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Child's Nervous System

, Volume 35, Issue 12, pp 2261–2263 | Cite as

An experimental challenge to bring the empirical study design a step closer to evidence-based medicine and quit ethically problematic situations

  • Shinji IjichiEmail author
  • Naomi Ijichi
  • Chikako Imamura
  • Hisami Sameshima
  • Yoichi Kawaike
Letter to the Editor

Dear Editor:

Together with the authorized specialists in this field (Appendix), we would like to make some consideration concerning the use of decompressive cranioplasty in patients with mild trigonocephaly and psychomotor retardation aimed at favoring cognitive development as reported in your journal [1, 2, 3]. The efficacy of the procedure for developmental conditions is scientifically unproven [4], and mild cases of trigonocephaly are not candidates for surgery because of its mild morphological changes [5]. As an excuse for the long continuation of their non-controlled trial for the unproven intervention, it has been claimed for approximately 20 years that the deprivation of the chance to enjoy the promising intervention in the patients allocated to the control group is unethical and unacceptable [3]. This serious misunderstanding could not be corrected despite repeated explanation of the Declaration of Helsinki [6, 7, 8, 9]. The huge performance bias in the field of developmental...

Notes

Compliance with ethical standards

Conflict of interest

The authors declare no conflict of interest.

References

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Health Service CenterKagoshima UniversityKagoshimaJapan
  2. 2.Institute for EGTKagoshimaJapan
  3. 3.Support Center for Students with DisabilitiesKagoshima UniversityKagoshimaJapan

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