How Psychiatry Journals Support the Unbiased Translation of Clinical Research. A Cross-Sectional Study of Editorial Policies

Introduction: Reporting guidelines (e. g. CONSORT) have been developed as tools to improve quality and reduce bias in reporting research findings. Trial registration has been recommended for countering selective publication. The International Committee of Medical Journal Editors (ICMJE) encourages the implementation of reporting guidelines and trial registration as uniform requirements (URM). For the last two decades, however, biased reporting and insufficient registration of clinical trials has been identified in several literature reviews and other investigations. No study has so far investigated the extent to which author instructions in psychiatry journals encourage following reporting guidelines and trial registration. Method: Psychiatry Journals were identified from the 2011 Journal Citation Report. Information given in the author instructions and during the submission procedure of all journals was assessed on whether major reporting guidelines, trial registration and the ICMJE's URM in general were mentioned and adherence recommended. Results: We included 123 psychiatry journals (English and German language) in our analysis. A minority recommend or require 1) following the URM (21%), 2) adherence to reporting guidelines such as CONSORT, PRISMA, STROBE (23%, 7%, 4%), or 3) registration of clinical trials (34%). The subsample of the top-10 psychiatry journals (ranked by impact factor) provided much better but still improvable rates. For example, 70% of the top-10 psychiatry journals do not ask for the specific trial registration number. Discussion: Under the assumption that better reported and better registered clinical research that does not lack substantial information will improve the understanding, credibility, and unbiased translation of clinical research findings, several stakeholders including readers (physicians, patients), authors, reviewers, and editors might benefit from improved author instructions in psychiatry journals. A first step of improvement would consist in requiring adherence to the broadly accepted reporting guidelines and to trial registration

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

GRADE Guidelines: 18. How ROBINS-I and other tools to assess risk of bias in nonrandomized studies should be used to rate the certainty of a body of evidence

To provide guidance on how systematic review authors, guideline developers, and health technology assessment practitioners should approach the use of the risk of bias in non-randomized studies of interventions (ROBINS-I) tool as part of GRADE's certainty rating process. Iterative discussions, testing in systematic reviews, presentation at GRADE working group meetings with feedback from the GRADE Working Group. We describe where to start the initial assessment of a body of evidence with the use of ROBINS-I, and where one would anticipate the final rating would end up. GRADE accounted for issues that mitigate concerns about confounding and selection bias by introducing the upgrading domains: large effects, dose-effect relations, and when plausible residual confounders or other biases increase certainty. They will need to be considered in an assessment of a body of evidence when using ROBINS-I. The use of ROBINS-I in GRADE assessments may allow for a better comparison of evidence from RCTs and NRS because they are placed on a common metric for risk of bias. Challenges remain that include appropriate presentation of evidence from RCTs and NRS for decision-making and how to optimally integrate RCTs and NRS in an evidence assessment

Empfehlungen der Ständigen Impfkommission (STIKO) und der Deutschen Gesellschaft für Tropenmedizin, Reisemedizin und Globale Gesundheit e.V. (DTG) zu Reiseimpfungen

Die STIKO empfiehlt Reiseimpfungen zum individuellen Schutz Reisender mit einem Expositionsrisiko gegenüber bestimmten impfpräventablen Erkrankungen und um den Import von Infektionserregern in das bereiste Land oder bei Rückreise nach Deutschland zu verhindern. Die im Epidemiologischen Bulletin 14/2023 veröffentlichten Empfehlungen zu Reiseimpfungen wurden von der STIKO-AG Reiseimpfungen in Zusammenarbeit mit externen Expertinnen und Experten erarbeitet. Neuerungen sind dabei u. a. die aktualisierte Epidemiologie bei Cholera, Hepatitis A, Hepatitis B, Meningokokken und Typhus sowie eine umfassende Literatur-Aktualisierung.Peer Reviewe

Empfehlungen der Ständigen Impfkommission (STIKO) und der Deutschen Gesellschaft für Tropenmedizin, Reisemedizin und Globale Gesundheit e.V. (DTG) zu Reiseimpfungen

Die STIKO empfiehlt Reiseimpfungen zum individuellen Schutz Reisender mit einem Expositionsrisiko gegenüber bestimmten impfpräventablen Erkrankungen und um den Import von Infektionserregern in das bereiste Land oder bei Rückreise nach Deutschland zu verhindern. Die im Epidemiologischen Bulletin 14/2023 veröffentlichten Empfehlungen zu Reiseimpfungen wurden von der STIKO-AG Reiseimpfungen in Zusammenarbeit mit externen Expertinnen und Experten erarbeitet. Neuerungen sind dabei u. a. die aktualisierte Epidemiologie bei Cholera, Hepatitis A, Hepatitis B, Meningokokken und Typhus sowie eine umfassende Literatur-Aktualisierung.Peer Reviewe

Empfehlungen der Ständigen Impfkommission (STIKO) und der Deutschen Gesellschaft für Tropenmedizin, Reisemedizin und Globale Gesundheit e.V. (DTG) zu Reiseimpfungen

Die STIKO empfiehlt Reiseimpfungen zum individuellen Schutz Reisender mit einem Expositionsrisiko gegenüber bestimmten impfpräventablen Erkrankungen und um den Import von Infektionserregern in das bereiste Land oder bei Rückreise nach Deutschland zu verhindern. Die im Epidemiologischen Bulletin 14/2023 veröffentlichten Empfehlungen zu Reiseimpfungen wurden von der STIKO-AG Reiseimpfungen in Zusammenarbeit mit externen Expertinnen und Experten erarbeitet. Neuerungen sind dabei u. a. die aktualisierte Epidemiologie bei Cholera, Hepatitis A, Hepatitis B, Meningokokken und Typhus sowie eine umfassende Literatur-Aktualisierung.Peer Reviewe

Empfehlungen der Ständigen Impfkommission (STIKO) und der Deutschen Gesellschaft für Tropenmedizin, Reisemedizin und Globale Gesundheit e.V. (DTG) zu Reiseimpfungen

Die STIKO empfiehlt Reiseimpfungen zum individuellen Schutz Reisender mit einem Expositionsrisiko gegenüber bestimmten impfpräventablen Erkrankungen und um den Import von Infektionserregern in das bereiste Land oder bei Rückreise nach Deutschland zu verhindern. Die im Epidemiologischen Bulletin 14/2023 veröffentlichten Empfehlungen zu Reiseimpfungen wurden von der STIKO-AG Reiseimpfungen in Zusammenarbeit mit externen Expertinnen und Experten erarbeitet. Neuerungen sind dabei u. a. die aktualisierte Epidemiologie bei Cholera, Hepatitis A, Hepatitis B, Meningokokken und Typhus sowie eine umfassende Literatur-Aktualisierung.Peer Reviewe

Do Journals Publishing in the Field of Urology Endorse Reporting Guidelines? A Survey of Author Instructions

Introduction: Reporting guidelines aim to ensure adequate and complete reporting of clinical studies and are an indispensable tool to translate scientific results into clinical practice. The extent to which reporting guidelines are incorporated into the author instructions of journals publishing in the field of urology remained unclear. Materials and Methods: We assessed the author instructions of uro-nephrological journals indexed in ‘Journal Citation Reports 2009’. Two authors independently assessed the author guidelines. We evaluated additional information including whether a journal was published by or in association with a medical association. Discrepancies were resolved by re-checking the respective author instructions and by discussion with a third author. Results: The recommendations of the International Committee of Journal Editors were endorsed by 32 journals (58.2%) but were mentioned in 12 (37.5%) only to give general advice about manuscript preparation. Fourteen journals (25.5%) mentioned at least one reporting guideline, with CONSORT the most frequently cited. Journals with high impact factors were more likely to endorse CONSORT (p ! 0.009). Other reporting guidelines were mentioned by ! 6% of the journals. Conclusion: All key stakeholders involved in the publication process should more frequently promote the awareness and use of reporting guidelines

Efficacy and safety of pharmacological agents in the treatment of erythema migrans in early Lyme borreliosis-systematic review protocol

Background: Erythema migrans represents an early cutaneous and most common manifestation of Lyme borreliosis. Recommendations regarding pharmacological agents, dose and duration of treatment are subject of intense debate. This review aims to explore differences in efficacy and safety between pharmacological treatments and control treatment. Methods: To identify relevant studies, we will conduct a systematic literature search. We will include randomised controlled trials (RCTs) and non-RCTs. Eligible comparative studies need to (1) consider patients with a diagnosis of erythema migrans resulting from Lyme borreliosis and (2) compare different pharmacological agents against each other, against any other non-pharmacological treatment, placebo or no treatment. Two review authors will independently assess included studies for risk of bias according to the methods of the Cochrane Handbook for Systematic Reviews of Interventions and related to specific study designs. We will address patient-relevant outcomes including clinical remission of cutaneous symptoms, any treatment-related adverse events, quality of life and progressive symptoms such as neuroborreliosis or Lyme carditis and flu-like symptoms. Provided that the identified trials are comparable in terms of clinical issues, combined estimates will be provided. Estimations of treatment effects will be calculated based on a random effects model. Heterogeneity will be evaluated based on I (2) and chi-square test. In case of significant heterogeneity, a pooled estimate will not be provided, but heterogeneity will be investigated on the basis of methodological and clinical study aspects. We plan subgroup analysis to reveal potential differences in the effect estimates between patient populations and treatment specifications. We will consider risk of bias using sensitivity analyses to decide whether to rely on the pooled estimates. The quality of a body of evidence for individual outcomes will be assessed using the GRADE approach. Discussion: Benefits and harms of pharmacological treatment in erythema migrans have not yet been adequately assessed. This systematic review will evaluate and summarise available evidence addressing benefits and harms of different pharmacological treatments. In addition, this summary of clinical evidence will inform decision-making between clinicians and patients and will play an important part in patient care. Systematic review registration: PROSPERO: CRD42016037932