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Biomedical subjects

Richelle J Cooper

Publications and source records attributed to Richelle J Cooper.

17 recordsLinked to original sources

Performance of a decision rule to predict need for computed tomography among children with blunt head trauma.

OBJECTIVE: To assess the ability of the NEXUS II head trauma decision instrument to identify patients with clinically important intracranial injury (ICI) from among children with blunt head trauma. METHODS: An analysis was conducted of the pediatric cohort involved in the derivation set of National Emergency X-Radiography Utilization Study II (NEXUS II), a prospective, observational, multicenter study of all patients who had blunt head trauma and underwent cranial computed tomography (CT) imaging at 1 of 21 emergency departments. We determined the test performance characteristics of the 8-variable NEXUS II decision instrument, derived from the entire NEXUS II cohort, in the pediatric cohort (0-18 years of age), as well as in the very young children (<3 years). Clinically important ICI was defined as ICI that required neurosurgical intervention (craniotomy, intracranial pressure monitoring, or mechanical ventilation) or was likely to be associated with significant long-term neurologic impairment. RESULTS: NEXUS II enrolled 1666 children, 138 (8.3%) of whom had clinically important ICI. The decision instrument correctly identified 136 of the 138 cases and classified 230 as low risk. A total of 309 children were younger than 3 years, among whom 25 had ICI. The decision instrument identified all 25 cases of clinically important ICI in this subgroup. CONCLUSIONS: The decision instrument derived in the large NEXUS II cohort performed with similarly high sensitivity among the subgroup of children who were included in this study. Clinically important ICI were rare in children who did not exhibit at least 1 of the NEXUS II risk criteria.

Adolescent↗

Conflict of Interest Disclosure Policies and Practices in Peer-reviewed Biomedical Journals.

OBJECTIVE: We undertook this investigation to characterize conflict of interest (COI) policies of biomedical journals with respect to authors, peer-reviewers, and editors, and to ascertain what information about COI disclosures is publicly available. METHODS: We performed a cross-sectional survey of a convenience sample of 135 editors of peer-reviewed biomedical journals that publish original research. We chose an international selection of general and specialty medical journals that publish in English. Selection was based on journal impact factor, and the recommendations of experts in the field. We developed and pilot tested a 3-part web-based survey. The survey included questions about the presence of specific policies for authors, peer-reviewers, and editors, specific restrictions on authors, peer-reviewers, and editors based on COI, and the public availability of these disclosures. Editors were contacted a minimum of 3 times. RESULTS: The response rate for the survey was 91 (67%) of 135, and 85 (93%) of 91 journals reported having an author COI policy. Ten (11%) journals reported that they restrict author submissions based on COI (e.g., drug company authors' papers on their products are not accepted). While 77% report collecting COI information on all author submissions, only 57% publish all author disclosures. A minority of journals report having a specific policy on peer-reviewer 46% (42/91) or editor COI 40% (36/91); among these, 25% and 31% of journals state that they require recusal of peer-reviewers and editors if they report a COI. Only 3% of respondents publish COI disclosures of peer-reviewers, and 12% publish editor COI disclosures, while 11% and 24%, respectively, reported that this information is available upon request. CONCLUSION: Many more journals have a policy regarding COI for authors than they do for peer-reviewers or editors. Even author COI policies are variable, depending on the type of manuscript submitted. The COI information that is collected by journals is often not published; the extent to which such "secret disclosure" may impact the integrity of the journal or the published work is not known.

Conflict of Interest↗

The availability of references and the sponsorship of original research cited in pharmaceutical advertisements.

BACKGROUND: The primary goal of pharmaceutical advertisements is to convince physicians to prescribe the manufacturer's product. We sought to determine what materials are cited in support of claims in pharmaceutical ads and medical research articles, and whether health care professionals seeking to verify the claims could obtain these references. METHODS: We reviewed 438 unique ads from the 1999 issues of 10 American medical journals, and a random sample of 400 references in medical research articles selected from the same journals. We classified references as journal article, data on file, meeting abstract or presentation, book or monograph, marketing report, prescribing information, government document or Internet site. We attempted to confirm or obtain each reference through library and Internet searches or by direct request from the manufacturer. The main outcome we sought to determine was the availability of the reference to a clinician. We also ascertained the source of funding for original research cited in the ads and the research articles. RESULTS: In the 438 ads with medical claims, 126 contained no references and 312 contained 721 unique references. Of these ad references, 55% (396/721) cited journal articles and 19% (135/721) cited data on file. In contrast, in the sample of research article references, 88% (351/400) cited journal articles and 8% (33/400) cited books. Overall, 84% of the citations from the ads were available: 98% of journal articles, 86% of books, 71% of meeting abstracts or presentations and 20% of data-on-file references. In all, 99% of the sample of research article references were available. We determined that 58% of the original research cited in the pharmaceutical ads was sponsored by or had an author affiliated with the product's manufacturer, as compared with 8% of the articles cited in the research articles. INTERPRETATION: Many pharmaceutical ads contain no references for medical claims. Although references to journal articles were usually obtainable, other published sources were not as easily acquired. The majority of unpublished data-on-file references were not available, and the majority of original research cited to substantiate claims in the pharmaceutical ads was funded by or had authors affiliated with the product's manufacturer.

Advertising↗

The quantity and quality of scientific graphs in pharmaceutical advertisements.

We characterized the quantity and quality of graphs in all pharmaceutical advertisements, in the 10 U.S. medical journals. Four hundred eighty-four unique advertisements (of 3,185 total advertisements) contained 836 glossy and 455 small-print pages. Forty-nine percent of glossy page area was nonscientific figures/images, 0.4% tables, and 1.6% scientific graphs (74 graphs in 64 advertisements). All 74 graphs were univariate displays, 4% were distributions, and 4% contained confidence intervals for summary measures. Extraneous decoration (66%) and redundancy (46%) were common. Fifty-eight percent of graphs presented an outcome relevant to the drug's indication. Numeric distortion, specifically prohibited by FDA regulations, occurred in 36% of graphs.

Advertising↗

Effect of vital signs on triage decisions.

STUDY OBJECTIVE: We sought to determine whether knowledge of vital signs changes nurse triage designations (TDs). We also sought to determine whether patient age and ability to communicate modify the effect of vital signs on triage decisions. METHODS: We performed a prospective observational study, in 24 emergency departments, of nurse-assigned TDs of all ED patients undergoing triage. Nurses performed their typical triage routine, except that they chose 1 of 5 hypothetical TDs (call 911, ED <2 hours, physician's office 2 to 8 hours, physician's office 8 to 24 hours, or home care) before and after measurement of vital signs. The main outcome measure was the change of TD after knowledge of a patient's vital signs, with stratification on the basis of patient age and communication barriers. The secondary outcome was the final ED disposition. RESULTS: Six hundred twenty-five experienced triage nurses at 24 different EDs collected data on 14,285 patients. TDs were downgraded (decreased in urgency) in 2.4% of patients, and 5.5% were upgraded (increased in urgency) after vital signs were known. Changes were more likely to occur in the young (< or = 2 years old; 11.4%) and the elderly (> or = 75 years old; 9.9%) than in those 3 to 74 years of age (7.5%). When nurses reported a communication barrier, a change in post-vital signs TD was also more common (11.2% versus 7.7%). The post-vital signs TD better predicted patient ED disposition. CONCLUSION: In this sample, 92.1% of the nurses' TDs were not affected by the knowledge of patient vital signs. For the other 7.9%, including many patients from vulnerable populations, the vital signs changed the nurses' assessments of the patients' triage designation. Methods of triage that do not determine vital signs may not adequately reflect the urgency of the patient's presentation.

Data Collection↗

Graphical literacy: the quality of graphs in a large-circulation journal.

STUDY OBJECTIVES: We sought to characterize the quantity and quality of graphs in the Journal of American Medicine (JAMA), contrasting articles published in 1999 with those published in 2000 after the addition of a dedicated tables and figures editor. We also sought to compare the quality of graphs in JAMA with the quality of graphs in Annals of Emergency Medicine. METHODS: Two reviewers independently assessed all graphs in original research articles from 12 randomly chosen issues of JAMA, 6 each from 1999 and 2000, using a standardized abstraction form. We noted graph type, clarity, and completeness and identified internal discrepancies. We examined the graphs and articles to observe discrepancies with text, to observe efficiency of graph presentation, and to determine whether the graph portrayed unaggregated data. Results were compared with results from a previously published study of graphs from 18 consecutive issues of Annals of Emergency Medicine beginning in January 1998. RESULTS: The 12 JAMA issues contained 56 research articles, with 64 graphs in the 37 articles that had graphs (28 in 27 1999 articles, 36 in 29 2000 articles). Simple bar or point charts (63%) predominated. We rarely encountered internal errors (8%), contradictions with text (3%), numeric distortion (6%), lack of visual clarity (5%), nonstandard graphing conventions (11%), or extraneous decoration (0%). Graphs generally defined all symbols (98%), but 31% were not self-explanatory; that is, despite knowing the study's design and reading the figure's legend, we could not unambiguously interpret the graph. Fourteen percent contained redundancies. Graphs infrequently portrayed by-subject data (9%) or advanced features (15%) such as pairing, symbolic dimensionality, or small multiples. Forty-eight percent (21/44) of graphs did not illustrate the underlying distribution, 48% (26/54) did not depict important covariates, and 67% (14/21) did not portray pairing inherent in the data. There were no differences between 1999 and 2000 graphs, although we noted more graphs in the 2000 issues. Graph quality was similar in Annals of Emergency Medicine and JAMA, but graphs were more common in the original research articles in JAMA. Although univariate displays predominated in both publications, there were more bivariate displays in Annals of Emergency Medicine but fewer advanced graphic features. CONCLUSION: The graphs in JAMA were similar to those in Annals of Emergency Medicine and, although generally clear and without errors, often failed to depict detailed data. Authors and editors could improve data presentations by incorporating graphic formats that depict stratified, detailed data.

Journalism, Medical↗

The effect of dedicated methodology and statistical review on published manuscript quality.

STUDY OBJECTIVE: We examine how dedicated methodology and statistical review affects the quality of manuscripts published in Annals of Emergency Medicine. DESIGN: The dedicated reviewers developed a manuscript scoring form based on previously used instruments. The form contained 84 unique elements. Eight items sought the presence of state-of-the-art features (eg, formal exploration of the sensitivity of results to assumptions); the others sought substandard quality. Two raters independently scored each original research publication appearing in 4 consecutive issues of Annals for the presence or absence of each relevant item. We then reviewed the formal methodology and statistical review and all subsequent correspondence between authors and editors to determine whether the methodology and statistical review provided guidance regarding each of the 84 items and whether the advice was incorporated into the final manuscript. RESULTS: There were 32 original research articles. One was never subjected to methodology and statistical review. Reviewers agreed on 94% of all items; single-item agreement ranged from 77% to 100%. State-of-the-art features were present in 31 (14%) of 217 ratings; the methodology and statistical review had commented on 13 (42%) of these. State-of-the-art features were absent in 186 (86%) ratings; the methodology and statistical review had commented on 33 (18%) of these. Substandard features were deemed present in 166 (12%) of 1,519 ratings; the methodology and statistical review had commented on 82 (44%) of these. Substandard features were absent in 1,333 (88%) ratings; the methodology and statistical review had commented on 132 (10%) of these. We found no fatal flaws in the published manuscripts. CONCLUSION: Methodology reviewers often failed to comment on deficiencies that they had classified as substandard when designing this study. Reviews also did not encourage inclusion of state-of-the-art abstract, article, and references features. When reviews identified areas in need of improvement, only half of the comments led to improved manuscripts. In the other half, authors either rebuked the suggestions or the editors did not act when suggestions were ignored.

Peer Review, Research↗