[First experiences with the implementation of EU Regulation 536/2014 (CTR) from the perspective of non-commercial academic research].

With the implementation of the new EU Regulation 536/2014 (Clinical Trials Regulation - CTR) on 31 January 2022, the approval and conduct of clinical trials with medicinal products for human use are to be harmonized within the European Union (EU). Approval is granted via the electronic Clinical Trials Information System (CTIS) portal of the European Medicines Agency (EMA). In addition to commercial sponsors, sponsors at academic institutions are also affected by the implementation of the CTR in the context of investigator-initiated clinical trials (IITs).

Psychological and social consequences of non-invasive prenatal testing (NIPT): a scoping review.

Background: Genomics-based noninvasive prenatal tests (NIPT) allow screening for chromosomal anomalies such as Down syndrome (trisomy 21). The technique uses cell-free fetal DNA (cffDNA) that circulates in the maternal blood and is detectable from 5 weeks of gestation onwards. Parents who choose to undergo this relatively new test (introduced in 2011) might be aware of its positive features (i.

Well informed physician-patient communication in consultations on back pain - study protocol of the cluster randomized GAP trial.

Background: Back pain is one of the most frequent causes of health-related work absence. In Germany, more than 70% of adults suffer from at least one back pain episode per annum. It has strong impact on health care costs and patients' quality of life.

Prophylactic antibiotics before cord clamping in cesarean delivery: a systematic review.

Introduction: The number of clinical trials investigating the optimal timing of prophylactic antibiotics in cesarean section has increased rapidly over the last few years. We conducted a systematic review to inform up-to-date evidence-based guidelines to prevent postpartum infectious morbidity in the mother and rule out any safety issues related to antepartum antibiotic exposure in infants.

Material And Methods: Four bibliographic databases were searched for published reports of trials.

Lack of controlled studies investigating the risk of postpartum haemorrhage in cesarean delivery after prior use of oxytocin: a scoping review.

Background: Postpartum haemorrhage (PPH) is a major cause of maternal mortality and morbidity worldwide. Experimental and clinical studies indicate that prolonged oxytocin exposure in the first or second stage of labour may be associated with impaired uterine contractility and an increased risk of atonic PPH. Therefore, particularly labouring women requiring cesarean delivery constitute a subset of patients that may exhibit an unpredictable response to oxytocin.

Dissemination bias in systematic reviews of animal research: a systematic review.

Background: Systematic reviews of preclinical studies, in vivo animal experiments in particular, can influence clinical research and thus even clinical care. Dissemination bias, selective dissemination of positive or significant results, is one of the major threats to validity in systematic reviews also in the realm of animal studies. We conducted a systematic review to determine the number of published systematic reviews of animal studies until present, to investigate their methodological features especially with respect to assessment of dissemination bias, and to investigate the citation of preclinical systematic reviews on clinical research.

[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.

Detecting, quantifying and adjusting for publication bias in meta-analyses: protocol of a systematic review on methods.

Background: Health professionals and policymakers aspire to make healthcare decisions based on the entire relevant research evidence. This, however, can rarely be achieved because a considerable amount of research findings are not published, especially in case of 'negative' results - a phenomenon widely recognized as publication bias. Different methods of detecting, quantifying and adjusting for publication bias in meta-analyses have been described in the literature, such as graphical approaches and formal statistical tests to detect publication bias, and statistical approaches to modify effect sizes to adjust a pooled estimate when the presence of publication bias is suspected.

Defining publication bias: protocol for a systematic review of highly cited articles and proposal for a new framework.

Background: Selective publication of studies, which is commonly called publication bias, is widely recognized. Over the years a new nomenclature for other types of bias related to non-publication or distortion related to the dissemination of research findings has been developed. However, several of these different biases are often still summarized by the term 'publication bias'.

A protocol for a systematic review on the impact of unpublished studies and studies published in the gray literature in meta-analyses.

Background: Meta-analyses are particularly vulnerable to the effects of publication bias. Despite methodologists' best efforts to locate all evidence for a given topic the most comprehensive searches are likely to miss unpublished studies and studies that are published in the gray literature only. If the results of the missing studies differ systematically from the published ones, a meta-analysis will be biased with an inaccurate assessment of the intervention's effects.

Publication bias in animal research: a systematic review protocol.

Background: Systematic reviews and meta-analyses of pre-clinical studies, in vivo animal experiments in particular, can influence clinical care. Publication bias is one of the major threats of validity in systematic reviews and meta-analyses. Previous empirical studies suggested that systematic reviews and meta-analyses have become more prevalent until 2010 and found evidence for compromised methodological rigor with a trend towards improvement.

Protocol for a systematic review on the extent of non-publication of research studies and associated study characteristics.

Background: Methodological research has found that non-published studies often have different results than those that are published, a phenomenon known as publication bias. When results are not published, or are published selectively based on the direction or the strength of the findings, healthcare professionals and consumers of healthcare cannot base their decision-making on the full body of current evidence.

Methods: As part of the OPEN project (http://www.

Interventions for enhancing consumers' online health literacy.

Background: Access to health information is critical to enable consumers to participate in decisions on health. Increasingly, such information is accessed via the internet, but a number of barriers prevent consumers making effective use of it. These barriers include inadequate skills to search, evaluate and use the information.

Evidence that patients can understand and use?

The impact that research evidence can have on patients making decisions about their own care is often overlooked. Regardless of whether patients want to lead or fully participate in their care, it appears that patients still want to be informed. We have health information that patients could benefit from knowing, a growing body of evidence and experiences about how to translate this information to patients.

[Uncertainty regarding patient information: insecurity or chance?].

There is a considerable amount of uncertainty regarding the care of individual patients. The present paper describes the handling of uncertainties in patient care and its relevance for shared and informed decision-making. What affects the physician-patient relationship, and which strategies may contribute to communicating uncertainties in a constructive manner? Data from clinical trials describe and reduce our knowledge about uncertainty of treatment effects.

[Patient participation in the Cochrane Collaboration--barriers, experience, and concepts in Germany].

The aim of the Cochrane Collaboration (CC) is to bridge the gap of information transfer between the clinician and the patient. For this purpose, the CC pursues since years the concept of involving the consumers in the process of collaborative review groups. In spite of a positive experience altogether, some barriers (for example the communication between the scientists involved in CC review groups and the patients) remain to be overcome.