Content uploaded by Yael Schenker
Author content
All content in this area was uploaded by Yael Schenker
Content may be subject to copyright.
Available via license: CC BY-NC 2.0
Content may be subject to copyright.
The Impact of Language Barriers on Documentation of Informed
Consent at a Hospital with On-Site Interpreter Services
Yael Schenker, MD
1
, Frances Wang, MS
1
, Sarah Jane Selig, BS
1
, Rita Ng, MD
1
,
and Alicia Fernandez, MD
1,2
1
Department of Medicine, University of California, San Francisco, CA, USA;
2
Clinical Medicine, University of California, San Francisco,
CA, USA.
BACKGROUND: Informed consent is legally and ethi-
cally required before invasive non-emergent proce -
dures. Language barriers make obtaining informed
consent more complex.
OBJECTIVE: Determine the impact of language bar-
riers on documentation of informed consent among
patients in a teaching hospital with on-site interpreter
services.
DESIGN: Matched retrospective chart review study.
SUBJECTS: Eligible Chinese- and Spanish-speaking
patients with limited English proficiency (LEP) who
received a thoracentesis, paracentesis, or lumbar punc-
ture were matched with eligible English-speaking
patients by procedure, hospital service, and date of
procedure.
MEASUREMENTS: Charts were reviewed for documen-
tation of informed consent (IC), including a procedure
note documenting an IC discussion and a signed
consent form. For LEP patients, full documentation of
informed consent also included evidence of interpreta-
tion, or a consent form in the patient’s primary
language.
RESULTS: Seventy-four procedures in LEP patients
were matched with 74 procedures in English speakers.
Charts of English-speaking patients were more likely
than those of LEP patients to contain full documenta-
tion of informed consent (53% vs 28%; odds ratio (OR):
2.81; 95% CI, 1.42–5.56; p=0.003). Upon multivariate
analysis adjusting for patient and service factors,
English speakers remained more likely than LEP
patients to have full documentation of informed consent
(Adj OR: 3.10; 95% CI, 1.49–6.47; p=0.003). When
examining the components of informed consent, charts
of English-speaking and LEP patients were similar in
the proportion documenting a consent discussion;
however, charts of English speakers were more likely
to contain a signed consent form in any language (85%
vs 70%, p=0.03).
CONCLUSIONS: Despite the availability of on-site pro-
fessional interpreter services, hospitalized patients who
do not speak English are less likely to have documen-
tation of informed consent for common invasive proce-
dures. Hospital quality initiatives should consider
monitoring informed consent for LEP patients.
KEY WORDS: language barriers; informed consent; health car e
disparities; limited English proficiency; Spanish; Chinese; interpreter
use.
J Gen Intern Med 22(Suppl 2):294–9
DOI: 10.1007/s11606-007-0359-1
© Society of General Internal Medicine 2007
BACKGROUND
Informed consent . . . is ethically required of healthcare
practitioners in their relationships with all patients, not
a luxury for a few.
1
Informed consent is central to the practice of ethical, safe,
legal, and patient-centered health care. Defined as “voluntary
consent given by a person or a responsible proxy (e.g., parent)
for participation in a study, immunization program, treatment
regimen, invasive procedure, etc., after being informed of the
purpose, methods, procedures, benefits and risks,”
2
informed
consent is a process of information exchange that by its very
nature requires dialog between patient and provider.
3,4
When
patient and provider speak different languages the process of
informed consent necessarily becomes more complex, as the
informed consent discussion must be conducted either in a
language the patient understands, or through an interpreter.
The population of the United States is growing linguistically
more diverse each year, with approximately 11 million people
reporting they speak English “not well” or “not at all” in the
2000 U.S. census.
5
Language barriers have been found to
complicate many aspects of patient care,
6
including receipt of
medical services,
7
patient satisfaction,
8–10
interpersonal pro-
cesses of care,
11
comprehension,
12,13
adherence to prescribed
medication regimens,
14
and length of hospital stay.
15
Advo-
cates for patients with limited English proficiency (LEP) have
searched for ways to make interpreters available to patients
who need them and to make LEP patients aware of their rights
to an interpreter.
16
To date, most patients and providers do not
have access to professional interpreters,
13
yet a body of
research suggests that interpreters may be underutilized even
when readily available.
12,17–19
Recognizing the importance of communication to informed
consent, we designed a study to compare informed consent
documentation for common invasive medical procedures be-
tween LEP and English-speaking patients at a large public
teaching hospital with interpreters on site. Documentation of
informed consent is required at this hospital and at most
294
hospitals in the United States and is a legal standard by which
to judge whether informed consent has taken place.
METHODS
Setting
The study was conducted at a public teaching hospital serving
the city and county of San Francisco. The county has a large
immigrant population; approximately 20% of patients do not
speak English, and more than 20 languages are spoken within
the hospital each month. The hospital has received several
national awards recognizing the depth and quality of its
interpreter services. Interpreter services are available on-site
for 19 languages through professional staff interpreters, with a
total of 25 languages available with prearrangement through
an “on-call” system of interpreters.
20
The Interpreter Services
Departm ent provides on-site interpreters 16 hours a day,
7 days a week. The hospital also subscribes to a commercially
available telephone interpreter service that can be accessed
through any bedside phone, at any time. Standard consent
forms for bed-side procedures, with blank spaces to insert the
type of procedure, common risks, and alternative treatments,
are available on the hospital wards and in the emergency
department in 5 languages, including English, Spanish, and
Chinese. The hospital is staffed by house officers from the
University of California, San Francisco residency programs,
and almost all procedures are performed by residents. The
university institutional review board and the hospital data
governance board approved the study.
Subjects
This was a matched retrospective chart review study. Study
participants were selected through a search of an electronic
administrative/clinical database by ICD-9 code. Adult patients
who received a lumbar puncture (03.31), thoracentesis (34.91),
or paracentesis (54.91) while hospitalized between January 1,
2004 and January 1, 2006 were potentia lly eligible. All
patients whose language field in the dataset identified the
patient as speaking either “Spanish” or “Cantonese/Chinese/
Mandarin” were assigned to the LEP group, whereas those
whose language field was “English” were assigned to the
English group. Reasoning that hospital service and secular
trends with respect to work load could influence consent
procedures and the adequacy of documentation of these
procedures, we matched LEP and English-speaking patients
by: 1) procedure, 2) medical service on which the patient was
hospitalized (medicine, neurology, or family practice), and 3)
the month the procedure occurred. A list of potential English-
speaking matches was generated for each LEP patient; the
closest eligible match was chosen.
Data Collection
Medical charts were reviewed for each potential study partic-
ipant. Information on patient gender, language, race/ethnicity,
age, and medical service was abstracted from the hospital’s
electronic administrative/clinical database. Date of admission,
date of discharge, and primary diagnosis at discharge were
obtained from an administrative coversheet in the paper chart
summarizing each admission.
All pages of the medical chart during the admission period
were searched for evidence of a procedure note and a consent
form. If a procedure note was identified, it was reviewed for
documentation of the following: informed consent obtained
(yes/no), patient unable to participate in informed consent
(yes/no, reason for inability to participate in informed con-
sent), informed consent obtained from family member (yes/
no), informed consent obtained in patient’s language (yes/no),
and interpreter used (yes/no). If a standard consent form was
identified, we abstracted the following: language in which the
form was written (English, Spanish, or Chinese), relationship
of the person signing the form (patient or surrogate), and
presence of an interpreter signature on the form.
Fifteen percent of the medical charts were randomly select-
ed and reabstracted by an investigator blinded to the study
hypothesis. Reabstraction demonstrated excellent agreement
on comparison of informed consent (kappa coefficient=0.83;
95% CI, 0.60–1.00). To verify that the patient’s language was
as given in the electronic dataset, the same charts were also
searched for documentation of the patient’ s primary language.
Confirmation of primary language was found in the visit notes
of 75% of LEP patient charts.
Eligibility
After review of the medical chart, patients who lacked health
care decision-making capacity at the time of the procedure
were excluded. Patients were determined to lack health care
decision-making capacity if the procedure note or progress
notes on the day of the procedure included documentation
that the patient was unable to participate in informed consent
for any clinical reason or indicated that the patient had altered
mental status. We also excluded patients on mechanical
ventilation at the time of the procedure and patients whose
consent form was signed by a surrogate. Finally, we excluded
patients whose procedure was performed by the interventional
radiology service or in the operating room, as these services
have a separate process for obtaining informed consent.
Documentation of Informed Consent
We defined full documentation of informed consent using the
hospital’s policy on informed consent documentation. This policy
is based on commonly applied legal standards and on the
principle of informed consent as a process requiring dialog.
21
Full documentation of informed consent required a proce-
dure note documenting a consent discussion and a signed
consent form. For LEP patients, full documentation addition-
ally required some evidence of interpretation. Acceptable
evidence of interpretation included 1 or more of the following:
1) documentation in the procedure note of a consent discus-
sion in the patient’s language or through an interpreter; 2) a
consent form written in the patient’s primary language; or 3)
an interpreter’s signature on the consent form.
Analysis Plan
We used chi-square analysis to determine differences in
informed consent documentation between procedures per-
295Schenker et al.: Language and Informed Consent DocumentationJGIM
formed on LEP and English-speaking patients. To furthe r
refine our understanding of these differences, we used multi-
variate analysis to determine the independent contribution of
patient factors (age, gender, primary language, and primary
diagnosis) and health care factors (procedure and setting [ED
vs wards]) to informed consent.
RESULTS
One hundred forty-six LEP patients were identified who had
187 procedures. Seventy-four procedures were excluded, leav-
ing 113 eligible procedures in 92 patients. Reasons for exclusion
were: medical records not available (9), documented altered
mental status (14), consent form signed by a surrogate (12),
patient intubated (9), procedure performed by interventional
radiology or in the operating room (25), and wrong procedure
coded (5). A total of 156 charts of potential English-speaking
matches were r eviewe d. Eighty-two proced ures in English
speakers were excluded for the following reasons: documented
altered mental status (28), consent form signed by a surrogate
(16), patient intubated (17), procedure performed by interven-
tional radiology (10), wrong procedure coded (4), and duplicate
match found (7). Of the 92 LEP patients, eligible English-
speaking matches were found for 74 procedures in 70 LEP
patients, and these constitute our study sample.
Table 1 shows the characteristics of the patients and
procedures. LEP and English-speaking patients did not differ
by age or diagnosis, but English speakers were more likely to
be male (78% vs 59%, p=0.01). The LEP population was 69%
Latino and 31% Asian, whereas the English speakers were of
diverse races. The majority of procedures were performed while
patients were hospitalized on a Medicine service (54%),
followed by the Emergency Department (28%) and Neurology
or Family Practice (18%). Most patients underwent procedures
related to a primary diagnosis of infection (41%) or malignancy
(13%). Slightly more than half (54%) of procedures were
lumbar punctures.
English-speaking patients were significantly more likely than
LEP patients to have full documentation of informed consent
(including evidence of interpretation for LEP patients) (53% vs
28%, OR: 2.81; 95% CI, 1.42–5.56; p =0.003). W hen the
components of informed consent documentation were exam-
ined (Table 2), English speakers and LEP patients did not differ by
whether a procedure note was present in the chart (86% vs 89%,
p=0.6) or by whether the procedure note reported an informed
consent discussion (58% vs 59%, p=0.9). However, English
speakers were more likely than LEP patients to have a consent
form (in any language) in the chart (85% vs 70%, p=0.03). Further,
only 41% of LEP patients had a consent form in their primary
language or signed by an interpreter . Involvement of an interpreter
was documented for similar numbers of Chinese-speaking and
Spanish-speaking patients (22% vs 29%, p=0.5; data not shown).
In a multivariate analysis, adjusting for patient age, gender,
primary diagnosis, procedure type, or medical service did not
significantly alter the results (Table 3). Language was the only
factor significantly associated with documentation of informed
consent.
Race was not included in the multivariate analysis as the
overlap between race and language in the LEP group did not
allow us to analyze their independent contributions. We found
no differences in documentation of informed consent among
English speakers when the analysis was stratified by race, and
in the LEP group, we found no difference between Chinese-
and Spanish-speaking patients (39% vs 23%; OR: 2.09; 95%
CI, 0.73–6.02; p=0.17).
DISCUSSION
To our knowledge, this is the first study to investigate the
impact of language barriers on informed consent documenta-
Table 1. Characteristics of Patients Undergoing Invasive
Procedures by English Proficiency
LEP* English-Speaking p value
(n=74) (n=74)
Mean Age ± SD, years 50±16 47±12 0.3
Male N (%) 44 (59) 58 (78) 0.01
Race N (%) <0.001
White 28 (38)
Black 26 (35)
Latino 51 (69) 10 (14)
Asian 23 (31) 10 (14)
Medical Service N (%) 0.9
Medicine 41 (55) 39 (53)
Emergency Department 21 (28) 21 (28)
Neurology/Family Practice 12 (16) 14 (19)
Diagnosis N (%) 0.5
Infection 29 (39) 32 (43)
Malignancy 12 (16) 7 (9)
Other 33 (45) 35 (47)
Procedure N (%) 1
Lumbar puncture 40 (54) 40 (54)
Thoracentesis 10 (14) 10 (14)
Paracentesis 24 (32) 24 (32)
*LEP—Limited English Proficiency
Table 2. Rates of Informed Consent Documentation for Invasive
Procedures in LEP* and English-Speaking Patients
LEP English-
Speaking
p value
(n=74)
N (%)
(n=74)
N (%)
A. Procedure note 66 (89) 64 (86) 0.6
B. Procedure note documentation of
informed consent discussion
44 (59) 43 (58) 0.9
C. Procedure note documentation of
informed consent discussion in
patient’s primary language or
through an interpreter
5 (7) N/A
D. Consent form-any language 52 (70) 63 (85) 0.03
E. Consent form-patient’s
language or signed by an
interpreter
30 (41) 63 (85) <0.0001
F. Procedure note documentation of
informed consent discussion +
consent form-any language (B+D)
40 (54) 39 (53) 0.9
G. Full documentation of informed
consent (including evidence of
interpretation for LEP patients)
(B+E or C+D)
21 (28) 39 (53) 0.003
*LEP—Limited English Proficiency
296 Schenker et al.: Language and Informed Consent Documentation JGIM
tion in a clinical setting. We found that patients who spoke
English were almost twice as likely as patients with limited
English proficiency to have documentation of informed con-
sent for 3 invasive medical procedures while hospitalized at a
large urban hospital with on-site interpreter services. The
relationship between primary language and informed consent
documentation was not affected by patient age, gender,
primary diagnosis, procedure, or medical service.
The differ ences we found in rates of inform ed consent
documentation between LEP and English-speaking patients
are substantial and suggest disparities in the process of
informed consent. W hereas it is possible that failure t o
properly document evidence of interpretation when obtaining
consent from LEP patients may partially explain our results,
the finding that LEP patients were significantly less likely than
English-speakers to have a consent form present in the chart—
in any language—suggests that differences in practice, not
documentation alone, drive our findings.
We also found low rates of documented informed consent for
English-speaking patients. Whereas adequate documentation
may not reflect the quality of an informed consent discussion,
short of direct observation it remains the only way to judge
whether such a discussion occurred. Informed consent docu-
mentation is therefore dictated by hospital policy and the law.
Our findings for English-speaking patients highlight a need for
increased training of resident physicians in the legal and
ethical requirements of informed consent and informed con-
sent documentation for all patients.
Despite Federal and State law requiring providers to use
interpreters
22,23
and this hospital’s policy that interpreter use
be documented in the patient’ s medical record,
21
fewer than a
third of LE P patients had documentation of interpreter
involvement in the process of informed consent. It is important
to consider all possible explanations for these findings, as
many factors may be involved. Because we did not measure
language ability directly, it is possible that some of the patients
classified as LEP may understand and speak sufficient English
to participate in the process of informed consent without the
services of an interpreter. Another possibility is that residents
may be relying on their own language skills to consent patients
and neglecti ng to document this i n the chart. However,
whereas more residents at this institution speak Spanish than
Cantonese or Mandarin
18
, we found similar rates of documen-
ted interpreter use between the groups, suggesting that use of
resident l anguage skills do not entirely account for our
findings. A third possible explanation is the undocumented
use of ad hoc interpreters such as family members or
untrained staff. Residents may be reluctant to document ad
hoc interpreter use and, unlike professional interpreters at our
institution who are trained to sign consent forms after they
finish interpreting, ad hoc interpreters will not do so indepen-
dent of a physician request. Ad hoc interpr eter use is a
common practice in the clinical care of LEP patients, and one
that has been shown to result in decreased patient satisfac-
tion, impaired communication, and potentially significant
medical errors.
24,25
Although the scenarios discussed may partially explain our
findings, we believe that the low rates of documented inter-
preter use combined with fewer signed consent forms in the
chart s of LEP patients point to an al ternate explanation:
underuse of interpreters and hence inadequate or absent
informed consent. This explanation is consistent with prior
studies suggesting that residents underutilize interpreters
when caring for LEP patients.
12,17–19
In a survey of resident
and attending physicians affiliated with this residency pro-
gram, 66% reported recent incidences in the outpatient setting
in which they did not use an interpreter but wished they
had.
18
Previous training in interpreter use has been associated
with increased use of professional interpreters, thus poor use
of interpreters may be related at least in part to inadequate
training of clinicians.
18,24
In a recent national survey of
medical residents, 35% reported no or very little instruction
in delivering care through a medical interpreter, and only 51%
reported receiving instruction in a patient’s legal right to a
medical interpreter.
24
Getting by on limited language skills or
with ad hoc interpreters for informed consent discussions is
Table 3. Independent Predictors of Informed Consent Documentation for Invasive Procedures in LEP* and English-speaking Patients
Consent Form—Any Language Full Documentation of Informed Consent
Unadjusted Adjusted Unadjusted Adjusted
Language
English 2.42 (1.08–5.46) 2.82 (1.15–6.92) 2.81 (1.42–5.56) 3.10 (1.49–6.47)
LEP Ref
Age 1.00 (0.97–1.03) 0.97 (0.94–1.01) 1.02 (0.99–1.04) 1.03 (1.00–1.06)
Gender
Female 1.27 (0.53–2.99) 1.69 (0.59–4.78) 0.70 (0.34–1.45) 0.66 (0.29–1.51)
Male Ref
Diagnosis
Infection 0.51 (0.22–1.18) 0.44 (0.17–1.16) 0.99 (0.49–2.00) 0.94 (0.41–2.15)
Malignancy 1.14 (0.29–4.55) 1.00 (0.23–4.38) 1.37 (0.49–3.80) 1.53 (0.50–4.71)
Other Ref
Procedure
Lumbar Puncture 0.75 (0.22–2.51) 1.44 (0.35–6.01) 1.05 (0.39–2.86) 1.98 (0.60–6.49)
Paracentesis 1.08 (0.29–4.03) 1.23 (0.31–4.89) 0.98 (0.34–2.85) 1.08 (0.34–3.37)
Thoracentesis Ref
Medical Service
E.D. 0.26 (0.12–0.59) 0.18 (0.07–0.49) 0.48 (0.22–1.05) 0.49 (0.21–1.17)
Wards Ref
Figure represent odds ratios (95% confidence intervals).
*LEP—Limited English Proficiency
297Schenker et al.: Language and Informed Consent DocumentationJGIM
particularly problematic, as these conversations are often
complex and require high-level language skills to ensure full
comprehension on the part of the patient. More instruction on
the appropriate use of professional interpreters is needed, as is
research to understand the decision making and ultimately
impact the practice of clinicians.
The process of informed consent requires attention and
communication skills from physicians who often have multiple
demands on their time. For patients who do not speak English,
additional time and effort may be required to find a consent
form in the patient’s primary language, obtain the services of
an interprete r, and ensure adequate unders tanding. Low
literacy, which is common at public hospitals,
26
has also been
shown to complicate the process of informed consent.
27,28
Yet
providers have an ethical and legal obligation to provide
informed consent for all patients, no matter how time con-
suming the process may be. Whereas it may present particular
challenges, informed consent among vulnerable patient groups
is cr itic al to e nsure patien t safety and th e provisi on of
equitable, patient-centered health care. The National Quality
Forum, a voluntary consensus standard-setting organization,
recently endorsed improving informed consent for patients
with limited health literacy or limited English proficiency as 1
of 30 evidence-based Safe Practices for Better Healthcare.
29
This endorsement and similar initiatives by hospital accredi-
tation groups may set the stage for ongoing quality monitoring,
which is likely necessary to eliminate language disparities in
informed consent.
Our study had several limitations. First, it was a study of
documentation of informed consent, and the possibility of bias
owing to differences in documentation requirements cannot be
completely excluded. Second, it was a study at 1 teaching
hospital and results may not generalize to other settings.
However, our results may actually represent a “best case”
scenario, as the setting is atypical in ways that would suggest
better practice with LEP patients, including highly trained
professional interpreters and residents accustomed to working
with a large volume of LEP patients. Third, we studied 3
invasive bedside procedures performed by residents on hospi-
talized patients. R ates of informed consent may vary f or
different procedures performed by more seasoned physicians
or in different settings. Fourth, the time of day of the procedure
was not captured, a nd while the hospital has in-person
interpreters available 16 hours a day and telephone inter-
preters available 24 hours a day, residents may have been less
likely to document the involvement of telephone interpreters.
Despite these limitations, our study has several important
implications. Informed consent is a fundamental tenet of the
US health care system. It has long been legally recognized for
its importance to the ethical practice of medicine, and it is
increasingly being recognized as a key constituent of quality
and patient safety.
30
Ethnic disparities in informed consent are
unacceptable and correctable. In response to our findings on
documentation of informed consent, our institution has recom-
mitted to providing resident physicians adequate instruction in
the care of patients with limited English proficiency, the use of
professional interpreters, and the process and documentation
of informed consent. Other institutions may similarly wish to
examine local practice and institute appropriate training.
Meanwhile, hospitals and quality regulatory groups should
consider adding informed consent for patients with limited
English proficiency to their monitored measures of quality.
Acknowledgements: We gratefully acknowledge the advice and
assistance of Robert Brody, MD, Andrew Brunner JD, Chris Elliot,
Gloria Garcia-Orme, Jeffrey Kohlwes, MD, and Margaret Wheeler,
MD, on this project.
Funding Sources: Dr. Fernandez’s efforts were supported from
NIH Career Development Award K23- RR018324-01. Ms. Wang was
partially supported by HRSA grant D54HP03400.
Conflicts of Interest: None disclosed.
Corresponding Author: Alicia Fernandez, MD; Clinical Medicine,
University of California, Box 1364, San Francisco, CA 94143, USA
(e-mail: afernandez@medsfgh.ucsf.edu).
REFERENCES
1. President’s commission for the study of ethical problems in medicine and
biomedical and behavioral research. Making healthcare decisions: the
ethical and legal implications of informed consent in the patient–
practitioner relationship. New York; 1982 [cited 2006 Sept 15]. Available
from: http://www.bioethics.gov/reports/past_commissions/index.html.
2. Stedman’s Medical Dictionary, 27th Ed. Baltimore: Lippincott Williams &
Wilkins; 2000.
3. Rozovsky F. Consent to Treatment: A Practical Guide. 2nd Ed. Boston:
Little, Brown and Company; 1990.
4. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 5th Ed.
New York: Oxford University Press; 2001.
5. United States Census 2000. [cited 2006 Sept 15]. Available from: http://
www.census.gov/main/www/cen2000.html.
6. Chen A. Doctoring across the language divide. Health Aff. (Millwood).
2006;25:808–13.
7. Woloshin S, Schwartz LM, Katz SJ, Welch HG. Is language a barrier to
the use of preventive services? J Gen Intern Med. 1997;12:472–7.
8. Baker DW, Hayes R, Fortier JP. Interpreter use and satisfaction with
interpersonal aspects of care for Spanish-speaking patients. Med Care.
1998;36:1461–70.
9. Carrasquillo O, Orav EJ, Brennan TA, Burstin HR. Impact of language
barriers on patient satisfaction in an emergency department. J Gen
Intern Med. 1999;14:82–7.
10. Morales LS, Cunningham WE, Brown JA, Liu H, Hays RD. Are Latinos
less satisfied with communication by health care providers? J Gen Intern
Med. 1999;14:409–17.
11. Fernandez A, Schillinger D, Grumbach K, Rosenthal A, Stewart AL,
Wang F, Perez-Stable EJ. Physician language ability and cultur al
competence. An exploratory study of communication with Spanish-
speaking patients. J Gen Intern Med. 2004;19:167–74.
12. Baker DW, Parker RM, Williams MV, Coates WC, Pitkin K. Use and
effectiveness of interpreters in an emergency department. JAMA.
1996;275:783–8.
13. Wilson E, Chen AH, Grumbach K, Wang F, Fernandez A. Effects of
limit ed English proficiency and physician language on health care
comprehension. J Gen Intern Med. 2005;20:800–6.
14. Apter AJ, Reisine ST, Affleck G, Barrows E, ZuWallack RL. Adherence
with twice-daily dosing of inhaled steroids. Socioeconomic and health-
belief differences. Am J Respir Crit Care Med. 1998;157:1810–17.
15. John-Baptiste A, Naglie G, Tomlinson G, et al. The effect of English
language proficiency on length of stay and in-hospital mortality. J Gen
Intern Med. 2004;19:221–8.
16. Grubbs V, Chen AH, Bindman AB, Vittinghoff E, Fernandez A. Effect
of awareness of language law on language access in the health care
setting. J Gen Intern Med. 2006;21:683–8.
17. Burbano O ’ Leary SC, Federico S, Hampers LC. The truth abou t
language barriers: one residency program’s experience. Pediatrics.
2003;111:e569–73.
18. Karliner LS, Perez-Stable EJ, Gildengorin G. The language divide. The
importance of training in the use of interpreters for outpatient practice.
J Gen Intern Med. 2004;19:175–83.
19. Yawman D, McIntosh S, Fernandez D, Auinger P, Allan M, Weitzman
M. The use of Spanish by medical students and residents at one
university hospital. Acad Med. 2006;81:468–73.
20. Written communication with Gloria Garcia-Orme, Director of Interpreter
Services, San Francisco General Hospital. San Francisco. 2006.
21. San Francisco General Hospital Medical Center, Policy and Procedures.
Consent to Medical and Surgical Procedures. Section 3.9. 2006.
298 Schenker et al.: Language and Informed Consent Documentation JGIM
22. Executive Order 13166. Improving access to services for persons with
limited English proficiency. The White House; August 11, 2000 [cited
2006 Sept 15]. Available from: http://www.usdoj.gov/.
23. Title VI of the 1964 U.S. Civil Rights Act, 42 U.S.C 200d. 1964 [cited
2006 Sept 15]. Available from: http://www.usdoj.gov/.
24. Lee KC, Winickoff JP, Kim MK, et al. Resident physicians’ use of
professional and nonprofessional interpreters: a national survey. JAMA.
2006;296:1050–3.
25. Flores G. The impact of medical interpreter services on the quality of
health care: a systematic review. Med Care Res Rev 2005;62:255–99.
26. Williams MV, Parker RM, Baker DW, Parikh NS, Pitkin K, Coates WC,
Nurss JR. Inadequate functional health literacy among patients at two
public hospitals. JAMA. 1995;274:1677–82.
27. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for
informed-consent forms as compared with actual readability. N Engl J
Med 2003;348:721–6.
28. Sudore RL, Landefeld CS, Williams BA, Barnes DE, Lindquist K,
Schillinger D. Use of a modified informed consent process among
vulnerable patients: a descriptive study. J Gen Intern Med. 2006;
21:867–73.
29. National Quality Forum. Implementing a national voluntary consensus
standa rd for informed conse nt. Washington, DC: National Quality
Forum; 2005. Available from http://www.qualityforum.org.
30. Institute of Medicine (U.S.) Committee on Quality of Health Care in
America. Crossing the Quality Chasm: A New Health System for the 21st
Century. National Academy Press; 2001.
299Schenker et al.: Language and Informed Consent DocumentationJGIM
