Pub Date : 2024-07-22DOI: 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.
{"title":"Sleep-loss related to itch in atopic dermatitis: assessing content validity and psychometric properties of a patient-reported sleep-loss rating scale.","authors":"Alissa Rams, Jessica Baldasaro, Laurine Bunod, Laure Delbecque, Sara Strzok, Juliette Meunier, Hany ElMaraghy, Luna Sun, Evangeline Pierce","doi":"10.1186/s41687-024-00764-2","DOIUrl":"10.1186/s41687-024-00764-2","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"77"},"PeriodicalIF":2.4,"publicationDate":"2024-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263400/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141749180","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}
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.
{"title":"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.","authors":"Krista Verlis, Kirsten McCaffery, Tessa Copp, Rachael Dodd, Rebekah Laidsaar-Powell, Brooke Nickel","doi":"10.1186/s41687-024-00755-3","DOIUrl":"10.1186/s41687-024-00755-3","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"75"},"PeriodicalIF":2.4,"publicationDate":"2024-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264639/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141727910","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}
Pub Date : 2024-07-19DOI: 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.
{"title":"Comparison of the EQ-5D-5L and the patient-reported outcomes measurement information system preference score (PROPr) in the United States.","authors":"Ron D Hays, Maria Orlando Edelen, Anthony Rodriguez, Nabeel Qureshi, David Feeny, Patricia M Herman","doi":"10.1186/s41687-024-00749-1","DOIUrl":"10.1186/s41687-024-00749-1","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>We administered a health survey to 4,098 KnowledgePanel<sup>®</sup> 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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"76"},"PeriodicalIF":2.4,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264606/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141724573","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}
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}
Pub Date : 2024-07-15DOI: 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}
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.
{"title":"Validity and reliability of the Greek Migraine-Specific Quality of Life Questionnaire (MSQ Version 2.1-GR).","authors":"Ermioni Giannouli, Eleni Giannouli, Athanasia Alexoudi, Chryssa Arvaniti, Nikolaos Fakas, Theodoros S Constantinidis, Evangelos Kouremenos, Dimos-Dimitrios Mitsikostas","doi":"10.1186/s41687-024-00762-4","DOIUrl":"10.1186/s41687-024-00762-4","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Design-sample-methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>MSQv2.1-GR is a valid and reliable tool to determine the effect migraine has on the quality of life of Greek-speaking migraineurs.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"72"},"PeriodicalIF":2.4,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11250746/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141617302","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}
Pub Date : 2024-07-12DOI: 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.
{"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}
Pub Date : 2024-07-12DOI: 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.
{"title":"Resilience and quality of life in patients who underwent mechanical ventilation due to COVID-19, one year after discharge: a cross-sectional study.","authors":"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","doi":"10.1186/s41687-024-00748-2","DOIUrl":"10.1186/s41687-024-00748-2","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"70"},"PeriodicalIF":2.4,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11245452/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141591615","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}
Pub Date : 2024-07-10DOI: 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).
Pub Date : 2024-07-09DOI: 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.
{"title":"Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.","authors":"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","doi":"10.1186/s41687-024-00727-7","DOIUrl":"10.1186/s41687-024-00727-7","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"64"},"PeriodicalIF":2.4,"publicationDate":"2024-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11231111/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141559893","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}