Durvalumab or placebo plus gemcitabine and cisplatin in participants with advanced biliary tract cancer (TOPAZ-1): updated overall survival from a randomised phase 3 study.

Background: In the preplanned interim analysis of the TOPAZ-1 study, durvalumab plus gemcitabine-cisplatin significantly improved overall survival versus placebo plus gemcitabine-cisplatin in participants with advanced biliary tract cancer. We aimed to report updated overall survival and safety data from TOPAZ-1 with additional follow-up and data maturity beyond the interim analysis.

Methods: TOPAZ-1 was a phase 3, randomised, double-masked, placebo-controlled, global study done at 105 sites in 17 countries.

From "wading through treacle" to "making haste slowly": A comprehensive yet parsimonious model of drivers and challenges to implementing patient data sharing projects based on an EPaCCS evaluation and four pre-existing literature reviews.

Conceptually, this study aimed to 1) identify the challenges and drivers encountered by England's Electronic Palliative Care Coordination System (EPaCCS) projects in the context of challenges and drivers in other projects on data sharing for individual care (also referred to as Health Information Exchange, HIE) and 2) organise them in a comprehensive yet parsimonious framework. The study also had a strong applied goal: to derive specific and non-trivial recommendations for advancing data sharing projects, particularly ones in early stages of development and implementation. Primary data comprised 40 in-depth interviews with 44 healthcare professionals, patients, carers, project team members and decision makers in Cambridgeshire, UK.

A survey of the knowledge, perceptions of and attitudes to digital health of healthcare professionals in 14 Bulgarian hospitals: First large-scale study on digital health in Bulgarian inpatient facilities.

Objective: To explore the knowledge, perceptions of and attitudes to digital health of Bulgarian hospital professionals in the first study of digital health in this professional group.

Methods: A paper-based questionnaire was administered to doctors, trainee doctors, nurses, midwives, and laboratory assistants working in multiprofile or specialized hospitals. Topics included the following: state, objectives, benefits, and future of digital health; data storage, access, security, and sharing; main software used; patient-held Personal Information System (PIS); and telemedicine.

A synthesis of concepts of resilience to inform operationalization of health systems resilience in recovery from disruptive public health events including COVID-19.

This article is part of the Research Topic 'Health Systems Recovery in the Context of COVID-19 and Protracted Conflict' Health systems resilience has become a ubiquitous concept as countries respond to and recover from crises such as the COVID-19 pandemic, war and conflict, natural disasters, and economic stressors . However, the operational scope and definition of health systems resilience to inform health systems recovery and the building back better agenda have not been elaborated in the literature and discourse to date. When widely used terms and their operational definitions appear nebulous or are not consistently used, it can perpetuate misalignment between stakeholders and investments.

Lower fluorodeoxyglucose positron emission tomography maximum standardized uptake value may show a better response to stereotactic body radiotherapy of adrenals in oligometastatic disease.

Introduction: Stereotactic body radiotherapy (SBRT) is well established for oligometastatic disease, and it is increasingly used to treat adrenal metastases.

Material And Methods: In this retrospective study we performed an analysis of 75 metastatic adrenal lesions in 64 patients with oligometastatic disease. According to the fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) maximum standardized uptake value (SUV) of adrenal metastases, patients were categorized into three groups: low, intermediate, and high SUVmax.

Timely community palliative and end-of-life care: a realist synthesis.

Background: Community-based and home-based palliative and end-of-life care (PEoLC) services, often underpinned by primary care provision, are becoming increasingly popular. One of the key challenges associated with them is their timely initiation. The latter requires an accurate enough prediction of how close to death a patient is.

Gemcitabine/Nab-Paclitaxel versus FOLFIRINOX in Locally Advanced Pancreatic Cancer: A European Multicenter Study.

Background: Gemcitabine/nab-paclitaxel (GN) and FOLFIRINOX (FFX) are two standard first-line therapies for metastatic pancreatic cancer (PC) but have rarely been compared, especially in patients with locally advanced PC (LAPC).

Methods: This is a retrospective European multicenter study including patients with LAPC treated with either GN or FFX as the first-line therapy between 2010 and 2019. Coprimary objectives were progression-free survival (PFS) and overall survival (OS), both estimated using the Kaplan-Meier method.

Comparison of the health-related quality of life of end stage kidney disease patients on hemodialysis and non-hemodialysis management in Uganda.

Background: Health-related quality of life is recognized as a key outcome in chronic disease management, including kidney disease. With no national healthcare coverage for hemodialysis, Ugandan patients struggle to pay for their care, driving families and communities into poverty. Studies in developed countries show that patients on hemodialysis may prioritize quality of life over survival time, but there is a dearth of information on this in developing countries.

Health-related quality of life, palliative care needs and 12-month survival among patients with end stage renal disease in Uganda: protocol for a mixed methods longitudinal study.

Background: The prevalence of chronic kidney disease is on the rise globally and in sub-Saharan Africa. Due to its "silent" nature, many patients often present with advanced disease. At this point options for care are often limited to renal replacement therapies such as hemodialysis and kidney transplantation.

Lost in reviews: Looking for the involvement of stakeholders, patients, public and other non-researcher contributors in realist reviews.

The involvement of non-researcher contributors (eg, stakeholders, patients and the public, decision and policy makers, experts, lay contributors) has taken a variety of forms within evidence syntheses. Realist reviews are a form of evidence synthesis that involves non-researcher contributors yet this practice has received little attention. In particular, the role of patient and public involvement (PPI) has not been clearly documented.

Dying individuals and suffering populations: applying a population-level bioethics lens to palliative care in humanitarian contexts: before, during and after the COVID-19 pandemic.

Background: Humanitarian crises and emergencies, events often marked by high mortality, have until recently excluded palliative care-a specialty focusing on supporting people with serious or terminal illness or those nearing death. In the COVID-19 pandemic, palliative care has received unprecedented levels of societal attention. Unfortunately, this has not been enough to prevent patients dying alone, relatives not being able to say goodbye and palliative care being used instead of intensive care due to resource limitations.

Illness-related suffering and need for palliative care in Rohingya refugees and caregivers in Bangladesh: A cross-sectional study.

Background: Despite recognition that palliative care is an essential component of any humanitarian response, serious illness-related suffering continues to be pervasive in these settings. There is very limited evidence about the need for palliative care and symptom relief to guide the implementation of programs to alleviate the burden of serious illness-related suffering in these settings. A basic package of essential medications and supplies can provide pain relief and palliative care; however, the practical availability of these items has not been assessed.

Oncologist Burnout Syndrome in Eastern Europe: Results of the Multinational Survey.

Purpose: Burnout is defined as a three-dimensional syndrome-emotional exhaustion (EE), depersonalization (DP), and reduced personal accomplishment (PA)-caused by chronic occupational stress. The aim of the current study was to investigate the prevalence of burnout among oncologists in Eastern Europe and to identify the contributing factors.

Methods: The study was conducted as an online survey between October 2017 and March 2018.

Neutrophil to lymphocyte ratio as a potential predictive marker for treatment with pembrolizumab as a second line treatment in patients with non-small cell lung cancer.

The aim of this multicentric retrospective study is to evaluate the predictive and prognostic performance of neutrophil to lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR) and their dynamics in patients with non-small cell lung cancer (NSCLC) treated with pembrolizumab as a second line. Patients with metastatic NSCLC (n = 119), whose tumors expressed programmed death-ligand 1 (PD-L1) ≥ 1%, were retrospectively analyzed between Apr 2017 and Apr 2019. All patients received platinum-containing chemotherapy as a first line treatment.

Response to Correspondence from Kolstoe and colleagues concerning our paper entitled, Research approvals iceberg: How a 'low-key' study in England needed 89 professionals to approve it and how we can do better.

In their letter to the Editor in this issue, Kolstoe and Carpenter challenge a core aspect of our recently published case study of research approvals [BMC Medical Ethics 20:7] by arguing that we conflate research ethics with governance and funding processes. Amongst the key concerns of the authors are: 1) that our paper exemplifies a typical conflation of concepts such as governance, integrity and ethics, with significant consequences for claims around the responsibility and accountability of the organisations involved; 2) that, as a consequence of this conflation, we misrepresent the ethics review process, including in fundamental aspects such as the ethics approval-opinion distinction; 3) that it is difficult to see scope for greater integration of processes such as applying for funding, research approvals, Patient and Public Involvement, etc., as suggested by us.

Research approvals iceberg: how a 'low-key' study in England needed 89 professionals to approve it and how we can do better.

Background: The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service (NHS) procedures and the electronic Integrated Research Application System (IRAS). We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive research, and suggest directions for radical system change.

Between "the best way to deliver patient care" and "chaos and low clinical value": General Practitioners' and Practice Managers' views on data sharing.

Objective: In the UK, General Practitioners and Practice Managers are key to enabling health information exchange (typically referred to as 'data sharing'). This study aimed to survey GPs and PMs for familiarity, engagement with and perceptions of patient data sharing.

Methods: Cross-sectional survey.

Career opportunities and benefits for young oncologists in the European Society for Medical Oncology (ESMO).

The European Society for Medical Oncology (ESMO) is one of the leading societies of oncology professionals in the world. Approximately 30% of the 13 000 ESMO members are below the age of 40 and thus meet the society's definition of young oncologists (YOs). ESMO has identified the training and development of YOs as a priority and has therefore established a comprehensive career development programme.

Crash course in EPaCCS (Electronic Palliative Care Coordination Systems): 8 years of successes and failures in patient data sharing to learn from.

Background: Electronic Palliative Care Coordination Systems (EPaCCS) are England's pre-eminent initiative in enabling advance care planning and improved communication and coordination at the end of life. EPaCCS have been under development for 8 years after being proposed, as Locality Registers, in the 2008 End of Life Care Strategy for England. EPaCCS are electronic registers or tools and processes for sharing data which aim to enable access to information about dying patients.

Search terms and a validated brief search filter to retrieve publications on health-related values in Medline: a word frequency analysis study.

Objective: Healthcare debates and policy developments are increasingly concerned with a broad range of values-related areas. These include not only ethical, moral, religious, and other types of values 'proper', but also beliefs, preferences, experiences, choices, satisfaction, quality of life, etc. Research on such issues may be difficult to retrieve.