Authors’ response

Thank you for your interest in our article. Regarding the research ethics committee, what was agreed upon when the project was submitted was that all patients would be treated at the end of the study. In situations of nonparticipation in the clinical study, the patients had already waited a certain amount of time from the initial consultation to the beginning of treatment. This delay was due to the fact that the treatments were performed in public offices in Brazil, where the demand is much greater than the supply of treatment. The following specific answers are given to the specific questions of the reviewers:

  • (1)

    There was no stratification by sex in the patient allocation process. The equal distribution of males and females in the control and intervention groups was simply a coincidence.

  • (2)

    The specific outcome of the pilot study was explained in the article on page 305: “The impact of AOB [anterior open bite] treatment was adopted as the main outcome of this study and, the sample size was calculated for application of repeated-measures analysis of variance (ANOVA) with the data obtained from the total score obtained in the CPQ8-10 [Child Perceptions Questionnaire 8-10] of the treated and control groups of the pilot study.” The total CPQ8-10 score obtained in the pilot study was the specific outcome used for the sample calculation.

  • (3)

    In general, the Hawthorne effect occurs when individuals change their behavior because they know they are being observed. A systematic review that investigated the possible impact of the Hawthorne effect on the behavior of individuals who were aware that they were being investigated showed that conscious participation in research may influence behavior in some, but not all, circumstances. Moreover, the study showed that the 19 summarized cases showed a wide variation in the Hawthorne effect and that no summary of the overall impact of the Hawthorne effect could be calculated. Therefore, it is clear that the Hawthorne effect, in the context of research, is a complex bias to be evaluated and quantified, and it is difficult to know, with any certainty, under which mechanisms it operates. We believe that the probability of there being any Hawthorne effect in our study is minimal. First, because the time between re-administering the questionnaire was quite long (3 months after the first application and at least 9 months after the second application). The Hawthorne effect is more likely to occur in situations where observation is performed continuously. Second, this was a controlled study. If the Hawthorne effect had occurred because of repeated administration of the questionnaire, it would have resulted in a systematic bias in the control and treated groups. However, our results showed different trends between the groups (ie, worse quality of life in the control group and improvement in the treated group).

  • (4)

    Initially, we thought of including such normative data so that it would be possible to quantitatively correlate the closure of the open bite with the change in quality of life; however, so many data were generated that it made it impossible to include them all in a single article. Further analyses will be conducted to correlate these data.

  • (5)

    Although we appreciate you making your point, we must disagree with it. First, it should be clarified that the removal of the fixed palatal crib from patients in the treated group occurred after complete correction of AOB; therefore, all patients in the treated group experienced total correction of AOB. Second, our results showed that fixed palatal crib placement initially resulted in poor quality of life in only 2 oral health–related quality of life (OHRQOL) constructs (specifically, oral symptoms and functional limitations). In all other constructs, the placement of the appliance resulted in improvement or maintenance of OHRQOL. In the overall score of CPQ8-10 (the main study outcome), there was no change after placement of the appliance. The worsening in the domains related to oral symptoms and functional limitations in the treated group seems to us to be a logical result, and we believe that we addressed this issue well in the discussion (paragraph 2 of the discussion, page 308). In addition, it is important to highlight that the control group (ie, patients who were not treated) worsened in all aspects of OHRQOL over time, which, in our opinion, is sufficient to justify an intervention to correct the AOB.

The viewpoints expressed are solely those of the author(s) and do not reflect those of the editor(s), publisher(s), or Association.

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Mar 9, 2020 | Posted by in Orthodontics | Comments Off on Authors’ response
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