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Content validation of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (NFLymSI-18) in indolent B-cell non-Hodgkin's lymphoma. 国家综合癌症网络/癌症治疗功能评估淋巴瘤症状指数-18(NFLymSI-18)在轻度B细胞非霍奇金淋巴瘤中的内容验证。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-07-09 DOI: 10.1186/s41687-024-00752-6
Courtney N Hurt, Karen Kaiser, Sara Shaunfield, Kimberly A Webster, Karen Keating, Lara Boyken, Sara Duffey, Jessica Garcia, David Cella

Background: The NFLymSI-18 is a patient-reported outcome measure comprised of the highest priority symptoms, emotional concerns, treatment side effects, and other concerns identified by lymphoma patients and oncologists. This study assessed the content validity of the NFLymSI-18 for patients with indolent B-cell non-Hodgkin's lymphoma (iNHL), with a focus on the Disease-Related Symptoms Physical (DRS-P) subscale.

Methods: Patients with a confirmed iNHL diagnosis who had received one or more lines of treatment were recruited during clinic visits. Patients described their symptoms, treatment side effects, and emotional concerns related to iNHL in a semi-structured interview. Qualitative data were analyzed using NVivo10.

Results: Data saturation was obtained by the 18th interview. Most participants (67%) had follicular lymphoma. 28% of participants had marginal zone lymphoma, and one participant had lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia. Mean age of the 18 participants was 67 years. 56% of the sample was male. Most participants (67%) had a college or advanced degree. When asked to describe their iNHL symptoms, patients most often discussed swelling (n = 14), fatigue (n = 11), and pain (n = 8). The following symptoms were mentioned by three patients each: anxiety, appetite loss, rash, sleep disruption, trouble breathing, and malaise. Mapping of NFLymSI-18 content to these concerns showed the instrument includes all those most frequently mentioned symptoms.

Conclusions: This study supports the content validity of the NFLymSI-18, including its DRS-P Subscale, for patients with iNHL. The instrument shows strong validity for the most referenced symptoms of swelling, fatigue, and pain. The diversity of additional symptoms reported by patients is consistent with the heterogeneous symptomology of iNHL.

背景:NFLymSI-18是一种患者报告的结果测量方法,由淋巴瘤患者和肿瘤学家确定的最优先症状、情绪问题、治疗副作用和其他问题组成。本研究评估了NFLymSI-18对惰性B细胞非霍奇金淋巴瘤(iNHL)患者的内容效度,重点是疾病相关症状(DRS-P)分量表:在门诊期间招募确诊为 iNHL 并接受过一种或多种治疗的患者。患者在半结构化访谈中描述了他们的症状、治疗副作用以及与 iNHL 相关的情绪问题。定性数据使用 NVivo10 进行分析:第 18 次访谈时数据达到饱和。大多数参与者(67%)患有滤泡性淋巴瘤。28%的参与者患有边缘区淋巴瘤,一名参与者患有淋巴浆细胞性淋巴瘤/瓦尔登斯特伦巨球蛋白血症。18 名参与者的平均年龄为 67 岁。56%的样本为男性。大多数参与者(67%)拥有大学或高级学位。当被要求描述 iNHL 症状时,患者最常讨论的症状是肿胀(14 例)、疲劳(11 例)和疼痛(8 例)。以下症状各有三名患者提及:焦虑、食欲不振、皮疹、睡眠障碍、呼吸困难和乏力。将 NFLymSI-18 的内容与这些关注点进行映射后发现,该工具包含了所有这些最常被提及的症状:本研究支持NFLymSI-18(包括其DRS-P分量表)在iNHL患者中的内容有效性。该工具在肿胀、疲劳和疼痛等最常提及的症状方面显示出很强的有效性。患者报告的其他症状的多样性与 iNHL 的异质性症状一致。
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引用次数: 0
Are all cancer survivors included when using electronically administered patient reported outcomes in primary healthcare cancer rehabilitation? A cross-sectional study. 在初级医疗癌症康复中使用电子管理的患者报告结果时,是否包括所有癌症幸存者?一项横断面研究。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-07-08 DOI: 10.1186/s41687-024-00753-5
Sine Rossen, Mette Thønnings Sandager, Dorte Thoning Hofland, Claus Vinther Nielsen, Thomas Maribo

Background: Patient reported outcomes (PROs) are being used frequently in clinical practice. PROs often serve several purposes, such as increasing patient involvement, assessing health status, and monitoring and improving the quality-of-care at an aggregated level. However, the lack of representative PRO-data may have implications for all these purposes. This study aims to assess the association of non-administration of (not sending an electronic invite to PRO) and non-response to (not responding to PRO) electronically administered PROs with social inequality in a primary healthcare cancer rehabilitation setting. Furthermore, it examines whether the workflows surrounding PRO have an impact on non-administration and non-response.

Methods: This is a cross sectional study using routinely collected data from electronic health records and registers including cancer survivors (CSs) over 18 years booked for an initial consultation in a primary healthcare cancer rehabilitation setting using PROs for systematic health status assessment. During the study period two different PRO platforms were used, each associated with different workflows. Non-administration and non-response rates were calculated for sociodemographic characteristics for each PRO platform. Crude and adjusted odds ratios were calculated using univariate and multivariate logistic regression.

Results: In total, 1868 (platform 1) and 1446 (platform 2) CSCSs were booked for an initial consultation. Of these, 233 (12.5%) (platform 1) and 283 (19.6%) (platform 2) were not sent a PRO (non-administration). Among those who received a PRO, 157 (9.6%) on platform 1 and 140 (12.0%) on platform 2 did not respond (non-response). Non-administration of and non-response to PROs were significantly associated with lower socioeconomic status. Moreover, the workflows surrounding PROs seem to have an impact on non-inclusion in and non-response to PROs.

Conclusions: Non-administration of and non-response to PROs in clinical practice is associated with determinants of social inequality. Clinical workflows and the PRO platforms used may potentially worsen this inequality. It is important to consider these implications when using PROs at both the individual and aggregated levels. A key aspect of implementing PROs in clinical practice is the ongoing focus on representativeness, including a focus on monitoring PRO administration and response.

背景:临床实践中经常使用患者报告结果(PROs)。患者报告结果通常有几个目的,如提高患者的参与度、评估健康状况以及监测和改善总体护理质量。然而,缺乏具有代表性的 PRO 数据可能会对所有这些目的产生影响。本研究旨在评估在初级医疗癌症康复环境中,未管理(未向 PRO 发出电子邀请)和未回应(未对 PRO 作出回应)电子管理的 PRO 与社会不平等之间的关系。此外,该研究还探讨了围绕项目研究的工作流程是否会对不登记和不回复产生影响:这是一项横断面研究,使用了从电子健康记录和登记册中收集的常规数据,包括在初级医疗癌症康复机构预约初次咨询的 18 岁以上癌症幸存者(CSs),使用 PROs 进行系统的健康状况评估。研究期间使用了两个不同的PRO平台,每个平台都有不同的工作流程。针对每个 PRO 平台的社会人口特征,计算了未使用率和未回复率。使用单变量和多变量逻辑回归计算了粗略和调整后的几率比:共有 1868 名(平台 1)和 1446 名(平台 2)CSCS 预约了初步咨询。其中,233 人(12.5%)(平台 1)和 283 人(19.6%)(平台 2)未收到 PRO(未进行管理)。在收到问卷的受访者中,平台 1 有 157 人(9.6%)和平台 2 有 140 人(12.0%)没有回复(未回复)。未使用和未回复 PRO 与较低的社会经济地位明显相关。此外,围绕 PROs 的工作流程似乎对未纳入和未回应 PROs 有影响:结论:在临床实践中,不使用和不响应PROs与社会不平等的决定因素有关。临床工作流程和所使用的 PRO 平台可能会加剧这种不平等。在个人和综合层面使用PROs时,必须考虑到这些影响。在临床实践中实施PROs的一个关键方面是持续关注代表性,包括重点监控PRO的管理和响应。
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引用次数: 0
A mixed methods evaluation of patient perspectives on the implementation of an electronic health record-integrated patient-reported symptom and needs monitoring program in cancer care. 在癌症护理中实施电子健康记录集成患者报告症状和需求监测计划的患者观点混合方法评估。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-07-02 DOI: 10.1186/s41687-024-00742-8
Madison J Lyleroehr, Kimberly A Webster, Laura M Perry, Elijah A Patten, Jackelyn Cantoral, Justin D Smith, David Cella, Frank J Penedo, Sofia F Garcia

Background: As cancer centers have increased focus on patient-centered, evidenced-based care, implementing efficient programs that facilitate effective patient-clinician communication remains critical. We implemented an electronic health record-integrated patient-reported symptom and needs monitoring program ('cPRO' for cancer patient-reported outcomes). To aid evaluation of cPRO implementation, we asked patients receiving care in one of three geographical regions of an academic healthcare system about their experiences.

Methods: Using a sequential mixed-methods approach, we collected feedback in two waves. Wave 1 included virtual focus groups and interviews with patients who had completed cPRO. In Wave 2, we administered a structured survey to systematically examine Wave 1 themes. All participants had a diagnosed malignancy and received at least 2 invitations to complete cPRO. We used rapid and traditional qualitative methods to analyze Wave 1 data and focused on identifying facilitators and barriers to cPRO implementation. Wave 2 data were analyzed descriptively.

Results: Participants (n = 180) were on average 62.9 years old; were majority female, White, non-Hispanic, and married; and represented various cancer types and phases of treatment. Wave 1 participants (n = 37) identified facilitators, including cPRO's perceived value and favorable usability, and barriers, including confusion about cPRO's purpose and various considerations for responding. High levels of clinician engagement with, and patient education on, cPRO were described as facilitators while low levels were described as barriers. Wave 2 (n = 143) data demonstrated high endorsement rates of cPRO's usability on domains such as navigability (91.6%), comprehensibility (98.7%), and relevance (82.4%). Wave 2 data also indicated low rates of understanding cPRO's purpose (56.7%), education from care teams about cPRO (22.5%), and discussing results of cPRO with care teams (16.3%).

Conclusions: While patients reported high value and ease of use when completing cPRO, they also reported areas of confusion, emphasizing the importance of patient education on the purpose and use of cPRO and clinician engagement to sustain participation. These results guided successful implementation changes and will inform future improvements.

背景:随着癌症中心越来越重视以患者为中心、以证据为基础的护理,实施促进患者与医生有效沟通的高效项目仍然至关重要。我们实施了一项电子健康记录集成患者报告症状和需求监测计划("cPRO",即癌症患者报告结果)。为了帮助评估 cPRO 的实施情况,我们询问了在一个学术医疗系统的三个地理区域之一接受治疗的患者的经历:方法:我们采用顺序混合方法,分两波收集反馈意见。第 1 波包括虚拟焦点小组和对已完成 cPRO 的患者的访谈。在第二阶段,我们进行了一次结构化调查,系统地研究了第一阶段的主题。所有参与者均已确诊为恶性肿瘤,并至少收到过两次完成 cPRO 的邀请。我们采用了快速和传统的定性方法来分析第 1 波数据,重点是确定 cPRO 实施的促进因素和障碍。我们对第二波数据进行了描述性分析:参与者(n = 180)的平均年龄为 62.9 岁;大多数为女性、白人、非西班牙裔、已婚;代表了不同的癌症类型和治疗阶段。第 1 波参与者(n = 37)指出了促进因素,包括 cPRO 的感知价值和良好的可用性,以及障碍因素,包括对 cPRO 目的的困惑和响应时的各种考虑。临床医生对 cPRO 的高度参与和患者教育被描述为促进因素,而低水平参与和患者教育被描述为障碍因素。第 2 波(n = 143)数据显示,cPRO 在导航性(91.6%)、可理解性(98.7%)和相关性(82.4%)等方面的可用性认可率较高。第 2 波数据还显示,对 cPRO 目的的理解率(56.7%)、护理团队对 cPRO 的教育率(22.5%)以及与护理团队讨论 cPRO 结果的比率均较低(16.3%):患者在填写 cPRO 时表示其价值很高且易于使用,但他们也表示存在困惑之处,这强调了就 cPRO 的目的和使用对患者进行教育以及临床医生参与以维持患者参与的重要性。这些结果为成功实施改革提供了指导,并将为未来的改进提供参考。
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引用次数: 0
Re-examining the factor structure of the Insomnia Severity Index (ISI) and defining the meaningful within-individual change (MWIC) for subjects with insomnia disorder in two phase III clinical trials of the efficacy of lemborexant. 重新研究失眠症严重程度指数(ISI)的因子结构,并界定在两项关于利眠宁疗效的 III 期临床试验中失眠症受试者有意义的个体内变化(MWIC)。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-06-29 DOI: 10.1186/s41687-024-00744-6
William R Lenderking, Yulia Savva, Mark J Atkinson, Renee Campbell, Isabelle Chabot, Margaret Moline, Genevieve Meier, Charles M Morin

Background: The Insomnia Severity Index (ISI) is a widely used measure of insomnia severity. Various ISI research findings suggest different factor solutions and meaningful within-individual change (MWIC) to detect treatment response in patients with insomnia. This study examined an ISI factor solution and psychometric indices to define MWIC in a robust patient sample from clinical trial settings.

Methods: We endeavored to improve upon previous validation of ISI by examining structural components of confirmatory factor analysis (CFA) models using two large, placebo-controlled clinical trials of lemborexant for insomnia. Using the best-fitting two-factor solution, we evaluated anchor-based, distribution-based and receiver operating characteristic (ROC) curve methods to derive an estimate of the MWIC.

Results: The model structure for the 7-item scale proposed in other research did not fit the observed data from our two lemborexant clinical trials (N = 1956) as well as a two-factor solution based on 6 items did. Using triangulation of anchor-based, distribution-based, and ROC methods, we determined that a 5-point reduction using 6 items best represented a clinically meaningful improvement in individuals with insomnia in our patient sample.

Conclusions: A 6-item two-factor scale had better psychometric properties than the 7-item scale in this patient sample. On the 6-item scale, a reduction of 5 points in the ISI total score represented the MWIC. Generalizability of the proposed MWIC may be limited to patient populations with similar demographic and clinical characteristics.

背景:失眠严重程度指数(ISI)是一种广泛使用的失眠严重程度测量方法。各种ISI研究结果表明,不同的因子解决方案和有意义的个体内变化(MWIC)可检测失眠患者的治疗反应。本研究对 ISI 因子解决方案和心理测量指数进行了检验,以在临床试验环境中的可靠患者样本中定义有意义的个体内变化(MWIC):方法:我们利用两项大型安慰剂对照临床试验,研究了确认性因子分析(CFA)模型的结构成分,以改进之前对 ISI 的验证。利用最拟合的双因素解决方案,我们评估了基于锚、基于分布和接收者操作特征曲线(ROC)的方法,以得出 MWIC 的估计值:结果:其他研究中提出的 7 个条目量表的模型结构与我们的两项利眠宁临床试验(N = 1956)中观察到的数据不匹配,而基于 6 个条目的双因素解决方案却很匹配。通过锚定法、分布法和ROC法的三角测量,我们确定,在我们的患者样本中,使用6个项目减少5分最能代表失眠症患者有临床意义的改善:结论:在该患者样本中,6 个项目的双因素量表比 7 个项目的量表具有更好的心理测量特性。在 6 个项目的量表中,ISI 总分减少 5 分即为 MWIC。所提出的 MWIC 的通用性可能仅限于具有相似人口统计学和临床特征的患者群体。
{"title":"Re-examining the factor structure of the Insomnia Severity Index (ISI) and defining the meaningful within-individual change (MWIC) for subjects with insomnia disorder in two phase III clinical trials of the efficacy of lemborexant.","authors":"William R Lenderking, Yulia Savva, Mark J Atkinson, Renee Campbell, Isabelle Chabot, Margaret Moline, Genevieve Meier, Charles M Morin","doi":"10.1186/s41687-024-00744-6","DOIUrl":"10.1186/s41687-024-00744-6","url":null,"abstract":"<p><strong>Background: </strong>The Insomnia Severity Index (ISI) is a widely used measure of insomnia severity. Various ISI research findings suggest different factor solutions and meaningful within-individual change (MWIC) to detect treatment response in patients with insomnia. This study examined an ISI factor solution and psychometric indices to define MWIC in a robust patient sample from clinical trial settings.</p><p><strong>Methods: </strong>We endeavored to improve upon previous validation of ISI by examining structural components of confirmatory factor analysis (CFA) models using two large, placebo-controlled clinical trials of lemborexant for insomnia. Using the best-fitting two-factor solution, we evaluated anchor-based, distribution-based and receiver operating characteristic (ROC) curve methods to derive an estimate of the MWIC.</p><p><strong>Results: </strong>The model structure for the 7-item scale proposed in other research did not fit the observed data from our two lemborexant clinical trials (N = 1956) as well as a two-factor solution based on 6 items did. Using triangulation of anchor-based, distribution-based, and ROC methods, we determined that a 5-point reduction using 6 items best represented a clinically meaningful improvement in individuals with insomnia in our patient sample.</p><p><strong>Conclusions: </strong>A 6-item two-factor scale had better psychometric properties than the 7-item scale in this patient sample. On the 6-item scale, a reduction of 5 points in the ISI total score represented the MWIC. Generalizability of the proposed MWIC may be limited to patient populations with similar demographic and clinical characteristics.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11217251/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141477574","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
Iterative qualitative approach to establishing content validation of a patient-reported outcome measure for arm lymphedema: the LYMPH-Q Upper Extremity Module. 采用迭代定性方法对患者报告的手臂淋巴水肿疗效进行内容验证:LYMPH-Q 上肢模块。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-06-26 DOI: 10.1186/s41687-024-00701-3
Manraj N Kaur, Sylvie D Cornacchi, Elena Tsangaris, Lotte Poulsen, Louise M Beelen, Louise Bordeleau, Toni Zhong, Mads Gustaf Jorgensen, Jens Ahm Sorensen, Babak Mehrara, Joseph Dayan, Andrea L Pusic, Anne F Klassen

Background: Breast cancer-related lymphedema (BRCL) is one of the most common causes of upper extremity (UE) lymphedema in developed nations and substantially impacts health-related quality of life. To advance our understanding of the epidemiology and treatment of BRCL, rigorously developed and validated patient-reported outcome measures (PROMs) are needed. This study aimed to demonstrate the iterative content validity of a modular UE lymphedema-specific PROM called the LYMPH-Q UE module.

Methods: A multi-step iterative qualitative approach was used. Semi-structured interview data from in-depth qualitative interviews with adult women (18 years and older) with BCRL were used to develop the first set of the LYMPH-Q UE scales. The content validity of these scales was demonstrated with patient and clinician feedback. Over the course of cognitive debriefing interviews, additional concepts of lymphedema worry and impact on work were identified as missing from the LYMPH-Q UE module. Subsequently, two new qualitative studies (a focus group and in-depth concept elicitation interviews with patients) were conducted, and two new scales were developed to measure lymphedema worry and impact on work life and their content validity was demonstrated.

Results: Qualitative data from in-depth and cognitive interviews with 15 (age 40-74 years) and 16 (age 38-74 years) women with BRCL, respectively, and feedback from 12 clinical experts, were used to develop and demonstrate the content validity of six LYMPH-Q UE scales measuring symptoms, function, appearance, psychological, information, and arm sleeve. Additionally, data from in-depth interviews with 12 (age 35-72 years) women with UE lymphedema and four focus groups (n = 16 women; age 35-74 years) was used to develop and assess the content validity of two new LYMPH-Q UE scales measuring lymphedema worry and impact on work life. The content validity of the previously established six scales was also demonstrated in these subsequent qualitative studies.

Conclusion: The LYMPH-Q UE is a modular PROM developed using international guidelines for PROM development and can be used in clinical practice, research, and quality improvement to enhance patient-centered shared decision-making. This study's innovative and iterative approach to content validation demonstrates that the LYMPH-Q UE is a comprehensive measure that includes important concepts relevant to patients with UE lymphedema.

背景:乳腺癌相关淋巴水肿(BRCL)是发达国家上肢(UE)淋巴水肿最常见的原因之一,严重影响了与健康相关的生活质量。为了促进我们对 BRCL 流行病学和治疗的了解,需要严格开发和验证患者报告的结果测量(PROMs)。本研究旨在证明名为 LYMPH-Q UE 模块的 UE 淋巴水肿专用 PROM 的迭代内容有效性:方法:采用多步骤迭代定性方法。通过对患有 BCRL 的成年女性(18 岁及以上)进行深入定性访谈获得的半结构化访谈数据被用于开发第一套 LYMPH-Q UE 量表。患者和临床医生的反馈证明了这些量表的内容有效性。在认知汇报访谈过程中,发现 LYMPH-Q UE 模块中还缺少淋巴水肿担忧和对工作的影响这两个概念。随后,我们进行了两项新的定性研究(焦点小组和对患者进行的深度概念激发访谈),并开发了两个新的量表来测量淋巴水肿担忧和对工作生活的影响,并证明了它们在内容上的有效性:分别对 15 名(40-74 岁)和 16 名(38-74 岁)患有 BRCL 的女性患者进行了深度访谈和认知访谈,并根据 12 名临床专家的反馈意见,制定了六种 LYMPH-Q UE 量表,并证明了其内容有效性,这六种量表分别测量症状、功能、外观、心理、信息和臂套。此外,通过对 12 名患有 UE 淋巴水肿的女性(年龄在 35-72 岁之间)进行深入访谈,以及通过四个焦点小组(n = 16 名女性,年龄在 35-74 岁之间)获得的数据,开发并评估了两个新的 LYMPH-Q UE 量表的内容效度,这两个量表分别测量淋巴水肿担忧和对工作生活的影响。结论:LYMPH-Q UE量表的内容有效性在随后的定性研究中也得到了证实:结论:LYMPH-Q UE 是根据国际 PROM 开发指南开发的模块化 PROM,可用于临床实践、研究和质量改进,以加强以患者为中心的共同决策。本研究采用创新和迭代的方法进行内容验证,表明 LYMPH-Q UE 是一种全面的测量方法,包含了与 UE 淋巴水肿患者相关的重要概念。
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引用次数: 0
Participants' perceived benefits from the GLA:D™ program for individuals living with hip and knee osteoarthritis: a qualitative study. 针对髋关节和膝关节骨关节炎患者的 GLA:D™ 计划参与者的获益感知:一项定性研究。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-06-26 DOI: 10.1186/s41687-024-00740-w
Ania Kania-Richmond, Lauren A Beaupre, Geneviève Jessiman-Perreault, Danika Tribo, Jason Martyn, David A Hart, Jill Robert, Mel Slomp, C Allyson Jones

Background: The Good Life with osteoArthritis: Denmark (GLA:D™), an evidence-based education and exercise program designed for conservative management of knee and hip osteoarthritis (OA), has been shown to benefit participants by reducing pain, improving function, and quality of life. Standardized reporting in the GLA:D databases enabled the measurement of self-reported and performance-based outcomes. There is a paucity of qualitative research on the participants' perceptions of this program, and it is important to understand whether participants' perceptions of the benefits of the program align with reported quantitative findings.

Methods: We conducted semi-structured telephone interviews with individuals who participated in the GLA:D program from January 2017 to December 2018 in Alberta, Canada. Data were analyzed using an interpretive description approach and thematic analysis to identify emergent themes and sub-themes associated with participants perceived benefits of the GLA:D program. We analyzed the data using NVivo Pro software. Member checking and bracketing were used to ensure the rigour of the analysis.

Results: 30 participants were interviewed (70% female, 57% rural, 73% knee OA). Most participants felt the program positively benefited them. Two themes emerged from the analysis: wellness and self-efficacy. Participants felt the program benefited their wellness, particularly with regard to pain relief, and improvements in mobility, strength, and overall well-being. Participants felt the program benefited them by promoting a sense of self-efficacy through improving the confidence to perform exercise and routine activities, as well as awareness, and motivation to manage their OA symptoms. Twenty percent of participants felt no benefits from the program due to experiencing increased pain and feeling their OA was too severe to participate.

Discussion: The GLA:D program was viewed as beneficial to most participants, this study also identified factors (e.g., severe OA, extreme pain) as to why some participants did not experience meaningful improvements. Early intervention with the GLA:D program prior to individuals experiencing severe OA could help increase the number of participants who experience benefits from their participation.

Conclusion: As the GLA:D program expands across jurisdictions, providers of the program may consider recruitment earlier in disease progression and targeting those with mild and moderate OA.

背景:骨关节炎患者的美好生活:丹麦 (GLA:D™)是一项循证教育和锻炼计划,旨在对膝关节和髋关节骨关节炎 (OA) 进行保守治疗。通过 GLA:D 数据库中的标准化报告,可以对自我报告和基于表现的结果进行测量。有关参与者对该计划的看法的定性研究很少,因此了解参与者对该计划益处的看法是否与报告的定量结果一致非常重要:我们于 2017 年 1 月至 2018 年 12 月在加拿大艾伯塔省对参与 GLA:D 计划的个人进行了半结构化电话访谈。我们采用解释性描述方法和主题分析法对数据进行了分析,以确定与参与者感知到的 GLA:D 计划益处相关的新出现主题和次主题。我们使用 NVivo Pro 软件对数据进行了分析。为确保分析的严谨性,我们使用了成员检查和括号:30 名参与者接受了访谈(70% 为女性,57% 为农村居民,73% 为膝关节 OA 患者)。大多数参与者认为该计划使他们受益匪浅。分析中出现了两个主题:健康和自我效能。参与者认为该计划有益于他们的健康,尤其是在缓解疼痛、改善活动能力、力量和整体健康方面。参与者认为,该计划通过提高他们进行锻炼和日常活动的自信心,以及对控制 OA 症状的认识和动力,增强了他们的自我效能感,从而使他们受益匪浅。20%的参与者认为该计划没有给他们带来任何益处,因为他们感到疼痛加剧,并认为自己的OA症状太严重,无法参加该计划:讨论:GLA:D计划被认为对大多数参与者有益,但这项研究也发现了一些参与者没有得到明显改善的原因(如严重的OA、极度疼痛)。在参与者出现严重 OA 之前对 GLA:D 计划进行早期干预,有助于增加从参与中获益的参与者人数:结论:随着GLA:D计划在各辖区的推广,该计划的提供者可以考虑在疾病进展的早期进行招募,并以轻度和中度OA患者为目标。
{"title":"Participants' perceived benefits from the GLA:D™ program for individuals living with hip and knee osteoarthritis: a qualitative study.","authors":"Ania Kania-Richmond, Lauren A Beaupre, Geneviève Jessiman-Perreault, Danika Tribo, Jason Martyn, David A Hart, Jill Robert, Mel Slomp, C Allyson Jones","doi":"10.1186/s41687-024-00740-w","DOIUrl":"10.1186/s41687-024-00740-w","url":null,"abstract":"<p><strong>Background: </strong>The Good Life with osteoArthritis: Denmark (GLA:D™), an evidence-based education and exercise program designed for conservative management of knee and hip osteoarthritis (OA), has been shown to benefit participants by reducing pain, improving function, and quality of life. Standardized reporting in the GLA:D databases enabled the measurement of self-reported and performance-based outcomes. There is a paucity of qualitative research on the participants' perceptions of this program, and it is important to understand whether participants' perceptions of the benefits of the program align with reported quantitative findings.</p><p><strong>Methods: </strong>We conducted semi-structured telephone interviews with individuals who participated in the GLA:D program from January 2017 to December 2018 in Alberta, Canada. Data were analyzed using an interpretive description approach and thematic analysis to identify emergent themes and sub-themes associated with participants perceived benefits of the GLA:D program. We analyzed the data using NVivo Pro software. Member checking and bracketing were used to ensure the rigour of the analysis.</p><p><strong>Results: </strong>30 participants were interviewed (70% female, 57% rural, 73% knee OA). Most participants felt the program positively benefited them. Two themes emerged from the analysis: wellness and self-efficacy. Participants felt the program benefited their wellness, particularly with regard to pain relief, and improvements in mobility, strength, and overall well-being. Participants felt the program benefited them by promoting a sense of self-efficacy through improving the confidence to perform exercise and routine activities, as well as awareness, and motivation to manage their OA symptoms. Twenty percent of participants felt no benefits from the program due to experiencing increased pain and feeling their OA was too severe to participate.</p><p><strong>Discussion: </strong>The GLA:D program was viewed as beneficial to most participants, this study also identified factors (e.g., severe OA, extreme pain) as to why some participants did not experience meaningful improvements. Early intervention with the GLA:D program prior to individuals experiencing severe OA could help increase the number of participants who experience benefits from their participation.</p><p><strong>Conclusion: </strong>As the GLA:D program expands across jurisdictions, providers of the program may consider recruitment earlier in disease progression and targeting those with mild and moderate OA.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11208368/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141451767","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
Psychometric evaluation of the patient-reported experience of cognitive impairment in schizophrenia (PRECIS) scale. 精神分裂症患者认知障碍体验报告量表(PRECIS)的心理测量学评估。
IF 2.7 Q3 Medicine Pub Date : 2024-06-17 DOI: 10.1186/s41687-024-00731-x
William R Lenderking, Mark J Atkinson, Mary Kate Ladd, Yulia Savva, Stephanie Sommer, Matthew Sidovar, Claudia Hastedt

Background: Cognitive impairment associated with schizophrenia (CIAS) represents a distinct, persistent, and core group of schizophrenia symptoms. Cognitive symptoms have been shown to have an impact on quality of life. There are several published CIAS measures, but none based on direct patient self-report. It is important to capture the patient's perspective to supplement performancebased outcome measures of cognition to provide a complete picture of the patient's experience. This paper describes additional validation work on the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) instrument.

Methods: Data from two large, international, pharmaceutical clinical trials in medically and psychiatrically stable English-speaking patients with schizophrenia and 88 healthy controls were analyzed. An exploratory factor analysis (EFA) was conducted in one trial (n = 215), using the original 35-item PRECIS. The factor structure suggested by EFA was further evaluated using item response theory (IRT; Samejima's graded response model), and tested using confirmatory factor analysis (CFA). Both EFA and CFA results were tested in a second trial with similar inclusion/exclusion characteristics (n = 410). Additional statistical properties were evaluated in healthy controls.

Results: EFA suggested that the best solution after item reduction suggested a factor structure of 6 factors based on 26 items (memory, communication, self-control, executive function, attention, sharpness of thought), supporting a total score, with an additional 2-item bother score (28 items in all). IRT analysis indicated the items were well-ordered within each domain. The CFA demonstrated excellent model fit, accounting for 69% of the variance. The statistical properties of the 28-item version of the PRECIS were confirmed in the second trial. Evidence for internal consistency and test-retest reliability was robust. Known-groups validity was supported by comparison of healthy controls with patients with schizophrenia. Correlations indicated moderate associations between PRECIS and functioning instruments like the Schizophrenia Cognition Rating Scale (SCoRS), but weak correlations with performance-based outcomes like MATRICS Consensus Cognitive Battery (MCCB).

Discussion: Using two clinical trial samples, we identified a robust factor structure for the PRECIS and were able to replicate it in the second sample. Evaluation of the meaningful score difference (MSD) should be repeated in future studies, as these samples did not show enough change for it to be evaluated.

Conclusions: This analysis provides strong evidence for the reliability and validity of the PRECIS, a 28-item, patient-reported instrument to assess cognitive impairment associated with schizophrenia. The correlation with functioning and the weak correlation with performance on cognitive tasks sug

背景:与精神分裂症相关的认知障碍(CIAS)是一组独特、持久和核心的精神分裂症症状。认知症状已被证明会影响生活质量。目前有几种已公布的 CIAS 测量方法,但没有一种是基于患者的直接自我报告。重要的是要捕捉患者的视角,以补充基于认知表现的结果测量,从而全面反映患者的经历。本文介绍了精神分裂症患者认知障碍体验报告(PRECIS)工具的其他验证工作:方法:分析了来自两项大型国际药物临床试验的数据,试验对象是病情和精神状况稳定的英语精神分裂症患者以及 88 名健康对照者。在一项试验(n = 215)中,使用最初的 35 个项目的 PRECIS 进行了探索性因子分析(EFA)。使用项目反应理论(IRT;Samejima 的分级反应模型)进一步评估了 EFA 提出的因子结构,并使用确认性因子分析(CFA)进行了检验。EFA 和 CFA 结果均在具有类似纳入/排除特征(n = 410)的第二次试验中进行了测试。此外,还对健康对照组的其他统计特性进行了评估:EFA表明,项目缩减后的最佳解决方案是基于26个项目(记忆、沟通、自我控制、执行功能、注意力、思维敏锐度)的6个因子的因子结构,支持一个总分,另外还有一个2个项目的困扰分(共28个项目)。IRT 分析表明,各项目在每个领域内的排序良好。CFA表明模型的拟合度很高,占方差的69%。28 个项目版 PRECIS 的统计特性在第二次试验中得到了证实。其内部一致性和测试-再测可靠性均十分可靠。通过将健康对照组与精神分裂症患者进行比较,证实了已知组的有效性。相关性表明,PRECIS与精神分裂症认知评定量表(SCoRS)等功能性工具之间存在中度相关性,但与MATRICS共识认知电池(MCCB)等基于表现的结果之间的相关性较弱:通过两个临床试验样本,我们确定了 PRECIS 的稳健因子结构,并在第二个样本中进行了复制。由于这些样本没有显示出足够的变化,因此在今后的研究中应再次评估有意义分数差异(MSD):这项分析为 PRECIS 的可靠性和有效性提供了有力的证据,PRECIS 是一种由患者报告的 28 个项目的工具,用于评估与精神分裂症相关的认知功能障碍。与功能的相关性以及与认知任务表现的弱相关性表明,患者对认知功能障碍的报告是对患者经历的一个独特方面的测量。
{"title":"Psychometric evaluation of the patient-reported experience of cognitive impairment in schizophrenia (PRECIS) scale.","authors":"William R Lenderking, Mark J Atkinson, Mary Kate Ladd, Yulia Savva, Stephanie Sommer, Matthew Sidovar, Claudia Hastedt","doi":"10.1186/s41687-024-00731-x","DOIUrl":"10.1186/s41687-024-00731-x","url":null,"abstract":"<p><strong>Background: </strong>Cognitive impairment associated with schizophrenia (CIAS) represents a distinct, persistent, and core group of schizophrenia symptoms. Cognitive symptoms have been shown to have an impact on quality of life. There are several published CIAS measures, but none based on direct patient self-report. It is important to capture the patient's perspective to supplement performancebased outcome measures of cognition to provide a complete picture of the patient's experience. This paper describes additional validation work on the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) instrument.</p><p><strong>Methods: </strong>Data from two large, international, pharmaceutical clinical trials in medically and psychiatrically stable English-speaking patients with schizophrenia and 88 healthy controls were analyzed. An exploratory factor analysis (EFA) was conducted in one trial (n = 215), using the original 35-item PRECIS. The factor structure suggested by EFA was further evaluated using item response theory (IRT; Samejima's graded response model), and tested using confirmatory factor analysis (CFA). Both EFA and CFA results were tested in a second trial with similar inclusion/exclusion characteristics (n = 410). Additional statistical properties were evaluated in healthy controls.</p><p><strong>Results: </strong>EFA suggested that the best solution after item reduction suggested a factor structure of 6 factors based on 26 items (memory, communication, self-control, executive function, attention, sharpness of thought), supporting a total score, with an additional 2-item bother score (28 items in all). IRT analysis indicated the items were well-ordered within each domain. The CFA demonstrated excellent model fit, accounting for 69% of the variance. The statistical properties of the 28-item version of the PRECIS were confirmed in the second trial. Evidence for internal consistency and test-retest reliability was robust. Known-groups validity was supported by comparison of healthy controls with patients with schizophrenia. Correlations indicated moderate associations between PRECIS and functioning instruments like the Schizophrenia Cognition Rating Scale (SCoRS), but weak correlations with performance-based outcomes like MATRICS Consensus Cognitive Battery (MCCB).</p><p><strong>Discussion: </strong>Using two clinical trial samples, we identified a robust factor structure for the PRECIS and were able to replicate it in the second sample. Evaluation of the meaningful score difference (MSD) should be repeated in future studies, as these samples did not show enough change for it to be evaluated.</p><p><strong>Conclusions: </strong>This analysis provides strong evidence for the reliability and validity of the PRECIS, a 28-item, patient-reported instrument to assess cognitive impairment associated with schizophrenia. The correlation with functioning and the weak correlation with performance on cognitive tasks sug","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11182991/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141332029","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
Update to state of the Journal of Patient-Reported Outcomes. 患者报告结果期刊》的最新情况。
IF 2.7 Q3 Medicine Pub Date : 2024-06-12 DOI: 10.1186/s41687-024-00715-x
Rasa Ruseckaite, Chih-Hung Chang
{"title":"Update to state of the Journal of Patient-Reported Outcomes.","authors":"Rasa Ruseckaite, Chih-Hung Chang","doi":"10.1186/s41687-024-00715-x","DOIUrl":"10.1186/s41687-024-00715-x","url":null,"abstract":"","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11166605/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141307027","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
Relationship between pruritus and sleep in participants with primary biliary cholangitis in the Phase 2b GLIMMER trial. 原发性胆汁性胆管炎患者在 GLIMMER 2b 期试验中瘙痒与睡眠之间的关系。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-06-12 DOI: 10.1186/s41687-024-00722-y
Robyn von Maltzahn, Marlyn J Mayo, Helen T Smith, April Thompson, Sugato Das, Andrea Ribeiro de Souza, Edoardo Lisi, Cynthia Levy, Megan M McLaughlin, David Jones

Background: Cholestatic pruritus and fatigue are debilitating conditions associated with primary biliary cholangitis (PBC) and can significantly impact patients' quality of life. Pruritus in PBC often worsens at night and patients frequently report sleep disturbance, which contributes to cognitive symptoms and fatigue. Linerixibat is an ileal bile acid transporter inhibitor in clinical development for the treatment of pruritus associated with PBC and was recently assessed versus placebo in the Phase 2b GLIMMER trial. This post-hoc analysis assesses the relationship between pruritus severity and sleep disturbance in participants of GLIMMER regardless of treatment group.

Methods: GLIMMER (NCT02966834), a multicenter, double-blind, randomized, placebo-controlled trial, recruited 147 patients with PBC and moderate-to-severe pruritus. Following 4 weeks single-blind placebo, patients (randomized 3:1) received linerixibat or placebo for 12 weeks (to Week 16). Participants graded their itch (twice daily) and its interference with sleep (once daily) in an electronic diary using a 0-10 numerical rating scale (NRS). Weekly and monthly itch scores were calculated as the mean of the worst daily itch score over the respective time period. At study visits, participants completed the 5-D itch scale and the PBC-40 quality of life questionnaire, both of which contain an item specific to itch-related sleep disturbance. The impact of pruritus on sleep was assessed post hoc through correlations between the changes in NRS, 5-D itch, and PBC-40.

Results: Strong correlations were found between change from baseline in weekly itch and sleep NRS scores (r = 0.88 [95% confidence interval (CI): 0.83; 0.91]) at the end of treatment (Week 16), as well as in monthly itch and sleep NRS scores (r = 0.84 [95% CI: 0.80; 0.87]). Patients with improved weekly pruritus score severity category demonstrated reduced perceived sleep interference on average. Itch responders (≥2-point improvement in weekly itch score from baseline) displayed larger improvements in weekly sleep NRS score, 5-D itch, and PBC-40 sleep items, than itch non-responders (<2-point improvement).

Conclusions: A strong correlation exists between changes in pruritus severity and sleep interference in patients with PBC; pruritus reduction could generate concomitant improvement in sleep.

背景:胆汁淤积性瘙痒和疲劳是原发性胆汁性胆管炎(PBC)的相关症状,会严重影响患者的生活质量。PBC 患者的瘙痒常常在夜间加重,患者经常报告睡眠障碍,这也是认知症状和疲劳的原因之一。Linerixibat 是一种回肠胆汁酸转运体抑制剂,目前正处于治疗 PBC 相关瘙痒症的临床开发阶段,最近在 2b 期 GLIMMER 试验中与安慰剂进行了对比评估。这项事后分析评估了GLIMMER试验参与者(无论治疗组别)的瘙痒严重程度与睡眠障碍之间的关系:GLIMMER(NCT02966834)是一项多中心、双盲、随机、安慰剂对照试验,共招募了147名患有中重度瘙痒症的PBC患者。在4周的单盲安慰剂治疗后,患者(随机3:1)接受了为期12周(至第16周)的林尼西巴或安慰剂治疗。患者在电子日记中使用0-10数字评分表(NRS)对瘙痒(每天两次)及其对睡眠的干扰(每天一次)进行评分。每周和每月的瘙痒评分按相应时间段内每日最严重瘙痒评分的平均值计算。在研究访问中,参与者填写了 5-D 瘙痒量表和 PBC-40 生活质量问卷,这两个问卷都包含一个专门针对与瘙痒相关的睡眠障碍的项目。通过对 NRS、5-D 痒度和 PBC-40 的变化进行相关性分析,对瘙痒对睡眠的影响进行了事后评估:在治疗结束时(第 16 周),每周瘙痒评分与睡眠 NRS 评分(r = 0.88 [95% 置信区间 (CI):0.83; 0.91])以及每月瘙痒评分与睡眠 NRS 评分(r = 0.84 [95% CI:0.80; 0.87])与基线相比的变化之间存在很强的相关性。每周瘙痒评分严重程度类别有所改善的患者平均睡眠干扰感知降低。与无瘙痒反应的患者相比,有瘙痒反应的患者(每周瘙痒评分比基线改善≥2分)在每周睡眠NRS评分、5-D瘙痒和PBC-40睡眠项目上的改善幅度更大(结论:瘙痒与睡眠干扰之间存在很强的相关性:PBC患者瘙痒严重程度的变化与睡眠干扰之间存在很强的相关性;减少瘙痒可同时改善睡眠。
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引用次数: 0
Translation and reliability and validity of the Chinese version of Amyotrophic Lateral Sclerosis-Specific Quality of Life-Short Form. 肌萎缩侧索硬化症生活质量简表》中文版的翻译、信度和效度。
IF 2.7 Q3 Medicine Pub Date : 2024-06-10 DOI: 10.1186/s41687-024-00738-4
Zhijie Zhang, Xin He, Jialu Cui, Jing Wang, Baoxin Shi

Objective: To translate Amyotrophic Lateral Sclerosis-Specific Quality of Life-Short Form (ALSSQOL-SF) and test its reliability and validity, so that explore feasibility in Chinese mainland and make up the gap of specific tools for measuring quality of life of patients with ALS.

Methods: This was a cross-sectional design. The Brislin translation model was used to translate ALSSQOL-SF, and the Chinese version of ALSSQOL-SF (C-ALSSQOL-SF) was revised through cultural adaptation and pre-test. The convenience sampling method was used to investigate 138 patients with ALS in Tianjin to test the reliability and validity of the C-ALSSQOL-SF.

Results: The C-ALSSQOL-SF included 20 items, covering 6 dimensions: physical symptoms, bulbar function, negative emotion, interaction with people and the environment, religiosity and intimacy. The scale-level content validity index (S-CVI) of C-ALSSQOL-SF was 0.964, and the item-level content validity index (I-CVI) was between 0.857 to 1.000. The results of Confirmatory Factor Analysis (CFA) showed that CMIN/DF = 1.161, RMSEA = 0.034, GFI = 0.892, IFI = 0.976, TLI = 0.969, CFI = 0.975, and the 6-factor model fitted well. The scores of C-ALSSQOL-SF and WHOQOL-BREF were positively correlated (r = 0.745). The Cronbach's α coefficient of the scale was 0.85, the Cronbach's α coefficient of each dimension was between 0.59 to 0.86, and the split-half reliability was 0.78.

Conclusion: The Chinese version of ALSSQOL-SF has good reliability and validity, and can be used as a tool to evaluate the quality of life of patients with ALS in Chinese mainland.

目的翻译肌萎缩侧索硬化症生活质量短表(ALSSQOL-SF),并测试其信度和效度,以探讨其在中国大陆的可行性,弥补ALS患者生活质量测量专用工具的空白:方法:采用横断面设计。方法:本研究为横断面设计,采用布里斯林翻译模型翻译 ALSSQOL-SF,并通过文化适应和预试验对中文版 ALSSQOL-SF (C-ALSSQOL-SF)进行修订。采用方便抽样法对天津市 138 名 ALS 患者进行调查,以检验 C-ALSSQOL-SF 的信度和效度:C-ALSSQOL-SF包括20个条目,涵盖6个维度:躯体症状、球部功能、负性情绪、与人和环境的互动、宗教信仰和亲密关系。C-ALSSQOL-SF 的量表级内容效度指数(S-CVI)为 0.964,项目级内容效度指数(I-CVI)在 0.857 至 1.000 之间。确证因子分析(CFA)结果显示,CMIN/DF = 1.161,RMSEA = 0.034,GFI = 0.892,IFI = 0.976,TLI = 0.969,CFI = 0.975,6 因子模型拟合良好。C-ALSSQOL-SF 和 WHOQOL-BREF 的得分呈正相关(r = 0.745)。量表的 Cronbach's α 系数为 0.85,各维度的 Cronbach's α 系数在 0.59 至 0.86 之间,二分信度为 0.78:中文版 ALSSQOL-SF 具有良好的信度和效度,可作为评估中国大陆 ALS 患者生活质量的工具。
{"title":"Translation and reliability and validity of the Chinese version of Amyotrophic Lateral Sclerosis-Specific Quality of Life-Short Form.","authors":"Zhijie Zhang, Xin He, Jialu Cui, Jing Wang, Baoxin Shi","doi":"10.1186/s41687-024-00738-4","DOIUrl":"10.1186/s41687-024-00738-4","url":null,"abstract":"<p><strong>Objective: </strong>To translate Amyotrophic Lateral Sclerosis-Specific Quality of Life-Short Form (ALSSQOL-SF) and test its reliability and validity, so that explore feasibility in Chinese mainland and make up the gap of specific tools for measuring quality of life of patients with ALS.</p><p><strong>Methods: </strong>This was a cross-sectional design. The Brislin translation model was used to translate ALSSQOL-SF, and the Chinese version of ALSSQOL-SF (C-ALSSQOL-SF) was revised through cultural adaptation and pre-test. The convenience sampling method was used to investigate 138 patients with ALS in Tianjin to test the reliability and validity of the C-ALSSQOL-SF.</p><p><strong>Results: </strong>The C-ALSSQOL-SF included 20 items, covering 6 dimensions: physical symptoms, bulbar function, negative emotion, interaction with people and the environment, religiosity and intimacy. The scale-level content validity index (S-CVI) of C-ALSSQOL-SF was 0.964, and the item-level content validity index (I-CVI) was between 0.857 to 1.000. The results of Confirmatory Factor Analysis (CFA) showed that CMIN/DF = 1.161, RMSEA = 0.034, GFI = 0.892, IFI = 0.976, TLI = 0.969, CFI = 0.975, and the 6-factor model fitted well. The scores of C-ALSSQOL-SF and WHOQOL-BREF were positively correlated (r = 0.745). The Cronbach's α coefficient of the scale was 0.85, the Cronbach's α coefficient of each dimension was between 0.59 to 0.86, and the split-half reliability was 0.78.</p><p><strong>Conclusion: </strong>The Chinese version of ALSSQOL-SF has good reliability and validity, and can be used as a tool to evaluate the quality of life of patients with ALS in Chinese mainland.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11164839/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141296852","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
期刊
Journal of Patient-Reported Outcomes
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