Protocol for a retrospective, controlled cohort study of the impact of a change in Nature journals' editorial policy for life sciences research on the completeness of reporting study design and execution.
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ABSTRACT:
SUBMITTER: Cramond F
PROVIDER: S-EPMC4909786 | biostudies-literature | 2016
REPOSITORIES: biostudies-literature
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Protocol for a retrospective, controlled cohort study of the impact of a change in Nature journals' editorial policy for life sciences research on the completeness of reporting study design and execution.
Cramond Fala F Irvine Cadi C Liao Jing J Howells David D Sena Emily E Currie Gillian G Macleod Malcolm M
Scientometrics 20160511
In recent years there has been increasing concern about the rigor of laboratory research. Here we present the protocol for a study comparing the completeness of reporting of in vivo and in vitro research carried in Nature Publication Group journals before and after the introduction of a change in editorial policy (the introduction of a set of guidelines for reporting); and in similar research published in other journals in the same periods. ...[more]
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Project description:BackgroundSince the early 2000s, a number of publications in the medical literature have highlighted inadequacies in the design, conduct and reporting of pilot trials. This work led to two notable publications in 2016: a conceptual framework for defining feasibility studies and an extension to the CONSORT 2010 statement to include pilot trials. It was hoped that these publications would educate researchers, leading to better use of pilot trials and thus more rigorously planned and informed randomised controlled trials. The aim of the present work is to evaluate the impact of these publications in the field of physical activity by reviewing the literature pre- and post-2016. This first article presents the pre-2016 review of the reporting and the current editorial policy applied to pilot trials published in physical activity journals.MethodsFourteen physical activity journals were screened for pilot and feasibility studies published between 2012 and 2015. The CONSORT 2010 extension to pilot and feasibility studies was used as a framework to assess the reporting quality of the studies. Editors of the eligible physical activity journals were canvassed regarding their editorial policy for pilot and feasibility studies.ResultsThirty-one articles across five journals met the eligibility criteria. These articles fell into three distinct categories: trials that were carried out in preparation for a future definitive trial (23%), trials that evaluated the feasibility of a novel intervention but did not explicitly address a future definitive trial (23%) and trials that did not have any clear objectives to address feasibility (55%). Editors from all five journals stated that they generally do not accept pilot trials, and none gave reference to the CONSORT 2010 extension as a guideline for submissions.ConclusionThe result that over half of the studies did not have feasibility objectives is in line with previous research findings, demonstrating that these findings are not being disseminated effectively to researchers in the field of physical activity. The low standard of reporting across most reviewed articles and the neglect of the extended CONSORT 2010 statement by the journal editors highlight the need to actively disseminate these guidelines to ensure their impact.
| S-EPMC6048748 | biostudies-literature
Project description:OBJECTIVE:We assessed the adequacy of randomized controlled trial (RCT) registration, changes to registration data and reporting completeness for articles in ICMJE journals during 2.5 years after registration requirement policy. METHODS:For a set of 149 reports of 152 RCTs with ClinicalTrials.gov registration number, published from September 2005 to April 2008, we evaluated the completeness of 9 items from WHO 20-item Minimum Data Set relevant for assessing trial quality. We also assessed changes to the registration elements at the Archive site of ClinicalTrials.gov and compared published and registry data. RESULTS:RCTs were mostly registered before 13 September 2005 deadline (n?=?101, 66.4%); 118 (77.6%) started recruitment before and 31 (20.4%) after registration. At the time of registration, 152 RCTs had a total of 224 missing registry fields, most commonly 'Key secondary outcomes' (44.1% RCTs) and 'Primary outcome' (38.8%). More RCTs with post-registration recruitment had missing Minimum Data Set items than RCTs with pre-registration recruitment: 57/118 (48.3%) vs. 24/31 (77.4%) (?(2) (1)?=?7.255, P?=?0.007). Major changes in the data entries were found for 31 (25.2%) RCTs. The number of RCTs with differences between registered and published data ranged from 21 (13.8%) for Study type to 118 (77.6%) for Target sample size. CONCLUSIONS:ICMJE journals published RCTs with proper registration but the registration data were often not adequate, underwent substantial changes in the registry over time and differed in registered and published data. Editors need to establish quality control procedures in the journals so that they continue to contribute to the increased transparency of clinical trials.
| S-EPMC3177887 | biostudies-literature
Project description:ObjectiveTo assess whether the completeness of reporting of health research is related to journals' endorsement of reporting guidelines.DesignSystematic review.Data sourcesReporting guidelines from a published systematic review and the EQUATOR Network (October 2011). Studies assessing the completeness of reporting by using an included reporting guideline (termed "evaluations") (1990 to October 2011; addendum searches in January 2012) from searches of either Medline, Embase, and the Cochrane Methodology Register or Scopus, depending on reporting guideline name.Study selectionEnglish language reporting guidelines that provided explicit guidance for reporting, described the guidance development process, and indicated use of a consensus development process were included. The CONSORT statement was excluded, as evaluations of adherence to CONSORT had previously been reviewed. English or French language evaluations of included reporting guidelines were eligible if they assessed the completeness of reporting of studies as a primary intent and those included studies enabled the comparisons of interest (that is, after versus before journal endorsement and/or endorsing versus non-endorsing journals).Data extractionPotentially eligible evaluations of included guidelines were screened initially by title and abstract and then as full text reports. If eligibility was unclear, authors of evaluations were contacted; journals' websites were consulted for endorsement information where needed. The completeness of reporting of reporting guidelines was analyzed in relation to endorsement by item and, where consistent with the authors' analysis, a mean summed score.Results101 reporting guidelines were included. Of 15,249 records retrieved from the search for evaluations, 26 evaluations that assessed completeness of reporting in relation to endorsement for nine reporting guidelines were identified. Of those, 13 evaluations assessing seven reporting guidelines (BMJ economic checklist, CONSORT for harms, PRISMA, QUOROM, STARD, STRICTA, and STROBE) could be analyzed. Reporting guideline items were assessed by few evaluations.ConclusionsThe completeness of reporting of only nine of 101 health research reporting guidelines (excluding CONSORT) has been evaluated in relation to journals' endorsement. Items from seven reporting guidelines were quantitatively analyzed, by few evaluations each. Insufficient evidence exists to determine the relation between journals' endorsement of reporting guidelines and the completeness of reporting of published health research reports. Journal editors and researchers should consider collaborative prospectively designed, controlled studies to provide more robust evidence.Systematic review registrationNot registered; no known register currently accepts protocols for methodology systematic reviews.
| S-EPMC4070413 | biostudies-literature
Project description:BackgroundOpen access (OA) journals are becoming a publication standard for health research, but it is not clear how they differ from traditional subscription journals in the quality of research reporting. We assessed the completeness of results reporting in abstracts of randomized controlled trials (RCTs) published in these journals.MethodsWe used the Consolidated Standards of Reporting Trials Checklist for Abstracts (CONSORT-A) to assess the completeness of reporting in abstracts of parallel-design RCTs published in subscription journals (n?=?149; New England Journal of Medicine, Journal of the American Medical Association, Annals of Internal Medicine, and Lancet) and OA journals (n?=?119; BioMedCentral series, PLoS journals) in 2016 and 2017.ResultsAbstracts in subscription journals completely reported 79% (95% confidence interval [CI], 77-81%) of 16 CONSORT-A items, compared with 65% (95% CI, 63-67%) of these items in abstracts from OA journals (P?<?0.001, chi-square test). The median number of completely reported CONSORT-A items was 13 (95% CI, 12-13) in subscription journal articles and 11 (95% CI, 10-11) in OA journal articles. Subscription journal articles had significantly more complete reporting than OA journal articles for nine CONSORT-A items and did not differ in reporting for items trial design, outcome, randomization, blinding (masking), recruitment, and conclusions. OA journals were better than subscription journals in reporting randomized study design in the title.ConclusionAbstracts of randomized controlled trials published in subscription medical journals have greater completeness of reporting than abstracts published in OA journals. OA journals should take appropriate measures to ensure that published articles contain adequate detail to facilitate understanding and quality appraisal of research reports about RCTs.
| S-EPMC6889688 | biostudies-literature
Project description:ObjectiveTo evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials.DesignRandomised controlled trial (RCT).SettingBMJ Open's quality improvement programme.Participants24 manuscripts describing RCTs.InterventionsWe used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review.OutcomesThe primary outcome is the number of adequately reported items (0-8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention.ResultsManuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min.ConclusionsWe demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability.Trial registration numberNCT03751878.
| S-EPMC7239541 | biostudies-literature
Project description:BackgroundThe quality of biomedical reporting is guided by statements of several organizations. Although not all journals adhere to these guidelines, those that do demonstrate "editorial leadership" in their author community. To investigate a possible relationship between editorial leadership and journal quality, research journals from two European countries, one Anglophone and one non-Anglophone, were studied and compared. Quality was measured on a panel of bibliometric parameters while editorial leadership was evaluated from journals' instructions to authors.Methodology/principal findingsThe study considered all 76 Italian journals indexed in Medline and 76 randomly chosen UK journals; only journals both edited and published in these countries were studied. Compared to UK journals, Italian journals published fewer papers (median, 60 vs. 93; p = 0.006), less often had online archives (43 vs. 74; p<0.001) and had lower median values of impact factor (1.2 vs. 2.7, p<0.001) and SCImago journal rank (0.09 vs. 0.25, p<0.001). Regarding editorial leadership, Italian journals less frequently required manuscripts to specify competing interests (p<0.001), authors' contributions (p = 0.005), funding (p<0.001), informed consent (p<0.001), ethics committee review (p<0.001). No Italian journal adhered to COPE or the CONSORT and QUOROM statements nor required clinical trial registration, while these characteristics were observed in 15%-43% of UK journals (p<0.001). At multiple regression, editorial leadership predicted 37.1%-49.9% of the variance in journal quality defined by citation statistics (p<0.0001); confounding variables inherent to a cross-cultural comparison had a relatively small contribution, explaining an additional 6.2%-13.8% of the variance.Conclusions/significanceJournals from Italy scored worse for quality and editorial leadership than did their UK counterparts. Editorial leadership predicted quality for the entire set of journals. Greater appreciation of international initiatives to improve biomedical reporting may help low-quality journals achieve higher status.
| S-EPMC2438474 | biostudies-literature
Project description:This paper analyses the Editorial Board (EB) distribution of Occupational Therapy journals from a gender perspective. The "Occupational Therapy" field in the Scimago Journal and Country Rank (SJR) and the "Occupational Therapy" term in the title search of the Journal Citation Report (JCR) were used to find the Occupational Therapy-specific journals. The following indicators were calculated: Editorial Board Member (EBM) gender distribution by journal, publisher, subject speciality, country, and journal quartile. Thirty-seven journals were located, including 667 individuals, 206 males (31%) and 461 females (69%). Referring to the EB positions, most members (557) were EB members, 70 were listed as Associate Editors, and 20 as Editorial Leaders. The results show that the proportion of women in the EB's of Occupational Therapy journals represents a majority. Regarding the distribution by gender of the EBMs, six journals had a female proportion below the cut-off point revealed in this study (69%). Four did not reach parity, with female representation below 50%. Additionally, the balance among the EBMs is significantly underrepresented compared to the percentage of female Occupational Therapy practitioners.
| S-EPMC9966705 | biostudies-literature
Project description:PurposeThe purpose of this study is to determine whether study quality and completeness of reporting of systematic reviews (SR) and meta-analyses (MA) published in high impact factor (IF) radiology journals is associated with citation rates.MethodsAll SR and MA published in English between Jan 2007-Dec 2011, in radiology journals with an IF >2.75, were identified on Ovid MEDLINE. The Assessing the Methodologic Quality of Systematic Reviews (AMSTAR) checklist for study quality, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist for study completeness, was applied to each SR & MA. Each SR & MA was then searched in Google Scholar to yield a citation rate. Spearman correlation coefficients were used to assess the relationship between AMSTAR and PRISMA results with citation rate. Multivariate analyses were performed to account for the effect of journal IF and journal 5-year IF on correlation with citation rate. Values were reported as medians with interquartile range (IQR) provided.Results129 studies from 11 journals were included (50 SR and 79 MA). Median AMSTAR result was 8.0/11 (IQR: 5-9) and median PRISMA result was 23.0/27 (IQR: 21-25). The median citation rate for SR & MA was 0.73 citations/month post-publication (IQR: 0.40-1.17). There was a positive correlation between both AMSTAR and PRISMA results and SR & MA citation rate; ρ=0.323 (P=0.0002) and ρ=0.327 (P=0.0002) respectively. Positive correlation persisted for AMSTAR and PRISMA results after journal IF was partialed out; ρ=0.243 (P=0.006) and ρ=0.256 (P=0.004), and after journal 5-year IF was partialed out; ρ=0.235 (P=0.008) and ρ=0.243 (P=0.006) respectively.ConclusionThere is a positive correlation between the quality and the completeness of a reported SR or MA with citation rate which persists when adjusted for journal IF and journal 5-year IF.
| S-EPMC4361663 | biostudies-literature
Project description:ImportanceIndividuals with perceived experience and expertise are invited by editorial boards to provide commentary through editorials. Female representation among editorialists is not yet defined.ObjectiveTo determine female representation as editorial authors in 3 high-impact general ophthalmology journals.Design, setting, and participantsThis cross-sectional study investigates the proportion of female authorship in editorials published between 2005 to 2009 and 2015 to 2019 in 3 journals: Ophthalmology, JAMA Ophthalmology, and American Journal of Ophthalmology. Data were collected from April to June 2020.Main outcomes and measuresProportions of female first and senior (last or solo) authors between 2005 to 2009 compared with 2015 to 2019. Secondary outcome measures include representation by sex across degree types and subspecialties. Comparisons were made for all editorialists and ophthalmologist editorialists.ResultsOf 814 editorial articles, there were 1179 (first and senior) authors identified. Women held 301 (25.5%) of these authorships, including 116 of 365 first authorships (32.9%) and 185 of 814 senior authorships (23.9%). Overall, female first and senior authorships grew by 68.0% between 2005 to 2009 and 2015 to 2019 (85 of 469 [18.1%] vs 216 of 710 [30.4%]; difference, 12.3%; 95% CI, 7.4-317.2; P < .001). Between 2005 to 2009 and 2015 to 2019, first and senior authorships by women increased (first: 33 of 133 [24.8%] vs 83 of 232 [35.8%]; difference, 11.0%; 95% CI, 1.4-320.6; P = .03; senior: 52 of 336 [15.5%] vs 133 of 478 [27.8%]; difference, 12.3%; 95% CI, 6.8-317.9; P < .001). JAMA Ophthalmology most substantially contributed to the increase in female first and senior authorships (13.8% and 16%), although the test for homogeneity among the 3 journals was not significant. The proportion of female ophthalmologist first authors was greater than the proportion of American Board of Ophthalmology-certified female ophthalmologists (81 of 281 [28.9%] vs 123 of 672 [18.3%]; difference, 10.6%; 95% CI, 5.3-315.9; P < .001).Conclusions and relevanceThe proportion of female senior authors increased by 68.0% between 2005 to 2009 and 2015 to 2019, but female authors represented only 25.5% of editorialists. Compared with male ophthalmologists, female ophthalmologists were more commonly first than senior authors. Additionally, female authors were more likely to be nonophthalmologists or to hold nonmedical, non-PhD degrees. While the swelling rank of female editorialists has paralleled the rising proportion of female ophthalmologists over time, parity by sex has yet to be attained. Greater awareness of disparities and strategies to mitigate them may help equalize representation.
| S-EPMC8529415 | biostudies-literature
Project description:BackgroundSpontaneous reports of adverse drug reactions (ADRs) form an essential component of both drug safety monitoring and patient safety initiatives. Pharmacists are well positioned to report ADRs, but many barriers exist to their doing so. Over the past decade, substantial changes have occurred with regard to drug regulations and medication safety initiatives, and it is possible that knowledge-based interventions may be needed to enhance ADR reporting by pharmacists.ObjectiveTo determine whether ADR reporting behaviours of pharmacists improved after release of a revised policy on the reporting of medication incidents.MethodsA telephone survey was administered to pharmacists practising in the Canadian Forces Health Services Group. Self-reported behaviours and perceived barriers related to ADR reporting were compared before and 3 months after the updated policy was released. Accuracy in participants' self-assessed ADR reporting was evaluated using independently derived workload statistics.ResultsDuring the second survey phase (after release of the revised policy), a greater proportion of respondents reported awareness of institutional policies on ADR reporting and declared that they were able to complete all necessary ADR reports during their assigned work hours. However, the number of ADR reports submitted did not increase. Participants' recall of their ADR reporting behaviour was corroborated by workload data. During the second survey phase, there was a noticeable reduction in the number of free-form comments mentioning lack of staff as a barrier to ADR reporting.ConclusionsRelease of a more comprehensive policy was not associated with an increase in the number of ADR reports generated by pharmacists in the study setting. Interventions to strengthen the organization's work processes for detection of ADRs and submission of individual ADR reports should be strongly considered, to reinforce and enhance existing ADR reporting behaviours among pharmacists.
| S-EPMC6118825 | biostudies-literature