An analysis of studies on piezoelectric surgery in the oral and craniomaxillofacial region with regard to human subject protection and financial conflicts

Autor: J.-Ch. Bertrand, Chistian Herve, Alexander Hemprich, Kittipong Dhanuthai, R.A. Sader, P. Pitak-Arnnop, C. Hennig
Přispěvatelé: 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, Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
Jazyk: angličtina
Rok vydání: 2009
Předmět:
[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
Zdroj: International Journal of Oral and Maxillofacial Surgery
International Journal of Oral and Maxillofacial Surgery, Elsevier, 2009, 38 (10), pp.1011-3. 〈10.1016/j.ijom.2009.04.014〉
International Journal of Oral and Maxillofacial Surgery, Elsevier, 2009, 38 (10), pp.1011-3. ⟨10.1016/j.ijom.2009.04.014⟩
ISSN: 0901-5027
1399-0020
Popis: 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.
Databáze: OpenAIRE
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