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Reporting quality of randomized controlled trials evaluating non-vitamin K oral anticoagulants in atrial fibrillation: a systematic review

BMC Cardiovascular Disorders volume 23, Article number: 229 (2023) Cite this article

Abstract

Background

Randomized controlled trials (RCTs) are subject to bias if they lack methodological quality. Furthermore, optimal and transparent reporting of RCT findings aids their critical appraisal and interpretation. This study aimed to comprehensively evaluate the report quality of RCTs of non-vitamin K oral anticoagulants (NOACs) for the treatment of atrial fibrillation (AF) and to analyze the factors influencing the quality.

Methods

By searching PubMed, Embase, Web of Science, and Cochrane Library databases RCTs published from inception to 2022 evaluating the efficacy of NOACs on AF were collected. By using the 2010 Consolidated Standards for Reporting Tests (CONSORT) statement, the overall quality of each report was assessed.

Results

Sixty-two RCTs were retrieved in this study. The median of overall quality score in 2010 was 14 (range: 8.5–20). The extent of compliance with the Consolidated Standards of Reporting Trials reporting guideline differed substantially across items: 9 items were reported adequately (more than 90%), and 3 were reported adequately in less than 10% of trials. Multivariate linear regression analysis showed that the higher reporting scores were associated with higher journal impact factor (P = 0.01), international collaboration (P < 0.01), and Sources of trial funding (P = 0.02).

Conclusions

Although a large number of randomized controlled trials of NOACs for the treatment of AF were published after the CONSORT statement in 2010, the overall quality is still not satisfactory, thus weakening their potential utility and may mislead clinical decisions. This survey provides the first hint for researchers conducting trials of NOACs for AF to improve the quality of reports and to actively apply the CONSORT statement.

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Introduction

Randomized Controlled Trial (RCT) is an optimal design to evaluate the effect of treatment [1]. High-quality RCTs can effectively reduce bias and provide evidence for clinical practice, while poor RCTs may adversely affect routine clinical practice [2]. Since high-quality reporting helps readers critically evaluate the quality of trials, it is of great significance to identify major quality predictions for such reporting. The Consolidated Test Reporting Standard (CONSORT) is a set of recommendations based on the least evidence, including checklists and flowcharts for RCT reports, which can help to judge the standardization and repeatability of RCTs [3]. Its purpose is to promote transparent and comprehensive trials reporting and to assist in the critical evaluation and interpretation of trials.

Atrial fibrillation (AF), one of the most common arrhythmias [4], is associated with a high rate of disability and mortality [5], increasing the risks of stroke, embolism, and death [6,7,8]. With the aging of the population, the incidence of AF is also on the increase year by year [9]. Therefore, the early treatment of AF is quite important.

Drug is administered primarily for the prevention of stroke and systemic embolism in the treatment of AF In the guidelines, warfarin has long been recommended as the preferred anticoagulation agent for AF, but it is subject to certain limitations and requires long-term and frequent laboratory tests [10]. As a new type of anticoagulant, the non-vitamin K oral anticoagulant (NOAC) works by preventing thrombin production and inhibiting factor Xa, which eliminates the need for long-term monitoring. Research has shown that NOACs are more effective and safer than warfarin [11,12,13,14], making it a promising replacement for warfarin in the future [15]. Therefore, it is particularly important to determine the accuracy of the RCTs of NOACs for AF.

This study aimed to evaluate the overall reporting quality and identify some essential issues of published RCTs of NOACs for AF based on the CONSORT statement and to analyze possible related causes, so as to provide reliable evidence for subsequent related studies and meta-analyses.

Methods

This systematic review was reported according to the PRISMA statement [16].

Search strategy

A comprehensive literature search was conducted to identify humans’ prospective randomized controlled trials. Through a manual trial search on advanced PubMed, Embase, Web of Science, and Cochrane Library databases all journal articles published in English as of September 2022 were obtained. The survey was accomplished in duplicate. Also, the final search standards were " atrial fibrillation " and “one of the four NOACs–apixaban, dabigatran, edoxaban, and rivaroxaban”. There was no limit to the year of publication, to the sample size or to the type of research (advantages, equivalence, non-disadvantages).

Inclusion and exclusion criteria

Studies meeting the following criteria were included in the study: (1) randomized controlled trials; (2) study subjects involved patients with AF; (3) interventions related to one of the four NOACs–apixaban, dabigatran, edoxaban, and rivaroxaban. The exclusion criteria were as follows: (1) duplicate publications; (2) animal experiments, and subsequently withdrawn publications; (3) abstract or full text not available.

Assessment of the reporting quality

Two reviewers (YYG and HYB) independently followed a standardized evaluation checklist to review and extract data from eligible articles. The 2010 CONSORT criteria were adopted. Each item on the criteria checklist was scored, from satisfied to dissatisfied. Any divergence between these two reviewers about these articles would be resolved by a third reviewer(ZGL). Cohen’s kappa will be calculated to assess consistency between reviewer ratings(0.45 to 0.81). A total of 25 spouse statements were revised in 2010. Among them, 12 items were separated into two parts (37 items in total). 1 point was assigned if item was reported, 0.5 points was assigned if sub-item was reported and 0 point was assigned if these items were not reported. An overall CONSORT score (score range 0 to25) was calculated by totaling the scores of all 37 quality items.

Statistical analysis

By using SPSS Version 24.0, descriptive statistics were generated, covering CONSORT (0–25) based on median and interquartile ranges. Categorical data are presented as a number (n) and percent (%), and the reporting score is recorded as mean and standard deviations (SD). Independence t-test and one-way analysis of variance (ANOVA) are used to compare the differences of general features, as the data are consistent with the homogeneity and normality of variance. Multi-distant linear regression analysis was used to explore the relationship between influencing factors and report quality. Potential predictors were coded as follows: Year of publication: 2001–2010 = 1, 2011–2022 = 2; Region in which trials were: Asia = 1, Europe and North America = 2; Sources of trial funding: Funding not reported = 1, Completely funded by industry = 2, Government and industry = 3, Government/foundation = 4; Journal impact factor:< 4 = 1, 4–10 = 2, ≥ 10 = 3; Sample size;≤200 = 1, 200–400 = 2, ≥ 400 = 3; International collaboration: no = 1, yes = 2. For all analyses, the statistical significance level was set at P < 0.05.

Results

Search results

According to the literature search results, 290 studies (Fig. 1) were found. Among them, 16 studies were removed as they were unrelated to AF, and 201 studies were excluded because they were not RCTs. Also, 11 studies were ruled out since they didn’t include NOACs. In the end, 62 studies were included, which were also parallel controlled studies.

Fig. 1
figure 1

Selection of randomized clinical trials in the systematic review

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Characteristics of the included studies

Table 1 showed the Characteristics of RCTs included in this study. Most articles were published after 2010, accounting for 93.54%. 58.06% of the trials were conducted in Europe and North America. 46.77% of the trials were completely funded by the industry. 45.16% of the trials were published in journals with an impact factor greater than 10. 37 (59.86%) trials were compared with warfarin. The sample size of 50% trials is more than 400. Most of the trials (56.45%) did not involve international cooperation. In addition, the differences in consort scores of “Sources of trial funding” (P = 0.040), “Journal impact factor”(P < 0.01), “Sample size”(P < 0.01) and “International collaboration”(P = 0.017) were statistically significant.

Table 1 Trial characteristics
Full size table

Reporting of all items

Figure 2 showed the research characteristics and descriptive results. Overall, the average reporting rate of all items was 55.45%. Specifically, Table 2 displays that 6 items were fully reported (> 95%) and 5 items were poorly reported (< 15%). The median of overall quality score in 2010 was 14 (range: 8.5–20). Figure 3 shows the frequency bar graphs of all researched OQS.

Fig. 2
figure 2

Overall Quality of Reporting: Rating Based on Items in the 2010 CONSORT Statement (n = 62)

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Table 2 Report details for selected items
Full size table
Fig. 3
figure 3

The frequency bar graphs of all researched OQS (n = 62)

Full size image

Factors associated with reporting quality

Table 3 shows the results of the linear regression modeling. Six independent variables are input into the multiple linear regression model, among which the Sources of trial funding(P = 0.02), journal impact factor (P = 0.01), and international collaboration (P < 0.01) as noticeable predictors of the overall CONSORT score.

Table 3 Factors associated with key elements of the CONSORT guidelines
Full size table

Discussion

In order to ensure accuracy and consistency in the reporting of RCTs, it is crucial that they are presented in an open and transparent manner, adhering strictly to the CONSORT guidelines. Failure to do so may result in overestimation of therapeutic efficacy and conflicting conclusions. [17,18,19,20]. Since 1996, the reporting quality of RCTs has improved dramatically when the CONSORT was launched [21], particularly those trials concerning drugs [22, 23]. CONSORT was updated in 2001 and 2010 [24, 25], respectively.

Unfortunately, although most RCTs of NOACs in AF have been published since the revision of 2010 CONSORT statement, the overall reporting quality was still unsatisfactory, with an overall average reporting rate of 55.45%, which is similar to the findings in the fields of lung cancer, and COVID-19. In addition, fewer project reports were added to or redefined in the 2010 revision compared with the 2001 CONSORT statement.

In this study, it was found that some items and measures of clinical characteristics had a high reporting rate of results, such as items 2a, 4a, 12a, 13a, 15, 17a, (95.16%, 98.39%, 96.77%, 96.77%, 96.77%,95.16%), which put emphasis on the theoretical background of the trials, eligibility criteria, statistical methods, participants assigned, baseline demographic table, and results with effect size and precision. However, the reporting rates of Changes to trial after commencement, Changes to outcomes, Interim analyses and stopping guidelines, Allocation, enrollment and assignment personnel, Blinding, Similarity of interventions, and Dates of recruitment (items 3b,6b,7b,10,11a,11b,14b) were only 8.06%, 14.52%, 16.13%, 4.94%, 14.52%, 8.06% and 16.13%, respectively. The results are worrying because the missing reporting items are also an important part of the details of the trial, and they are equally noteworthy. This finding was consistent with earlier research [26,27,28].

The results are worrying because the missing reporting items are also an important part of the details of the trial, and they are equally noteworthy. Inappropriate methods of randomization can lead to selection and confounding bias [29], and most trials that lack details of the randomization procedure provided also have problems with randomization-related bias, as well as influencing the reader’s assessment of the risk of selection bias [30]. In RCTs, blinding is used to avoid subjective bias. However, inappropriate blinding can increase the risk of bias and exaggerated results [30,31,32]. Some of the RCTs of NOACs for AF included in this study were not completely randomized trials per se, but used district group randomization, and patients in different groups may have different clinical characteristics and risk factors, which may introduce some bias and thus affect the reliability of the results [33,34,35,36,37]. Similarly, the lack of reporting of the way in which warfarin blinding was performed (blinded, unblended, masked) in some of the trials that were compared with warfarin may have introduced bias in the trial results [35, 38,39,40,41]. These should be discussed in the report. Reporting of significant events (patients lost to follow-up, treatment adherence, unbinding, and cross-contamination) after trial initiation is important, and these factors may also have an impact on trial results [42]. Especially in trials related to NOACs, the reporting of bleeding events plays an important role in the reliability of trial results. Secondly, the reporting of abnormal events is also essential in clinical trials, as these events may affect the validity and reliability of trial results [43]. For example, in the RE-LY trial, the reporting of myocardial infarction rate is an important issue because it may affect the interpretation and promotion of the trial results [44,45,46]. Therefore, accurate and clear event reporting in clinical trials is important and helps to increase the accuracy and reliability of trial results. The reason for these problems may be that the clinical features of RCTs are considered more important and engaging since many authors are also clinicians.

The reason for these problems may be that the clinical features of RCTs are considered more important and attractive because many authors are also clinicians. Here, it is suggested that the design of experimental methods should be carried out through full cooperation of scientists and clinicians. In addition, it is possibly lied in that most trials had developed detailed plans and remedial measures before they started, and that the trials proceeded smoothly without errors or RCTs with early termination or negative results are often rejected for publication [47]. For the sake of simplicity, the detailed test procedures of some articles cannot be fully reported, thus affecting the quality of the report. Experiments have shown a close relationship between inadequately informed trials and poorly designed or conducted tests [48, 49]. Hence, it is suggested that journals can revise their requirements for word count, especially for RCT, or offer online resources that facilitate authors to make these key omissions.

This study shows that journal impact factors, experimental Sources of trial funding and international collaboration are also important factors in the quality of RCTs reporting. Better reporting quality is associated with higher journal impact factors, international cooperation and high sample size, which is similar to a previous study [50, 51]. This may be because journals with higher impact factors have higher requirements for papers [52], and many countries participate in cooperative experiments with more perfect and detailed experimental designs. We believe that the potential reason for the poor quality of RCT reports is that some journals do not evaluate articles strictly according to the CONSORT statement, so we suggest that journal editors and peer reviewers should strictly judge the completeness and accuracy of the tests according to the CONSORT statement when reviewing the RCT. Meanwhile, the journal should also increase the promotion of CONSORT statement, calling on researchers to refer to CONSORT statement to design RCT experiments and write articles.

Nevertheless, this study is also plagued by several limitations. The release time of NOACs is relatively short; there are few RCTs on it; the number of included trials is limited. Besides, each CONSORT item is assigned with an equal weight, which may overemphasize some less important things. In addition, some of the item requirements in the CONSORT statement are very complex; although it provides explanatory notes, and we have designed and tried data collection templates prior to data collection, including detailed reporting requirements for specific items (such as allocation, hiding, blocking or setting and location), it is still impossible to avoid subjective factors during grading.

Conclusion

According to the data collected herein, there is currently a lack of clinical randomized controlled studies of NOACs in the treatment of atrial fibrillation. The quality of the existing articles needs to be improved. However, for confirming the effect of treatment, RCT is still recommended by this study as the preferred design in an ideal environment. In the future, more comprehensive efforts shall be made to increase the awareness of readers, reviewers, and editors on these issues. At the same time, the quality and accuracy improvement of such research conclusions shall also be focused on to guarantee the credibility of the evidence that they have offered.

Data Availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

References

  1. Tsui M, Rehal S, Jairath V, Kahan BC: Most noninferiority trials were not designed to preserve active comparator treatment effects. Journal of Clinical Epidemiology 2019, 110:82–89.

    Article  PubMed  Google Scholar 

  2. Calvert M, King M, Mercieca-Bebber R, Aiyegbusi O, Kyte D, Slade A, Chan AW, Basch E, Bell J, Bennett A et al: SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials. Bmj Open 2021, 11(6).

  3. Cuschieri S: The CONSORT statement. Saudi Journal of Anaesthesia 2019, 13:27–30.

    Article  Google Scholar 

  4. Vitolo M, Proietti M, Harrison S, Lane DA, Potpara TS, Boriani G, Lip GYH: The Euro Heart Survey and EURObservational Research Programme (EORP) in atrial fibrillation registries: contribution to epidemiology, clinical management and therapy of atrial fibrillation patients over the last 20 years. Internal and Emergency Medicine 2020, 15(7):1183–1192.

    Article  PubMed  Google Scholar 

  5. Panchal G, Mahmood M, Lip GYH: Revisiting the risks of incident atrial fibrillation: a narrative review. Part 2. Kardiologia Polska 2019, 77(5):515–524.

    Article  PubMed  Google Scholar 

  6. Healey JS, Amit G, Field TS: Atrial fibrillation and stroke: how much atrial fibrillation is enough to cause a stroke? Current Opinion in Neurology 2020, 33(1):17–23.

    Article  PubMed  Google Scholar 

  7. Bencivenga L, Komici K, Nocella P, Grieco FV, Spezzano A, Puzone B, Cannavo A, Cittadini A, Corbi G, Ferrara N et al: Atrial fibrillation in the elderly: a risk factor beyond stroke. Ageing Research Reviews 2020, 61.

  8. Waldmann V, Jouven X, Narayanan K, Piot O, Chugh SS, Albert CM, Marijon E: Association between Atrial Fibrillation and Sudden Cardiac Death Pathophysiological and Epidemiological Insights. Circulation Research 2020, 127(2):301–309.

    Article  CAS  PubMed  Google Scholar 

  9. Diez-Villanueva P, Alfonso F: Atrial fibrillation in the elderly. Journal of Geriatric Cardiology 2019, 16(1):49–53.

    CAS  PubMed  PubMed Central  Google Scholar 

  10. McRae HL, Militello L, Refaai MA: Updates in anticoagulation therapy monitoring. Biomedicines 2021, 9(3).

  11. Fanaroff AC, Ohman EM: Non-Vitamin K Antagonist Oral Anticoagulants in the Treatment of Atrial Fibrillation. In: Annual Review of Medicine, Vol 70. Volume 70, edn. Edited by Klotman ME; 2019: 61–75.

  12. Jin H, Zhu KB, Wang LN, Zhou WJ, Zhi H: Efficacy and safety of non-vitamin K anticoagulants and warfarin in patients with atrial fibrillation and heart failure: a network meta-analysis. Thrombosis Research 2020, 196:109–119.

    Article  CAS  PubMed  Google Scholar 

  13. Lee SR, Choi EK, Kwon S, Han KD, Jung JH, Cha MJ, Oh S, Lip GYH: Effectiveness and safety of contemporary oral anticoagulants among Asians with Nonvalvular Atrial Fibrillation. Stroke 2019, 50(8):2245–2249.

    Article  CAS  PubMed  Google Scholar 

  14. Peterson ED, Ashton V, Chen YW, Wu BC, Spyropoulos AC: Comparative effectiveness, safety, and costs of rivaroxaban and warfarin among morbidly obese patients with atrial fibrillation. American Heart Journal 2019, 212:113–119.

    Article  CAS  PubMed  Google Scholar 

  15. Lai A, Davidson N, Galloway SW, Thachil J: Perioperative management of patients on new oral anticoagulants. British Journal of Surgery 2014, 101(7):742–749.

    Article  CAS  PubMed  Google Scholar 

  16. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, Shamseer L, Tetzlaff JM, Moher D: Updating guidance for reporting systematic reviews: development of the PRISMA 2020 statement. Journal of Clinical Epidemiology 2021, 134:103–112.

    Article  PubMed  Google Scholar 

  17. Soland J: Is measurement noninvariance a threat to Inferences Drawn from Randomized Control trials? Evidence from empirical and Simulation Studies. Applied Psychological Measurement 2021, 45(5):346–360.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Schulz KF, Chalmers I, Hayes RJ, Altman DG: EMPIRICAL-EVIDENCE OF BIAS - DIMENSIONS OF METHODOLOGICAL QUALITY ASSOCIATED WITH ESTIMATES OF TREATMENT EFFECTS IN CONTROLLED TRIALS. Jama-Journal of the American Medical Association 1995, 273(5):408–412.

    Article  CAS  Google Scholar 

  19. Mills EJ, Ayers D, Chou R, Thorlund K: Are current standards of reporting quality for clinical trials sufficient in addressing important sources of bias? Contemporary Clinical Trials 2015, 45:2–7.

    Article  PubMed  Google Scholar 

  20. Li WT, van Wely M, Gurrin L, Mol B: Integrity of randomized controlled trials: challenges and solutions. Fertility and Sterility 2020, 113(6):1113–1119.

    Article  PubMed  Google Scholar 

  21. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D et al: Improving the quality of reporting of randomized controlled trials - the CONSORT statement. Jama-Journal of the American Medical Association 1996, 276(8):637–639.

    Article  CAS  Google Scholar 

  22. Turner L, Shamseer L, Altman DG, Schulz KF, Moher D: Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A cochrane review. Systematic Reviews 2012, 1.

  23. Zhang X, Lam WC, Liu F, Li M, Zhang L, Xiong W, Zhou X, Tian R, Dong C, Yao C et al: A cross-sectional literature survey showed the reporting quality of multicenter randomized controlled trials should be improved. J Clin Epidemiol 2021, 137:250–261.

    Article  PubMed  Google Scholar 

  24. Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Journal of the American Podiatric Medical Association 2001, 91(8):437–442.

    Article  CAS  PubMed  Google Scholar 

  25. Schulz KF, Altman DG, Moher D, Grp C: CONSORT 2010 Statement: updated guidelines for reporting parallel Group Randomized trials. Annals of Internal Medicine 2010, 152(11):726-W293.

    Article  Google Scholar 

  26. Soon YY, Chen D, Tan TH, Tey J: Quality of radiotherapy reporting in randomized controlled trials of prostate cancer. Radiation Oncology 2018, 13.

  27. Adams YJ, Kamp K, Liu CC, Stommel M, Thana K, Broome ME, Smith B: Revisiting the quality of reporting randomized controlled trials in nursing literature. Journal of Nursing Scholarship 2018, 50(2):200–209.

    Article  PubMed  Google Scholar 

  28. Wilson B, Burnett P, Moher D, Altman DG, Salman RA: Completeness of reporting of randomised controlled trials including people with transient ischaemic attack or stroke: a systematic review. European Stroke Journal 2018, 3(4):337–346.

    Article  PubMed  PubMed Central  Google Scholar 

  29. Schulz KF, Grimes DA: Generation of allocation sequences in randomised trials: chance, not choice. Lancet 2002, 359(9305):515–519.

    Article  PubMed  Google Scholar 

  30. Kahan BC, Rehal S, Cro S: Risk of selection bias in randomised trials. Trials 2015, 16:405.

    Article  PubMed  PubMed Central  Google Scholar 

  31. Martin GL, Trioux T, Gaudry S, Tubach F, Hajage D, Dechartres A: Association between lack of blinding and Mortality results in critical care randomized controlled trials: a Meta-epidemiological study. Critical care medicine 2021, 49(10):1800–1811.

    Article  PubMed  Google Scholar 

  32. Hróbjartsson A, Thomsen AS, Emanuelsson F, Tendal B, Rasmussen JV, Hilden J, Boutron I, Ravaud P, Brorson S: Observer bias in randomized clinical trials with time-to-event outcomes: systematic review of trials with both blinded and non-blinded outcome assessors. International journal of epidemiology 2014, 43(3):937–948.

    Article  PubMed  Google Scholar 

  33. Lopes RD, Heizer G, Aronson R, Vora AN, Massaro T, Mehran R, Goodman SG, Windecker S, Darius H, Li J et al: Antithrombotic therapy after Acute Coronary syndrome or PCI in Atrial Fibrillation. The New England journal of medicine 2019, 380(16):1509–1524.

    Article  CAS  PubMed  Google Scholar 

  34. De Vriese AS, Caluwé R, Van Der Meersch H, De Boeck K, De Bacquer D: Safety and efficacy of vitamin K antagonists versus Rivaroxaban in Hemodialysis patients with Atrial Fibrillation: a Multicenter Randomized Controlled Trial. Journal of the American Society of Nephrology: JASN 2021, 32(6):1474–1483.

    Article  PubMed  PubMed Central  Google Scholar 

  35. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J et al: Dabigatran versus warfarin in patients with atrial fibrillation. The New England journal of medicine 2009, 361(12):1139–1151.

    Article  CAS  PubMed  Google Scholar 

  36. Bertaglia E, Anselmino M, Zorzi A, Russo V, Toso E, Peruzza F, Rapacciuolo A, Migliore F, Gaita F, Cucchini U et al: NOACs and atrial fibrillation: incidence and predictors of left atrial thrombus in the real world. International journal of cardiology 2017, 249:179–183.

    Article  PubMed  Google Scholar 

  37. Maeng M, Steg PG, Bhatt DL, Hohnloser SH, Nordaby M, Miede C, Kimura T, Lip GYH, Oldgren J, Ten Berg JM et al: Dabigatran Dual Therapy Versus Warfarin Triple Therapy Post-PCI in patients with Atrial Fibrillation and Diabetes. JACC Cardiovascular interventions 2019, 12(23):2346–2355.

    Article  PubMed  Google Scholar 

  38. Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Špinar J et al: Edoxaban versus warfarin in patients with atrial fibrillation. The New England journal of medicine 2013, 369(22):2093–2104.

    Article  CAS  PubMed  Google Scholar 

  39. Calkins H, Willems S, Gerstenfeld EP, Verma A, Schilling R, Hohnloser SH, Okumura K, Serota H, Nordaby M, Guiver K et al: Uninterrupted dabigatran versus warfarin for ablation in Atrial Fibrillation. The New England journal of medicine 2017, 376(17):1627–1636.

    Article  CAS  PubMed  Google Scholar 

  40. Cappato R, Marchlinski FE, Hohnloser SH, Naccarelli GV, Xiang J, Wilber DJ, Ma CS, Hess S, Wells DS, Juang G et al: Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation. European heart journal 2015, 36(28):1805–1811.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  41. Hori M, Matsumoto M, Tanahashi N, Momomura S, Uchiyama S, Goto S, Izumi T, Koretsune Y, Kajikawa M, Kato M et al: Rivaroxaban vs. warfarin in japanese patients with atrial fibrillation – the J-ROCKET AF study –. Circulation journal: official journal of the Japanese Circulation Society 2012, 76(9):2104–2111.

    Article  CAS  PubMed  Google Scholar 

  42. Li G, Taljaard M, Van den Heuvel ER, Levine MA, Cook DJ, Wells GA, Devereaux PJ, Thabane L: An introduction to multiplicity issues in clinical trials: the what, why, when and how. International journal of epidemiology 2017, 46(2):746–755.

    PubMed  Google Scholar 

  43. Samaan Z, Mbuagbaw L, Kosa D, Borg Debono V, Dillenburg R, Zhang S, Fruci V, Dennis B, Bawor M, Thabane L: A systematic scoping review of adherence to reporting guidelines in health care literature. Journal of multidisciplinary healthcare 2013, 6:169–188.

    PubMed  PubMed Central  Google Scholar 

  44. Hohnloser SH, Oldgren J, Yang S, Wallentin L, Ezekowitz M, Reilly P, Eikelboom J, Brueckmann M, Yusuf S, Connolly SJ: Myocardial ischemic events in patients with atrial fibrillation treated with dabigatran or warfarin in the RE-LY (Randomized evaluation of long-term anticoagulation therapy) trial. Circulation 2012, 125(5):669–676.

    Article  CAS  PubMed  Google Scholar 

  45. Larsen TB, Rasmussen LH, Gorst-Rasmussen A, Skjøth F, Rosenzweig M, Lane DA, Lip GY: Myocardial ischemic events in ‘real world’ patients with atrial fibrillation treated with dabigatran or warfarin. The American journal of medicine 2014, 127(4):329–336.e324.

    Article  CAS  PubMed  Google Scholar 

  46. Kupó P, Szakács Z, Solymár M, Habon T, Czopf L, Hategan L, Csányi B, Borbás J, Tringer A, Varga G et al: Direct anticoagulants and risk of myocardial infarction, a multiple Treatment Network Meta-Analysis. Angiology 2020, 71(1):27–37.

    Article  PubMed  Google Scholar 

  47. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR: PUBLICATION BIAS IN CLINICAL RESEARCH. Lancet 1991, 337(8746):867–872.

    Article  CAS  PubMed  Google Scholar 

  48. Sidani S, Fox M, Epstein DR, Miranda J: Challenges in using the Randomized Trial Design to examine the influence of treatment preferences. Canadian Journal of Nursing Research 2016, 48(1):7–13.

    Article  Google Scholar 

  49. Murray DM: Influential methods reports for group-randomized trials and related designs. Clinical Trials 2022, 19(4):353–362.

    Article  PubMed  Google Scholar 

  50. Yin YH, Gao JX, Zhang YY, Zhang XL, Ye JY, Zhang JX: Evaluation of reporting quality of abstracts of randomized controlled trials regarding patients with COVID-19 using the CONSORT statement for abstracts. International Journal of Infectious Diseases 2022, 116:122–129.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  51. Sarkis-Onofre R, Poletto-Neto V, Cenci MS, Pereira-Cenci T, Moher D: Impact of the CONSORT Statement endorsement in the completeness of reporting of randomized clinical trials in restorative dentistry. Journal of Dentistry 2017, 58:54–59.

    Article  PubMed  Google Scholar 

  52. Tang PA, Pond GR, Welch S, Chen EX: Factors associated with publication of randomized phase III cancer trials in journals with a high impact factor. Current Oncology 2014, 21(4):E564-E572.

    Article  PubMed Central  Google Scholar 

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Acknowledgements

We extend our thanks to the Department of Cardiac Sciences and Public Health (The First Affiliated Hospital of Heilongjiang University of Chinese Medicine) for the support.

Funding

This work was supported by the scientific research of Heilongjiang University of Chinese Medicine (grant no. 2019TD01), “Double First-class” Discipline Development Assistance Fund for Integrated Traditional Chinese and Western Medicine of Heilongjiang University of Chinese Medicine (grant no HLJSYL1001).

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Authors and Affiliations

  1. Heilongjiang University of Chinese Medicine, Harbin, P. R. China

    YueGuang Yang

  2. The First Department of Cardiovascular, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, 26 Heping Road, Xiangfang, Harbin, Heilongjiang, 150040, P.R. China

    YuBo Han, GuoLiang Zou, YanBo Sui, Juan Jin & Li Liu

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  6. Li Liu
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Contributions

YYG: data collection or management, manuscript writing/editing. ZGL and HYB data analysis, group developed the search strategy. JJ: manuscript writing/editing. SYB: Revision and submission of manuscript. LL: protocol/project development, manuscript writing/editing. All authors read and approved the final manuscript.

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Correspondence to Li Liu.

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Yang, Y., Han, Y., Zou, G. et al. Reporting quality of randomized controlled trials evaluating non-vitamin K oral anticoagulants in atrial fibrillation: a systematic review. BMC Cardiovasc Disord 23, 229 (2023). https://doi.org/10.1186/s12872-023-03258-z

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Keywords

BMC Cardiovascular Disorders

ISSN: 1471-2261

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