Audit of informed consent document for major surgical procedures at a tertiary care hospital
Dhara Goswami1, Swapnil Sudhirkumar Agarwal2, Smruti B Vaishnav3, Lavlesh Kumar4, Krishnadutt Harishankar Chavali5
1 MBBS Student, Pramukhswami Medical College and Shri Krishna Hospital, Karamsad, Gujarat, India
2 Department of Forensic Medicine and Toxicology, Pramukhswami Medical College and Shri Krishna Hospital, Karamsad, Gujarat, India
3 Department of Obstetrics and Gynaecology, Pramukhswami Medical College and Shri Krishna Hospital, Karamsad, Gujarat, India
4 Department of Forensic Medicine and Toxicology, SBKS Medical College and Research Institute and Dhiraj Hospital, Vadodara, Gujarat, India
5 Department of Forensic Medicine and Toxicology, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India
Swapnil Sudhirkumar Agarwal
Department of Forensic Medicine and Toxicology, Pramukhswami Medical College and Shri Krishna Hospital,
Source of Support: None, Conflict of Interest: None
Background: Consent is being regarded as the cornerstone of a doctor patient relationship. No patient can be forced, directly or indirectly, to accept treatment which it may refuse, even if it is painless, beneficial to him and without any risk including the fact that refusal may have life threatening consequences. Lack of an informed consent is an area that can win legal suits for the patient even when the claim for any negligence is weak.
Aim: To review the informed consent documents in cases of major surgical procedures conforming the accepted principles of informed consent and to prepare a checklist for help in future audit of informed consent documents.
Methods: Authors compiled a list of desirable and essential content areas in informed consent document based on commonly accepted professional standards. Informed consent forms of planned major surgical procedures for department of surgery, obstetrics and gynecology and orthopedics were included. 100 informed consent forms, selected randomly by computer at medical records department, for each department were studied for 23 attributes. Descriptive statistics and exploratory data analysis techniques were used to analyze the data.
Result: The consent documents lacked a third of essential elements in totality for all the departments [08/ 23] while few partially.
Conclusion: There is ample room for training of treating registered medical practitioner on how an informed consent should be documented so as to be safe ethically as well as legally. Consent is never a defense in an allegation of medical negligence.