Consolidated Standards Of Reporting Trials Recommendations Research Articles

Reporting quality of abstracts of veterinary randomized controlled trials.

To evaluate the adherence of veterinary randomized controlled trial (RCT) abstracts to the recommendations on minimum abstract information included in the Consolidated Standards of Reporting Trials (CONSORT) checklist for RCT abstracts and to identify characteristics associated with the number of CONSORT items reported. 212 abstracts representing all RCTs published in 5 general veterinary journals in 2013 and 2018. 2 investigators independently assessed whether each of the 15 CONSORT checklist items for abstracts applicable to veterinary medicine was reported. Generalized linear mixed models were built to explore associations of selected variables with the total number of checklist items reported. Abstracts included a median of 5 checklist items (range, 2 to 10 items). None met the recommendations for reporting participant recruitment and funding source. Less than 25% of abstracts met the recommendations for the title, participant eligibility criteria, primary outcome, randomization technique, blinding, numbers analyzed, primary outcome results, and harms to participants. The number of items reported was higher in abstracts of RCTs that included clinical patients (vs other participants; OR, 1.13; 95% CI, 1.05 to 1.22). The number of items reported did not significantly change over time. Results suggested that the reporting quality of abstracts of RCTs in general veterinary journals was suboptimal per CONSORT recommendations. Because abstracts may be the only reference material available in certain settings, improvements are warranted to ensure readers have the information they need to properly interpret reported findings.

Methodological reporting in feasibility studies: a descriptive review of the nursing intervention research literature.

In reaction to weaknesses in feasibility studies reporting, the Consolidated Standards of Reporting Trials (CONSORT) statement published an extension for feasibility studies in 2016. The aim of this study was to systematically review and appraise the reporting of feasibility studies in the nursing intervention research literature based on the CONSORT statement extension for feasibility studies. Papers published prior to January 2018 that described feasibility studies of nursing interventions were retrieved. Components of feasibility studies were coded, and code frequencies were analysed. The review included 186 papers. Although most papers (n = 142, 76.3%) included the label 'pilot' or 'feasibility' in their title, reporting for other components generally did not adhere to one or several CONSORT recommendations. Most papers reported objectives (n = 116, 62.4%), designs (n = 95, 51%), or rationales for sample size (n = 165, 88.7%) that were incongruent with the purpose of feasibility studies. This review results in two main implications for nursing research. First, we noted that the reporting of feasibility studies is weak. While all papers described feasibility studies, almost half focused exclusively on testing the effectiveness of an intervention. Second, we identified rationales for sample size along with key references that could offer guidance in reporting feasibility studies while being coherent with the CONSORT recommendations.

Adverse Event Reporting in Clinical Trials of Intravenous and Invasive Pain Treatments: An ACTTION Systematic Review.

This systematic review of AE reporting in intravenous and invasive pain treatment trials shows that little improvement has been made since the 2004 CONSORT harms reporting guidelines. Better assessment and reporting of treatment AEs is necessary to understand the full clinical effect of intravenous and invasive treatments.

Reporting quality of abstracts in phase III clinical trials of systemic therapy in metastatic solid malignancies.

BackgroundManuscript abstracts represent a critical source of information for oncology practitioners. Practitioners may utilize the information contained in abstracts as a basis for treatment decisions particularly when full-text articles are not accessible. In 2007, the Consolidated Standards of Reporting Trials (CONSORT) extension statement for abstracts provided a minimum list of elements that should be included in abstracts. In this study we evaluate the degree of adherence to these recommendations and accessibility of full text publications in oncology publications.MethodsA systematic review of abstracts of randomized, controlled, phase III trials in metastatic solid malignancies published between January 2009 and December 2011 in PubMed, Medline, and Embase was completed. s were assigned a completeness score of 0–18 based on the number of CONSORT-recommended elements. Accessibility through open access was recorded.Results174 abstracts with data for 95,956 patients were reviewed. The median completeness score was 9 (range, 3–17). Open access to full text articles was available for 80 % of abstracts. The remaining 20 % (35 out of 174) had a median cost of 38 USD (range: $22–49.95). The least frequently reported elements were: trial design description (20 %), participant allocation method (13 %), blinding (24 %), trial enrollment status (22 %), registration and name of trial (26 %) and funding source (18 %). The most frequently reported elements were eligibility criteria (98 %), study interventions (100 %), and primary endpoint (87 %).ConclusionThere is poor adherence to the CONSORT recommendations for abstract reporting in publications of randomized cancer clinical trials which could negatively impact clinical decision-making. Full-text articles are frequently available through open access.

Poor patient-reported outcomes reporting according to CONSORT guidelines in randomized clinical trials evaluating systemic cancer therapy

BackgroundThe Consolidated Standards of Reporting Trials (CONSORT) guidance was extended in 2013 to provide a set of specific recommendations regarding patient-reported outcomes (PROs) reporting in randomized clinical trials (RCTs). There is limited data regarding how well current publications of oncology RCTs report PROs if assessed using these guidelines. DesignAll phase III medical oncology RCTs published between 2007 and 2011 were reviewed according to the 2013 PROs CONSORT recommendations and an 11-point PROs reporting quality score (PRORQS) was defined based on the criteria. ResultsThe majority of trials did not report on PROs at all (201 of 325; 62%). Of the remaining 124 trials, the mean PRORQS score was 5.0 on an 11-point scale. The items related to methods of PROs collection and analysis were poorly reported (Description of the prespecified PRO hypothesis: 26% of RCTs; methods for PRO data collection (paper, telephone, electronic, other): 16%; statistical approaches for managing missing data: 37%). The only factor significantly associated with improved PROs reporting was where PROs reporting was the subject of a dedicated secondary manuscript, as was the case in 36 of the 124 (29%) of RCTs. ConclusionDespite their clinical relevance, our findings show that some aspects of PROs reporting may greatly be improved, especially critical methodological aspects of PROs collection and analysis. The exceptions were where PROs were described in PROs-specific secondary publication. Use of the 2013 PROs CONSORT extensions should be encouraged and their effects on PROs reporting subsequently reassessed.

The Quality of Reporting Harms-Related Data in Clinical Trials of Adjuvant Trastuzumab in Early-Stage Breast Cancer Treatment.

Randomized controlled trials (RCTs) usually place less emphasis on the harmful effects than on the efficacy of interventions. The 10 CONSORT (Consolidated Standards of Reporting Trials) recommendations for harms reporting aim to improve harms data reporting of RCTs. The aim of this study was to assess the reporting of harms data in adjuvant trastuzumab studies in early-stage breast cancer. The resources PubMed, Cochrane Library, the American Society of Clinical Oncology, and the San Antonio Breast Cancer Symposium were searched for relevant RCTs that met the eligibility criteria. Each RCT was reviewed to determine whether the reporting of data complied with the 10 CONSORT recommendations for harms reporting, and the frequency of compliance with each CONSORT recommendation criterion was reviewed. Five RCTs met the eligibility criteria. Overall, selected RCTs failed to adhere to CONSORT recommendations in all sections of reporting. These results suggest that there is a need to standardize harms data reporting.

Pharmacy journal abstracts published in PubMed that abide by the CONsolidated Standards Of Reporting Trials (CONSORT) guidelines.

The purpose of this research was to determine the proportion of abstracts in pharmacy journals that are prepared according to the CONsolidated Standards Of Reporting Trials (CONSORT) criteria for abstracts. Certain abstracts for randomized controlled clinical trials (RCTs) indexed in PubMed were eligible for inclusion, with the primary endpoint being median overall compliance to CONSORT recommendations for abstracts. A total of 63 RCT abstracts were included in the analysis, with only 56% of the recommended CONSORT items represented in the sample. It is recommended that pharmacy journals encourage authors to follow CONSORT recommendations for abstracts when submitting RCTs for publication.

Adherence to CONSORT harms-reporting recommendations in publications of recent analgesic clinical trials: An ACTTION systematic review

Recommendations for harms (ie, adverse events) reporting in randomized clinical trial publications were presented in a 2004 extension of the Consolidated Standards of Reporting Trials (CONSORT) statement. Our objectives were to assess harms reporting in 3 major pain journals (European Journal of Pain, Journal of Pain, and PAIN®) to determine whether harms reporting improved following publication of the 2004 CONSORT recommendations, and to examine study factors associated with adequacy of harms reporting. A total of 101 randomized, double-blind, noninvasive pharmacologic trials were identified in the 2000–2003 (epoch 1) and 2008–2011 (epoch 2) issues of these journals. Out of 10 reporting recommendations, the mean number fulfilled was 6.08 (SD2.65). Although more harms recommendations were fulfilled in epoch 2 (m2=6.49, SD2.66) than in epoch 1 (m1=5.39, SD2.52; P=0.04), only the recommendation to report harms per arm was satisfied by >90% of trials in epoch 2, whereas <60% reported withdrawals due to harms. Several trial characteristics (study design, participant type, pain type, frequency of treatment administration, treatment administration method, sponsor, and number of randomized participants) were significantly associated with harms reporting. However, when trial characteristics and epoch were entered into a multiple regression analysis, only trials studying pain patients, those using oral treatments, and industry-sponsored trials were associated with better harms reporting. Despite some improvement in harms reporting, greater improvement is needed to provide informative, consistent reporting of adverse events and safety in analgesic clinical trials.

Relevance of CONSORT reporting criteria for research on eHealth interventions

Objective In 1996, 2001, and 2010, the Consolidated Standards of Reporting Trials (CONSORT) group released criteria for reporting critical information about randomized clinical trials [1,2]. These criteria were intended to improve the quality and completeness of reporting of RCTs in health care research. This paper discusses the relevance of the CONSORT recommendations for the reporting and design of eHealth research. Methods We reviewed the CONSORT recommendations and discussed their particular relevance to eHealth (electronic information, support and/or communication resources designed to promote health) research. This review focuses on such issues as recruitment and screening of participants, description of treatment elements, and reporting of outcome data and adverse events. Results eHealth research presents special challenges regarding the comprehensive and effective reporting of research information. However, the strategic application of CONSORT recommendations holds great promise for improving the quality and informativeness of eHealth research. Conclusion Investigators need to consider CONSORT recommendations at all stages of the research enterprise, including planning, execution and reporting in order to increase the informativeness of their research efforts. Practice implications The recommendations contained in this paper have the potential to enhance the public health and scientific value of eHealth research.

Clinical Trials Focusing on Cancer Pain Educational Interventions: Core Components to Include During Planning and Reporting

Robust recommendations on the reporting of methods and results of clinical trials such as therapeutic intervention trials are widely used, such as the Consolidated Standards of Reporting Trials (CONSORT) recommendation. There has not been agreement on analogous publication standards for educational intervention trials, making interpretation of educational intervention studies difficult. The purpose of this report is to describe common deficiencies in reporting of educational intervention trials for cancer pain control, and to offer suggestions for authors to consider as they plan their studies, and report and publish research findings for educational interventions that use randomized controlled trials and other educational trial methodologies. A systematic review of published knowledge translation intervention trials intended to improve cancer pain was undertaken, of which most were educational interventions. Many educational intervention clinical trials designed to improve management of cancer pain appeared methodologically weak, and their results were more difficult to interpret because of reporting deficiencies. In the course of the review, patterns of deficiencies in reporting of methods and trial results were documented. Deficiencies in reporting were compared with the CONSORT recommendations for reporting clinical trials, and parallel recommendations were drafted for educational intervention trials. Patterns of deficiency in reporting cancer pain educational intervention trials were synthesized into seven domains, generically applicable to a range of study designs. Draft recommendations intended to address these deficiencies were constructed to improve communication of educational research results. Development of a standardized reporting template for clinical trials in cancer pain educational interventions could advance knowledge transfer research and thereby increase effectiveness of national and international cancer control policy designed to support cancer pain control.

Reporting of participant compliance in randomized controlled trials of nutrition supplements during pregnancy

Randomized controlled trials (RCT) are widely considered to be the gold standard for demonstrating intervention effects. Adequacy of reporting of participant compliance in RCTs affects the interpretation of study results. Our aims were two-fold: first, to assess the adequacy of reporting of participant compliance in RCTs investigating the effect of maternal nutritional supplements on infant outcomes; and second, to examine authors' adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines on participant flow. Papers reporting trials of nutritional supplementation during pregnancy, and published after revision of the CONSORT recommendations, were identified using a search of medical databases. Two researchers systematically reviewed the papers to assess the reporting of participant compliance according to specified criteria, and the presentation of participant flow data recommended in the CONSORT guidelines. The literature search identified 58 papers. Almost a third (n = 18) did not describe how participant compliance was assessed. Nearly half of the papers (n = 27) failed to report participant compliance numerically (absolute numbers or percentage) and differences in compliance data between treatment arms were not reported in 52% of papers (n = 28). The majority (83%) gave no information on whether the study protocol included any researcher input aimed at maximizing compliance. In addition to inadequate reporting of compliance, two of the CONSORT requirements (eligibility criteria and numbers discontinuing the intervention) were inadequately reported in 69% and 60% of papers, respectively. We conclude that participant compliance in nutrition trials is frequently inadequately reported. 'False negative' results from RCTs with poor compliance could wrongly influence policy and inhibit further research concerned with nutritional supplementation for women of child-bearing age. We suggest that changes to the CONSORT guidelines may improve RCT reporting.

The 2001 STRICTA Recommendations for Reporting Acupuncture Research: A Review with Implications for Improving Controlled Clinical Trial Design

The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in 1996 by researchers and journal editors to improve the quality of reporting of biomedical research by providing a standardized format for researchers to present information on randomized controlled clinical trials (RCTs). This improved data reporting allows readers to independently assess the quality and conclusions of these studies, and has been widely incorporated in contemporary research reports. In 2001, a supplemental set of criteria that specifically address the reporting of design and implementation issues for RCTs involving the use of acupuncture was introduced, termed the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) recommendations.The CONSORT guidelines are stated to be part of a broader effort to improve the quality of research, as they can be used by researchers to optimize the design of future trials. Similarly, the STRICTA recommendations outline research reporting standards that are and should be considered when designing controlled clinical trials that involve the use of acupuncture. The CONSORT and STRICTA recommendations thus not only serve to improve research reporting, but also serve to provide guidance for optimizing the designs of future clinical trials. This paper presents a review of the STRICTA recommendations for reporting the results of controlled trials utilizing acupuncture, discusses their potential limitations, and offers suggestions for additions/enhancements to those standards based on research issued subsequent to the issuance of the STRICTA recommendations in 2001.

Endorsement of the CONSORT statement by high impact medical journals: survey of instructions for authors

The CONSORT (Consolidated Standards of Reporting Trials) statement of 1996, updated in 2001,1 2 gives recommendations for reporting randomised controlled trials and has been endorsed by the World Association of...

The Consolidated Standards of Reporting Trials (CONSORT): Better Presentation of Surgical Trials in the Journal of Hand Surgery

To assure readers that study results are scientifically valid, the methods of a clinical trial should be described adequately. Since randomization, blinding, and intention-to-treat-analysis are major bias-reducing techniques, these aspects should be reported most accurately. The Consolidated standards of reporting trials (CONSORT) are recommendations to improve the reporting of trials. CONSORT requires that trial authors describe basic methodological aspects that readers need to appraise the strengths of reported clinical trials. This article presents the CONSORT recommendations and explains some of their main aspects. From now on, the Journal of Hand Surgery will use CONSORT to assist authors of randomized controlled trials in improving the description of their studies. We believe that this decision increases the scientific validity of study reports and helps readers when critically appraising articles.

Has CONSORT improved the reporting of randomized controlled trials in the palliative care literature? A systematic review.

In 1996, the CONSORT (CONsolidated Standards Of Reporting Trials) statement for the reporting of clinical trials was produced, based on empirical evidence regarding bias. This study assessed the quality of reporting of randomized controlled trials (RCTs) in the palliative care literature. Three specialist journals were hand searched for RCTs. A checklist was devised based on CONSORT recommendations. Two investigators independently assessed all the trials against this checklist. The trials were grouped into time cohorts of five years and quality comparisons made. Trials looking at pain were compared with those trials looking at other aspects of palliative care. Ninety-three RCTs were identified. The number of trials has increased over time: nine in the first cohort, 37 in the second and 47 in the last cohort. The number of patients in the individual trials has also increased over time. Generally, the reporting quality was poor, particularly the areas of allocation concealment, randomization technique and intention to treat analysis, where there is empirical evidence, that it leads to trial bias. Although there were more pain papers than non-pain papers, the quality of reporting was only better for blinding and intention to treat analysis. The quality of reporting of RCTs in the palliative care literature is generally poor. However, there has been an increase in the number and the size of RCTs being carried out. This shows recognition of the importance of an evidence base in palliative care. However, in order to guide clinical decision making, future trials need to improve the quality of their reporting by adhering to the CONSORT statement.

Reporting number needed to treat and absolute risk reduction in randomized controlled trials.

Ongoing efforts to improve the quality of reporting for randomized controlled trials (RCTs) include the Consolidated Standards of Reporting Trials (CONSORT) statement. We examined the frequency of explicit reporting of the number needed to treat (NNT) and the absolute risk reduction (ARR) in RCTs. Five frequently cited journals were investigated: Annals of Internal Medicine, BMJ, JAMA, The Lancet, and the New England Journal of Medicine. For each journal, 4 years were evaluated: 1989, 1992, 1995, and 1998. All issues of each journal for each year were reviewed manually. Eligible articles were those in which an RCT was conducted on the use of a medication showing a significant treatment effect. Elements abstracted from each eligible article were the condition investigated, event being treated or prevented, intervention, study results, and reporting methods (relative risk reduction, NNT, and ARR). Of 359 eligible articles, NNT was reported in 8 articles. Six of the 8 studies were from 1998. Absolute risk reduction was reported in 18 articles, 10 of which were from 1998. Despite CONSORT recommendations, few authors expressed their findings in terms of NNT or ARR. Consideration should be given to including these values in reports of RCTs.