The impact of textual elements on the comprehensibility of drug label instructions (DLIs): A systematic review.

INTRODUCTION: Correct interpretation of drug labels instructions (DLIs) is needed for safe use and better adherence to prescribed drugs. DLIs are often too difficult for patients, especially for those with limited health literacy. What is yet unknown, is how specific textual elements in DLIs (e.g., the presentation of numbers, or use of medical jargon) and patients' health literacy skills are related to the comprehension of DLIs. In order to provide concrete directions for health professionals on how to optimize drug prescriptions, we performed a systematic review to summarize the available research findings on which textual elements facilitate or hinder the correct interpretation of DLIs in relation to patients' health literacy. METHOD: A systematic search was performed in PubMed, EMBASE, PsychINFO, and Smartcat (until April 2019) to identify studies investigating textual elements that facilitate or hinder the correct interpretation of DLIs in relation to patients' health literacy. RESULTS: A total of 434 studies were identified of which 28 studies met our inclusion criteria. We found that textual elements contributing to the correct interpretation of DLIs were: using explicit time periods in dosage instructions, using plain language, presenting numbers in a numerical format, and providing DLIs in patients' native language. Multistep instructions per instruction line, using abbreviations and medical jargon seem to hinder the correct interpretation of DLIs. Although health literacy was taken into account in a majority of the studies, none of them assessed the effectiveness of specific textual elements on patients' comprehensibility of DLIs. CONCLUSION: Based on our findings, we provide an overview of textual elements that contribute to the correct interpretation of DLIs. Optimizing the textual instruction on drug labels may increase the safety and adherence to prescribed drugs, taking into account that a significant proportion of patients has low health literacy.

How accurate is the neurosurgery literature? A review of references.

BACKGROUND: The reference list is an important part of academic manuscripts. The goal of this study is to evaluate the reference accuracy in the field of neurosurgery. METHODS: This study examines four major peer-reviewed neurosurgery journals, chosen based on their clinical impact factor: Neurosurgery, J Neurosurg, World Neurosurg, and Acta Neurochir. For each of the four journals, five articles from each of the journal's 12 issues published in 2019 were randomly selected using an online generator. This resulted in a total of 240 articles, 60 from each journal. Additionally, from each article's list of references, one reference was again randomly selected and checked for a citation or quotation error. The chi-square test was used to analyze the association between the occurrence of citation and quotation errors and the presence of hypothesized risk factors that could impact reference accuracy. RESULTS: 62.1% of articles had a minor citation error, 8.33% had a major citation error, 12.1% had a minor quotation error, and 5.8% of articles had a major quotation error. Overall, Acta Neurochir presented with the fewest quotation errors compared with the other journals evaluated. The only association between the frequency of errors and potential markers of reference mistakes was with the length of the bibliography. Surprisingly, this correlation indicated that the articles with longer reference lists had fewer citation errors (p < 0.01). Statistical significance was found between the occurrence of citation errors and the journals of publication (p < 0.01). CONCLUSIONS: In order to advance medical treatment and patient care in neurosurgery, detailed documentation and attention to detail are necessary. The results from this analysis illustrate that improved reference accuracy is required.

Update on the global neurosurgery movement: A systematic review of international vernacular, research trends, and authorship.

In 2015, key global and neurosurgical organizations increased collaboration to improve neurosurgical care access, delivery, and outcomes, particularly in low- to middle-income countries (LMICs); sparking what has been termed the global neurosurgery movement. The authors sought to assess trends in usage of the term 'global neurosurgery' in academic literature with particular focus on author affiliations, world regions most frequently discussed, and topics of research performed. A PubMed search for articles indexed as 'global neurosurgery' was completed yielding 277 articles which met inclusion criteria. It was found that over time, use of the term 'global neurosurgery' has increased, with increasing growth notable starting in the year 2008 and continuing into October 2019. Statistical comparisons showed authors with affiliated global neurosurgery centers were more likely to publish studies related to the continent of Africa (47.4% vs 15.9%, p < 0.001), and less likely to focus on countries in Asia (2.6% vs 20.9%, p = 0.023). Use of the term 'global neurosurgery' in the article abstract/title/keywords was associated with focus on LMICs (18.6% vs. 5.1%, p = 0.006). Use of the term 'global neurosurgery' was associated with workforce and capacity as research topics (41.9% vs 22.6%, p = 0.036). While fairly new, the global neurosurgery movement has seen a rapid increase in publications utilizing the term 'global neurosurgery.' Articles frequently have focused on collaborative, targeted workforce capacity building in LMICs. We encourage the development of more global neurosurgery academic centers, especially in non-USA countries, to continue this momentum.

How to Create a Great Radiology Report.

The radiology report represents the sum of a radiologist's highest level of synthesis and insight into a patient's condition. It is the most important product that radiologists generate to help direct patient care. Despite the self-evident importance of clear and effective radiology reporting, radiologists usually receive little or no formal reporting education during training. Instead, it is learned in a piecemeal and often indirect fashion through occasional correction and imitating the reports of other radiologists. The audience of the radiology report extends far beyond the ordering provider and includes patients and their families, medical support staff, subspecialty providers, other radiologists, and research interests. Creating a report that fulfills the needs of this diverse group is a formidable if not quixotic ambition. However, there are certain key principles to reporting the imaging findings, impression, and recommendations that serve as a guide and promote careful consideration about how reports are understood. The findings section should emphasize short, informative, and factual observations while avoiding inappropriate interpretation, excessive use of terms of perception, and redundancy. The impression is the thoughtful synthesis of the meaning of the findings leading to a diagnosis, a differential diagnosis, and management recommendations. Creating a clear and impactful impression allows radiologists to provide the highest level of clinical care and direction but takes time and effort beyond simply restating the findings. The impression should use language that is understandable, memorable, and actionable. Reporting skills require ongoing attention and must adapt to the evolving practice patterns and communication styles in medicine. ©RSNA, 2020.

Writing Accountability Groups Are a Tool for Academic Success: The Obesity Health Disparities PRIDE Program.

Introduction: The current hypercompetitive extramural funding environment in the United States emphasizes the critical need for effective research training programs that focus not only on grantsmanship, but on skill development across the full range of research activities, culminating in writing research results for publication. Using Writing Accountability Groups (WAG), the National Heart, Lung, and Blood Institute (NHLBI) funded Obesity Health Disparities (OHD) PRIDE is one of the few research training and mentoring programs that places an equal focus on scientific writing and grant writing. This article reports on the utility of WAGs for OHD PRIDE mentees. Method: Participants included 14 of 26 individuals who were fellows in the OHD PRIDE research training and mentoring program. A typical WAG has between four and eight members who meet for one hour each week over a 10-week period and commit a priori to attend at least 70% of the sessions. Summary statistics were produced to characterize number of peer-reviewed publications, grants, years in academic rank, and category of current academic rank, barriers to frequency of writing, and duration of writing. Results from pre- and post-WAG surveys were compared to determine the overall impact of the WAG. The study period discussed in this article took place between January and December 2017 and included data from three 10-week cycles beginning in February, May, and September. Results: Fifty-three percent of OHD PRIDE participants successfully completed at least one 10-week WAG cycle. The WAGs did not have a statistically significant impact on either the frequency of writing or the duration of writing. However, the majority of the participants who successfully completed at least one WAG cycle reported that they either maintained or increased their frequency or duration of writing. Conclusion: By providing a structured approach to developing and/or enhancing a practice of consistent writing, time management skills, and collaborative relationships, the WAG has promise for enhancing scientific writing skills for many trainees and early-career faculty. Longer term follow-up is needed to more fully assess the potential impact of WAGs.

Primed to comply: Individual participant data sharing statements on ClinicalTrials.gov.

In June 2017, the International Committee of Medical Journal Editors (ICMJE) announced a requirement that authors reporting the results of clinical trials to journals that follow ICMJE recommendations must include an individual participant data (IPD) sharing statement with manuscripts submitted after 01 July 2018. Additionally, all new clinical trials for which enrollment began on or after 01 January 2019 must include a data sharing statement in the trial's publicly posted registration. This study sought to understand whether IPD sharing statements of clinical trials first registered on ClinicalTrials.gov before 01 January 2019 reflected comprehension of the expectations and a willingness to share. To establish baseline characteristics for the prevalence and quality of IPD sharing statements, we examined IPD sharing statements among 2,040 clinical trials first posted on ClinicalTrials.gov between 01 January 2018 and 06 June 2018. Two independent coders further analyzed the quality of the IPD sharing statements of trials whose registration records indicated the intent to share IPD. The vast majority of trials included in this study did not indicate an intent to share IPD (n = 1,928; 94.5%). Among the trials that did commit to sharing IPD (n = 112, 5.5%), significant variability existed in the content and structure of IPD sharing statements. The results of this study suggest that successful compliance with the IPD sharing statement requirements of the ICMJE will require further clarification, enhanced education, and outreach to investigators.

Recommendations for designing genetic test reports to be understood by patients and non-specialists.

Patients and non-specialist healthcare professionals are increasingly expected to understand and interpret the results of genetic or genomic testing. These results are currently reported using a variety of templates, containing different amounts, levels, and layouts of information. We set out to establish a set of recommendations for communicating genetic test results to non-expert readers. We employed a qualitative-descriptive study design with user-centred design principles, including a mixture of in-person semi-structured interviews and online questionnaires with patients, healthcare professionals and the general public. The resulting recommendations and example template include providing at-a-glance comprehension of what the test results mean for the patient; suggested next steps; and details of further information and support. Separation and inclusion of technical methodological details enhances non-specialists' understanding, while retaining important information for specialists and the patients' records. The recommendations address the high-level needs of patients and their non-specialist clinicians when receiving genetic test results. These recommendations provide a solid foundation for the major content and structure of reports, and we recommend further engagement with patients and clinicians to tailor reports to specific types of test and results.

Usefulness of applying research reporting guidelines as Writing Aid software: a crossover randomised controlled trial.

OBJECTIVES: To assess the intention of using a Writing Aid software, which integrates four research reporting guidelines (Consolidated Standards of Reporting Trials, Preferred Reporting Items for Systematic Reviews and Meta-Analyses, Strengthening the Reporting of Observational Studies in Epidemiology and STrengthening the Reporting of Observational Studies in Epidemiology-nutritional epidemiology) and their Elaboration & Explanation (E&E) documents during the write-up of research in Microsoft Word compared with current practices. DESIGN: Two-arms crossover randomised controlled trial with no blinding and no washout period. SETTING: Face-to-face or online sessions. PARTICIPANTS: 54 (28 in arm 1 and 26 in arm 2) doctoral and postdoctoral researchers. INTERVENTIONS: Reporting guidelines and their E&E document were randomly administered as Writing Aid or as Word documents in a single 30 min to 1 hour session, with a short break before crossing over to the other study intervention. PRIMARY AND SECONDARY OUTCOMES: Using the Technology Acceptance Model, we assessed the primary outcome: the difference in the mean of intention of use; and secondary outcomes: the difference in mean perceived ease of use and perceived usefulness. The three outcomes were measured using questions with a 7-point Likert-scale. Secondary analysis using structural equation modelling (SEM) was applied to explore the relationships between the outcomes. RESULTS: No significant difference in reported intention of use (mean difference and 95% CI 0.25 (-0.05 to 0.55), p=0.10), and perceived usefulness (mean difference and 95% CI 0.19 (-0.04 to 0.41), p=0.10). The Writing Aid performed significantly better than the word document on researchers' perceived ease of use (mean difference and 95% CI 0.59 (0.29 to 0.89), p<0.001). In the SEM analysis, participants' intention of using the tools was indirectly affected by perceived ease of use (beta 0.53 p=0.002). CONCLUSIONS: Despite no significant difference in the intention of use between the tools, administering reporting guidelines as Writing Aid is perceived as easier to use, offering a possibility to further explore its applicability to enhance reporting adherence.

Effect of revealing authors' conflicts of interests in peer review: randomized controlled trial.

OBJECTIVE: To assess the effect of disclosing authors' conflict of interest declarations to peer reviewers at a medical journal. DESIGN: Randomized controlled trial. SETTING: Manuscript review process at the Annals of Emergency Medicine. PARTICIPANTS: Reviewers (n=838) who reviewed manuscripts submitted between 2 June 2014 and 23 January 2018 inclusive (n=1480 manuscripts). INTERVENTION: Reviewers were randomized to either receive (treatment) or not receive (control) authors' full International Committee of Medical Journal Editors format conflict of interest disclosures before reviewing manuscripts. Reviewers rated the manuscripts as usual on eight quality ratings and were then surveyed to obtain "counterfactual scores"-that is, the scores they believed they would have given had they been assigned to the opposite arm-as well as attitudes toward conflicts of interest. MAIN OUTCOME MEASURE: Overall quality score that reviewers assigned to the manuscript on submitting their review (1 to 5 scale). Secondary outcomes were scores the reviewers submitted for the seven more specific quality ratings and counterfactual scores elicited in the follow-up survey. RESULTS: Providing authors' conflict of interest disclosures did not affect reviewers' mean ratings of manuscript quality (Mcontrol=2.70 (SD 1.11) out of 5; Mtreatment=2.74 (1.13) out of 5; mean difference 0.04, 95% confidence interval -0.05 to 0.14), even for manuscripts with disclosed conflicts (Mcontrol= 2.85 (1.12) out of 5; Mtreatment=2.96 (1.16) out of 5; mean difference 0.11, -0.05 to 0.26). Similarly, no effect of the treatment was seen on any of the other seven quality ratings that the reviewers assigned. Reviewers acknowledged conflicts of interest as an important matter and believed that they could correct for them when they were disclosed. However, their counterfactual scores did not differ from actual scores (Mactual=2.69; Mcounterfactual=2.67; difference in means 0.02, 0.01 to 0.02). When conflicts were reported, a comparison of different source types (for example, government, for-profit corporation) found no difference in effect. CONCLUSIONS: Current ethical standards require disclosure of conflicts of interest for all scientific reports. As currently implemented, this practice had no effect on any quality ratings of real manuscripts being evaluated for publication by real peer reviewers.

Scientific Medical Writing in Practice: the «IMR@D®¼ Format.

INTRODUCTION: The quality of an original scientific paper (OSP) depends on compliance with the principles of scientific medical writing. This review aimed to enlighten the authors on the roles, organization, mistakes to be avoided and recommendations, related to the structure of an OSP. METHODS: Narrative review of the literature regarding the structure adopted when drafting an OSP. RESULTS: The format "IMR@D®" (Introduction, Methods, Results, Discussion, and References) is now, and will remain, the guiding structure of the majority of OSPs published in biomedical scientific journals. The "Introduction" section is the answer to the question: what is the problem? It describes the reasoning, the purposes and the objectives of the study and concisely describes the study hypothesis. The "Methods" section is the answer to the question: how did the author try to solve the problem? It specifies the study design, the selection process, the applied procedures, the data collected, and the type of statistical analysis that will be performed to confirm/refute the research hypothesis. The section "Results" is the answer to the interrogation: what have the author found? It presents the descriptive and the analytical data of the study. The "Discussion" section is the answer to the question: what difference does it make? It interpreted the results and compared them with these reported in the literature. The "References" section is the answer to the question: what have the author consulted? It clearly explains what is not based on information derived from the study, and provides means to verify that cited statements have been really recorded in the literature. CONCLUSION: The "IMR@D®" format should make the scientific medical writing more pleasant while increasing the possibility that the OSP is accepted for publication.

Scientific Medical Writing in Practice: How to Succeed the Writing Style?

The quality of an original scientific article depends, in addition to the relevance of the subject and the validity of the method, on the conformity to the principles of the scientific medical writing (SMW) with regard to both structure and style. For the structure, the IMR@D® plan (Introduction, Methods, Results, Discussion, and References) is often used. For the style, the C2PS rule (concise, clear, precise and simple) is essential. This paper provides tips / recommendations for authors considering submitting an original scientific paper for publication in a peer-reviewed medical journal. The following points were addressed: concision, clarity, precision, simple writing, passive voice, use of the first person, specificity of scientific medical English, strength of verbs in the SMW, Latin terminology, ethics of the SMW, recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals.

Writers' uncertainty in scientific and popular biomedical articles. A comparative analysis of the British Medical Journal and Discover Magazine.

Distinguishing certain and uncertain information is of crucial importance both in the scientific field in the strict sense and in the popular scientific domain. In this paper, by adopting an epistemic stance perspective on certainty and uncertainty, and a mixed procedure of analysis, which combines a bottom-up and a top-down approach, we perform a comparative study (both qualitative and quantitative) of the uncertainty linguistic markers (verbs, non-verbs, modal verbs, conditional clauses, uncertain questions, epistemic future) and their scope in three different corpora: a historical corpus of 80 biomedical articles from the British Medical Journal (BMJ) 1840-2007; a corpus of 12 biomedical articles from BMJ 2013, and a contemporary corpus of 12 scientific popular articles from Discover 2013. The variables under observation are time, structure (IMRaD vs no-IMRaD) and genre (scientific vs popular articles). We apply the Generalized Linear Models analysis in order to test whether there are statistically significant differences (1) in the amount of uncertainty among the different corpora, and (2) in the categories of uncertainty markers used by writers. The results of our analysis reveal that (1) in all corpora, the percentages of uncertainty are always much lower than that of certainty; (2) uncertainty progressively diminishes over time in biomedical articles (in conjunction with their structural changes-IMRaD-and to the increase of the BMJ Impact Factor); and (3) uncertainty is slightly higher in scientific popular articles (Discover 2013) as compared to the contemporary corpus of scientific articles (BMJ 2013). Nevertheless, in all corpora, modal verbs are the most used uncertainty markers. These results suggest that not only do scientific writers prefer to communicate their uncertainty with markers of possibility rather than those of subjectivity but also that science journalists prefer using a third-person subject followed by modal verbs rather than a first-person subject followed by mental verbs such as think or believe.