ORIGINAL ARTICLE: Clinical Endoscopy
Patient preferences of a resect and discard paradigm Hongha T. Vu, MD, Gregory S. Sayuk, MD, Neil Gupta, MD, Thomas Hollander, MS, Aram Kim, MD, Dayna S. Early, MD St. Louis, Missouri, USA
Background: Resect and discard is a new paradigm for management of diminutive polyps. It is unknown whether patients will embrace this new paradigm in which small polyps would not be sent for histopathologic review. Objective: To determine whether patients would be willing to pay for pathology costs with their own money and which factors influence patients’ decisions to pay or not pay for pathology costs with their own money. Design: Single-center, prospective, survey study. Setting: Hospital outpatient endoscopy center. Patients: Adults undergoing colonoscopy for screening or routine polyp surveillance. Interventions: Patient survey. Main Outcome Measurements: Willingness to pay out-of-pocket for pathology costs when a diminutive polyp is found and factors that influence patients’ decisions to pay or not pay for pathology costs with their own money. Results: A total of 500 participants completed the survey. A total of 360 respondents (71.9%) indicated a hypothetical willingness to pay out-of-pocket for histopathologic polyp analysis if this interpretation was not covered by insurance. Patient factors significantly associated with willingness to pay for polyp analysis included higher income and education and female sex. Limitations: Single center, hypothetical situation. Conclusion: Over two-thirds of patients were willing to pay to have their diminutive polyp sent for pathologic evaluation if their insurance carrier would not pay the cost. Factors associated with willingness to pay included higher income, higher education, and female sex. Patients who were unwilling to pay raised concerns about cost and are less concerned about cancer risk compared with those willing to pay. (Clinical trial registration number: NCT02305251.) (Gastrointest Endosc 2015;82:381-4.)
Diminutive (defined as!6 mm in size) colorectal polyps are prevalent (O50%) in the screening and surveillance colonoscopy population but have low risk for harboring advanced villous or dysplastic components and for developing into colorectal cancer (CRC).1,2 Resect and discard is a new paradigm for management of these diminutive polyps in which their histology is determined by real-time
imaging and then they are discarded after resection rather than being sent for histopathologic review.3 One of the purported advantages of a resect and discard approach is that costs associated with colonoscopy are decreased; because the cost of histopathology is reduced, the overall cost-effectiveness of CRC screening improves.4,5 However, patient preferences are an important consideration in
Abbreviation: CRC, colorectal cancer.
Copyright ª 2015 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2015.01.042
DISCLOSURE: All authors disclosed no financial relationships relevant to this article.
Received December 12, 2014. Accepted January 15, 2015.
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Patient preferences of a resect and discard paradigm
establishing policies about such strategies. There have been several studies regarding the accuracy of a resect and discard approach,6-12 but currently there are no data regarding patient attitudes toward this approach. It is important to know whether patients would embrace this new paradigm in which diminutive polyps would not be analyzed for pathology. In addition, should third-party insurers adopt such an approach, patients may be faced with the burden of an additional cost of pathology analysis if they want to have their diminutive polyps analyzed by a pathologist. We designed a patient survey to determine whether patients are willing to pay pathology costs themselves, in a hypothetical situation in which their insurance companies would not pay for analysis of diminutive polyps. The aims of the present study were to determine whether patients would be willing to pay for pathology costs with their own money and to determine factors that influence patients’ decisions to pay or not pay for pathology costs with their own money.
METHODS Consecutive patients presenting for screening or routine polyp surveillance colonoscopy in a hospital outpatient endoscopy center were included. Patients undergoing colonoscopy for an indication other than screening or surveillance were excluded. Patients with a known polyposis syndrome or those in whom polyposis or CRC was identified at the time of colonoscopy also were excluded. A survey was administered in the before-procedure area to patients undergoing screening and/or surveillance colonoscopies (Appendix 1, available online at www.giejournal. org). We administered the survey in the before-procedure area so patient answers would not be affected by the procedure results or sedation. Surveys were anonymous and did not contain any identifying information. The survey presented an illustration comparing the risk of having cancer in a diminutive polyp to the risk of being struck by lightning (similar risk), dying in a car crash (lower risk), or having identical twins (lower risk). Patients were then presented with a hypothetical scenario in which their insurance companies would not pay for histopathologic evaluation of diminutive polyps, and then patients were asked to choose whether or not they would be willing to pay $150 out of pocket to have their diminutive polyp sent for pathologic evaluation and which factors influenced their choice. Willingness to pay was defined via this hypothetical situation, with choice B selection equating a willingness to pay for histopathologic analysis. The importance of 3 factors (cost, risk of cancer in a diminutive polyp, and doctor performing the colonoscopy) were measured on a visual analog scale with very important on the left and not important at all on the right. The wording of the survey as well as the verbal instructions 382 GASTROINTESTINAL ENDOSCOPY Volume 82, No. 2 : 2015
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given were very clear that this represented a hypothetical situation and was not relevant to the colonoscopy that they were about to undergo. Data regarding patient demographics and family history of CRC also were collected. This study was approved by the Washington University in St. Louis Human Research Protection Office and was registered with clinicaltrials.gov (NCT02305251).
Statistical considerations We recorded and reported in percentages how many patients would choose to pay out of pocket to have their diminutive polyp analyzed by histopathology. Subject demographics and measures of central tendency were assessed as means or median values where appropriate. For the purposes of results reporting and ease of interpretation, income was dichotomized into lower and/or higher income (cutoff at $50,000 annual income). The education level variable was maintained in categorical form (ie, some high school Z 1, high school graduate or equivalent Z 2, some college Z 3). Coding the variable in this format allowed us to evaluate the incremental willingness to pay as respondents achieved higher educational levels (eg, going from some high school to high school graduate or from high school graduate to some college). We analyzed 3 factors that could have an influence on respondents’ decisions: cost, risk of having a cancerous polyp, and the physician performing the colonoscopy. Differences in the importance scales for each of these factors between those willing to pay and not willing to pay were determined by using a t test. We also analyzed patient demographic and family history factors to assess which of these factors were associated with willingness to pay for histopathologic analysis out of pocket. Univariate analysis, with generation of odds ratios (approximated by exponential beta values) and 95% confidence intervals, was determined by using logistic regression analyses. Multivariate logistic regression was performed to assess the independent value of these patient factors in predicting patients’ willingness to pay for polyp analysis. A P value of ! .05 was used to establish statistical significance in all instances.
RESULTS A total of 500 participants (mean [ standard deviation] age 59.3 9.3 years, 61.1% female) completed the survey. A total of 269 patients (46.2%) were married, with a median household income of $50,000 per year. A total of 474 patients (94.6%) had a primary care physician, and 469 (93.6%) had health insurance. A total of 145 patients (27.0%) reported a family history of CRC, with 84 (16.8%) having a first-degree relative with CRC. Of the 500 respondents, 360 (71.9%) indicated a hypothetical willingness to pay out of pocket for histopathologic polyp analysis if this interpretation was not covered by insurance, with 242 of 360 (67.2%) replying definitely www.giejournal.org
Vu et al
Patient preferences of a resect and discard paradigm
7.2
4
6.2
24.4 62.3
Odds ratio (95% CI)
3
2
1
0 Age
Definitely
Probably
Maybe
Do Not Know
Figure 1. Hypothetical patient willingness to pay out of pocket for histopathologic analysis of polyps.
Female Sex
Higher Income
Higher Education
Married
Family Hx CRCA
1st Deg Relative CRCA
Figure 3. Odds ratios for demographic and family history factors associated with willingness to pay out of pocket for histopathologic analysis of polyps. CI, confidence interval; Hx, history; CRCA, colorectal cancer; Deg, degree. TABLE 1. Multivariate logistic regression assessing patients factors as independent predictors of patient willingness to pay for histopathologic analysis of diminutive polyps
Figure 2. Importance of factors associated with willingness to pay out of pocket for histopathologic analysis of polyps.
P value
Exp (B)
95% CI
Age
1.004
0.974-1.034
.81
Female sex
2.32
1.35-3.98
.002
Higher income
4.05
2.03-8.05
! .001
Education
0.99
0.77-1.29
.98
Married
0.88
0.49-1.58
.67
Family history of CRC
1.62
0.65-4.23
.31
First degree relative CRC
1.009
0.33-3.12
.99
Exp, Exponentiated; CI, confidence interval; CRC, colorectal cancer.
The American Society for Gastrointestinal Endoscopy document addressing the resect and discard paradigm states that cost analyses have found that the resect
and discard paradigm is associated with substantial cost savings, with negligible impact on patient cancer risk.3 The substantial cost savings refer to a societal benefit, but do not consider the advantages and disadvantages for an individual patient. Most patients undergoing screening colonoscopy have health insurance coverage that includes histopathology, so a resect and discard paradigm does not result in a perceived out-of-pocket cost savings for an individual patient. If a resect and discard strategy were to be widely accepted, however, and insurance companies decline to pay for histopathology costs, these costs then become the responsibility of the patient. There are no published data regarding whether or not patients would accept a resect and discard strategy. It is unknown whether patients would be comfortable having their diminutive polyps discarded without histopathologic analysis. We therefore created a pilot survey to assess patient attitudes. According to our results, when presented with a hypothetical scenario describing a resect and discard paradigm for diminutive polyps, over two-thirds of patients were willing to pay their own money to have their diminutive polyp sent for pathologic evaluation if their insurance carriers would not pay the cost. This suggests that the majority of patients are uncomfortable not having their
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and 88 of 360 (24.4%) replying probably. A further categorization of those indicating a willingness to pay (choice B) for histopathologic analysis is shown in Figure 1. The factors in patient willingness to pay for histopathologic analysis of polyps are shown in Figure 2. Cost was less important to those expressing a willingness to pay for polyp analysis, and perceived risk of cancer was more important to these same individuals. Patient factors significantly associated with willingness to pay for polyp analysis included female sex, higher income, and increasing education (Fig. 3). Any family history of CRC also predicted willingness to pay but was not further enhanced by having a first-degree relative with CRC. In multivariate analysis, female sex and higher income remained as independent predictors of patients’ willingness to pay for polyp histopathologic analysis (Table 1).
DISCUSSION
Patient preferences of a resect and discard paradigm
Vu et al
be willing to incur for histopathologic analysis was not explored in this study but would be an important future direction. Further, scenarios in which high-grade dysplasia was found in the diminutive polyp warrant evaluation. In conclusion, our data show that perceived risk and pathology costs are important factors for patients in determining which patients are willing to pay out of pocket for polyp histopathologic analysis. The majority of patients reported a willingness to pay $150 to have their diminutive polyp analyzed to exclude CRC. These observations suggest that most patients would not be willing to accept a resect and discard strategy to the extent that they would be willing to pay for histopathologic analysis out of pocket.
diminutive polyp analyzed for cancer to the extent that they are willing to pay out-of-pocket for histopathology. Factors associated with willingness to pay included higher income, higher education, and female sex. It is not surprising that higher income was associated with willingness to pay, because these individuals have greater resources than those with lower incomes. The association between higher education and willingness to pay is less clear. Assuming that these respondents understood the relative risk examples, this association may indicate that these respondents were more concerned about cancer risk than those unwilling to pay. As expected, a significant degree of correlation exists between education and income in the study sample (r Z 0.42; P ! .001). The multivariate regression analysis performed, although limited by this variable colinearity, suggests that income is the predominant factor driving willingness to pay for polyp histopathology. Any family history of CRC was associated with a 2-fold greater likelihood of willingness to pay for histopathology. These individuals likely have a perceived greater risk of CRC enhancing their willingness to assume the cost of polyp analysis. Having a first-degree relative with CRC was associated with a greater willingness to pay, although it did not reach statistical significance. In part, this observation may reflect the relatively small number of participants (17% of the total study population) with this risk factor, leaving the study underpowered to fully assess this factor. At the same time, this finding provides indirect evidence that those individuals with a first-degree relative with CRC may not fully recognize the potential increased risk in CRC associated with such a family history. Patients who were unwilling to pay raised concerns about cost and are less concerned about cancer risk compared with those willing to pay for histopathologic analysis of colon polyps. Our study has limitations. This study was conducted at a single, tertiary-care center, and the results may not be applicable to other settings. The scenario in the survey was clearly described as a hypothetical situation, so the answers may not reflect patients’ views if they were truly faced with the decision to pay for histopathology analysis. However, we understand that patients undergoing colonoscopy are somewhat anxious, and we did not want to increase their anxiety by presenting a scenario for which they were unprepared. The scenario also was created to reflect the finding of a single diminutive polyp and assigned a value of $150 to the histopathology evaluation. This scenario therefore does not take into account instances in which more than one diminutive polyp was found and circumstances where pathology costs are greater than or less than $150. Both of these situations would likely affect patient willingness to pay for histopathologic analysis. Different thresholds (dollar amounts) that patients would
1. Lieberman D, Moravec M, Holub J, et al. Polyp size and advanced histology in patients undergoing colonoscopy screening: implications for CT colonography. Gastroenterology 2008;135:1100-5. 2. Butterfly LF, Chase MP, Pohl H, et al. Prevalence of clinically important histology in small adenomas. Clin Gastroenterol Hepatol 2006;4:343-8. 3. Douglas K, Rex, Charles Kahi, Michael O'Brien, et al. The American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable Endoscopic Innovations) on real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc 2011;73:419-22. 4. Kessler WR, Imperiale TF, Klein RW, et al. A quantitative assessment of the risks and cost savings of forgoing histologic examination of diminutive polyps. Endoscopy 2011;43:683-91. 5. Hassan C, Pickhardt PJ, Rex DK. A resect and discard strategy would improve cost-effectiveness of colorectal cancer screening. Clin Gastroenterol Hepatol 2010;8:865-9. 6. Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology 2009;136:1174-81. 7. Rastogi A, Keighley J, Singh V, et al. High accuracy of narrow band imaging without magnification for the real-time characterization of polyp histology and its comparison with high-definition white light colonoscopy: a prospective study. Am J Gastroenterol 2009;104:2422-30. 8. Ignjatovic A, East J, Suzuki N, et al. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol 2009;10:1171-8. 9. Paggi S, Rondonotti E, Amato A. Resect and discard strategy in clinical practice: a prospective cohort study. Endoscopy 2012;44:899-904. 10. Kuiper T, Marsman WA, Jansen JM, et al. Accuracy for optical diagnosis of small colorectal polyps in nonacademic settings. Clin Gastroenterol Hepatol 2012;10:1016-20. 11. Ladabaum U, Fioritto A, Mitani A, et al. Real-time optical biopsy of colon polyps with narrow band imaging in community practice does not yet meet key thresholds for clinical decisions. Gastroenterology 2013;144:81-91. 12. Rastogi A, Early DS, Gupta N, et al. Randomized, controlled trial of standard-definition white-light, high-definition white-light, and narrow-band imaging colonoscopy for the detection of colon polyps and prediction of polyp histology. Gastrointest Endosc 2011;74: 593-602.
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REFERENCES
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APPENDIX 1. PATIENT PREFERENCES FOR A RESECT AND DISCARD PARADIGM SURVEY. DO NOT WRITE YOUR NAME, BIRTHDAY OR ANY PERSONAL INFORMATION ON THIS SURVEY. WE WANT YOUR RESPONSES TO BE ANONYMOUS. YOU ARE ANSWERING QUESTIONS ABOUT A HYPOTHETICAL SITUATION. WHAT YOU READ BELOW HAS NOTHING TO DO WITH YOUR COLONOSCOPY PROCEDURE TODAY. During your colonoscopy today, your doctor may find small polyps in your colon. He/she will remove them and send them to the pathology department to be analyzed to determine if there is cancer in the polyp. The chance of cancer in a small polyp is about 1 in 3,000. The chart below gives you an idea of how common this is:
Patient preferences of a resect and discard paradigm
Which of the following would be important to you in making your decision (put an X on the line to tell how important)? The cost I would have to pay:
The risk of having cancer in a small polyp:
The doctor who is performing my colonoscopy
Chances of:
What is your age? ______ What is your sex? ________ What is your approximate household income? ____ ! $25,000 per year ____ between $25,000 and $50,000 per year ____ between $50,000 and $75,000 per year ____ more than $75,000 per year
Please think about what you might do IF your doctor finds a small polyp(s). Consider the two choices below and mark your answer on the line with an “X”. REMEMBER WE ARE ASKING YOU ABOUT A HYPOTHETICAL SITUATION. Choice B Choice A You would agree to have your You would agree to have your polyp(s) removed and discarded polyp(s) sent to the pathology department for analysis. The (thrown away) by the doctor pathology department would who does your colonoscopy, tell you if they thought the without being tested to polyp had cancer in it. Each determine if there is cancer in polyp analyzed would cost the polyp. There would be no around $150 of your own additional cost to you. money.
What do you think you would decide to do? (Circle your answer)
What is the highest level of education you have finished (circle)? Some high school High school graduate or equivalent Some college College degree Professional degree/Masters/ PhD Has anyone in your family had colon cancer? ____ Y N if yes, who? ______________ Are you..
___
Married Single Divorced Widowed
Choice A Choice B Do you have a primary care doctor? YES Do you have medical insurance? YES
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NO
NO
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