The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease

Trying to conceive and being pregnant is an emotional period for those involved. In the majority of patients suffering from inflammatory bowel disease, maintenance therapy is required during pregnancy to control the disease, and disease control might necessitate introduction of new drugs during a vulnerable period. In this updated consensus on the reproduction and pregnancy in inflammatory bowel disease reproductive issues including fertility, the safety of drugs during pregnancy and lactation are discussed.

Standard procedures for adults in accredited sleep medicine centres in Europe

The present paper describes standardized procedures within clinical sleep medicine. As such, it is a continuation of the previously published European guidelines for the accreditation of sleep medicine centres and European guidelines for the certification of professionals in sleep medicine, aimed at creating standards of practice in European sleep medicine. It is also part of a broader action plan of the European Sleep Research Society, including the process of accreditation of sleep medicine centres and certification of sleep medicine experts, as well as publishing the Catalogue of Knowledge and Skills for sleep medicine experts (physicians, non-medical health care providers, nurses and technologists), which will be a basis for the development of relevant educational curricula. In the current paper, the standard operational procedures sleep medicine centres regarding the diagnostic and therapeutic management of patients evaluated at sleep medicine centres, accredited according to the European Guidelines, are based primarily on prevailing evidence-based medicine principles. In addition, parts of the standard operational procedures are based on a formalized consensus procedure applied by a group of Sleep Medicine Experts from the European National Sleep Societies. The final recommendations for standard operational procedures are categorized either as 'standard practice', 'procedure that could be useful', 'procedure that is not useful' or 'procedure with insufficient information available'. Standard operational procedures described here include both subjective and objective testing, as well as recommendations for follow-up visits and for ensuring patients' safety in sleep medicine. The overall goal of the actual standard operational procedures is to further develop excellence in the practice and quality assurance of sleep medicine in Europe.

Charakteristika schwer essgestörter Patientinnen in einer universitären Einrichtung und therapeutische Richtlinien

Patientinnen und Patienten mit einer schweren Essstörung (Anorexie, Bulimie, weitere) finden einerseits selten Eingang in systematische Studien, sind andererseits aber häufig auf ein stationäres Behandlungssetting in einem tertiären Zentrum angewiesen. Die kürzlich veröffentlichte S3-Leitlinie zur Behandlung von Essstörungen erlaubt eine klarere Einschätzung der Hospitalisationsbedürftigkeit schwer Essgestörter als bisher. In der vorliegenden Arbeit wurden 26 Patientinnen und Patienten mit einer schweren Essstörung, die konsekutiv auf einer spezialisierten psychosomatisch/internistischen universitären Einrichtung hospitalisiert wurden, retrospektiv hinsichtlich ihrer biologischen, psychologischen und sozialen Merkmale charakterisiert und in Bezug zur S3-Leitlinie gestellt. Die biopsychosozialen Charakteristika der untersuchten Population zeigen, dass die Hospitalisierung schwer Essgestörter im tertiärmedizinischen Setting mit einem multiprofessionellen Behandlungsteam evidenzbasiert erfolgt.

[Body-packer ; body-stuffer - a medical challenge]

Since the seventies, the practice of drug smuggling in the form of body packing has increased in the Western world. The goal of our study was to present an algorithm for the safe management of intracorporal drug transport based on clinical experience and current evidence. The retrospective study, conducted over the past four years in our hospital prison, analyzes and discusses the diagnostic and therapeutic concepts. Thirty-four patients hospitalized 37 times in a 48-month period were included. In 28 patients drug packages were identified. Only two patients suffered from serious complications. The study demonstrates that following a specifically designed management algorithm based on clinical experience and principles of evidence-based medicine can optimize risk management, improve quality assurance and patient safety.

Sacral neuromodulation for neurogenic lower urinary tract dysfunction: systematic review and meta-analysis

Context Treatment of neurogenic lower urinary tract dysfunction (LUTD) is a challenge, because conventional therapies often fail. Sacral neuromodulation (SNM) has become a well-established therapy for refractory non-neurogenic LUTD, but its value in patients with a neurologic cause is unclear. Objective To assess the efficacy and safety of SNM for neurogenic LUTD. Evidence acquisition Studies were identified by electronic search of PubMed, EMBASE, and ScienceDirect (on 15 April 2010) and hand search of reference lists and review articles. SNM articles were included if they reported on efficacy and/or safety of tested and/or permanently implanted patients suffering from neurogenic LUTD. Two reviewers independently selected studies and extracted data. Study estimates were pooled using Bayesian random-effects meta-analysis. Evidence synthesis Of the 26 independent studies (357 patients) included, the evidence level ranged from 2b to 4 according to the Oxford Centre for Evidence-Based Medicine. Half (n = 13) of the included studies reported data on both test phase and permanent SNM; the remaining studies were confined to test phase (n = 4) or permanent SNM (n = 9). The pooled success rate was 68% for the test phase (95% credibility interval [CrI], 50–87) and 92% (95% CrI, 81–98%) for permanent SNM, with a mean follow-up of 26 mo. The pooled adverse event rate was 0% (95% CrI, 0–2%) for the test phase and 24% (95% CrI, 6–48%) for permanent SNM. Conclusions There is evidence indicating that SNM may be effective and safe for the treatment of patients with neurogenic LUTD. However, the number of investigated patients is low with high between-study heterogeneity, and there is a lack of randomised, controlled trials. Thus, well-designed, adequately powered studies are urgently needed before more widespread use of SNM for neurogenic LUTD can be recommended.

[Ethics, empiricism and uncertainty]

Accidents can lead to difficult boundary situations. Such situations often take place in the emergency units. The medical team thus often and inevitably faces professional uncertainty in their decision-making. It is essential to communicate these uncertainties within the medical team, instead of downplaying or overriding existential hurdles in decision-making. Acknowledging uncertainties might lead to alert and prudent decisions. Thus uncertainty can have ethical value in treatment or withdrawal of treatment. It does not need to be covered in evidence-based arguments, especially as some singular situations of individual tragedies cannot be grasped in terms of evidence-based medicine.

Reverse-translational biomarker validation of Abnormal Repetitive Behaviors in mice: an illustration of the 4P's modeling approach

The NIMH's new strategic plan, with its emphasis on the "4P's" (Prediction, Pre-emption, Personalization, and Populations) and biomarker-based medicine requires a radical shift in animal modeling methodology. In particular 4P's models will be non-determinant (i.e. disease severity will depend on secondary environmental and genetic factors); and validated by reverse-translation of animal homologues to human biomarkers. A powerful consequence of the biomarker approach is that different closely related disorders have a unique fingerprint of biomarkers. Animals can be validated as a highly specific model of a single disorder by matching this 'fingerprint'; or as a model of a symptom seen in multiple disorders by matching common biomarkers. Here we illustrate this approach with two Abnormal Repetitive Behaviors (ARBs) in mice: stereotypies and barbering (hair pulling). We developed animal versions of the neuropsychological biomarkers that distinguish human ARBs, and tested the fingerprint of the different mouse ARBs. As predicted, the two mouse ARBs were associated with different biomarkers. Both barbering and stereotypy could be discounted as models of OCD (even though they are widely used as such), due to the absence of limbic biomarkers which are characteristic of OCD and hence are necessary for a valid model. Conversely barbering matched the fingerprint of trichotillomania (i.e. selective deficits in set-shifting), suggesting it may be a highly specific model of this disorder. In contrast stereotypies were correlated only with a biomarker (deficits in response shifting) correlated with stereotypies in multiple disorders, suggesting that animal stereotypies model stereotypies in multiple disorders.

[How can the mentally ill achieve sustained employment? Supported employment versus pre-vocational training]

People with severe mental disorders are often without work, although work may have a positive effect on their health. The paper presents some results in this field from the German S3 guidelines on psychosocial therapies. In terms of evidence-based medicine supported employment (SE - first place then train) has proven to be most effective. Nevertheless, SE is still rare in Germany. Pre-vocational training, however, follows the concept first train then place and is offered in rehabilitation of the mentally ill (RPK) centres in Germany. There is some evidence that the programs are beneficial for users. The UN Convention for the Rights of Persons with Disabilities outlines an obligation for work on an equal basis with others and for vocational training. So far, the German mental health system only partly meets these requirements.

Use of human embryonic stem cells and umbilical cord blood stem cells for research and therapy: a prospective survey among health care professionals and patients in Switzerland

BACKGROUND: Scientific progress in the biology of hematopoietic stem cells (HSCs) provides opportunities for advances in therapy for different diseases. While stem cell sources such as umbilical cord blood (UCB) are unproblematic, other sources such as human embryonic stem cells (hESCs) raise ethical concerns. STUDY DESIGN AND METHODS: In a prospective survey we established the ethical acceptability of collection, research, and therapy with UCB HSCs versus hESCs among health care professionals, pregnant women, patients undergoing in vitro fertilization therapy, parents, and HSC donors and recipients in Switzerland. RESULTS: There was overall agreement about an ethical justification for the collection of UCB for research and therapy in the majority of participants (82%). In contrast, research and therapy with hESCs was acceptable only by a minority (38% of all responders). The collection of hESCs solely created for HSC collection purposes met overall with the lowest approval rates. Hematologists displayed among the participants the highest acceptance rates for the use of hESCs with 55% for collection, 63% for research, and 73% for therapy. CONCLUSIONS: This is the first study assessing the perception of hESCs for research and therapy in comparison with UCB HSCs in different target groups that are exposed directly, indirectly, or not at all to stem cell-based medicine. Our study shows that the debate over the legitimacy of embryo-destructive transplantation medicine is far from over as particularly hESC research continues to present an ethical problem to an overwhelming majority among laypersons and even among health care professionals.