Adherence to the CONSORT Statement in the Reporting of Randomized Controlled Trials on Pharmacological Interventions Published in Iranian Medical Journals.
IntroductionMany manuscripts with various methodologies are submitted to biomedical journals annually. Among such manuscripts, randomized controlled trials (RCTs) are the backbone of evidence-based medicine. According to Bastian and colleagues, (1) the number of RCTs is on the increase. Hence, their protocols should be designed meticulously and their results should be reported clearly.
To improve the quality of RCT reporting, a group of methodologists, epidemiologists, statisticians, and researchers developed the Consolidated Standards of Reporting Trials (CONSORT) Statement in 1996, (2) which was updated in 2001 (3) and then in 2010. (4)
According to previous studies, the adherence of RCTs to the CONSORT Checklist was not sufficient. (5-8) Indeed, although there have been few reports on the quality of pharmacological RCTs published in Iranian medical journals so far, all of them have reported poor adherence to the CONSORT Statement. (9-11) Given the rise in the number of articles published in Iran, (12,13) we aimed to evaluate the extent of adherence to the CONSORT Statement in pharmacological RCTs published in Iranian medical journals from September 2012 to September 2013. We also sought to address the fact that there were no reports on the comparison of adherence to CONSORT between articles in English and in Persian.
On the other hand, some researchers have reported that adherence to CONSORT 2010 among CONSORT-endorsing journals is more sufficient than that among other journals. (5,14-18) Therefore, we decided to assess adherence to CONSORT 2010 among articles published in Iranian CONSORT-endorsing medical journals in the mentioned period.
Materials and Methods
In this cross-sectional study, we analyzed the content of all published articles in all Iranian medical journals ranked as "scientific" by the Iranian Commission for Accreditation of Medical Journals, affiliated to the Iranian Ministry of Health and Medical Education from September 2012 to September 2013. Three out of 296 journals were excluded because their publishing date was not within this period, they had no accurate contact information, or they lacked an active website. One hundred twenty-three journals contained pharmacological RCTs. The title of each journal was searched via Google, Yahoo, Bing, and Web Search to retrieve articles meeting our inclusion criteria from the journal sites. Out of 14,964 articles published in the journals, 493 reported pharmacological interventions.
All RCTs with pharmacological interventions were selected based on the study design described in the method section of the articles, although the authors might have mistakenly described their studies as experimental, semi-experimental, quasi-experimental, interventional, case control, or even cohort studies. Some articles that mentioned no specific design were included if their study method was compatible with RCTs.
Non-randomized, community, crossover, field, non-human, and before-after trials were excluded.
In 44 articles, a pharmacological intervention was compared with a non-pharmacological or herbal intervention. Fourteen of these articles whose authors aimed to evaluate the efficacy of pharmacological interventions were included. Of all the pharmacological RCTs, 213 articles were written in the English language and 280 in the Persian language.
Additionally, the instructions for authors specified by all the mentioned journals were reviewed to determine whether or not they demanded implementation of the CONSORT Statement. Of 123 journals publishing pharmacological articles, 12 were CONSORT-endorsing; all of them were in the English language.
The CONSORT Statement 2010 was downloaded from www.CONSORT-statement. org. (4) The original CONSORT Checklist has 25 items. Considering that some items consisted of several sections, we subdivided them to assess the RCTs more accurately. Accordingly, a checklist with 51 items was prepared and the articles were evaluated on the basis of whether or not they reported the items existing in the checklist.
Microsoft Excel 2007 was employed to enter and analyze the data. A score of 1 was allocated to the items reported and a score of 0 to those not reported. In case of the non-applicability of an item for reporting, the related cell in the software was only highlighted.
The frequencies and the percentiles for all the reported, not reported, and non-applicable items were calculated. The procedure was thereafter repeated for the English and Persian language articles and those published in the CONSORT-endorsing and non-CONSORT-endorsing journals.
The [x.sup.2] test was applied to compare the proportions of each item between the English and Persian language articles and between those published in the CONSORT-endorsing and non-CONSORT-endorsing journals. MedCalc (version 8.0.0.0, MedCalc Software, Belgium) was used for these comparisons. A P value less than 0.05 was considered statistically significant.
The confidentiality of the authors and journals was taken into consideration.
Results
In the mentioned period, 493 pharmacological RCTs were published in Iranian medical journals. The adherence of the above-mentioned articles to CONSORT 2010 is shown in table 1. Twenty-five items were reported in fewer than 50% of the articles. Scientific background was reported in all the articles, and none of them declared where the full trial protocol could be accessed. Most of the underreported items were related to the method and the result parts of the checklist.
Eleven articles only reported the setting of the study and the locations were not reported; of them 6 were in the Persian language and 5 in the English language. In 2 articles, no description was available for the second arm of the trial (1 in the English language and 1 in the Persian language articles).
A clear "hypothesis" was mentioned in only 24 articles (4 in the Persian language and 20 in the English language articles).
Table 2 compares the items of non-adherence between the Persian and English language articles. The differences between the 2 groups were statistically significant in 17 items.
Thirty-two articles were published in CONSORT-endorsing journals. Table 3 compares the items of non-adherence between the CONSORT-endorsing and non-CONSORT-endorsing journals. The differences between these 2 groups of journals were significant just in 8 items.
Discussion
In the present study, we drew upon CONSORT 2010 to evaluate pharmacological RCTs with respect to their adherence to all the 51 items of the checklist. We found that the evaluated articles could have adhered more to CONSORT 2010 had they been conducted more meticulously. Using a CONSORT 2010 Checklist with 37 items, Nojomi and colleagues (10) assessed the quality of reporting in RCTs published in Iranian medical journals from 2008 to 2010 and reported poor adherence among the articles; this finding chimes in with the results of our study. Nevertheless, there are differences between their study and ours. First, they used CONSORT 2010 to assess the articles published in the preceding years, which may have affected the results. Second, they evaluated adherence to 37 items, while we checked all the 51 items, aiming to increase the accuracy of the study findings. Third, whereas they used CONSORT 2010 for all types of RCTs, we categorized RCTs to pharmacological, non-pharmacological, and herbal and devised specific subcategories for each type. In this study, pharmacological studies are reported and presented.
In another report from Iran, Ayatollahi et al. (9) focused on only 4 items of CONSORT in 25 Iranian medical journals. They reported no adherence to all those items in the assessed journals. Our study seems to be more comprehensive than the aforementioned ones because we surveyed all the items in all Iranian medical journals.
Hopewell and coworkers (19) compared adherence to the CONSORT 2001 Checklist between RCTs indexed in PubMed in 2000 and those indexed in 2006. They concluded that although several items were reported more frequently in 2006, in general the quality of reporting was not acceptable. This result is in line with our findings.
Mills and others (20) evaluated adherence to 12 items of the CONSORT 2001 Checklist in 193 published RCTs and reported poor adherence.
Ahmadzadeh and colleagues (21) randomly selected 50 RCTs published in 5 high-rank journals and used CONSORT 2010 to assess the quality of reporting of all kinds of RCTs. Likewise, Mills and others (7) evaluated adherence to only 7 methodological items of the CONSORT 2001 Statement among RCTs published in 5 journals with the highest impact factor. Elsewhere, Uetani et al. (5) in their study concluded that the RCTs published in Japanese Journals in early 2004 failed to adhere to CONSORT.
Smith and others (6) assessed the quality of reporting in 96 RCTs published in 4 nursing journals in 2006 via the CONSORT 2001 Checklist by subdividing some of the items of the checklist for better evaluation and constructing a 48-item checklist. They found that only 15 out of the 48 items were reported by more than 75% of the reviewed articles. Their method is somehow similar to ours insofar as they subdivided the items to reach more comprehensive findings. Their findings are more similar to ours as.
In another study from London, adherence to CONSORT 2010 among RCTs on solid organ transplantation published in the period between 2007 and 2009 was evaluated. The results demonstrated that adherence to the items was poor. In contrast to our study, the researchers excluded non-English language articles and did not subcategorize the RCTs using specific types of CONSORT. (8)
We compared adherence to the CONSORT 2010 Checklist between 280 Persian language articles and 213 English language articles and found that the differences between the 2 groups were statistically significant in 17 items. Most of these items were reported more frequently in the English language articles than in the Persian language ones. To the best of our knowledge, there are few studies comparing adherence to CONSORT between RCTs in the English language and other languages. (22,23) Junker (23) compared RCTs conducted in German and English. Because the publication years of the evaluated articles predated the development of the CONSORT Checklist, the researcher did not use the CONSORT Statement and concluded that there was no difference between these 2 groups of RCTs. Klassen and others (22) compared quality between English and non-English language (Danish, Dutch, French, German, Italian, Japanese, and Spanish) RCTs. They did not use CONSORT for the assessment because of the year of publication and arrived at the conclusion that the English language RCTs enjoyed better quality. We believe that using a structural guideline such as CONSORT to compare English language articles with non-English language ones may yield more accurate findings. This approach can be the strength of our study.
To our knowledge, since the development of the CONSORT Checklist, the present study is the first assessment and comparison of adherence to CONSORT between English and Persian RCTs. This is all but a truism that English language articles should be reported with acceptable quality because they are meant to be published in journals with international readers. Indeed, such articles should endeavor to report accurate information for citation and use in meta-analyses. In our study, although some items were reported more frequently in the English language articles, most of the items did not adhere to the checklist. It would, therefore, be reasonable to suggest that Iranian medical editors pay heed to the CONSORT guidelines as an important tool that can boost the visibility of their published RCTs.
Having evaluated 493 pharmacological RCTs published in 296 Iranian medical journals during a 1-year period, we can claim that the current study boasts the largest sample size of all the studies hitherto conducted in this field. In previous similar studies, only 80 journals, (10) 25 journals, (9) 4 high-impact-factor pharmacological journals, (20) 4 high-rank journals, (24) 5 high-rank journals, (7,21) 71 Japanese journals, (5) and 20 RCTs published in the Journal of Cardiology (25) were evaluated. In light of the aforesaid studies, we can assert that another salient strong point of our study is the evaluation of a larger number of articles and journals.
Low adherence to the CONSORT Statement among the RCTs in our selected journals by comparison with those published in high-rank journals reported by Ahmadzadeh and colleagues, (21) Mills and others, (7) and Han et al. (26) can be explained by the fact that high-rank journals usually receive and select RCTs with the utmost quality.
A developing country with a considerable number of journals, Iran can be representative of other countries in the Eastern Mediterranean Region. Therefore, our findings propose poor adherence to CONSORT in published pharmacological RCTs can be generalized to other RCTs published in other regional countries. It is worth mentioning that the Iranian Ministry of Health and Medical Education attaches great significance to enhancing the quality of articles published in Iranian medical journals. The fact that despite such emphasis the quality of RCTs in our region falls short of the standards set by high-rank journals underscores the need for more rigorous supervision.
We did not calculate the average adherence of the evaluated RCTs compared with what Nojomi, Ahmadzadeh, and Han and others did. (10,21,26) We think that each item in the CONSORT Checklist carries a significant weight. For example, randomization, blinding, sample size determination, flow diagram, and registration number are important methodological items that can weigh differently in different studies; hence, reporting the whole score may not show the overall quality of the reported RCTs.
In the present study, we compared adherence between RCTs published in CONSORT-endorsing journals and those published in non-CONSORT-endorsing ones and found that the 2 groups were meaningfully different in terms of adherence in 8 items. All of the 8 items were reported more frequently in the articles published in the CONSORT-endorsing journals. Overall, adherence to the CONSORT 2010 Checklist was not sufficient in the 2 groups.
Pandis et al. (18) in their study concluded that the articles published in the period after the implementation of CONSORT reported more items. Miller and others (27) compared general medical journals and specialty journals that endorsed CONSORT and concluded that both groups failed to properly implement CONSORT in reporting trials. Turner and coworkers (17) compared RCTs published in CONSORT-endorsing journals with those published in non-CONSORT-endorsing journals and concluded that the former group might help authors to report more adherent RCTs, although it did not mean that the RCTs published in CONSORT-endorsing journals were reported sufficiently.
First and foremost among the strengths of the current study is that we assessed all the 25 items of the CONSORT Statement together with all their respective subcategories. Such comprehensive evaluation has not yet been done on the CONSORT guidelines. There are, nevertheless, some limitations in our study. When the websites of some journals were not available, we referred to www.magiran.com or www.sid.org. Whenever we found articles comparing drug interventions with herbal or non-pharmacological interventions we used a checklist suitable for the dominant intervention. Another drawback of note is that the low number of the articles published in CONSORT-endorsing journals may have affected the results of the comparisons.
Conclusion
Adherence to the CONSORT Statement among our selected RCTs, published in Persian and English in Iranian medical journals, was not sufficient. In addition, the articles published in both CONSORT-endorsing and non-CONSORT-endorsing journals failed to adhere to CONSORT adequately. We would recommend that authors, reviewers, and editors seek out further training in the proper implementation of the CONSORT statement and that editors be sure to endorse CONSORT in their instructions for authors and monitor adherence to it. What would also be beneficial is the development of a checklist suitable for reporting pharmacological interventions comparing herbal, non-pharmacological, and acupunctural interventions.
Acknowledgment
This article was derived from an MSc thesis by Dr. Pooneh Sarveravan in the field of medical journalism, and it was approved and financially supported by the Vice Chancellery for Research Affairs of Shiraz University of Medical Sciences. We acknowledge Professor Mehrdad Askarian for his idea in reviewing the instructions for authors and Dr. Peyman Jafari for his idea in the comparison of the English language RCTs with Persian language RCTs.
Conflict of Interest: None declared.
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Pooneh Sarveravan (1), MD, MSc;
Behrooz Astaneh (1), MD;
Nasrin Shokrpour (2), PhD
(1) Department of Medical Journalism, School of Paramedical, Shiraz University of Medical Sciences, Shiraz, Iran;
(2) Department of English Language, School of Paramedical, Shiraz University of Medical Sciences, Shiraz, Iran
Correspondence:
Behrooz Astaneh, MD; Department of Medical Journalism, School of Paramedical, Meshkinfam Street, Zip code: 71439-14693, Shiraz, Iran
Tel: +98 71 32294720
Fax: +98 71 32279781
Email: [email protected]
Received: 22 April 2017
Revised: 27 May 2017
Accepted: 28 May 2017
What's Known
* Randomized controlled trials (RCTs) are the backbone of evidence-based medicine. All RCT reports should adhere to the standard checklist of CONSORT.
What's New
* Adherence to CONSORT among RCTs published in Iranian medical journals (in English and Persian) was not sufficient.
* Articles published in the CONSORT-endorsing and non-CONSORT-endorsing journals did not adhere adequately to CONSORT.
Table 1: Adherence to the CONSORT 2010 checklist among the evaluated
pharmacological randomized controlled trials
Items Checklist items
1a 1 Identification as a randomized trial in the title
1b 2 Structured summary of the trial design, methods, results,
and conclusions
2a 3 Scientific background and explanation of rationale
2b 4 Specific objectives or hypotheses
3a 5 Description of the trial design (e.g., parallel and
factorial)
6 Allocation ratio
3b 7 Important changes to the methods after trial
commencement (e.g., eligibility criteria), with reasons
4a 8 Eligibility criteria for the participants
4b 9 Settings and locations where the data were collected
5 10 Interventions for each group with sufficient details to allow
replication, including how and when they were actually
administered
6a 11 Completely defined pre-specified primary outcome
measures
12 Completely defined pre-specified secondary outcome
measures
13 How and when they were assessed
6b 14 Any changes to the trial outcomes after the trial
commenced, with reasons
7a 15 How the sample size was determined
7b 16 When applicable, explanation of any interim analyses and
stopping guidelines
8a 17 Method used to generate the random allocation sequence
8b 18 Type of randomization and details of any restriction
(e.g., blocking and block size)
9 19 Mechanism used to implement the random allocation
sequence (e.g., sequentially numbered containers) and
describing any steps taken to conceal the sequence until
interventions were assigned
10 20 Who generated the random allocation sequence
21 Who enrolled the participants
22 Who assigned the participants to interventions
11a 23 If done, who was blinded after assignment to
interventions (e.g., participants, care providers, and those
assessing the outcomes) and how
11b 24 If relevant, description of the similarity of the
interventions
12a 25 Statistical methods used to compare the groups for the
primary and secondary outcomes
12b 26 Methods for additional analyses such as subgroup
analyses and adjusted analyses
13a 27 For each group, the number of the participants who were
randomly assigned
28 For each group, the number of the participants who
received the intended treatment
29 For each group, the number of the participants who
completed the study protocol
13a 30 For each group, the number of the participants who were
analyzed for the primary outcome
13b 31 For each group, losses and exclusions after randomization
together with reasons
14a 32 Dates defining the periods of recruitment
33 Dates defining the periods of follow-up
14b 34 Why the trial ended or was stopped
15 35 A table showing baseline demographic and clinical
characteristics for each group
16 36 Flow diagram
17a 37 For each group, the number of the
participants (denominator) included in each analysis and
whether the analysis was by the original assigned groups
38 For each primary and secondary outcome, results for each
group
39 Estimated effect size
40 Its precision (e.g., 95% confidence interval)
17b 41 For binary outcomes, presentation of absolute effect sizes
17b 42 For binary outcomes, presentation of relative effect sizes
18 43 Results of any other analyses performed, including
subgroup analyses and adjusted analyses, distinguishing
pre-specified from exploratory
19 44 All important harms or unintended effects in each group
20 45 Trial limitations, addressing sources of potential bias,
imprecision, and, if relevant, multiplicity of analyses
21 46 Generalizability (external validity and applicability) of the
trial findings
22 47 Interpretation consistent with the results, balancing
benefits and harms, and considering other relevant
evidence
23 48 Registration number
24 49 Name of the trial registry
50 Where the full trial protocol can be accessed, if available
25 51 Sources of funding and other support (such as supply of
drugs) and the role of the funders
n (%)
Reported (n=493) Not reported Not
applicable
1a 117 (23.73) 376 (76.27) 0
1b 480 (97.36) 13 (2.64) 0
2a 493 (100) 0 0
2b 483 (97.97) 10 (2.03) 0
3a 491 (99.59) 2 (0.41) 0
15 (3.04) 478 (96.96) 0
3b 0 0 493 (100)
4a 491 (99.59) 2 (0.41) 0
4b 419 (84.99) 74 (15.01) 0
5 490 (99.39) 3 (0.61) 0
6a 48 (9.74) 445 (90.26) 0
38 (7.71) 455 (92.29) 0
487 (98.78) 6 (1.22) 0
6b 1 (0.20) 0 492 (99.80)
7a 167 (33.87) 326 (66.13) 0
7b 1 (0.20) 0 492 (99.80)
8a 174 (35.29) 319 (64.71) 0
8b 64 (12.98) 429 (87.02) 0
9 64 (12.98) 319 (64.71) 0
10 13 (2.64) 480 (97.36) 0
4 (0.81) 489 (99.19) 0
16 (3.25) 477 (96.75) 0
11a 285 (57.81) 208 (42.19) 0
11b 404 (81.95) 49 (9.94) 40 (8.11)
12a 484 (98.17) 9 (1.83) 0
12b 137 (27.79) 356 (72.21) 0
13a 473 (95.94) 4 (4.06) 0
289 (58.62) 204 (41.38) 0
142 (28.80) 351 (71.20) 0
13a 179 (36.31) 314 (63.69) 0
13b 192 (38.96) 301 (61.05) 0
14a 286 (58.01) 207 (41.99) 0
476 (96.55) 17 (3.45) 0
14b 1 (0.20) 0 492 (99.80)
15 304 (61.66) 189 (38.34) 0
16 74 (15.01) 419 (84.99) 0
17a 162 (32.86) 331 (67.14) 0
491 (99.59) 2 (0.41) 0
3 (0.61) 490 (99.39) 0
42 (8.52) 451 (91.48) 0
17b 2 (0.41) 39 (7.91) 452 (91.68)
17b 15 (3.04) 26 (5.27) 452 (91.68)
18 99 (20.08) 394 (79.92) 0
19 285 (57.81) 208 (42.19) 0
20 214 (43.41) 279 (56.59) 0
21 239 (48.48) 204 (41.38) 50 (10.14)
22 490 (99.39) 3(0.61) 0
23 196 (39.76) 297 (60.24) 0
24 154 (31.24) 339 (68.76) 0
0 493 (100) 0
25
174 (35.29) 319 (64.71) 0
Table 2: (Continued)
Items Checklist items
1a 1 Identification as a randomized trial in the title
1b 2 Structured summary of the trial design,
methods, results, and conclusions
2a 3 Scientific background and explanation of
rationale
2b 4 Specific objectives or hypotheses
3a 5 Description of the trial design (e.g., parallel
and factorial)
6 Allocation ratio
3b 7 Important changes to the methods after trial
commencement (e.g., eligibility criteria), with
reasons
4a 8 Eligibility criteria for the participants
4b 9 Settings and locations where the data were
collected
5 10 Interventions for each group with sufficient
details to allow replication, including how
and when they were actually administered
6a 11 Completely defined pre-specified primary
outcome measures
12 Completely defined pre-specified secondary
outcome measures
13 How and when they were assessed
6b 14 Any changes to the trial outcomes after the
trial commenced, with reasons
7a 15 How the sample size was determined
7b 16 When applicable, explanation of any interim
analyses and stopping guidelines
8a 17 Method used to generate the random
allocation sequence
8b 18 Type of randomization and details of any
restriction (e.g., blocking and block size)
9 19 Mechanism used to implement the random
allocation sequence (e.g., sequentially
numbered containers), describing any
steps taken to conceal the sequence until
interventions were assigned
10 20 Who generated the random allocation
sequence
21 Who enrolled the participants
22 Who assigned the participants to
interventions
11a 23 If done, who was blinded after assignment
to interventions (e.g., participants, care
providers, and those assessing the
outcomes) and how
11b 24 If relevant, description of the similarity of
interventions
12a 25 Statistical methods used to compare the
groups for the primary and secondary
outcomes
12b 26 Methods for additional analyses such as
subgroup analyses and adjusted analyses
13a 27 For each group, the number of the
participants who were randomly assigned
28 For each group, the number of the
participants who received the intended
treatment
29 For each group, the number of the
participants who completed the study
protocol
13a 30 For each group, the number of the
participants who were analyzed for the
primary outcome
13b 31 For each group, losses and exclusions after
randomization, together with reasons
14a 32 Dates defining the periods of recruitment
33 Dates defining the periods of follow-up
14b 34 Why the trial ended or was stopped
15 35 A table showing baseline demographic and
clinical characteristics for each group
16 36 Flow diagram
17a 37 For each group, number of the
participants (denominator) included in each
analysis and whether the analysis was by
the original assigned groups
38 For each primary and secondary outcome,
results for each group
39 Estimated effect size
40 Its precision (e.g., 95% confidence interval)
17b 41 For binary outcomes, presentation of
absolute effect sizes
17b 42 For binary outcomes, presentation of
relative effect sizes
18 43 Results of any other analyses performed,
including subgroup analyses and adjusted
analyses, distinguishing pre-specified from
exploratory
19 44 All important harms or unintended effects in
each group
20 45 Trial limitations, addressing sources of
potential bias, imprecision, and, if relevant,
multiplicity of analyses
21 46 Generalizability (external validity and
applicability) of the trial findings
22 47 Interpretation consistent with the results,
balancing benefits and harms, and
considering other relevant evidence
23 48 Registration number
49 Name of the trial registry
24 50 Where the full trial protocol can be
accessed, if available
25 51 Sources of funding and other support (e.g.,
supply of drugs) and the role of the funders
Not reported n(%) P value (confidence
Persian English articles interval)*
articles (n=280) (n=213)
1a 240 (85.71) 136 (63.85) <0.0001 (14.22-29.50)
1b 0 13 (6.10) 0.0001 (2.89-9.32)
2a 0 0 -
2b 7 (2.50) 3 (1.41) 0.59 (-1.32-3.51)
3a 1 (0.36) 1 (0.47) 0.60 (-1.41-1.27)
277 (98.93) 201 (94.37) 0.0079 (1.23-7.88)
3b 0 0 -
4a 2 (0.71) 0 0.60 (-0.27-1.69)
4b 39 (13.93) 35 (16.43) 0.52 (-3.91-8.92)
5 2 (0.71) 1 (0.47) 0.81 (-1.10-1.59)
6a 270 (96.43) 175 (82.16) <0.0001 (8.68-19.85)
270 (96.43) 185 (86.85) 0.0002 (4.54-14.61)
3 (1.07) 3 (1.41) 0.93 (-1.65-2.32)
6b 0 0 -
7a 185 (66.07) 141 (66.20) 0.94 (-8.30-8.55)
7b 0 0 -
8a 190 (67.86) 129 (60.56) 0.11 (-1.24-15.84)
8b 250 (89.29) 179 (89.04) 0.11 (-0.86-11.35)
9 256 (91.43) 173 (81.22) 0.0013 (4.02-16.39)
10 276 (98.57) 204 (95.77) 0.10 (-0.24-5.83)
279 (99.64) 210 (98.59) 0.43 (-0.67-2.78)
269 (96.07) 208 (97.65) 0.46 (-1.47-4.63)
11a 118 (42.14) 90 (42.25) 0.94 (-8.69-8.91)
11b 20 (7.14) 28 (13.16) 0.03 (0.55-11.44)
12a 8 (2.86) 1 (0.47) 0.10 (0.23-4.54)
12b 208 (74.26) 148 (69.48) 0.28 (-3.22-12.82)
13a 12 (4.29) 8 (3.76) 0.94 (-2.99-4.01)
159 (56.79) 45 (21.13) <0.0001 (27.67-43.63)
222 (79.29) 129 (60.56) <0.0001 (10.62-26.82)
13a 113 (53.05) 201 (71.79) <0.0001 (10.20-27.25)
13b 192 (68.57) 109 (51.17) 0.0001 (8.76-26.03)
14a 76 (35.68) 131 (46.79) 0.01 (2.40-19.79)
8 (2.86) 9 (4.23) 0.56 (-14.96-4.69)
14b 0 0 -
15 127 (45.36) 62 (29.11) 0.0003 (7.81-24.68)
16 268 (95.71) 151 (70.89) <.0001 (18.27-31.36)
17a 75 (75.71) 119 (55.87) <.0001 (11.52-28.22)
1 (0.36) 1 (0.36) 0.60 (-1.41-1.26)
279 (99.64) 211 (99.06) 0.81 (-0.89-2.05)
257 (91.76) 194 (91.07) 0.90 (-4.29-5.70)
17b 16 (5.71) 21 (9.86) 0.11 (-0.69-8.98)
17b 9 (3.21) 15 (7.04) 0.08 (-0.18-7.83)
18 230 (82.14) 164 (77.00) 0.19 (-2.69-12.36)
19 134 (47.86) 74 (34.74) 0.0047 (4.44-21.78)
20 174 (62.14) 105 (49.30) 0.0058 (4.05-21.64)
21 117 (41.79) 87 (40.85) 0.90 (-7.83-9.71)
22 1 (0.36) 2 (0.94) 0.81 (-0.89-2.05)
23 163 (58.21) 134 (62.91) 0.33 (-3.98-13.38)
189 (67.50) 150 (70.42) 0.55 (-5.30-11.14)
24 280 (100) 213 (100) -
25 188 (67.14) 131 (61.50) 0.22 (-5.30-11.14)
*[X.sup.2] test
Table 3: Comparison of the items of non-adherence to the CONSORT 2010
checklist between the evaluated pharmacological randomized controlled
trials (RCTs) published in the CONSORT-endorsing and
non-CONSORT-endorsing journal
Items Checklist items
1a 1 Identification as a randomized trial in
the title
1b 2 Structured summary of the trial
design, methods, results, and
conclusions
2a 3 Scientific background and explanation
of rationale
2b 4 Specific objectives or hypotheses
3a 5 Description of the trial design
(e.g., parallel and factorial)
6 Allocation ratio
3b 7 Important changes to the methods
after trial commencement
(e.g., eligibility criteria), with reasons
4a 8 Eligibility criteria for the participants
4b 9 Settings and locations where the data
were collected
5 10 Interventions for each group with
sufficient details to allow replication,
including how and when they were
actually administered
6a 11 Completely defined pre-specified
primary outcome measures
12 Completely defined pre-specified
secondary outcome measures
13 How and when they were assessed
6b 14 Any changes to the trial outcomes after
the trial commenced, with reasons
7a 15 How the sample size was determined
7b 16 When applicable, explanation of
any interim analyses and stopping
guidelines
8a 17 Method used to generate the random
allocation sequence
8b 18 Type of randomization and details of
any restriction
(e.g., blocking and block size)
9 19 Mechanism used to implement the
random allocation sequence
(e.g., sequentially numbered
containers), describing any steps
taken to conceal the sequence until
interventions were assigned
10 20 Who generated the random allocation
sequence
21 Who enrolled the participants
22 Who assigned the participants to
interventions
11a 23 If done, who was blinded after
assignment to interventions
(e.g., participants, care providers, and
those assessing outcomes) and how
11b 24 If relevant, description of the similarity
of interventions
12a 25 Statistical methods used to compare
the groups for primary and secondary
outcomes
12b 26 Methods for additional analyses such
as subgroup analyses and adjusted
analyses
13a 27 For each group, the number of the
participants who were randomly
assigned
28 For each group, the number of
the participants who received the
intended treatment
29 For each group, the number of the
participants who completed the study
protocol
13a 30 For each group, the number of the
participants who were analyzed for
the primary outcome
13b 31 For each group, losses and
exclusions after randomization,
together with reasons
14a 32 Dates defining the periods of
recruitment
33 Dates defining the periods of
follow-up
14b 34 Why the trial ended or was stopped
15 35 A table showing baseline
demographic and clinical
characteristics for each group
16 36 Flow diagram
17a 37 For each group, number of the
participants (denominator) included
in each analysis and whether the
analysis was by original assigned
groups
38 For each primary and secondary
outcome, results for each group
39 Estimated effect size
40 Its precision (e.g., 95% confidence
interval)
17b 41 For binary outcomes, presentation of
absolute effect sizes
17b 42 For binary outcomes, presentation of
relative effect sizes
18 43 Results of any other analyses
performed, including subgroup
analyses and adjusted analyses,
distinguishing pre-specified from
exploratory
19 44 All important harms or unintended
effects in each group
20 45 Trial limitations, addressing sources
of potential bias, imprecision, and, if
relevant, multiplicity of analyses
21 46 Generalizability (external validity and
applicability) of the trial findings
22 47 Interpretation consistent with the
results, balancing benefits and
harms, and considering other relevant
evidence
23 48 Registration number
49 Name of the trial registry
24 50 Where the full trial protocol can be
accessed, if available
25 51 Sources of funding and other
support (e.g., supply of drugs) and
the role of the funders
Not reported n (%) P value (confidence
CONSORT- Non-CONSORT- interval) (*)
Endorsing (n=32) Endorsing (n=461)
1a 22 (68.75) 354 (76.78) 0.41 (-8.47-24.55)
1b 0 13 (2.82) 0.69 (1.30-4.32)
2a 0 0 -
2b 1 (3.12) 9 (1.95) 0.84 (-4.98-7.33)
3a 1 (3.12) 1 (0.22) 0.28 (-3.13-8.95)
29 (90.62) 449 (97.40) 0.10 (-3.43-16.97)
3b 0 0 -
4a 0 2 (0.43) 0.28 (-0.16-1.03)
4b 7 (21.87) 67 (14.53) 0.38 (-7.33-22.02)
5 0 3 (0.65) 0.47 (-0.08-1.38)
6a 25 (78.12) 420 (91.11) 0.03 (-1.57-27.53)
26 (81.25) 429 (93.06) 0.03 (-1.91-25.52)
1 (3.12) 5 (1.08) 0.85 (-4.06-8.14)
6b 0 0 -
7a 20 (62.05) 306 (66.38) 0.79 (-13.44-21.19)
7b 0 0 -
8a 18 (26.25) 301 (65.21) <0.0001 (24.67-55.91)
8b 26 (81.25) 403 (87.42) 0.46 (-7.69-20.02)
9 26 (81.25) 403 (87.42) 0.46 (-7.69-20.02)
10 29 (90.62) 451 (97.83) 0.05 (-2.98-17.39)
30 (93.75) 459 (99.57) 0.01 (-2.59-14.22)
30 (93.75) 447 (96.96) 0.63 (-5.31-11.74)
11a 8 (25) 199 (43.17) 0.06 (2.49-33.83)
11b 4 (12.50) 45 (9.76) 0.84 (-9.03-14.51)
12a 1 (3.12) 8 (1.74) 0.90 (-4.75-7.53)
12b 22 (68.75) 334 (72.45) 0.80 (-12.86-20.27)
13a 2 (6.25) 18 (3.90) 0.85 (-6.22-10.91)
6 (18.75) 198 (42.95) 0.01 (9.94-38.45)
22 (68.75) 329 (71.37) 0.90 (-13.96-19.19)
13a 17 (53.13) 297 (64.43) 0.27 (-6.53-29.13)
13b 17 (53.13) 284 (61.61) 0.44 (-9.37-26.33)
14a 13 (40.63) 194 (42.08) 0.98 (-16.14-19.06)
1 (3.13) 16 (3.47) 0.69 (-5.91-6.60)
14b 0 0 -
15 7 (21.87) 182 (39.48) 0.07 (2.60-32.60)
16 22 (68.75) 397 (86.12) 0.01 (0.99-33.73)
17a 17 (53.12) 314 (68.11) 0.12 (-2.81-32.79)
0 2 (0.43) 0.28 (0.16-1.03)
32 (100) 458 (99.40) 0.47 (-0.08-1.38)
29 (90.62) 422 (91.54) 0.88 (-9.49-11.32)
17b 1 (3.12) 39 (8.46) 0.46 (-1.20-11.87)
17b 1 (3.12) 26 (5.64) 0.83 (-3.87-8.89)
18 26 (81.25) 368 (79.83) 0.97 (-12.58-15.43)
19 8 (25) 200 (43.39) 0.06 (2.71-34.05)
20 20 (62.50) 259 (56.18) 0.60 (-11.05-23.69)
21 15 (46.87) 189 (40.99) 0.64 (-11.98-23.74)
22 0 3 (0.65) <0.0001 (95.81-101.58)
23 18 (56.25) 279 (60.52) 0.77 (-13.48-22.02)
25 (78.12) 314 (68.11) 0.32 (-4.92-24.95)
24 32 (100) 461 (100) -
25 18 (56.25) 301 (65.29) 0.39 (-8.68-26.77)
(*) [X.sup.2] test
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| Title Annotation: | Original Article |
|---|---|
| Author: | Sarveravan, Pooneh; Astaneh, Behrooz; Shokrpour, Nasrin |
| Publication: | Iranian Journal of Medical Sciences |
| Article Type: | Report |
| Date: | Nov 1, 2017 |
| Words: | 7160 |
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