Viscum album L. extracts in breast and gynaecological cancers: a systematic review of clinical and preclinical research

<p>Abstract</p> <p>Background</p> <p><it>Viscum album </it>L. extracts (VAE, European mistletoe) are a widely used medicinal plant extract in gynaecological and breast-cancer treatment.</p> <p>Methods</p> <p>Systematic review to evaluate clinical studies and preclinical research on the therapeutic effectiveness and biological effects of VAE on gynaecological and breast cancer. Search of databases, reference lists and expert consultations. Criteria-based assessment of methodological study quality.</p> <p>Results</p> <p>19 randomized (RCT), 16 non-randomized (non-RCT) controlled studies, and 11 single-arm cohort studies were identified that investigated VAE treatment of breast or gynaecological cancer. They included 2420, 6399 and 1130 patients respectively. 8 RCTs and 8 non-RCTs were embedded in the same large epidemiological cohort study. 9 RCTs and 13 non-RCTs assessed survival; 12 reported a statistically significant benefit, the others either a trend or no difference. 3 RCTs and 6 non-RCTs assessed tumour behaviour (remission or time to relapse); 3 reported statistically significant benefit, the others either a trend, no difference or mixed results. Quality of life (QoL) and tolerability of chemotherapy, radiotherapy or surgery was assessed in 15 RCTs and 9 non-RCTs. 21 reported a statistically significant positive result, the others either a trend, no difference, or mixed results. Methodological quality of the studies differed substantially; some had major limitations, especially RCTs on survival and tumour behaviour had very small sample sizes. Some recent studies, however, especially on QoL were reasonably well conducted. Single-arm cohort studies investigated tumour behaviour, QoL, pharmacokinetics and safety of VAE. Tumour remission was observed after high dosage and local application. VAE application was well tolerated. 34 animal experiments investigated VAE and isolated or recombinant compounds in various breast and gynaecological cancer models in mice and rats. VAE showed increase of survival and tumour remission especially in mice, while application in rats as well as application of VAE compounds had mixed results. <it>In vitro </it>VAE and its compounds have strong cytotoxic effects on cancer cells.</p> <p>Conclusion</p> <p>VAE shows some positive effects in breast and gynaecological cancer. More research into clinical efficacy is warranted.</p

The Heidelberg Milestones Communication Approach (MCA) for patients with prognosis &lt;12 months: protocol for a mixed-methods study including a randomized controlled trial

Background: The care needs of patients with a limited prognosis (&lt;12 months median) are complex and dynamic. Patients and caregivers must cope with many challenges, including physical symptoms and disabilities, uncertainty. and compromised self-efficacy. Healthcare is often characterized by disruptions in the transition between healthcare providers. The Milestones Communication Approach (MCA) is a structured, proactive, interprofessional concept that involves physicians and nurses and is aimed at providing coherent care across the disease trajectory. This study aims to evaluate these aspects of MCA: (1) the training of healthcare professionals, (2) implementation context and outcomes, (3) patient outcomes, and (4) effects on interprofessional collaboration. Methods/design: A multiphase mixed-methods design will be used for the study. A total of 100 patients and 120 healthcare professionals in a specialized oncology hospital will be involved. The training outcomes will be documented using a questionnaire. Implementation context and outcomes will be explored through semi-structured interviews and written questionnaires with healthcare professionals and with the training participants and through a content analysis of patient files. Patient outcomes will be assessed in a pragmatic non-blinded randomized controlled trial and in qualitative interviews with patients and caregivers. Trial outcomes are supportive care needs (SCNS-SF34-G), quality of life (SeiQol and Fact-L), depression and anxiety symptoms (PHQ-4), and distress (Distress Thermometer). Qualitative semi-structured interviews on patients’ views will focus on shared decision-making, communication needs, feeling empathy, and further utilization of healthcare services. Interprofessional collaboration will be explored using the UWE-IP-D before the implementation of MCA (t0) and after 3 (t1), 9 (t2), and 12 (t3) months. Discussion: Using guideline-concordant early palliative care, MCA aims to foster patient-centered communication with shared decision-making and facilitation of advance care planning including end-of-life decisions, thus increasing patient quality of life and decreasing aggressive medical care at the end of life. It is assumed that the communication skills training and interprofessional coaching will improve the communication behavior of healthcare providers and influence team communications and team processes. Trial registration German Clinical Trials Register, DRKS00013649 and DRKS00013469. Registered on 22 December 2017

Adherence of Antenatal Consultations by Midwives – A Quantitative Content Analysis

Hintergrund: Geburtshilfliche Interventionen nehmen weltweit zu, auch in Deutschland. Um deren Zahl zu reduzieren entstehen verschiedene Ansätze zur Förderung der normalen Geburt, so auch der deutsche „Expertinnenstandard Förderung der physiologischen Geburt“. Unter anderem wird darin eine Hebammensprechstunde gefordert. Inwieweit Hebammensprechstunden in Einrichtungen, die den Expertinnenstandard eingeführt haben, implementiert sind und ob sie in ihrer Ausgestaltung den Empfehlungen, so wie sie von den Entwicklerinnen intendiert waren (Adhärenz), folgen, ist bisher nicht bekannt. Ziel dieser Studie ist es, Analysemerkmale für die Hebammensprechstunde zu entwickeln, die Zielgruppe und Inhalte zu identifizieren und die Adhärenz zu untersuchen. Methode: Eine Delphi-Befragung zur Entwicklung von Analysemerkmalen mit 3 Entwicklerinnen und eine quantitative Dokumentenanalyse der Dokumente der Hebammensprechstunden zweier Krankenhäuser wurde durchgeführt (Krankenhaus 1: n=92; Krankenhaus 2: n=62). Ergebnisse: Sechs Merkmale (Dokumentation von „Sorgen und Ängste“, „Absprachen“, „Beratungsthemen“, „Themen, die besprochen wurden“, „Nachvollziehbarkeit der Möglichkeiten der Geburtsplanung“ und „Optionen der Geburtsplanung) wurden aus dem Expertinnenstandard identifiziert. Vor allem Erstgebärende (77,2%) nehmen die Hebammensprechstunde in Anspruch. Es zeigt sich ein breites Spektrum an Themen, die im Rahmen der Hebammensprechstunde angesprochen werden. Die Dokumente von Krankenhaus 2 belegen eine hohe Adhärenz, während die Dokumente von Krankenhaus 1 eine mittlere Adhärenz zeigen. Schlussfolgerungen: Die Untersuchung der Adhärenz ermöglicht es Krankenhäusern, die Hebammensprechstunde auf ihre Umsetzung hin einzuschätzen. Auf Grundlage der hier vorgestellten Analyse können Anpassungen, z. B. an der Dokumentenstruktur oder den Beratungsinhalten vorgenommen werden. Im Kontext der Hebammensprechstunde besteht weiterer Forschungsbedarf zu den Implementierungsprozessen, um vorhandene Unterschiede in der Adhärenz besser zu erklären.Purpose: Worldwide the use of medical interventions in childbirth is increasing, which holds true in Germany as well. In response, different approaches are being developed to enhance normal childbirth. Also, in Germany there is now an expert care standard to promote physiological childbirth, which mandates antenatal consultation conducted by midwives. The extent to which antenatal consultation based on this standard has been implemented and the degree of adherence (as intended by the developers) remain unclear. The aim of this study is to investigate who makes use of antenatal consultations, the topics and content of consultation documents and adherence to the antenatal consultation requirement in 2 hospitals. Method: Criteria for analyzing consultation documents were derived based on the content of the care standard and using the Delphi method by 3 experts who had participated in developing the expert care standard. A content analysis of the documents (hospital 1: n=92; hospital 2: n=62) used in antenatal consultation based on criteria identified in the standard was conducted. Results: Six criteria (“worries and anxieties,” “agreements,” “suggested topics,” “all topics,” “traceability of birth plan” and “options of birth plan”) for analyzing consultation documents were identified. Especially primiparae women (77.2%) avail themselves of antenatal consultation. The variety of topics covered in antenatal consultation is broad. The documents in hospital 2 show high adherence to the standard to promote normal childbirth. The documents of hospital 1 show moderate adherence. Conclusions: The investigation of adherence helps to determine implementation success and to identify areas needing revision and their modification. Implementation processes require further research to explain the differences in adherence

Sustainability of hospital-based midwife-led antenatal care consultation — a qualitative study

Background!#!All evidence-based knowledge and improvement strategies for quality care must be implemented so patients can benefit from them. In Germany, national expert standards (NES) contribute to quality care in nursing and midwifery. The NES defines for several action levels a dedicated level of quality, which is operationalized by structure, process, and outcome (SPO) criteria. An NES to promote normal childbirth was developed and implemented in 2014. The first action level involves midwife-led antenatal consultation (ML-AC) being conducted in a structured way. Most implementation processes aim to accomplish sustainability, but implementation studies rarely use definitions or a theory of sustainability, even when assessing sustainability. This lack led to the assumption that intervention sustainability after implementation is still a largely unexplored domain. The aim of this study is to investigate the sustainability of midwife-led antenatal consultation (ML-AC) implemented at two hospitals, in Germany.!##!Methods!#!In a qualitative approach, 34 qualitative interviews were conducted (between March and October 2017) using semi-structured interview guides. All interviews were transcribed verbatim, anonymized and analyzed thematically using framework method. Four groups of stakeholders in two hospitals offering ML-AC were interviewed: managers (n = 8), midwives conducting ML-AC (n = 10), pregnant women who attended ML-AC (n = 8), and physicians working in obstetrics (n = 8) at the hospitals.!##!Results!#!The interviewees identified key benefits of ML-AC on a personal and unit level, e.g., reduced obstetric interventions, easier admission processes. Furthermore, the participants defined key requirements that are needed for routinized and institutionalized ML-AC, such as allocating working time for ML-AC, and structural organization of ML-AC. All study participants saw a need to establish secure long-term funding. Additionally, the interviewed staff members stated that ML-AC topics need evaluating and adapting in the future.!##!Conclusions!#!Implementing ML-AC in the hospital setting has led to manifold benefits. However, reimbursement through the health care system will be needed to sustain ML-AC. Hospitals implementing ML-AC will need to be aware that adaptations of the NES are necessary to accomplish routinization and institutionalization. After initial implementation, sustaining ML-AC will generally require on-going monitoring and evaluating of benefits, routinization/institutionalization and further development

Heidelberger Meilenstein Kommunikation (HeiMeKOM) – Erfahrungen, Best Practice Beispiele und Empfehlungen aus dem Abschluss-Symposium am 30./31. Januar 2020

The National Cancer Plan emphasises the importance of medical communication and calls for its integration into medical education and training. In this context, the Milestone Communication Approach meets the communicative challenges in dealing with lung cancer patients. Interprofessional tandems, consisting of doctors and nurses, conduct structured conversations at defined moments with patients and their relatives. The concept aims at shared decision making, continuity in the care of lung cancer patients and the early integration of palliative care. During the symposium on the Heidelberg Milestone Communication in January 2020, recommendations on the care situation of lung cancer patients in advanced stages were developed. In addition, the further adaptability of HeiMeKOM to other settings and hospitals and to other diseases was discussed as well as the possibility of implementing such a concept in standard care. This article presents the experiences, best practice examples and recommendations discussed during the symposium in order to enable their extrapolation to other similarly oriented projects. The long-term goal is to transfer the milestone concept to other hospital, primarily certified lung cancer centers, and to ensure permanent funding. For further dissemination of the concept and, above all, to have it established in standard care, health policy awareness and support are required in addition to the integration of the concept in competence catalogues of continuing medical and nursing education