The Study of the Epidemiology of Pediatric Hypertension Registry (SUPERHERO): Rationale and Methods.

Despite increasing prevalence of hypertension in youth and high adult cardiovascular mortality rates, the long-term consequences of youth-onset hypertension remain unknown. This is due to limitations of prior research such as small sample sizes, reliance on manual record review, and limited analytic methods that did not address major biases. The Study of the Epidemiology of Pediatric Hypertension (SUPERHERO) is a multisite retrospective Registry of youth evaluated by subspecialists for hypertension disorders. Sites obtain harmonized electronic health record data using standardized biomedical informatics scripts validated with randomized manual record review. Inclusion criteria are index visit for International Classification of Diseases Diagnostic Codes, 10th Revision (ICD-10 code)-defined hypertension disorder ≥January 1, 2015 and age <19 years. We exclude patients with ICD-10 code-defined pregnancy, kidney failure on dialysis, or kidney transplantation. Data include demographics, anthropomorphics, U.S. Census Bureau tract, histories, blood pressure, ICD-10 codes, medications, laboratory and imaging results, and ambulatory blood pressure. SUPERHERO leverages expertise in epidemiology, statistics, clinical care, and biomedical informatics to create the largest and most diverse registry of youth with newly diagnosed hypertension disorders. SUPERHERO's goals are to (i) reduce CVD burden across the life course and (ii) establish gold-standard biomedical informatics methods for youth with hypertension disorders.

Patient perception of burden of disease and treatment preferences in non-small cell lung cancer: Results from a European survey.

OBJECTIVES: To understand European non-small cell lung cancer (NSCLC) patients' perceptions of disease burden, treatment, and future expectations of treatment and care. MATERIALS AND METHODS: A 32-item online survey was conducted on a sample of NSCLC patients across Europe. Descriptive statistics were used to analyse the data. Results were presented by disease stage (I-III vs. IV). RESULTS: NSCLC patients (N = 292) from 10 countries responded. Most patients resided in France, Spain, Italy, Germany and UK, with 16 patients from five other countries. Patients' knowledge of biomarker testing was limited (23% of 376 responses indicated no knowledge). Patients reported fear (stage I-III: 40%, stage IV: 27%), anxiety (stage I-III: 44%, stage IV: 33%) and depression (stage I-III: 24%, stage IV: 20%), but also hope (stage I-III: 57%, stage IV: 59%). Professional status was majorly impacted for 43% of stage I-III patients and 58% stage IV patients. Household finances were impacted for âˆ¼70% of all patients. Oral treatment was preferred (60%), and respondents understood dosing schedules (stage I-III: 82%, stage IV: 97%) remembering to take medications (stage I-III: 82%, stage IV: 87%). Most respondents were willing to take more pills, but some indicated that this would be difficult. CONCLUSION: Approximately half of the patients in this survey were aware of clinical trial options, but most lacked information about their molecular tumor profile, making it difficult for patients to engage in discussions about their care. The results also suggest that NSCLC patients have significant information and support needs, especially in the areas of emotional and financial burden. Action is needed to address these burdens associated with NSCLC. Furthermore, patients should be provided with the information needed to actively participate in treatment decisions.

Assessing stakeholder opinion on relations between cancer patient groups and pharmaceutical companies in Europe.

BACKGROUND: The relationship between the pharmaceutical industry and cancer patient groups has been the subject of much scrutiny and skepticism, and some high-profile negative media coverage has focused attention on some of the problematic aspects of the relationship. Both the pharmaceutical industry and cancer patient groups have made an effort in recent years to improve the transparency and openness of their relations, specifically with regard to the financial support offered by pharmaceutical companies to patient groups. OBJECTIVE: The objectives of this survey were to benchmark perceptions held by different stakeholder groups about current relationships between cancer patient groups and pharmaceutical companies in Europe, and to explore opinions about ways in which partnerships between patient groups and pharmaceutical companies could evolve to the benefit of cancer patients. METHODS: The survey was conducted using a structured questionnaire that contained a combination of matrix, scaled, and open-ended questions. The questionnaire was developed based on a literature search and the findings from ten in-depth interviews conducted with policy makers and advocates working at an EU level. Telephone interviews were carried out using a structured questionnaire with a convenience sample of 161 policy makers, cancer healthcare group representatives, and cancer patient group leaders from France, Germany, Hungary, Italy, Latvia, the Netherlands, Poland, Portugal, Romania, Spain, Sweden, and the UK. The interviews took place in the relevant language of the country. RESULTS: The current relationship between the pharmaceutical industry and cancer patient groups in Europe is generally viewed as positive, but it is also viewed as being unequal, not transparent enough, and not sufficiently patient-centric. There is broad agreement that cancer patient groups can help companies identify unmet needs and contribute to the development of innovative medicines; however, there is some concern about cancer patients' competence to take on this role. Also, pharmaceutical companies and patient groups have a common interest in working together on the development of non-promotional patient information and strategies to support medicines adherence. Respondents also indicated that the two sectors have a legitimate interest in ensuring that patients in need access appropriate treatments in a timely manner. Ongoing cooperation between health professionals, pharmaceutical companies, and cancer patient groups is also viewed as important. Efforts should continue to make relations between pharmaceutical companies and cancer patient groups as equal, open, and transparent as possible. CONCLUSION: Despite ongoing concerns about the openness and transparency of relations between pharmaceutical companies and patient groups, there is scope for these two sectors to work together on issues of common interest.

The requirements of a specialist Prostate Cancer Unit: a discussion paper from the European School of Oncology.

The widely recognised benefits of a multidisciplinary approach to treating cancer may be particularly important in prostate cancer, where there are so many treatment options to choose from. It offers patients the best chance of receiving high-quality medical procedures administered by a team of specialists in prostate disease, which is able to tailor treatment and observational strategies to their needs, and ensure access to specialist counselling, supportive care and rehabilitation. This article proposes Prostate Cancer Units as the most suitable structures for organising specialist multidisciplinary care for patients at all stages, from newly diagnosed to advanced disease, including preventing and managing the main complications, whether physical, emotional or psychological, arising from the disease and its treatment. Following the German example with prostate cancer, the British example with urological malignancies and the European breast cancer units, this article proposes general recommendations and mandatory requirements for Prostate Cancer Units, with a view to laying the basis for a network of certified units across Europe. Such a network could help improve standards of care throughout the region, providing patients, practitioners and health authorities with a means of identifying high-quality units and providing a system of quality control and audit. The article is intended as a contribution to the debate within the European uro-oncologic community on the best way to organise prostate cancer care.

Defining the scope of haematology nursing practice in Europe.

PURPOSE: The changing role of haematology nurses has never been mapped systematically which makes it difficult to plan practice development initiatives in a strategic manner. METHOD: A survey was conducted to gain insight into the role of European haematology nurses and identify their learning needs. RESULTS: Two hundred and seventy one questionnaires were completed by nurses from 25 countries, most of who were unit-based clinical nurses (116, 43%), had 10 years or more of experience in haematology (56%) and no specialist qualification (65%). The most common professional activities undertaken involved the detection and management of side effect. Respondents believe that they are well trained, possess good communication skills and play a key role within the multidisciplinary team. However, a small but significant number of nurses indicated that they had a limited role to play in patient education (42%) and only 38% (102) agreed that they played an important role in facilitating patient choice. Lack of time, limited course availability and staff shortages are perceived as key barriers to developing practice. CONCLUSIONS: Nurses are most interested in receiving further education about graft versus host disease and late effects of treatment. The knowledge component of the questionnaire revealed numerous deficits. Demographic factors such as role and experience had a significant influence on responses.

International collaborations in cancer control and the Third International Cancer Control Congress.

Over the past few decades, there has been growing support for the idea that cancer needs an interdisciplinary approach. Therefore, the international cancer community has developed several strategies as outlined in the WHO non-communicable diseases Action Plan (which includes cancer control) as the World Health Assembly and the UICC World Cancer Declaration, which both include primary prevention, early diagnosis, treatment, and palliative care. This paper highlights experiences/ideas in cancer control for international collaborations between low, middle, and high income countries, including collaborations between the European Union (EU) and African Union (AU) Member States, the Latin-American and Caribbean countries, and the Eastern Mediterranean countries. These proposals are presented within the context of the global vision on cancer control set forth by WHO in partnership with the International Union Against Cancer (UICC), in addition to issues that should be considered for collaborations at the global level: cancer survival (similar to the project CONCORD), cancer control for youth and adaptation of Clinical Practice Guidelines. Since cancer control is given lower priority on the health agenda of low and middle income countries and is less represented in global health efforts in those countries, EU and AU cancer stakeholders are working to put cancer control on the agenda of the EU-AU treaty for collaborations, and are proposing to consider palliative care, population-based cancer registration, and training and education focusing on primary prevention as core tools. A Community of Practice, such as the Third International Cancer Control Congress (ICCC-3), is an ideal place to share new proposals, learn from other experiences, and formulate new ideas. The aim of the ICCC-3 is to foster new international collaborations to promote cancer control actions in low and middle income countries. The development of supranational collaborations has been hindered by the fact that cancer control is not part of the objectives of the Millennium Development Goals (MGGs). As a consequence, less resources of development aids are allocated to control NCDs including cancer.

The US and European regulatory systems: a comparison.

Regulatory agencies have a responsibility to ensure that high-quality safe, and effective medicines are made available to patients in a timely manner. Despite the fact that all regulators worldwide share the same aims, they do not adopt a consistent approach to drug approval, and as a result, medicines are often approved quicker in some countries than in others. There is a significant difference in cancer drug approval time between the US Food and Drug Administration and the European Medicines Evaluation Agency (EMEA; 304 versus 448 days). There are a number of reasons for this difference, not least the fact that EMEA appears to be much more conservative in its approach to fast-tracking the evaluation of promising cancer drugs. Increasing dialogue between the different stakeholder groups involved may help address this unsatisfactory situation.