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Sleep-loss related to itch in atopic dermatitis: assessing content validity and psychometric properties of a patient-reported sleep-loss rating scale. 特应性皮炎患者睡眠不足与瘙痒的关系:评估患者报告的睡眠不足评分量表的内容有效性和心理测量学特性。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-07-22 DOI: 10.1186/s41687-024-00764-2
Alissa Rams, Jessica Baldasaro, Laurine Bunod, Laure Delbecque, Sara Strzok, Juliette Meunier, Hany ElMaraghy, Luna Sun, Evangeline Pierce

Background: Sleep loss is a key factor contributing to disease burden in people with atopic dermatitis (AD). Mitigating itch to improve sleep is an important outcome of AD treatment. This study explored the content validity and measurement properties of the Sleep-Loss Scale, a single-item rating scale for assessing itch interference with sleep in clinical trials of AD treatments.

Methods: Concept elicitation and cognitive debriefing interviews were conducted with 21 adults and adolescents (12-17 years of age) with moderate-to-severe AD to develop a conceptual model of patient experience in AD and explore the content validity of the scale. Data collected from adults with moderate-to-severe AD enrolled in a phase 2b study (NCT03443024) were used to assess Sleep-Loss Scale's psychometric performance, including reliability, construct validity, and ability to detect change. Meaningful within-patient change (MWPC) thresholds were also determined using anchor-based methods.

Results: Qualitative findings from concept elicitation highlighted the importance of sleep-loss related to itch in AD. Debriefing analysis of the Sleep-Loss Scale indicated that the scale was relevant, appropriate, and interpreted as intended. Trial data supported good reliability, construct validity and ability to detect improvement. MWPC was defined as a 1-point improvement using trial data, a finding supported by qualitative data.

Conclusions: The Sleep-Loss Scale provides a valid and reliable patient-reported measure of the impact of itch on sleep in patients with AD, and can detect change, indicating it is fit-for-purpose to evaluate the efficacy of AD treatments in moderate-to-severe patients.

背景:睡眠不足是造成特应性皮炎(AD)患者疾病负担的一个关键因素。减轻瘙痒以改善睡眠是特应性皮炎治疗的一项重要成果。本研究探讨了睡眠损失量表的内容效度和测量特性,该量表是一种单项评分量表,用于评估AD治疗临床试验中痒对睡眠的干扰:对21名患有中重度AD的成人和青少年(12-17岁)进行了概念激发和认知汇报访谈,以建立AD患者体验的概念模型,并探索量表的内容效度。从参加 2b 期研究(NCT03443024)的中重度注意力缺失症成人患者处收集的数据用于评估失眠量表的心理测量性能,包括信度、结构效度和检测变化的能力。此外,还使用基于锚的方法确定了患者内部有意义变化(MWPC)阈值:结果:概念激发的定性研究结果强调了失眠对注意力缺失症患者瘙痒的重要性。对失眠量表的汇报分析表明,该量表是相关的、适当的,并能按照预期进行解释。试验数据证明该量表具有良好的可靠性、结构效度和检测改善的能力。试验数据将MWPC定义为改善1分,定性数据也支持这一结论:失眠量表提供了一种有效、可靠的患者报告测量方法,用于测量瘙痒对AD患者睡眠的影响,并能检测到变化,这表明它适用于评估AD治疗对中重度患者的疗效。
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引用次数: 0
Exploring the factors impacting choice and quality of overnight private hospital stays and consumer perspectives on patient reported experience measures (PREMs) in Australia: a qualitative interview study. 探究影响过夜私立医院住宿选择和质量的因素,以及消费者对澳大利亚患者报告体验措施(PREMs)的看法:一项定性访谈研究。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-07-20 DOI: 10.1186/s41687-024-00755-3
Krista Verlis, Kirsten McCaffery, Tessa Copp, Rachael Dodd, Rebekah Laidsaar-Powell, Brooke Nickel

Objectives: Patient reported experience measures (PREMs) are tools often utilised in hospitals to support quality improvements and to provide objective feedback on care experiences. Less commonly PREMs can be used to support consumers choices in their hospital care. Little is known about the experience and views of the Australian consumer regarding PREMs nor the considerations these consumers have when they need to make decisions about attending hospital. This study aimed to explore consumer awareness of PREMs, consumer attitudes towards PREMs and the utility of PREMs as a decision-making tool in accessing hospital care.

Methods: Qualitative study involving semi-structured interviews conducted over the phone. Participants (n = 40) were recruited from across Australia and purposively sampled according to key characteristics: holding private health insurance, > 30-years of age, may have accessed private hospital care in the past year, variety of educational and cultural backgrounds, and if urban or rural residing. Interviews were audio-recorded, transcribed, and analysed thematically.

Results: Four overarching themes and six subthemes were identified from the data. Major findings were that prior awareness of PREMs was limited; however, many had filled in a PREM either for themselves or for someone they cared for following a hospital stay. Most respondents preferred to listen to experience of self or family/friends or the recommendation of their physician when choosing a hospital to attend. Participants appeared to be more interested in the treating clinician than the hospital with this clinician often dictating the hospital or hospital options. If provided choice in hospital, issues of additional costs, timeliness of treatment and location were important factors.

Conclusion: While PREMs were considered a possible tool to assist in hospital decision-making process, previous hospital experiences, the doctor and knowing up-front cost are an overriding consideration for consumers when choosing their hospital. Consideration to format and presentation of PREMs data is needed to facilitate understanding and allow meaningful comparisons. Future research could examine the considerations of those consumers who primarily access public healthcare facilities and how to improve the utility of PREMs.

目的:患者报告体验测量(PREMs)是医院经常使用的工具,用于支持质量改进和提供有关护理体验的客观反馈。较少见的是,PREMs 可用于支持消费者选择医院护理。澳大利亚消费者对PREMs的体验和看法,以及他们在需要做出住院决定时的考虑因素都鲜为人知。本研究旨在探讨消费者对 PREMs 的认识、消费者对 PREMs 的态度以及 PREMs 作为医院护理决策工具的效用:定性研究:通过电话进行半结构化访谈。参与者(n = 40)从澳大利亚各地招募,根据主要特征有目的性地抽样:持有私人医疗保险、年龄大于 30 岁、在过去一年中可能使用过私人医院护理、具有不同的教育和文化背景、居住在城市或农村。对访谈进行了录音、转录和专题分析:结果:从数据中确定了四个总体主题和六个次主题。主要发现是,受访者之前对 PREM 的了解有限;但是,许多人在住院后为自己或自己照顾的人填写过 PREM。在选择就诊医院时,大多数受访者更愿意听取自己或家人/朋友的经验或医生的建议。与医院相比,受访者似乎对主治医生更感兴趣,因为医院或医院选择往往由主治医生决定。如果可以选择医院,额外费用、治疗的及时性和地点也是重要因素:虽然 PREMs 被认为是协助医院决策过程的一种可能工具,但以往的医院经验、医生和了解预付费用是消费者选择医院时的首要考虑因素。需要考虑 PREMs 数据的格式和呈现方式,以便于理解和进行有意义的比较。未来的研究可以探讨那些主要使用公立医疗机构的消费者的考虑因素,以及如何提高 PREMs 的实用性。
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引用次数: 0
Comparison of the EQ-5D-5L and the patient-reported outcomes measurement information system preference score (PROPr) in the United States. 美国 EQ-5D-5L 与患者报告结果测量信息系统偏好评分 (PROPr) 的比较。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-07-19 DOI: 10.1186/s41687-024-00749-1
Ron D Hays, Maria Orlando Edelen, Anthony Rodriguez, Nabeel Qureshi, David Feeny, Patricia M Herman

Background: In contrast to prior research, our study presents longitudinal comparisons of the EQ-5D-5L and Patient-Reported Outcomes Measurement Information System (PROMIS) preference (PROPr) scores. This fills a gap in the literature, providing a much-needed understanding of these preference-based measures and their applications in healthcare research. Furthermore, our study provides equations to estimate one measure from the other, a tool that can significantly facilitate comparisons across studies.

Methods: We administered a health survey to 4,098 KnowledgePanel® members living in the United States. A subset of 1,256 (82% response rate) with back pain also completed the six-month follow-up survey. We then conducted thorough cross-sectional and longitudinal analyses of the two measures, including product-moment correlations between scores, associations with demographic variables, and health conditions. To estimate one measure from the other, we used ordinary least squares (OLS) regression with the baseline data from the general population.

Results: The correlation between the EQ-5D-5L and PROPr scores was 0.69, but the intraclass correlation was only 0.34 because the PROPr had lower (less positive) mean scores on the 0 (dead) to 1 (perfect health) continuum than the EQ-5D-5L. The associations between the two preference measures and demographic variables were similar at baseline. The product-moment correlation between unstandardized beta coefficients for each preference measure regressed on 22 health conditions was 0.86, reflecting similar patterns of unique associations. Correlations of change from baseline to 6 months in the two measures with retrospective perceptions of change were similar. Adjusted variance explained in OLS regressions predicting one measure from the other was 48%. On average, the predicted values were within a half-standard deviation of the observed EQ-5D-5L and PROPr scores. The beta-binomial regression model slightly improved over the OLS model in predicting the EQ-5D-5L from the PROPr but was equivalent to the OLS model in predicting the PROPr.

Conclusion: Despite substantial mean differences, the EQ-5D-5L and PROPr have similar cross-sectional and longitudinal associations with other variables. We provide the OLS regression equations for use in cost-effectiveness research and meta-analyses. Future studies are needed to compare these measures with different conditions and interventions to provide more information on their relative validity.

背景:与之前的研究不同,我们的研究对 EQ-5D-5L 和患者报告结果测量信息系统 (PROMIS) 偏好 (PROPr) 分数进行了纵向比较。这填补了文献中的空白,使人们对这些基于偏好的测量方法及其在医疗保健研究中的应用有了亟需的了解。此外,我们的研究还提供了从一个测量值估算另一个测量值的方程,这一工具可极大地促进不同研究间的比较:我们对居住在美国的 4,098 名 KnowledgePanel® 会员进行了健康调查。其中 1,256 人(回复率为 82%)患有背痛,他们也完成了为期 6 个月的跟踪调查。然后,我们对这两项指标进行了全面的横向和纵向分析,包括分数之间的乘积矩相关性、与人口统计学变量和健康状况的关联。为了估算一个指标与另一个指标之间的关系,我们使用普通最小二乘法(OLS)对普通人群的基线数据进行了回归:结果:EQ-5D-5L 和 PROPr 分数之间的相关性为 0.69,但等级内相关性仅为 0.34,这是因为 PROPr 在 0(死亡)到 1(完全健康)的连续区间内的平均分数低于 EQ-5D-5L(正相关性较低)。基线时,两种偏好测量与人口统计学变量之间的相关性相似。每种偏好测量法与 22 种健康状况回归的非标准化贝塔系数之间的乘积-矩相关系数为 0.86,反映了相似的独特关联模式。两个测量指标从基线到 6 个月的变化与回顾性变化感知的相关性相似。在 OLS 回归中,从一项测量预测另一项测量的调整方差解释率为 48%。平均而言,预测值与观察到的 EQ-5D-5L 和 PROPr 分数相差不到半个标准差。在根据 PROPr 预测 EQ-5D-5L 时,β-二叉回归模型比 OLS 模型略胜一筹,但在预测 PROPr 时,β-二叉回归模型与 OLS 模型相当:结论:尽管 EQ-5D-5L 和 PROPr 的平均值存在很大差异,但它们与其他变量的横向和纵向关系相似。我们提供的 OLS 回归方程可用于成本效益研究和荟萃分析。未来的研究需要将这些测量方法与不同的条件和干预措施进行比较,以提供更多关于其相对有效性的信息。
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引用次数: 0
Self and proxy symptom reporting in glioma patient-caregiver dyads: the role of psychosocial function in rating accuracy. 胶质瘤患者-护理者二人组的自我和代理症状报告:社会心理功能在评分准确性中的作用。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-07-17 DOI: 10.1186/s41687-024-00726-8
Meagan Whisenant, Stella Snyder, Shiao-Pei Weathers, Eduardo Bruera, Kathrin Milbury

Background: Illness-related communication and depressive symptoms within families may play an important role in caregivers' ability to accurately understand patients' symptom burden. We examined the associations between these psychosocial factors and symptom accuracy in patients with glioma and their family caregivers.

Methods: Patients and caregivers (n = 67 dyads) completed measures of depressive symptoms (CES-D), illness communication (CICS), and QOL (SF-36). Patients reported on their own cancer-related symptoms (MDASI-BT) while caregivers reported on their perception of the patients' symptoms (i.e., proxy reporting). Paired t-tests and difference scores were used to test for agreement (absolute value of difference scores between patients and caregiver proxy symptom and interference severity reports) and accuracy (caregiver underestimation, overestimation, or accurate estimation of patient symptom and interference severity).

Results: Clinically significant disagreement was found for all means scores of the MDASI-BT subscales except for gastrointestinal symptoms and general symptoms. Among caregivers, 22% overestimated overall symptom severity and 32% overestimated overall symptom interference. In addition, 13% of caregivers underestimated overall symptom severity and 21% of caregivers underestimated overall symptom interference. Patient illness communication was associated with agreement of overall symptom severity (r=-0.27, p = 0.03) and affective symptom subscale (r=-0.34, p < 0.01). Caregivers' reporting of illness communication (r=-0.33, p < 0.01) and depressive symptoms (r = 0.46, p < 0.0001) were associated with agreement of symptom interference. Caregiver underestimating symptom severity was associated with lower patient physical QOL (p < 0.01); caregiver underestimating symptom interference was associated with lower patient physical QOL (p < 0.0001) and overestimating symptom interference was associated with lower patient physical QOL (p < 0.05). Patient and caregiver mental QOL was associated with caregiver underestimating (p < 0.05) and overestimating (p < 0.05) symptom severity.

Conclusion: The psychosocial context of the family plays an important role in the accuracy of symptom understanding. Inaccurately understanding patients experience is related to poor QOL for both patients and caregivers, pointing to important targets for symptom management interventions that involve family caregivers.

背景:家庭中与疾病相关的交流和抑郁症状可能对照顾者准确理解患者症状负担的能力起到重要作用。我们研究了这些心理社会因素与胶质瘤患者及其家庭照顾者的症状准确性之间的关系:患者和照顾者(n = 67 对)完成了抑郁症状(CES-D)、疾病沟通(CICS)和 QOL(SF-36)的测量。患者报告自己的癌症相关症状(MDASI-BT),而护理人员报告他们对患者症状的看法(即代理报告)。采用配对 t 检验和差分来检验一致性(患者和护理人员代理症状和干扰严重程度报告之间差分的绝对值)和准确性(护理人员对患者症状和干扰严重程度的低估、高估或准确估计):结果:除胃肠道症状和一般症状外,MDASI-BT 各分量表的所有平均得分均存在明显的临床分歧。在护理人员中,22%的人高估了总体症状严重程度,32%的人高估了总体症状干扰程度。此外,13% 的护理人员低估了总体症状严重程度,21% 的护理人员低估了总体症状干扰程度。患者疾病沟通与总体症状严重程度(r=-0.27,p = 0.03)和情感症状分量表(r=-0.34,p 结论:患者疾病沟通与总体症状严重程度(r=-0.27,p = 0.03)和情感症状分量表(r=-0.34,p = 0.03)的一致性相关:家庭的社会心理环境对症状理解的准确性起着重要作用。对患者经历的理解不准确与患者和护理人员的 QOL 差异有关,这为涉及家庭护理人员的症状管理干预措施指明了重要目标。
{"title":"Self and proxy symptom reporting in glioma patient-caregiver dyads: the role of psychosocial function in rating accuracy.","authors":"Meagan Whisenant, Stella Snyder, Shiao-Pei Weathers, Eduardo Bruera, Kathrin Milbury","doi":"10.1186/s41687-024-00726-8","DOIUrl":"10.1186/s41687-024-00726-8","url":null,"abstract":"<p><strong>Background: </strong>Illness-related communication and depressive symptoms within families may play an important role in caregivers' ability to accurately understand patients' symptom burden. We examined the associations between these psychosocial factors and symptom accuracy in patients with glioma and their family caregivers.</p><p><strong>Methods: </strong>Patients and caregivers (n = 67 dyads) completed measures of depressive symptoms (CES-D), illness communication (CICS), and QOL (SF-36). Patients reported on their own cancer-related symptoms (MDASI-BT) while caregivers reported on their perception of the patients' symptoms (i.e., proxy reporting). Paired t-tests and difference scores were used to test for agreement (absolute value of difference scores between patients and caregiver proxy symptom and interference severity reports) and accuracy (caregiver underestimation, overestimation, or accurate estimation of patient symptom and interference severity).</p><p><strong>Results: </strong>Clinically significant disagreement was found for all means scores of the MDASI-BT subscales except for gastrointestinal symptoms and general symptoms. Among caregivers, 22% overestimated overall symptom severity and 32% overestimated overall symptom interference. In addition, 13% of caregivers underestimated overall symptom severity and 21% of caregivers underestimated overall symptom interference. Patient illness communication was associated with agreement of overall symptom severity (r=-0.27, p = 0.03) and affective symptom subscale (r=-0.34, p < 0.01). Caregivers' reporting of illness communication (r=-0.33, p < 0.01) and depressive symptoms (r = 0.46, p < 0.0001) were associated with agreement of symptom interference. Caregiver underestimating symptom severity was associated with lower patient physical QOL (p < 0.01); caregiver underestimating symptom interference was associated with lower patient physical QOL (p < 0.0001) and overestimating symptom interference was associated with lower patient physical QOL (p < 0.05). Patient and caregiver mental QOL was associated with caregiver underestimating (p < 0.05) and overestimating (p < 0.05) symptom severity.</p><p><strong>Conclusion: </strong>The psychosocial context of the family plays an important role in the accuracy of symptom understanding. Inaccurately understanding patients experience is related to poor QOL for both patients and caregivers, pointing to important targets for symptom management interventions that involve family caregivers.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"74"},"PeriodicalIF":2.4,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11255136/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141627950","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
Capturing patient-reported sleep disturbance in atopic dermatitis clinical trials. 在特应性皮炎临床试验中捕捉患者报告的睡眠障碍。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-07-15 DOI: 10.1186/s41687-024-00751-7
Carla Dias-Barbosa, Jonathan I Silverberg, Sonja Ständer, Danielle Rodriguez, Fatoumata Fofana, Dina Filipenko, Liliana Ulianov, Christophe Piketty, Jorge Puelles

Background: Patient-focused approaches to capturing day-to-day variability in sleep disturbance are needed to properly evaluate the sleep benefits of new treatments. Such approaches rely on patient-reported outcome (PRO) measures validated in the target patient population.

Methods: Using atopic dermatitis (AD) as an example of a disease in which sleep is commonly disturbed, we developed a strategy for measuring sleep disturbance in AD trials. In developing this strategy, we conducted a targeted literature review and held concept elicitation interviews with adolescents and adults with AD. We subsequently identified potentially suitable PRO measures and cognitively debriefed them. Finally, we evaluated their psychometric properties using data from phase 2b (NCT03100344) and phase 3 (NCT03985943 and NCT03989349) clinical trials.

Results: The literature review confirmed that sleep disturbance is a key impact of AD but failed to identify validated PRO measures for assessing fluctuations in sleep disturbance. Subsequent concept elicitation interviews confirmed the multidimensional nature of sleep disturbance in AD and supported use of a single-item measure to assess overall sleep disturbance severity, complemented by a diary to capture individual components of sleep disturbance. The single-item sleep disturbance numerical rating scale (SD NRS) and multi-item Subject Sleep Diary (SSD)-an AD-adapted version of the Consensus Sleep Diary-were identified as potentially suitable PRO measures. Cognitive debriefing of the SD NRS and SSD demonstrated their content validity and their understandability to patients. Psychometric analyses based on AD trial data showed that the SD NRS is a well-defined, reliable, and fit-for-purpose measure of sleep disturbance in adults with AD. Furthermore, the SD NRS correlated with many SSD sleep parameters, suggesting that most concepts from the SSD can be covered using the SD NRS.

Conclusions: Using these findings, we developed an approach for measuring sleep disturbance in AD trials. Subject to further research, the same approach could also be applied to future trials of other skin diseases where itch causes sleep disturbance.

背景:为了正确评估新疗法对睡眠的益处,需要采用以患者为中心的方法来捕捉睡眠障碍的日常变化。这种方法依赖于在目标患者群体中验证的患者报告结果(PRO)测量:方法:以特应性皮炎(AD)为例,我们开发了一种在特应性皮炎试验中测量睡眠障碍的策略。在制定该策略的过程中,我们进行了有针对性的文献回顾,并与患有特应性皮炎的青少年和成人进行了概念激发访谈。随后,我们确定了可能合适的 PRO 测量方法,并对其进行了认知汇报。最后,我们利用第 2b 期(NCT03100344)和第 3 期(NCT03985943 和 NCT03989349)临床试验的数据对其心理计量特性进行了评估:文献综述证实睡眠障碍是注意力缺失症的一个主要影响因素,但未能找到有效的PRO测量方法来评估睡眠障碍的波动。随后进行的概念征询访谈证实了AD患者睡眠障碍的多维性,并支持使用单项测量方法来评估整体睡眠障碍的严重程度,同时辅以日记来记录睡眠障碍的各个组成部分。单项目睡眠障碍数字评分量表(SD NRS)和多项目受试者睡眠日记(SSD)--共识睡眠日记的AD改编版--被认为是潜在的合适PRO测量方法。对 SD NRS 和 SSD 进行的认知汇报证明了其内容的有效性和患者的可理解性。基于 AD 试验数据的心理计量分析表明,SD NRS 是一种定义明确、可靠且适用于 AD 成人睡眠障碍的测量方法。此外,SD NRS 还与许多 SSD 睡眠参数相关,这表明 SD NRS 可以涵盖 SSD 中的大多数概念:利用这些发现,我们开发了一种测量 AD 试验中睡眠障碍的方法。有待进一步研究,同样的方法也可应用于未来其他皮肤病的试验中,因为瘙痒会导致睡眠障碍。
{"title":"Capturing patient-reported sleep disturbance in atopic dermatitis clinical trials.","authors":"Carla Dias-Barbosa, Jonathan I Silverberg, Sonja Ständer, Danielle Rodriguez, Fatoumata Fofana, Dina Filipenko, Liliana Ulianov, Christophe Piketty, Jorge Puelles","doi":"10.1186/s41687-024-00751-7","DOIUrl":"10.1186/s41687-024-00751-7","url":null,"abstract":"<p><strong>Background: </strong>Patient-focused approaches to capturing day-to-day variability in sleep disturbance are needed to properly evaluate the sleep benefits of new treatments. Such approaches rely on patient-reported outcome (PRO) measures validated in the target patient population.</p><p><strong>Methods: </strong>Using atopic dermatitis (AD) as an example of a disease in which sleep is commonly disturbed, we developed a strategy for measuring sleep disturbance in AD trials. In developing this strategy, we conducted a targeted literature review and held concept elicitation interviews with adolescents and adults with AD. We subsequently identified potentially suitable PRO measures and cognitively debriefed them. Finally, we evaluated their psychometric properties using data from phase 2b (NCT03100344) and phase 3 (NCT03985943 and NCT03989349) clinical trials.</p><p><strong>Results: </strong>The literature review confirmed that sleep disturbance is a key impact of AD but failed to identify validated PRO measures for assessing fluctuations in sleep disturbance. Subsequent concept elicitation interviews confirmed the multidimensional nature of sleep disturbance in AD and supported use of a single-item measure to assess overall sleep disturbance severity, complemented by a diary to capture individual components of sleep disturbance. The single-item sleep disturbance numerical rating scale (SD NRS) and multi-item Subject Sleep Diary (SSD)-an AD-adapted version of the Consensus Sleep Diary-were identified as potentially suitable PRO measures. Cognitive debriefing of the SD NRS and SSD demonstrated their content validity and their understandability to patients. Psychometric analyses based on AD trial data showed that the SD NRS is a well-defined, reliable, and fit-for-purpose measure of sleep disturbance in adults with AD. Furthermore, the SD NRS correlated with many SSD sleep parameters, suggesting that most concepts from the SSD can be covered using the SD NRS.</p><p><strong>Conclusions: </strong>Using these findings, we developed an approach for measuring sleep disturbance in AD trials. Subject to further research, the same approach could also be applied to future trials of other skin diseases where itch causes sleep disturbance.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"73"},"PeriodicalIF":2.4,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11250737/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141617301","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
Validity and reliability of the Greek Migraine-Specific Quality of Life Questionnaire (MSQ Version 2.1-GR). 希腊偏头痛生活质量问卷(MSQ 2.1-GR 版)的有效性和可靠性。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-07-15 DOI: 10.1186/s41687-024-00762-4
Ermioni Giannouli, Eleni Giannouli, Athanasia Alexoudi, Chryssa Arvaniti, Nikolaos Fakas, Theodoros S Constantinidis, Evangelos Kouremenos, Dimos-Dimitrios Mitsikostas

Background: To assess the validity and reliability of the Migraine-Specific Quality of Life Questionnaire 2.1 (MSQv.2.1) in a group of Greek migraineurs.

Design-sample-methods: The Greek version of MSQv.2.1 (MSQv.2.1-GR), a self-report measure with 14 items in 3 domains (Role Restrictive (RR), Role Preventive (RP) and Emotional Function (EF)), was administered during a cross-sectional study to 141 Greek adult migraineurs and 135 controls without migraine or any other primary headache disorder, along with Migraine Disability Assessment Scale (MIDAS) and Short Form Health Survey (SF-12) to assess validity. MSQv.2.1-GR was re-administered in a group of participants with migraine two weeks afterwards to assess reliability. Content and construct validity was assessed using Intraclass Correlation Coefficient (ICC), Spearman rho, McDonald's omega, Cronbach's alpha. Confirmatory factor analysis (CFA) was used to test the latent structure of the MSQv.2.1-GR in migraineurs.

Results: A total of 276 adults participated in the study. Internal consistency of the three MSQv.2.1-GR scales RR, RP and EF yielded a range of McDonald's omega from 0.832 to 0.923 (Cronbach's alpha from 0.814 to 0.923). CFA confirmed the proposed three-factor MSQv.2.1-GR latent structure with acceptable goodness of fit indices and factor loadings. Correlations were established between MSQv2.1-GR component and MIDAS scores, showing moderate and statistically significant relationships (from - 0.519 to -0.562, all p < 0.001) for RR, RP and EF. Correlations between MSQv2.1-GR and SF-12 component scores were identified, with values from 0.1 to 0.4, indicating low to moderate associations. ICC was calculated at 0.997, indicating a high level of reliability between the measures. Notably, all MSQv2.1-GR scores (RR, RP, EF) were significantly higher in the controls compared to migraineurs (p < 0.001 for all scales). These findings suggest that MSQv2.1-GR is internally consistent, shows significant correlations with relevant measures, and is effective in discriminating controls from migraineurs.

Conclusion: MSQv2.1-GR is a valid and reliable tool to determine the effect migraine has on the quality of life of Greek-speaking migraineurs.

背景:评估偏头痛患者生活质量问卷 2.1(MSQv.2.1)的有效性和可靠性:目的:评估偏头痛生活质量问卷2.1(MSQv.2.1)在一组希腊偏头痛患者中的有效性和可靠性:希腊语版MSQv.2.1(MSQv.2.1-GR)是一种自我报告测量方法,包含3个领域(角色限制(RR)、角色预防(RP)和情感功能(EF))的14个项目,在一项横断面研究中对141名希腊成年偏头痛患者和135名无偏头痛或任何其他原发性头痛疾病的对照者进行了测量,同时还进行了偏头痛残疾评估量表(MIDAS)和简表健康调查(SF-12)以评估其有效性。MSQv.2.1-GR在两周后对一组患有偏头痛的参与者进行了重新施测,以评估其可靠性。采用类内相关系数(ICC)、Spearman rho、McDonald's omega和Cronbach's alpha评估内容和结构的有效性。对偏头痛患者的MSQv.2.1-GR采用了确认性因子分析(CFA)来测试其潜在结构:结果:共有276名成人参加了研究。MSQv.2.1-GR的三个量表RR、RP和EF的内部一致性为0.832至0.923(Cronbach's alpha为0.814至0.923)。CFA证实了所提出的三因素MSQv.2.1-GR潜在结构,其拟合优度指数和因素负荷均可接受。MSQv2.1-GR 分量与 MIDAS 分数之间建立了相关关系,显示出中等程度的统计学显著关系(从-0.519 到-0.562,均为 p):MSQv2.1-GR是确定偏头痛对希腊语偏头痛患者生活质量影响的有效而可靠的工具。
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引用次数: 0
The association between malnutrition risk and revised Edmonton Symptom Assessment System (ESAS-r) scores in an adult outpatient oncology population: a cross-sectional study. 成人肿瘤门诊患者营养不良风险与修订版埃德蒙顿症状评估系统 (ESAS-r) 评分之间的关联:一项横断面研究。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-07-12 DOI: 10.1186/s41687-024-00750-8
Katherine McLay, Nicole Stonewall, Laura Forbes, Christine Peters

Background: Cancer-associated malnutrition is associated with worse symptom severity, functional status, quality of life, and overall survival. Malnutrition in cancer patients is often under-recognized and undertreated, emphasizing the need for standardized pathways for nutritional management in this population. The objectives of this study were to (1) investigate the relationship between malnutrition risk and self-reported symptom severity scores in an adult oncology outpatient population and (2) to identify whether a secondary screening tool for malnutrition risk (abPG-SGA) should be recommended for patients with a specific ESAS-r cut-off score or group of ESAS-r cut-off scores.

Methods: A single-institution retrospective cross-sectional study was conducted. Malnutrition risk was measured using the Abridged Patient-Generated Subjective Global Assessment (abPG-SGA). Cancer symptom severity was measured using the Revised Edmonton Symptom Assessment System (ESAS-r). In accordance with standard institutional practice, patients completed both tools at first consult at the cancer centre. Adult patients who completed the ESAS-r and abPG-SGA on the same day between February 2017 and January 2020 were included. Spearman's correlation, Mann Whitney U tests, receiver operating characteristic curves, and binary logistic regression models were used for statistical analyses.

Results: 2071 oncology outpatients met inclusion criteria (mean age 65.7), of which 33.6% were identified to be at risk for malnutrition. For all ESAS-r parameters (pain, tiredness, drowsiness, nausea, lack of appetite, shortness of breath, depression, anxiety, and wellbeing), patients at risk for malnutrition had significantly higher scores (P < 0.001). All ESAS-r parameters were positively correlated with abPG-SGA score (P < 0.01). The ESAS-r parameters that best predicted malnutrition risk status were total ESAS-r score, lack of appetite, tiredness, and wellbeing (area under the curve = 0.824, 0.812, 0.764, 0.761 respectively). Lack of appetite score ≥ 1 demonstrated a sensitivity of 77.4% and specificity of 77.0%. Combining lack of appetite score ≥ 1 with total ESAS score > 14 yielded a sensitivity of 87.9% and specificity of 62.8%.

Conclusion: Malnutrition risk as measured by the abPG-SGA and symptom severity scores as measured by the ESAS-r are positively and significantly correlated. Given the widespread use of the ESAS-r in cancer care, utilizing specific ESAS-r cut-offs to trigger malnutrition screening could be a viable way to identify cancer patients at risk for malnutrition.

背景:癌症相关营养不良与症状严重程度、功能状态、生活质量和总体生存率下降有关。癌症患者的营养不良往往未得到充分认识和治疗,因此需要对这一人群进行标准化的营养管理。本研究的目的是:(1) 调查成人肿瘤门诊患者营养不良风险与自我报告症状严重程度评分之间的关系;(2) 确定是否应针对特定 ESAS-r 临界评分或一组 ESAS-r 临界评分的患者推荐使用营养不良风险二级筛查工具(abPG-SGA):进行了一项单一机构的回顾性横断面研究。营养不良风险采用简略患者主观全面评估(abPG-SGA)进行测量。癌症症状严重程度采用修订版埃德蒙顿症状评估系统(ESAS-r)进行测量。根据机构的标准做法,患者在癌症中心首次就诊时填写这两种工具。2017年2月至2020年1月期间在同一天完成ESAS-r和abPG-SGA的成人患者均被纳入其中。统计分析采用斯皮尔曼相关性、曼-惠特尼U检验、接收器操作特征曲线和二元逻辑回归模型。结果:2071名肿瘤门诊患者符合纳入标准(平均年龄65.7岁),其中33.6%的患者被确定为有营养不良风险。在 ESAS-r 的所有参数(疼痛、疲倦、嗜睡、恶心、食欲不振、呼吸急促、抑郁、焦虑和幸福感)中,有营养不良风险的患者得分明显更高(P 14 的灵敏度为 87.9%,特异性为 62.8%):结论:abPG-SGA测量的营养不良风险与ESAS-r测量的症状严重程度得分呈显著正相关。鉴于ESAS-r在癌症护理中的广泛应用,利用特定的ESAS-r临界值来触发营养不良筛查可能是一种识别有营养不良风险的癌症患者的可行方法。
{"title":"The association between malnutrition risk and revised Edmonton Symptom Assessment System (ESAS-r) scores in an adult outpatient oncology population: a cross-sectional study.","authors":"Katherine McLay, Nicole Stonewall, Laura Forbes, Christine Peters","doi":"10.1186/s41687-024-00750-8","DOIUrl":"10.1186/s41687-024-00750-8","url":null,"abstract":"<p><strong>Background: </strong>Cancer-associated malnutrition is associated with worse symptom severity, functional status, quality of life, and overall survival. Malnutrition in cancer patients is often under-recognized and undertreated, emphasizing the need for standardized pathways for nutritional management in this population. The objectives of this study were to (1) investigate the relationship between malnutrition risk and self-reported symptom severity scores in an adult oncology outpatient population and (2) to identify whether a secondary screening tool for malnutrition risk (abPG-SGA) should be recommended for patients with a specific ESAS-r cut-off score or group of ESAS-r cut-off scores.</p><p><strong>Methods: </strong>A single-institution retrospective cross-sectional study was conducted. Malnutrition risk was measured using the Abridged Patient-Generated Subjective Global Assessment (abPG-SGA). Cancer symptom severity was measured using the Revised Edmonton Symptom Assessment System (ESAS-r). In accordance with standard institutional practice, patients completed both tools at first consult at the cancer centre. Adult patients who completed the ESAS-r and abPG-SGA on the same day between February 2017 and January 2020 were included. Spearman's correlation, Mann Whitney U tests, receiver operating characteristic curves, and binary logistic regression models were used for statistical analyses.</p><p><strong>Results: </strong>2071 oncology outpatients met inclusion criteria (mean age 65.7), of which 33.6% were identified to be at risk for malnutrition. For all ESAS-r parameters (pain, tiredness, drowsiness, nausea, lack of appetite, shortness of breath, depression, anxiety, and wellbeing), patients at risk for malnutrition had significantly higher scores (P < 0.001). All ESAS-r parameters were positively correlated with abPG-SGA score (P < 0.01). The ESAS-r parameters that best predicted malnutrition risk status were total ESAS-r score, lack of appetite, tiredness, and wellbeing (area under the curve = 0.824, 0.812, 0.764, 0.761 respectively). Lack of appetite score ≥ 1 demonstrated a sensitivity of 77.4% and specificity of 77.0%. Combining lack of appetite score ≥ 1 with total ESAS score > 14 yielded a sensitivity of 87.9% and specificity of 62.8%.</p><p><strong>Conclusion: </strong>Malnutrition risk as measured by the abPG-SGA and symptom severity scores as measured by the ESAS-r are positively and significantly correlated. Given the widespread use of the ESAS-r in cancer care, utilizing specific ESAS-r cut-offs to trigger malnutrition screening could be a viable way to identify cancer patients at risk for malnutrition.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"71"},"PeriodicalIF":2.4,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11245459/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141591616","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
Resilience and quality of life in patients who underwent mechanical ventilation due to COVID-19, one year after discharge: a cross-sectional study. 因 COVID-19 而接受机械通气的患者出院一年后的恢复能力和生活质量:一项横断面研究。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-07-12 DOI: 10.1186/s41687-024-00748-2
David Rene Rodriguez Lima, Cristhian Rubio Ramos, Mateo Andrés Diaz Quiroz, Edith Elianna Rodríguez Aparicio, Leonardo Andrés Gómez Cortes, Laura Otálora González, Gilma Hernández-Herrera, Ángela María Pinzón Rondón, Ángela María Ruiz Sternberg

Background: Patients with COVID-19 often experience severe long-term sequelae. This study aimed to assess resilience and Quality of Life (QoL) of patients who underwent mechanical ventilation due to COVID-19, one year after discharge.

Methods: This cross-sectional study enrolled patients who received mechanical ventilation for severe COVID-19 and were assessed one-year post-discharge. Participants completed a structured questionnaire via telephone comprising the Connor-Davidson Resilience Scale (CD-RISC) and the Post-COVID-19 Functional Status scale (PCFS). To establish the association between QoL and resilience, Spearman correlations were calculated between the PCFS and the CD-RISC. Linear regression models were adjusted to evaluate which factors were associated with QoL, with the total score of PCFS as the dependent variable.

Results: A total of 225 patients were included in the analysis. The CD-RISC had a median score of 83 (IQR 74-91). The PCFS results showed that 61.3% (n = 138) of the patients were able to resume their daily activities without limitations. Among them, 37.3% (n = 84) were classified as Grade 0 and 24% (n = 54) as Grade 1. Mild and moderate functional limitations were found in 33.7% of the patients, with 24.8% (n = 56) classified as Grade 2 and 8.8% (n = 20) as Grade 3. Severe functional limitations (Grade 4) were observed in 4.8% (n = 11) of the patients. High CD-RISC scores were associated with lower levels of PCFS score (p < 0.001).

Conclusions: In this cohort of critically ill patients who underwent mechanical ventilation due to COVID-19, 38% of patients experienced a significant decline in their QoL one year after hospital discharge. Finally, a high level of resilience was strongly associated with better QoL one year after discharge.

背景:COVID-19 患者通常会经历严重的长期后遗症。本研究旨在评估因 COVID-19 而接受机械通气的患者出院一年后的恢复能力和生活质量(QoL):这项横断面研究招募了因严重 COVID-19 而接受机械通气的患者,并对其出院一年后的情况进行了评估。参与者通过电话填写了一份结构化问卷,其中包括康纳-戴维森复原力量表(CD-RISC)和COVID-19后功能状态量表(PCFS)。为了确定 QoL 与复原力之间的关联,计算了 PCFS 与 CD-RISC 之间的斯皮尔曼相关性。以 PCFS 总分为因变量,调整线性回归模型以评估哪些因素与 QoL 相关:结果:共有 225 名患者参与了分析。CD-RISC 的中位数为 83 分(IQR 74-91)。PCFS 结果显示,61.3%(n = 138)的患者能够恢复日常活动而不受任何限制。其中,37.3%(84 人)为 0 级,24%(54 人)为 1 级。33.7%的患者存在轻度和中度功能限制,24.8%(56 人)为 2 级,8.8%(20 人)为 3 级。4.8%的患者(11 人)出现严重功能限制(4 级)。高 CD-RISC 评分与较低的 PCFS 评分水平相关(p 结论:高 CD-RISC 评分与较低的 PCFS 评分水平相关:在这批因 COVID-19 而接受机械通气的重症患者中,38% 的患者在出院一年后生活质量显著下降。最后,高水平的复原力与出院一年后更好的生活质量密切相关。
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引用次数: 0
Demonstrating the benefit of a cellulitis-specific patient reported outcome measure (CELLUPROM©) as part of the National Cellulitis Improvement Programme in Wales. 作为威尔士全国蜂窝组织炎改善计划的一部分,展示蜂窝组织炎特定患者报告结果测量(CELLUPROM©)的益处。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-07-10 DOI: 10.1186/s41687-024-00754-4
Marie Gabe-Walters, Melanie Thomas, Linda Jenkins

Purpose: Despite a known risk of cellulitis recurrence, the management of the wider impact and risk factors has been neglected. The innovative National Cellulitis Improvement Programme (NCIP) addresses this by providing evidence-based and individualised care to improve patient reported outcomes and reduce the risk of recurrence. The aim of this paper is to examine the longer-term impact of cellulitis and to identify a suitable and clinically relevant Patient Reported Outcome Measure (PROM).

Methods: A review of existing cellulitis-specific PROMs was undertaken, alongside literature detailing the patient-focused impact of cellulitis, to identify a suitable PROM for clinical use. A group of expert therapists and patient representatives (n = 14) shared their individual and collective experiences over a series of events to discuss and debate the impact of cellulitis and review available PROMs. CELLUPROM© is introduced with anonymised PROM data and case study information reported to establish the impact of CELLUPROM© within usual NCIP care.

Results: No cellulitis-specific PROMs were identified. Literature focused on the signs and symptoms of an acute episode of cellulitis, with outcome measures primarily used to evidence the impact of an intervention. An enduring physical, social and emotional impact of cellulitis was identified in this study, providing the basis for the new cellulitis-specific PROM (CELLUPROM©), which has been implemented with good effect in clinical care.

Conclusion: This study has highlighted the lasting impact of cellulitis. Using CELLUPROM© within the risk-reduction NCIP has helped develop Value-Based Healthcare and support programme evaluation.

目的:尽管已知蜂窝织炎有复发的风险,但对更广泛的影响和风险因素的管理却一直被忽视。创新性的全国蜂窝组织炎改善计划(NCIP)通过提供循证和个性化护理来改善患者的治疗效果并降低复发风险,从而解决这一问题。本文旨在研究蜂窝组织炎的长期影响,并确定一个合适且与临床相关的患者报告结果测量指标(PROM):方法:我们对现有的蜂窝组织炎专用PROM进行了回顾,同时还查阅了详细说明蜂窝组织炎对患者影响的文献,以确定适合临床使用的PROM。一组专家治疗师和患者代表(n = 14)在一系列活动中分享了他们的个人和集体经验,就蜂窝组织炎的影响进行了讨论和辩论,并对现有的 PROM 进行了回顾。介绍了 CELLUPROM©,并报告了匿名的 PROM 数据和病例研究信息,以确定 CELLUPROM© 在常规 NCIP 护理中的影响:结果:未发现针对蜂窝组织炎的 PROM。文献主要集中在蜂窝组织炎急性发作的体征和症状上,而结果测量主要用于证明干预措施的影响。本研究确定了蜂窝组织炎对身体、社会和情感的持久影响,为新的蜂窝组织炎专用PROM(CELLUPROM©)提供了基础,该PROM已在临床护理中得到了良好的应用:结论:本研究强调了蜂窝组织炎的长期影响。在降低风险的国家医疗保险计划(NCIP)中使用 CELLUPROM©,有助于发展以价值为基础的医疗保健并支持计划评估。
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引用次数: 0
Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024. 结果测量工具 (OMI) 系统综述报告指南:用于 OMIs 的 PRISMA-COSMIN 2024。
IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-07-09 DOI: 10.1186/s41687-024-00727-7
Ellen B M Elsman, Lidwine B Mokkink, Caroline B Terwee, Dorcas Beaton, Joel J Gagnier, Andrea C Tricco, Ami Baba, Nancy J Butcher, Maureen Smith, Catherine Hofstetter, Olalekan Lee Aiyegbusi, Anna Berardi, Julie Farmer, Kirstie L Haywood, Karolin R Krause, Sarah Markham, Evan Mayo-Wilson, Ava Mehdipour, Juanna Ricketts, Peter Szatmari, Zahi Touma, David Moher, Martin Offringa

Purpose: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024.

Methods: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement.

Results: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts.

Conclusion: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. NOTE: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

目的:尽管关于如何对结果测量工具(OMIs)进行系统综述的指南已经全面普及,例如 COSMIN(基于共识的健康测量工具选择标准)倡议,但已发表的报告中往往缺少关键信息。本文介绍了系统综述和元分析首选报告项目 (PRISMA) 2020 指南的扩展:方法:方法:开发过程遵循 "提高健康研究的质量和透明度(EQUATOR)"指南,包括文献检索、专家咨询、德尔菲研究、混合工作组会议、试点测试和项目结束会议,患者/公众也参与其中:结果:从文献和专家咨询中确定了 49 个可能相关的报告项目。德尔菲研究的第一轮由 103 名专家组成员完成,第二轮和第三轮由 78 名专家组成员完成。经过三轮研究,就 44 个项目的纳入和措辞达成了一致意见(≥67%)。在有 24 人参加的工作组会议上讨论了 11 个未就纳入和/或措辞达成共识的项目。会议就 10 个项目的纳入和措辞达成了一致意见,并删除了 1 个项目。与 65 位 OMI 系统性综述的作者进行了试点测试,通过对措辞和结构的细微改动进一步完善了指南,并在项目结束会议上最终定稿。促进完整系统综述报告报告的最终核对表包含 54 个(子)项目,涉及综述的标题、摘要、通俗语言摘要、开放科学、引言、方法、结果和讨论。与标题和摘要有关的 13 个项目也包含在单独的摘要核对表中,为作者报告会议摘要等提供指导:2024年开放媒介的PRISMA-COSMIN包括两份核对表(报告全文;摘要)、相应的解释和阐述文件(详细说明每个项目的原理和示例)以及数据流图。用于 OMIs 2024 的 PRISMA-COSMIN 可改进 OMIs 系统性综述的报告,促进其可重复性,使最终用户能够评估 OMIs 的质量,并为特定应用选择最合适的 OMI。注:为鼓励其广泛传播,本文可在以下期刊的网站上免费获取:健康与生活质量结果》、《临床流行病学杂志》、《患者报告结果杂志》、《生活质量研究》。
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Journal of Patient-Reported Outcomes
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