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Using the CONSORT Statement to Evaluate the Completeness of Reporting of Addiction Randomised Trials: a Cross- Sectional Review

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Using the CONSORT Statement to Evaluate the Completeness of Reporting of Addiction Randomised Trials: a Cross- Sectional Review Open access Original research BMJ Open: first published as 10.1136/bmjopen-2019-032024 on 6 September 2019. Downloaded from Using the CONSORT statement to evaluate the completeness of reporting of addiction randomised trials: a cross- sectional review Matthew Vassar, Sam Jellison, Hannah Wendelbo, Cole Wayant, Harrison Gray, Michael Bibens To cite: Vassar M, Jellison S, ABSTRACT Strengths and limitations of this study Wendelbo H, et al. Using Objectives Evaluate the completeness of reporting of the CONSORT statement to addiction randomised controlled trials (RCTs) using the ► Application of robust methodology, as recommend- evaluate the completeness Consolidated Standards of Reporting Trials (CONSORT) of reporting of addiction ed by the Cochrane collaboration. statement. randomised trials: a cross- ► 15 addiction journals included over a 5-year period. Setting Not applicable. sectional review. BMJ Open ► Cross-sectional design, limited to addiction journals, Participants RCTs identified using a PubMed search of 2019;9:e032024. doi:10.1136/ reduces generalisability of our findings. bmjopen-2019-032024 15 addiction journals and a 5-year cross-section. Outcome measures Completeness of reporting. ► Prepublication history for Results Our analysis of 394 addiction RCTs found that the this paper is available online. mean number of CONSORT items reported was 19.2 (SD To view these files, please visit variable, but often suboptimal and in need of the journal online (http:// dx. doi. 5.2), out of a possible 31. Twelve items were reported in improvement. <50% of RCTs; similarly, 12 items were reported in >75% org/ 10. 1136/ bmjopen- 2019- To address reporting deficiencies, 032024). of RCTs. Journal endorsement of CONSORT was found to improve the number of CONSORT items reported. researchers have developed reporting guide- Received 31 May 2019 Conclusions Poor reporting quality may prohibit readers lines which provide best-practice guidance Revised 07 August 2019 from critically appraising the methodological quality of to study authors on reporting pertinent Accepted 20 August 2019 addiction trials. We recommend journal endorsement of information for various study designs. The CONSORT since our study and those previous have shown Consolidated Standards of Reporting Trials 6 that CONSORT endorsement improves the quality of (CONSORT) statement is an evidence-based http://bmjopen.bmj.com/ reporting. set of 25 items that provides specific guid- ance for reporting randomised trials and has an accompanying flow diagram to docu- INTRODUCTION ment the flow of participants throughout a The completeness and clarity of reporting trial. CONSORT has been widely adopted by research studies is essential for readers to 585 journals; over 50% of core medical jour- fully appreciate and evaluate a study’s meth- nals listed in the Abridged Index Medicus odological rigour. Complete reporting is also on PubMed currently endorse or require on October 3, 2021 by guest. Protected copyright. necessary to determine the applicability of CONSORT.7 We found only four addiction findings to patient care. Sims et al1 likened journals listed as endorsers on the CONSORT poor reporting to blinding readers when website. important methodological details or results In this study, we evaluate the completeness © Author(s) (or their are omitted from published reports. Moher et of reporting of addiction clinical trials, an employer(s)) 2019. Re-use al argue that, “inadequate reporting borders area of study in which little is known about permitted under CC BY-NC. No on unethical practice when biased results reporting practices. We used the CONSORT commercial re-use. See rights 2 statement as the basis for this investiga- and permissions. Published by receive false credibility”. Previous studies BMJ. have found that clinical trial interventions tion, as CONSORT is widely recognised as Psychiatry and Behavioral are insufficiently reported to permit repli- the authoritative source for trial reporting. Sciences, Oklahoma State cation or to allow physicians to enact the Results from this investigation will assist in University Center for Health intervention in the clinical setting.3 4 Others identifying areas well reported within addic- Sciences, Tulsa, Oklahoma, USA have found that the poor reporting of system- tion trials and areas where improvements are Correspondence to atic reviews does not even permit the initial needed. We also evaluate whether particular 5 Dr Cole Wayant; searches to be replicated. Thus, across the trials characteristics are associated with more cole. wayant@ okstate. edu clinical research spectrum, reporting is complete reporting. Vassar M, et al. BMJ Open 2019;9:e032024. doi:10.1136/bmjopen-2019-032024 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-032024 on 6 September 2019. Downloaded from METHODS Table 1 Included journals (ordered by Google Scholar We conducted a cross-sectional study of published addic- ranking) and mean adherence to CONSORT items (n=31) tion clinical trials; therefore, our study was not subject to Journal Mean (SD) Institutional Review Board oversight as it did not meet the regulatory definition of human subjects research. Addiction (n=65) 24.8 (3.2) For purposes of reporting, we followed the reporting Drug and Alcohol Dependence (n=73) 19.9 (4.2) 8 guidelines for meta-epidemiological studies and, when Nicotine & Tobacco Research (n=61) 18.8 (4.4) relevant, the Preferred Reporting Items for Systematic Addictive Behaviors (n=37) 15.4 (4.8) Reviews and Meta-analyses guidelines.9 Alcoholism, Clinical and Experimental 19.7 (5.7) Research (n=32) Bibliographic databases searches and journal selection One investigator (MV) searched PubMed (which includes Psychology of Addictive Behaviors 13.7 (4.5) the MEDLINE collection) on 22 June 2018. This search (n=19) was conducted to identify clinical trials published between The International Journal on Drug Mean not calculated 1 January 2013 and 31 December 2017 using PubMed’s Policy (n=1) Clinical Trial[ptyp] filter. This filter has been shown to Addiction Biology (n=3) Mean not calculated maximise sensitivity to ensure relevant studies are not Journal of Substance Abuse 18.3 (3.7) excluded.10 Journals listed in the addiction category of Treatment (n=52) Google Scholar metrics were selected based on their Alcohol and Alcoholism (n=15) 19.9 (4.4) h5-index. Beginning with the journal with the highest Journal of Studies on Alcohol and 15.6 (4.6) h5-index, we conducted PubMed searches to see whether Drugs (n=12) each journal had published at least 10 clinical trials. We Drug and Alcohol Review (n=4) Mean not calculated continued this process until 15 journals were selected. We deployed the final search string as follows: The American Journal on Addictions 16.8 (4.4) ((((((((((((((“Addiction (Abingdon, England)“[- (n=13) Journal]) OR (“Drug and alcohol dependence’”[- Substance Use & Misuse (n=7) Mean not calculated Journal])) OR (“Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco”[Journal])) OR “Addictive behaviors”[Journal]) letters to the editor, other editorials, commentaries and OR (“Alcoholism, clinical and experimental research”[- perspectives articles. Journal])) OR “Psychology of addictive behaviors : Two investigators (SJ and HW) screened all studies journal of the Society of Psychologists in Addictive Behav- for eligibility in an independent, blinded fashion which iors”[Journal]) OR “Addiction biology”[Journal]) OR is consistent with our previous investigations.12–14 We (“Journal of studies on alcohol and drugs”[Journal])) used Rayyan, an online systematic review application, to http://bmjopen.bmj.com/ OR “The International journal on drug policy”[Journal]) screen PubMed records for eligibility with the blinding OR (“Drug and alcohol review”[Journal])) OR (“Alcohol feature turned on. After the initial screening process and alcoholism (Oxford, Oxfordshire)“[Journal])) OR was completed, the two investigators held a consensus “Journal of substance abuse treatment”[Journal]) OR meeting to review the screening decisions and resolve “Alcohol (Fayetteville, N.Y.)“[Journal]) OR “The Amer- disagreements by discussion. ican journal on addictions”[Journal]) OR “Substance use & misuse”[Journal] AND (Clinical Trial[ptyp] AND Data extraction and scoring (“2013/01/01”[PDat] : “2017/12/31”[PDat])). Two investigators (SJ and HW) performed blinded, on October 3, 2021 by guest. Protected copyright. double data extraction. As with screening, a consensus Screening records for eligibility meeting was held after completion of the data extraction To be eligible for inclusion, a study must have reported the process to review and resolve discrepancies. The following use of a randomised clinical trial design and address one items were extracted from each article: journal, year of of the following related to drugs, alcohol or tobacco: (1) publication and funding source. We next evaluated each addiction prevention, (2) stabilisation following excessive item of the CONSORT Statement, which can be found in use of a substance (drugs, alcohol or tobacco), (3) relapse table 1. For each included journal, we manually reviewed prevention and (4) recovery maintenance. For purposes the Instructions for Authors page (or equivalent) to of this study, the National Institutes of Health definition determine if CONSORT was endorsed. of clinical trial was used to determine inclusion, which We planned a multiple regression analysis to investi- involves the prospective
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