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 Table of Contents  
ORIGINAL ARTICLE
Year : 2019  |  Volume : 33  |  Issue : 2  |  Page : 91-96

Audit of informed consent document for major surgical procedures at a tertiary care hospital


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

Date of Submission15-Oct-2018
Date of Decision21-Jan-2019
Date of Acceptance26-Jan-2019
Date of Web Publication11-Feb-2020

Correspondence Address:
Swapnil Sudhirkumar Agarwal
Department of Forensic Medicine and Toxicology, Pramukhswami Medical College and Shri Krishna Hospital, Karamsad, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jms.jms_69_18

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  Abstract 


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.

Keywords: Audit, checklist, consent, informed, obstetrics and gynecology, surgery


How to cite this article:
Goswami D, Agarwal SS, Vaishnav SB, Kumar L, Chavali KH. Audit of informed consent document for major surgical procedures at a tertiary care hospital. J Med Soc 2019;33:91-6

How to cite this URL:
Goswami D, Agarwal SS, Vaishnav SB, Kumar L, Chavali KH. Audit of informed consent document for major surgical procedures at a tertiary care hospital. J Med Soc [serial online] 2019 [cited 2020 Oct 1];33:91-6. Available from: http://www.jmedsoc.org/text.asp?2019/33/2/91/278106




  Introduction Top


Consent 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, without any risk, or even life threatening.[1]

As per Se ction 13 of Indian Contracts Act, 1872, when two or more persons agree upon the same thing in the same sense, they are said to consent. The implications of Indian Penal Code [IPC] Section 87 are that only a person equal to or above 18 years of age can give a legally valid consent for any procedure that includes risk to life.[2] Another Section 89 IPC empowers the guardian of an infant under 12 years or a mentally ill person of any age, to consent to the infliction of harm to the infant or the mentally ill person, provided it is done in good faith and is done for his benefit.

Persons above the age of 12 years are considered to be capable of giving consent under Section 88 IPC. This section differs from Section 87 in two particulars – (1) under it any harm except death may be inflicted and (2) the age of the person consenting is not mentioned (but under Section 90, the age of the consenting party must be at least being 12 years).[2]

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. Thus, better understanding of the informed consent process not only protects but also advances the interests of both patient and doctor.[3] It is, therefore, imperative that consents taken are legally valid covering all the components of an informed consent.

In case, consent is not obtained that will give rise to cause of action for seeking the remedy criminally for making any invasive procedure without consent of patient amounting to assault with criminal force under Section 350 IPC and can also seek a civil remedy for compensation for the injury occurred to the patient in accordance with Law of Torts. If a doctor fails to obtain a legally valid consent, then even without any damage occurring, the patient has a right to sue the doctor for the injury on his personal or private rights.[4]

The National Consumer Disputes Redressal Commission (NCDRC) awarded compensation of Rs. 1 Lac with interest at 15% together with cost of Rs. 1000/- where the patient underwent an operation for acute appendicitis under spinal anesthesia which lasted for 11 h (usually takes about 4 h). A second operation, in the name of re-exploration, was done after a week without consent of the patient. Consent for re-exploration was not signed by patient, had name of the anesthetist only, and not associated with any surgical record.[5]

In another case, prescribed format was used to obtain patient's signature with no endorsement as to consent written on the form; instead written portion interpolated subsequently to accommodate space available above the signature, giving rise to bona fide and legitimate doubt about authenticity and genuineness of consent.[6]

The NCDRC stated that concept of “informed consent” postulates that all information are to be explained to the patient and/or guardian in easily comprehensible nonmedical terms, preferably in local language about: (1) diagnosis, (2) nature of treatment, (3) risks involved, (4) prospects of success, (5) prognosis if procedure is not performed, and (6) alternative methods of treatment. The given case had signature in consent form obtained 2 days after surgery, procedure to be performed was neither mentioned in clearly understandable terms nor explained to the patient or guardian in simple local language, many columns were left blank, name of the doctor was not filled up, and signature of husband of patient was obtained in the column meant for witness. There was no consent for blood transfusion and anesthesia. On this basis, partly filled up consent form cannot be construed as informed consent and constituted deficiency in service.[7]

NCDRC has held that with no specific mention about name of surgery, the type of anesthesia, and signatures being taken in a mechanical fashion much in advance on the date of scheduled surgery, such consent forms cannot be considered “informed consents.”[8]

Supreme court has held “deficiency in service” where consent was given for excision biopsy while surgeon removed the entire tumor with patient becoming paraplegic on grounds that consent for excision biopsy cannot be taken as implied consent, much less informed consent for surgery of the tumor.[9]

NCDRC has held “deficiency in service” for not obtaining consent of a conscious and mentally alert patient where it was obtained from the grandson. Form also did not document the rationale for performing surgery and associated risks involved being communicated to the patient.[10]

No negligence was held by the NCDRC in a case, where consent was given for laparoscopic procedure explicitly authorizing the doctor to carry out any additional procedure in case of emergency. The doctor had done conventional/open cholecystectomy as he encountered dense adhesions in the gallbladder abandoning laparoscopic procedure.[11] Consent for hysterectomy where there was no name of the surgeon along with not even the name of patient to be operated has been held “not to be valid consent.”[12]

These are few examples where legally invalid consent invited trouble to attending medical practitioner(s). Hence, this study was undertaken at a teaching tertiary care center with intention to peruse the informed consent documents (ICDs) for their legal validity taken for elective major surgical procedures. Major surgical procedure is defined as any operation: (1) within or upon the contents of the abdominal, pelvic, cranial, or thoracic cavities or (2) which, given the locality, condition of patient, level of difficulty, or length of time to perform, constitutes a hazard to life or function of an organ or tissue. Major surgery usually requires general anesthesia and a period of hospitalization of varying length (often a week).[13] The objectives were to review the ICDs in cases of planned major surgical procedures conforming the accepted principles of informed consent and to prepare a checklist for help in the future audit of ICDs.


  Material and Methods Top


The current study was started after due approval from the Institutional Ethics Committee with source of data being the Medical Records Department. A checklist was prepared before the start of study forming the “case report form” of the study. A list of desirable and essential content areas in informed consent based on commonly accepted professional standards, additional elements relevant to shared decision-making, and suggestions from a surgeon ethicist were included in the study. A preliminary checklist was prepared, tested on ten cases, and based on the results; components of the checklist were improved to be used for the study. The final checklist was filled depending on the presence or absence of particular component(s) of a legally valid consent.

One hundred informed consent forms of the departments of surgery, obstetrics, and gynecology (OBG) and orthopedics each, selected randomly by computer, were studied. Emergency procedures for these departments as well as consent for anesthesia were excluded from the study.

The data gathered were entered in MS Excel Worksheet and analyzed using SPSS (Statistical Package for Social Sciences by IBM) (Trial version 14). Descriptive statistics and exploratory data analysis techniques were used to analyze the data.


  Results Top


Twenty-three attributes were studied from the files for informed consent form [as per [Table 1] with results found depicted in [Table 2], [Table 3], [Table 4], [Table 5].
Table 1: Informed consent preliminary checklist (case report form)

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Table 2: Preliminaries

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Table 3: Procedure/surgery/treatment specific particulars

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Table 4: Acknowledgment from patient/legally acceptable representative

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Table 5: Overall impression

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All three departments did not mention experience of operating surgeon for the given procedure, name of the practitioner who shall be actually doing the procedure, date of the procedure (except in 4 cases of OBG), optional treatment/procedure(s), time required for the procedure, presence of any third party/assistants during the procedure, and information with regard to filming/televising the procedure for educational purpose.

Surgery consent forms lacked date when consent was obtained, name of the patient in the consent form, explanation of benefits of procedure and likelihood of additional surgery, possible risks, and known complications of planned procedure.

Benefits of procedure were found in all orthopedic consents, which also had explanations for possible risks and known complications of the procedure and likelihood of revision surgery.

In OBG, there was only one case where there was no witness evidence for illiterate patient. In orthopedics, there were two cases where there were no signatures/left thumb impression (LTI) of either the patient/legally acceptable representative (LAR), while in surgery, there was one case where there was no signature/LTI of either the patient/LAR and one case of illiterate patient with no signature of witness (only patient's LTI).

None of the departments had included exonerating clause for doctor, nurse, hospital, etc., or given assurance or guarantee of success of the planned procedure.

This is based on the review of the ICD, which appeared to be mostly mechanical with most of the matter already typed and incomplete information. It is subjective in nature.


  Discussion Top


In a study, content analysis of hospital informed consent forms for procedures undertaken was conducted for evidence of the basic elements of informed consent and items that might enhance patient–physician interaction reflecting shared decision-making. The content of most forms did not meet accepted standards of informed consent or patient–physician interactions.[14] In our study, except for seven attributes as stated in results, most of the attributes were found to be fulfilled.

In another study, questionnaires sent to 196 psychologists in private practice revealed that content of the forms dealt primarily with issues regarding fees and not with information that satisfies the requirements of informed consent with average readability for the consent forms returned as “difficult.”[15] This was not the case in our study as content was easily readable and comprehensible (in whatever was written).

In a survey undertaken with 10% of all US hospitals to determine the content of informed consent forms and their ability to be understood by individuals with differing reading comprehension levels, it was found that majority of procedural forms were complex and not easily understood by an average patient. Majority did not list specific benefits or potential complications of the planned procedure.[16] In our study, consent forms were easy to read and comprehend, but specific benefits were mentioned by the department of orthopedics only in totality.

An interview, based on structured questionnaire, on 106 patients over the age of 18 years who had undergone elective or emergency surgery revealed that, in 8.5% cases, no consent was obtained, 38% actually understood the information, 66% were informed about the type of anesthesia, none was given any hint about complications of anesthesia, and only 11% actually signed the consent forms themselves.[17] In our study, barring few exceptions, all the forms had relevant signatures/LTIs of the patients or their LARs.

An audit of consent form completion was conducted with an educational intervention followed by re-audit to reassess compliance where 37 forms were analyzed. Re-audit demonstrated an improvement in documentation of benefits (91%–100%) and additional procedures (0%–7.5%). Additional areas for improvement such as offering a copy of the consent form to the patient and confirmation of consent if a delay occurred between consenting and the procedure were identified.[18] In our study, none of the department mentioned who actually shall be doing the procedure and the date of procedure.

In a consent audit on 100 adult participants undergoing major procedure on elective basis under general anesthesia, 99% participants could state the correct name and site of the procedure, 92% could state the mode of anesthesia, while only 39% received an information leaflet regarding the operation, of which 80% claimed this could enhance their understanding of the procedure. About 70% could recall the potential surgical risks. Most essential items were completed in the consent forms. Nearly 24% forms involved witnesses. About 6% of consent documents had illegible surgeon's handwriting.[19] In our study, there was no issue of illegible handwriting of person who had taken consent. Declaration of possible risks and complications was present in one-third cases of OBG and surgery while in 99% cases of orthopedics.

A retrospective study done on the medical notes of 54 patients undergoing three types of elective gynecological surgery over a 7-month period assessed for the presence of consent forms, the legibility of the doctor's name, and his/her suitability and the extent to which risks of the operations were documented. All contained signed NHS (National Health Services) consent forms with signatures of doctors and patients. All identified doctors were assessed suitable to take consent with only two names not clearly legible. The documentation of risks was found to be incomplete.[20] This was not the case in our study.

A prospective audit of 76 patients undergoing elective orthopedic surgery assessing how effectively patients are consented at a busy teaching hospital demonstrated that patients were often given incomplete information about their management. Despite this, patients themselves felt that the level of information given to them was appropriate and allowed them to make an informed decision.[21] Our study did not reflect shared decision-making, as important elements to be known before informed consent can be given were lacking.


  Conclusion Top


The concept of “informed consent” has gained importance due to suits brought by patients who allege that they did not understand the nature of medical procedure to which they gave consent.[22] A well-explained and documented informed consent not only protects the physician from exposure to liability but also increases the patient's autonomy in decisions concerning health and encourages compliance with treatment.

The present study served as an audit of ICD for planned major surgeries in departments of surgery, orthopedics, and OBG. Lacunae found have been intimated to improve upon them, taking care to maintain privacy and confidentiality of stakeholders with an educational intervention planned for medical practitioners. After using the checklist for 300 cases, the lacunae were identified and a new checklist developed which can be used to audit ICDs by institutes. It is in process for copyright following which it shall be published too for everybody's use.

Acknowledgment

Acknowledgment is due to Prof. (Dr.) Dinesh Kumar, Professor Community Medicine, for his immense help in analysis of the data.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Jones MA. Medical Negligence. 4th ed. Sweet & Maxwell, London: Indian Reprint 2010; 2008. p. 548.  Back to cited text no. 1
    
2.
Ratanlal R, Dhirajlal KT. The Indian Penal Code. 33rd ed. Nagpur: Lexis Nexis; 2011.  Back to cited text no. 2
    
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Raab EL. The parameters of informed consent. Trans Am Ophthalmol Soc 2004;102:225-30.  Back to cited text no. 3
    
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Marodia K, Punjabi Nursing Home. Madhya Pradesh State Consumer Disputes Redressal Commission; 2003 (2) CLD 852: 2003 (3) CPJ 194.  Back to cited text no. 4
    
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Shah S, Rathod AJ. First Appeal No. 597/95, Decided on 8.5.2003 Reported in LJCP; National Consumer Disputes Redressal Commission; 2003. p. 384.  Back to cited text no. 5
    
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Thamil Selvi S, Kala S. National Consumer Disputes Redressal Commission; 2007 (2) CPJ 216: 2007 (2) CPR 24.  Back to cited text no. 7
    
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Dhanaka PS. Nizam Institute of Medical Sciences; 2009 (2) CPJ 61:2009 (3) CPR 81: 2009 9^0 SCC 1: 2009 Cri LJ 3012: 2010 ACJ 38: 2009 (4) All. LJ 549: 2009 (7) SCALE 407 (SC).  Back to cited text no. 9
    
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Asha, Mohd, Quasim. National Consumer Disputes Redressal Commission; 2013 (2) CPJ 398.  Back to cited text no. 12
    
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The Free Dictionary. As available at World Wide Web http://medical-dictionary.thefreedictionary.com/major+surgery. [Last assessed on 2019 Feb 06].  Back to cited text no. 13
    
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Bottrell MM, Alpert H, Fischbach RL, Emanuel LL. Hospital informed consent for procedure forms: Facilitating quality patient-physician interaction. Arch Surg 2000;135:26-33.  Back to cited text no. 14
    
15.
Handelsman MM, Kemper MB, Kesson-Craig P, McLain J, Johnsrud C. Use, content, and readability of written informed consent forms for treatment. Prof Psychol Res Pr 1986;17:514-8.  Back to cited text no. 15
    
16.
Hopper KD, TenHave TR, Tully DA, Hall TE. The readability of currently used surgical/procedure consent forms in the United States. Surgery 1998;123:496-503.  Back to cited text no. 16
    
17.
Siddiqui FG, Shaikh JM, Memon MM. An audit of informed consent in surgical patients at a university hospital. J Ayub Med Coll Abbottabad 2010;22:133-5.  Back to cited text no. 17
    
18.
Leng C, Sharma K. An audit cycle of consent form completion: A useful tool to improve junior doctor training. Indian J Plast Surg 2016;49:72-5.  Back to cited text no. 18
[PUBMED]  [Full text]  
19.
Wong J, Chan DT, Tam YH, Simon SM, Philip CT, Leung WW, et al. Audit on surgical patients' understanding of their informed consent. Surg Pract 2015;19:48-59. Available form: https://onlinelibrary.wiley.com/doi/full/10.1111/1744-1633.12110. [Last assessed on 2019 Feb 06].  Back to cited text no. 19
    
20.
Shittu S, Boraei S, Khalifa L. An audit of informed consent for elective gynaecological surgery in a district general hospital. Internet J Gynecol Obstet 2008;12.  Back to cited text no. 20
    
21.
Sharma P, Arya A, Singh S. Informed consent for orthopedic surgery: A prospective audit. Clinical Governance: An International Journal 2003;8:236-41.  Back to cited text no. 21
    
22.
HS Tuli V. PGIMER, 2008 (1) CPJ 392 [NCDRC].  Back to cited text no. 22
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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