Does big data require a methodological change in medical research?

Background: Use of big data is becoming increasingly popular in medical research. Since big data-based projects differ notably from classical research studies, both in terms of scope and quality, a debate is apt as to whether big data require new approaches to scientific reasoning different from those established in statistics and philosophy of science.

Main Text: The progressing digitalization of our societies generates vast amounts of data that also become available for medical research.

Roles and Responsibilities in the Provision of Accredited Continuing Medical Education/Continuing Professional Development.

The Cologne Consensus Conference 2015 has focused on "Providers in accredited CME[continuing medical education]/CPD [continuing professional development]". As an outcome of the CCC 2015, the authors of this paper, who were part of the faculty, propose a contemporary definition of the roles and responsibilities of stakeholders involved in the different stages of planning, delivery and evaluation of CME/CPD.

Effect of specialist palliative care services on quality of life in adults with advanced incurable illness in hospital, hospice, or community settings: systematic review and meta-analysis.

 To assess the effect of specialist palliative care on quality of life and additional outcomes relevant to patients in those with advanced illness. Systematic review with meta-analysis. Medline, Embase, Cochrane Central Register of Controlled Trials, PsycINFO, and trial registers searched up to July 2016.

Pharmacological interventions for pruritus in adult palliative care patients.

Background: This is an update of the original Cochrane review published in 2013 (Issue 6). Pruritus occurs in patients with disparate underlying diseases and is caused by different pathologic mechanisms. In palliative care patients, pruritus is not the most prevalent but is one of the most puzzling symptoms.

[Is the age of causality over?].

For the assessment of diagnostic and therapeutic interventions a sound scientific base has been developed during the last twenty years. Under the headline of Evidence-based Medicine nowadays a comprehensive set of tools is offered which can be used to assess the benefit and the risk of medical interventions. The overarching rule which evolved for the grading of evidence from studies is to maximize the protection against bias.

Pylorus-preserving pancreaticoduodenectomy (pp Whipple) versus pancreaticoduodenectomy (classic Whipple) for surgical treatment of periampullary and pancreatic carcinoma.

Background: Pancreatic cancer is the fourth-leading cause of cancer death for both, men and women. The standard treatment for resectable tumours consists of a classic Whipple (CW) operation or a pylorus-preserving pancreaticoduodenectomy (PPW). It is unclear which of these procedures is more favourable in terms of survival, postoperative mortality, complications, and quality of life.

A European multi-language initiative to make the general population aware of independent clinical research: the European Communication on Research Awareness Need project.

Background: The ECRAN (European Communication on Research Awareness Needs) project was initiated in 2012, with support from the European Commission, to improve public knowledge about the importance of independent, multinational, clinical trials in Europe.

Methods: Participants in the ECRAN consortium included clinicians and methodologists directly involved in clinical trials; researchers working in partnership with the public and patients; representatives of patients; and experts in science communication. We searched for, and evaluated, relevant existing materials and developed additional materials and tools, making them freely available under a Creative Commons licence.

[Up for Discussion: Using study registries for Oncology: StudyBox and the German Clinical Trials Register (DRKS)].

Study registries serve various purposes. Primarily, they provide as complete an overview as possible on planned, ongoing and completed studies and are thus intended to contribute to transparency in research. As such, they are an instrument for identifying and reducing publication bias.

Specialist palliative care services for adults with advanced, incurable illness in hospital, hospice, or community settings--protocol for a systematic review.

Background: Specialist palliative care (SPC) interventions aim to relieve and prevent suffering in the physical, psychological, social, and spiritual domain. Therefore, SPC is carried out by a multi-professional team with different occupations (e.g.

Evidence-informed recommendations to reduce dissemination bias in clinical research: conclusions from the OPEN (Overcome failure to Publish nEgative fiNdings) project based on an international consensus meeting.

Background: Dissemination bias in clinical research severely impedes informed decision-making not only for healthcare professionals and patients, but also for funders, research ethics committees, regulatory bodies and other stakeholder groups that make health-related decisions. Decisions based on incomplete and biased evidence cannot only harm people, but may also have huge financial implications by wasting resources on ineffective or harmful diagnostic and therapeutic measures, and unnecessary research. Owing to involvement of multiple stakeholders, it remains easy for any single group to assign responsibility for resolving the problem to others.

Cell-assisted lipotransfer.

Background: Because of their easy accessibility and versatile biological properties, mesenchymal stem cells taken from fatty tissue (adipose-derived stem cells, ADSC) are attractive for various potential clinical uses. For example, ADSC can be added to fatty tissue before transplantation in the hope of improving the outcome of autologous lipotransfer: the modified procedure is called cell-assisted lipotransfer. The clinical use and commercial promotion of this novel stem-cell treatment (and others) are spreading rapidly, even though there is not yet any clear clinical evidence for its safety and efficacy.

Erratum: The National Institutes of Health and guidance for reporting preclinical research.

This is an Erratum to BMC Medicine 2015, 13:34, highlighting a corrected references list. Please see related article: http://www.biomedcentral.

The National Institutes of Health and guidance for reporting preclinical research.

The quality of reporting clinical and preclinical research is not optimal. Reporting guidelines can help make reports of research more complete and transparent, thus increasing their value and making them more useful to all readers. Getting reporting guidelines into practice is complex and expensive, and involves several stakeholders, including prospective authors, peer reviewers, journal editors, guideline developers, and implementation scientists.

Drug treatments for pruritus in adult palliative care.

Background: Pruritus is a rare but troublesome symptom in palliative-care patients with a variety of underlying diseases. The pharmacotherapy of pruritus is often off-label, and an evidence-based evaluation is needed.

Methods: A Cochrane Review published in 2013 was updated with a systematic literature search up to January 2014.

Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries.

Background: The synthesis of published research in systematic reviews is essential when providing evidence to inform clinical and health policy decision-making. However, the validity of systematic reviews is threatened if journal publications represent a biased selection of all studies that have been conducted (dissemination bias). To investigate the extent of dissemination bias we conducted a systematic review that determined the proportion of studies published as peer-reviewed journal articles and investigated factors associated with full publication in cohorts of studies (i) approved by research ethics committees (RECs) or (ii) included in trial registries.

[Measurement and assessment of study quality and reporting quality].

Clinical trials are undertaken to evaluate the effectiveness and safety of clinical interventions or to investigate other unclarified (e.g. diagnostic) research questions.

Non-steroidal antiandrogen monotherapy compared with luteinizing hormone-releasing hormone agonists or surgical castration monotherapy for advanced prostate cancer: a Cochrane systematic review.

To assess the effects of non-steroidal antiandrogen monotherapy compared with luteinizing hormone-releasing hormone agonists or surgical castration monotherapy for treating advanced hormone-sensitive stages of prostate cancer. We searched the Cochrane Prostatic Diseases and Urologic Cancers Group Specialized Register (PROSTATE), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Web of Science with Conference Proceedings, three trial registries and abstracts from three major conferences to 23 December 2013, together with reference lists, and contacted selected experts in the field and manufacturers. We included randomized controlled trials comparing non-steroidal antiandrogen monotherapy with medical or surgical castration monotherapy for men in advanced hormone-sensitive stages of prostate cancer.

[Potentials for research and innovations in allied health professions in Germany].

In order to address the increasing complexity and continuously changing needs and demands in the German healthcare system, there is a need to strengthen knowledge translation, evidence-based practice and the conduct of clinical trials in the field of allied health professions. An interdisciplinary working group representing the fields of nursing, midwifery, physiotherapy, occupational therapy and speech therapy developed a guide and a concept for seminars to provide potential analyses for research and innovations in the allied health professions in Germany. These potential analyses compare the current state of health care delivery for specific health problems and the corpus of evidence for the effectiveness of related interventions.