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Urine Metabolites as Indicators of Chronic Pain and Related Symptoms in Active-Duty Service Members: A Secondary Data Analysis of a Pragmatic Clinical Trial With SMART Design. 尿代谢物作为现役军人慢性疼痛和相关症状的指标
IF 2.2 4区 医学 Q1 NURSING Pub Date : 2025-07-01 Epub Date: 2025-04-15 DOI: 10.1097/NNR.0000000000000827
Dahee Wi, Hannah Choi, Nathan Tintle, Nicholas Ieronimakis, Diane M Flynn, Jeffrey C Ransom, Kira P Orr, Honor M McQuinn, Tyler J Snow, Ardith Z Doorenbos

Background: Chronic pain is a major cause of distress and disability, and biomarkers may aid in the assessment and treatment of it. Urine metabolites may be valuable bioindicators that can provide biological insight regarding chronic pain.

Objectives: To investigate the relationship between a multimarker composite measure of metabolites and patient-reported outcomes scores in adults with chronic pain, using data from a pragmatic clinical trial with a sequential, multiple-assignment randomized trial design.

Methods: Self-reported measures and urine samples from 169 active-duty service members with chronic pain were collected. Urine was analyzed using a preestablished panel of metabolites, including four previously identified biomarkers of pain: kynurenic acid, pyroglutamic acid, ethylmalonic acid, and methylmalonate. Multivariable linear regression models-adjusted for participant characteristics such as age and sex-were used to cross-sectionally examine the relationship between 11 patient-reported outcomes (fatigue, sleep-related impairment, anxiety, depression, anger, pain catastrophizing, physical function, pain interference, satisfaction with participation with social roles, pain intensity, and pain impact score) and the four urine metabolites both individually and as a composite (urine metabolite pain indicator, or UMPI). Given the study's small sample size and exploratory nature, a significance threshold of p ≤ .10 was used for all analyses.

Results: The UMPI showed statistically significant associations with five self-reported measures (fatigue, anxiety, depression, physical functioning, and pain impact score); adjusted Pearson correlations ranged from .18 to .25. Individual metabolite analyses supported these findings, with all relationships between individual metabolites and self-reported measures showing positive associations. Kynurenic acid and ethylmalonic acid showed the strongest associations, each having statistically significant relationships with four individual self-reported measures, while pyroglutamic acid had statistically significant relationships with three self-reported measures and methylmalonate with none. The UMPI demonstrated feasible reliability.

Discussion: Our finding of associations between the UMPI and components of the self-reported measures supports the development of the UMPI and these four urine metabolites as biomarkers for chronic pain outcomes. Further research is planned and will be essential for establishing mechanistic insight and guiding biomarker development within the context of pain management.

摘要:背景:慢性疼痛是痛苦和残疾的主要原因,生物标志物可能有助于评估和治疗慢性疼痛。尿液代谢物可能是有价值的生物指标,可以提供关于慢性疼痛的生物学见解。目的:研究成人慢性疼痛患者代谢物的多标志物复合测量与患者报告的结局评分之间的关系,使用一项具有顺序、多任务随机试验设计的实用临床试验的数据。方法:收集169例慢性疼痛现役军人的自述量表和尿样。使用预先建立的代谢物组分析尿液,包括四种先前确定的疼痛生物标志物:犬尿酸、焦谷氨酸、乙基丙二酸和甲基丙二酸。采用多变量线性回归模型(调整了参与者的年龄和性别等特征)横断面检验了11个患者报告的结果(疲劳、睡眠相关障碍、焦虑、抑郁、愤怒、疼痛灾难、身体功能、疼痛干扰、参与社会角色的满意度、疼痛强度、和疼痛影响评分)和四种尿液代谢物(尿代谢物疼痛指标,或UMPI)的单独和复合。考虑到本研究的小样本量和探索性,所有分析均采用p≤0.10的显著性阈值。结果:UMPI与五项自我报告的测量(疲劳、焦虑、抑郁、身体功能和疼痛影响评分)有统计学显著相关性;调整后的Pearson相关性在0.18到0.25之间。个体代谢物分析支持这些发现,个体代谢物与自我报告测量之间的所有关系都显示出正相关。Kynurenic acid和乙基丙二酸表现出最强的相关性,每一种都与四种自我报告的测量有统计学意义的关系,而焦谷氨酸与三种自我报告的测量有统计学意义的关系,而甲基丙二酸则没有。验证了UMPI的可行性和可靠性。讨论:我们发现UMPI与自我报告测量的组成部分之间存在关联,这支持了UMPI和这四种尿液代谢物作为慢性疼痛结局生物标志物的发展。进一步的研究计划,将是必不可少的建立机制的洞察力和指导生物标志物的开发在疼痛管理的背景下。
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引用次数: 0
Scoping Review of Gamification in Rehabilitation Care of Adults With Chronic Illnesses. 游戏化在成人慢性疾病康复护理中的应用综述。
IF 2.2 4区 医学 Q1 NURSING Pub Date : 2025-05-01 Epub Date: 2025-03-13 DOI: 10.1097/NNR.0000000000000816
Hualong Ma, Qinyang Wu, Ke Hu, Jiahui Liu, Yuexin Huang, Xiaoge Liu, Qiaohong Yang

Background: Gamification uses game-based mechanics, aesthetics, and game thinking to engage people, motivate action, promote learning, and solve problems. However, gaps remain in understanding and implementing gamification in rehabilitation care, necessitating further exploration and clarification of the best evidence for application of gamification.

Objective: To conduct a scoping review of the use of gamification in rehabilitation care for adults with chronic illnesses, summarizing the scope, forms, elements, guiding theories, effectiveness, and ease of use of gamification.

Methods: Eight databases in English or Chinese were searched from January 1, 2011 to May 20, 2024 following the standard scoping review framework.

Results: A total of 24 papers were included. Gamification was applied in the rehabilitation of endocrine, skeletal, circulatory, neurological, and cerebrovascular diseases, primarily using virtual reality and three-dimensional forms. Eight gamification elements were most commonly utilized. Positive outcomes included enhanced rehabilitation knowledge, improved attitudes, better physical function, and increased self-care ability. Most patients found gamified rehabilitation care engaging and easy to use.

Discussion: The application of gamification in adult chronic disease rehabilitation care shows great promise. However, the lack of theory-driven or longitudinal data in some studies highlights the need for more randomized controlled and longitudinal research to explore the effectiveness of gamified intervention.

背景:游戏化使用基于游戏的机制、美学和游戏思维来吸引人们、激励行动、促进学习和解决问题。然而,在理解和实施游戏化在康复护理方面仍然存在差距,需要进一步探索和澄清游戏化应用的最佳证据。目的:对游戏化在成人慢性疾病康复护理中的应用进行范围综述,总结游戏化的范围、形式、要素、指导理论、效果及易用性。方法:检索2011年1月1日至2024年5月20日的8个中英文数据库,按照标准的范围审查框架进行检索。结果:共纳入24篇论文。游戏化主要应用于内分泌、骨骼、循环、神经和脑血管疾病的康复,主要利用虚拟现实和三维形式。最常使用的游戏化元素有8个。积极结果包括增强康复知识、改善态度、改善身体功能和提高自我照顾能力。大多数患者认为游戏化康复护理具有吸引力且易于使用。讨论:游戏化在成人慢性病康复护理中的应用前景广阔。然而,一些研究缺乏理论驱动或纵向数据,这表明需要更多的随机对照和纵向研究来探索游戏化干预的有效性。
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引用次数: 0
Self-Advocacy Among Women With Uterine Malignancies. 子宫恶性肿瘤妇女的自我宣传。
IF 2.2 4区 医学 Q1 NURSING Pub Date : 2025-05-01 Epub Date: 2025-02-11 DOI: 10.1097/NNR.0000000000000813
Xiaojie Chen, Xiaohan Xu, Yunhong Du, Wei Liu, Xiao Zhang, Li Wang

Background: Self-advocacy plays a crucial role in the mental health and treatment outcomes of oncology patients, particularly those with uterine malignancies. Despite its significance, research on the self-advocacy levels and influencing factors among Chinese patients with uterine malignancies remains limited.

Objectives: To assess the self-advocacy levels among Chinese patients with uterine malignancies and identify the demographic, psychological resilience, and decision self-efficacy factors that influence self-advocacy.

Methods: This cross-sectional study was conducted from March 1 to September 1, 2023, involving 220 inpatients with uterine malignancies from three tertiary hospitals in Shandong Province, China. Participants were recruited using convenience sampling and completed the General Information Questionnaire, Female Cancer Survivorship Self-advocacy Scale, Connor-Davidson Resilience Scale, and Decision Self-efficacy Scale.

Results: The average self-advocacy score among participants was 59.44 ± 10.14. Significant positive correlations were found between self-advocacy, psychological resilience, and decision self-efficacy. The random forest algorithm identified decision self-efficacy, psychological resilience, family average income, type of medical insurance, educational level, and residence as the six most important influencing factors, with the optimal model performance observed when lambda (λ) = 1.191. Multiple linear regression analysis further confirmed that decision self-efficacy, psychologic resilience, family average income, educational level, and residence were significant predictors of self-advocacy.

Discussion: The self-advocacy levels of Chinese patients with uterine malignancies were relatively low, with decision self-efficacy, psychological resilience, and socioeconomic factors significantly influencing their self-advocacy abilities. Future targeted interventions should focus on enhancing patients' decision self-efficacy and psychological resilience, thereby guiding them to actively respond and participate in decision-making, ultimately improving self-advocacy among patients with uterine malignancies.

摘要:背景:自我倡导在肿瘤患者,特别是子宫恶性肿瘤患者的心理健康和治疗效果中起着至关重要的作用。尽管具有重要意义,但对我国子宫恶性肿瘤患者自我倡导水平及其影响因素的研究仍然有限。目的:评估中国子宫恶性肿瘤患者的自我倡导水平,确定影响自我倡导的人口学、心理弹性和决策自我效能等因素。方法:本研究于2023年3月1日至9月1日对山东省三所三级医院的220例住院子宫恶性肿瘤患者进行横断面研究。采用方便抽样法,对被试进行一般信息问卷、女性癌症生存自我倡导量表、康诺-戴维森韧性量表和决策自我效能量表的问卷调查。结果:参与者自我倡导得分平均为59.44±10.14分。自我倡导、心理弹性与决策自我效能之间存在显著正相关。随机森林算法将决策自我效能、心理弹性、家庭平均收入、医疗保险类型、教育程度和居住地作为6个最重要的影响因素,当lambda (λ) = 1.191时,模型表现最优。多元线性回归分析进一步证实,决策自我效能、心理弹性、家庭平均收入、受教育程度和居住地是自我倡导的显著预测因子。讨论:我国子宫恶性肿瘤患者自我倡导水平相对较低,决策自我效能、心理弹性和社会经济因素显著影响其自我倡导能力。未来有针对性的干预应侧重于提高患者的决策自我效能感和心理弹性,从而引导患者积极响应和参与决策,最终提高子宫恶性肿瘤患者的自我倡导能力。
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引用次数: 0
A Call to Action: Nursing Science That Supports Patient Care. 行动呼吁:支持病人护理的护理科学。
IF 2.2 4区 医学 Q1 NURSING Pub Date : 2025-05-01 DOI: 10.1097/NNR.0000000000000798
Laura Beth Kalvas, Martha A Q Curley
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引用次数: 0
Randomized Trial of Group Postpartum Care Model Improves Knowledge and Clinical Outcomes. 小组产后护理模式提高知识和临床效果的随机试验。
IF 2.2 4区 医学 Q1 NURSING Pub Date : 2025-05-01 Epub Date: 2025-02-13 DOI: 10.1097/NNR.0000000000000814
Yenupini Joyce Adams, John Stephen Agbenyo, Elizabeth Lau, Jessica Young, David Haas

Background: In sub-Saharan Africa, the risk of obstetric complications remains high throughout the postpartum period.

Objective: We developed and tested a novel, integrated model of group postpartum care titled Focused-Postpartum Care (Focused-PPC) to improve outcomes. In this paper, we report clinical outcomes of participants in the intervention arm and differences in knowledge of postbirth warning signs among those in the intervention and control arms.

Methods: Focused-PPC encompassed recommended clinical assessments, targeted education, and peer support up to 1 year after birth. Focused-PPC was implemented as a parallel randomized controlled trial involving 192 postpartum women across four health centers in Tamale, Ghana, from February 2022 to August 2023. Eligible participants 18 years or older with a live birth were randomly assigned to either the Focused-PPC intervention arm or the control arm at a 1:1 allocation and were not blinded to their allocation. At each health center, 48 participants were allocated to either an intervention or control arm. Focused-PPC groups in the intervention arm consisted of eight participants per group. Participants in the intervention arm received the Focused-PPC integrated group model of care. Participants in the control arm received the standard of postnatal care already administered at each health center.

Results: Baseline analysis included 96 participants from the control arm and 91 participants from the intervention arm. We found that vital signs and clinical outcomes were relatively stable; however, incidences of hypertension substantially decreased among participants in the intervention arm. By 3 months postbirth, most participants in the intervention arm were able to identify all postbirth warning signs and retain this knowledge compared to the control arm. Those in the intervention arm were also knowledgeable of more warning signs at each time point compared to the control arm.

Discussion: An integrated, evidence-based approach to postpartum care, such as Focused-PPC, has potential to increase knowledge and improve clinical outcomes among mothers in Ghana.

背景:在撒哈拉以南非洲,整个产后期间产科并发症的风险仍然很高。目的:我们开发并测试了一种新型的综合产后护理模式,即集中产后护理(focus - ppc),以改善预后。在本文中,我们报告了干预组参与者的临床结果,以及干预组和对照组参与者对出生后警告信号知识的差异。方法:焦点ppc包括推荐的临床评估,有针对性的教育,以及出生后1年的同伴支持。重点ppc是一项平行随机对照试验,于2022年2月至2023年8月在加纳塔马莱的四个保健中心实施,涉及192名产后妇女。年龄在18岁或以上且活产的符合条件的参与者被随机分配到焦点ppc干预组或对照组,按1:1分配,并且对他们的分配不盲目。在每个健康中心,48名参与者被分配到干预组或对照组。干预组的重点ppc组由每组8名参与者组成。干预组的参与者接受了focus - ppc综合组护理模式。对照组的参与者接受了每个保健中心已经提供的标准产后护理。结果:基线分析包括96名控制组参与者和91名干预组参与者。我们发现生命体征和临床结果相对稳定;然而,干预组的高血压发病率显著降低。出生后3个月,与对照组相比,干预组的大多数参与者能够识别所有出生后警告信号并保留这些知识。与对照组相比,干预组在每个时间点对警告信号的了解也更多。讨论:综合的、基于证据的产后护理方法,如focus - ppc,有可能增加加纳母亲的知识并改善临床结果。
{"title":"Randomized Trial of Group Postpartum Care Model Improves Knowledge and Clinical Outcomes.","authors":"Yenupini Joyce Adams, John Stephen Agbenyo, Elizabeth Lau, Jessica Young, David Haas","doi":"10.1097/NNR.0000000000000814","DOIUrl":"10.1097/NNR.0000000000000814","url":null,"abstract":"<p><strong>Background: </strong>In sub-Saharan Africa, the risk of obstetric complications remains high throughout the postpartum period.</p><p><strong>Objective: </strong>We developed and tested a novel, integrated model of group postpartum care titled Focused-Postpartum Care (Focused-PPC) to improve outcomes. In this paper, we report clinical outcomes of participants in the intervention arm and differences in knowledge of postbirth warning signs among those in the intervention and control arms.</p><p><strong>Methods: </strong>Focused-PPC encompassed recommended clinical assessments, targeted education, and peer support up to 1 year after birth. Focused-PPC was implemented as a parallel randomized controlled trial involving 192 postpartum women across four health centers in Tamale, Ghana, from February 2022 to August 2023. Eligible participants 18 years or older with a live birth were randomly assigned to either the Focused-PPC intervention arm or the control arm at a 1:1 allocation and were not blinded to their allocation. At each health center, 48 participants were allocated to either an intervention or control arm. Focused-PPC groups in the intervention arm consisted of eight participants per group. Participants in the intervention arm received the Focused-PPC integrated group model of care. Participants in the control arm received the standard of postnatal care already administered at each health center.</p><p><strong>Results: </strong>Baseline analysis included 96 participants from the control arm and 91 participants from the intervention arm. We found that vital signs and clinical outcomes were relatively stable; however, incidences of hypertension substantially decreased among participants in the intervention arm. By 3 months postbirth, most participants in the intervention arm were able to identify all postbirth warning signs and retain this knowledge compared to the control arm. Those in the intervention arm were also knowledgeable of more warning signs at each time point compared to the control arm.</p><p><strong>Discussion: </strong>An integrated, evidence-based approach to postpartum care, such as Focused-PPC, has potential to increase knowledge and improve clinical outcomes among mothers in Ghana.</p>","PeriodicalId":49723,"journal":{"name":"Nursing Research","volume":" ","pages":"171-178"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12036783/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143450731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Psychometric Analysis of Disrespect and Abuse Scale. 不尊重和虐待量表的心理测量分析。
IF 2.2 4区 医学 Q1 NURSING Pub Date : 2025-05-01 Epub Date: 2025-02-06 DOI: 10.1097/NNR.0000000000000809
Fatima Alzyoud

Background: Disrespect and abuse of laboring and child-birthing women in health care is a global problem that violates the universal human rights of childbearing women. There is a lack of reliable and valid tools for measuring these behaviors. One instrument, the Disrespect and Abuse scale, has preliminary data with no established psychometrics in diverse populations. Further analysis is required to ensure the reliability and validity of this tool in diverse populations and health care settings.

Objectives: We examined the psychometric properties of the Disrespect and Abuse scale in diverse international nursing and midwifery populations.

Methods: A cross-sectional descriptive design was used to measure disrespect and abuse toward women during childbirth. Data were collected from 231 nurses and midwives across international labor and delivery units. Exploratory factor analysis was conducted using principal component analysis with oblimin rotation as the factor extraction method.

Results: The psychometric assessment yielded a two-factor structure. Factor 1 consisted of 13 items characterizing physical and verbal abuse. Factor 2 contained nine items reflecting disrespectful behaviors. The Cronbach's alpha coefficients reflected high internal consistency.

Discussion: The scale was shown to be reliable and valid in assessing self-reported disrespectful and abusive behaviors among nurses and midwives in a diverse international sample. Use could assist in the assessment of these behaviors in maternal health care facilities. Further research is warranted to confirm the scale's robustness and applicability across various populations and settings and use the Disrespect and Abuse scale to identify the burden and predictors of mistreatment of women in different health care settings.

背景:在医疗保健中对劳动妇女和分娩妇女的不尊重和虐待是一个全球性问题,违反了生育妇女的普遍人权。缺乏可靠和有效的工具来衡量这些行为。其中一个工具,不尊重和虐待量表,有初步的数据,没有在不同人群中建立心理测量。需要进一步分析,以确保这一工具在不同人群和卫生保健环境中的可靠性和有效性。目的:我们在不同的国际护理和助产人群中检查了不尊重和虐待量表的心理测量特性。方法:采用横断面描述性设计测量分娩时对妇女的不尊重和虐待。数据收集自国际分娩和分娩单位的231名护士和助产士。探索性因子分析采用主成分分析法,提取因子的方法为oblimin旋转。结果:心理测量量表具有双因素结构。因素1包括表征身体和语言虐待的13个项目。因子2包含9个反映不尊重行为的项目。Cronbach’s alpha系数反映了高度的内部一致性。讨论:该量表在评估护士和助产士在不同国际样本中自我报告的不尊重和虐待行为方面是可靠和有效的。使用它可以帮助评估产妇保健设施中的这些行为。有必要进一步研究以确认该量表在不同人群和环境中的稳健性和适用性,并使用不尊重和虐待量表来确定不同卫生保健环境中虐待妇女的负担和预测因素。
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引用次数: 0
Lessons Learned in Virtual Launch of an Antenatal Opioid Exposure Study During the COVID-19 Pandemic. 在COVID-19大流行期间虚拟启动产前阿片类药物暴露研究的经验教训。
IF 2.2 4区 医学 Q1 NURSING Pub Date : 2025-05-01 Epub Date: 2025-01-24 DOI: 10.1097/NNR.0000000000000807
Jamie E Newman, Megan Dhawan, Leslie Clarke, Sharon Owen, Traci Beiersdorfer, Lindsay M Parlberg, Stephanie L Merhar, Sara B DeMauro, Scott A Lorch, Deanne Wilson-Costello, Namasivayam Ambalavanan, Myriam Peralta-Carcelen, Brenda Poindexter, Jonathan M Davis, Nicole Mack, Catherine Limperopoulos, Carla M Bann

Background: The COVID-19 pandemic prompted researchers to develop new ways to design and launch studies and recruit and retain participants. Pregnant women and infants are considered vulnerable populations in research, and families affected by substance use are particularly difficult to recruit and retain. Recruitment for studies involving medical technologies such as MRI can also be difficult due to misconceptions and fear of the technologies.

Objectives: This article aims to describe "lessons learned" during the launch of the Outcomes of Babies with Opioid Exposure (OBOE) study, including successes and challenges when working with high-risk infants and families and the importance of engaging participants through recruitment materials and retention efforts.

Methods: The OBOE study is a multisite prospective longitudinal cohort study comparing infants with antenatal opioid exposure to unexposed controls from birth to 2 years of age. Chi-square tests were used to examine refusal reasons among caregivers of eligible infants by exposure group and differences in 6-month retention among subgroups based on social determinants of health.

Results: Four factors were essential in establishing the consortium, implementing the study, and retaining participants: (a) creating venues for collaboration, (b) pivoting from in-person to virtual training, (c) anticipating potential enrollment barriers and addressing them directly, and (d) engaging participants through recruitment materials and retention efforts. With these factors in place, only 5% of caregivers of eligible opioid-exposed infants and 8% of control infants declined to participate in the study because of MRIs. Of 310 enrolled infants, 234 infants had attended the 6-month visit. Subgroups of enrolled infants were similar in retention at 6 months.

Discussion: Reporting our successes and challenges in setting up a nationwide consortium during the pandemic may help other consortia that need to be set up virtually. We anticipated that the serial MRIs would be a barrier to participation; however, few indicated they refused to participate because of MRIs, suggesting that our efforts to address this potential barrier to enrollment were successful.

背景:2019冠状病毒病大流行促使研究人员开发新的方法来设计和启动研究,招募和留住参与者。在研究中,孕妇和婴儿被视为弱势群体,受药物使用影响的家庭尤其难以招募和留住。由于误解和对技术的恐惧,招募涉及核磁共振等医疗技术的研究人员也可能很困难。目的:描述在阿片类药物暴露婴儿(OBOE)研究结果启动期间的“经验教训”,包括与高风险婴儿和家庭合作时的成功和挑战,以及通过招募材料和保留努力吸引参与者的重要性。方法:OBOE研究是一项多地点前瞻性纵向队列研究,比较产前阿片类药物暴露的婴儿和从出生到2岁未暴露的对照组。卡方检验用于检查暴露组中符合条件的婴儿的照顾者拒绝的原因,以及基于健康的社会决定因素的亚组中6个月保留的差异。结果:在建立联盟、实施研究和留住参与者方面,有四个因素是必不可少的:(a)创造合作场所;(b)从面对面培训转向虚拟培训;(c)预测潜在的入学障碍并直接解决这些障碍;(d)通过招聘材料和留住参与者的努力吸引参与者。有了这些因素,只有5%的符合条件的阿片类药物暴露婴儿的护理人员和8%的对照婴儿因为核磁共振而拒绝参加这项研究。在310名登记的婴儿中,234名婴儿参加了为期6个月的随访。在6个月时,所登记婴儿的亚组在保留率方面相似。讨论:报告我们在大流行期间建立全国联盟方面取得的成功和面临的挑战,可能有助于需要建立虚拟联盟的其他联盟。我们预期连续的核磁共振会成为参与的障碍;然而,很少有人表示他们因为核磁共振而拒绝参加,这表明我们为解决这一潜在障碍所做的努力是成功的。
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引用次数: 0
A Decision-Making Grid for Coenrollment in Multiple Clinical Trials. 共同参与多项临床试验的决策网格。
IF 2.2 4区 医学 Q1 NURSING Pub Date : 2025-05-01 Epub Date: 2024-12-16 DOI: 10.1097/NNR.0000000000000802
Martha A Q Curley, Laura Beth Kalvas, Mallory A Perry-Eaddy, Lisa A Asaro, David Wypij

Background: Although subject coenrollment into multiple trials is desirable, thoughtful consideration is required to avoid compromising each trial's scientific integrity.

Objective: We developed a Decision-Making Grid (GRID) to help investigators determine whether a clinical trial is compatible with a second clinical trial, thus allowing coenrollment, or if it should be considered competing, prohibiting coenrollment.

Methods: The GRID evaluates 21 elements across four domains: scientific integrity, data interpretation, feasibility/burden, and additional considerations. Optimally, each principal investigator shares their protocol, completes the GRID independently, and then meets to compare their perspectives, seeking a mutually acceptable agreement.

Results: The GRID has facilitated coenrollment decision-making for the RESTORE and PROSpect pediatric critical care clinical trials. In RESTORE , five trials were reviewed; one was approved for coenrollment, and four were deemed competing. In PROSpect , 26 trials have been reviewed; 20 are approved for coenrollment, and six were deemed competing. In both RESTORE and PROSpect , the principal investigators of multiple trials arranged a mutually acceptable sharing agreement.

Discussion: The GRID provides a systematic process to help investigators evaluate the effect of coenrollment in multiple clinical trials.

背景:虽然受试者同时入组多个试验是可取的,但需要深思熟虑,以避免损害每个试验的科学完整性。目的:我们开发了一个决策网格(Grid)来帮助研究者确定一个临床试验是否与第二个临床试验兼容,从而允许共同入组,或者如果应该考虑竞争,禁止共同入组。方法:GRID评估了4个领域的21个要素:科学完整性、数据解释、可行性/负担和附加考虑。最理想的情况是,每个PI共享他们的协议,独立完成GRID,然后开会比较他们的观点,寻求一个双方都能接受的协议。结果:GRID促进了RESTORE和PROSpect儿科重症临床试验的共同入组决策。在RESTORE中,回顾了5项试验;一个被批准共同注册;其中四个被认为是竞争对手。在PROSpect中,26项试验已被审查;批准共招生20人;6个被认为是竞争对手。在RESTORE和PROSpect中,多个试验的pi都安排了一个双方都可以接受的共享协议。讨论:GRID提供了一个系统的过程来帮助研究者评估在多个临床试验中合并入组的效果。
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引用次数: 0
The Truth About Science. 科学的真相。
IF 2.2 4区 医学 Q1 NURSING Pub Date : 2025-05-01 DOI: 10.1097/NNR.0000000000000812
Rita H Pickler
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引用次数: 0
Research in Nursing Practice-What? 护理实践研究——什么?
IF 2.2 4区 医学 Q1 NURSING Pub Date : 2025-05-01 DOI: 10.1097/NNR.0000000000000800
Edward J Halloran
{"title":"Research in Nursing Practice-What?","authors":"Edward J Halloran","doi":"10.1097/NNR.0000000000000800","DOIUrl":"https://doi.org/10.1097/NNR.0000000000000800","url":null,"abstract":"","PeriodicalId":49723,"journal":{"name":"Nursing Research","volume":"74 3","pages":"167-168"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143991936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Nursing Research
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