Dear Editor,
Randomized controlled trials (RCTs) are the highest level of experimental evidence available. Using these trials we are able to assess the efficacy of a new treatment, medication or protocol compared to either an old treatment (the previous best treatment) or a placebo. However, not all RCTs are of the same quality in design, quality, or reportingCitation1.
Writing a very well conducted RCT in a poor way can result in a paper that is not beneficial to furthering our knowledge, whereas a poor RCT written well allows for proper assessments of the pros and cons and a balanced interrogation of its suitability for publication.
A well conducted RCT with a methodology that is not complete and does not adhere to strict constraints becomes uninterpretable, and therefore less than usefulCitation2. Furthermore, a well conducted RCT written well can have profound positive influences on patient treatment, allowing for the best treatments to be identified for the benefit of our patients.
To this end, assessment not of the outcomes of RCTs, but of the technical quality of the writing of the RCTs is important. Appreciation of well written RCTs will allow authors to understand how to better write their own RCTs in the future. This will result in the good RCTs having maximum positive impact on patient care, and for poor RCTs to have the good points conveyed while allowing for any deficiencies in the study design to be highlighted. This will enable readers to appreciate these differences and take the appropriate approach to the results.
We propose a new method of assessing the quality of the reporting of RCTs in the scientific literature. The objective assessment of the quality of RCTs is difficult, as there are many tools and different writing styles. To this end, the quality can be assessed universally by measuring the adherence to the CONSORT statement, whether there is evidence that the study had followed the CONSORT flow diagram, and the Jadad score of assessing the randomization of a RCT.
The CONSORT statement is a 25 item checklist generating a final score out of 37Citation2.
A cross-sectional study in 2013 looks at RCTs in the larger journals available. It was concluded that the quality of the RCTs published in these journals were not adhering to the CONSORT statement, even after it had been proposed initially in 1996 and the quality of the RCTs were found to be of a quality not acceptable for adequate interpretationCitation3. A systematic review in 2013 looked at 81 meta-analyses. Sixty-nine of these showed better completion and therefore a more useful RCT from using the CONSORT flow chart. The review also concluded that journals did not advocate CONSORT endorsement to those putting forward RCTs to be publishedCitation4.
The Jadad score is an appendix to the CONSORT score. There are 7 points to the score, 2 of which are negative marks so can result in a range of score from zero to five points, one of which is for being able to find evidence of adherence to the CONSORT flow chart (the RCT must use a blinding technique)Citation5.
By jointly assessing the quality of a report with these two methods, we suggest that the reliability of the assessment will be greatly increased. This means the total score attainable under this assessment method is 42. This will result in a score that provides information not about the outcomes of a RCT, but of the technical quality of the article that is used to publish the results. This can then enable a fair and unbiased evaluation of the results of an RCT.
It is clear that the CONSORT statement and Jadad score are suitable and appropriate for analyzing the quality of RCTs, and it is also true that the quality of RCTs is low. Therefore, the methods of analysis are not being implemented as often as they could be or should be. It is believed that improving RCT reports can be achieved by adhering to existing standards and guidelinesCitation6.
The joint use of the methods (CONSORT and Jadad score) can be used for individual papers in the appraisal by the authors prior to the submission to a journal, for the appraisal by journals of the quality of RCTs submitted and can also be used to assess multiple papers in a specific area of research. In a Cochrane review it is suggested that journals should take further action in implementing CONSORTCitation4. This will facilitate clarity and completeness before publishing. It may be possible to require this score and the Jadad score to be provided by the authors at the time of submission to a journal to ensure the published RCTs are of a standard that is acceptable.
“The whole of medicine depends on the transparent reporting of clinical trials”Citation6.
Transparency
Declaration of funding
This letter was not funded.
Declaration of financial/other relationships
D.R.M., J.M.N., and G.L.B. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this letter.
CMRO peer reviewers on this manuscript have no financial or other relationships to disclose.
References
- Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001;357:1191-4
- Schulz KF, Altman DG, Moher D; and the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Trials 2010;11:32. doi: 10.1186/1745-6215-11-32
- Ahmadzadeh J, Rezaeian S, Mobaraki K. The quality of the reporting of randomized controlled trials after CONSORT statement in the prestigious journals. Shiraz E-Medical Journal 2013;14:130-8
- Turner L, Shamseet L, Altman DG, et al. 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;1:60. doi: 10.1186/2046-4053-1-60
- Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Controlled Clin Trials 1996;17:1-12
- Ghimire S, Kyung E, Kang W, Kim E. Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals. Trials 2012;13:77