Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon

BackgroundFive years of prospective clinical trials confirm that the paclitaxel drug-coated balloon (DCB) (IN.PACT Admiral, Medtronic, Dublin, Ireland) is safe and effective to treat femoropopliteal artery disease. A recent meta-analysis of heterogeneous trials of paclitaxel-based balloons and stents reported that they are associated with increased mortality and that higher doses are linked to higher mortality from 2 to 5 years.ObjectivesThe purpose of this study was to determine if there is a correlation between paclitaxel exposure and mortality by conducting an independent patient-level meta-analysis of 1,980 patients with up to 5-year follow-up.MethodsData from 2 single-arm and 2 randomized independently adjudicated prospective studies of a paclitaxel DCB (n = 1,837) and uncoated percutaneous transluminal angioplasty (PTA) (n = 143) were included. Analyses of baseline, procedure, and follow-up data of individual patients were performed to explore correlations of paclitaxel dose with long-term mortality. Survival time by paclitaxel dose tercile was analyzed with adjustment of inverse probability weighting to correct baseline imbalances and study as random effect. A standard cohort was defined to compare DCB- and PTA-treated patients with similar characteristics by applying criteria from pivotal studies (n = 712 DCB, n = 143 PTA).ResultsA survival analysis stratified nominal paclitaxel dose by low, mid, and upper terciles; mean doses were 5,019.0, 10,007.5, and 19,978.2 μg, respectively. Rates of freedom from all-cause mortality between the 3 groups through 5 years were 85.8%, 84.2%, and 88.2%, respectively (p = 0.731). There was no significant difference in all-cause mortality between DCB and PTA through 5 years comparing all patients (unadjusted p = 0.092) or patients with similar characteristics (adjusted p = 0.188).ConclusionsThis independent patient-level meta-analysis demonstrates that this paclitaxel DCB is safe. Within DCB patients, there was no correlation between level of paclitaxel exposure and mortality. (Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I], NCT01175850; IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II], NCT01566461; MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery [MDT-2113 SFA], NCT01947478; The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population, NCT02118532; and IN.PACT Global Clinical Study, NCT01609296)     

The impact of Professional Boundaries for Health Professionals (PBHP) training on knowledge,comfort, experience,and ethical decision-making: a longitudinal randomized controlled trial

Purpose: A randomized controlled trial was conducted to evaluate the impact of Professional Boundaries for Health Professionals (PBHP) training program on the knowledge, comfort, experience, and ethical decision-making of multidisciplinary practitioners facing client–practitioner boundary dilemmas.

Methods: In all, 36 rehabilitation practitioners from an Australian state-wide spinal cord injuries service were assigned to experimental and control groups. The Boundaries in Practice (BIP) Scale measured outcomes at four points: pre, post, 3 months, and 1 year. The control group received the training after 3 months. Nonparametric Friedman’s two-way analysis of variance was used to examine the trajectories over time.

Results: Analysis was conducted using the data of 10 experimental and 13 control group participants who responded at four data collection points. The experimental group showed significant improvement in knowledge (χ²?=?10.673, p?=?0.014) and comfort (χ²?=?9.727, p?=?0.021) managing professional boundaries post-training. The control group showed no significant change in knowledge or comfort. No significant change was seen in experience across either experimental (χ²?=?3.609, p?=?0.307) or control group (χ²?=?7.800, p?=?0.050). Ethical decision-making improved in the control group (χ²?=?13.188, p?=?0.004) following training, however remained unchanged in the experimental group.

Conclusions: The findings do not definitively support this training approach. Ethical decision-making may improve more substantially within the practice context and organizational culture change. Multifaceted approaches are indicated.

• Implications for Rehabilitation

• Ethical dilemmas related to boundaries between clients and practitioners are a frequent occurrence in the rehabilitation setting.

• In a relatively small sample, the current randomized trial provided inconclusive evidence on the benefit of a 1-day needs-oriented training program to improve knowledge, comfort, and ethical decision-making.

• Randomized trials of education and training for rehabilitation practitioners are fraught with challenges in the clinical environment of the rehabilitation setting.

• Multifaceted training approaches, management support and training as well as changes to policy and organizational context in the rehabilitation setting may be needed to more holistically address the issues surrounding professional boundaries in the rehabilitation setting.

     

Social participation of relatives post-stroke: the role of rehabilitation and related ethical issues

Purpose.?(1) Describe the challenges facing relatives of persons with stroke in accomplishing their daily activities and social roles (participation). (2) Reflect on the role of rehabilitation for relatives and ethical issues that may emerge following the adoption of a family-centred approach.

Method.?Review of the scientific literature in Medline (1996 to July 2009), Embase (1996 to July 2009) databases using keywords: stroke AND participation AND family OR spouse OR caregivers AND ethics AND burden. Selection criteria were as follows: study must examine the participation of relatives post-stroke (or equivalent concept such as burden), rehabilitation interventions for relatives post-stroke or ethical issues related to being a relative of a person with stroke. Articles not written in English or French were excluded.

Results.?The sample comprised 17 scientific articles. According to five studies, social participation of relatives is characterised by increased responsibilities and a reduction in interpersonal relationships and leisure. In rehabilitation, there is no consensus regarding what should be done for relatives; guidelines exist but are not applied in practice. Little has been formally reported regarding ethical issues likely to emerge for relatives.

Conclusions.?The main impact of stroke is on social roles of relatives such as responsibilities, interpersonal relationships and leisure. The role of rehabilitation and related ethical issues needs further examination.     

践行康复伦理促进康复事业发展

目的 研究分析康复医学的伦理价值及其对康复医学服务的影响.方法 采用文献查阅法、调查法和分析法,结合康复医学行为过程,对康复医学伦理价值进行研究和证示,并对相关问题提出建议.结果 康复医学伦理具有重要的价值,对康复医学服务的效果有较大影响.结论 文章提出了在康复医疗中如何践行医学伦理原则的意义和方法 ,指出了落实医学伦...     

情境模拟案例教学法对五年制高职护生护理伦理决策能力的影响

目的 探讨情境模拟案例教学法在五年制高职护生的护理伦理决策能力教学中的应用效果。方法 2017年8月—2019年1月,采用先按年级分层,再用抽签法按班级随机整群抽样法,抽取我校6个班级268名五年制高职护生,随机分为对照组和干预组,在“护理伦理学”教学中对五年制高职护生进行护理伦理决策能力的培养。对照组采用传统教学法,干预组采用情境模拟案例教学法,为期1学年。干预前后采用护理伦理决策能力问卷测量6个班五年制高职护生的护理伦理决策能力,来评价情境模拟案例教学法实施效果。结果 干预后,干预组五年制高职护生护理伦理决策能力得分为（313.96±24.07）分,高于对照组的（307.64±23.89）分,经统计分析,差异有统计学意义（t=2.154,P<0.05）。结论 情境模拟案例教学法有助于提高五年制高职护生的护理伦理决策能力,效果优于传统教学法。     

Ending Gender Inequality in Cardiovascular Clinical Trial Leadership: JACC Review Topic of the Week

Women are under-represented as leaders of cardiovascular randomized controlled trials, representing 1 in 10 lead authors of cardiovascular trials published in high-impact journals. Although the proportion of cardiovascular specialists who are women has increased in recent years, the proportion of cardiovascular clinical trialists who are women has not. This gap, underpinned by systemic sexism, has not been adequately addressed. The benefits of diverse randomized controlled trial leadership extend to patients and professionals. In this position statement, we present strategies adopted by some organizations to end gender inequality in research leadership. We offer an actionable roadmap for early-career researchers, scientists, academic institutions, professional societies, trial sponsors, and journals to follow, with the goal of harnessing the strength of women and under-represented groups as research leaders and facilitating a just culture in the cardiovascular clinical trial enterprise.     

The significance of nurse supervisors' different ethical decision-making styles

BACKGROUND: The role of the nurse supervisor is very important, because of his/her ability to influence the atmosphere within the clinical nursing supervision group. AIM: To present and interpret nurse supervisors' different ethical decision-making styles. METHOD: A hermeneutic interpretation of three studies on nurse supervisors' different ethical decision-making styles. RESULTS: The significance of the nurse supervisor's ethical decision-making style is reflected in the awareness of their responsibility for creating a relationship with the supervisee. The supervisors focus on ensuring safety, integrating theoretical knowledge and clinical practice, willingness and preparedness to supervise on the substance of nursing, sharing the supervisees' feelings and challenging them, reflecting on the content of clinical nursing supervision as well as promoting justice and integrity in clinical nursing supervision. CONCLUSIONS: The interpretation highlights the importance of the nurse supervisor's style for the outcome of clinical nursing supervision, as they are role models for the supervisees. There is a need for further research to explore the advantages and disadvantages of nurse supervisors' different ethical decision-making styles, especially in relation to the influence of clinical nursing supervision on the quality of care and various support systems.     

Care as a matter of courage: vulnerability, suffering and ethical formation in nursing care

The aim of the study was to explore nurses' experience of how their own vulnerability and suffering influence their ethical formation and their capacity to provide professional care when they are confronted with the patient's vulnerability and suffering. Care is shaped in the meeting between human beings. Professional care is informed by the patient's appeal for help as it is expressed in the meeting. Ethical formation is understood as a personal ethical and existential process, resulting in the capacity to provide professional care. A nurse must have the sense of being a complete human being with own personal attributes and sensitivity in order to be able to relate to other people. The study is based on qualitative interviews with 23 experienced nurses from Sweden, Finland and Denmark. The analyses and interpretation were carried out in line with Steinar Kvale's three levels of interpretation. The study clarifies that ethical formation is a union of the nurse's personal attributes and professional qualifications and that ethical formation is developed over time. Moreover, it also demonstrates that the nurse's personal and professional life experiences of vulnerability and suffering influence ethical formation. Vulnerability and suffering have proven to be sensitive issues for nurses, like a sore point that either serve as an eye-opener or cause the development of blind spots. Furthermore, vulnerability, suffering and the sore points are seen to shape the nurse's courage in relation to care. Courage appears to be a significant unifying phenomenon that manifests itself as the courage to help patients face their own vulnerability and suffering, to bear witness to patients' vulnerability and suffering and to have faith in oneself in arguing for and providing professional care. Courage thus seems to play a significant role in nurses' ability to engage in care. Nurses' own vulnerability, suffering and sore points seem to shape their courage.     

Starry night: using story to inform aesthetic knowing in women's health nursing

AIM OF THE PAPER: This paper describes the use of story as a vehicle to inform aesthetic knowing in nursing. Because health care demands that nurses know two distinct languages, the language of nursing science with its quantifiable outcomes as well as the experiential observations of health and illness, it is critical that nurses be fluent in each discourse. BACKGROUND: Nursing scholars have long voiced a commitment to two epistemological domains: scientifically derived knowledge (empirics) as well as the expressive, creative, intuitive application of knowledge (aesthetics). In recognition of the need for these interpretive paradigms for practice, nursing scholars have sought to identify the kinds of knowing which provide the nursing discipline with its unique perspective. DISCUSSION: Stories mould every human encounter and telling one's story in the context of a trusting relationship allows women and nurses to journey together to uncover and discover the meanings inherent in the story. Through this mutual process of unfolding the story, nurses engage the women in deep reflection and focus on what 'might be' so that possibilities for the future are illuminated. This is important in all nursing, but particularly in women's health nursing because the emergence of story suggests that contextual, phenomena-centred knowledge has found its voice in the nursing care of women as a way of knowing that focuses on personal experience and relies on methods in which woman-to-woman caring facilitates the disclosure of the human health-illness experience. CONCLUSIONS: Storytelling is a useful strategy to inform aesthetic knowing in nursing. Stories supply a foundation for nursing scholarship because truly to hear women's stories require nurses analyse information, formulate hypotheses, and seek to understand the causal relationships as expressed by women. Through this analysis and attention to detail, nurses are able to glimpse possibilities for the future, thus transforming the experience.