1. An analysis of studies on piezoelectric surgery in the oral and craniomaxillofacial region with regard to human subject protection and financial conflicts
- Author
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J.-Ch. Bertrand, Chistian Herve, Alexander Hemprich, Kittipong Dhanuthai, R.A. Sader, P. Pitak-Arnnop, C. Hennig, Stomatologie- Chirurgie maxillo-faciale, Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], Department of Oral, Craniomaxillofacial and Facial Plastic Surgery, University Hospital of Leipzig, Laboratoire d'éthique médicale et médecine légale ( LEM ), Université Paris Descartes - Paris 5 ( UPD5 ) -Réseau Inserm de Recherche en éthique médicale, University Frankfurt am Main, Department of Oral Pathology, Chulalongkorn University, Private practice, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Laboratoire d'éthique médicale et médecine légale (LEM), Université Paris Descartes - Paris 5 (UPD5)-Réseau Inserm de Recherche en éthique médicale, Chulalongkorn University [Bangkok], Duchange, Nathalie, and Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
- Subjects
[SDV.MHEP.CHI] Life Sciences [q-bio]/Human health and pathology/Surgery ,MESH : Retrospective Studies ,Ultrasonic Therapy ,MESH: Editorial Policies ,MESH : Conflict of Interest ,Human subject protection ,MESH : Guideline Adherence ,MESH : Ethics, Research ,0302 clinical medicine ,Informed consent ,MESH: Informed Consent ,MESH : Helsinki Declaration ,Medicine ,030212 general & internal medicine ,MESH : Ethics, Dental ,MESH: Orthognathic Surgical Procedures ,[ SDV.MHEP.CHI ] Life Sciences [q-bio]/Human health and pathology/Surgery ,MESH : Financial Support ,MESH: Publishing ,Helsinki Declaration ,Clinical Trials as Topic ,Informed Consent ,MESH: Helsinki Declaration ,MESH: Financial Support ,MESH: Ultrasonic Therapy ,3. Good health ,MESH: Ethics, Dental ,MESH : Orthognathic Surgical Procedures ,MESH : Publishing ,MESH: Conflict of Interest ,MESH: Research Subjects ,MESH: Guideline Adherence ,[ SDV.ETH ] Life Sciences [q-bio]/Ethics ,Guideline Adherence ,Oral Surgery ,Editorial Policies ,MESH: Clinical Trials as Topic ,Research Subjects ,education ,MEDLINE ,Specialty ,[SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery ,MESH : Ultrasonic Therapy ,Ethics, Research ,03 medical and health sciences ,Ethics, Dental ,Financial Support ,Humans ,Medical journal ,MESH: Ethics, Research ,Retrospective Studies ,Piezoelectric surgery ,Finance ,Publishing ,MESH: Humans ,business.industry ,Conflict of Interest ,Orthognathic Surgical Procedures ,MESH : Humans ,MESH: Retrospective Studies ,030206 dentistry ,[SDV.ETH] Life Sciences [q-bio]/Ethics ,[SDV.ETH]Life Sciences [q-bio]/Ethics ,MESH : Clinical Trials as Topic ,MESH : Informed Consent ,Otorhinolaryngology ,MESH : Editorial Policies ,Surgery ,Observational study ,business ,Declaration of Helsinki ,MESH : Research Subjects - Abstract
International audience; This retrospective, observational study investigated whether published studies on the use of piezoelectric surgery (PS) in the oral and craniomaxillofacial region fulfilled the requirements of the International Committee of Medical Journal Editors (ICMJE) and the Declaration of Helsinki (DoH) with respect to human subject protections (HSP) and disclosure of financial conflicts (FC). A Medline/PUBMED search was performed in April 2008 to identify all clinical studies on PS, published in English, French and German. Disclosure of HSP (obtaining ethical approval and subjects' informed consent) and FC mentioned in the retrieved articles were analysed. 29 clinical articles were identified in 18 journals, of which 14 journals (78%) required the disclosure of both HSP and FC. Ethical approval was documented in two studies (7%); patient consent was reported in four publications (14%). Four articles disclosed no FC. 21 reports (72%) mentioned neither HSP nor FC. The relationships between funding source and study outcomes could not be identified. Most studies on the use of PS hardly adhered to the regulations recommended by the ICMJE and DoH, and do not mention HSP and FC, indicating the study results with a high degree of suspicion. It is recommended that oral and craniomaxillofacial surgery journals adhere strictly to these regulations because they carry a heavy responsibility regarding the scientific integrity of publications in this specialty.
- Published
- 2009