Quality of Informed Consent for Invasive Procedures

Mayer Brezis, Sarah Israel, Avital Weinstein-Birenshtock, Pnina Pogoda, Ayelet Sharon and Renana Tauber,
Center for Clinical Quality and Safety, Hadassah Hebrew University Medical Center, 91120 Jerusalem, Israel

Abstract and Introduction

Abstract

Objective: To assess quality of informed consent among patients undergoing procedures and patient's preferences about
decision-making.
Design: Cross-sectional survey of hospitalized patients about informed consent before surgery or other procedures.
Preference for decision-making was elicited in hospitalized and ambulatory patients.
Setting: Large academic general hospital and 10 general clinics, over the years 2002–04.
Intervention: Data of initial survey were presented at staff meetings, recommending asking patients to restate what was
explained to them.
Main outcome measures: Rate of patient's recall for explanations on risks and alternative options; rate of patients
preferring shared, autonomous and paternalistic modes of decision-making; degree of satisfaction from the decision-
making.
Results: Half of the patients did not recall receiving explanations about risks and two-third did not remember discussion of
alternative options. The intervention failed, <10% of patients being asked to re-state what was explained to them.
Expectations about decision varied: ~60% favored shared decision, nearly 20% preferred autonomous decision and the
remainder wanted physicians to make decisions. Satisfaction was rated as good or very good by 80% of patients.
Conclusions: Most patients do not remember receiving explanations about risks or alternatives for procedures, and
physicians resist attempts to improve informed consent. Tools should be developed to measure the quality of consent.
Since patients significantly differ in their preferred mode of decision-making, the informed consent should be patient-
specific.

Introduction

Informed consent of patients undergoing procedures is important not only for ethical and legal reasons [1] but also for the
quality of care: patient's understanding allows cooperation, improves results and satisfaction and also helps preventing
errors.[2] Procedures to obtain consent must ensure that the patient understands the nature of his or her condition, the
risks and benefits of the proposed treatment and its alternatives, and agrees to it voluntarily. Complex decisions such as
surgery or other invasive procedure require a discussion of uncertainties. Although informed consent is a well-established
practice, it often fails to meet its purpose.[3] Recall of information in the context of the informed consent has been reported
as poor by many authors in different settings[4-14] and conspicuously inconsistent: varying from 18 to 81% for surveys
conducted on the same day the information had been given to the patient. [3]

Since the informed consent is culture-dependent and we were unaware of clinical research on its implementation in our
country, we set about to evaluate some aspects of this process at our institution. Rather than looking at the quantity of
information remembered by patients, we wished to look at some qualitative aspects of this exchange: Was the patient
satisfied with decision-making? Could the patient recall any mention of risks or alternatives? Had she or he wished to
receive more information? What is the preferred mode of decision-making: autonomous, shared or paternalistic? Had the
patient signed an informed consent? Had she or he been asked to repeat the explanations?

Although the necessary legal requirements for informed consent have been reviewed in great detail, [15] we were more
interested in examining and framing the issues from the viewpoint of quality of care. We prospectively surveyed patients
surrounding invasive procedures, exploring gaps between perceived and preferred modes of decision, attempting to
construct a basis for a standard for the quality of the informed consent.

Survey Procedure
Patients undergoing invasive procedures were surveyed using an anonymous questionnaire, with a help from a surveyor
to explain unclear questions. The surveyors were medical students doing their MD thesis in one of the different aspects of
the present work. The formal pre-testing was carried out on the first 30 patients to verify understanding, using at-face
validity criterion and refining formulation of questions until no further comment arose indicative of ambiguity.

The questions focused on patients' recall of information about risks and alternative treatment options, preferences about
the decision process and overall satisfaction from the informed consent procedure ( Table 1 ). Additional questions
referred to demographic data, education, date and nature of procedure, urgency of treatment and need for an interpreter
to answer the questions. Patients were interviewed in different wards before or after undergoing the procedure, usually
within a day or two from their signature of the informed consent. Qualitative comments volunteered by patients were
written as notes on the back of survey sheet. The survey took on average <15 min to conduct.

The research was approved by our Institutional Review Board.

Setting

The survey took place in the wards of a large academic general hospital (Hadassah Hebrew University Medical Center,
Jerusalem, Israel). In the course of the survey, it became apparent that probing the patient's preferred mode of decision
elicited a fairly stable heterogeneity of answers in different wards of the hospital (while slightly over half of patients wished
a shared decision-making, the remainder appears to be equally divided between either favoring paternalism or autonomy).
We began to perceive that this preference would be important in order to build a standard for appropriate informed
consent. We wished to explore the consistency of distribution for preferred modes of decision-making in a population
outside the hospital, not contemplating any invasive procedure. We therefore extended this portion of the survey to 350
patients scheduled for ambulatory visits (not scheduled for invasive procedures) in 10 general clinics in the city of
Jerusalem (and as part of a different survey on the quality of ambulatory care).

Study Participants

Over the years 2002–04, we collected a sample of 613 consecutive hospitalized patients undergoing surgery or invasive
procedure in various departments of the Hadassah Hebrew University hospital (General Surgery, Obstetrics and
Gynecology and Internal Medicine and Cardiology) to assess the quality of their informed consent to the procedure.
Preference for decision-making was elicited from 496 of the hospitalized patients (in internal medicine, the survey
included a related but differently worded question and therefore these patients were not included in the analysis of
answers to this question).

The types of procedures that the patients were undergoing in the various departments are described in Table 2 .

Intervention

The survey was conducted in two periods in three departments. In these departments (General Surgery, Obstetrics and
Gynecology and Cardiology), after the first period, an attempt was made to improve the process of the informed consent.
The data of the initial survey were presented at the staff meeting, at which discussion of the results took place, and
literature was presented recommending asking patients to restate what was explained to them. In addition, a yellow
sticker was attached to all informed consent forms in use in the department, as a reminder for the physician in charge of
getting the patient's signature, to ask the patient the following three questions: (i) Do you have any question? (ii) Do you
wish to get more information about risks or alternatives for the procedure? (iii) Could you please re-state for me what you
understood about the procedure? Several weeks later, the second part of the survey was conducted, including a specific
question to the patient: 'Were you asked to repeat the explanation?'

Methods of Data Analysis

As it became apparent that the intervention had no significant effect on the apparent practice related to the informed
consent in any department, the results of the two periods of survey were combined and presented as one set of data. Chi-
square testing was applied for the findings presented in the tables. For Table 3 , after an overall testing detected
significant differences, each department was iteratively compared with another, first for 'Explanations about risks' and then
for 'Discussion of alternatives'. Using the Bonferroni's correction for multiple comparisons, α was set at 0.01 for this table.
Results

Response rate was 94% for hospitalized patients (576/613) and 58% in the ambulatory setting (203/350). The patient
population was as follows: patient's age ranged from 18 to 83, average 54 (SD, 17). Forty-six percent of patients had been
born in Israel, the others been from diverse origins (mostly from Africa, Europe, East Europe or America) but were fluent
in Hebrew (help from a translator for answering questionnaire was needed in <10% of cases). High school education was
reported in 37%; academic education in 43%; the remainder reporting elementary school or lesser level of education.
Outside the obstetrics and gynecology ward, 43% patients were female and 85% were or had been married. The majority
of procedures were performed under elective conditions. In general and obstetric surgery, about one-third of the
procedures were done under private coverage with a specific surgeon.

Table 3 shows rates of recall for explanations about risks and alternatives during informed consent in different wards.
Between 39 and 60% of patients recalled receiving explanations about risks of procedures, and between 8 and 40%
remembered discussion about alternative management options. Patients in internal medicine and cardiology had lower
recall of risks than patients in surgery and obstetrics and gynecology (P <0.0001). Patients in internal medicine had higher
and patients in cardiology had lower recall of alternatives than patients in surgery and obstetrics and gynecology (P
<0.0001). Patients who did not recall explanations about risks were asked about their preference for more information on
the risks: about one-half of them stated they would have wanted additional information.

Not shown in the table, the explanations about the procedure were described as 'clear and detailed' by 75% of patients.
Three quarters of the patients also stated that they had enough time to think about the procedure and the decision. Over
98% of patients recalled having signed the required informed consent for surgery or for the invasive procedure. Less than
10% remembered having been asked to repeat the explanation they had received. The overall satisfaction from the
decision-making process was rated as good or very good by 80% of the patients did not significantly differ between wards
and did not correlate with the recall of information.

Table 4 describes the preferences for the decision-making process stated by hospitalized patients and by ambulatory
patients. It appears that in both settings a majority of patients favors a shared decision. Preferences about decision
varied: while ~60% favored shared decision, nearly 20% preferred an autonomous decision and the remainder wanted the
physician to make the decision for them. No consistent correlation was found between the preferred mode of decision and
the age, education, ethnic origin or setting of survey.

Discussion

In our survey, most patients did not remember having received information about complications or alternatives for
procedures, even though it is an inherent requirement of the voluntary and understanding informed consent they had
signed. Our results are consistent with other observations showing that recall from the informed consent is poor, [3-14,16] in
part because of the difficulty in the comprehension of the information. Our study differs since we did not ask patients
about specific risks or alternatives but only whether they had heard about them. Our study could not examine to what
extent the treating physician had attempted to convey information. The clinical setting appeared to influence the degree to
which risks and alternatives were perceived to have been discussed with patients. As shown in Table 3 , a surgical setting
appears to heighten the perception of risks (both by patients and by physicians), even though absolute risks may not be
always higher than in medical wards or invasive cardiology. Conversely, alternatives appear to be discussed more readily
in internal medicine, while in cardiology, the perception conveyed by physicians may be that 'there is no really other
options' (as reported in discussions of these results with cardiology staff).

Interestingly, despite these apparent major omissions in the informed consent, most patients viewed explanations as
'clear and detailed', with enough time to think about the decision, and overall satisfaction from the decision-making
process. This contradiction is only apparent: explanations may be perceived as good about some other aspects of the
treatment (such as technicalities on procedure, anesthesia or recovery), while risks and alternative options have not been
discussed. In addition, overall high satisfaction reported in surveys often overshadows deficiencies in quality of care
apparent on more specific questioning.[17]

Failure of recall may occur because of omission in physician's explanation, or inability of patients to understand,
assimilate or recollect the information. Several interventions have been suggested, including use of written explanations [18]
or audio-visual materials[19] and asking patients to re-state what they have been told during the informed consent. [6] In the
present study, we discussed survey results with the staff and suggested asking patients to re-state their understanding
before signing. In the repeated survey in three wards (surgery, obstetrics and cardiology) no improvement was seen and
<10% of patients were asked to re-state their understanding of the informed consent. During the discussions with staff, it
became apparent that the resistance to change relate to several factors, including lack of time, perception of informed
consents as legal documents unrelated to quality of care (as discussed by Lemaire) [3] and failure to grasp the extent of
health literacy gap, making communication of risks and alternatives a difficult task (although no literature could be found
on this issue).

A frequent dilemma in the informed consent, also raised in the discussion with the staff, is how much risk information is
appropriate, e.g. should a chance of death in the order of 1 in 1000 be communicated? Some argue that any severe
complication should be discussed; others say such details might frighten patients who would put off necessary
procedures. An interesting approach would be to ask patients how much information they want. [20] As also shown in Table
4 , patients greatly differ in their preferred mode of decision-making, as reported by others. [21-27] Although a majority of
patients favor shared decision, a growing proportion prefers autonomy and a significant fraction still adheres to a
paternalistic approach, having the physician decides for them. Every approach is legitimate and, as clinical ethicists have
proposed, the informed consent process should be patient-specific. [28] Since patients may actually shift from one approach
to another depending on the clinical setting, such as in critical illness, [29] the informed consent should perhaps be both
patient and setting-specific.

Our study has several limitations. We did not observe the actual discussion taking place during the process of the
informed consent: our data relate only to subjective perception and recall by patients, a several hours (up to a day or two)
after they had signed consent. Admittedly, it would be better to test recall immediately, giving a chance for correction and
improvement of the process, with inclusion of the question: do you wish to get more information about risks or alternatives
for the procedure? Our work was not intended to define standards for the quality of the informed consent but our findings
may be the basis for the development of tools for that goal. Since it was conducted in one city, it may appear difficult to
generalize our findings, although our population of both patients and staff is multicultural and probably not too different
currently from many institutions in Western countries. Finally, our analyses did not find reliable predictors of recall of
explanation, wish for more information, preferred mode of decision, and satisfaction with the decision process or
consistent associations between these variables, perhaps because of the limited size of our population.

In conclusion, since routine informed consent appears to be suboptimal, we suggest that its quality be regularly assessed,
as part of the evaluation of healthcare processes. The first step should be to encourage efforts to construct accurate tools
to measure the quality of consent, a critical step before adopting policies for periodic assessment.

Source:

[Link]
 College of Nursing
Silliman University
Dumaguete City

Journal Reading on:

Quality of Informed Consent for Invasive Procedures

Submitted to:
Asst. Prof. Junabelle A. Yuipco

Submitted By:

Chelo Belle E. Cala

This study was done in order to assess just how much information an informed consent really gives to a patient and how
this can affect his/her decisions. The study was conducted to define standards for the quality of the informed consent but
rather encourage efforts to construct accurate tools to measure the quality of consent, a critical step before adopting
policies for periodic assessment.

The study revealed that not all patients were not able to recall about the risk and complications or alternatives of the
procedures before signing the consent. However when patients were asked how they find the explanations given to them
they would describe it as “clear and detailed”. The study also showed how the given information affected that client’s
decision regarding the procedure and about 60% of the patients claim to have made a shared decision with the physician.

The study challenges healthcare workers just how much information should be revealed to a patient since disclosure of
unnecessary information may lead to the patient backing out of needed procedures. Through and through, it all boils down
to empowering the patient with adequate information for them to make appropriate choices about their health.

Reaction:

It is a common practice here in the Philippines for nurses to be the one to obtain the informed consent form the
patients. This would imply that not all necessary information that could have affected the client’s decision would be
relayed since a physician’s point of view about the procedure greatly differs from that of a nurse. And also generally, our
patients, especially those admitted in public hospitals, are not assertive. They just simply nod to whatever the doctors
have to say and immediately agree sometimes even without understanding anything. As nurses, it is our duty to help them
make informed decisions by allowing them time to process information and asking them whether or not they have
questions. If they have, then a scheduling of another appointment with the physician for them to clarify their concerns is a
simple yet effective way for them to understand better.