Recruitment phase

  • 文章类型: Journal Article
    需要活体供体肾脏移植(LDKT)的患者必须经常自己询问潜在供体(PLD)。这是一项艰巨的任务,医疗保健可以通过第一次接触来减轻他们的负担,还确保PLD收到正确的信息。我们调查了PLD如何收到来自医疗保健的关于LDKT的信,活体肾脏捐赠,并邀请他们与专业人士会面以获取更多信息。
    这封信(LD-letter)被发送给了46个人,其中有目的的15人样本使用半结构化指南进行了采访,涵盖了他们对这封信的经历,关于被医疗保健接触的观点,以及关于风格和内容的意见。使用常规归纳分析对访谈进行分析。
    我们确定了三类经验:类别(1)对收到信件的思考,包含三个子类别,涉及这封信如何没有引起捐赠压力,不影响PLD与肾病患者的关系,并使收信人在移植过程中感到重要;类别(2)这封信创造了澄清和信任,还包含三个子类别,关于它如何澄清捐赠的自愿性和医疗保健提供者关于PLD的决定的中立性,阐明了患有肾脏疾病的患者的当前疾病阶段(移植即将到来),无患者自行联系PLDs的责任;第(3)类关于信函和进一步沟通的意见和建议,有四个子类别,关于将一封信作为关于LDKT的沟通的第一步,关于风格和内容的建议,对跟进这封信的意见,以及关于LDKT的公开会议如何成为重要的信息来源。此外,80%的受访者认为这封信的信息全面,67%的人发现它易于阅读和尊重。86%的人认为它很好或非常好。
    潜在的捐献者喜欢并推荐一封信,作为关于LD沟通的第一步。LD-letter解除了患者询问PLDs的负担,并强调捐赠的自愿性,不会让PLDs感到被胁迫或导致与患者的关系产生负面影响。
    Patients who need a live donor kidney transplant (LDKT) must often ask potential donors (PLDs) themselves. This is a difficult task and healthcare could unburden them by making this first contact, ensuring also that PLDs receive correct information. We investigated how PLDs experience receiving a letter from healthcare about LDKT, live kidney donation, and inviting them to meet with professionals to get more information.
    The letter (LD-letter) was sent to a cohort of 46 individuals, from which a purposeful sample of 15 were interviewed using a semi-structured guide covering their experience of the letter, views on being approached by healthcare, and opinions on style and content. Interviews were analyzed using conventional inductive analysis.
    We identified three categories of experiences: Category (1) Reflections on receiving the letter, contains three subcategories relating to how the letter did not induce pressure to donate, did not affect the PLD\'s relationship with the patient with kidney disease, and made the letter-receiver feel important in the transplant process; Category (2) The letter creates clarification and trust, also contains three subcategories, relating to how it clarified the voluntariness of donation and neutrality of healthcare providers with respect to the PLD\'s decision, elucidated the patient with kidney disease\'s current stage of disease (where transplantation was approaching), and unburdened patients from the responsibility of contacting PLDs on their own; Category (3) Opinions and suggestions about the letter and further communication, with four subcategories, relating to preference of a letter as the first step for communication about LDKT, suggestions on style and content, views on following up the letter, and how open meetings about LDKT were an important information source. Furthermore, 80% of the interviewees found the letter\'s information comprehensive, 67% found it easy to read and respectful, and 86% rated it as good or very good.
    Potential donors prefer and recommend a letter as the first step for communication regarding LD. The LD-letter unburdens patients from the task of asking PLDs and stresses the voluntariness of donation, does not leave PLDs feeling coerced or lead to negative effects in their relationship with the patient.
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  • 文章类型: Clinical Trial
    目标:鉴于癌症晚期患者面临的心理社会负担,需要创新的护理理念。同时,这些脆弱的患者群体很难参与干预研究,随机纳入患者可能不可行.本文旨在确定在招募阶段发生的系统性偏见,分别选择效应,并基于非随机,晚期癌症患者的多中心干预研究。
    方法:在德国三个城市的四家医院招募了被诊断患有16种预定义癌症中至少一种的患者。通过健康相关生活质量(EORTCQLQ-C30)衡量社会护理护士持续参与急性肿瘤科病房的效果,信息和参与偏好,决策冲突,医患沟通,健康素养和症状感知。将绝对标准化平均差异计算为标准化效应大小,以测试干预组和对照组之间的基线特征平衡。
    结果:该研究招募了362名患者,干预组150人,对照组212人。除了性别,两组在相关的社会人口统计学特征上有所不同,例如关于年龄和教育背景。关于诊断的分布,干预组的症状负担高于对照组.此外,与干预组相比,对照组在基线时报告了更好的生活质量(52.6分(SD21.7);47.8分(SD22.0),ASMD=0.218,p=0.044)。
    结论:总体而言,干预组比对照组表现出更多的社会和健康脆弱性。除其他因素外,包括的诊断范围广泛,以及招募诊所之间的结构差异增加了偏倚的风险.我们建议关闭,在招聘阶段持续监测相关的社会和健康相关特征,并使用适当的统计分析策略进行调整,如倾向评分法。
    背景:德国临床试验注册(DRKS-ID:DRKS00013640);注册于2017年12月29日。
    OBJECTIVE: Given the psychosocial burdens patients in advanced stages of cancer face, innovative care concepts are needed. At the same time, such vulnerable patient groups are difficult to reach for participation in intervention studies and randomized patient inclusion may not be feasible. This article aims to identify systematic biases respectively selection effects occurring during the recruitment phase and to discuss their potential causes based on a non-randomized, multicenter intervention study with patients in advanced stages of cancer.
    METHODS: Patients diagnosed with at least one of 16 predefined cancers were recruited at four hospitals in three German cities. The effect of social care nurses\' continuous involvement in acute oncology wards was measured by health-related quality of life (EORTC QLQ-C30), information and participation preferences, decisional conflicts, doctor-patient communication, health literacy and symptom perception. Absolute standardized mean difference was calculated as a standardized effect size to test baseline characteristics balance between the intervention and control groups.
    RESULTS: The study enrolled 362 patients, 150 in the intervention and 212 in the control group. Except for gender, both groups differed in relevant socio-demographic characteristics, e.g. regarding age and educational background. With respect to the distribution of diagnoses, the intervention group showed a higher symptom burden than the control group. Moreover, the control group reported better quality of life at baseline compared to the intervention group (52.6 points (SD 21.7); 47.8 points (SD 22.0), ASMD = 0.218, p = 0.044).
    CONCLUSIONS: Overall, the intervention group showed more social and health vulnerability than the control group. Among other factors, the wide range of diagnoses included and structural variation between the recruiting clinics increased the risk for bias. We recommend a close, continuous monitoring of relevant social and health-related characteristics during the recruitment phase as well as the use of appropriate statistical analysis strategies for adjustment, such as propensity score methods.
    BACKGROUND: German Clinical Trials Register (DRKS-ID: DRKS00013640 ); registered on 29th December 2017.
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