Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting

ObjectiveTo describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials.Study Design and SettingThe AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009.ResultsOf the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011–2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable.ConclusionTrials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously.     

The quality of reporting of trial abstracts is suboptimal: Survey of major general medical journals

ObjectiveTo evaluate the quality of reporting of abstracts describing randomized controlled trials (RCTs) published in four major general medical journals.Study Design and SettingSystematic survey of published RCT abstracts, with two reviewers independently extracting data. We searched MEDLINE and identified 227 RCT abstracts published in the New England Journal of Medicine (NEJM), Journal of the American Medical Association (JAMA), British Medical Journal (BMJ), and The Lancet in the year 2006.ResultsMost abstracts identified the study as a randomized trial (98.7%), reported the objectives (92.5%), described the population (90.3%), detailed the intervention (81.5%), and defined the primary outcome (71.3%). Methodological quality was poorly reported: one (0.4%) described allocation concealment; 21 (9.3%) clearly specified blinding; 51 (22.5%) described intention-to-treat analysis; and 32 (14.1%) outlined losses to follow-up. Most of the abstracts reported the effect size and the confidence intervals (62.3%), but just half of them reported side effects or harms.ConclusionThe quality of reporting of RCT abstracts published in main general medical journals is suboptimal. Space limitations notwithstanding, with the recent recommendations from the CONSORT for Abstracts, it is expected that the transparency of abstract reporting can and should improve.     

Reporting in randomized clinical trials improved after adoption of the CONSORT statement

OBJECTIVE: To examine the extent to which the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines improved clinical trials reporting and subject attrition, which may undermine the credibility of published randomized clinical trials (RCTs). STUDY DESIGN AND SETTING: Published RCTs reported in two major medical journals before and after the CONSORT guidelines were systematically reviewed; one used the CONSORT statement (JAMA) and one did not (NEJM). RESULTS: The quality of RCT reporting improved for both journals, but JAMA showed more significant and consistent improvements in all aspects of RCT reporting. Subject attrition was better accounted for after the publication of CONSORT, although the attrition rates for various reasons actually increased. Attrition due to unknown reasons, as a percentage of total attrition, declined dramatically, from 68.7% pre-CONSORT to 13.0% post-CONSORT. CONCLUSIONS: Attrition of study subjects remains a serious problem in RCTs. Bias from selective attrition can undermine the presumptive scientific advantage of RCTs. The CONSORT guidelines improved RCT reporting when they were implemented but did not substantially improve reported attrition rates.     

Reporting of methods was better in the Clinical Trials Registry-India than in Indian journal publications

ObjectiveWe sought to evaluate if editorial policies and the reporting quality of randomized controlled trials (RCTs) had improved since our 2004–05 survey of 151 RCTs in 65 Indian journals, and to compare reporting quality of protocols in the Clinical Trials Registry-India (CTRI).Study Design and SettingAn observational study of endorsement of Consolidated Standards for the Reporting of Trials (CONSORT) and International Committee of Medical Journal Editors (ICMJE) requirements in the instructions to authors in Indian journals, and compliance with selected requirements in all RCTs published during 2007–08 vs. our previous survey and between all RCT protocols in the CTRI on August 31, 2010 and published RCTs from both surveys.ResultsJournal policies endorsing the CONSORT statement (22/67, 33%) and ICMJE requirements (35/67, 52%) remained suboptimal, and only 4 of 13 CONSORT items were reported in more than 50% of the 145 RCTs assessed. Reporting of ethical issues had improved significantly, and that of methods addressing internal validity had not improved. Adequate methods were reported significantly more frequently in 768 protocols in the CTRI, than in the 296 published trials.ConclusionThe CTRI template facilitates the reporting of valid methods in registered trial protocols. The suboptimal compliance with CONSORT and ICMJE requirements in RCTs published in Indian journals reduces credibility in the reliability of their results.     

Citation analysis of identical consensus statements revealed journal-related bias

ObjectiveTo examine whether the prestige of a journal, measured by its impact factor, influences the numbers of citations obtained by published articles, independently of their scientific merit.Study Design and SettingIn this cohort study, citation counts were retrieved for articles describing consensus statements that were published in multiple journals and were correlated with the impact factors of the source journals.ResultsFour consensus statements were published in multiple copies: QUOROM (QUality Of Reporting Of Meta-analyses) was published in three journals, CONSORT (CONsolidated Standards Of Reporting Trials) in eight journals, STARD (STAndards for Reporting of Diagnostic accuracy) in 14 journals, and STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) in eight journals. For each consensus statement, the impact factor of the source journal and the number of citations were highly correlated (Spearman correlation coefficients: QUOROM, 1.00; CONSORT, 0.88; STARD, 0.65; and STROBE, 0.81—all P < 0.02). When adjusted for time since publication, each logarithm unit of impact factor predicted an increase of 1.0 logarithm unit of citations (95% confidence interval: 0.7–1.3, P < 0.001), and the variance explained was 66% (adjusted r² = 0.66).ConclusionsThe prominence of the journal where an article is published, measured by its impact factor, influences the number of citations that the article will gather over time. Citation counts are not purely a reflection of scientific merit.     

Influence of trial registration on reporting quality of randomized trials: Study from highest ranked journals

ObjectiveTo evaluate the reporting quality of key methodological items of randomized control trials (RCTs) in 55 of the highest ranked journals.Study Design and SettingA list of the highest top ranked journals was identified, and a search for detecting RCTs in those journals was made. Two hundred sixty four journals were screened and 55 of them were identified having at least one RCT. Three RCTs were randomly selected a priori from each journal; 148 RCTs were finally included. RCTs were assessed by two reviewers using the Consolidated Standards of Reporting Trials (CONSORT) statement.ResultsOnly 11 (8%) RCTs had all items adequately reported. In addition, 36% of RCTs reported that the study was registered in any trial registry. We found a significant difference in the quality of reporting for baseline characteristics, recruitment, participant's flow, and randomization implementation between those studies having reported the registration of their RCT in a trial registry and those that have not. Adherence to key methodological items of the CONSORT statement was as follows: sample size determination (60%), sequence generation (49%), allocation concealment (40%), and blinding (25%).ConclusionsReporting of varied CONSORT items remains suboptimal. Registration in a trial registry was associated with improved reporting. Further efforts to enhance RCT registration could contribute to this improvement.     

Investigating Trends in the Quality of Reporting of Patient-Reported Outcomes in Oncology Over Time: Analysis of 631 Randomized Controlled Trials Published Between 2004 and 2019

ObjectivesIncomplete reporting of key information on patient-reported outcomes (PROs) in randomized controlled trials (RCTs) in oncology has been highlighted repeatedly as a major barrier to the use of study findings in clinical practice. We investigated whether the quality of reporting of PRO data in cancer RCTs has improved over the last 15 years.MethodsWe identified all cancer RCTs with PRO endpoints conducted across the most prevalent solid tumor types worldwide published between 2004 and 2019. The quality of PRO reporting was assessed using the International Society for Quality of Life Research recommended standards, which include important aspects related to assessment methodology, statistical analyses, and interpretation of data.ResultsWe assessed a total of 631 cancer RCTs in breast (n = 187), lung (n = 131), prostate (n = 120), colorectal (n = 107), and gynecological (n = 86) cancer. We observed a higher adherence to the International Society for Quality of Life Research reporting criteria in the more recently published studies. In a multivariable linear regression analysis, we observed a statistically significant improvement in the quality of PRO reporting over time (P<.001), and this relationship was independent of other measured confounding factors, such as sample size and study sponsorship. Overall, the quality of PRO reporting was higher for studies published after the publication of the Consolidated Standards of Reporting Trials-PRO Extension.ConclusionsThe quality of PRO reporting in cancer RCTs published in the last 15 years has improved significantly. Our findings are encouraging because better reporting of PRO results may translate into a greater impact of study findings on real-world practice.     

Systematic reviews published in higher impact clinical journals were of higher quality

ObjectivesTo compare the methodological quality of systematic reviews (SRs) published in high- and low–impact factor (IF) Core Clinical Journals. In addition, we aimed to record the implementation of aspects of reporting, including Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) flow diagram, reasons for study exclusion, and use of recommendations for interventions such as Grading of Recommendations Assessment, Development and Evaluation (GRADE).Study Design and SettingWe searched PubMed for systematic reviews published in Core Clinical Journals between July 1 and December 31, 2012. We evaluated the methodological quality using the Assessment of Multiple Systematic Reviews (AMSTAR) tool.ResultsOver the 6-month period, 327 interventional systematic reviews were identified with a mean AMSTAR score of 63.3% (standard deviation, 17.1%), when converted to a percentage scale. We identified deficiencies in relation to a number of quality criteria including delineation of excluded studies and assessment of publication bias. We found that SRs published in higher impact journals were undertaken more rigorously with higher percentage AMSTAR scores (per IF unit: β = 0.68%; 95% confidence interval: 0.32, 1.04; P < 0.001), a discrepancy likely to be particularly relevant when differences in IF are large.ConclusionMethodological quality of SRs appears to be better in higher impact journals. The overall quality of SRs published in many Core Clinical Journals remains suboptimal.     

Rationale for unequal randomization in clinical trials is rarely reported: a systematic review

ObjectivesTo assess the reporting of the unequal randomization ratio in reports of trials with this design and to identify the justification for the design.Study Design and SettingSystematic review of reports of trials with unequal randomization. We selected all original reports of two parallel-group randomized controlled trials with unequal randomization, which were published in 2009 and 2010 in core clinical journals in MEDLINE on the basis of the abstract (and full text, if necessary). Additional information was collected by an author survey.ResultsWe retrieved 106 reports (prevalence, 4.7%). The randomization ratio was not stated in 8.5% of reports and 51.9% of abstracts. Sample size calculation was reported in 70 reports, with unequal randomization not taken into account in 25.7% (n = 18). Justification for unequal randomization was not reported in 77.4% (n = 82) of reports. Combining information from reports and author surveys, we had justification for 41 trials. The main justification was safety issues for 20 trials. In 11 of those latter 20 reports, adverse events were not fully reported.ConclusionA better reporting of the randomization ratio, sample size calculation, and justification to unequal randomization could help readers appraise the quality and risk of bias of such trials.     

Reporting and methodological qualities of published surgical meta-analyses

ObjectivesTo assess the overall qualities of published surgical meta-analysis and predictive factors for high qualities.Study Design and SettingAll meta-analyses pertinent to surgical procedures published in year 2013 were selected from PubMed and EMBASE. The characteristics of the included meta-analyses were collected, and their reporting and methodologic qualities were assessed by the PRISMA (27 items) and AMSTAR (11 items) checklists, respectively. Independent predictive factors associated with these two qualities were evaluated by univariate and multivariate analyses.ResultsHundred ninety-seven meta-analyses representing 10 surgical subspecialties were included. The mean PRISMA and AMSTAR adherences (by items) were 22.2 ± 2.4 and 7.8 ± 1.2, respectively, and a positive linear correlation was found between them with an R² of 0.793. Those meta-analyses conducted by the first authors having meta-analysis publication previously had significantly higher reporting and methodologic qualities than those who did not (P = 0.002 and P = 0.001). Meanwhile, there were also significant differences in these two qualities between studies published in Q1-ranked and (Q2 + Q3)-ranked journals as rated by the SCImago indicator (P < 0.001 and P < 0.001). On multivariate analyses, region of origin (non-Asia vs. Asia), publishing experience of first authors (ever vs. never), rank of publishing journals (Q1 vs. Q2 + Q3), and preregistration (presence vs. absence) were independently associated with superior reporting and methodologic qualities.ConclusionsThe reporting and methodologic qualities of current surgical meta-analyses remained suboptimal, and first authors' experience and ranking of publishing journals were independently associated with both qualities. Preregistration might be an effective measure to improve the quality of meta-analyses, which deserves more attention from future study conductors.     

A systematic review and meta-analysis of the effects of aerobic exercise interventions on cardiorespiratory fitness in adults with intellectual disability

BackgroundAdults with an intellectual disability (ID) have low cardiorespiratory fitness (CRF). Low CRF has been associated with a high risk of cardiovascular disease and all-cause mortality. Participation in regular exercise can help adults with ID increase their CRF.ObjectiveTo perform a systematic review and meta-analysis of published, peer-reviewed clinical trials that evaluated the effects of aerobic exercise (AE) interventions on CRF in adults with ID, ages 18–65 years.MethodsEnglish-language articles were searched up to June 2021 from 11 electronic databases. Data were extracted using an author-developed form. Two independent authors assessed the risk of bias using the Tool for the Assessment of Study Quality and reporting in Exercise (TESTEX). Meta-analysis was performed using the RevMan 5.3.ResultsOf the 1870 article titles and abstracts screened, 16 articles were included. The average TESTEX score (out of 15) was 8.1 (SD = 3.5, range 2–14). The pooled effect was statistically significant (SMD = 0.41, 95% CI: 0.19 to 0.63, z = 3.59; p = .000) with moderate heterogeneity (I² = 35%, p = .000). Both types of intervention produced statistically significant CRF gains, with interventions that combined AE with resistance, balance, and/or flexibility exercises being slightly more effective (SMD = 0.40, 95% CI: 0.11 to 0.70, p = .007) than non-combined interventions (SMD = 0.42, 95% CI: 0.05 to 0.79, p = .02). Heterogeneity was moderate but non-significant for both types of intervention.ConclusionsThe review supports the use of AE interventions in promoting CRF in adults with ID. The interpretation is limited by the quality of evidence and by poorly described and/or executed familiarization and measurement protocols.     

Cohort study of trials submitted to ethics committee identified discrepant reporting of outcomes in publications

ObjectivesTo identify factors associated with discrepant outcome reporting in randomized drug trials.Study Design and SettingCohort study of protocols submitted to a Swiss ethics committee 1988–1998: 227 protocols and amendments were compared with 333 matching articles published during 1990–2008. Discrepant reporting was defined as addition, omission, or reclassification of outcomes.ResultsOverall, 870 of 2,966 unique outcomes were reported discrepantly (29.3%). Among protocol-defined primary outcomes, 6.9% were not reported (19 of 274), whereas 10.4% of reported outcomes (30 of 288) were not defined in the protocol. Corresponding percentages for secondary outcomes were 19.0% (284 of 1,495) and 14.1% (334 of 2,375). Discrepant reporting was more likely if P values were <0.05 compared with P ≥ 0.05 [adjusted odds ratio (aOR): 1.38; 95% confidence interval (CI): 1.07, 1.78], more likely for efficacy compared with harm outcomes (aOR: 2.99; 95% CI: 2.08, 4.30) and more likely for composite than for single outcomes (aOR: 1.48; 95% CI: 1.00, 2.20). Cardiology (aOR: 2.34; 95% CI: 1.44, 3.79) and infectious diseases (aOR: 1.77; 95% CI: 1.01, 3.13) had more discrepancies compared with all specialties combined.ConclusionDiscrepant reporting was associated with statistical significance of results, type of outcome, and specialty area. Trial protocols should be made freely available, and the publications should describe and justify any changes made to protocol-defined outcomes.     

Randomized controlled trials of herbal interventions underreport important details of the intervention

Objective

To examine the quality of reporting and predictors of reporting in randomized clinical trials (RCTs) of herbal medicine interventions.

Study Design and Setting

We searched Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, and Academy of Microscope Enhanced Dentistry up to December 2007 for any English language RCT of 11 commonly used herbal medicine interventions. Two individuals separately and independently assessed all trials using the Consolidated Standards of Reporting Trials (CONSORT) checklist for herbal medicines interventions. We randomly selected 100 of these trials, extracted a set of potential predictor variables identified through a literature search and consultation with experts, and performed a conceptually driven stepwise elimination regression analyses for predictor variables.

Results

The 406 trials reported on average 38% of the information suggested in the checklist. Regression analyses revealed better overall reporting in trials with a participant flow diagram (P = 0.008), those of Panax quinquefolius (P = 0.018), and those published in more recent years (P = 0.02).

Conclusion

Our results indicate that RCTs of herbal medicine interventions frequently do not report important characteristics of the intervention. Trialists should refer to the CONSORT for herbal medicines when reporting their trials.     

Predictors of Incident Fear of Falling in Community-Dwelling Older Adults

ObjectivesFear of falling (FoF) is common in older people and may lead to physical decline, disability, poor quality of life, and falls. Several risk factors for FoF have been identified in cross-sectional studies, but evidence on predictors of its incidence is scarce. We investigated the latter in community-dwelling older people undergoing a comprehensive geriatric assessment at baseline and after a 2-year follow-up.DesignLongitudinal study.Setting and ParticipantsConvenience sample of community-dwelling people aged ≥60 years evaluated in an Irish university hospital.MethodsParticipants were evaluated at baseline (August 2007–May 2009) and after a 2-year follow-up. FoF was measured using the Modified Falls Efficacy Scale. Predictors of incident FoF at 2 years were investigated.ResultsAt baseline, there were 563 participants (69% female, mean age 73 years). Among individuals that were not fearful at baseline, 105 (18.7%) developed FoF (incident FoF) after a median follow-up of 2.1 years. Individuals reporting incident FoF were older at baseline (P < .001), had worse performance in balance and physical function tests, and more frequently needed a walking aid (P < .001). Anxiety (P = .012) and depressive symptoms (P < .001) were more prevalent, as well as self-reported previous falls (P < .001). In multivariate analysis, older age, walking aid use, and a higher burden of depressive symptoms at baseline were predictors of incident FoF.Conclusions and ImplicationsAlmost a fifth of older adults using a walking aid and reporting depressive symptoms at baseline developed FoF after 2 years. These identifiable prodromal factors could help design FoF prevention strategies.     

Summary-of-findings tables in Cochrane reviews improved understanding and rapid retrieval of key information

ObjectiveTo measure the effects of a summary-of-findings (SoF) table on user satisfaction, understanding, and time spent finding key results in a Cochrane review.Study Design and SettingWe randomized participants in an evidence-based practice workshop (randomized controlled trial [RCT] I) and a Cochrane Collaboration entities meeting (RCT II) to receive a Cochrane review with or without an SoF table. In RCT I, we measured user satisfaction. In RCT II, we measured correct comprehension and time spent finding key results.ResultsRCT I: Participants with the SoF table (n = 47) were more likely to “agree” or “strongly agree” that it was easy to find results for important outcomes than (n = 25) participants without the SoF table—68% vs. 40% (P = 0.021). RCT II: Participants with the SoF table (n = 18) were more likely to correctly answer two questions regarding results than (n = 15) those without the SoF table: 93% vs. 44% (P = 0.003) and 87% vs. 11% (P < 0.001). Participants with the SoF table spent an average of 90 seconds to find key information compared with 4 minutes for participants without the SoF table (P = 0.002).ConclusionIn two small trials, we found that inclusion of an SoF table in a review improved understanding and rapid retrieval of key findings compared with reviews with no SoF table.     

Factors affecting workforce participation and healthy worker biases in U.S. women and men

PurposeTo investigate potential attenuation of healthy worker biases in populations in which healthy women of reproductive age opt out of the workforce to provide childcare.MethodsWe used 2013–2015 data from 120,928 U.S. women and men aged 22–44 years participating in the Gallup-Healthways Well-Being Index. We used logistic regression to estimate adjusted prevalence odds ratios (PORs) and 95% confidence intervals (CIs) for associations between health and workforce nonparticipation.ResultsWomen and men reporting poor health were more likely to be out of the workforce than individuals reporting excellent health (POR: 3.7, 95% CI: 3.2–4.2; POR: 6.7, 95% CI: 5.7–7.8, respectively), suggesting potential for healthy worker bias. For women (P < .001) but not men (P = .30), the strength of this association was modified by number of children in the home: POR: 7.3 (95% CI: 5.8–9.1) for women with no children, decreasing to POR: 0.9 (95% CI: 0.6–1.5) for women with four or more children.ConclusionsThese results are consistent with attenuation of healthy worker biases when healthy women opt out of the workforce to provide childcare. Accordingly, we might expect the magnitude of these biases to vary with the proportion of women with differing numbers of children in the population.     

CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials

Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias.A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs.During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement.After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias.This explanatory and elaboration document—intended to enhance the use, understanding, and dissemination of the CONSORT statement—has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included.The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials.