J Community Health (2010) 35:235–239 DOI 10.1007/s10900-010-9227-8
ORIGINAL PAPER
Mailed Fecal-Immunochemical Test for Colon Cancer Screening Jeanette M. Daly • Barcey T. Levy Mary L. Merchant • Jason Wilbur
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Published online: 2 February 2010 Ó Springer Science+Business Media, LLC 2010
Abstract Various interventions have been implemented to increase the rate of colon cancer screening. The purpose of this study was to determine if persons who are regular patients of a clinic, ages 50–64 years, and not up-to-date with colon cancer screening will complete the at-home fecal-immunochemical test (FIT) if it is mailed to them. This intervention was designed to have the subject avoid the signing of an informed consent and having to ask for the screening test; and, only one stool specimen was needed. Three hundred and fifty potential subjects were randomly selected from an electronic medical record database after meeting inclusion criteria. Eighty-seven fecal immunochemical tests were returned. Seven of the FIT kit results were positive for occult blood. Each respondent was sent a letter giving them their results. A minimal cue CRC screening intervention, a FIT kit sent in the mail without prerequisite of a signed informed consent, was offered to the study subjects. Twenty-six percent of the eligible persons were screened for colon cancer by this method. A mailed FIT kit or one handed to the patient at an office visit has minimal cost which can be recovered through insurance coverage. Commitment by health care providers is necessary for prevention. This method is one of several that could reach the hard to screen population. Keywords Colon cancer screening Fecal immunochemical test
J. M. Daly (&) B. T. Levy M. L. Merchant J. Wilbur Department of Family Medicine, University of Iowa, 200 Hawkins Drive, Iowa City, IA 52242, USA e-mail:
[email protected]
Introduction Colorectal cancer (CRC) is the second leading cause of cancer-related deaths and is the third most common cancer diagnosis in the United States [1]. Approximately 150,000 persons are diagnosed with colon cancer each year and about one-third of those persons will die from it [1]. Iowa’s incidence rate for in-situ and malignant CRC from 2000– 2004 was among the highest of the SEER registries at 59.3/100,000, age-adjusted to 2000 U.S. standard population [2]. Colorectal cancer screening allows for the detection and treatment of precancerous polyps and possible cancer in its earliest stages, which prevents cancer from developing or progressing. Colon cancer deaths are largely preventable through CRC screening but despite available tests, over half of eligible adults are not adherent with CRC screening guidelines [3]. It is estimated that U.S. mortality for the disease could be reduced 23% by 2020 if screening rates increased to 70% [4]. The multiple factors related to low rates of CRC screening have been identified by many investigators and include insurance coverage [5], source of medical care [3, 5], patients’ education level [5], test preferences [6], and physician attitudes and preferences [7]. Researchers have studied various methods of encouraging eligible adults not up-to-date with CRC screening to be screened: video-based decision aid [8]; personalized mailings to patients overdue for screening [9]; patient email promotion of CRC [10], and physician-directed strategies to improve rates of CRC screening [11]. In a review of the literature on adherence to CRC screening with fecal occult blood testing (FOBT) and sigmoidoscopy, prevalence of the tests, interventions to increase adherence, and reasons for nonadherence were examined [12]. The most intensive
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strategies involving personalized mailings and phone call follow-up with FOBT tests yielded above 50% adherence while the least personal, minimally delivered interventions yielded between 10 and 30% adherence [12]. The patient’s decision regarding a CRC screening method is further limited by factors such as physician time to discuss preventive tests [13, 14], office reminder systems [14], and patient preferences. Schroy et al. [15] found that patients preferred test accuracy when asked to rate CRC screening test features, however, Pignone [16] found that number of options and out-of-pocket costs may also influence patient decisions. Patient preferences for CRC tests are associated with test features; colonoscopy was selected if accuracy was the priority, FOBT if non-invasiveness was most important [17]. When physicians and patients consider financial costs of the various CRC tests, the relatively inexpensive FOBT often becomes the method of choice. Interventions for increasing CRC screening are also affected by the fiscal and personnel resources of clinical practices. Interventions that are effective in improving CRC screening for patients are associated with cost, personnel time, and additional materials such as mailed reminders [9], educational videos, and brochures [8]. Electronic health record and paper chart reminders for physicians to order CRC screening helped improve CRC screening as well as ordering of tests for CRC screening [9]. Many physician offices lack systems to support CRC screening [7]. In patients adherent to yearly testing, highly sensitive, relatively cheap stool-based tests, such as the fecal immunochemical test (FIT), may be comparable to screening colonoscopy [18]. Physicians’ CRC recommendations have changed over time, and now most recommend colonoscopy and do not offer patients the full menu of tests [7]. Although new evidence suggests that FOBT is effective in reducing CRC mortality, fewer physicians recommend this test to their patients [7]. Adherence over time is the key determinant of the effectiveness of strategies that rely on frequent testing [18]. The American Cancer Society recommends the FIT over guaiac-based tests because they are more patient-friendly and likely to be equal or better in sensitivity and specificity [19]. The FIT tests do not depend on peroxidase action as do the guaiac-based FOBT; thus, patients have no diet and medication restrictions [20]. Studies of interventions designed to increase CRC screening in clinical practice require access to patients’ medical information and thus institutional review board approval with signed informed consent documents by all participants. While necessary for protection of individual privacy, many object to the signing of a consent form and thus giving permission to review their medical record. Such studies involve considerable research staff time for
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recruitment of subjects. Studies without informed consent involve interventions mailed or given to all patients attending a clinic or working for a company as an overall effort to improve screening efforts, known as opportunistic testing. Vernon [12] reports low adherence rates for minimal or impersonal interventions such as offering FOBT kits to employees (picked up at the company medical department) [21], handing out FOBT kits in a clinic [22], and mailing an offer to clinic patients requiring them to return a post card request for a kit [23]. This intervention study was designed to avoid the signing of an informed consent and having to ask for the screening test; and, only one stool specimen was needed. The purpose of this study was to determine if persons who are regular patients of a clinic, ages 50–64 years, and not up-to-date with colon cancer screening will complete the at-home fecal-immunochemical test if it is mailed to them.
Methods This study was conducted in a tertiary Midwestern medical center’s family medicine clinic. Institutional Review Board approval was received for this project and a signed informed consent was not required from each subject. Subject Recruitment An electronic medical record data pull was conducted to determine eligible participants for the study. Inclusion criteria included patients who were 50–64 years of age, insured, and with at least one office visit to the family medicine clinic in the preceding 2 years. Patients were excluded from the data pull if they had a history of colon cancer, ulcerative colitis, or Crohn’s disease. Patients were also excluded if they had a hemoccult test every year in the last 5.5 years, flexible sigmoidoscopy in the last 5.5 years, colonoscopy in the last 10.5 years, or a barium enema in the last 5.5 years. From the electronic medical record, 6,223 potential subjects were identified of which 3,314 (53%) were not upto-date with CRC screening according to the criteria listed above. From the 3,314 patient list, 1,644 patients had a visit in the last 2 years in the family medicine clinic. Patients who only visited other clinics in the institution were omitted from the pool. The 1,644 patients who had visits in the family medicine clinic may also have had visits in other clinics. Eighty subjects had addresses outside of Iowa and were omitted from the list, leaving 1,564 eligible patients. Three hundred and fifty potential subjects were randomly selected from the list of 1,564 patients. The 350 subjects were mailed a packet that included a cover letter on clinic letterhead signed by two of the
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researchers (one a physician in the clinic) explaining the opportunity to have a stool specimen tested for occult blood, a FIT kit, and a return postage paid mailer. The plastic FIT kit specimen container and return cardboard mailer had duplicate identification numbers recorded to match the patient receiving the mailing. After receiving the packet of information, a potential subject could decide if they wanted to participate by returning their stool specimen. Three weeks after the initial mailing, a reminder letter was sent to non-respondents.
237 6,223 Potential Subjects 3,314 Not up-to-date CRC 1,644 Had Office Visit Within Last 2 Years 80 Subjects Addresses Outside Iowa
1,564 eligible 350 Randomly Selected (3 Reported Ip-to-date Colonoscopy) (1 Reported Bleeding Hemorrhoids) (1 Reported Being Treated for Colon Cancer) 344 Eligible Subjects
Fecal Immunochemical Test The FIT, an alternative for the guaiac-based FOBT, was mailed to all subjects. The FIT detects occult blood in the stool and has higher sensitivity and specificity for colorectal neoplasia than the FOBT [24–26]. The FIT uses antibodies specific to human hemoglobin, albumin, or other blood components to capture hemoglobin on a test strip and is highly specific for detecting human blood of colonic origin. This test only requires one sample and has no dietary restrictions, making it much easier for patients to remain compliant with sample collection requirements. The Clearview ULTRA FOB Test (Inverness Medical) was the FIT kit type sent to the potential subjects [27]. The FIT kit had the following directions for stool specimen collection: (1) place supplied collection paper inside toilet bowl on top of water, (2) deposit stool sample on top of collection paper, (3) collect sample from stool before paper sinks and stool sample touches water, and (4) flush, collection paper is biodegradable and will not harm septic systems. The stool specimens returned from the FIT kits were developed by research staff who were trained by the Clearview representative and were supervised by the research director and staff physicians. Testing of the FIT kit is Clinical Laboratory Improvement Amendments (CLIA) waived test. Mailing From the initial mailing in the summer of 2008, one letter was returned for an incorrect address. Three persons telephoned the investigator reporting they were up-to-date with a colonoscopy, one person reported bleeding hemorrhoids, and another reported being treated for colon cancer at another hospital. This left 344 subjects remaining in the study.
Results Eighty-seven FIT kits were returned after the first mailing and three were returned after the second mailing for a total
87 FIT Returned First Mailing 3 FIT Returned Second Mailing Total 90 (26%) Return Rate 7 (2%) Positive FIT results
Fig. 1 Patient selection and FIT results
return of 90 (26%). Seven (2%) of the FIT kit results were positive for occult blood (Fig. 1). Each respondent was sent a letter giving them their results. A second duplicate letter was also enclosed in the mailing for them to provide to their physician.
Discussion A minimal cue CRC screening intervention, a FIT kit sent in the mail without prerequisite of a signed informed consent, was offered to the study subjects. Twenty-six percent of the eligible persons were screened for colon cancer by this method. In another recent randomized trial, the direct mail FOBT intervention netted 13% screening completed and only 14% return for those who received the direct mail FOBT with reminder letters and telephone calls [28]. This study included informed consents, a questionnaire, and the FOBT. Our results were doubled and less expensive using the FIT kit and no informed consent or questionnaire. In similar CRC studies using FOBT, returns of the FOBT have been higher. Thirty-nine percent of persons who received FOBT tests in the mail with a cover letter by their physician and instructions on dietary restriction of vitamin C returned the cards [29]. Another intervention trial had a 55% return for the group with the mailed cover letter and FOBT [30]. In a four-group intervention trial, completion of the FOBT was highest at 32% with the FOBT mailed with an invitation for a health check. However, in the group with only the mailed FOBT, 26% completed the test [31]. It is not known if these participants signed an informed consent.
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The earlier studies using FOBT 3-card tests [29, 30], had higher percent returns than our findings. Screening for colon cancer originated in the 1960–1970s and sigmoidoscopies and barium enemas were the norm if a stool specimen was positive for occult blood [32]. Information from the National Health Interview Survey (NHIS) indicated that in 1992 only 17.3% of people 50 years of age or older had undergone fecal occult blood testing in the previous year, and 9.4% had undergone sigmoidoscopy in the previous 3 years which was an increase of less than 5% since 1987 [33, 34]. Medicare had covered FOBT and sigmoidoscopy for average risk in 1998 and then extended expansion of those covered for colonoscopy in 2001, and the CRC screening rates have increased [35]. In the 2005, the CRC screening rate for Medicare enrollees C65 years was 47% [35]. This study’s intervention was targeted at the 53% of clinic patients who were not screened. A 26% return meant that only 21% were left unscreened. Over time, the population screened for CRC has increased, leaving those not screened as more difficult to recruit. An email intervention study for CRC screening with 218 eligible participants, found that over half (56%) refused to participate at the consent stage. Those who participated (N = 97) were randomized to different interventions and 23% in all groups returned a mailed FOBT, concluding that an emailed reminder is no more effective than a mailed reminder [10]. It may be possible that using a simpler test, the FIT, and not requiring an informed consent does increase the percent return. Thus, a 26% return may be respectable and certainly not costly as the mailer for the FIT and envelope was about $4/package. This intervention is one that physicians and clinics might implement if prevention becomes a primary goal. As an office intervention, mailing of the FIT kit for CRC screening would require health care providers to be trained to develop the FIT kit specimens, in a CLIA waived laboratory. Administrative staff would need to establish a tickler system or in the electronic health record set up a system where each month, 1/12 of the patients without routine office visits who need screening would be mailed a cover letter and FIT kit. For those patients with regular office visits, the FIT kit could be handed to them at their office visit. An algorithm would need to be developed for the electronic medical record, to omit patients who have been screened by any of the available methods. Inverness Medical has a patient reminder program, free of cost to their customers, that is an automated telephone reminder system that calls patients on the physician’s behalf to remind them to complete the FIT kit and return it to their office. The product website and interface to the program can be found at http://www.clearview-fobt.com/. An advantage of this program is that it is ongoing and not a one-time follow-up.
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Most insurance companies reimburse $23.22 per FIT kit test, with practices billing between $25 and $30 per test. Costs for collection and handling could be recouped from this intervention and a higher percent of patients could be up-to-date with CRC screening. Limitation of this study involved inaccuracies in the electronic medical record data which did not have information on patients’ CRC tests completed in other institutions. Only persons having screening tests at the institution were omitted, whereas persons screened at other institutions who may have already been up-to-date may have received the FIT kit. Seven individuals who had positive FIT results were not followed by the study team but only received a letter with the FIT, instructing them to discuss the results with their physician. We could not conclude if they proceeded to have a colonoscopy. The study did not obtain demographic information on subjects and only the age range for inclusion criteria is known. This minimal cue CRC screening intervention, a FIT kit sent in the mail without prerequisite of a signed informed consent, was successful in screening 26% of a clinic sample and thus raising the percent of overall clinic population screened. A mailed FIT kit or one handed to the patient at an office visit has minimal cost which can be recovered through insurance coverage. Commitment by health care providers is necessary for prevention. This method is one of several that could reach the hard to screen population. CRC screening trials need to be as least complicated as possible to be feasible for primary care office providers to implement.
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