Tracking the timely dissemination of clinical studies. Characteristics and impact of 10 tracking variables [version 1; peer review: 2 approved]

Background: Several meta-research studies and benchmarking activities have assessed how comprehensively and timely, academic institutions and private companies publish their clinical studies. These current “clinical trial tracking” activities differ substantially in how they sample relevant studies, and how they follow up on their publication. Methods: To allow informed policy and decision making on future publication assessment and benchmarking of institutions and companies, this paper outlines and discusses 10 variables that influence the tracking of timely publications. Tracking variables were initially selected by experts and by the authors through discussion. To validate the completeness of our set of variables, we conducted i) an explorative review of tracking studies and ii) an explorative tracking of registered clinical trials of three leading German university medical centres. Results: We identified the following 10 relevant variables impacting the tracking of clinical studies: 1) responsibility for clinical studies, 2) type and characteristics of clinical studies, 3) status of clinical studies, 4) source for sampling, 5) timing of registration, 6) determination of completion date, 7) timeliness of dissemination, 8) format of dissemination, 9) source for tracking, and 10) inter-rater reliability. Based on the description of these tracking variables and their influence, we discuss which variables could serve in what ways as a standard assessment of “timely publication”. Conclusions: To facilitate the tracking and consequent benchmarking of how often and how timely academic institutions and private companies publish clinical study results, we have two core recommendations. First, the improvement in the link between registration and publication, for example via institutional policies for academic institutions and private companies. Second, the comprehensive and transparent reporting of tracking studies according to the 10 variables presented in this paper

Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS Trial): study protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Multiple sclerosis is the most common chronic inflammatory disease of the central nervous system in young adults. Despite the fact that numerous lines of evidence link both the risk of disease development and the disease course to the serum level of 25-hydroxyvitamin D it still remains elusive whether multiple sclerosis patients benefit from boosting the serum level of 25-hydroxyvitamin D, mainly because interventional clinical trials that directly address the therapeutic effects of vitamin D in multiple sclerosis are sparse. We here present the protocol of an interventional clinical phase II study to test the hypothesis, that high-dose vitamin D supplementation of multiple sclerosis patients is safe and superior to low-dose supplementation with respect to beneficial therapeutic effects.</p> <p>Methods/Design</p> <p>The EVIDIMS trial is a German multi-center, stratified, randomized, controlled and double-blind clinical phase II pilot study. Eighty patients with the diagnosis of definite multiple sclerosis or clinically isolated syndrome who are on a stable immunomodulatory treatment with interferon-β1b will be randomized to additionally receive either high-dose (average daily dose 10.200 IU) or low-dose (average daily dose 200 IU) cholecalciferol for a total period of 18 months. The primary outcome measure is the number of new lesions detected on T2-weighted cranial MRI at 3 tesla. Secondary endpoints include additional magnetic resonance imaging and optical coherence tomography parameters for neuroinflammation and -degeneration, clinical parameters for disease activity, as well as cognition, fatigue, depression, and quality of life. Safety and tolerability of high-dose vitamin D supplementation are further outcome parameters.</p> <p>Discussion</p> <p>In light of the discrepancy between existing epidemiological and preclinical data on the one hand and available clinical data on the other the EVIDIMS trial will substantially contribute to the evaluation of the efficacy of high-dose vitamin D supplementation in MS patients. The study design presented here fulfills the criteria of a high-quality clinical phase II trial in MS.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov Identifier: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01440062">NCT01440062</a></p

Family planning of women suffering from chronic neuroimmunological diseases: the example of myasthenia gravis and multiple sclerosis

Einleitung: Entscheidungen zur Familienplanung sind oft komplex, insbesondere für Frauen mit neurologischen Erkrankungen. Unsicherheiten und Sorgen bestehen häufig auf beiden Seiten – bei der Patientin und beim behandelnden Arzt. Ziel dieser Arbeit war es, Aspekte der Entscheidungsfindung in Bezug auf Familienplanung bei chronisch neurologisch erkrankten Patientinnen (hier Myasthenia gravis, MG) zu erheben, sowie das Wissen bzw. Beratungsverhalten von Ärzten im Bereich Familienplanung bei MG bzw. Multipler Sklerose (MS) zu erfassen. Methodik: Die verschiedenen Aspekte der Entscheidungsfindung in Bezug auf Familienplanung bei MG wurden anhand einer anonymen Befragung an einer großen MG-Population in Deutschland erhoben. Das Wissen bzw. Beratungsverhalten in Bezug auf Familienplanung bei MG von in Berlin niedergelassenen Neurologen sowie von in Myasthenie-Zentren tätigen Ärzten wurde in einer anonymen Befragungen erhoben, ebenso wie das Wissen hinsichtlich MS von in Berlin niedergelassenen Neurologen/Nervenärzten. Ergebnisse: Das Wissen von MG-Patientinnen über schwangerschaftsbezogenen Themen bei der MG war gering. An einer MG zu leiden beeinflusst die Familienplanung; mehr als die Hälfte der Patientinnen haben auf (weitere) Kinder verzichtet oder verzichten deshalb auf (weitere) Kinder. Als Hauptsorge bei der Entscheidungsfindung wurde der mögliche Einfluss der MG-Medikation auf das Neugeborene benannt. Der Partner, der die MG behandelnde Arzt/Neurologe und der behandelnde Gynäkologe waren die wichtigsten Personen bei der Entscheidungsfindung. Geringeres Wissen und der Mangel an persönlicher Erfahrung einer Schwangerschaft unter MG waren unabhängig voneinander mit der Wahrscheinlichkeit, anderen betroffenen Frauen von Kindern abzuraten, assoziiert. Die Erhebung des Beratungsverhaltens zum Thema MG und Familienplanung ergab, dass die Beratungskompetenz von Neurologen in spezialisierten Zentren insgesamt gesehen höher war als die Beratungskompetenz von Neurologen in der Niederlassung. Sie hing von der indikationsspezifischen Erfahrung des Arztes ab. Die Quote falscher Empfehlungen war in beiden Arztgruppen sehr niedrig und die der richtigen bzw. vertretbaren Empfehlungen sehr hoch. Die niedergelassenen Neurologen würden entsprechende Fälle häufiger an einen Kollegen verweisen. Die Erhebung des Wissens zu schwangerschaftsbezogenen Themen bei MS ergab, dass nur etwa die Hälfte aller Fragen korrekt beantwortet wurde. Dabei war die Anzahl der korrekten Antworten signifikant assoziiert mit der Anzahl der behandelten MS-Patienten. Schlussfolgerung: Frauen mit chronischen neurologischen Erkrankungen benötigen eine spezifische Beratung zum Thema Familienplanung. Patientinnen mit Beratungswunsch sollten sich an spezialisierte Zentren oder an Ärzte mit viel Erfahrung in der jeweiligen Indikation wenden, da die Beratungssicherheit hier am höchsten ist. Eine spezifische und spezialisierte Beratung ist insbesondere von Bedeutung, um Schäden von Mutter oder Kind zu vermeiden, aber auch damit Patientinnen mit Kinderwunsch nicht unnötigerweise auf Kinder verzichten.Background: Decisions on family planning are often complex, especially for women with neurological disorders. Uncertainties and concerns often exist on both sides, in patients and physicians. The aim of this study was to analyze aspects of decision making regarding family planning in chronic neurologically diseased patients (here myasthenia gravis, MG), as well as to assess the knowledge and counseling behavior of physicians in the context of family planning and pregnancy in MG and multiple sclerosis (MS). Methods: The various aspects of decision making with respect to family planning in MG were assessed by an anonymous survey of a large MG population in Germany. The knowledge and consulting behavior regarding family planning in MG of neurologists in private practice in Berlin and in neurologists working in MG centers was assessed by an anonymous survey, as well as the knowledge regarding pregnancy related topics in MS of neurologists (here: also with board certification in both, neurology and psychiatry) in private practice in Berlin. Results: The knowledge of MG patients about pregnancy-related issues in MG was low. To suffer from MG affects the patient´s family planning; more than half of the patients had abstained from having (more) children due to MG. The concern mentioned most often was the possible influence of MG medication on the unborn child. Spouses/partners, the MG treating physician and treating gynecologist were the most important persons involved in the decision-making process. The survey on the consulting behavior related to MG and family planning revealed that the consulting expertise was higher in neurologists in specialized centers than in neurologists in private practice. The level of expertise was related to the indication-specific experience of the physician. The rate of false recommendations was very low in both groups of physicians and the rate of correct and justifiable recommendations very high. In the survey on knowledge in pregnancy related topics in MS only about half of all questions were answered correctly. The number of correct responses was significantly associated with the number of treated MS patients. Conclusions: Women with chronic neurological disorders need specific advice on family planning. Since advisory quality appears higher in dedicated centers, patients with counseling request should address specialized centers or doctors with extensive experience in the respective indication. A specific and specialized advice is particularly important to avoid harm of the mother or child, but also to avoid that patients who wish to have children unnecessarily abstain from starting or enlarging a family

Pregnancy in Multiple Sclerosis: A Questionnaire Study

<div><p>Background</p><p>Multiple sclerosis (MS) preferentially affects females at childbearing age. For this reason patients and treating physicians were frequently confronted with questions concerning family planning, pregnancy and birth.</p><p>Objective</p><p>The aim of this study was to evaluate the expertise about pregnancy related topics in multiple sclerosis of neurologists in private practice.</p><p>Methods</p><p>We developed a survey with 16 multiple choice questions about pregnancy related topics and sent it to neurologists in private practice in Berlin, Germany.</p><p>Results</p><p>56 completed questionnaires were sent back. 54% of all questions were answered correctly, 21% of the questions were answered with “I don’t know”. Correct answers were more often given by physicians who treat more than 400 MS patients per year (p = 0.001). Further positive associations were found for assumed relevance of the topic (p = 0.002) and the degree of counseling (p<0.001).</p><p>Conclusion</p><p>To provide a comprehensive counseling, MS patients with desire for children should be counseled by physicians with a lot of experience in MS treatment.</p></div

Assessing the Organizational Climate for Translational Research with a New Survey Tool

Promoting translational research as a means to overcoming chasms in the translation of knowledge through successive fields of research from basic science to public health impacts and back is a central challenge for research managers and policymakers. Organizational leaders need to assess baseline conditions, identify areas needing improvement, and to judge the impact of specific initiatives to sustain or improve translational research practices at their institutions. Currently, there is a lack of such an assessment tool addressing the specific context of translational biomedical research. To close this gap, we have developed a new survey for assessing the organizational climate for translational research. This self-assessment tool measures employees’ perceptions of translational research climate and underlying research practices in organizational environments and builds on the established Survey of Organizational Research Climate, assessing research integrity. Using this tool, we show that scientists at a large university hospital (Charité Berlin) perceive translation as a central and important component of their work. Importantly, local resources and direct support are main contributing factors for the practical implementation of translation into their own research practice. We identify and discuss potential leverage points for an improvement of research climate to foster successful translational research.Peer Reviewe

Demographic characteristics.

<p>Demographic characteristics.</p

Survey results.

<p>IMT: immunomodulatory therapy.</p

Percentage of correct and I don’t know-answers in relation to the number of treated MS patients per quarter: Kruskal-Wallis-test.

<p>Percentage of correct and I don’t know-answers in relation to the number of treated MS patients per quarter: Kruskal-Wallis-test.</p