Editorial/Letters

Getting more grip on genetic risk prediction studies: the GRIPS statement

Commentary: Left ventricular assist device infections and epidemiologic literature—still more work to be done

Observational studies examining patient management in infectious diseases

Dialysis Facility Ownership and Epoetin Dosing in Patients Receiving Hemodialysis: The Authors Respond

AUA-recommended Antibiotic Prophylaxis for Primary Penile Implantation Results in a Higher, Not Lower, Risk for Postoperative Infection: A Multicenter Analysis.

Poor reporting of biomedical research has been a persistent and prominent problem throughout modern history. In many different scientific fields, study results have failed to be reproduced and replicated, oftentimes due to incomplete reporting. When information is missing about how a study was designed, conducted, and analyzed, researchers and clinicians are unable to use results to inform health policies and clinical care. To address this issue, reporting guidelines (RG) were created to establish the minimum criteria that authors need to disclose when discussing study results. A reporting guideline for observational studies was published in 2007 which contains 22-items and guidance for authors of case-control, cohort, and cross-sectional studies. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement is supported by many journals and editorial groups, however, at quite low rates. Lack of awareness is widespread and it is unclear what authors think about STROBE. Furthermore, while STROBE been expanded upon for specific fields and methodologies through the creation of “extensions” – little is known about perceptions towards these documents, their content, or usefulness. In order to better implement STROBE and reporting guidelines like it, research is needed into current processes by authors and how their environment affects their work. The work in this dissertation was guided by the Promoting Action on Research Implementation in Health Services (PARIHS) knowledge translation strategy. This approach looks at the 1) evidence, 2) context, and 3) facilitators in order to implement research successfully. Transforming STROBE from simply a reporting guideline into an educational tool required investigation into these three facets. I began by investigating the content in the STROBE extensions to identify strengths and weaknesses in the checklist items. Results found that the content in the STROBE extensions is problematic as it is sometimes redundant – potentially indicating a poor understanding of the concepts within STROBE or issues with its content. Concurrently, I determined the endorsement rates of the extensions to establish the publishing context in which authors are working. I found that journals are largely not endorsing STROBE and the language that they use is ambiguous and vague. The STROBE extensions are endorsed at extremely low rates or not at all. Next, I assessed researcher’s awareness of, experiences with, and attitudes towards the STROBE checklist. This established the facilitators, timing and motivators (context), and perceptions (evidence) of use. The second project found that there is a large disagreement regarding the level of specificity desired in STROBE and its usefulness. Generally, authors are not opposed to using it but there is often no strong motivating force. Their coauthors do not use it and journals are not requiring it. Authors also hold some internal views that are detrimental to the promotion of STROBE, such as the over-confidence in one’s abilities. The work from the first two projects provided the content and support for an educational intervention that is integrated within the writing process, accessible by a worldwide audience, and open-source and editable. It is built using R and is open-source and editable via GitHub and the repository is publicly launched alongside this dissertation.

Quality Improvement is a Professional Responsibility in Diabetes Care

The definition of the venous ulcer

Leaving No Stone Unturned in the Search for Adverse Events Associated With Use of Proton Pump Inhibitors

Risk of myocardial infarction, ischemic stroke, and cardiovascular death in patients with atopic dermatitis

Extracorporeal Cardiopulmonary Resuscitation: Prehospital or In-Hospital Cannulation?

BackgroundApproximately 90% of currently published clinical and public health research is in the form of observational studies. Having a detailed and registered study protocol prior to data collection is important in any empirical study. Without this, there is no reliable way to assess the occurrence of publication bias, outcome reporting bias, and other protocol deviations. However, there is currently no solid guidance available on the information that a protocol for an observational study should contain.ObjectiveThe aim of this study is to formulate the Standardized Protocol Items Recommendations for Observational Studies (SPIROS) reporting guidelines, which focus on 3 main study designs of analytical epidemiology: cohort, case-control, and cross-sectional studies.MethodsA scoping review of published protocol papers of observational studies in epidemiology will identify candidate items for the SPIROS reporting guidelines. The list of items will be extended with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist items and recommendations from the SPIROS steering committee. This long list serves as the basis for a 2-round Delphi survey among experts to obtain consensus on which items to include. Each candidate item from the long list will be rated on a 5-point Likert scale to assess relevance for inclusion in the SPIROS reporting guidelines. Following the Delphi survey, an expert-driven consensus workshop will be convened to finalize the reporting guidelines.ResultsA scoping review of published observational study protocols has been completed, with 59 candidate items identified for inclusion into the Delphi survey, itself launched in early 2020.ConclusionsThis project aims to improve the timeliness, completeness, and clarity of study protocols of observational studies in analytical epidemiology by producing expert-based recommendations of items to be addressed. These reporting guidelines will facilitate and encourage researchers to prepare and register study protocols of sufficient quality prior to data collection in order to improve the transparency, reproducibility, and quality of observational studies.International Registered Report Identifier (IRRID)PRR1-10.2196/17864

Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in west Africa?

Firearms are the leading cause of death in US children and adolescents, but little is known about whether the overall legal landscape was associated with excess mortality after a landmark US Supreme Court decision in 2010. To measure excess mortality due to firearms among US children aged 0 to 17 years after the McDonald v Chicago US Supreme Court decision (2010). An excess mortality analysis was conducted using the US Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research (WONDER) database before and after McDonald v Chicago, the landmark 2010 US Supreme Court decision on firearms regulation. States were divided into 3 groups based on legal actions taken before and since 2010, most permissive, permissive, and strict. Firearm mortality trends before (1999-2010) and after (2011-2023) were determined and compared across the 3 groups for all intents and by intent (homicide and suicide). Subgroup analysis by observed race and ethnicity was conducted. For each US state, pre-and post-McDonald v Chicago all-intent pediatric firearm mortality incident rates were compared. These data were analyzed January 2011 through December 2023. The pre- and post-McDonald v Chicago legal landscape. Excess mortality during the post-McDonald v Chicago period. During the post-McDonald v Chicago period (2011-2023), there were 6029 excess firearm deaths (incidence rate [IR], 158.6 per million population; 95% CI, 154.8-162.5) in the most permissive group. In the permissive group, there were 1424 excess firearm deaths (IR, 107.5 per million person-years; 95% CI, 103.8-111.3). In the strict group, there were -55 excess firearm deaths (IR, -2.5 per million person-years; 95% CI, -5.8 to 0.8). Non-Hispanic Black populations had the largest increase in firearm mortality in the most permissive and permissive state groupings. Four states (California, Maryland, New York, and Rhode Island) had decreased pediatric firearm mortality after McDonald v Chicago, all of which were in the strict firearms law group. States in the most permissive and permissive firearm law categories experienced greater pediatric firearm mortality during the post-McDonald v Chicago era. Future work should focus on determining which types of laws conferred the most harm and which offered the most protection.

Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case–control and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case–control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the websites of PLoS Medicine, Annals of Internal Medicine and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.