An experimental challenge to bring the empirical study design a step closer to evidence-based medicine and quit ethically problematic situations
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 , and mild cases of trigonocephaly are not candidates for surgery because of its mild morphological changes . 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 . 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...
Compliance with ethical standards
Conflict of interest
The authors declare no conflict of interest.
- 4.Miyajima M (2014) Pathology, diagnosis, and treatment of trigonocephaly with clinical symptoms: the 2013 abstract report of a government-granted study (Ministry of Health, Labor and Welfare, National Bib. No.: 22431487, Ref. No.:201324159B). National Diet Library, Tokyo (in Japanese)Google Scholar
- 5.Shimoji T (2018) Shimoji’s cranioplasty yielding life-quality improvements in mild trigonocephaly (SCYLIMIT). J Stem Cells Regen Med 14:88Google Scholar
- 9.Ijichi S, Ijichi N, Ishida A, Yotsumoto M, Nagata J, Tanuma R, Imamura C, Toki A, Sakajiri T, Hirotsune H, Nakadoi Y, Tanaka S, Kimura K, Tanaka K (2015) Ethical fallacies, tricky ambiguities, and the misinterpretation of the outcomes in the cranioplasty for mild trigonocephaly. Childs Nerv Syst 31:1009–1012. https://doi.org/10.1007/s00381-015-2714-6 CrossRefPubMedGoogle Scholar
- 14.Wall SA, Thomas GPL, Johnson D, Byren JC, Jayamohan J, Magdum SA, McAuley DJ, Richards PG (2014) The preoperative incidence of raised intracranial pressure in nonsyndromic sagittal craniosynostosis is underestimated in the literature. J Neurosurg Pediatr 14:674–681. https://doi.org/10.3171/2014.8.PEDS1425 CrossRefPubMedGoogle Scholar
- 16.Starr JR, Lin HJ, Ruiz-Correa S, Cunningham ML, Ellenbogen RG, Collett BR, Kapp-Simon KA, Speltz ML (2010) Little evidence of association between severity of trigonocephaly and cognitive development in infants with single-suture metopic synostosis. Neurosurgery 67:408–415; discussion 415-416. https://doi.org/10.1227/01.NEU.0000371992.72539.8B CrossRefPubMedPubMedCentralGoogle Scholar
- 17.Cho SM, Park DH, Yoon SH (2019) Continuous intracranial pressure monitoring in 24 microcephalic children with developmental delay: a significant portion of microcephalic children with developmental delay have high intracranial pressure. World Neurosurg 123:e760–e765. https://doi.org/10.1016/j.wneu.2018.12.027 CrossRefPubMedGoogle Scholar
- 18.Takahashi S, Shimoji T, Miyajima M, Inagaki T (2010) O4-4 Prospective multi-center trial for trigonocephaly: to elucidate natural history and indication of operation: registration in 2009. Shouni No Noshinkei 35:213 (in Japanese)Google Scholar
- 19.Oi S, Shimoji T, Miyajima M et al (2011) A prospective multi-center trial for trigonocephaly: COE-Big 4 Trigonocephaly Japan. Shouni No Noshinkei 36:528–534 (in Japanese)Google Scholar