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Division of Cardiovascular Diseases and Internal Medicine, Department of Health Science Research, Mayo Clinic and Foundation,
200 First St SW, Rochester, Minnesota 55905, USA
b
Section of Biostatistics, Department of Health Science Research, Mayo Clinic and Foundation, 200 First St SW, Rochester, Minnesota 55905, USA
c
Section of Clinical Epidemiology, Department of Health Science Research, Mayo Clinic and Foundation, 200 First St SW,
Rochester, Minnesota 55905, USA
Accepted 14 April 2004
Abstract
Objectives: Questionnaires are used to estimate disease burden. Agreement between questionnaire responses and a criterion standard
is important for optimal disease prevalence estimates. We measured the agreement between self-reported disease and medical record diagnosis
of disease.
Study Design and Setting: A total of 2,037 Olmsted County, Minnesota residents 45 years of age were randomly selected.
Questionnaires asked if subjects had ever had heart failure, diabetes, hypertension, myocardial infarction (MI), or stroke. Medical records
were abstracted.
Results: Self-report of disease showed 90% specificity for all these diseases, but sensitivity was low for heart failure (69%) and
diabetes (66%). Agreement between self-report and medical record was substantial (kappa 0.710.80) for diabetes, hypertension, MI,
and stroke but not for heart failure (kappa 0.46). Factors associated with high total agreement by multivariate analysis were age 65
years, female sex, education 12 years, and zero Charlson Index score (P .05).
Conclusion: Questionnaire data are of greatest value in life-threatening, acute-onset diseases (e.g., MI and stroke) and chronic disorders
requiring ongoing management (e.g.,diabetes and hypertension). They are more accurate in young women and better-educated subjects.
2004 Elsevier Inc. All rights reserved.
Keywords: Cardiovascular diseases; Epidemiologic methods; Questionnaires; Recall; Reliability
1. Introduction
Epidemiologic studies and surveys often rely on selfadministered questionnaires to obtain information on subject
health status [111]. The agreement between questionnaire
data and a criterion standard, such as the medical record, is
critical for obtaining meaningful estimates of disease
prevalence.
A number of studies have attempted to assess the value
of a self-reported disease by comparing self-reports with a
criterion standard, such as the medical record, for a range of
cardiovascular conditions [119]. When comparing results
other authors limited their investigation to those who reported the presence of disease [7,13,16,17]. Limiting evaluation of a criterion standard (e.g., chart abstraction) only to
persons who report the presence of disease may result in
underestimation of disease prevalence because false-negative reports are not taken into account.
Criterion standards for the presence of disease have also
been inconsistent. Some investigators have used physicians
diagnosis in medical records, whereas others have required
the presence of a morbidity endpoint at the time of clinical
measurement or evaluation [2,19]. Harlow pointed out that
the lack of consistency in analytic methods to measure
agreement makes comparison across studies difficult and suggested that investigations should incorporate standardized
methodologies to enable comparison of results across studies
[20]. However, study limitations, such as referral bias, insufficient sample size, nonuniform archival style, short archival
period, or incomplete archive, may limit the ability to achieve
interpretable results.
The purpose of this study was to measure the agreement
between self-reported cardiovascular disease and extensive
medical record documentation of disease in a well-characterized, population-based cohort with a long record archival
period. We also sought to determine the subject characteristics that are associated with agreement.
1097
2. Methods
1098
Table 1
Framingham criteria for the clinical diagnosis of CHF
Major criteria
Paroxysmal nocturnal dyspnea
Orthopnea
Elevated jugular venous pressure
Pulmonary rales
Third heart sound
Cardiomegaly on chest radiograph
Pulmonary edema on chest radiograph
Minor criteria
Peripheral edema
Night cough
Dyspnea on exertion
Hepatomegaly
Pleural effusion
Heart rate 120/min
Weight loss 4.5 kg in 5 da
a
Weight loss 4.5 kg in 5 days is considered a major criterion if it
occurred in response to therapy for CHF. A patient was considered to have
validated CHF if two major criteria were present or one major and two
minor criteria were present concurrently.
3. Results
The characteristics of the cohort are described in Table
2. Of 2,037 participants, 1,950 (95.7%) filled out the questionnaire without assistance. The median participant age
was 61 years, and the median length of the patient medical
record archive was 36 years.
The agreement between self-report and the medical record
for heart failure, diabetes, hypertension, MI, and stroke is
presented in Table 3. Self-report was most sensitive and
specific (89.5% and 98.2%, respectively) for MI. In contrast,
a self-report of heart failure was 68.6% sensitive and 97%
specific for the diagnosis of heart failure (Table 3). Kappa
ranged from 0.71 to 0.80 for diabetes, hypertension, MI,
and stroke, suggesting a good level of agreement. In contrast,
only moderate agreement (kappa 0.46) was found for
heart failure.
Heart failure had a high questionnaire false-positive rate
and a low PPV (36.8%), with questionnaire responses indicating a nearly two-fold higher heart failure prevalence than
was recorded in the medical record (4.7% and 2.5%, respectively). For diabetes, there was a high questionnaire falsenegative rate and low questionnaire sensitivity (66.0%). Of
Age (y)
Medical record duration (y)
Number of hospital admissions
Number
981
1,056
757
1,152
51
150
768
105
74
991
397
649
48.2
51.8
39.7
60.4
2.5
7.4
37.7
5.2
3.6
48.7
19.5
31.9
25th
Percentile
Median
75th
Percentile
61
36
3
70
49
5
53
25
1
1099
4. Discussion
51 false-negative responders, 37 reported borderline diabetes, whereas their medical records contained a diagnosis of
diabetes rather than borderline diabetes. As a result, the
questionnaire responses indicated a lower prevalence of diabetes than did medical records (5.2% versus 7.4%).
The prevalence of hypertension based on the questionnaire responses was close to that based on diagnosis in the
medical records (35.8% and 37.7%, respectively). However,
a considerable number of false-positive and false-negative
responses reduced specificity, NPV, and total agreement.
In contrast to the other diagnoses, MI had a small number
of false-negative responses, resulting in the highest sensitivity (89.5%), specificity (98.2%), and kappa (0.80) among the
five diseases. Although stroke showed high total agreement,
a considerable number of false-positive responses reduced
the PPV.
The association of participant characteristics with
strength of agreement between self-reports and medical
records is shown in Table 4. Female sex, younger age,
higher education, fewer hospital admissions, shorter archival
Table 3
Sensitivity and specificity of self-reported cardiovascular disease for medical record-documented disease in 2,037 men and women in Olmsted
County, Minnesota
Heart failure
Diabetes
Hypertension
MI
Stroke
Sensitivity (%)
Specificity (%)
PPV (%)
NPV (%)
Kappa
95% CI
68.6
66.0
82.0
89.5
78.4
97.0
99.7
92.2
98.2
98.6
36.8
94.3
86.4
73.4
67.4
99.2
97.4
89.4
99.4
99.2
0.46
0.76
0.75
0.80
0.71
0.360.56
0.700.82
0.720.78
0.740.85
0.630.79
96.3
97.2
88.4
97.8
97.8
Abbreviations: PPV, positive predictive value; NPV, negative predictive value; CI, confidence interval; MI, myocardial infarction.
Total agreement (%) (MRQN) (MRQN)/number of total participants 100; where MRQN are participants whose affirmative reports
were confirmed in their medical records (true positive) and MRQN are participants who neither reported diseases nor had diseases confirmed in their
medical history (true negative).
1100
Table 4
Association of participant characteristics with strength of agreement between self-report and the medical record
Hypertension
MI
Diabetes
Stroke
Sensitivity Specificity % agreement Sensitivity Specificity % agreement Sensitivity Specificity % agreement Sensitivity Specificity % agreement Sensitivity Specificity % agreement
Gender
Male
94.9
Female 98.8
Age
4564 y 98.5
6596 y 94.5
Years of education
12 y 94.4
12 y 98.5
Number of admissions
0
98.5
13
97.5
47
96.9
8
93.2
Length of record
36 y 97.9
36 y 96.2
Charlson index
0
99.6
1
94.3
75.8
55.6
94.3**
98.1
91.5
92.9
81.1
82.9
87.7
89.0
97.2
99.1
92.3
81.5
96.8**
98.7
99.5
99.8
66.7
64.9
96.4*
97.9
98.7
98.4
83.3
71.9
98.1
97.6
83.3
64.1
98.4**
93.1
91.1
94.7
85.3
79.5
89.5
86.7
99.4
96.3
96.4
87.0
99.3**
95.4
99.7
99.7
77.1
56.3
98.4**
95.4
99.3
97.5
82.4
77.2
99.0**
96.0
81.5
52.2
93.9
97.6
91.5
92.6
81.4
83.2
86.9
89.4
97.3
98.6
89.5
88.9
96.7*
98.3
99.6
99.8
57.3
74.6
95.4**
98.3
97.6
99.0
73.0
82.9
96.4**
98.5
44.4
71.4
61.5
81.8
97.6**
97.2
96.0
92.3
89.1
93.6
93.2
92.5
80.2
79.5
83.7
85.0
86.2
89.3
89.0
88.7
99.2
98.7
97.6
96.6
84.6
88.5
94.1
87.5
98.8*
98.3
97.3
95.7
100
99.9
99.0
100
60.0
72.5
60.0
70.0
97.6*
98.3
96.0
96.0
99.2
99.3
97.8
97.1
73.3
91.7
87.5
65.2
98.4**
99.2
97.3
94.7
63.2
71.9
97.2*
95.4
91.9
93.0
83.2
81.2
89.3
87.6
98.6
98.0
88.6
90.0
98.1
97.5
100
99.4
71.9
62.4
98.3**
96.1
99.1
98.0
77.3
78.4
98.7*
97.1
50.0
71.1
99.3*
93.3
92.4
91.9
78.4
83.9
88.7
88.0
99.4
97.0
92.3
89.1
99.3*
96.3
99.8
99.5
68.2
65.6
99.1*
95.3
99.0
98.1
81.8
77.8
98.8**
96.8
Heart failure
Group
1101
Table 5
Patient characteristics associated with questionnaire and medical record agreement in a logistic regression model (N 2037)
Analysis variables
Unadjusted
Age 65 y
Female gender
Education 12 y
Medical record 36 y
Any hospital admission
Charlson index 1
Adjusteda
Age 65 y
Female gender
Education 12 y
Medical record 36 y
Any hospital admission
Charlson index 1
Heart failure
Diabetes
Hypertension
MI
OR
95% CI
OR
0.22
3.14
2.60
0.60
0.58
0.10
0.130.37*
1.875.27*
1.614.19*
0.370.97*
0.311.08
0.050.21*
0.30
2.77
1.85
1.25
0.72
0.18
0.170.54*
1.624.74*
1.113.08*
0.732.15
0.371.38
0.080.39*
Stroke
95% CI
OR
95% CI
OR
95% CI
OR
95% CI
0.35
1.74
2.74
0.42
0.84
0.18
0.200.60*
1.012.99*
1.574.79*
0.230.75*
0.441.59
0.090.36*
0.76
1.14
1.27
0.85
1.31
0.94
0.581.00
0.871.50
0.961.69
0.651.12
0.971.77
0.721.23
0.14
2.43
1.93
0.75
0.48
0.18
0.060.30*
1.284.59*
1.073.51*
0.411.38
0.201.14
0.080.41*
0.24
0.82
2.47
0.45
0.70
0.36
0.120.47*
0.451.49
1.344.56*
0.230.87*
0.321.51
0.180.69*
0.53
1.63
2.02
0.76
1.02
0.28
0.290.99*
0.932.87
1.133.61*
0.401.45
0.512.02
0.130.59*
0.81
1.09
1.25
0.92
1.40
1.09
0.591.11
0.811.45
0.931.68
0.671.26
1.011.95*
0.811.46
0.17
2.38
1.52
1.76
0.45
0.34
0.080.39*
1.244.59*
0.802.86
0.913.40
0.171.16
0.150.78*
0.34
0.77
1.87
0.85
0.97
0.50
0.170.71*
0.421.43
0.993.53
0.421.71
0.442.13
0.251.01
Abbreviations: OR, odds ratio; CI, confidence interval; MI, myocardial infarction.
a
Adjusted for all variables.
* P .05.
1102
Acknowledgments
We thank Tammy Burns for expert preparation of this
manuscript for publication. This study was funded by
grants from the Public Health Service NIH HL-55502
(R.J.R.) and NIH AR-30582 (S.J.J.), by Merck-Banyu fellowship award (Y.O.), and by the Mayo Foundation.
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