Patients’ perceived purpose of clinical informed consent: Mill’s individual autonomy model is preferred

Abstract

BackgroundAlthough informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients’ perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient’s self decision-making. Different purposes require different processes.MethodsWe surveyed 488 adults who were planning to undergo or had recently undergone written informed consent-requiring procedures. Perceptions of informed consent purpose (from norm and current practice perspectives) were explored by asking respondents to rank (1 = most reflective) 10 randomly-presented statements: “meaningless routine”, “courtesy gesture” “litigation protection”, “take away compensation rights”, “inform patient’, “make sure patient understand”, “document patient’s decision”, “discover patient’s preferences”, “have shared decision”, and “help patient decide”.ResultsRespondents’ mean (SD) age was 38.3 (12.5); 50.4% were males, 56.8% had ≥ college education, and 37.3% had undergone a procedure. From the norm perspective, the least reflective statement was “meaningless routine” (ranked 1–3 by 2.6% of respondents) and the most reflective statements were “help patient decide”, “make sure patient understand”, and “inform patient” (ranked 1–3 by 65%, 60%, and 48% of respondents with median [25%,75%] ranking scores of 2 [1,5], 3 [2,4], and 4 [2,5], respectively). Compared to their counterparts, males and pre-procedure respondents ranked “help patient decide” better, whereas females and post-procedure respondents ranked “inform patient” better (p = 0.007 to p < 0.001). Age was associated with better ranking of “help patient decide” and “make sure patient understand” statements (p < 0.001 and p = 0.002, respectively), which were ranked 1–3 by only 46% and 42% of respondents from the current practice perspective (median ranking score 4 [2,6], p < 0.001 vs. norm perspective for both).Conclusions1) the informed consent process is important to patients, however, patients vary in their views of its purpose with the dominant view being enabling patients’ self decision-making, 2) males, pre-procedure, and older patients more favor a self decision-making purpose, whereas females and post-procedure patients more favor an information disclosure purpose, and 3) more self decision-making and more effective information disclosure than is currently practiced are desired. An informed consent process consistent with Mill’s individual autonomy model may be suitable for most patients.

The relationship between knowledge and perception of patients regarding informed consent in surgical procedures in Rwanda

“…These results were different from Hammami et al where nearly all participants (95.7%) were aware that their next of kin could sign on their behalf. 4 The results of this study revealed that there is a significant weak positive correlation between patient's knowledge and perception of patients towards informed consent for surgical procedures (r = 0.487), (-1≤ r ≤1, p=0.00). This means that as the patient' knowledge increases the perception also increases towards informed consent for surgical procedures.…”

“…3 Informed consent is built on patient competence to understand information and making a deliberate decision to undergo a specific surgical procedure and is valid until the patient' disease has not been changed or no new findings that may change the planned procedure are revealed. 4 Patient's self-reflection should be empowered as it enables them to take treatment decisions themselves. Nevertheless, poor patient's perception to informed consent compromises their autonomy and self-determination, therefore they feel powerless and unaccountable for their treatment.…”

“…Nevertheless, poor patient's perception to informed consent compromises their autonomy and self-determination, therefore they feel powerless and unaccountable for their treatment. 4 The study done in Saudi Arabia revealed 48% of patients believing that they sign the consent because they thought the surgery would not be performed without signing and 42% thought they would destroy their relationship with their physician. 5 A survey conducted in Uganda at three university teaching hospitals has shown that patients 'knowledge towards informed consent are diverse and limited because some patients do not know even the identity of the surgeon or the reason for surgery.…”

Saudi female university employee self-determination in their own health-related issues

“…Consequently, Personal choices are only accepted if they are the "right" ones. [6] However, Hammami et al [7] concluded in their survey study with 488 Saudi patients (both male and female) that their results showed a strong sense of individual autonomy orientation, a strong sense of self-efficacy, and reduced trust in the healthcare system. However, Marrone, [8] argued that Saudi women usually will defer to their husband's or father's decision making.…”

Knowledge and perception of surgical informed consent and associated factors among adult surgical patients in Gondar University Comprehensive and Specialized Hospital, Ethiopia

“…Surgical informed consent is the process whereby patients are informed of all the necessary information about health care and subsequent treatment plans, risk, and alternatives. An informed consent is built by competent patient to make decision about his/her surgical procedure with enough information which is clear and understandable and valid unless the patient's disease has not been changed, and or no new findings that may change the planned procedure are revealed (1). Whatever it is, the patient has still full right to refuse the treatment, called informed refusal, but the reality is not true in clinical practice (2,3).…”