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The Adequacy of Informed Consent for Placement of Gastrostomy Tubes
Allan S. Brett, MD;
Jason C. Rosenberg, MD
Arch Intern Med. 2001;161:745-748.
ABSTRACT
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Background Gastrostomy tubes are placed commonly in patients with limited life
expectancy. However, it is unclear whether the process of informed consent
is adequate in these patients. This study examined the quality of informed
consent in hospitalized patients undergoing placement of gastrostomy tubes.
Methods Retrospective review of the medical records of a cohort of 154 consecutive
hospitalized adults undergoing placement of gastrostomy tubes in the context
of chronic progressive illness, in the setting of a large community-teaching
hospital.
Results The medical record documented a procedure-specific discussion of benefits
and burdens of and alternatives to tube feeding in only 1 of 154 patients.
Only 12 of 33 definitely or probably competent patients signed the hospital
consent form; in the remaining 21, a surrogate decision-maker signed the form.
The cumulative 1-year mortality for this cohort was 50%.
Conclusions The quality of informed consent for placement of gastrostomy tubes was
inadequate in a large community-teaching hospital. Indirect evidence from
the literature suggests that these results are not unique to this institution.
Physicians should become more familiar with the medical and ethical issues
relevant to medically administered nutrition near the end of life, and institutions
should develop procedures to improve the quality of decision-making for patients
considering this intervention.
INTRODUCTION
GASTROSTOMY tubes are used commonly to provide nutrition and hydration
for patients unable or unwilling to maintain an adequate oral intake. Among
hospitalized patients aged 65 years or older in the United States, the number
undergoing placement of a gastrostomy tube increased from 61 000 in 1988
to 121 000 in 1995.1 In 1990 and 1991,
roughly 1 in every 100 hospitalized patients aged 85 years or older received
a gastrostomy tube.1-2
The short-term mortality rates following gastrostomy placement are high.3-4 In a cohort of more than 7000 US veterans
who underwent placement of percutaneous endoscopic gastrostomy (PEG) tubes
between 1990 and 1992, median survival was 7.5 months and 1-year mortality
was 59%.5 Among Medicare beneficiaries receiving
gastrostomy tubes in 1991, 30-day and 1-year mortality was 24% and 63%, respectively.1 Because tube insertion itself is associated with fatal
complications only rarely, the high short-term mortality clearly reflects
a substantial underlying comorbidity in this population. Most patients receiving
gastrostomy tubes have advanced dementia, other types of severe neurologic
impairment, cancer, or advanced failure of other internal organs.1-2,5
The growing use of tube feeding in a population with limited life expectancy
inevitably raises the following question: Do physicians discuss the benefits
and burdens of tube feeding adequately with patients or surrogate decision-makers
before gastrostomy tubes are inserted? Assessing benefits and burdens is an
integral part of informed decision-making and should precede any elective
life-sustaining intervention. However, anecdotal observations6-7
and a recent interview study8 raise serious
questions about the quality of the informed consent process preceding the
insertion of gastrostomy tubes. We therefore conducted a retrospective analysis
of the medical records of consecutive patients receiving gastrostomy tubes,
with particular attention to the quality of documented informed consent.
MATERIALS AND METHODS
The study was conducted at Palmetto Richland Memorial Hospital, Columbia,
a 649-bed community-teaching hospital affiliated with the University of South
Carolina School of Medicine. Patients are admitted to teaching services (covered
by residents under attending physician supervision) and nonteaching services
(covered only by private physicians). The hospital provides primary care for
metropolitan Columbia and serves as a referral hospital for central South
Carolina. In fiscal year 1998-1999, there were 22 275 discharges of adults
aged 18 years and older; nonwhites (nearly all of whom were black) comprised
52% of discharges.
A computerized search of medical records identified all patients who
had gastrostomy tubes placed surgically, endoscopically, or radiologically
(International Classification of Diseases, Ninth Revision, Clinical Modification, codes 43.11 and 43.19)
between July 1, 1997, and June 30, 1998. We reviewed the medical records of
all adults aged 21 years and older. To limit the study to patients whose gastrostomy
tubes were placed in the context of chronic progressive illness, we excluded
patients in whom tube placement was intended to be temporary (eg, after trauma,
following head and neck cancer surgery with curative intent).
We reviewed each medical record in detail to obtain demographic and
clinical information, and we read every physician's progress note in the chart.
We classified patients into 4 categories of primary diagnoses: acute stroke,
chronic dementia, other neurologic conditions, and nonneurologic conditions
with failure to thrive. The latter category included patients with terminal
cancer or advanced failure of 1 or more organ systems. If the medical record
directly alluded to the patient's capacity for decision-making during the
period before gastrostomy tube placement, the patient was categorized as clearly
competent or incompetent. In cases with no direct statement, we inferred competence
or incompetence through review of progress notes or other information suggesting
the presence or absence of delirium or dementia. To assess informed consent,
we searched for progress notes documenting discussions with patients or surrogate
decision-makers. We considered any documented discussion of specific benefits
and burdens of and alternatives to tube feeding, however brief, to constitute
adequate informed consent. The hospital's generic surgical consent form has
a place to write in the name of the procedure but no space in which to record
procedure-specific benefits, burdens, and alternatives.
To assess mortality following discharge from the hospital, workers at
the South Carolina Department of Public Health and Information Services, Columbia,
searched a microfilm database to determine the vital status of each discharged
patient. The database was complete through September 1, 1999.
RESULTS
Between July 1, 1997, and June 30, 1998, 272 gastrostomy tubes were
placed in adults aged 21 years and older. We excluded 118 patients (48 with
a primary diagnosis of trauma, 29 undergoing treatment for head and neck cancer,
27 with an unavailable complete medical record, and 14 for miscellaneous reasons),
leaving 154 patients for inclusion in the study.
Demographic and clinical characteristics of patients are noted in Table 1. The mean age (± SD) was
71 years (± 13.9). The large proportion (69.5%) of nonwhite patients
is higher than the hospital's overall nonwhite proportion of 52%. More than
two thirds of the patients had neurologic diagnoses; the nonneurologic group
consisted primarily of patients with advanced cardiac, pulmonary, kidney,
or liver disease, and patients with cancer. Competence or incompetence was
clearly indicated in 67.5% of patients. In most cases, the procedure was authorized
by a surrogate decision-maker (according to the signature on the official
hospital consent form).
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Table 1. Characteristics of Study Population*
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The progress notes documented a discussion with the patient or surrogate
outlining procedure-specific benefits and burdens of and alternatives to tube
feeding in only 1 of the 154 patients. According to the formal hospital consent
form, surrogate decision-makers (usually family members) authorized the procedure
in 92.2% of cases (70.1% with an actual signature and 22.1% over the telephone).
Although we judged 33 patients to be competent (18 clearly so and 15 by inference),
only 12 signed the hospital consent form. Only 11 of the 18 clearly competent
patients signed the form; in the remaining 7, a surrogate decision-maker signed
the form.
Eighty-two patients (53%) died during a follow-up period ranging from
14 to 26 months. In-hospital mortality was 17%, and an additional 15% died
within 1 month of hospital discharge (usually in a chronic care facility).
The cumulative mortality 1 year after discharge, including deaths during the
index admission, was 50% (Table 2).
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Table 2. Cumulative Mortality*
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COMMENT
Our study strongly suggests that the quality of informed consent for
gastrostomy tube placement was inadequate in a large community-teaching hospital.
Several observations support this conclusion. First and most important, only
1 of 154 medical records contained a progress note documenting a discussion
with the patient or surrogate decision-maker regarding specific benefits and
burdens of and alternatives to permanent gastrostomy tube feedings. The standard
hospital informed consent form was signed in all cases, but this document
was a generic surgical consent form, with no specific entries about permanent
medically administered nutrition. Second, although 33 patients appeared to
be competent to make medical decisions, only 12 of them signed the consent
form; a surrogate for the patient authorized the procedure in the other 21
cases. Third, 34 of the 142 surrogate decision-makers did not sign the consent
form but instead authorized the procedure over the telephone, with a nurse
signing on behalf of the surrogate in all these cases. Gastrostomy tube placement
was always elective, and surrogate decision-makers were nearly always family
members living within a reasonable distance from the hospital. Thus, there
should have been adequate opportunity for surrogates to have face-to-face
discussions with members of the health care team and to sign the forms themselves.
A small body of literature suggests that fully informed patients or
their surrogates might in fact decline permanent tube feeding at a higher-than-expected
rate. For example, in the study by Callahan et al,8
nearly half of patients undergoing gastrostomy placement (or their surrogates)
reported that no alternatives had been discussed before insertion of the tube.
O'Brien and colleagues9 asked 379 mentally
competent nursing home residents if they would want a gastrostomy tube if
they became unable to eat because of permanent brain damage; only 33% expressed
a preference for tube feedings in this circumstance. In an interview study10 of 121 competent patients with amyotrophic lateral
sclerosis, only 28% favored feeding by gastrostomy.
The most important potential limitation of our study is that the written
medical record may not capture adequately the quality of informed consent.
Although high-quality but undocumented discussions might have occurred in
some cases, we believe that to be the exception and not the rule. Our close
reading of all medical chart notes suggested an inevitability about gastrostomy
placement, with no consideration of alternatives. Typically, at some point
during the hospitalization, a progress note would document dysphagia, aspiration,
or inadequate energy intake in a patient unable or unwilling to swallow and
would conclude with a comment that the patient may need a gastrostomy tube.
Next, in many patients a swallowing assessment would be obtained from a consultant
in the physical and occupational therapy department, who invariably would
confirm the clinical impression of dysphagia or aspiration. Finally, a consultant
(usually a gastroenterologist) would examine the patient, agree with the necessity
for tube feeding, and schedule the procedure. Occasionally, percutaneous tubes
were placed fluoroscopically by a radiologist, without additional consultation.
This general sequence was recently suggested by Callahan et al8
in their interview study of patients (or their surrogates) who had received
percutaneous endoscopic gastrostomy tubes during the previous few months.
According to the authors, respondents generally perceived "the decision for
PEG as a forgone conclusion"8(p1107) and that
the process was "an irreversible cascade"8(p1107)
once the idea was first raised.
Second, our patients may not be representative of patients receiving
gastrostomy tubes generally in the United States. However, our mix of underlying
diagnoses and our in-hospital and 1-year mortality rates were similar to those
previously reported1-5
for patients receiving gastrostomy tubes. The proportion (68.2%) of black
patients in our cohort was higher than the proportion (about 50%) of black
admissions to our hospital and much higher than the proportion of black persons
in the US population. Other studies1-2
from large databases have noted that black patients undergo gastrostomy tube
placement at a rate roughly twice that of white patients. It is unclear whether
this reflects differences in underlying disease prevalence or racial differences
in attitudes about tube feedings.
Third, it is possible that physicians in our institution are less likely
than other American physicians are to conduct and document discussions of
the benefits and burdens of tube feeding. However, a systematic difference
between our physicians and others seems unlikely for 2 reasons. First, physicians
and ethicists from several clinical institutions have questioned the quality
of decision-making for gastrostomy tube placement in recent years.1, 6-8,11-12
And second, although we did not formally assess informed consent for other
procedures, the progress notes of some patients documented such discussions
for other life-sustaining interventions, notably cardiopulmonary resuscitation
and mechanical ventilation. Thus, our physicians were capable of documenting
end-of-life discussions but seemed less inclined to do so for tube feeding
than for certain other interventions. Interestingly, a recently published
study13 from a hospital in New York found documented
discussions about withholding or withdrawing care in only 10% of acutely ill
patients with end-stage dementia.
A final limitation is that our methods did not allow us to identify
medical records of patients who considered but declined placement of a gastrostomy
tube. Conceivably, discussions of benefits, burdens, and alternatives were
documented in the progress notes of those patients.
We believe that 4 steps can be taken to improve the quality of decision-making
regarding permanent medically administered nutrition. First, professional
organizations should mount educational campaigns to ensure that practicing
physicians are familiar with the medical evidence on outcomes of permanent
tube feeding. A good starting point is a recent literature review by Finucane
and colleagues,4 which summarizes published
data on mortality and complications associated with tube feeding. These authors
show, for example, that contrary to popular belief, there is no clear evidence
that tube feeding prevents aspiration pneumonia.
Second, similar educational campaigns should focus on the ethical and
legal issues surrounding tube feeding in advanced dementia. A recent excellent
and provocative essay by Gillick11 should be
required reading not only for primary care physicians but also for consultants
who insert gastrostomy tubes.
Third, the process of informed consent should be institutionalized in
a way that maximizes the likelihood of meaningful discussions of benefits
and burdens of and alternatives to tube feedings. In a recent analysis14 of consent forms from 616 US hospitals, spaces to
document procedure-specific risks, benefits, and alternatives were present
in only 30%, 6%, and 5% of the forms, respectively. Although the written consent
form is no substitute for meaningful discussions between physicians and patients
or surrogates, a form requiring procedure-specific details could at least
trigger such discussions more consistently. In addition, institutions should
consider developing preprinted materials that present a balanced overview
of permanent tube feedings to patients and families. One group15
has proposed a specific clinical guideline for decision-making when a gastrostomy
tube is considered.
Finally, several authors6-7,16
have implied that unreflective placement of gastrostomy tubes occurs frequently
because of the pressure to move patients quickly from hospital to nursing
home. The rationale is that, for patients with borderline swallowing function
and diminished capacity for self-feeding, it is more efficient for nursing
home staff to administer tube feedings than to take the time to feed patients
orally. Although this tactic is understandable from the perspective of economic
pressures facing hospitals and chronic care facilities, it is ethically unacceptable
and deserves attention at the level of national policy-making.
In conclusion, our study provides evidence that informed consent for
gastrostomy tube placement was inadequate in a large US hospital; the literature
suggests that our findings are generalizable to other settings. We encourage
researchers to conduct additional studies at other centers. In addition, we
challenge educators to develop ways to enhance physicians' understanding of
medical and ethical issues relevant to medically administered nutrition near
the end of life, and institutions to develop procedures to improve the quality
of decision-making for patients considering this intervention.
AUTHOR INFORMATION
Accepted for publication August 22, 2000.
Corresponding author: Allan S. Brett, MD, Department of Medicine,
University of South Carolina School of Medicine, 2 Medical Park, Suite 502,
Columbia, SC 29203 (e-mail: allansb{at}medpark.sc.edu).
From the Center for Bioethics, University of South Carolina (Dr Brett),
and Department of Medicine, University of South Carolina School of Medicine
(Drs Brett and Rosenberg), Columbia.
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