1

Introduction

The importance of transparent reporting of research studies not least randomized controlled trials (RCTs) is well-established. The CONsolidated Standards of Reporting Trials (CONSORT) guidelines were directed at informing the reporting of RCTs . CONSORT has been endorsed by most leading journals with authors encouraged to adhere to recommendations within their submissions. Moreover, numerous modifications to CONSORT have been made to account for variations in trial design, setting and outcomes .

While CONSORT has become established and accepted, a plethora of research from biomedical specialties suggests that the published literature remains beset by poor reporting . In particular, reporting of trials published in the medical and dental literature have been suboptimal and, while some benefit has accrued from endorsement of reporting guidelines , expose the ineffectiveness of existing passive approaches to CONSORT compliance with more innovative or involved systems required to optimise reporting. This has spawned a range of initiatives including more involved editorial processes and automated means of improving reporting , with increased editorial involvement leading to considerable improvement in reporting of clinical trials within in a dental specialty journal .

The American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) has been proactive in promoting reporting in accordance with CONSORT with the approach to enhancing CONSORT compliance evolving in recent years. Initially (from June 2011), a systematic process involving the editor-in-chief (EiC), an associate editor (AE) and RCT authors was adopted whereby initial RCT submissions were first assessed by the AE to ensure all CONSORT items were reported completely following transfer from the EiC. The AE replied to the authors listing unreported items and highlighting ways to address incompletely reported items prior to resubmission. Resubmitted manuscripts were again scrutinized by the AE for CONSORT adherence and then sent for standard peer review. This initiative led to near complete reporting of most CONSORT items in published articles but did require significant input from the editorial team . Similar approaches may not, however, be applicable to other journals in view of the increased onus on editorial, time, input and expertise. In order to improve reporting at the submission level, the approach changed in January 2014 with the adoption of a publication template incorporating 20 subheadings corresponding to the 27 CONSORT items. A model clinical trial report and a specialty specific CONSORT explanation paper providing the rationale for reporting of individual items were also published .

As such, the present study examines the impact the use of subheadings based on CONSORT items on the reporting of clinical trials submitted to a dental specialty journal. We also aimed to highlight areas where deficient reporting within initial submissions exists.

2

Methods

The completeness of reporting was compared between RCTs submitted to AJO-DO with or without subheadings based on the CONSORT items. Both cohorts included all RCTs submitted for publication between the January 2014 and June 2016. The sample was divided based on whether the submission was presented in-line with suggested subheadings ( Table 1 ) . No inclusion restrictions in terms of trial design were applied. Two experienced researchers were involved in the data extraction process. Data from 10 papers were extracted independently and consensus was reached for training and calibration purposes. Consequently, the first author extracted all data from the remaining papers.

RCT reports were assessed based on whether they reported all items completely. Items were rated as either not reported, incompletely reported, or completely reported. Furthermore, a scoring system was used based on a modified and expanded CONSORT item list for the evaluation of quality of reporting, in line with a previous analysis . Scores for each item ranged from 1 to 3 with 1 indicating no description, a score of 2 representing inadequate description, and 3 indicative of adequate description. The scores for all 37 items were combined and a percentage score was derived. Non-applicable items did not receive any score. For example, the maximum for a trial with adequate description for all items was 111 corresponding to 100%. On the same basis, an RCT with 30 applicable items could receive a maximum score of 90, also equivalent to 100%. Subsequently, each item was converted to a binary variable to enable comparison of RCTs submitted with subheadings to those without subheadings for each reporting item using a dichotomous measure (i.e. adequate reporting vs no reporting/inadequate reporting).

Descriptive statistics and frequency distributions of compliance with CONSORT items were reported for both cohorts. A t -test was conducted to identify differences in reporting scores between submissions with and without subheadings. All analyses were carried out using Stata 14.1 (Stata Corp, College Station, TX, USA), with the level of statistical significance set at p = 0.05.

2

Methods

The completeness of reporting was compared between RCTs submitted to AJO-DO with or without subheadings based on the CONSORT items. Both cohorts included all RCTs submitted for publication between the January 2014 and June 2016. The sample was divided based on whether the submission was presented in-line with suggested subheadings ( Table 1 ) . No inclusion restrictions in terms of trial design were applied. Two experienced researchers were involved in the data extraction process. Data from 10 papers were extracted independently and consensus was reached for training and calibration purposes. Consequently, the first author extracted all data from the remaining papers.

RCT reports were assessed based on whether they reported all items completely. Items were rated as either not reported, incompletely reported, or completely reported. Furthermore, a scoring system was used based on a modified and expanded CONSORT item list for the evaluation of quality of reporting, in line with a previous analysis . Scores for each item ranged from 1 to 3 with 1 indicating no description, a score of 2 representing inadequate description, and 3 indicative of adequate description. The scores for all 37 items were combined and a percentage score was derived. Non-applicable items did not receive any score. For example, the maximum for a trial with adequate description for all items was 111 corresponding to 100%. On the same basis, an RCT with 30 applicable items could receive a maximum score of 90, also equivalent to 100%. Subsequently, each item was converted to a binary variable to enable comparison of RCTs submitted with subheadings to those without subheadings for each reporting item using a dichotomous measure (i.e. adequate reporting vs no reporting/inadequate reporting).

Descriptive statistics and frequency distributions of compliance with CONSORT items were reported for both cohorts. A t -test was conducted to identify differences in reporting scores between submissions with and without subheadings. All analyses were carried out using Stata 14.1 (Stata Corp, College Station, TX, USA), with the level of statistical significance set at p = 0.05.

3

Results

Over the 30-month period (January 2014–June 2016), a total of 71 RCTs were submitted to the AJO-DO and assessed for completeness of reporting. Forty- nine of these initial submissions incorporated subheadings, while 22 did not. The majority of submission were from authors in Asia/Other regions (n = 41; 58%), with 23% (n = 16) from the Americas and 20% (n = 14) from Europe.

A number of pivotal items were more frequently adequately reported when RCTs were submitted with inclusion of subheadings ( Table 2 ). In particular, sample size (subheadings: 25/49, 51%; no subheadings: 6/22, 27%), random sequence generation (subheadings: 33/49, 67% vs no subheadings: 9/22, 41%), allocation concealment (subheadings: 21/49, 43%; no subheadings: 4/22, 18%), blinding (subheadings: 42/49, 86% vs no subheadings: 12/22, 55%), CONSORT flow diagram (subheadings: 40/49, 82% vs no subheadings: 9/22, 41%), baseline information table (subheadings: 37/49, 76%; no subheadings: 11/22, 50%), study limitations (subheadings: 42/49, 86%; no subheadings: 8/22, 36%) and generalizability (subheadings: 38/49, 78% vs no subheadings: 3/22, 14%) were more commonly adequately reported in submissions incorporating subheadings. Notwithstanding this, items such as sample size, allocation concealment or estimates/confidence intervals remain in need of a considerable improvement in reporting ( Table 2 ).

Table 2

Frequency distributions on reporting of items based on the CONSORT checklist and included in the subheadings, according to the structure of the manuscript at initial submission.

	Presence of subheadings at submission stage
	No		Yes		Total
	No.	%	No.	%	No.	%
Title
Adequate	6	27	46	94	52	73
Inadequate	16	73	3	6	19	27
Structured Abstract
Adequate	4	18	42	86	46	65
Inadequate	18	82	7	14	25	35
Background
Adequate	19	86	48	98	67	94
Inadequate	3	14	1	2	4	6
Introduction
Adequate	18	82	47	96	65	92
Inadequate	4	18	2	4	6	8
Objective
Adequate	20	91	48	98	68	96
Inadequate	2	9	1	2	3	4
Trial Design
Adequate	11	50	41	84	52	73
Inadequate	8	36	8	16	16	23
No description	3	14	0	0	3	4
Changes after trial commencement
Adequate	0	0	2	4	2	3
Non-applicable	21	95	47	96	68	96
No description	1	5	0	0	1	1
Eligibility criteria
Adequate	22	100	49	100	71	100
Settings
Adequate	18	82	48	98	66	93
Inadequate	2	9	1	2	3	4
No description	2	9	0	0	2	3
Interventions
Adequate	22	100	48	98	70	99
Inadequate	0	0	1	2	1	1
Outcomes
Adequate	21	95	47	96	68	96
Inadequate	1	5	1	2	2	3
No description	0	0	1	2	1	1
Outcome changes
Adequate	0	0	1	2	1	1
Non-applicable	22	100	48	98	70	99
Sample Size
Adequate	6	27	25	51	31	44
Inadequate	14	64	23	47	37	52
No description	2	9	1	2	3	4
Interim analysis
Adequate	0	0	2	4	2	3
Non-applicable	22	100	47	96	69	97
Random number generation
Adequate	9	41	33	67	42	59
Inadequate	10	45	16	33	26	37
No description	3	14	0	0	3	4
Restrictions in randomization
Adequate	6	27	13	27	19	27
Inadequate	0	0	4	8	4	6
No description	16	73	32	65	48	68
Allocation Concealment
Adequate	4	18	21	43	25	35
Inadequate	6	27	15	31	21	30
No description	12	55	13	27	25	35
Implementation of Randomization
Adequate	8	36	27	55	35	49
Inadequate	1	5	14	29	15	21
No description	13	59	8	16	21	30
Blinding
Adequate	12	55	42	86	54	76
Inadequate	2	9	3	6	5	7
Non-applicable	1	5	2	4	3	4
No description	7	32	2	4	9	13
Similarity of Interventions
Adequate	3	14	6	12	9	13
Inadequate	1	5	1	2	2	3
Non-applicable	16	73	40	82	56	79
No description	2	9	2	4	4	6
Statistical Methods
Adequate	13	59	33	67	46	65
Inadequate	9	41	16	33	25	35
Subgroup analysis
Adequate	2	9	2	4	4	6
Inadequate	1	5	2	4	3	4
Non-applicable	19	86	44	90	63	89
No description	0	0	1	2	1	1
Flow Diagram with reason
Adequate	9	41	40	82	49	69
Inadequate	2	9	9	18	11	15
No description	11	50	0	0	11	15
Recruitment Dates
Adequate	7	32	41	84	48	68
No description	15	68	8	16	23	32
Premature trial stop
Adequate	0	0	1	2	1	1
Non-applicable	22	100	48	98	70	99
Baseline Table
Adequate	11	50	37	76	48	68
Inadequate	4	18	8	16	12	17
No description	7	32	4	8	11	15
Intention-to-treat
Adequate	2	9	6	12	8	11
Inadequate	2	9	5	10	7	10
No description	18	82	38	78	56	79
Estimates/Confidence Intervals
Adequate	3	14	10	20	13	18
Inadequate	0	0	8	16	8	11
No description	19	86	31	63	50	70
If Binary Outcome/absolute numbers
Adequate	1	5	6	12	7	10
Non-applicable	21	95	43	88	64	90
Ancillary analysis
Adequate	0	0	1	2	1	1
Inadequate	1	5	1	2	2	3
Non-applicable	21	95	47	96	68	96
Harms
Adequate	4	18	32	65	36	51
Inadequate	3	14	2	4	5	7
Non-applicable	3	14	12	24	15	21
No description	12	55	3	6	15	21
Limitations
Adequate	8	36	42	86	50	70
Inadequate	3	14	1	2	4	6
No description	11	50	6	12	17	24
Generalizability
Adequate	3	14	38	78	41	58
Inadequate	3	14	3	6	6	8
No description	16	73	8	16	24	34
Interpretation
Adequate	10	45	43	88	53	75
Inadequate	11	50	6	12	17	24
No description	1	5	0	0	1	1
Registration
Adequate	5	23	8	16	13	18
Inadequate	0	0	2	4	2	3
Non-applicable	5	23	33	67	38	54
No description	12	55	6	12	18	25
Protocol
Adequate	3	14	5	10	8	11
Inadequate	1	5	2	4	3	4
Non-applicable	6	27	37	76	43	61
No description	12	55	5	10	17	24
Funding
Adequate	8	36	17	35	25	35
Non-applicable	5	23	28	57	33	46
No description	9	41	4	8	13	18
Total	22	100	49	100	71	100

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