ORIGINAL INVESTIGATION ONLINE FIRST Long-term Outcomes Following Positive Fecal Occult Blood Test Results in Older Adults Benefits and Burdens Christine E. Kistler, MD, MASc; Katharine A. Kirby, MS; Delia Lee, BS; Michele A. Casadei, BS; Louise C. Walter, MD Background: In the United States, older adults have low nificant adenomas and 6 cancers. Ten percent experi- rates of follow-up colonoscopy after a positive fecal oc- enced complications from colonoscopy or cancer treatment cult blood test (FOBT) result. The long-term outcomes (12 of 118). Forty-six percent of those without fol- of these real world practices and their associated ben- low-up colonoscopy died of other causes within 5 years efits and burdens are unknown. of FOBT (43 of 94), while 3 died of colorectal cancer within 5 years. Eighty-seven percent of patients with worst life Methods: Longitudinal cohort study of 212 patients 70 expectancy experienced a net burden from screening (26 years or older with a positive FOBT result at 4 Veteran Af- of 30) as did 70% with average life expectancy (92 of 131) fairs (VA) facilities in 2001 and followed up through 2008. and 65% with best life expectancy (35 of 51) (P=.048 We determined the frequency of downstream outcomes for trend). during the 7 years of follow-up, including procedures, colo- noscopic findings, outcomes of treatment, complica- Conclusions: Over a 7-year period, older adults with best tions, and mortality based on chart review and national life expectancy were less likely to experience a net bur- VA and Medicare data. Net burden or benefit from screen- den from current screening and follow-up practices than ing and follow-up was determined according to each pa- tient’s life expectancy. Life expectancy was classified into are those with worst life expectancy. The net burden could 3 categories: best (age, 70-79 years and Charlson-Deyo co- be decreased by better targeting FOBT screening and fol- morbidity index [CCI], 0), average, and worst (age, 70-84 low-up to healthy older adults. years and CCI, Ն4 or age, Ն85 years and CCI, Ն1). Arch Intern Med. 2011;171(15):1344-1351. Results: Fifty-six percent of patients received fol- Published online May 9, 2011. low-up colonoscopy (118 of 212), which found 34 sig- doi:10.1001/archinternmed.2011.206 N MANY REAL-WORLD SETTINGS, have caused symptoms years later must be fewer than 60% of patients re- weighed against immediate burdens of fol- ceive a colonoscopy within 1 year low-up procedures and treatments stem- of a positive FOBT result.1-4 A re- ming from a positive screening result.9 cent study found that many older Ipatients without follow-up are in poor See Editor’s Note health or decline follow-up, which sug- gests that they should not have been at end of article screened in the first place.5 In addition, Randomized trials of FOBT suggest that See also pages 1332 a person should have a life expectancy of Author Affiliations: and 1335 at least 5 years to derive survival benefit Department of Family from screening; otherwise they are only Medicine, University of rates of follow-up have shown minimal subject to the potential burdens.9,10 We are North Carolina at Chapel Hill improvement over the last decade.3,4,6,7 De- not aware of any studies of real-world prac- (Dr Kistler); Division of spite persistently low rates of follow-up tices that observe older patients for more Geriatrics, San Francisco colonoscopy in older adults with positive than 3 years after a positive FOBT result Veterans Affairs Medical Center, to determine whether patients lived long and University of California, FOBT results, the long-term outcomes of San Francisco (Mss Kirby and these real-world screening and follow-up enough to potentially benefit from detect- 3,4,8 Casadei and Dr Walter); and practices have not been described. ing large adenomas or early stage colorec- University of Arkansas School The benefit of finding asymptomatic tal cancer, or whether they only experi- of Medicine (Ms Lee). cancer or precancerous polyps that would enced burdens from follow-up procedures ARCH INTERN MED/ VOL 171 (NO. 15), AUG 8/22, 2011 WWW.ARCHINTERNMED.COM 1344 ©2011 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/27/2021 and treatments (eg, false-positive results, repeated test- patient and outpatient visits. These notes contain information ing, complications).3,4 Such information about the ben- about follow-up that occurs outside the VA per patient report efits and burdens experienced by older adults with posi- to their VA clinician.15 tive FOBT results would help to guide individualized screening and follow-up decisions in clinical practice. OUTCOMES OF SCREENING We describe 7-year outcomes following a positive FOBT result in older adults in real-world clinical practice. We took First, we categorized patients as having received follow-up colo- a novel approach of combining VA and Medicare claims noscopy related to their positive FOBT result or not. Patients and medical chart review to follow the downstream out- who did not receive colonoscopy over the 7 years or had a colo- comes after a positive FOBT result among patients 70 years noscopy for gastrointestinal (GI) tract bleeding or other symp- or older screened at 4 geographically diverse VA facilities. toms unrelated to their positive FOBT result were categorized with the “no follow-up colonoscopy” group. Patients with fol- Downstream outcomes included follow-up testing, polyp- low-up colonoscopy were categorized according to whether they ectomies, cancer diagnoses and treatments, procedural com- were diagnosed as having cancer, significant adenoma, or non- plications, and overall mortality. Net benefit or burden re- significant or normal findings. Significant adenoma was de- sulting from these screening and follow-up practices was fined as 1 or more large adenomas (Ն1 cm), 3 or more small determined according to each patient’s predicted life ex- adenomas (Ͻ1 cm), or any adenoma with villous pathologic pectancy.11 The goal was to inform how clinical practice characteristics based on standard GI guidelines.16 Nonsignifi- could improve to maximize the net benefit of FOBT screen- cant or normal findings included findings of diverticula, fewer Ͻ ing and follow-up in older adults. than 3 small adenomas ( 1 cm), angiodysplasia, hyperplastic polyps, and normal mucosa. Next, we determined downstream outcomes over 7 years METHODS in those with and without follow-up colonoscopy. Outcomes included cancer diagnoses, complications from treatment, fre- quency of follow-up testing, and 5-year mortality. Cancer di- DATA SOURCES AND PATIENTS agnoses included cancer stage and treatment. Complications included those documented in the medical chart as being re- We conducted a longitudinal cohort study of 212 adults aged lated to colonoscopy or cancer treatment (eg, pain and/or dis- 70 years or older who had a positive FOBT result during 2001 comfort, gastrointestinal bleeding, infection, death). Fre- at 4 VA facilities (Minneapolis, Minnesota; Durham, North Caro- quency of follow-up testing included the number of repeated lina; Portland, Oregon; and West Los Angeles, California) and FOBTs, sigmoidoscopies, barium enemas, and/or colonosco- observed them for 7 years to determine downstream out- pies patients received during the 7 years. Five-year mortality comes. We chose to focus on positive FOBT results as the FOBT was determined from the VA Vital Status File.17 is the most common colorectal cancer screening test within the 12 Next, 2 of us (C.E.K. and L.C.W.) reviewed each patient’s out- VA. To identify our cohort, we used outpatient claims from comes to determine whether they experienced net benefit or net the VA National Patient Care Database to identify all patients burden from screening and follow-up. Patients were consid- 70 years or older who had a FOBT between January 1, 2001, ered to have experienced net benefit if they had a significant ad- and December 31, 2001, at the 4 facilities and met our inclu- 5 enoma and/or colorectal cancer found on follow-up and lived at sion and exclusion criteria (n=2410). All patients had con- least 5 years, even if they had complications or repeated proce- tinuous enrollment in Medicare Parts A and B and fee-for- dures.18,19 Net benefit or burden was indeterminate for (1) pa- service coverage from January 1, 2000, through December 31, tients with 1 or 2 small adenomas who lived at least 5 years be- 2002. Patients were excluded if they had a history of colorec- cause some clinicians believe that this group potentially benefitted tal cancer or polyps, inflammatory bowel disease, colectomy, 20-22 5 from screening ; or (2) patients who had a colonoscopy out- or colostomy, or were not due for screening. We used claims side of the VA without an available pathology report and lived from 6 months before their FOBTs and medical chart review at least 5 years. All other patients, including those with normal to exclude patients with signs or symptoms that would justify findings on follow-up colonoscopy (ie, false-positive FOBT re- performance of FOBT for nonscreening purposes (eg, iron- sults), those without follow-up colonoscopy (ie, had a positive deficiency anemia, gastrointestinal bleeding, abdominal pain, 5 FOBT result that was not worked up), and those who died within change in bowel habits, unexplained weight loss). Two hun- 5 years of their FOBT (ie, subjected to tests for an asymptom- dred twelve of 2410 patients had positive FOBT results (9%), atic disease that would never have affected them), were defined which were extracted from the Veterans Health Information Sys- as experiencing net burden.