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Original Research |
1 Department of Professional Development & Continuing Medical Education, JFK
Medical Center, 65 James St., Edison, NJ 08818.
2 Department of Health Sciences, Seton Hall University, School of Graduate
Medical Education, South Orange, NJ.
Received January 12, 2006;
accepted after revision July 10, 2006.
Address correspondence to C. T. Kolber
(ckolber{at}solarishs.org).
Abstract
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MATERIALS AND METHODS. Facilities from six diverse, geographically representative U.S. regions performing full-body CT screening were used as the study sites. A pretestonly descriptive survey design was used to study 94 patient volunteers scheduled to undergo full-body CT screening. Descriptive statistics were used in examining information about the demographics, health, and knowledge characteristics of the patients. The chi-square test for independence and Spearman's correlation coefficient for ranked data were used to analyze associations among patient characteristics and responses to expectation statements. An alpha value of 0.05 was the level of significance.
RESULTS. Survey participants were 35-65 years old, predominantly white, married, and health conscious with income and educational levels several times above the national averages. The patients' highest expectations related to consumer empowerment and their lowest expectations related to the limitations of the procedure. The five patient characteristics found to have significant associations with patient expectations were patient sex; referral method; level of personal health concern; number of other health screening procedures patient had undergone; and patients' self-estimations of their current health status.
CONCLUSION. This study provided quantitative and descriptive data that are consistent with and add to the existing, primarily anecdotal, knowledge base about patients' expectations of full-body CT screening. These findings can be used to educate patients before they provide informed consent for the procedure.
Keywords: CT • CT screening • full-body CT • patient expectations • radiologic screening • self-referral • whole-body CT
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Full-body screening in the context of this research project was defined as CT screening of multiple organ systems—generally in the chest, abdomen, and pelvis. The accelerated development and subsequent decline of the many centers offering full-body CT screening support the critical need to study the expectations of patients self-referring for this controversial radiologic screening procedure [1].
Recurrent issues emerge in evaluating the effectiveness of full-body CT screening and other radiologic screening examinations [1]. Lead-time bias, length-time bias, and overdiagnosis bias may result in erroneous conclusions that the screening test prolonged survival when it was actually some other factor [2-5]. False-positive findings may lead to additional unnecessary interventions and the associated costs and morbidity. False-negative findings may provide false assurances and result in a patient not receiving or in a patient delaying important treatment [3, 4, 6]. In addition, the risks of radiation exposure to asymptomatic individuals may outweigh any benefits to be derived from the test [4, 7-9]. Finally, the cost-effectiveness of full-body screening is inconclusive because consumers pay out-of-pocket for the initial procedure, but the cost of any necessary follow-up is assumed by the private and public health care system [7, 10].
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One such model, the health belief model, was developed by Hochbaum and associates [22, 23] working in the Public Health Service in the 1950s to explain patient participation in tuberculosis screening examinations. Perceived susceptibility to disease [23] was one component of the health belief model that was considered to have direct relevance to patient expectations of full-body CT screening. Thus, the model was adapted for and served as the theoretic basis of the present study. Explaining the relationship between patients' perceived susceptibility to disease and their expectations of full-body CT screening will assist physicians and patient educators in designing appropriate educational programs to facilitate informed decision-making and informed consent before a patient participates in full-body CT screening.
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Potential study sites were initially identified through Web site directories that list imaging centers offering full-body screening procedures. Six diverse, geographically representative regions of the United States were selected for inclusion in the study. A researcher directed preliminary telephone calls and emails to at least one imaging center offering the procedure in each of these six regions to facilitate representation of the desired geographic regions.
Ten centers responded to the researcher's telephone calls or e-mails. After having conversations with a radiologist or nonphysician administrator at a potential study site, the researcher forwarded preliminary copies of the study instruments and other relevant written materials. After reviewing these materials, centers interested in participating were required to submit a letter to the Seton Hall University IRB authorizing their inclusion in the study. Six of the 10 centers agreed to participate in the study and were anonymously named on the basis of the region in which they were located—that is, Northeast, Southeast, Midwest, far West, northern Pacific, and southern Pacific. The four imaging centers that declined participation cited proprietary reasons for their exclusion, but they expressed overall support for the research and study design.
Subjects
Each subject was a patient at a study site who voluntarily agreed to
complete a survey before undergoing a full-body CT screening procedure. The
only inclusion criterion required subjects to be 21 years old or older.
Through the use of either a verbal script or written correspondence, patients
were informed by the sites that their medical office or facility was
participating in a voluntary, university-based research study. If interested
in further information, patients were directed to the researcher's
solicitation letter. Consent was demonstrated by the participant voluntarily
completing the hard-copy survey, enclosing it in the addressed envelope,
sealing the envelope, and submitting it at the site or anonymously e-mailing
it to the researcher.
Instrumentation
The Patient Expectation Survey consisted of four sections. For the first
three sections, data relevant to the following 13 independent variables, the
patients' characteristics, were collected: age, sex, marital status, race and
ethnicity, educational level, income, referral source, self-estimation of
current health status, level of concern for personal health, number of health
concerns (Fig. 1), number of
other health screening tests, number of preventive health activities
(Fig. 2), and patient
knowledge. The survey was constructed so that each of these independent
variables had a minimum of one corresponding statement on the survey and
several levels of response.
The fourth section collected data relevant to the dependent variables: patient expectations of full-body CT screening. This section of the survey used a 5-point Likert scale in which respondents indicated their level of agreement or disagreement (strongly agree, agree, neutral, disagree, or strongly disagree) with a series of 15 statements designed to assess expectations of the benefits of full-body CT screening. Three options were available for completion of the identical survey. These were, first, an on-site hard copy; second, an at-home hard copy; and, third, an at-home online copy. Four of the six study sites elected to use only the on-site option.
Validity Studies
A panel of 12 experts, seven radiologists and five nonradiologists,
assessed the content and face validity of a preliminary survey instrument. The
radiologists represented both academic and private practice settings. Before
selecting the panel, we determined that experts should meet one or more of the
following criteria: first, 10 or more years of medical or technical experience
performing radiologic procedures and appropriate professional certification or
licensing; second, 5 or more years of administrative experience or operational
familiarity with radiologic practice operations; and, third, recognized
scholarship as a radiology or health care researcher or as a published author
or journal editor.
Appropriate content and format revisions were incorporated into a revised survey instrument on the basis of the suggestions of the review panel, and the revised survey was used for the pilot and full studies. A pilot study was conducted for a 2-week period. Twelve surveys were analyzed. The patients were able to independently complete the surveys and did not ask any statements specific to understanding the survey items.
Data Analysis
Descriptive statistics and statistical tests were used to analyze the data.
The descriptive statistics took the form of frequencies, means, medians, and
SDs. They were used to examine the specific characteristics of the study
population with respect to their demographic attributes, health perceptions
and practices, and knowledge about full-body CT screening. Descriptive
statistics were also used to examine trends in the Likert scale scores on the
responses with respect to the 15 patient expectation statements and the six
patient expectation dimensions.
The patient expectation statements were analyzed as discrete variables and were grouped into six patient expectation dimensions, each of which represented a cluster of two or three discrete patient expectations statements. The six dimensions were conceptualized from current controversies identified in the scientific literature pertinent to the risks and benefits of CT screening for health care consumers [2, 4, 5, 7, 8, 24-28]. The terminology used as the title for each dimension represents an extrapolation of the specific controversial issue into a specific consumer expectation. The dimensions were labeled as follows: Reassurance, Cure, Prevention, Empowerment, Satisfaction, and Limitations. Table 1 delineates the six patient expectations dimensions and the corresponding patient expectation statements clustered in that dimension.
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Statistical testing was used to analyze associations between the patient characteristic independent variables and the patient expectation dependent variables. Examination of the distribution of data indicated that the data were not normally distributed. Therefore, two nonparametric tests, the chi-square test for independence and the Spearman's correlation coefficient for ranked data, were identified as appropriate methods for analyzing these associations. For both statistical tests, an alpha value of 0.05 was used as the level of significance.
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Descriptive Statistics: Demographic Characteristics of the Study Sample
Sixty-nine percent of the study participants reported an annual household
income of more than $100,000, with the median income being over $100,000 per
year. This finding is in sharp contrast to U.S. Census figures that show only
15% of the general population are in the over-$100,000 income category
[29]. Likewise, 64% of
participants reported holding bachelor's or graduate degrees, in contrast with
24% of the general population, based on U.S. Census figures
[29]. Fifty-nine percent of
the participants were men and 41% were women. Eighty-nine percent identified
their race and ethnicity as "white." Eighty-five percent of the
participants were either self-referred or requested the referral from a
physician. Eighty-one percent were married.
Patient knowledge of full-body CT screening—Most study participants first learned about full-body CT screening in conventional ways (e.g., friends, relatives, and television and radio advertisements). Only one fifth of participants reported first learning about it from a physician. More than 58% of the survey participants reported consulting one or two other sources of information after initially learning about the procedure, whereas 38% did not consult any other sources. Of those survey participants who did consult other sources, the most frequent sources consulted, in descending order, were the Internet, popular media, and physicians.
Fifteen patient expectation statements— Most participants strongly agreed or agreed with most items with the median score being 4 on 11 of the 15 statements. The one statement that did show variability was statement 6, which asserts "Effective treatments exist for almost any condition this test may find." Participants' responses to each of the 15 patient expectations are delineated in Table 3.
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Six patient education dimensions—The median Likert scale scores on the responses were examined with respect to each of the six patient expectation dimensions and are shown in Table 4. In summary, the descriptive data for the six patient expectation dimensions suggest that patients tended to have the highest level of agreement with survey expectation statements in the Patient Empowerment dimension and the lowest level of agreement with survey expectation statements in the Limitations dimension.
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Results of Statistical Analysis: Associations Between Patient Characteristics and Patient Expectations
The associations between the patient characteristics and the patient
expectations were primarily analyzed through statistical testing. The
chi-square test for independence and two-way tables were used to analyze the
associations among the 13 patient characteristics, the independent variables,
and the 15 patient expectation statements, the dependent variables. Spearman's
correlation coefficient for ranked data was used to analyze the associations
among the 13 independent variables and each of the six patient expectation
dimensions. The results of the chi-square test and Spearman's correlation
coefficient for ranked data were used to analyze the study hypothesis that
there is a significant association between patients' perceptions of their
susceptibility to disease and their expectations of the health benefits of
full-body CT screening.
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Chi-Square Test for Independence
The data analysis using the chi-square test for independence suggested that
there were significant associations between several patient characteristics
and patient expectations of full-body CT screening. The significant
characteristics were as follows: level of personal health concern, number of
other health screening examinations patient had undergone, patient sex, and
method of referral.
Level of personal health concern—A significant association
was found between the level of concern that patients reported regarding their
personal health and their expectations that knowing the results of this test
may improve their overall health (
2 [4, 91] = 10.07,
p = 0.04). This expectation is included in the Prevention patient
expectation dimension. The data suggest that patients who were
"extremely concerned," "very concerned," or
"moderately concerned" about their health tended to have higher
expectations that knowing the results of this test may improve their overall
health than patients who were only "somewhat concerned" or
"not concerned," as graphically shown in
Figure 3.
Number of other health screening examinations—A significant
association was found between the number of other health screening
examinations patients reported undergoing and patient expectations that the
results of the CT screening would be discussed with them by a health care
professional (2 [8, 90] = 17.80, p = 0.02). This
expectation is included in the Empowerment patient expectation dimension. The
data suggest that the higher the number of other previous health screening
examinations that patients reported having undergone, the higher their
expectations that a health care professional would be available to discuss the
results of their full-body CT screening examination, as graphically shown in
Figure 4.
Sex—Significant associations were observed between sex and
three of the patient expectations statements. One of the three associations
was in the Reassurance dimension and the other two associations were in the
Satisfaction dimension. In the Reassurance dimension, a significant
association was observed between sex and patients' expectations that
"full-body CT screening may be repeated throughout a person's
lifetime." The data suggest that although both men and women generally
had a high level of agreement with this statement, a higher percentage of
women than men agreed or strongly agreed that full-body CT screening may be
repeated throughout a person's lifetime (2 [2, 91] = 9.77,
p = 0.01).
In the Satisfaction dimension, two significant associations were observed
between sex and two of the patient expectation statements
[1]. In examining the first
association, "the comprehensive nature of full-body CT screening makes
it unlikely that patients will require further testing," the data
suggest that women are more likely than men to be satisfied that they will not
need to undergo additional tests (2 [2, 91] = 12.08,
p = 0.01) [2]. In
examining the second association in the Satisfaction dimension, the data
suggest that a higher percentage of women than men agreed or strongly agreed
that they will want to "recommend" full-body CT screening to their
"close friends and relatives" (2 [2, 89] = 8.09,
p =0.02).
Method of referral—A significant association was found
between the method of referral for full-body CT screening and the expectation
that this test is available to both self-referred and physician-referred
patients (2 [2, 91] = 15.1678, p = 0.001). The data
suggest that patients who were self-referred had higher expectations that
full-body CT screening is available to both self-referred and
physician-referred patients than patients who were physician-referred.
Spearman's Correlation Coefficient for Ranked Data Analysis
Using the Spearman's correlation coefficient for ranked data analysis,
significant associations were found between patients' self-estimations of
their current health status and three of the six patient expectation
dimensions—namely, Empowerment (r =0.30, p =0.004),
Reassurance (r =0.23, p = 0.003), and Prevention (r
=0.22, p = 0.04). The data from the Spearman's correlation
coefficient for ranked data analysis suggest that of these three significant
relationships, the strongest association was between "self-estimation of
current health status" and Empowerment (r =0.30, p =
0.004).
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Summary of Results
Patients' highest expectations related to consumer empowerment and their
lowest expectations related to the limitations of the procedure. Statistical
testing found five patient characteristics to have significant associations
with patient expectations. They were as follows: level of personal health
concern; number of other health screening examinations; patients'
self-estimations of their current health status; sex; and referral method.
The primary purpose of this study was to develop a scientific knowledge base about patient expectations of full-body CT screening and to determine whether specific characteristics of patients influence their expectations of the health benefits of the procedure. Two of the five significant associations found in this study between patient characteristics and patient expectations—namely, level of personal health concern and participation in other health screening examinations—support our initial hypothesis. This hypothesis stated that a significant association exists between patients' perceptions of their susceptibility to disease and their expectations of the health benefits of full-body CT screening.
Our findings also support the health belief model's [22, 23] utility in explaining patient expectations of the health benefits of full-body CT screening. The model suggests that patients who more frequently think about their health may feel more susceptible to disease and have higher expectations that the procedure will provide preventive health benefits. Similarly, the model also suggests that patients who participate in more health screening examinations may also feel more susceptible to disease and have higher expectations that full-body CT screening will empower them to better manage their health care than patients who participate in fewer health screening examinations.
Conversely, three of the five significant associations found in this study—namely, patients' self-estimations of their current health status, patient sex, and referral method—are not explained or are only partially explained by the health belief model [22, 23]. For example, a positive association, rather than the expected negative association, was found between patients' self-estimations of their current health status and their expectations of the health benefits of full-body CT screening. However, patients who considered themselves to be in better health would have been expected to feel less susceptible to disease and, thus, to have lower expectations of the health benefits of the procedure.
The significant findings for sex and referral method need to be interpreted in the context of other study findings and are thus only partially explained by the health belief model [22, 23]. Our data suggest that women have higher expectations for reassurance and satisfaction from full-body CT screening than men. This finding is consistent with those of previous studies that have shown women to have a higher perceived susceptibility to disease [30]. Likewise, the data suggested that self-referring patients had higher expectations for empowerment than physician-referred patients. This finding is expected given the fact that 85% of the study sample was self-referred or had requested the referral from their physician.
Need for Contemporary Models and New Health Screening Paradigms
The study findings support much of the anecdotal literature indicating that
the rationale for participating in full-body CT screening and the expectations
of its health benefits may represent a new health screening paradigm that may,
in part, be driven and explained by two contemporary consumer needs:
empowerment in health care management and comprehensive wellness.
The patients who volunteered to participate in the study generally had high expectations regarding the perceived benefits of full-body CT screening, as evidenced by the fact that most of their responses to the patient expectation statements were in the agree and strongly agree categories. Nevertheless, the comparison of the median response scores for the six patient expectation dimensions indicated that patients' highest levels of agreement corresponded to statements in the Empowerment dimension. The saliency of consumer empowerment in the promotion and growth of self-referral for new imaging procedures has been repeatedly mentioned in the cited literature about the new consumerism in medicine [24, 28, 31-33].
The demographic data provided by the self-reports of study volunteers provide evidence that the individuals self-referring for the procedure generally have the financial resources to pay for this aspired level of control. However, although the ability to purchase out-of-pocket medical services may enhance empowerment and choice for the affluent, this ability may further widen the disparities in the health care options available to those who cannot afford such services. This study is not intended to make policy recommendations because such policy decisions may be premature without additional clinical evidence.
In today's consumer-driven health care environment, the rationale for seeking screening and the expectations of its benefits may be expanding from individuals perceiving themselves as susceptible to specific diseases and wanting reassurance that they are free of that disease to a need to feel invulnerable and protected from an array of disease states and health conditions. Several authors have discussed the quest for immortality and longer life span that motivates the baby boomers [24, 32].
This expanded concept of wellness may explain why three quarters of the survey participants reported being in excellent or very good health but, nonetheless, wanted to undergo the full-body CT screening procedure. Fewer than 5% of participants estimated their health status as fair or poor. Moreover, few participants reported personal health histories of cancer or other serious illnesses, although many did report family histories of serious illnesses.
Our study's findings about the health concerns and health practice characteristics of the survey participants further support the anecdotal reports and opinions indicating that most individuals self-referring for the procedure are healthy and asymptomatic [33]. The study data also support the results of the Lemon et al. study [18], in which those researchers found that individuals who participate in one type of health screening procedure are more likely to participate in other types of screening procedures and preventive health activities. Most important, our study data affirm many of the cautions and concerns expressed in the literature about administering full-body CT screening and many targeted CT screening examinations to a basically healthy population, although the scientific data have not been collected [4-7, 9].
In summary, the study findings support the anecdotal literature that cite the concepts of consumer empowerment and the desire for comprehensive wellness to explain why individuals seek full-body CT screening and the health benefits they expect to attain from it. These findings also support the need for patient and physician education about the risks and benefits of the procedure.
Empowerment of the health care consumer and the quest for wellness require patients to have information regarding the procedures they are considering and the skills to effectively make decisions about their health care management. Only one fifth of participants reported learning about full-body CT screening from a physician. This finding is a concern because patients considering full-body CT screening need to be cognizant of the potential benefits and the responsibilities and risks inherent in their freedom to make decisions through self-referral. Likewise, physician and patient educators needs to incorporate an evidenced-based approach in providing information about the extent to which the procedure may or may not promote the comprehensive level of wellness that consumers expect to achieve.
The study also strongly validates the need for further study of the clinical aspects of full-body CT screening. Physician educators and patient educators require a valid scientific knowledge base if they are to effectively train other physicians and educate patients. This knowledge base currently does not exist and in part accounts for why this study is primarily descriptive. To date, there are no conclusive clinical or scientific criteria for scoring surveys. However, the responses of the patients to the survey items have provided some of the first scientific data about patient perceptions and expectations of full-body CT screening.
In conclusion, the health belief model [22, 23] was used as the theoretic basis for this study. Although still a useful model in explaining patient participation and expectations of targeted screening programs, the model only partially explains patients' expectations of full-body CT screening. A paradigm shift may be occurring in which consumer empowerment and the desire for comprehensive wellness may be a complementary model to explain patient participation in and expectations of full-body CT screening and new imaging technologies. The findings of this study have substantiated the need for education about the risks and benefits of full-body CT screening, so patients may engage in informed decision-making before providing informed consent [34, 35].
Acknowledgments
We would like to express our deep appreciation to the clinicians,
administrators, and staff of the six study sites for participating in this
study and for their commitment to supporting research on patient expectations
of full-body CT screening. Our very special thanks extends as well to the many
patient volunteers who completed the surveys. We are, in addition, extremely
grateful to the panel of experts who reviewed the patient expectation survey
documents and contributed their expertise, mentorship, and valuable input:
Robert J. Stanley, Jeffrey Jarvik, James Ehrlich, Larry Brock, Marc Kahn,
Ronald Kolber, Judith Illes, Ann Hewitt, Nancy Fiamingo, Erin Collins, John
Bebee, Lindy Schmitt, and Linda Koretic. We would also like to acknowledge
Seton Hall University School of Graduate Medical Education and JFK Medical
Center/Solaris Health System for their outstanding efforts to promote
scholarly research and learning for practicing health care professionals.
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