A pair of researchers in Turkey have lost a 2021 paper on a randomized controlled trial in pediatric surgery after a reader raised concerns about the methodology reported in the article.
However, the retraction notice – detailed though it might be – reveals that the problems could, and likely should, have been caught during peer review.
The paper, “Effect of care programme based on Comfort Theory on reducing parental anxiety in the paediatric day surgery: Randomised controlled trial,” appeared last July in the Journal of Clinical Nursing, a Wiley title. The authors, Fahriye Pazarcikci and Emine Efe, were affiliated with Isparta University of Applied Sciences and Akdeniz University, respectively.
“Paediatric day surgery” turns out to be male circumcision in boys ages 4 to 7 years, as the trial registration information on ClinicalTrials.gov indicates. Circumcision is mentioned in the full text of the paper, but not the abstract.
According to the retraction notice, however, the trial wasn’t prospectively logged:
The retraction has been agreed following concerns raised by a reader that the trial has methodological issues that render the findings of the randomised controlled trial (RCT) unreliable. Further investigation into these concerns by the Journal Editors concluded that:
The study was not prospectively registered on a clinical trials registry which represents a deviation from accepted standards for the conduct and reporting of RCTs.
When comparing the original protocol, retrospective trial registration and published article, only 1 of 6 outcomes was reported.
The outcome reported in the Journal was not listed as the primary outcome which does not accord with best trial conduct or reporting practice where the sample size should be based on the primary outcome, and all outcomes should be reported together in a single paper.
An additional exclusion criterion was added that was not included in the retrospective registration or original trial protocol.
A lack of clarity about the sample size calculation creates a lack of confidence in the interpretation of this trial and its explicit recommendations for practice.
As a result of these methodological and reporting issues, the Editors no longer have confidence in the results reported and are issuing this retraction.
Pazarcikci told us that she and her co-author:
disagree with JCN’s decision to withdraw the article. However, we respect the decision.
In a response to the journal, Pazarcikci – who said the study was an extension of thesis work by her co-author – admitted that the research was not prospectively registered at the time they submitted the manuscript:
When the registration number was obtained, the first participants had been included, but the data collection process was not complete. The thesis study was performed within the framework of ethical principles. For this reason, there was no infringement related to reporting of findings.
Pazarcikci attributed the delay to “the inexperience of the thesis student” and offered to correct the article to point out the reason for the discrepancy:
If we publish this correction, readers will have increased possibility of obtaining information about changes and additionally we will explain the features of the changes. Thus, readers may continue to benefit from our paper.
Pazarcikci also noted – citing Elsevier – that journal policies appear to allow that “different sections of thesis studies may be presented in different articles.”
As for the questions about the new outcome and the sample size, Pazarcikci pushed back on both:
One of the exclusion criteria stated in the clinicaltrials.gov registration was “The child or their parent does not have a special situation that causes difficulties in understanding and perception”. Anxiety disorder is a situation affecting thoughts, understanding and perception. In the literature, it is reported that anxiety in the parent makes it difficult to obtain valid informed consent due to disrupting understanding/perception (Kampouroglou et al., 2020; Salgado et al., 2011). In this article, the “special situation that causes difficulties in understanding and perception” was interpreted and expressed as “parental anxiety disorder”. The exclusion criteria were simply reported in a different way, using different words. For this reason, the interpretation of “an additional exclusion criterion has been added” is considered to be a comment that is due to a different perception than the real situation regarding the exclusion criteria. If the respected editor accepts it we can publish a correction to prevent misunderstanding of the exclusion criteria in the article.
And as for the sample size:
The determination of the sample size in the article is very clear. The article states “An appropriate sampling method was used to include participants in the research. Power analysis was performed with the G*Power 3.1 program to determine the size of the research sample (Faul et al., 2009). For the research, two groups comprising 49 participants each were found to be sufficient for 0.6 effect size, 5% error and 90% confidence interval. In a similar study, a fraying rate of 20% was expected (Chartrand et al., 2017), so a total of 120 participants were included.” This explains the process of calculating the sample size to readers because the aim of this study was to obtain a moderate effect size in this study. Therefore, as in a similar study (He et al., 2015), the effect size was calculated as 0.6.
We asked Mark Hayter, the editor-in-chief of the journal, if he believed the issues surrounding the paper could have been identified prior to publication. He didn’t respond directly to that question, but said:
We have made changes to our process and this work is ongoing.
When we followed up about the peer review, he said:
The retraction statement covers the Journal’s position.
Hayter also directed us to an editorial he co-authored last November with the editors of two other nursing journals titled “Improving the quality of trials reporting.”
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