Professional medical writing support and the reporting quality of randomized controlled trial abstracts among high-impact general medical journals.
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SUBMITTER: Mills I
PROVIDER: S-EPMC5615774 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background:Many authors choose to work with professional medical writers when reporting the results of clinical trials. We conducted a systematic review to examine the relationship between professional medical writing support (PMWS) and the quality, ethics and timeliness of publications reporting clinical trials. Methods:Using terms related to 'medical writer' and 'observational study', we searched MEDLINE and Embase (no date limits), as well as abstracts and posters from meetings of the International Society for Medical Publication Professionals (ISMPP; 2014-2018). We also hand-searched the journals Medical Writing and The Write Stuff (2014-2018) and the bibliographies of studies identified in the electronic searches. We screened the results to identify studies that compared the quality, ethics and timeliness of clinical trial publications written with and without declared PMWS. Results:Our searches identified 97 potentially relevant studies, of which 89 were excluded during screening and full paper review. The remaining eight studies compared 849 publications with PMWS with 2073 articles developed without such support. In these eight studies, PMWS was shown to be associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines (in 3/3 studies in which this was assessed), publication in journals with an impact factor (one study), a higher quality of written English (one study), and a lower likelihood of reporting non-pre-specified outcomes (one study). PMWS was not associated with increased adherence to CONSORT for Abstracts guidelines (one study) or with the impact of published articles (mean number of citations per year, mean number of article views per year and Altmetric score; one study). In studies that assessed timeliness of publication, PMWS was associated with a reduced time from last patient visit in clinical trials to primary publication (one study), whereas time from submission to acceptance showed inconsistent results (two studies). Conclusions:This systematic review of eight observational studies suggests that PMWS is positively associated with measures of overall quality of reporting of clinical trials and may improve the timeliness of publication.
| S-EPMC6621980 | biostudies-literature
Project description:Academic degrees following author names are often included in medical research papers. However, it remains unclear how many journals choose to include academic degrees and whether this is more common in certain types of journals. We examined the 100 highest impact medical journals and found that only 24 medical journals reported academic degrees. Moreover, this was substantially more common in journals based in North America compared with Europe. Further research is required to explore the implications of listing academic degrees on the readers' attitude towards research quality.
| S-EPMC7014575 | biostudies-literature
Project description:ObjectiveTo investigate the effect of the CONSORT for Abstracts guidelines, and different editorial policies used by five leading general medical journals to implement the guidelines, on the reporting quality of abstracts of randomised trials.DesignInterrupted time series analysis.SampleWe randomly selected up to 60 primary reports of randomised trials per journal per year from five high impact, general medical journals in 2006-09, if indexed in PubMed with an electronic abstract. We excluded reports that did not include an electronic abstract, and any secondary trial publications or economic analyses. We classified journals in three categories: those not mentioning the guidelines in their instructions to authors (JAMA and New England Journal of Medicine), those referring to the guidelines in their instructions to authors but with no specific policy to implement them (BMJ), and those referring to the guidelines in their instructions to authors with an active policy to implement them (Annals of Internal Medicine and Lancet). Two authors extracted data independently using the CONSORT for Abstracts checklist.Main outcomeMean number of CONSORT items reported in selected abstracts, among nine items reported in fewer than 50% of the abstracts published across the five journals in 2006.ResultsWe assessed 955 reports of abstracts of randomised trials. Journals with an active policy to enforce the guidelines showed an immediate increase in the level of mean number of items reported (increase of 1.50 items; P=0.0037). At 23 months after publication of the guidelines, the mean number of items reported per abstract for the primary outcome was 5.41 of nine items, a 53% increase compared with the expected level estimated on the basis of pre-intervention trends. The change in level or trend did not increase in journals with no policy to enforce the guidelines (BMJ, JAMA, and New England Journal of Medicine).ConclusionActive implementation of the CONSORT for Abstracts guidelines by journals can lead to improvements in the reporting of abstracts of randomised trials.
| S-EPMC3382226 | biostudies-literature
Project description:ObjectivesTo evaluate the methodological quality of randomised controlled trial (RCT) abstracts in leading critical care nursing journals against the Consolidated Standards of Reporting Trials-Abstracts (CONSORT-A) checklist and to identify variables related with abstract reporting quality.DesignDescriptive methodological quality review.Data sourceWe searched the PubMed database and the websites of each included journal.Eligibility criteriaWe included RCT abstracts published between 2011 and 2021 in the first 11 Scopus-ranking (2021) critical care nursing journals that reported the results of RCTs in English that referred to the care of adult patients with acute/critical illness or their relatives and/or caregivers and conducted in ICUs.Data extraction and synthesisTwo independent investigators extracted the data using a prespecified 17-item checklist directly derived from CONSORT-A. For the primary outcome, each item was evaluated whether it was adequately reported or not and descriptive statistics were reported. An overall score was calculated by summing the results of all items and multivariate linear regression was conducted to detect potential predictors.ResultsSeventy-eight RCT abstracts were included in this review. The items with the highest CONSORT-A adherence were authors, objective, conclusion, participants, interventions and outcome. The randomisation item had the lowest CONSORT-A adherence, followed by trial registration, funding source, harms or side effects, recruitment, blinding and outcome results. The average CONSORT-A score was 8.5±1.5 points (of the maximum 17.5 points). Multivariate analysis indicated that the categorised word score and publication date were positively associated with the overall CONSORT-A score, while the first author's country being in Asia was negatively associated with the overall CONSORT-A score.ConclusionsThe 78 RCT abstracts showed poor overall adherence to CONSORT-A. The results indicate that the methodological reporting quality of RCT abstracts in critical care nursing journals requires improvement to facilitate assessment of the applicability and relevance of the results reported.
| S-EPMC10030738 | biostudies-literature
Project description:Multivariable logistic regression (MLR) has been increasingly used in Chinese clinical medical research during the past few years. However, few evaluations of the quality of the reporting strategies in these studies are available.To evaluate the reporting quality and model accuracy of MLR used in published work, and related advice for authors, readers, reviewers, and editors.A total of 316 articles published in 5 leading Chinese clinical medical journals with high impact factor from January 2010 to July 2015 were selected for evaluation. Articles were evaluated according 12 established criteria for proper use and reporting of MLR models.Among the articles, the highest quality score was 9, the lowest 1, and the median 5 (4-5). A total of 85.1% of the articles scored below 6. No significant differences were found among these journals with respect to quality score (χ = 6.706, P = .15). More than 50% of the articles met the following 5 criteria: complete identification of the statistical software application that was used (97.2%), calculation of the odds ratio and its confidence interval (86.4%), description of sufficient events (>10) per variable, selection of variables, and fitting procedure (78.2%, 69.3%, and 58.5%, respectively). Less than 35% of the articles reported the coding of variables (18.7%). The remaining 5 criteria were not satisfied by a sufficient number of articles: goodness-of-fit (10.1%), interactions (3.8%), checking for outliers (3.2%), collinearity (1.9%), and participation of statisticians and epidemiologists (0.3%). The criterion of conformity with linear gradients was applicable to 186 articles; however, only 7 (3.8%) mentioned or tested it.The reporting quality and model accuracy of MLR in selected articles were not satisfactory. In fact, severe deficiencies were noted. Only 1 article scored 9. We recommend authors, readers, reviewers, and editors to consider MLR models more carefully and cooperate more closely with statisticians and epidemiologists. Journals should develop statistical reporting guidelines concerning MLR.
| S-EPMC5457877 | biostudies-literature
Project description:ImportanceSince the 1990s, reporting guidelines have developed that uniformly require authors to report a measure of precision (confidence intervals [CIs]) in addition to effect size.ObjectiveTo investigate the time trend of statistical inference and statistical reporting style in abstracts of major cancer journals.Design, setting, and participantsThis cross-sectional study reviewed all abstracts published between January 1, 1990, and December 31, 2020, in 10 high-ranking cancer journals (Lancet Oncology, Journal of Clinical Oncology, Cancer Discovery, Cancer Cell, JAMA Oncology, Annals of Oncology, Molecular Cancer, Journal of Thoracic Oncology, Journal of the National Cancer Institute, and Trends in Cancer) using a previously validated computerized algorithm to search the PubMed database. For the time trend analyses, 2 journals with only a few years of existence (JAMA Oncology and Trends in Cancer) were excluded.ExposuresCalendar year, journal, and type of abstract (randomized clinical trial or other).Main outcomes and measuresProportions of abstracts containing CIs, P values without CIs, and qualitative expressions of statistical significance only were compared over time among journals.ResultsOverall, 24 034 of 42 509 abstracts (56.5%) contained statistical inference. Reporting of CIs increased over time in 5 of 8 journals. From 2016 to 2020, the most prevailing statistical reporting style was the presentation of CIs (3070 of 4895 [62.7%]). However, the proportion of abstracts reporting statistical inference based solely on the terms significant or nonsignificant was still 1195 of 4895 (24.4%) during this period and was most prevalent among basic science-oriented cancer journals (eg, 63 of 66 [95.5%] in Cancer Cell). A higher prevalence of CI reporting was associated with reporting of results from randomized clinical trials and the requirement to report according to guidelines (eg, 522 of 574 [90.9%] in Lancet Oncology).Conclusions and relevanceThese findings suggest that the reporting style of statistical inference in abstracts of major cancer journals has improved over time. A requirement in journals' instructions for authors to present statistical inference in accordance with reporting guidelines and the implementation of these guidelines in submitted manuscripts on the part of journal editors may improve reporting.
| S-EPMC9227005 | biostudies-literature
Project description:IntroductionThe quality of reporting of abstracts of randomised controlled trials (RCTs) in major general medical journals and in some category-specific journals was shown to be poor before the publication of the ConsolidatedStandards of ReportingTrials (CONSORT) extension for abstracts in 2008, and an improvement in the quality of reporting of abstracts was observed after its publication. The effect of the publication of the CONSORT extension for abstracts on the quality of reporting of RCTs in emergency medicine journals has not been studied. In this paper, we present the protocol of a systematic survey of the literature, aimed at assessing the quality of reporting in abstracts of RCTs published in emergency medicine journals and at evaluating the effect of the publication of the CONSORT extension for abstracts on the quality of reporting.Methods and analysisThe Medline database will be searched for RCTs published in the years 2005-2007 and 2014-2015 in the top 10 emergency medicine journals, according to their impact factor. Candidate studies will be screened for inclusion in the review. Exclusion criteria will be the following: the abstract is not available, they are published only as abstracts, still recruiting, or duplicate publications. The study outcomes will be the overall quality of reporting (number of items reported) according to the CONSORT extension and the compliance with its individual items. Two independent reviewers will screen each article for inclusion and will extract data on the CONSORT items and on other variables, which can possibly affect the quality of reporting.Ethics and disseminationThis is a library-based study and therefore exempt from research ethics board review. The review results will be disseminated through abstract submission to conferences and publication in a peer-reviewed biomedical journal.
| S-EPMC5566942 | biostudies-literature
Project description:ObjectiveWe assessed how well articles in major medical and psychiatric journals followed best reporting practices in presenting results of intervention studies.MethodStandardised data collection was used to review studies in high-impact and widely read medical (JAMA, Lancet and New England Journal of Medicine) and psychiatric (American Journal of Psychiatry, JAMA Psychiatry, Journal of Clinical Psychiatry and Lancet Psychiatry) journals, published between 1 September 2018 and 31 August 2019. Two team members independently reviewed each article.MeasuresThe primary outcome measure was proportion of papers reporting consensus elements required to understand and evaluate the results of the intervention. The secondary outcome measure was comparison of complete and accessible reporting in the major medical versus the major psychiatric journals.ResultsOne hundred twenty-seven articles were identified for inclusion. At least 90% of articles in both medical and psychiatric journals included sample size, statistical significance, randomisation method, elements of study flow, and age, sex, and illness severity by randomisation group. Selected elements less frequently reported by either journal type were confidence intervals in the abstract, reported in 93% (95% CI 84% to 97%) of medical journal articles and 58% (95% CI 45% to 69%) of psychiatric journal articles, and sample size method (93%, 95% CI 84% to 97% medical; 69%, 95% CI 57% to 80% psychiatric), race and ethnicity by randomisation group (51%, 95% CI 40% to 63% medical; 73%, 95% CI 60% to 83% psychiatric), and adverse events (94%; 95% CI 86% to 98% medical; 80%, 95% CI 68% to 88% psychiatric) in the main text. CIs were included less often in psychiatric than medical journals (p<0.004 abstract, p=0.04 main text, after multiple-testing correction).ConclusionsRecommendations include standard inclusion of a table specifying the outcome(s) designated as primary, and the sample size, effect size(s), CI(s) and p value(s) corresponding to the primary test(s) for efficacy.
| S-EPMC9748970 | biostudies-literature
Project description:ObjectiveTo analyze the reporting of statistical inference in psychiatry.MethodWe searched 63,928 abstracts, published in 15 leading psychiatric journals (1975-2015).ResultsMedian abstract length increased from 664 (1975) to 1,323 (2015) characters, and median use of numbers from two to 14/abstract. A total of 3.6% of all abstracts exclusively contained significance terminology in a nonstatistical sense, and 45% showed some form of statistical inference, increasing from 26% to 52%. In those abstracts, statistical inference based on thresholds was dominant. Its proportion decreased from 99% to 66%, but with rising numbers of articles, figures rose from 1,095 to 2,382. Although reporting p values without thresholds did not appear 40 years ago and remains rare, combining precise p values with thresholds is now common. In 2010-2015, 86% of abstracts contained p values or p value thresholds, 22% confidence intervals, and 7% confidence intervals only. Results varied across journals.ConclusionThere is a moderate shift from reporting p values along set thresholds, such as p ≤ 0.05, to presenting precise p values and confidence intervals, but not as pronounced as in epidemiology and general medicine. The long debate on estimation over testing has not led to a substantial replacement of p values by confidence intervals. Null hypothesis testing ("p ≤ .05") dominates statistical thinking.
| S-EPMC6877207 | biostudies-literature
Project description:IntroductionThe recent past has seen a significant increase in the number of trauma and orthopaedic randomised clinical trials published in "the big five" general medical journals. The quality of this research has, however, not yet been established.MethodsWe therefore set out to critically appraise the quality of available literature over a 10-year period (April 2010-April 2020) through a systematic search of these 5 high-impact general medical journals (JAMA, NEJM, BMJ, Lancet and Annals). A standardised data extraction proforma was utilised to gather information regarding: trial design, sample size calculation, results, study quality and pragmatism. Quality assessment was performed using the Cochrane Risk of Bias 2 tool and the modified Delphi list. Study pragmatism was assessed using the PRECIS-2 tool.ResultsA total of 25 studies were eligible for inclusion. Over half of the included trials did not meet their sample size calculation for the primary outcome, with a similar proportion of these studies at risk of type II error for their non-significant results. There was a high degree of pragmatism according to PRECIS-2. Non-significant studies had greater pragmatism that those with statistically significant results (p < 0.001). Only 56% studies provided adequate justification for the minimum clinically important difference (MCID) in the population assessed. Overall, very few studies were deemed high quality/low risk of bias.ConclusionsThese findings highlight that there are some important methodological concerns present within the current evidence base of RCTs published in high-impact medical journals. Potential strategies that may improve future trial design are highlighted.Level of evidenceLevel 1.
| S-EPMC9587938 | biostudies-literature