ESMO expert consensus statements on the screening and management of financial toxicity in patients with cancer.

BACKGROUND: Financial toxicity, defined as both the objective financial burden and subjective financial distress from a cancer diagnosis and its treatment, is a topic of interest in the assessment of the quality of life of patients with cancer and their families. Current evidence implicates financial toxicity in psychosocial, economic and other harms, leading to suboptimal cancer outcomes along the entire trajectory of diagnosis, treatment, supportive care, survivorship and palliation. This paper presents the results of a virtual consensus, based on the evidence base to date, on the screening and management of financial toxicity in patients with and beyond cancer organized by the European Society for Medical Oncology (ESMO) in 2022. METHODS: A Delphi panel of 19 experts from 11 countries was convened taking into account multidisciplinarity, diversity in health system contexts and research relevance. The international panel of experts was divided into four working groups (WGs) to address questions relating to distinct thematic areas: patients with cancer at risk of financial toxicity; management of financial toxicity during the initial phase of treatment at the hospital/ambulatory settings; financial toxicity during the continuing phase and at end of life; and financial risk protection for survivors of cancer, and in cancer recurrence. After comprehensively reviewing the literature, statements were developed by the WGs and then presented to the entire panel for further discussion and amendment, and voting. RESULTS AND DISCUSSION: A total of 25 evidence-informed consensus statements were developed, which answer 13 questions on financial toxicity. They cover evidence summaries, practice recommendations/guiding statements and policy recommendations relevant across health systems. These consensus statements aim to provide a more comprehensive understanding of financial toxicity and guide clinicians globally in mitigating its impact, emphasizing the importance of further research, best practices and guidelines.

Endovascular Treatment of Cerebrovascular Lesions Using Nickel- or Nitinol-Containing Devices in Patients with Nickel Allergies.

Nickel is used in many cerebral endovascular treatment devices. However, nickel hypersensitivity is the most common metal allergy, and the relative risk of treatment in these patients is unknown. This retrospective analysis identified patients with nickel or metal allergies who underwent cerebral endovascular treatment with nickel-containing devices. Seven patients with nickel and/or other metal allergies underwent treatment with 9 nickel-containing devices. None experienced periprocedural complications. No patient received treatment with corticosteroids or antihistamines. At a mean clinical follow-up for all patients of 22.8 months (range, 10.5-38.0 months), no patients had symptoms attributable to nickel allergic reactions. The mean radiographic follow-up for all patients at 18.4 months (range, 2.5-37.5 months) showed successful treatment of the targeted vascular pathologies, with no evidence of in-stent stenosis or other allergic or hypersensitivity sequelae. The treatment of cerebrovascular lesions with a nickel-containing device resulted in no adverse outcomes among these patients and was safe and effective.

Role and responsibility of oncologists in assisted suicide. Practice and views among members of the German Society of Haematology and Medical Oncology.

BACKGROUND: Physician-assisted suicide (PAS) is a controversial practice and regulatory frameworks differ regarding assigned physicians' roles. This study explores clinical experience and views of German oncologists concerning ethically and legally relevant aspects of PAS after change of the law. MATERIALS AND METHODS: An online survey was conducted among members of the German Society of Haematology and Medical Oncology (DGHO) in March 2021. Descriptive analysis, bivariate and multivariable logistic regression of quantitative data on determinants related to (un)willingness to assist with suicide as well qualitative analysis of free-text comments were carried out. RESULTS: Seven hundred and forty-five of 3588 DGHO members responded (20.8%). Of these, 29.9% reported requests for a lethal drug and 3.0% (n = 22) reported to have assisted with suicide. Almost half of them (47.0%, n = 350) objected to providing PAS, whereas 45.9% indicated a willingness at least under certain conditions. Of those respondents who did not object to PAS, 25.4% would also consider assistance if those willing to die had a psychiatric disease and 10.2% if requestors had no disease at all. A majority viewed a role for physicians regarding different tasks associated with assisted suicide. Respondents with <10 years of professional experience, working in hospital with religious affiliation and with subspecialisation in palliative care were significantly less frequently willing to assist suicide. CONCLUSIONS: Respondents are divided in their personal attitudes towards PAS but a majority supports involvement of physicians regarding different tasks related to assisted suicide. Data about the practice and envisaged professional role may inform development of an acceptable ethico-legal framework for a controversial practice.

Multicenter Postmarket Analysis of the Neuroform Atlas Stent for Stent-Assisted Coil Embolization of Intracranial Aneurysms.

BACKGROUND AND PURPOSE: The Neuroform Atlas is a new microstent to assist coil embolization of intracranial aneurysms that recently gained FDA approval. We present a postmarket multicenter analysis of the Neuroform Atlas stent. MATERIALS AND METHODS: On the basis of retrospective chart review from 11 academic centers, we analyzed patients treated with the Neuroform Atlas after FDA exemption from January 2018 to June 2019. Clinical and radiologic parameters included patient demographics, aneurysm characteristics, stent parameters, complications, and outcomes at discharge and last follow-up. RESULTS: Overall, 128 aneurysms in 128 patients (median age, 62 years) were treated with 138 stents. Risk factors included smoking (59.4%), multiple aneurysms (27.3%), and family history of aneurysms (16.4%). Most patients were treated electively (93.7%), and 8 (6.3%) underwent treatment within 2 weeks of subarachnoid hemorrhage. Previous aneurysm treatment failure was present in 21% of cases. Wide-neck aneurysms (80.5%), small aneurysm size (<7 mm, 76.6%), and bifurcation aneurysm location (basilar apex, 28.9%; anterior communicating artery, 27.3%; and middle cerebral artery bifurcation, 12.5%) were common. A single stent was used in 92.2% of cases, and a single catheter for both stent placement and coiling was used in 59.4% of cases. Technical complications during stent deployment occurred in 4.7% of cases; symptomatic thromboembolic stroke, in 2.3%; and symptomatic hemorrhage, in 0.8%. Favorable Raymond grades (Raymond-Roy occlusion classification) I and II were achieved in 82.9% at discharge and 89.5% at last follow-up. mRS ≤2 was determined in 96.9% of patients at last follow-up. The immediate Raymond-Roy occlusion classification grade correlated with aneurysm location (P < .0001) and rupture status during treatment (P = .03). CONCLUSIONS: This multicenter analysis provides a real-world safety and efficacy profile for the treatment of intracranial aneurysms with the Neuroform Atlas stent.

[Ethical frameworks as a corrective in daily clinical practice? : Reflection on the significance of organizational ethics in tackling the challenges of economization in the medical system]. / Klinikkodizes als Korrektiv im ärztlichen Alltag? : Eine Reflexion zur Bedeutung organisationsethischer Aspekte im Umgang mit der Ökonomisierung des Medizinsystems.

BACKGROUND: Economic considerations play an ever-increasing role in the decisions and actions of physicians, at times compromising the doctor-patient relationship and the quality of treatment. A reflection on an appropriate form of economization in the medical system therefore seems to be necessary. OBJECTIVES: This article examines the conditions under which moral standards can be effective in daily clinical practice. MATERIALS AND METHODS: Strategies against the scarcity of resources are evaluated using ethical criteria. Organizational ethics approaches are discussed as a possible solution. RESULTS: Economic considerations are desirable if they increase efficiency in the healthcare system. However, rationing for purely cost reasons or delivering services to increase profit are ethically questionable motives. In addition to individual care decisions, cost decisions need to be transparently weighed at the institutional and health policy levels. Through this higher-level approach, carers will be better able to focus on the core of medical treatment which is the patient's well-being. CONCLUSIONS: Codes of conduct such as the DGIM (German Society of Internal Medicine) Clinic Codex can be useful ethical guidelines for patient care if they are institutionally implemented and actually used in the institution.

Methods for measuring financial toxicity after cancer diagnosis and treatment: a systematic review and its implications.

Patients experiencing financial distress as a side-effect of cancer are not only reported in the United States, but also in third-party payer healthcare systems in Europe. Since validated survey instruments are a prerequisite for robust and comparable results, we aimed to compile and classify available instruments to enable both a better understanding of the underlying construct of financial toxicity and to facilitate further studies that are adjustable to various healthcare systems. We did a systematic literature search on studies that provide data on perceived cancer-related financial distress experienced by adult patients using PubMed, CINAHL and Web of Science databases up to 2018. We analyzed all detected instruments, items domains and questions with regard to their wording, scales and the domains of financial distress covered. Among 3298 records screened, 41 publications based on 40 studies matched our inclusion criteria. Based on the analysis of 352 different questions we identified 6 relevant subdomains that represent perceptions of and reactions to experienced financial distress: (i) active financial spending, (ii) use of passive financial resources, (iii) psychosocial responses, (iv) support seeking, (v) coping with care or (vi) coping with ones' lifestyle. We found an inconsistent coverage and use of these domains that makes it difficult to compare and quantify the prevalence of financial distress. Moreover, some existing instruments do not reflect relevant domains for patients in third-party payer systems. There is neither a consistent understanding of the construct of financial burden nor do available instruments cover all relevant aspects of a patients' distress perception. We encourage using the identified six domains to further develop survey instruments and adjust them to different health systems.

Comparison of single- and dual-monitor approaches to differentiate sitting from lying in free-living conditions.

High levels of sedentary time have been detrimentally linked to health outcomes. Differentiating sitting from lying may help to further understand the mechanisms associated with these health impacts. This study compares the inter-method agreement between the "single-monitor" method (thigh-worn activPAL3TM ) and a more robustly validated "dual-monitor" method (trunk and thigh-worn activPAL3TM ) in their classifications of sitting and lying under free-living conditions. Thirty-five participants (20-50 years) wore two activity monitors (thigh and trunk) for 24 hours. Total time spent lying and sitting was calculated for both methods, and agreement was determined using ICC and Bland-Altman methods. As there was no gold standard, further data were collected from five participants during structured activities that were designed to challenge classification, to better understand any disagreement between the methods. ICCs were 0.81 for sitting time and 0.64 for lying time. The single-monitor method detected less lying time than the dual-monitor method, with a mean difference of -25 minutes (95% agreement limits: -172 to 221 minutes), including three cases with extreme disagreement (mostly in daytime lying classification). The additional data collection suggested a major source of disagreement was failure of the single-monitor method to identify lying that involved no rotation around the longitudinal axis. In conclusion, there was some agreement between the single- and dual-monitor estimates of lying time under free-living conditions, but measures were not interchangeable. The main disagreement was in how the methods classified daytime lying and lying tasks involving no lateral movement. Both methods yield promise for measuring time in bed.

A longitudinal communication approach in advanced lung cancer: A qualitative study of patients', relatives' and staff's perspectives.

Communication and the care of patients with advanced cancer are a dynamic, interactive and challenging process, often characterised in every day practice by discontinuity and lack of coordination. The objective of this study was to explore the patients' and family-caregivers' needs and preferences regarding communication, quality of life and care over the trajectory of disease. The second aim was to assess health professionals' views on a longitudinally structured, forward-thinking communication approach based on defined milestones. A qualitative approach was chosen incorporating semi-structured interviews with nine patients with metastatic lung cancer and nine relatives, and focus groups with 15 healthcare providers from different professions involved in the care of these patients. Patients and relatives described a situation of shock and coping deficits with moments of insufficient communication and lack of continuity in care. Healthcare providers reported the strong need for improvement in communication within the team and between patients and professionals and welcomed the implementation of a longitudinal communication approach. Requirements for the implementation of a longitudinal communication approach include specific communication training with focus on the process that patients and relatives are involved in. Team-building measures and the necessary flexibility to respect individuality in life should be incorporated.

Cross-sectoral cancer care: views from patients and health care professionals regarding a personal electronic health record.

Cross-sectoral cancer care is complex and involves collaboration from health care professionals (HCPs) across multiple sectors. However, when health information exchange (HIE) is not adequate, it results in impeded coordination and continuity of care. A web-based personal electronic health record (PEPA) under patients' control, providing access to personal health data across sectors, is being developed. Aim of this study was to explore perceived benefits and concerns. Using a qualitative approach, 10 focus groups were performed collecting views of three prospective user groups: patients with colorectal cancer (n = 12), physicians (n = 17) and other HCPs (n = 16). Representatives from different health sectors across the Rhine-Neckar region (Germany) participated. Data were audio- and videotaped, transcribed verbatim and thematically analysed. Our study shows that patients and HCPs expected a PEPA to enhance cross-sectoral availability of information, cross-sectoral cooperation and facilitate data management. Quality of cancer care was expected to be improved. Concerns were expressed in terms of data protection and data security. Concepts like a PEPA offer the chance to support HIE and avoid gaps of information in cross-sectoral cancer care. This may lead to improvements in coordination and continuity of care. Issues concerning data security and protection have to be addressed.

Evaluating the effectiveness of organisational-level strategies with or without an activity tracker to reduce office workers' sitting time: a cluster-randomised trial.

BACKGROUND: Office workers engage in high levels of sitting time. Effective, context-specific, and scalable strategies are needed to support widespread sitting reduction. This study aimed to evaluate organisational-support strategies alone or in combination with an activity tracker to reduce sitting in office workers. METHODS: From one organisation, 153 desk-based office workers were cluster-randomised (by team) to organisational support only (e.g., manager support, emails; 'Group ORG', 9 teams, 87 participants), or organisational support plus LUMOback activity tracker ('Group ORG + Tracker', 9 teams, 66 participants). The waist-worn tracker provided real-time feedback and prompts on sitting and posture. ActivPAL3 monitors were used to ascertain primary outcomes (sitting time during work- and overall hours) and other activity outcomes: prolonged sitting time (≥30 min bouts), time between sitting bouts, standing time, stepping time, and number of steps. Health and work outcomes were assessed by questionnaire. Changes within each group (three- and 12 months) and differences between groups were analysed by linear mixed models. Missing data were multiply imputed. RESULTS: At baseline, participants (46 % women, 23-58 years) spent (mean ± SD) 74.3 ± 9.7 % of their workday sitting, 17.5 ± 8.3 % standing and 8.1 ± 2.7 % stepping. Significant (p < 0.05) reductions in sitting time (both work and overall) were observed within both groups, but only at 12 months. For secondary activity outcomes, Group ORG significantly improved in work prolonged sitting, time between sitting bouts and standing time, and overall prolonged sitting time (12 months), and in overall standing time (three- and 12 months); while Group ORG + Tracker, significantly improved in work prolonged sitting, standing, stepping and overall standing time (12 months). Adjusted for confounders, the only significant between-group differences were a greater stepping time and step count for Group ORG + Tracker relative to Group ORG (+20.6 min/16 h day, 95 % CI: 3.1, 38.1, p = 0.021; +846.5steps/16 h day, 95 % CI: 67.8, 1625.2, p = 0.033) at 12 months. Observed changes in health and work outcomes were small and not statistically significant. CONCLUSIONS: Organisational-support strategies with or without an activity tracker resulted in improvements in sitting, prolonged sitting and standing; adding a tracker enhanced stepping changes. Improvements were most evident at 12 months, suggesting the organisational-support strategies may have taken time to embed within the organisation. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry: ACTRN12614000252617 . Registered 10 March 2014.

Feasibility, effectiveness and cost-effectiveness of a telephone-based weight loss program delivered via a hospital outpatient setting.

Engaging patients in a group-based weight loss program is a challenge for the acute-care hospital outpatient setting. To evaluate the feasibility, effectiveness and cost-effectiveness of a telephone-based weight loss service and an existing face-to-face, group-based service a non-randomised, two-arm feasibility trial was used. Patients who declined a two-month existing outpatient group-based program were offered a six-month research-based telephone program. Outcomes were assessed at baseline, two months (both groups) and six months (telephone program only) using paired t tests and linear regression models. Cost per healthy life year gained was calculated for both programs. The telephone program achieved significant weight loss (-4.1 ± 5.0 %; p = 0.001) for completers (n = 35; 57 % of enrolees) at six months. Compared to the group-based program (n = 33 completers; 66 %), the telephone program was associated with greater weight loss (mean difference [95%CI] -2.0 % [-3.4, -0.6]; p = 0.007) at two months. The cost per healthy life year gained was $33,000 and $85,000, for the telephone and group program, respectively. Telephone-delivered weight management services may be effective and cost-effective within an acute-care hospital setting, likely more so than usual (group-based) care.

Psychometric evaluation of the German Version of the Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C-G) of cancer patients.

This study aimed for psychometric validation of the German version of the Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C-G). In- and outpatients with lung, urological and gastrointestinal cancer at Heidelberg University Hospital in Germany and in each case one relevant caregiver were asked to complete a set of questionnaires assessing their unmet needs together with distress, depression, anxiety and caregiver strain. In addition, medical data of the patients were collected. Fully completed questionnaires were received from 188 pairs of patients and their caregivers. Using exploratory factor analysis, four domains of unmet needs were identified with an appropriate variance explanation (58.7%) and acceptable (>0.70) internal consistencies (α = 0.95 to 0.76) for each domain. Convergent validity was found with respect to significant positive correlations (>0.40) of the SCNS-P&C-G domains with caregivers' anxiety, depression and strain. Although poorer health status of the patient indicated more unmet caregiver needs, this finding was not consistent for all need domains. Overall, associations were only moderate to weak pointing out the necessity of a separate screening for caregivers' needs. The findings of this study support that the SCNS-P&C-G is an appropriate research instrument to assess caregivers' needs on different domains throughout the disease trajectory.

Framework for timing of the discussion about forgoing cancer-specific treatment based on a qualitative study with oncologists.

BACKGROUND: Many patients with advanced cancer receive aggressive chemotherapy close to death and are referred too late to palliative or hospice care. AIM: The aim of this study was to investigate oncologists' and oncology nurses' perceptions of the optimal timing for discussions about forgoing cancer-specific therapy at the End-of-Life (EOL) and the reasons that might hinder them. DESIGN: Qualitative in-depth interviews with oncologists and oncology nurses were carried out. The empirical data were evaluated from a normative perspective. SETTING/PARTICIPANTS: Twenty-nine physicians and nurses working at the Department of Hematology and Oncology of a German university hospital were interviewed. RESULTS: Health-care professionals differed considerably in their understanding of when to initiate discussions about forgoing cancer-specific therapy at the EOL. However, their views could be consolidated into three approaches: (1) preparing patients gradually throughout the course of disease (anticipatory approach) which is best suited to empower patient self-determination in decision-making, (2) waiting until the patient him/herself starts the discussion about forgoing cancer-specific treatment, and (3) waiting until all tumor-specific therapeutic options are exhausted. CONCLUSION: The empirically informed ethical analysis clearly favors an approach that prepares patients for forgoing cancer-specific therapy throughout the course of disease. Since the last two approaches often preclude advance care planning, these approaches may be less ethically acceptable. The proposed framework could serve as a starting point for the development of concrete recommendations on the optimal timing for EOL discussions.

[Using the Work Environment as Access--A Multiplier Programme for Health Promotion for Low-Skilled Workforces with a High Proportion of Migrants: ReSuDi]. / Arbeitswelt als Zugang--ein Multiplikatorenprogramm zur Gesundheitsförderung von Un- und Angelernten mit hohem Migrantenanteil: ReSuDi.

To gain access to low-qualified workforces with a high proportion of migrants a multiplier programme has been developed. Prevention providers, such as statutory health insurances are appropriate multipliers across the individual enterprises. Intra-corporate multipliers are trained on different organisational levels: peer mentors on the level of the low-qualified workforces, supervisors, and members and dependents of the key management personnel. Provisional results show the effectiveness of the programme.

Biobanks and personalized medicine.

We provide a mini-review of how biobanks can support clinical genetics in the era of personalized medicine. We discuss types of biobanks, including disease specific and general biobanks not focused on one disease. We present considerations in setting up a biobank, including consenting and governance, biospecimens, risk factor and related data, informatics, and linkage to electronic health records for phenotyping. We also discuss the uses of biobanks and ongoing considerations, including genotype-driven recruitment, investigations of gene-environment associations, and the re-use of data generated from studies. Finally, we present a brief discussion of some of the unresolved issues, such as return of research results and sustaining biobanks over time. In summary, carefully designed biobanks can provide critical research and infrastructure support for clinical genetics in the era of personalized medicine.

Chronic γ-secretase inhibition reduces amyloid plaque-associated instability of pre- and postsynaptic structures.

The loss of synapses is a strong histological correlate of the cognitive decline in Alzheimer's disease (AD). Amyloid ß-peptide (Aß), a cleavage product of the amyloid precursor protein (APP), exerts detrimental effects on synapses, a process thought to be causally related to the cognitive deficits in AD. Here, we used in vivo two-photon microscopy to characterize the dynamics of axonal boutons and dendritic spines in APP/Presenilin 1 (APP(swe)/PS1(L166P))-green fluorescent protein (GFP) transgenic mice. Time-lapse imaging over 4 weeks revealed a pronounced, concerted instability of pre- and postsynaptic structures within the vicinity of amyloid plaques. Treatment with a novel sulfonamide-type γ-secretase inhibitor (GSI) attenuated the formation and growth of new plaques and, most importantly, led to a normalization of the enhanced dynamics of synaptic structures close to plaques. GSI treatment did neither affect spines and boutons distant from plaques in amyloid precursor protein/presenilin 1-GFP (APPPS1-GFP) nor those in GFP-control mice, suggesting no obvious neuropathological side effects of the drug.

Hypoglossal nerve paralysis in a burn patient following mechanical ventilation.

Traumatic injury resulting in isolated dysfunction of the hypoglossal nerve is relatively rare and described in few case reports. We present a patient with isolated unilateral palsy of the twelfth cranial nerve (CN XII) resulting from recurrent airway intervention following extensive burn injuries. The differential diagnosis for paralysis of the CN XII is also discussed herein. This case illustrates the significance of comprehensive diagnostic evaluation and the need for refined airway manipulation in patients that require multiple endotracheal intubations.

Une blessure traumatique résultant en un dysfonctionnement isolé du nerf hypoglosse est relativement rare et décrit dans quelques rapports de cas. Nous présentons un patient atteint de paralysie hypoglossal unilatérale isolée à la suite de l'intervention des voies respiratoires récurrentes après de brûlures extensives. Le diagnostic différentiel de la paralysie du nerf crânien (NC XII) est également discuté ici. Ce cas illustre l'importance de l'évaluation diagnostique complète et la nécessité pour la manipulation délicate des voies respiratoires chez les patients qui nécessitent de multiples intubations trachéales.

Delocalized and localized states of eg electrons in half-doped manganites.

We have studied the magnetic behaviour of half-doped manganite Y0.5Ca0.5MnO3 in an extended range of temperatures by means of magnetic susceptibility, χ(T), and electron spin resonance (ESR) experiments. At high temperature the system crystallizes in an orthorhombic structure. The resistivity value, ρ ≃ 0.05 Ω cm at 500 K, indicates a metallic behaviour, while the Curie-Weiss dependence of χ(T) and the thermal evolution of the ESR parameters are very well described by a model that considers a system conformed by localized Mn(4+) cores, [Formula: see text], and itinerant, eg, electrons. The strong coupling between t2g and eg electrons results in an enhanced Curie constant and an FM Curie-Weiss temperature that overcomes the AFM interactions between the [Formula: see text] cores. A transition to a more distorted phase is observed at T ≈ 500 K and signatures of localization of the eg electrons appear in the χ(T) behaviour below 300 K. A new Curie-Weiss regime is observed, where the Curie-constant value is consistent with dimer formation. Based on mean-field calculations, the dimer formation is predicted as a function of the interaction strength between the t2g and eg electrons.

Six-month outcomes from living well with diabetes: A randomized trial of a telephone-delivered weight loss and physical activity intervention to improve glycemic control.

BACKGROUND: Intensive lifestyle intervention trials in type 2 diabetes contribute evidence on what can be achieved under optimal conditions, but are less informative for translation in applied settings. PURPOSE: Living Well with Diabetes is a telephone-delivered weight loss intervention designed for real-world delivery. METHODS: This study is a randomized controlled trial of telephone counseling (n = 151) versus usual care (n = 151); 6-month primary outcomes of weight, physical activity, HbA1c; secondary diet outcomes; analysis was by adjusted generalized linear models. RESULTS: Relative to usual care, telephone counseling participants had small but significantly better weight loss [-1.12 % of initial body weight; 95 % confidence interval (CI) -1.92, -0.33 %]; physical activity [relative rate (RR) = 1.30; 95 % CI, 1.08, 1.57]; energy intake reduction (-0.63 MJ/day; 95 % CI, -1.01, -0.25); and diet quality (3.72 points; 95 % CI, 1.77, 5.68), with no intervention effect for HbA1c (RR = 0.99; 95 % CI, 0.96, 1.01). CONCLUSIONS: Results are discussed in light of challenges to intervention delivery.