Professional medical writing support and the reporting quality of randomized controlled trial abstracts among high-impact general medical journals.
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ABSTRACT:
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: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:INTRODUCTION:The 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 ANALYSIS:The 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 DISSEMINATION:This 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-other
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:Background and objectivesSurvey research is an important research method used to determine individuals' attitudes, knowledge, and behaviors; however, as with other research methods, inadequate reporting threatens the validity of results. This study aimed to describe the quality of reporting of surveys published between 2001 and 2011 in the field of nephrology.Design, setting, participants, & measurementsThe top nephrology journals were systematically reviewed (2001-2011: American Journal of Kidney Diseases, Nephrology Dialysis Transplantation, and Kidney International; 2006-2011: Clinical Journal of the American Society of Nephrology) for studies whose primary objective was to collect and report survey results. Included were nephrology journals with a heavy focus on clinical research and high impact factors. All titles and abstracts were screened in duplicate. Surveys were excluded if they were part of a multimethod study, evaluated only psychometric characteristics, or used semi-structured interviews. Information was collected on survey and respondent characteristics, questionnaire development (e.g., pilot testing), psychometric characteristics (e.g., validity and reliability), survey methods used to optimize response rate (e.g., system of multiple contacts), and response rate.ResultsAfter a screening of 19,970 citations, 216 full-text articles were reviewed and 102 surveys were included. Approximately 85% of studies reported a response rate. Almost half of studies (46%) discussed how they developed their questionnaire and only a quarter of studies (28%) mentioned the validity or reliability of the questionnaire. The only characteristic that improved over the years was the proportion of articles reporting missing data (2001-2004: 46.4%; 2005-2008: 61.9%; and 2009-2011: 84.8%; respectively) (P<0.01).ConclusionsThe quality of survey reporting in nephrology journals remains suboptimal. In particular, reporting of the validity and reliability of the questionnaire must be improved. Guidelines to improve survey reporting and increase transparency are clearly needed.
| S-EPMC4255395 | biostudies-literature
Project description:ObjectivesTo describe and summarise how the results of randomised controlled trials (RCTs) that did not find a significant treatment effect are reported, and to estimate how commonly trial reports make unwarranted claims.DesignWe performed a retrospective survey of published RCTs, published in four high impact factor general medical journals between June 2016 and June 2017.SettingTrials conducted in all settings were included.Participants94 reports of RCTs that did not find a difference in their main comparison or comparisons were included.InterventionsAll interventions.Primary and secondary outcomesWe recorded the way the results of each trial for its primary outcome or outcomes were described in Results and Conclusions sections of the Abstract, using a 10-category classification. Other outcomes were whether confidence intervals (CIs) and p values were presented for the main treatment comparisons, and whether the results and conclusions referred to measures of uncertainty. We estimated the proportion of papers that made claims that were not justified by the results, or were open to multiple interpretations.Results94 trial reports (120 treatment comparisons) were included. In Results sections, for 58/120 comparisons (48.3%) the results of the study were re-stated, without interpretation, and 38/120 (31.7%) stated that there was no statistically significant difference. In Conclusions, 65/120 treatment comparisons (54.2%) stated that there was no treatment benefit, 14/120 (11.7%) that there was no significant benefit and 16/120 (13.3%) that there was no significant difference. CIs and p values were both presented by 84% of studies (79/94), but only 3/94 studies referred to uncertainty when drawing conclusions.ConclusionsThe majority of trials (54.2%) inappropriately interpreted a result that was not statistically significant as indicating no treatment benefit. Very few studies interpreted the result as indicating a lack of evidence against the null hypothesis of zero difference between the trial arms.
| S-EPMC6738699 | biostudies-literature
Project description: Not available
| S-EPMC35347 | biostudies-literature