = 0.12). The BreastQ item \"Sexual well-being\" was significantly better in oncoplastic breast reduction surgery (p = 0.036).
    UNASSIGNED: BIS was better after reconstructive breast surgery than after oncoplastic surgery. Reconstructive breast surgery in experienced breast care units offers high patient satisfaction and a high quality of life.
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  • 文章类型: Journal Article
    基于植入物的乳房重建(IBR),乳房切除术后,显著影响患者的生活质量(QoL),需要通过心理上强大的患者报告结果测量(PROM)工具进行准确的测量。此文献计量分析旨在辨别趋势,找出差距,并评估IBR文献中此类工具的使用情况。
    在WebofScience上确定了关于基于植入物的重建中QoL的100篇引用最多的出版物,在2024年3月10日所有可用的期刊年(从1977年到2024年)。研究详情,包括引文计数,主要内容重点,结果衡量标准,以及心理问卷的使用,从每个出版物中提取并列出。牛津循证医学中心(OCEBM)对每项研究的证据水平(LOE)进行评估。
    确定了关于QoL在基于植入物的重建中引用最多的100种出版物,包括64,192例患者和28,114例重建乳房。每篇出版物的引文范围从62到457(平均值,124.95±73.05),引用次数最多的研究由Al-Ghazal撰写(n=457)。绝大多数出版物是LOEII(n=52),前瞻性队列研究的代表,非随机研究的系统评价,系统评价和荟萃分析。LOEV的出版物数量,IV,III,我分别为0、7、41和0。83种出版物的主要内容重点是"生活质量",显著利用了BREAST-Q问卷。共有80种出版物使用了经过验证的具有心理测量学发展的问卷。
    此分析表明,IBR内部的研究方法主要由中等质量的出版物组成;但是,特别是,我缺乏LOE研究,强调了该领域内高质量研究的差距。此外,只有62/100使用经过验证的PROM工具。未来的IBR研究应该集中在最可靠的方法上,结合经过验证的PROM工具,优化共享决策和知情同意。
    UNASSIGNED: Implant-based breast reconstruction (IBR), following mastectomy, significantly impacts patients\' quality of life (QoL), necessitating accurate measurement through psychometrically robust patient-reported outcome measure (PROM) tools. This bibliometric analysis aims to discern trends, identify gaps, and evaluate the use of such tools in the IBR literature.
    UNASSIGNED: The 100 most cited publications regarding QoL in implant-based reconstruction were identified on Web of Science, across all available journal years (from 1977 to 2024) on 10 March 2024. Study details, including the citation count, main content focus, outcome measures, and usage of psychological questionnaires, were extracted and tabulated from each publication. The Oxford Centre for Evidence-Based Medicine (OCEBM) levels of evidence (LOE) of each study were assessed.
    UNASSIGNED: The 100 most cited publications on QoL in implant-based reconstruction were identified, encompassing 64,192 patients and 28,114 reconstructed breasts. Citations per publication ranged from 62 to 457 (mean, 124.95 ± 73.05), with the highest-cited study being authored by Al-Ghazal (n = 457). The vast majority of publications were LOE II (n = 52), representative of prospective cohort studies, systematic reviews of non-randomised studies, and systematic review and meta-analysis. The number of publications for LOE V, IV, III, and I was 0, 7, 41, and 0, respectively. The main content focus was \"quality of life\" in 83 publications, with significant utilisation of the BREAST-Q questionnaire. A total of 80 publications used validated questionnaires with psychometric development.
    UNASSIGNED: This analysis demonstrates that the research methodologies within IBR mostly consist of moderate-quality publications; however, notably, there was a lack of LOE I studies, underscoring a gap in high-quality research within the field. Moreover, only 62/100 used validated PROM tools. Future IBR research studies should be focussed on most robust methodologies, incorporating validated PROM tools, to optimise shared-decision making and informed consent.
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  • 文章类型: Journal Article
    背景:高架运动员经常在极限运动范围内的位置进行快速而有力的投掷高架击球,增加上肢损伤的风险。Kerlan-Jobe骨科诊所(KJOC)肩肘评分已被证明是有效且可靠的问卷,可用于评估参与高要求高架运动的患者上肢的功能状态。然而,KJOC已被翻译成其他几种语言,希腊版本的KJOC尚不可用。方法:KJOC将按照国际准则在跨文化上适应希腊语。将招募至少100名有或没有肩膀或肘部投诉的头顶运动员,并要求他们两次填写希腊语版本的KJOC和手臂残疾,肩手问卷(DASH)一次。内部一致性和重测可靠性将使用Cronbach的α和组内相关系数(ICC)进行检查,分别。将计算测量的标准误差(SEM)和最小可检测变化(MDC),并检查可能的地面或天花板效应。将使用Pearson的相关性与希腊DASH评估收敛有效性。结果:这项研究的结果将在稍后发表的文章中发表。结论:本报告描述了KJOC希腊语版本的翻译和跨文化适应过程。我们相信研究方案将有助于该领域的研究人员改善类似研究的报告,从而提高研究质量。
    Background: Overhead athletes frequently perform rapid and powerful throwing overhead strokes in positions at the extreme range of motion, increasing the risk of upper limb injury. The Kerlan-Jobe Orthopedic Clinic (KJOC) Shoulder and Elbow Score has shown to be a valid and reliable questionnaire that can be used for the assessment of the functional status of the upper limb of patients involved in highly demanding overhead sports. The KJOC has been translated into several other languages however, a Greek version of the KJOC is not available yet. Methods: The KJOC will be cross-culturally adapted into Greek following international guidelines. At least 100 overhead athletes with or without shoulder or elbow complaints will be recruited and asked to fill in the Greek version of the KJOC twice and the Disabilities of Arm, Shoulder and Hand Questionnaire (DASH) once. The internal consistency and the test-retest reliability will be examined using Cronbach\'s alpha and the intraclass correlation coefficient (ICC), respectively. The standard error of measurement (SEM) and the minimum detectable change (MDC) will be calculated and possible ground or ceiling effects will be also examined. Convergent validity will be evaluated with the Greek DASH using Pearson\'s correlation. Results: The results of this study will be presented in an article to be published later. Conclusions: This report describes the process of translation and cross cultural adaptation of the Greek version of the KJOC. We believe a study protocol will assist researchers in the field to improve the reporting of similar studies and as a result improve the quality of their studies.
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  • 文章类型: Journal Article
    背景:我们旨在评估土耳其语版本的患者报告的痉挛影响测量(PRISM-TR)的有效性和可靠性。
    方法:使用专家意见和前后翻译方法进行语言验证。进行了Cronbachα和重测分析,以进行可靠性分析。PRISM-TR与改良阿什沃思量表(MAS)的相关性,数值评级量表(NRS),并评估了扩展的残疾状况量表(EDSS)。
    结果:共有206名多发性硬化症患者(MS;139名女性;平均年龄,47.7±11.3年;平均EDSS评分,在前3个月没有复发的5.2±1.5)纳入研究。对于量表的所有子维度,重测相关系数都很高(0.95-0.99)。PRISM-TR子尺寸的所有Cronbachα值,除了积极的影响,同样很高(0.85-0.94)。PRISM-TR分量表评分与MAS相关,NRS,和EDSS评分(P<.001)。
    结论:PRISM-TR是一种有效且可靠的量表,适用于患有MS的土耳其人。它在临床上使用简单,有助于在病程早期检测患者的痉挛状态。
    BACKGROUND: We aimed to evaluate the validity and reliability of the Turkish version of the Patient-Reported Impact of Spasticity Measure (PRISM-TR).
    METHODS: Expert opinions and the forward-back translation method were used for linguistic validation. Cronbach α and test-retest analysis were performed for reliability analysis. Correlations between the PRISM-TR and the Modified Ashworth Scale (MAS), the Numerical Rating Scale (NRS), and the Expanded Disability Status Scale (EDSS) were assessed.
    RESULTS: A total of 206 individuals with multiple sclerosis (MS; 139 women; mean age, 47.7 ± 11.3 years; mean EDSS score, 5.2 ± 1.5) who had not had a relapse in the previous 3 months were included in the study. Test-retest correlation coefficients were high for all subdimensions of the scale (0.95-0.99). All Cronbach α values for the PRISM-TR subdimensions, except for Positive Impact, were likewise quite high (0.85-0.94). PRISM-TR subscale scores were correlated with MAS, NRS, and EDSS scores (P < .001).
    CONCLUSIONS: PRISM-TR is a valid and reliable scale for use with Turkish individuals with MS. It is simple to use in the clinic and can be helpful in detecting patients\' spasticity early in the disease course.
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  • 文章类型: Journal Article
    背景:认知行为疗法(CBT)已成功用于改善普通人群的心理健康(MH)和生活质量(QoL),不管年龄。癌症,最常见于老年人,是一种使人衰弱的疾病,对患者的MH和QoL有有害和持久的影响。虽然许多研究已经证明了CBT的疗效,几乎没有证据表明它在老年癌症患者中的作用。这项研究,使用MH和QoL指标,评估CBT对老年癌症患者的有效性。
    方法:关注MH和QoL,平均年龄超过60岁,对17项临床试验进行了最终分析,总共124项效应大小,包括3073名接受CBT的参与者。使用R统计软件(4.2.2版)中的“隐喻”和“Robumeta”软件包进行分析,其中包括仅截距元回归中的鲁棒方差估计(RVE),和单变量元回归进行调节分析。
    结果:有17项临床试验和124种效应大小,我们的结果表明,CBT可以适度改善癌症患者的MH和QoL,d=0.19,95%CI0.0166-0.364,p<0.0399。通过人际技术干预与具有非常强的治疗效果大小的预编程片段相结合,该交付形式被证明是CBT有效性的强大调节剂(d=1.7307,95%CI1.5244-1.937,p<0.001)。
    结论:在老年癌症患者中使用CBT可在统计学上改善MH和QoL,递送形式和治疗阶段具有重要作用。仅技术的人际干预与预编程的CBT相结合,为针对老年成年癌症患者提供了一条途径。
    BACKGROUND: Cognitive behavioral therapy (CBT) has been successfully utilized in improving mental health (MH) and quality of life (QoL) in the general population, regardless of age. Cancer, which is most frequently diagnosed in older adults, is a debilitating illness that has a detrimental and long-lasting effect on patients\' MH and QoL. While numerous studies have demonstrated CBT\'s efficacy, little evidence exists for its role in older cancer patients. This study, using MH and QoL metrics, evaluates the effectiveness of CBT for older adult cancer patients.
    METHODS: Focusing on MH and QoL and an average age of over 60 years old, a final analysis was performed on 17 clinical trials with a total of 124 effect sizes, including 3073 participants receiving CBT. \"Metaphor\" and \"Robumeta\" packages in R Statistical Software (version 4.2.2) were used for analysis, which included robust variance estimation (RVE) in intercept-only meta-regression, and univariate meta-regression for moderator analysis.
    RESULTS: With 17 clinical trials and 124 effect sizes, our results show that CBT moderately improves MH and QoL in cancer patients d = 0.19, 95% CI 0.0166-0.364, p < 0.0399. The delivery format was shown to be a strong moderator of CBT effectiveness with interpersonal technological interventions combined with pre-programmed segments having a very strong treatment effect size (d = 1.7307, 95% CI 1.5244-1.937, p < 0.001).
    CONCLUSIONS: The use of CBT in older adult cancer patients statistically improves MH and QoL, with delivery format and stages of treatment having important roles. Tech-only interpersonal interventions combined with pre-programmed CBT provide an avenue for targeting older adult cancer patients.
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  • 文章类型: Journal Article
    背景:症状评估是确定胰腺外分泌功能不全(EPI)的疾病状态和最佳管理的关键因素。需要标准化的患者报告结果(PRO)问卷来评估诊断为EPI的患者的症状。这项定性研究的目的是从患者的角度增加对EPI症状体验的理解,并制定和评估美国EPI患者EPI症状问卷(EPI-SQ)的内容效度。
    方法:进行概念启发访谈(第一阶段),以了解临床诊断为EPI的患者的症状体验(即,根据最新值,粪便胰腺弹性蛋白酶值≤200mcg/g)归因于慢性胰腺炎或胰腺切除术。EPI-SQ是基于从第一阶段访谈中提取的数据和临床专家的反馈而开发的。接下来,进行单独的认知访谈(第二阶段),以评估参与者对说明的理解,items,反应量表,和仪器的召回期。
    结果:在第一阶段访谈中(n=21),19名参与者(90%)报告腹痛是最常见的EPI症状,生活方式改变是最常见的影响(n=18;86%)。第二阶段结果表明,所有参与者(n=7)认为12项EPI-SQ与他们的症状体验相关,并且他们理解这些项目,说明,和预期的响应选项。
    结论:本研究的定性数据支持EPI-SQ在美国诊断为EPI患者人群中测量EPI症状严重程度的内容有效性。
    BACKGROUND: Symptom assessment is the key factor in determining disease status and optimal management of exocrine pancreatic insufficiency (EPI). There is a need for a standardized patient-reported outcome (PRO) questionnaire to assess symptoms in patients diagnosed with EPI. The purpose of this qualitative study was to increase understanding of the EPI symptom experience from the patients\' perspective, and to develop and evaluate the content validity of the EPI Symptom Questionnaire (EPI-SQ) in US patients with EPI.
    METHODS: Concept elicitation interviews (Phase I) were conducted to understand the symptom experience in patients with a clinical diagnosis of EPI (i.e., fecal pancreatic elastase value of ≤ 200 mcg/g based on most recent value) due to chronic pancreatitis or pancreatectomy. The EPI-SQ was developed based on the data extracted from Phase I interviews and feedback from clinical experts. Next, separate cognitive interviews (Phase II) were conducted to evaluate participants\' understanding of the instructions, items, response scales, and recall periods of the instrument.
    RESULTS: During Phase I interviews (n = 21), 19 participants (90%) reported abdominal pain as the most frequent EPI symptom and lifestyle changes were the most frequently endorsed impacts (n = 18; 86%). Phase II results indicated that all participants (n = 7) felt the 12-item EPI-SQ was relevant to their symptom experience and that they understood the items, instructions, and response options as intended.
    CONCLUSIONS: The qualitative data from this study support the content validity of the EPI-SQ in measuring EPI symptom severity in US patient populations diagnosed with EPI.
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  • 文章类型: Journal Article
    患者报告的治疗负担(TBN)是指患者在管理其慢性健康状况方面投入的时间和精力。这项研究的目的是探讨冠心病(CAD)患者的TBN。
    连续邀请患有慢性疾病的患者完成研究问卷(TBN和EQ-5D)。
    在514名登记的患者中,116例(22.6%)患者患有CAD。CAD的平均TBN分数与非CAD为40.49±21.54和46.17±21.44(p=0.023),分别。
    与其他慢性疾病患者相比,CAD患者的TBN较低。
    UNASSIGNED: Patient-reported treatment burden (TBN) refers to the patient\'s time and effort invested in the management of their chronic health conditions. The aim of this research was to explore TBN in patients with coronary artery disease (CAD).
    UNASSIGNED: Consecutive patients with chronic medical condition(s) were invited to complete the study questionnaires (TBN and EQ-5D).
    UNASSIGNED: Of 514 enrolled patients, 116 (22.6%) patients had CAD. The mean TBN score for CAD vs. non-CAD was 40.49 ±21.54 and 46.17 ±21.44 (p = 0.023), respectively.
    UNASSIGNED: Patients with CAD could have a lower TBN in comparison to patients with other chronic medical conditions.
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