ORIGINAL RESEARCH
Psychiatrists’ Documentation of Informed Consent
Debbie Schachter, MD, MSc, FRCPC1, Irwin Kleinman, MD, FRCPC2
Objective: The present study was undertaken to determine current attitudes
and behaviour toward informed consent for antipsychotic medication and
documentation of the informed consent process in patient charts.
Method: Thirty psychiatrists treating a minimum of 10 patients on antipsychotic
medication were selected from teaching and nonteaching hospitals. Clinicians
completed questionnaires on their behaviour and attitudes regarding documentation
of informed consent and antipsychotic medication. Physicians’ charts were
reviewed to ascertain documentation.
Results: Psychiatrists reported sometimes documenting the informed consent
process. The chart review revealed that, on average, each psychiatrist
had documentation in 23% of charts. Physicians who either were affiliated
with a teaching hospital or spent more time reading medical journals were
more likely to document the informed consent process.
Conclusions: Physicians who use antipsychotic medication as a treatment
in their practice are not routinely documenting the informed consent process
in patient records. Physicians should pay more attention to this aspect
of record keeping because it is their only record of the consent process.
(Can J Psychiatry 1998;43:1012–1017)
Key Words:
informed consent, documentation, antipsychotics
Informed consent is obtained before initiating any medical treatment and
reflects our respect for the fundamental autonomy of the individual (1,2).
The elements of consent include that it be specific, informed, and voluntary
and that the patient be capable. For consent to be informed, P a person
must receive information that any reasonable person in the same circumstances
would require to make a decision (3). Information should refer to the nature
of the treatment; the benefits, material risks, and side effects of the
treatment; and the alternatives, including the option of no treatment.
Physicians who fail to inform patients about material risks of treatment
can be found negligent in their practice of informed consent (4,5).
Tardive dyskinesia (TD) is estimated to affect 20% to 25% of patients on
long-term antipsychotic medication and to be irreversible in as many as
50% of adults (6,7). TD has received considerable attention in the medical,
legal, and ethical literature (8). In keeping with the principle of patient
autonomy, it is important that patients be informed about TD as part of
the informed consent process for antipsychotic medication (4,6). The American
Psychiatric Association’s (APA) Task Force Report on Tardive Dyskinesia
has recommended that patients be informed about the benefits and risks
of antipsychotic medication, including the risk of TD (6,9).
A physician who fails to inform patients about the risks of treatment,
including the risk of TD, may, therefore, be considered negligent (4,10).
In several cases, physicians have been successfully sued for failure to
inform patients about the risks associated with antipsychotic medication.
The issue of informed consent for antipsychotic medication is particularly
complex for several reasons. First, empirical data suggest that patients
informed about the benefits and risks of medication do not always recall
what they were told (11–14). Among guardians of individuals with mental
retardation, the average recall of information about TD was only 43% (11).
In another study, although the informed consent process increased knowledge,
it was felt that patients did not learn the information necessary to make
an informed decision (13). Kleinman and others increased patient’s knowledge
about antipsychotic medication using a structured informing process (12).
However, some patients did not recall having been informed. In addition,
psychopathology at the time of the informed consent process affects patients’
ability to learn information about antipsychotic medication, with patients
who have more psychopathology learning less than those with less psychopathology
(15).
Documentation of the informed consent process may therefore be a physician’s
only record that a patient was informed about the benefits and risks of
medication. There is, then, a need for physicians to document somehow that
patients were informed about the benefits and risks of antipsychotic medication
(8,16,17). The APA has recommended that physicians record that the indications
for and risks of maintenance antipsychotic medication have been reviewed
with the patient and/or relatives (6,18).
There has been controversy concerning the appropriate method to document
that patients have been informed about the benefits and risks of long-term
antipsychotic therapy. Some attorneys and authors advocate the use of written
consent forms, arguing that the risk of TD represents a significant risk
and that, therefore, written informed consent is necessary (19). They feel
written consent is indicated when patients with TD need continued maintenance
antipsychotic medication or in patients who require antipsychotic medication
for periods of longer than 1 year.
In contrast, the APA argued that written informed consent forms were unnecessary,
because they are not routinely used in nonexperimental therapies and might
introduce a potentially detrimental and adversarial quality to physician–patient
relationships (6). Further, signed consent forms do not necessarily ensure
adequate disclosure. Courts are interested in what was disclosed (17,20),
and legal actions against physicians have occurred in the presence of signed
consent forms (17). Some psychiatrists and institutions have developed
checklists or forms to facilitate physicians’ documentation of the informed
consent process for antipsychotic medication (21,22). However, while community
centres and professional associations may develop clinical guidelines,
this does not always translate into clinical practice (23–26). In a review
of records in Ohio, a state with legislation on documentation, in a centre
where a checklist consent form was introduced to facilitate documentation,
only 40% of charts were deemed acceptable by the investigators (22).
Gurian and others, in a survey of elderly patients admitted to a teaching
hospital’s inpatient psychiatric unit, found documentation in only 8 of
28 charts (27). All 8 instances of documentation involved refusals of treatment.
Consistent with their documentation, only about one-half of the physicians
at the teaching hospital reported that they occasionally documented the
informed consent process. Lacro and others attempted to improve documentation
through a quality assurance project (28). Immediately after introducing
a consent form, 39% of patients on long-term antipsychotic medication had
signed consent forms.
The finding of low rates of documentation in the presence of either legislation
or hospital guidelines has important implications for actual physician
practice in situations where there are no externally directed guidelines
and where physicians are free to document as they feel is indicated. In
these situations, it is unclear to what extent physicians are actually
documenting the informed consent process.
Further, it is unclear why some physicians are not documenting the informed
consent process. The factors that influence physicians’ behaviour in terms
of documenting the informed consent process are largely unknown. Even when
practice guidelines disseminate widely accepted information, factors other
than knowledge have been suggested to influence physicians’ behaviour (23).
Factors postulated to influence behaviour include physicians’ education,
personal physician characteristics, practice characteristics, community
economic factors, and administrative influences (26). Attitudes of physicians
to documentation of the informed consent process may influence behaviour,
and these have not been well studied. In the APA survey of psychiatrists,
11% of psychiatrists favoured a written procedure, while 70% did not (9).
This study was undertaken to determine current attitudes and behaviour
of Canadian psychiatrists toward the documentation of the informed consent
process for antipsychotic medication. The physician characteristics associated
with more documentation and/or more favourable attitudes to documentation
of the informed consent process are examined.
Method
Subject Selection
Thirty psychiatrists were selected, divided equally between teaching- and
nonteaching-affiliated hospitals. No more than 6 psychiatrists were selected
from any 1 hospital. To be eligible to participate in this study, clinicians
needed to treat a minimum of 10 patients on antipsychotic medication in
their practice. Informed consent for participation in this study was obtained
from all physicians.
Procedure
Clinicians completed mailed questionnaires on their behaviour with respect
to informing competent patients or relatives of incompetent patients about
antipsychotic medication and documenting the informed consent process and
their attitudes toward documenting the informed consent process. Physicians
were subsequently interviewed. For each physician, the charts of the 10
most recently seen patients taking antipsychotic medication were reviewed
to see whether they had documented the informed consent process.
Instruments
Self-Report Questionnaire
Face validity of the questionnaire was determined by showing it to 9 experienced
psychiatrists and 10 experienced general practitioners. The questionnaire
was divided into 3 sections: 1) behaviour scale addressing information
provided to patients about the benefits and risks of antipsychotic medication,
2) items related to self-report of documentation of the informed consent
process, and 3) items related to attitudes toward documenting the informed
consent process. The behaviour scale was developed to summarize current
practice as it pertains to providing information regarding the benefits
and risks of antipsychotic medication to patients or relatives of incompetent
patients. Items addressed providing information on the reasons for medication,
the alternative treatments, the name of the medication, dosage of medication,
and the side effects associated with antipsychotic medication. Items of
behaviour were scored using a 5-point Likert scale (5 = always, 4 = almost
always, 3 = sometimes, 2 = almost never, 1 = never). The overall score
is a sum of the individual item scores.
Items dealing with documentation of the informed consent process were also
answered using a 5-point Likert scale (5 = always, 4 = almost always, 3
= sometimes, 2 = almost never, 1 = never).
Attitudes toward documentation of the informed consent process were assessed
using a 5-point Likert scale. Positively keyed attitudinal items were scored
as follows: 5 = strongly agree, 4 = agree, 3 = neutral, 2 = disagree, 1
= strongly disagree.
Results
Demographic Characteristics
The mean age of the psychiatrists was 44.8 years (SD 8.3), and 80% were
male. On average, they graduated from medical school in 1972 (SD 8.87 years),
spent 67 hours (SD 53) every year in formal continuing medical education
activities, and spent 12.3 hours (SD 10.11) each month reading medical
journals.
Self-Report of Disclosure and Documentation
Table 1 shows the frequency with which psychiatrists endorsed informing
patients about the benefits and risks of antipsychotic medication. While
all psychiatrists routinely discussed the reasons for antipsychotic medication,
only two-thirds routinely disclosed the risk for TD to patients. Table
2 shows the frequency with which psychiatrists endorsed documenting the
consent process with competent patients or relatives of incompetent patients.
No psychiatrist obtained written consent when prescribing antipsychotic
medication to competent patients.
|
Table 1. Percentage of psychiatrists (N = 30) indicating
the frequency
with which they inform competent patients
of various items
|
|
Item
|
Always or almost always
(%)
|
Sometimes
(%)
|
Never or almost never
(%)
|
|
Reasons for antipsychotic medication
|
100
|
0
|
0
|
|
The brand or generic name of medication
|
90
|
7
|
3
|
|
The dosage of the medication
|
87
|
13
|
0
|
|
The consequences of not receiving the medication
|
97
|
3
|
0
|
|
Akathisia
|
77
|
23
|
0
|
|
Dystonic reactions
|
67
|
30
|
3
|
|
Rigidity
|
83
|
17
|
0
|
|
Tardive dyskinesia
|
67
|
27
|
6
|
|
Constipation
|
64
|
33
|
3
|
|
Dry mouth
|
77
|
23
|
0
|
|
Table 2. Percentage of psychiatrists (N = 30) indicating the frequency
of various behaviours
|
|
Behaviour
|
Always or almost always
(%)
|
Sometimes
(%)
|
Never or almost never
(%)
|
|
Document in the chart that a competent patient was informed about risks
and benefits of antipsychotic medication
|
13
|
60
|
27
|
|
Obtain written consent when prescribing antipsychotics to competent patients
|
0
|
0
|
100
|
|
Document in the chart that a relative of an incompetent patient was informed
about risks and benefits of antipsychotic medication
|
44
|
28
|
28
|
|
Obtain written consent from relatives when prescribing antipsychotics to
incompetent patients
|
28
|
8
|
64
|
Documentation in Charts
The chart review revealed that, on average, each psychiatrist had documentation
in 23% of charts. There was a moderate correlation between self reports
of documentation and actual documentation as determined by chart reviews
(r = 0.39, n = 30, P < 0.04). Physicians who stated that they always or
almost always documented the informed consent process tended to overestimate
the frequency evidenced by the charts. For cases in which consent was obtained
from the patient, psychiatrists who reported always or almost always documenting
the informed consent process had documentation in 32% of charts (N = 3),
those who reported sometimes documenting the process had documentation
in 28 % of charts (N = 18), and those who reported never or almost never
documenting the informed consent process had documentation in 7% of charts
(N = 6). For cases in which consent was obtained from a relative, psychiatrists
who reported always or almost always documenting the process had done so
in 60% of charts (N = 1), those who reported sometimes documenting in 6%
(N = 3), and never or almost never documenting the process in 0% of charts
(N = 3).
Relationship Between Actual Documentation and Informing Behaviour
There was no significant association between actual documentation and the
total amount of information provided to patients on the self-report questionnaire
(r = 0.007, n = 30, not significant) or the amount of information provided
about TD (r = 0.13, n = 30, ns).
Correlates of Documentation Behaviour
There was a significant difference in the percentage of charts with documentation
between physicians with teaching- and nonteaching-hospital affiliations
(t[28] = 2.5, P < 0.018). Physicians from teaching hospitals were more
likely to document in charts (mean = 0.34, SD 0.28) than were physicians
from nonteaching hospitals (mean = 0.12, SD 0.19).
There was no significant gender difference in the percentage of charts
with documentation (t[28] = 0.21, ns). In bivariate analyses, the percentage
of charts with documentation correlated significantly with the number of
hours spent reading medical journals; physicians who spent more time reading
medical journals were more likely to document in charts than were those
who spent less time reading (r = 0.45, n = 30, P < 0.013). There was no
significant correlation between percentage of charts with documentation
and age (r = 0.25), number of hours spent in formal continuing medical education
(CME) activities (r = 0.21), and the time since certification (r = 0.26).
In a linear regression analysis, with percentage of charts with documentation
as the outcome variable, the following variables were considered as potential
predictor variables: gender, number of hours spent reading medical journals,
time since certification, hospital affiliation, and number of hours spent
in formal CME activities. The final regression equation explained 26% of
the variance in scores and was significant (F[2,26] = 6.03, P = 0.007).
Hospital affiliation (t[1,26] = 2.11, P = 0.04) and number of hours spent
reading medical journals (t[1,26] = 2.26, P = 0.03) were significant predictors
of documentation. Physicians from teaching hospitals compared with those
from nonteaching hospitals had more documentation in charts, and physicians
who spent more time reading medical journals were more likely to document
in charts. There was no interaction between hospital affiliation and time
spent reading medical journals.
Attitudes Toward Documentation
Table 3 shows a summary of psychiatrists attitudes toward documentation
of the informed consent process for antipsychotic medication. Most respondents
felt that informed consent for antipsychotic medication should be recorded
in charts and did not think that the process needed to be audio- or videotaped
or that signed consent forms were necessary. Physicians thought signed
forms may increase patients’ anxiety and might be detrimental to the patient–physician
relationship.
|
Table 3. Percentage of psychiatrists (N = 30) indicating attitudes toward
documentation
|
|
Statement
|
Agree or
strongly
agree
(%)
|
Neutral
(%)
|
Disagree or strongly
disagree
(%)
|
|
Informed consent process for antipsychotics should be recorded in the chart
|
70
|
17
|
13
|
|
Informed consent process for antipsychotics should be audiotaped or videotaped
|
7
|
3
|
90
|
|
Patients should sign consent forms for nonsurgical medical procedures
|
43
|
27
|
30
|
|
Signed consent forms may increase patient anxiety
|
70
|
13
|
17
|
|
It takes too much time to document in the chart that the risks and benefits
were explained to the patient
|
27
|
13
|
60
|
|
Consent forms for medication may be detrimental to patient–physician relationships
|
40
|
27
|
33
|
|
Signed consent forms for antipsychotics are unnecessary
|
73
|
17
|
10
|
|
Patients should sign consent forms for surgical procedures
|
93
|
7
|
0
|
|
Signed consent forms for medications with serious side effects are necessary
|
40
|
30
|
30
|
Correlation Between Attitudes to Documentation and Actual Documentation
There was no significant correlation between scale score measuring attitudes
to documentation and percentage of charts with documentation (r = 0.096).
There was no significant correlation between scores on any of the individual
items composing the documentation scale and percentage of charts with documentation
(r = 0.16 to r = 0.36). The highest association was between percentage
of charts with documentation and those who felt documentation should be
recorded (r = 0.36, n = 30, P = 0.052).
Discussion
Although almost all psychiatrists reported explaining some of the potential
benefits of and reasons for antipsychotic medication to patients or relatives
of incompetent patients, written documentation was not occurring routinely.
Documentation of the informed consent process was present in approximately
one-quarter of the charts. These low rates of documentation are at the
lower range of those reported by others (22,27). There are several explanations
for the low rates observed in this study. First, this may reflect the absence
of specific provincial guidelines on documentation in Ontario where the
study was undertaken. Second, this may be explained by the lower rates
of malpractice litigation in Canada compared with the United States, where
the earlier studies were conducted.
We had hypothesized that psychiatrists who were aware of the medicolegal
necessity of informing patients about TD would be more likely to both inform
patients about this side effect and make some notation or documentation
about this in patient records. We were unable to support this hypothesis.
Documentation was not associated with either the total information provided
to patients or information provide specifically regarding TD. This suggested
that documentation was not necessarily associated with awareness of the
medicolegal necessity of informing patients about TD. Further, only hospital
affiliation and reading of medical journals was associated with documentation
of the informed consent process. Physicians who read more journals or are
affiliated with teaching settings may be more aware of the need to document
the informed consent process or more conscientious in both record keeping
and the reading of medical literature. These findings are consistent with
those of Benson, who noted that physicians who read more journals disclosed
more information to patients (29). Physicians affiliated with teaching
hospitals were more likely to document in charts than nonteaching hospital
affiliated physicians. We do not know whether there were differences in
the hospitals’ policies regarding documentation of the informed consent
process. Neither gender, age, nor number of hours spent in CME) were associated
with documentation behaviour. This is consistent with CME not being related
to quality of care or charting practices among Ontario family physicians
(30,31). This, however, contradicts findings that CME is effective (32)
possibly because randomized trials for CME effectiveness look for outcome
specific to CME intervention. In studies of charting practices, there may
be no association between CME and documentation or care, since one is looking
at overall CME, rather than CME related to documentation.
The finding that neither gender nor age correlated with differences in
documentation behaviour differs from other findings on age and gender effects
on physician documentation behaviour. In a study of effect of demographics
on minimal standards for either care or documentation, younger physicians
performed better than older physicians (31). In addition, an audit of Ontario
family physicians’ charts revealed younger physicians and women had better
charting practices (33). In the latter study, the criteria for charting
consisted of only legibility, basic registration data, allergies, notations
for assessments and medication prescriptions. There was no examination
of documentation of informed consent process. Another possible explanation
for the differences in the studies is that the present study had a small
sample size and would, therefore, have the power to detect only large effect
sizes. It may be that with a larger sample, smaller differences would be
detected.
In terms of understanding other determinants of behaviour, while 70% of
physicians felt the informed consent process should be recorded, virtually
no physicians endorsed audio- or videotaping the informed consent process.
This is consistent with the findings of the APA survey (9). While 40% of
psychiatrists thought signed consent forms were necessary for medications
with serious side effects or for nonsurgical procedures, almost three-quarters
did not feel they were necessary for antipsychotic medications, which suggests
that they view these medications as not having serious side effects. Psychiatrists
thought signed consent forms could increase patients’ anxiety or be detrimental
to patient–physician relationships, in agreement with some of the concerns
raised by others in the literature (9).
This study had several limitations. First, the sample was not representative.
However, because care was taken not to overselect physicians from a particular
hospital or site, the sample may, in fact, be representative. Second, because
of the small sample size, there was limited power to detect small effects
for continuous variables or moderate effects for categorical variables.
Conclusion
Psychiatrists had favourable attitudes toward documentation in charts,
but they do not endorse audio- or videotaping the informed consent process
or using written consent forms. They had low rates of actual documentation
and overestimated their own behaviour. Since psychiatrists’ behaviour did
not reflect their attitudes, periodic chart reviews might heighten physicians’
awareness of their own charting practices. The development of checklists
or other tools might also facilitate charting the consent process. Finally,
the results of this study need to be replicated using a larger, representative
sample to ensure that the practices reported in this study generally reflect
those of all psychiatrists.
Clinical Implications
|
-
Psychiatrists have low rates of documentation of consent.
|
|
Periodic chart reviews may increase physicians’ awareness of their charting
practices.
|
|
The development of checklists or tools may facilitate charting of consent.
|
|
Limitations
|
-
The study sample was small.
|
|
There was limited power to detect moderate effects on documentation for
categorical variables.
|
The sample was not necessarily representative of all psychiatrists.
|
Acknowledgements
This research was funded by theNational Health and Research Development
Program, Grant No 6606-4226-57P and Grant No 6606-5304-301. The authors
thank Dr Jack Williams for his collaboration in this project. The authors
thank Catherine Turchon, Marta Chydzij, and Maggie Toplak for their assistance.
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Résumé
Objectif : La présente étude a été menée afin de déterminer les attitudes
et comportements courants à l’égard du consentement éclairé aux médicaments
antipsychotiques et de la documentation du processus du consentement éclairé
dans les dossiers des patients.
Méthode : Trente psychiatres traitant au moins 10 patients à l’aide d’antipsychotiques
ont été choisis dans des hôpitaux d’enseignement et autres établissements.
Les cliniciens ont rempli un questionnaire sur leurs attitudes et comportements
à l’égard de la documentation du consentement éclairé et des antipsychotiques.
Les dossiers des médecins ont été examinés pour s’assurer de la présence
de la documentation.
Résultats : Les psychiatres déclarent documenter parfois le processus du
consentement éclairé. L’examen des dossiers révèle qu’en moyenne, chaque
psychiatre a de la documentation dans 23 % des dossiers. Les médecins affiliés
à un hôpital d’enseignement ou qui consacrent plus de temps à la lecture
de revues médicales sont plus enclins à documenter le processus du consentement
éclairé.
Conclusions : Les médecins ayant recours aux antipsychotiques dans leur
pratique n’ont pas l’habitude de documenter le processus du consentement
éclairé dans les dossiers des patients. Ils devraient toutefois y accorder
plus d’attention, étant donné qu’il s’agit de la seule preuve du consentement
éclairé.
This paper was presented at the 48th annual meeting of the Canadian Psychiatric
Association, Calgary, Alberta, 1997.
Manuscript received January 1998, revised, and accepted May 1998.
1Assistant Professor, Department of Psychiatry and Public Health Sciences,
University of Toronto, The Centre for Addiction and Mental Health, Clarke
Division, Toronto, Ontario.
2Assistant Professor, Departments of Psychiatry and Family and Community
Medicine, University of Toronto, Mount Sinai Hospital, University of Toronto
Joint Centre for Bioethics, Toronto, Ontario.
Address for correspondence: Dr D Schachter, Clarke Institue of Psychiatry,
250 College Street, Toronto, ON M5T 1R8
Can J Psychiatry, Vol 43, December 1998