FEATURE ARTICLE

Assessing the Reporting Quality in Abstracts of Randomized Controlled Trials in Leading Journals of Oral Implantology Juliana Kiriakou, DDSa, Nikolaos Pandis, DDS, MS, Dr med dentb, Phoebus Madianos, DDS, PhDc, and Argy Polychronopoulou, DDS, MS, ScM, ScDa a

Department of Community and Preventive Dentistry, School of Dentistry, University of Athens, P.O. Box 18018, Athens 11610, Greece b Department of Orthodontics and Dentofacial Orthopedics, Dental School, Medical Faculty, University of Bern, Bern, Switzerland c Department of Periodontology, School of Dentistry, University of Athens, Athens, Greece

Abstract

Aim: Abstracts of randomized clinical trials are extremely important as trial appraisal is often based on the information included here. The objective of this study was to assess the quality of the reporting of RCTabstracts in journals of Oral Implantology. Material and Methods: Six leading Implantology journals were screened for RCTs between years 2008 and 2012. A 21-item modified CONSORT for abstracts checklist was used to examine the completeness of abstract reporting. Descriptive statistics and linear regression modeling were employed for data analysis. Results: One hundred and sixty three RCT abstracts were included in this study. The majority of the RCTs were published in the Clinical Oral Implants Research (42.9%). The mean overall reporting quality score was 58.6% (95% CI: 57.6–59.7). The highest score was noted in the European Journal of Oral Implantology (63.8%; 95% CI: 61.8–65.8). Multivariate analysis demonstrated that abstract quality score was related to publication journal and number of research centers involved. Most abstracts adequately reported interventions (89.0%), objectives (77.9%) and conclusions (74.8%) while failed to report randomization procedures, allocation concealment, effect estimate, confidence intervals, and funding. Registration of RCTs was not reported in any of the abstracts. Conclusions: The reporting quality in abstracts of RCTs published in Oral Implantology journals needs to be improved. Editors and authors should be

Corresponding author. Tel.: +30 697 760 9000; fax: +30 210 813 1181; E-mail: [email protected], [email protected]. Sources of support: This study was not supported by a research grant or any other source of funding. Conflicts of interest: The authors state no conflict of interest.

J Evid Base Dent Pract 2014;14:9-15 1532-3382/$36.00 Ó 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jebdp.2013.10.018

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encouraged to endorse the CONSORT for abstracts guidelines in order to achieve optimal quality in abstract reporting. Keywords: Abstracts, Reporting, Clinical trials, Implantology.

INTRODUCTION The field of oral implantology shows an increasing demand for improvement of treatment strategies with the ultimate goal to deliver optimal patient care. Clinicians are required to base their decisions on the best available research evidence by critically appraising and incorporating sound scientific evidence into everyday clinical practice.1 The randomized clinical trial (RCT) is the most rigorous clinical experiment available. It is regarded as the gold standard for evaluating the effectiveness of health care interventions as its procedure minimizes the risk of confounding factors influencing the results.2–8 Empirical evidence indicates that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, as well as lack of adequately reported randomization are associated with bias.5,9 Reporting of RCTs has been a subject of concern for several decades that led to the development of guidelines to help authors improve reporting quality. The CONSORT Statement for parallel trials includes a checklist of 25 items related to different aspects of a trial report that are considered important in the publication of an RCT.10–12 This checklist is followed by a flow diagram illustrating the passage of participants through the different stages of a randomized trial. Detailed and accurate abstracts of conferences and journal articles related to RCTs are of great importance as readers often base the assessment of a trial solely on the information in the abstract.13–15 Moreover; a properly constructed and written abstract facilitates the quick assessment of the validity and applicability of the trial findings. However, the CONSORT statement provided limited guidance about the reporting of abstracts, hence, the CONSORT for abstracts was developed.13 This extension to the CONSORT Statement consists of a list of items, that authors should consider when reporting an RCT in any journal or conference abstract, including details of the trial’s objectives, design, participants, interventions, outcomes and harms. A previous study attempted to evaluate the reporting quality of RCT abstracts in orthodontics,16 while another compared the reporting quality of RCT abstracts in periodontology and implant dentistry before and after publication of the CONSORT for Abstracts checklist.17 The present study aimed to assess the quality of the reporting of RCT abstracts in leading journals of oral im10

plantology. The primary objective was to evaluate the quality of reporting of RCT abstracts with reference to the CONSORT guidelines for abstracts. Identification of possible factors influencing the reporting of RCT abstracts, comparisons between the potential predictors, and investigation of items being underreported, were attempted as well.

MATERIAL AND METHODS The following six leading journals of oral implantology, based on 2011 impact factor, were selected to be electronically searched for RCTs with additional hand searching:      

The European Journal of Oral Implantology Clinical Implant Dentistry and Related Research Clinical Oral Implants Research Implant Dentistry Journal of Oral Implantology The International Journal of Oral and Maxillofacial Implants

The selected studies included all identified RCTs between the years 2008 and 2012 and met the following eligibility criteria:  The phrase ‘‘randomized controlled trial’’ or ‘‘randomized clinical trial’’ was in the title or abstract, or it was evident in the methodology of the trial that was an RCT.  Trials with words in the title or abstract such as ‘‘prospective,’’ ‘‘comparative,’’ ‘‘efficacy,’’ or words pointing that a comparison between treatment groups was undertaken prospectively, were further scrutinized to determine whether randomization was implemented or not. Ex-vivo studies in vitro studies, theses, and conference abstracts were excluded.  Ex-vivo studies in vitro studies, theses, and conference abstracts were excluded. The 21-item CONSORT checklist for abstracts modified by Fleming et al,16 was used as a reference for the reporting of the abstracts (Table 1). Each item received a score from 1 to 3, with 1 corresponding to ‘‘no description,’’ 2 to ‘‘inadequate description’’ and 3 representing ‘‘adequate description.’’ Especially for the title, it was assigned a score of 1 if RCT was not mentioned and a score of 2 if RCT was mentioned, but the PICO format was not used. Outcome reporting was given a score of 3 if both primary and secondary outcomes were defined in the abstract. Similarly, the level of statistical significance (P value) was given a score of 3 if P values for both primary March 2014

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TABLE 1. 21-item CONSORT for abstracts checklist modified by Fleming et al.16 Item Title Structured Trial design Methods Participants Intervention Objective Outcome Random number generation Randomization restrictions Allocation concealment Blinding Results Numbers randomized Numbers analyzed Effect estimate Confidence intervals Intention-to-treat analysis Harms Conclusions Registration Funding P value

Description Identification as randomized and PICO format Typical abstract format Description of trial design (such as parallel, factorial) including allocation ratio Eligibility criteria for participants, settings where data were collected The interventions for each group with details to allow replication Specific objective or hypothesis Completely defined primary and secondary outcome measures Method used to generate the random allocation sequence Type of randomization; details of any restriction (such as blocking) Mechanism used to implement the random allocation sequence Whether or not participants, care providers, and those assessing outcomes were blinded to group assignment Number of participants randomized to each group Number of participants analyzed in each group For each outcome the estimated effect size and its precision e.g. 95% confidence intervals Analyzing groups exactly as randomized Important adverse events or side effects General interpretation of the results Registration number and name of trial registry Sources of funding and other support, role of funders P value and whether it is >0.05 or 0.05).

RESULTS A total of 163 RCTs were identified in the 6 leading implantology journals from January 1, 2008, to December 31, 2012 (Table 2). The majority of the RCTs were published in either the Clinical Oral Implants Research (42.9%) or the European Journal of Oral Implantology (27.0%). Most of the research was conducted in Europe (75.4%), while Africa and Australia reported the lowest rates (3.7%). The vast majority of RCTs were single centered (81.6%), with numerously more studies reporting nonsignificant main outcomes (68.7%) than not. In relation to the reporting items, most abstracts (92.0%) were structured with clear reporting of interventions (89.0%), objectives (77.9%) and conclusions (74.8%). On the contrary, insufficient reporting of the randomization procedures and allocation concealment, and failure to report confidence intervals, effect estimate and sources of funding were almost universal. Registration of RCTs 11

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TABLE 2. Characteristics of the 163 RCTs. Characteristic Journals

Continents

Authors (n)

Centers Statistical significance of main finding

Category

n

%

CIDRR COIR EJOI IDE/JOI JOMI Europe Asia Americas Africa-Australia 10 Single center Multi-center No Yes

13 70 44 9 27 123 19 15 6 73 85 5 133 30 112 51

8.0 42.9 27.0 5.5 16.6 75.4 11.7 9.2 3.7 44.8 52.2 3.0 81.6 18.4 68.7 31.3

CIDRR, Clinical Implant Dentistry and Related Research; COIR, Clinical Oral Implants Research; EJOI, European Journal of Oral Implantology; IDE, Implant Dentistry; JOI, Journal of Oral Implantology; JOMI, The International Journal of Oral and Maxillofacial Implants.

was not reported in any of the identified abstracts (Tables 2 and 3). The mean overall reporting quality score was 58.6% (95% CI: 57.6–59.7). The highest score was noted in the European Journal of Oral Implantology (63.8%, Table 4). Lower scores were found for Clinical Oral Implants Research (57.7%), The International Journal of Oral and Maxillofacial Implants (57.3%), Clinical Implant Dentistry and Related Research (55.0%), and Implant Dentistry and Journal of Oral Implantology (49.7%). Quality score comparisons were made between baseline (reference category) and each potential predictor, including journal of publication, continent of publication, and number of authors, single- or multi-center setting, and significant findings. Table 5 provides the results of the linear regression modeling. Univariate analyses revealed that trials published in the European Journal of Oral Implantology had significantly higher reporting quality scores compared with the other 5 journals. Additionally, studies published in Europe and multicenter studies had significantly higher modified CONSORT scores. Multivariate analysis demonstrated that reporting quality was significantly better in the European Journal of Oral Implantology than in the other journals (Table 5). In particular, abstract reporting was significantly better in the European Journal of Oral Implantology versus Implant Dentistry and Journal of Oral 12

Implantology (13.5%; 95% CI: 17.6 to 9.3), and versus the Clinical Implant Dentistry and Related Research (8.2%; 95% CI: 11.8 to 4.6). Scores in The International Journal of Oral and Maxillofacial Implants and in Clinical Oral Implants Research were 5.7% (95% CI: 8.5 to 2.9) and 5.8% (95% CI: 8.0 to 3.6) lower on average than in the European Journal of Oral Implantology respectively. The adjusted model indicated, also, that abstract quality reporting was significantly higher in multi-center studies (3.1%; 95% CI: 0.7–5.4) than in single-center. No significant associations were found in the multivariate model for other variables including continent, number of authors, or significance of main outcome measures.

DISCUSSION The results of the present study indicate that the quality of reporting in abstracts of RCTs in implant dentistry is not optimal. Overall, the average score of reported items in each RCT abstract, based on the modified by Fleming et al CONSORT for abstracts checklist,16 was 58.6%. The vast majority of the abstracts failed to report adequately the key features of the trial design, including the method of generating the allocation sequence, concealment of the allocation, or the estimated effect size and its precision for the primary outcome. Slightly more than the half of the RCT abstracts fully reported the title and the number of participants randomized. These findings generally concur with previous studies in dental literature.16,17 A recent study16 which assessed the reporting quality of RCT abstracts in orthodontics using the extended 21-item CONSORT checklist found near-perfect reporting of interventions (97.4%), objectives (93.2%), and number of participants randomized (95.7%). Allocation concealment, harms, and funding, almost failed to be reported in any of the abstracts. In addition, the title was inadequately reported in 45.3% of the studies.16 Conversely, in our study the title included the word ‘‘randomized’’ in more than 65% of the studies, being fully reported in 55.2% of them. Moreover, reporting of harms was adequate in 19.0% of the RCTs we assessed. Comparable were the results in a study reporting quality of RCT abstracts in periodontology and implantology journals, using a condensed 15-item checklist.17 Items such as interventions, objectives and conclusions were almost universally reported, while others (randomization, trial registration, and funding) were never reported.17 Sources of funding were adequately reported in 2.5% of the trials we examined, while, both previous studies16,17 reported entire absence of this item in the abstracts they assessed. Inadequate reporting of RCT abstracts seems to be an issue that concerns not only journals of dentistry, but medical as well. Reviews of RCT abstracts published in March 2014

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TABLE 3. Percentage distribution of scoring for each quality item in the 21-item CONSORT checklist for abstracts modified by Fleming et al16 (n ¼ 163). Item 1.Title 2. Structured 3. Trial design 4. Participants 5. Intervention 6. Objective 7. Outcome 8. Random number generation 9. Randomization restrictions 10. Allocation concealment 11. Blinding 12. Numbers randomized 13. Numbers analyzed 14. Effect estimate 15. Confidence intervals 16. Intention-to-treat analysis 17. Harms 18. Conclusions 19. Registration 20. Funding 21. P value

No description (%)

Inadequate (%)

Adequate (%)

31.3 2.5 27.0 2.5 0.6 0.6 20.3 96.9 94.5 99.4 77.3 42.4 75.5 86.5 93.9 98.8 77.3 2.5 100.0 97.5 56.5

13.5 5.5 42.9 35.0 10.4 21.5 55.2 0.6 1.2 0.0 1.2 1.8 9.2 8.6 0.6 0.0 3.7 22.7 0.0 0.0 6.7

55.2 92.0 30.1 62.5 89.0 77.9 24.5 2.5 4.3 0.6 21.5 55.8 15.3 4.9 5.5 1.2 19.0 74.8 0.0 2.5 36.8

medical journals revealed suboptimal reporting of numerous items and failed to strictly adhere to the CONSORT guidelines.18–20 However, higher levels of adequate reporting of topics, including effect size and confidence intervals (62.3%), harms (50.6%) and intention-to-treat analysis (22.5%), were noted in a survey of major general medical journals, conducted by Berwanger et al.18 Similar were the results found by Peron and colleagues in a systematic review of RCTs in medical oncology. Allocation concealment was reported in 51% of the trials, blinding in 41%, and the method used to generate randomization in 29% of the studies.19 Evidently, there is substantial difference in quality reporting of certain aspects between medical and dental abstracts, as criteria like effect size and randomization are particularly underreported in dental RCT abstracts. Several studies attempted to assess any improvement in the reporting quality of RCT abstracts published in both dental and medical journals since the CONSORT guideline was introduced.17,21 A survey conducted in anesthesia journals showed significant improvement in identification of blinding (18.2% vs. 29%) and harmful events (31.6% vs. 42.1%) in post-CONSORT abstracts.21 Faggion and Giannakopoulos, respectively, found significant changes in the reporting of title (20.11% vs. 38.76%, P ¼ 0.00) and trial design (32.07% vs. 20.57%, P < 0.01).17 Despite some promising improvement, the overall reportVolume 14, Number 1

ing quality and adherence to the CONSORT checklist were insufficient.17,21 Poor reporting in abstracts of medical and dental journal has been associated with lack of structure.22,23 Burns et al22 in an analysis of RCT abstracts related to acute lung injury, noted significantly higher mean reporting scores for structured compared with unstructured abstracts using three different checklists, the 32-item, the 20-item and the 12-item (P ¼ 0.008, 0.014, and

Assessing the reporting quality in abstracts of randomized controlled trials in leading journals of oral implantology.

Abstracts of randomized clinical trials are extremely important as trial appraisal is often based on the information included here. The objective of t...
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