Dear Editor,

In response to the letter you have received from Dr Graham Sharpe, which is directed as a critique of our published study 'The value of frenotomy for ankyologlossia from a parental perspective'.

Firstly, we would like to thank Dr Sharpe for the interest he has taken in our paper.

Dr Sharpe seemed to dismiss our research on the grounds that it was not a randomised control trial. We are in full agreement that randomised controlled trials (RCTs) are indisputably the gold standard and constitute the highest form of medical evidence and agree that projects are often made more robust by the presence of a control group. However, we would also contest that the highest level of evidence is not always possible to achieve in every medical or scientific study, nor are RTCs even the most commonly published form of study. Peer reviewed medical journals also publish case reports, case series, observational studies and pilot studies, among the many other forms of simple, but useful data. Articles approved for publication in the NZMJ, whether an RCT or not, also must be scientifically robust, and provide a sufficiently valuable contribution to scientific discourse before being deemed worthy of publication by the expert panel.

We do agree that patient satisfaction (albeit extremely important for patient-centred medicine) is a very simple subjective endpoint, which is why the only question we asked relating to satisfaction was whether the patients would still make the same treatment decision again if facing the same circumstances. However, this answer was also not the only measured outcome. Other endpoints included feeding time, maternal nipple pain, feeding quality, and improvement in primary presenting complaint, all of which showed significant improvement. The 1/3rd of bottle-feeding babies who started breast feeding post-operatively is objective. Dr Sharpe has published his own similarly designed observational case series1 which demonstrates that he is aware that even simple studies can provide a useful base for scientific discussion.

Dr Sharpe also questions "the ethics of this study, in that it involved a surgical procedure on infants". The study was an observational study. No deviation was made from the standard treatment for any patient. The treatment would have continued to occur in exactly the same manner whether or not the information was captured in the study. HDEC approval was sought, and the study was deemed out of scope and therefore ethically appropriate to continue. Dr Sharpe's concerns around ethics should be assuaged.

The correspondent also raised concerns that no specialist opinions were included in the study. This concern is partially rebutted by reading the article itself. The initial project design was produced in consultation with a consultant paediatrician. What wasn’t mentioned, due to the constraints of word limits, is that the study was assessed by the University of Auckland department of Paediatrics (as coursework for a Post-Graduate Diploma of Paediatrics), and the manuscript reviewed by at least three other paediatricians, all of whom encouraged its publication.

Vitamin K was discussed as a matter of process, and is included on the consent form.

Dr Sharpe's letter also mis-represents the NICE guidelines, which state “Current evidence suggests that there are no major safety concerns about division of ankyloglossia (tongue-tie) and limited evidence suggests that this procedure can improve breastfeeding. This evidence is adequate to support the use of the procedure provided that normal arrangements are in place for consent, audit and clinical governance”.2 Closer to home, the recently updated Starship Clinical Guideline on Ankyloglossia, states “some babies with tongue-ties may have breastfeeding difficulties”,3 and then details how to perform the frenotomy procedure.

We appreciate the time the NZMJ peer reviewers spent on reviewing this work, and maintain that our paper serves as a valid and meaningful contribution to the scientific literature.

Yours faithfully,

The Authors.

‍

Dear Editor,

In response to the letter you have received from Dr Graham Sharpe, which is directed as a critique of our published study 'The value of frenotomy for ankyologlossia from a parental perspective'.

Firstly, we would like to thank Dr Sharpe for the interest he has taken in our paper.

Dr Sharpe seemed to dismiss our research on the grounds that it was not a randomised control trial. We are in full agreement that randomised controlled trials (RCTs) are indisputably the gold standard and constitute the highest form of medical evidence and agree that projects are often made more robust by the presence of a control group. However, we would also contest that the highest level of evidence is not always possible to achieve in every medical or scientific study, nor are RTCs even the most commonly published form of study. Peer reviewed medical journals also publish case reports, case series, observational studies and pilot studies, among the many other forms of simple, but useful data. Articles approved for publication in the NZMJ, whether an RCT or not, also must be scientifically robust, and provide a sufficiently valuable contribution to scientific discourse before being deemed worthy of publication by the expert panel.

We do agree that patient satisfaction (albeit extremely important for patient-centred medicine) is a very simple subjective endpoint, which is why the only question we asked relating to satisfaction was whether the patients would still make the same treatment decision again if facing the same circumstances. However, this answer was also not the only measured outcome. Other endpoints included feeding time, maternal nipple pain, feeding quality, and improvement in primary presenting complaint, all of which showed significant improvement. The 1/3rd of bottle-feeding babies who started breast feeding post-operatively is objective. Dr Sharpe has published his own similarly designed observational case series1 which demonstrates that he is aware that even simple studies can provide a useful base for scientific discussion.

Dr Sharpe also questions "the ethics of this study, in that it involved a surgical procedure on infants". The study was an observational study. No deviation was made from the standard treatment for any patient. The treatment would have continued to occur in exactly the same manner whether or not the information was captured in the study. HDEC approval was sought, and the study was deemed out of scope and therefore ethically appropriate to continue. Dr Sharpe's concerns around ethics should be assuaged.

The correspondent also raised concerns that no specialist opinions were included in the study. This concern is partially rebutted by reading the article itself. The initial project design was produced in consultation with a consultant paediatrician. What wasn’t mentioned, due to the constraints of word limits, is that the study was assessed by the University of Auckland department of Paediatrics (as coursework for a Post-Graduate Diploma of Paediatrics), and the manuscript reviewed by at least three other paediatricians, all of whom encouraged its publication.

Vitamin K was discussed as a matter of process, and is included on the consent form.

Dr Sharpe's letter also mis-represents the NICE guidelines, which state “Current evidence suggests that there are no major safety concerns about division of ankyloglossia (tongue-tie) and limited evidence suggests that this procedure can improve breastfeeding. This evidence is adequate to support the use of the procedure provided that normal arrangements are in place for consent, audit and clinical governance”.2 Closer to home, the recently updated Starship Clinical Guideline on Ankyloglossia, states “some babies with tongue-ties may have breastfeeding difficulties”,3 and then details how to perform the frenotomy procedure.

We appreciate the time the NZMJ peer reviewers spent on reviewing this work, and maintain that our paper serves as a valid and meaningful contribution to the scientific literature.

Yours faithfully,

The Authors.

‍