Reporting in randomized trials published in International Journal of Cardiology in 2011 compared to the recommendations made in CONSORT 2010

Abstract

Since its modest beginning in 1981, the International Journal of Cardiology (IJC) has progressed to become one of the most-recognized journals in the field of cardiology. The 2010 impact factor in the Science Citation Index (SCI) is 6.802, which has risen 6-fold in the last decade. The journal aims to present all aspects of cardiovascular medicine of relevance to the clinician from genes to populations. Randomized controlled trials (RCTs) are the standard method for the evaluation of treatments and technologies in clinical medicine. It has publishedmany RCTs in the IJC. Inadequate trial design and inadequate reporting forRCTs are associated with biased estimates of effect, and incomplete descriptions of important methodological details in RCT publications make it difficult to assess the quality of the design, conduct, and analysis of the trial and limit readers' ability to interpret the results. The Consolidated Standards of Reporting Trials (CONSORT) statement provides a standardized framework to help authors prepare reports of their trial findings in a complete and transparent manner. The aim of this study was to assess quality of reporting of trial methodology and outcomes in RCTs published in IJC based on the CONSORT Statement, and findwhere improvements were required for this journal. We identified studies that were classified by PubMed as randomized clinical trials and were published between January 2011 and December 2009. The specific search termswere as follows: “Journal of Cardiology” [Jour] ANDRandomizedControlled Trial [ptyp] AND(“2011/1/1” [Date— Publication]: “2011/12/31” [Date — Publication]). Articles were included in the analysis if theymet the following criteria: (1) the article was original article of full-lengthpublication, not editorials, letters to the editor, reviews, case reports. or notifications of meetings and courses.; (2) the study design was a RCT, not a cohort or case -control study. The eligible trials were analyzed for the presence or absence of 9 major items relevant to methodology quality criteria from the most recent CONSORT 2010 statement. [1] These items represent the elements of study design and reporting that are most useful for the assessment of bias and validity. Quality criteria, listed with the corresponding item number from the 2010 CONSORT checklist, were as follows. (1) 7aHowsample sizewas determined; (2) 8amethod used to generate the random allocation sequence; (3) 8b type of randomization; details of any restriction (such as blocking and block size); (4) 9 allocation concealment; mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned; (5) 10 who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions; (6) 11a if done,whowasblinded afterassignment to interventions (for example, participants, care providers, those assessing outcomes) and how (7) 15 A table showing baseline demographic and clinical characteristics for each group; (8) 16 for each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups (intention-to-treat analysis); (9) 18 results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory. The CONSORT 2010 statement is list in the appendix. We assigned a ‘Yes’ or ‘No’ answer to each item according to whether the author had reported it or not. Two independent reviewers evaluated the included reports. Any differences in evaluation between the reviewers were discussed and resolved. Frequencieswere reported as percentages. Fig. 1 shows the process of selecting study articles. A total of 40 potentially eligible citations were identified from the initial search, of which 12 citations were excluded because those were not full-length original articles, but letters to the editor. Among the remaining 28 articles [2–29], 4 were excluded because they were cohort studies [6,7,9,12], and 4 additional non randomized controlled trials [5,10,19,24] were also excluded. Consequently, a total of 20 reports [2–4,8,11,13–18,20–23,25–29] remained for analysis. Table 1 shows the detail of methodological quality evaluation according to CONSORT 2010 statement. The number of “Yes” varied between one and eightwith amaximumpossible total of nine. A total of 6 trials (30%) reported half or more items, but only one trial (5%) reported more than 80%. Meanwhile, there were nine trials (45%) reporting badly, only reporting 30% or less methodological items. The approach to estimation of sample size was reported in 9 (45%) articles [2–4,11,13,16,22,25,29]. Randomization methods were reported in four trials (20%) [22,25–27], with all generated by computers. Type of randomization was reported in three trials (15%) [25–27], all using blocking. The mechanism used to implement random allocation sequence was reported in two trials (10%), all using sequentially numbered sealed envelopes with a pre assigned random treatment [25,26]. Who enrolled participants, andwho assigned participants were reported in 8 articles (40%) [2–4,11,13,25–27]. Of all the articles, seven articles [2,4,14,25–27,29] (35%) reported that all participants, including patients, care providers and result surveyors, were blinded. All 20 articles [2–4,8,11,13–18,20–23,25–29] reported baseline demographic