1. Are patients truly informed? A retrospective chart review of the documentation of informed consent in laparoscopic cholecystectomy
- Author
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Williams, Erin, Selvam, Raj, Hopman, Wilma, and Nanji, Sulaiman
- Subjects
Surgical research ,Cholecystectomy -- Ethical aspects ,Physician and patient -- Ethical aspects ,Surgery, Experimental ,Informed consent (Medical law) -- Research ,Health ,Health care industry - Abstract
Background: Research on informed consent (IC) has traditionally focused on the documentation of the discussion with patients of potential complications. We sought to examine the completeness of documentation for all elements of IC for laparoscopic cholecystectomy (LC): potential complications, alternatives to LC and details of the procedure. Differences in the documentation of IC for elective and emergent LC were examined. Methods: A retrospective chart review of patients undergoing LC at our institution between 2015 and 2017 was performed. Completeness of documentation was defined as documentation of all 3 elements of IC in the clinic note, the operating room note or the consent form itself. Data were analyzed descriptively. We compared documention for emergent and elective cases as well as documentation by residents and attending physicians using t tests. Results: A total of 270 patients were included in the analysis. Only 5 (2%) had complete documentation of all elements of IC. Documentation of potential complications was noted in 232 cases (86%), of which 58 (25%) were elective and 174 (75%) were emergent. Details were noted in 28 (10%) cases, of which 21 (75%) were elective and 7 (25%) were emergent. Alternatives were documented the least frequently: they were documented in 23 cases (9%), of which 20 (87%) were elective and 3 (13%) were emergent. Residents performed better than attending physicians in documenting IC discussions in clinic notes and on consent forms, but not in operating room notes. Conclusion: Documentation of the elements of IC for LC was poor. Potential complications were the most frequently documented element of IC; alternatives and details were often omitted. Future studies comparing audiotaped IC conversations with the documentation of IC are warranted. The use of procedure-specific consent forms for LC may facilitate documentation. Contexte: La recherche sur le consentement eclaire (CE) s'est longtemps interessee surtout a la consignation du contenu des discussions avec les patients au sujet des complications potentielles. Nous avons voulu examiner l'exhaustivite de la consignation de tous les elements du CE pour la cholecystectomie laparoscopique (CL): complications potentielles, solutions de rechange a la CL et details de l'intervention. Nous avons observe des differences dans la consignation des elements du CE pour la CL urgente et non urgente. Methodes: Nous avons procede a un examen retrospectif des dossiers de patients soumis a une CL dans notre etablissement entre 2015 et 2017. La consignation au dossier etait jugee complete lorsque les 3 elements du CE etaient presents dans la note clinique, la note opera-toire ou le formulaire de consentement lui-meme. Nous avons effectue une analyse descriptive des donnees, et nous avons compare la consignation des elements pour les cas urgents et non urgents, effectuee par les residents et les medecins traitants au moyen de tests t. Resultats: Au total, 270 patients ont ete inclus dans l'analyse. Tous les elements du CE etaient adequatement consignes pour seulement 5 (2 %) d'entre eux. Les complications potentielles ont ete consignees dans 232 cas (86 %), dont 58 (25 %) etaient non urgents et 174 (75 %) etaient urgents. Les details de l'intervention ont ete notes dans 28 cas (10 %), dont 21 (75 %) etaient non urgents et 7 (25 %) etaient urgents. Ce sont les solutions de rechange qui ont ete le moins souvent consignees: elles ont ete notees dans 23 cas (9 %), dont 20 (87 %) etaient non urgents et 3 (13 %) etaient urgents. Les residents ont mieux fait que les medecins traitants pour ce qui est de consigner les discussions sur le CE dans les notes cliniques et les formulaires de CE, mais non dans les notes operatoires. Conclusion: La consignation des elements du CE pour la CL a ete faible. Les complications potentielles ont ete l'element du CE le plus souvent consigne au dossier; les solutions de rechange et les details de l'intervention ont souvent ete omis. Il faudra proceder a d'autres etudes pour comparer le contenu des discussions sur le CE enregistrees sur bande audio et sa consignation. L'utilisation de formulaires de CE specifiques aux interventions pourrait facili-ter la consignation de leurs elements., The concept of informed consent (IC) and its elements are well established, but little research has been devoted to examining the completeness of documentation of this critically important medical practice. [...]
- Published
- 2021
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