Neurourology and Urodynamics

CONSORT and the Internal Validity of Randomized Controlled Trials in Female Pelvic Medicine 1

Marianne Koch,1,2 Paul Riss,1,2 Wolfgang Umek,1,2 and Engelbert Hanzal1 Department of Obstetrics and Gynecology, Medical University Vienna, Vienna, Austria 2 € Spezielle Gyna€kologieund Geburtshilfe, Vienna, Austria Karl Landsteiner Institut fur

Aims: To investigate authors’ adherence to the CONSORT reporting guideline for randomized controlled trials (RCTs) in the sub-specialty Female Pelvic Medicine and to detect any changes in adherence between the years 2008 and 2013. Methods: Bibliometric study. We included Female Pelvic Medicine RCTs published in 2008 and 2012–2013 in 10 journals. Full-text versions of RCTs for the inclusion of the CONSORT checklist items Randomization, Allocation, Blinding, and Participants’ flowchart were screened. Each CONSORT checklist item was categorized for each included RCT as either ‘‘complete reporting’’, ‘‘insufficient reporting’’, ‘‘no reporting,’’ or ‘‘not applicable’’. We screened the ‘‘Instructions to authors’’ for the requirement to adhere to CONSORT. Results: We included 94 Female Pelvic Medicine RCTs for analysis. Most RCTs in 2008, 2012, and 2013 were published by IUJ (n ¼n39), followed by NAU (n ¼ 13), GREEN (n ¼ 12), European Urology (n ¼ 8), FMPRS (n ¼ 6), AJOG (n ¼ 4), Urology (n ¼ 3), NEJM (n ¼ 3), Lancet (n ¼ 1), and BJOG (n ¼ 1). Proportion of RCTs in the category ‘‘complete reporting’’ comparing 2008 and 2013 was (47 and 70%) for Randomization, (18 and 45%) for Allocation, and (29 and 52%) for Blinding; a flowchart was presented in (71 and 91%). The increase was not statistically significant in any of the investigated CONSORT items. Conclusions: Complete reporting of Female Pelvic Medicine RCTs has increased between 2008 and 2013. However, there are still a relevant number of published RCTs, which do not fulfill these criteria. Reporting according to the CONSORT guidelines should be further encouraged to improve internal validity of Female Pelvic Medicine RCTs. Neurourol. Urodynam. © 2015 Wiley Periodicals, Inc. Key words: CONSORT; female pelvic medicine; randomized controlled trial; reporting guidelines; research design; urogynecology INTRODUCTION

Randomized Controlled Trials (RCTs) are considered the gold standard for scientific methods to compare two (or more) clinical interventions.1,2 Critical characteristics of RCTs include Randomization, Allocation and Blinding, as well as a detailed description of the participants’ flow, including dropouts and withdrawals. Study participants are randomly assigned to comparison groups—a process, which should be characterized by unpredictability. Allocation describes the procedure of enrolling participants, during which the responsible person for allocation has to be shielded from foreknowledge of treatment assignment. Blinding concerns any persons involved in the trial, who might potentially be influenced by knowledge of treatment assignment.3 There is evidence that insufficient attention toward these methodological aspects, especially allocation concealment, leads to an exaggeration of treatment effects, making a study less reliable and reducing internal validity.4–6 Correct reporting of these characteristics of an RCT is essential for subsequent critical appraisal and reproducibility, and can guarantee completeness and transparency of research findings.7,8 Poor reporting of a trial may, on the other hand, reveal deficiencies of study design and therefore indicate low quality of the RCT. Consequently, authors are nowadays widely encouraged to adhere to reporting guidelines according to study type when writing their manuscripts, and many journals already require the use of reporting guidelines within their ‘‘instructions to authors’’. The CONSORT (Consolidated Standards of Reporting Trials) statement, a guideline for reporting parallel group randomized trials, was first introduced in 1996, updated in 2001 and again revised and published in 2010. Developed by a group of experts, #

2015 Wiley Periodicals, Inc.

this statement incorporates current methodological evidence, has been published in and adopted by a large number of medical journals and is widely recognized among researchers. The checklist of this CONSORT reporting guideline for RCTs includes 25 items covering all aspects of the reporting of a RCT, as well as a participants’ flow diagram template.2 For reporting of Randomization, the CONSORT checklist demands a detailed description of the method, which is used to generate the random allocation sequence (CONSORT checklist item 8a), as well as the applied type of randomization, e.g., simple, restricted, blocked or stratified randomization, or minimization (CONSORT checklist item 8b). Regarding Allocation, authors are asked to describe in detail the mechanisms that were used to implement the random allocation sequence, including any information on efforts taken to conceal the sequence until interventions are assigned (CONSORT checklist item 9). It should furthermore be documented, who was responsible for generating the random allocation sequence and who enrolled and assigned the participants into the study and to Dr. Fred Milani led the peer-review process as the Associate Editor responsible for the paper. Potential conflicts of interest: Dr. Hanzal has received honoraria from Astellas and Innovacell. Dr. Umek has received honoraria from Astellas, Innovacell, and Pfizer. Dr. Riss is co-editor-in-chief for the International Journal of Urogynecology. None of the authors declare any conflict of interest in relation to this study. Adherence to CONSORT in Female Pelvic Medicine RCTs has increased between 2012 and 2013, but still remains on a relatively low level. Funding: None. Correspondence to: Marianne Koch, M.D., Department of Obstetrics and Gynecology, Medical University Vienna, Vienna, Waehringerguertel 18-20, 1090 Vienna, Austria. E-mail: [email protected] Received 21 February 2015; Accepted 27 May 2015 Published online in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/nau.22811

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interventions (CONSORT checklist item 10). According to CONSORT checklist items 11a and 11b, authors should report which investigators or participants were blinded after assignment to intervention and, if applicable, they should include a description of similarity of interventions (e.g., appearance, taste, smell, and method of administration of drug and placebo).3 Our hypothesis for this study was that adherence to CONSORT reporting guidelines is currently low among RCTs in the sub-specialty Female Pelvic Medicine and Reconstructive Surgery. In addition, we hypothesized, that there has been an improvement of adherence to CONSORT reporting guidelines among Female Pelvic Medicine RCTs from the years 2008–2013. MATERIALS AND METHODS

We included RCTs from the sub-specialty of Female Pelvic Medicine, which were published in the time frame January to December 2008 and January 2012 to December 2013 in 10 different journals. Three of the investigated journals are specific for Female Pelvic Medicine: International Urogynecology Journal (IUJ), Neurourology and Urodynamics (NAU) and Female Pelvic Medicine and Reconstructive Surgery (FPMRS). Three journals are general gynecologic journals: Obstetrics & Gynecology (GREEN), American Journal of Obstetrics and Gynecology (AJOG), and An International Journal of Obstetrics and Gynaecology (BJOG); two journals are general medical journals: The Lancet and New England Journal of Medicine (NEJM) and two journals are specific for the specialty urology: Urology and European Urology. We chose these journals, because currently only three specific Female Pelvic Medicine journals are being published, all of which are categorized as ‘‘standard journals’’ within the specialty of Obstetrics and Gynecology. We, therefore, selected three general gynecology journals in the category ‘‘top journal’’, to include more Female Pelvic Medicine RCTs, and consequently allow a direct comparison between the two journal types regarding requirement of, and adherence to the reporting guideline CONSORT. In addition we looked into general medical top journals, as well as specific urology journals, to cover a broader spectrum of journals that publish urogynecology articles. Furthermore we aimed to compare the year 2008 with 2013. The time frame of 2012–2013 was chosen to present the status quo of adherence to CONSORT guidelines among Female Pelvic Medicine RCTs. In addition, we aimed to investigate whether there has been an improvement of adherence to CONSORT over time as CONSORT was last updated in 2010. We screened all articles that were published in 2008, 2012, and 2013 in the 10 journals and which were labeled as RCTs within the article title. As a second step, we identified those RCTs assigned to the sub-specialty Female Pelvic Medicine, which included all RCTs in the journals IUJ and FPMRS (n ¼ 51) and (n ¼ 45) RCTs in the remaining journals. In total, n ¼ 96 RCTs could be identified as Female Pelvic Medicine RCTs published in 2008, 2012, and 2013. All RCTs from the journal European Urology (n ¼ 8) included both female and male participants. The literature search was simultaneously conducted by two independent investigators (MK and PR). Articles were only included in this study if both investigators reached a consensus on the study type (RCT) and specialty assignment (Female Pelvic Medicine). Full-text PDFs of all eligible RCTs were accessed and downloaded through either the library of the Medical University Vienna or the private journal subscription by one of the investigators. Neurourology and Urodynamics DOI 10.1002/nau

We then screened all full-text versions of included Female Pelvic Medicine RCTs for the inclusion of the following CONSORT checklist items: Randomization (8a, 8b), Allocation (9,10), Blinding (11a, 11b), and Participants’ flowchart (13a, 13b). We furthermore screened all RCTs for an explicit citation of the CONSORT reporting guidelines. For this, the electronic PDF versions of all RCTs were searched for the term ‘‘CONSORT’’ using the automated PDF search function ([cmd F] for Macintosh; [ctrl F] for Windows). Each investigated CONSORT checklist item was categorized for each included RCT by the two investigators (MK and PR) independently as either ‘‘complete reporting/could be replicated’’ (2), ‘‘insufficient or inadequate reporting’’ (1), ‘‘no reporting’’ (0), or ‘‘not applicable’’ (n/a). Surveyed data were documented and saved in Excel files. Individual categorizations of the investigators were further compared within a merged Excel file. If the categorizations were not congruent, they were discussed among all co-authors until consensus was reached. Criteria to reach categorization2 ‘‘complete reporting/could be replicated’’ for the CONSORT checklist items Randomization, Allocation, Blinding, and Participants’ flowchart comprised that both sub-items for each checklist item were reported within the RCT (8a and 8b)/ (9 and 10)/(11a and 11b)/(13a and 13b). The category ‘‘insufficient or inadequate reporting’’ was given if either only one of the two sub-items was reported within the RCT, or if the investigators reached consensus that reporting was insufficient within the two sub-items. ‘‘No reporting’’ was given if the CONSORT checklist items were not reported at all within the RCT, and ‘‘not applicable’’ was given if the RCT study design did not include the respective relevant CONSORT checklist item (e.g., 11a and 11b for unblinded). Citation of CONSORT was categorized as either ‘‘yes’’ (1) or ‘‘no’’ (0). In addition, we also screened the current ‘‘Instructions to authors’’ of the 10 journals for the requirement to adhere to the CONSORT reporting guidelines. Requirement for Institutional Review Board (IRB) approval was waived by the Ethics Committee of the Medical University Vienna. RESULTS

We identified a total of 96 Female Pelvic Medicine studies, which were presented as ‘‘Randomized Controlled Trial’’ in the 10 investigated journals in 2008, 2012, and 2013. In the second step, six studies had to be excluded, as they did not fit the inclusion criteria (one animal study, three subgroup analyses of previous RCTs, one economic study alongside an RCT, one secondary analysis of previous RCTs). Consequently, we were able to include 90 Female Pelvic Medicine RCTs for analysis. Most Female Pelvic Medicine RCTs in 2008 and 2012–2013 were published by IUJ (n ¼ 39), followed by NAU (n ¼ 13), GREEN (n ¼ 12), European Urology (n ¼ 8), FMPRS (n ¼ 6), AJOG (n ¼ 4), NEJM (n ¼ 3), and Urology (n ¼ 3) and lastly, BJOG (n ¼ 1) and Lancet (n ¼ 1). Whereas the number of Female Pelvic Medicine RCTs increased between 2012 and 2013 in the four journals IUJ (þ14), NAU (þ1), GREEN (þ3), and Urology (þ1), it either remained stable or decreased in the three journals FPMRS (þ0), AJOG (4), Lancet (1), NEJM (1), BJOG (1), and European Urology ( 0). (Fig. 1) BJOG, AJOG, Lancet, NEJM, Urology, and European Urology did not publish any urogynecology RCTs in 2008 and FPMRS had not yet been indexed. The number of RCTs increased between 2008 and 2013 in IUJ (þ7), NAU (þ3), and GREEN (þ3). All investigated journals, except FPMRS, require the use of CONSORT for reporting of RCTs within their ‘‘instructions to authors’’.

CONSORT and Internal Validity of RCTs in Female Pelvic Medicine

Fig. 1. Total number of published Female Pelvic Medicine RCTs per journal in 2008, 2012, and 2013. (IUJ) International Urogynecology Journal, (NAU) Neurourology and Urodynamics, (FPMRS) Female Pelvic Medicine and Reconstructive Surgery, (GREEN) Obstetrics & Gynecology, (AJOG) American Journal of Obstetrics and Gynecology, (BJOG) An International Journal of Obstetrics and Gynecology, (NEJM) New England Journal of Medicine, (Europ Urol) European Urology.

In 2012 and 2013 together, the proportion of RCTs in the category ‘‘complete reporting/could be replicated’’ in the journal FPMRS was 66.6% throughout all four investigated methodological characteristics (randomization, allocation, blinding, participants’ flowchart). The range of proportions of RCTs in the same category regarding the four methodological characteristics among the other journals was as follows: IUJ (30–93%), NAU (9–82%), GREEN (33–100%), AJOG (25–75%), BJOG (0–100%), Lancet (0–100%), NEJM (33–100%), Urology (33–67%), and European Urology (13–100%). In 2008, the proportion of RCTs in the category ‘‘complete reporting/could be replicated’’ of the journals that published RCTs was as

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follows: IUJ (17–58%), NAU (50–100%), and GREEN (67–100%). The remaining journals did not publish any urogynecology RCTs in 2008. In 2012 and 2013 together, the CONSORT checklist items ‘‘Randomization, Allocation, and Blinding’’ (item number 8a, 8b, 9, 10, 11a, and 11b) were adequately reported in 44/73 (60%), 25/73 (34%), and 32/73 (44%) RCTs respectively. A participants’ flowchart (CONSORT checklist items 13a and 13b) was presented in 64/73 RCTs (88%) and CONSORT was explicitly cited in 18/73 RCTs (25%) (Table I). We furthermore compared the proportion of adequately reported CONSORT checklist items in Female Pelvic Medicine RCTs between the years 2008 and 2013, as well as between 2012 and 2013, to see whether there has been an improvement. As the general medical journals ‘‘The Lancet’’ and NEJM and the urology journals ‘‘Urology’’ and ‘‘European Urology’’ did not publish any urogynecology RCTs in 2008 and only a few in 2012/2013 (n ¼ 15), we did not include those journals into the comparison. Table II presents the total numbers and proportions of included Female Pelvic Medicine RCTs of the journals IUJ, NAU, FPMRS, GREEN, AJOG, and BJOG, in which, the CONSORT items ‘‘Randomization, Allocation, and Blinding’’ could be categorized as ‘‘complete reporting/could be replicated’’. They furthermore include the number and proportions of RCTs that presented a flowchart and that explicitly cited CONSORT either in the text or in the references. We were able to observe an increase in proportion of RCTs with adequate reporting of all investigated CONSORT items between 2008 and 2013 and also between 2012 and 2013. The proportion of Female Pelvic Medicine RCTs in which the reporting of Randomization could be categorized as ‘‘complete reporting/could be replicated’’ was 47% in 2008, 52% in 2012, and 70% in 2013. Allocation was adequately reported in 18% of RCTs in 2008, 32% in 2012 compared to 45% in 2013, and the proportion of RCTs with adequate reporting of Blinding rose from 29% in 2008 to 36% in 2012 and 52% in 2013. A flowchart was presented in 71% of Female Pelvic Medicine RCTs in 2008, 84% in 2012, and 91% in 2013. CONSORT was explicitly cited in 6% of articles in 2008 and 24% in 2012 compared to 36% in 2013. The increase in proportions did not reach significance at statistical testing in any of the investigated CONSORT items except for the explicit citing of CONSORT (P ¼ 0.020; Pearson’s x2 test).

TABLE I. Total Number of Published Female Pelvic Medicine RCTs in 2008, 2012, and 2013 and Number of RCTs in the Category ‘‘Complete Reporting/Could Be Replicated’’ RCTs (n) IUJ NAU FPMRS GREEN AJOG BJOG Lancet NEJM Urology Europ Urol Total

27 11 6 9 4 1 1 3 3 8 73

Randomization (8a, 8b)a 16 6 4 8 2 0 1 2 2 3 44

(59%) (55%) (67%) (89%) (50%) (0%) (100%) (67%) (67%) (38%) (60%)

a

Allocation (9,10) 8 1 4 8 1 1

(30%) (9%) (67%) (89%) (25%) (100%) 0 1 (33%) 0 1 (13%) 25 (34%)

Blinding (11a,11b)a 12 3 4 6 1 0 1 1

(44%) (27%) (67%) (67%) (25%) (0%) (100%) (33%) 0 4 (50%) 32 (44%)

Flowchart (13a, 13b) 25 9 4 9 3 1 1 3 1 8 64

(93%) (82%) (67%) (100%) (75%) (100%) (100%) (100%) (33%) (100%) (88%)

CONSORTb 11 2 0 3 1 0

(41%) (18%) (0%) (33%) (25%) (0%) 0 0 0 1 (13%) 18 (25%)

According to the CONSORT checklist items. CONSORT guidelines explicitly mentioned in the article text or references. (IUJ) International Urogynecology Journal, (NAU) Neurourology and Urodynamics, (FPMRS) Female Pelvic Medicine and Reconstructive Surgery, (GREEN) Obstetrics & Gynecology, (AJOG) American Journal of Obstetrics and Gynecology, (BJOG) An International Journal of Obstetrics and Gynecology, (NEJM) New England Journal of Medicine, (Europ Urol) European Urology. b

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TABLE II. Change of Implementation of CONSORT Checklist Items Between 2008 and 2013 in the Category ‘‘Complete Reporting/Could Be Replicated’’ 2008 RCTs (total n) Randomization (8a, 8b)a Allocation (9,10)a Blinding (11a, 11b)a Flowchart (yes) CONSORT (yes)b

17 8 3 5 12 1

2013 % 47 18 29 71 6

33 23 15 17 30 12

% 70 45 52 91 36

Difference 2008–2013

P-value

% þ23 þ27 þ23 þ20 þ30

0.118 0.052 0.136 0.063 0.020

a

CONSORT checklist item number. CONSORT guidelines explicitly mentioned in the article text or references.  Pearson’s x2 test [Asymp. Sig. (2-sided)], including the journals IUJ, NAU, FPMRS, GREEN, AJOG, BJOG. b

Power calculations were performed and adequately described in 12 of 17 articles (71%) in 2008, in 27 out of 33 (82%) in 2012, and 32 in 40 (80%) in 2013. DISCUSSION

Thorough reporting of RCTs, which represent the gold standard for the evaluation of healthcare interventions, is essential to facilitate their critical appraisal and consequently to guarantee their completeness and transparency. Adequate reporting of RCTs, specifically regarding methodological aspects, increases the studies’ internal validity and subsequently its quality.4,5,7 In recent years, attempts have been made to evaluate the quality of clinical studies of different medical specialties through evaluating the completeness of their reporting. However, most studies show a lack of adherence to reporting guidelines and/or lack of rigorous follow-up of requirements by publishing journals.9–12 CONSORT provides authors with a checklist for the reporting of their RCT, which many journals already require within their ‘‘instructions to authors’’. Regarding the sub-specialty of Female Pelvic Medicine, it was unclear to which extent authors of RCTs adhere to the CONSORT reporting guideline. We, therefore, aimed to estimate the adherence to the CONSORT checklist within published Female Pelvic Medicine RCTs of the past 2 years 2012–2013 and additionally in 2008 to see whether there has been an improvement over time. Randomization, Allocation, Blinding, and Participants’ flow are the essential characteristics of any RCT. We decided to focus only on CONSORT checklist items, which specifically target these methodological elements. In addition, we studied whether authors of Female Pelvic Medicine RCTs explicitly cited the use of CONSORT guidelines in their articles. We could demonstrate that adherence to the CONSORT guidelines varied depending on the journal and the respective CONSORT checklist item. The majority of Female Pelvic Medicine RCTs in 2008, 2012, and 2013 was published in IUJ and NAU (39 and 13 respectively), whereas the number ranged between 0 and 12 among the remaining journals. Comparing the years 2008 and 2013, all investigated items for quality and reproducibility (randomization, allocation, blinding, inclusion of participants’ flowchart, referencing CONSORT) seemed to have been reported more adequately and frequently. In 2013, Randomization was sufficiently reported (‘‘complete reporting/could be replicated’’) in 70% of the published Female Pelvic Medicine RCTs in the investigated journals, compared to 47% in 2008. Frequency of complete reporting of Blinding and Allocation also increased between 2008 and 2013 (29–52% and 18–45%, respectively), but still ranged on a lower level than Randomization. It is of particular interest to find Allocation least reported in the published articles, as the method of Allocation Concealment Neurourology and Urodynamics DOI 10.1002/nau

is considered even more important and determinant to the quality of an RCT than Randomization and Blinding.4 A participants’ flowchart was presented in 91% of RCTs in 2013, although this number includes any type of flowchart and not necessarily the CONSORT template. CONSORT guidelines were explicitly cited in only 36% of RCTs. However, the higher proportion of reported CONSORT checklist items in all articles suggests a higher implementation of CONSORT than cited. This corresponds to our previous observation that authors often do not explicitly cite reporting guidelines, even though it seems likely that they were actually used.13 Even though CONSORT is not required in the ‘‘instructions to authors’’ of one journal (FPMRS), the majority of RCTs published by FPMRS in 2012 and 2013 could be categorized as ‘‘complete reporting/could be replicated’’ regarding the four methodological characteristics Randomization, Allocation, Blinding, and Participants’ flow. This fact suggests that CONSORT is already widely known and implemented by authors of RCTs, no matter whether they publish their articles in journals which require the use of reporting guidelines or not. On the other hand, it is not guaranteed that published RCTs are adequately reported even if journals require the use of CONSORT. A limitation of our study is the fact that we did not conduct a systematic literature search, but restricted the inclusion of articles to Female Pelvic Medicine RCTs of 10 different journals. We believe that these 10 journals are sufficiently representative, as we included all journals that are specific for Female Pelvic Medicine and compared these to three general gynecology journals, as well as two general medical journals and two urology-specific journals. We could not detect differences in the adherence to CONSORT between these journals, and therefore assume that our findings also apply to other journals. The strength of our study is that we specifically read through the articles to determine whether CONSORT checklist items were implemented, and can, therefore, draw a direct conclusion whether the authors adhered to CONSORT recommendations or not. Even though we could show an increase of adherence to the CONSORT items Randomization, Allocation, and Blinding in Female Pelvic Medicine RCTs between 2008 and 2013, there still remain a relevant number of articles with reporting deficits. Our findings suggest that adherence to CONSORT still needs increased awareness among authors, but also editors and reviewers of Female Pelvic Medicine articles. The awareness for correct reporting should be implemented from early stages on, starting with the planning of an RCT, and should accompany researchers throughout conduction and eventually throughout the writing of the manuscript. Editors of journals should make sure that submitting authors are aware of the necessity to implement CONSORT in their RCTs, and also reviewers of submitted articles should be advised to assess the internal validity of the RCT on the basis of CONSORT.

CONSORT and Internal Validity of RCTs in Female Pelvic Medicine CONCLUSION

Complete and reproducible reporting of Female Pelvic Medicine RCTs based on the CONSORT checklist has generally increased between 2008 and 2013. However, there are still a relevant number of published RCTs, which do not fulfill these criteria. By 2013, 70% of investigated articles had complete reporting of Randomization, whereas Allocation and Blinding were only adequately reported in about half of the RCTs (45 and 52%). Reporting according to the CONSORT guidelines, specifically focused on allocation concealment, should be further encouraged in order to improve internal validity and reliability of RCTs in Female Pelvic Medicine.

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4. Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408–12. 5. Moher D, Pham B, Jones A, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 1998;352:609–13. 6. Moher D, Schulz KF. Randomized controlled trials in cancer: Improving the quality of their reports will also facilitate better conduct. Ann Oncol 1998;9:483–7. 7. Simera I, Moher D, Hirst A, et al. Transparent and accurate reporting increases reliability, utility, and impact of your research: Reporting guidelines and the EQUATOR Network. BMC Med 2010;8:24. 8. Simera I, Moher D, Hoey J, et al. The EQUATOR Network and reporting guidelines: Helping to achieve high standards in reporting health research studies. Maturitas 2009;63:4–6. 9. Cui Q, Tian J, Song X, et al. Does the CONSORT checklist for abstracts improve the quality of reports of randomized controlled trials on clinical pathways? J Eval Clin Pract 2014;20:827–33. 10. Peron J, Maillet D, Gan HK, et al. Adherence to CONSORT adverse event reporting guidelines in randomized clinical trials evaluating systemic cancer therapy: A systematic review. J Clin Oncol 2013;31:3957–63. 11. Blakely ML, Kao LS, Tsao K, et al. Adherence of randomized trials within children’s surgical specialties published during 2000 to 2009 to standard reporting guidelines. J Am Coll Surg 2013;217:394–9.e7. 12. Cavadas V, Branco F, Carvalho FL, et al. The quality of reporting of randomized controlled trials in pelvic organ prolapse. Int Urogynecol J 2011;22:1117–25. 13. Koch M, Riss P, Umek W, Hanzal E. The explicit mentioning of reporting guidelines in urogynecology journals in 2013: A bibliometric study. Neurourology and urodynamics 2015. PubMed PMID: 25620401