Sharon Fuller

Uptake and positive predictive value of fecal occult blood tests: A randomized controlled trial

OBJECTIVE The aim of this study is to compare the uptake of three mailed high-sensitivity fecal occult blood tests (FOBTs). METHODS We conducted a parallel 3-arm randomized controlled trial in an integrated healthcare delivery system in Washington State. From January 2010 through February 2011, automated data were used to identify potentially eligible patients aged 50-74 due for colorectal cancer screening. Participants were mailed one of three FOBT kits (1-sample OC-Auto® fecal immunochemical test [FIT], 2-sample InSure® FIT, or 3-sample guaiac Hemoccult SENSA®), instructions, and a postage-paid return envelope. We performed a modified intent-to-treat analysis with return of any FOBT within 6 months of randomization as the primary outcome. RESULTS Of the 9922 people invited, 2873 returned surveys, 2263 were randomized, and 2234 were analyzed. FOBTs were returned by 1431 participants. At 6 months post-randomization, the proportions screened by any FOBT were 0.69 (95% confidence interval [CI] 0.66-0.72) for the OC-Auto arm, 0.64 (95% CI: 0.61-0.68) for the InSure arm, and 0.61 (95% CI: 0.58-0.65) for the Hemoccult SENSA arm (P<0.001 for any difference). Pairwise comparisons showed significant differences between the OC-Auto group and each of the other groups after correction for multiple comparisons. CONCLUSION Uptake of mailed FOBT kits varies by kit type.

Self-reported menopausal symptoms in a racially diverse population and soy food consumption.

OBJECTIVES Evaluate the association of self-reported vasomotor symptom (VMS) frequency with race/ethnicity among a diverse midlife US population and explore menopause symptom differences by dietary soy isoflavone (genistein+daidzein) consumption. STUDY DESIGN Cross-sectional population-based study of peri- and postmenopausal women, ages 45-58. OUTCOMES Recent VMS frequency, VMS ever; recent symptom bother (hot flashes, night sweats, headache and joint-ache). RESULTS Of 18,500 potentially eligible women, 9325 returned questionnaires (50.4% response); 3691 were excluded (premenopausal, missing data, taking hormones). Of 5634 remaining women, 82.1% reported hot flashes ever, 73.1% reported night sweats ever; 48.8% and 38.6% reported recent hot flashes or night sweats, respectively. Compared with White women, Chinese, Japanese, Vietnamese, other Asian (each p<0.001) and Filipino (p<0.01) women less commonly reported ever having hot flashes; Asian women less commonly reported recent VMS bother (p<0.001). Black women more commonly reported hot flashes ever (p<0.05) and recent VMS bother (p<0.05). Compared with non-Hispanic White women, Hispanic women were less likely to report hot flashes (p<0.05) or night sweats (p<0.001) ever. Women were classified by isoflavone consumption: (1) none (n=1819), (2) 0.01-4.30 mg/day (n=1931), (3) 4.31-24.99 mg/day (n=1347) and (4) ≥ 25 mg/day (n=537). There were no group differences in recent VMS number/day: (1) 7.0 (95% CI 6.5, 7.5); (2) 6.4 (95% CI 6.0, 7.1); (3) 7.0 (95% CI 6.3, 8.2); and (4) 6.8 (95% CI 6.1, 7.7). CONCLUSIONS Menopausal symptoms, independent of isoflavone intake, varied considerably by race/ethnicity and were least common among Asian races.

Results of nurse navigator follow-up after positive colorectal cancer screening test: A randomized trial

Background: Follow-up after a positive colorectal cancer screening test is necessary for screening to be effective. We hypothesized that nurse navigation would increase the completion of colonoscopy after a positive screening test. Methods: This study was conducted between 2008 and 2012 at 21 primary care medical centers in western Washington State. Participants in the Systems of Support to Increase Colorectal Cancer Screening study who had a positive fecal occult blood test (FOBT) or flexible sigmoidoscopy needing follow-up were randomized to usual care (UC) or a nurse navigator (navigation). UC included an electronic health record–based positive FOBT registry and physician reminder system. Navigation included UC plus care coordination and patient self-management support from a registered nurse who tracked and assisted patients until they completed or refused colonoscopy. The primary outcome was completion of colonoscopy within 6 months. After 6 months, both groups received navigation. Results: We randomized 147 participants with a positive FOBT or sigmoidoscopy. Completion of colonoscopy was higher in the intervention group at 6 months, but differences were not statistically significant (91.0% in navigation group vs 80.8% in UC group; adjusted difference, 10.1%; P = .10). Reasons for no or late colonoscopies included refusal, failure to schedule or missed appointments, concerns about risks or costs, and competing health concerns. Conclusions: Navigation did not lead to a statistically significant incremental benefit at 6 months. Impact: Follow-up rates after a positive colorectal cancer (CRC) screening test are high in a health care system where UC included a registry and physician reminders. Because of high follow-up rates in a health care system where UC included a registry and physician reminders, and small sample size, we cannot rule out incremental benefits of nurse navigation.

Psychological Distress after a Positive Fecal Occult Blood Test Result among Members of an Integrated Healthcare Delivery System

Background: Colorectal cancer screening (CRCS) reduces morbidity and mortality; however, the positive benefits might be partially offset by long-term distress following positive screening results. We examined relationships among colorectal cancer–specific worry and situational anxiety after positive fecal occult blood tests [FOBT (+)] compared with receipt of negative results. Methods: Of note, 2,260 eligible members of Group Health, an integrated healthcare delivery system, completed baseline surveys and received FOBT screening kits, with 1,467 members returning the kits. We matched FOBT (+) patients (n = 55) 1:2 on age and sex with FOBT (−) respondents (n = 110). Both groups completed follow-up surveys at 7 to 14 days and 4 months after screening. We assessed situational anxiety (State-Trait Anxiety Inventory, STAI), colorectal cancer worry frequency, and mood disturbance. Results: Mean age was 59 years, and majority were women (62%) and White (89%). After adjusting for age, sex, and baseline worry, at 7 to 14 days after screening, the FOBT (+) group was 3.82 [95% confidence interval (CI), 1.09–13.43] times more likely to report colorectal cancer–related mood disturbances and significantly higher mean STAI scores than the FOBT (−) group (mean = 38.8 vs. 30.9; P = 0.007). At 4-month posttest, mood disturbances and situational anxiety seemed to drop to baseline levels for FOBT (+). No colon cancer worry frequency was observed. Conclusions: FOBT (+) results are associated with short-term situational anxiety and colorectal cancer–specific mood disturbances. Impact: Distress from FOBT (+) results declined to near-baseline levels by 4 months. Additional studies are needed to clarify the relationship between long-term distress and follow-up colonoscopy. Cancer Epidemiol Biomarkers Prev; 23(1); 154–9. ©2013 AACR.

Nonparticipation in a Population-Based Trial to Increase Colorectal Cancer Screening

BACKGROUND Many trials have tested different strategies to increase colorectal cancer (CRC) screening. Few describe whether participants are representative of the population from which they are recruited. PURPOSE To determine risk factors related to nonparticipation among patients enrolled in an integrated health plan and not up to date for CRC testing, in a trial to increase screening rates. METHODS Between July 2008 and October 2009, a total of 15,000 adults aged 50-74 years from 21 clinics in Washington State who were due for CRC screening were contacted. Nonparticipants were defined as English-speaking patients who did not engage in the call or refused participation while still potentially eligible. Log-binomial regression models were used to estimate the relative risk of nonparticipation. Analyses were completed between October 2010 and June 2011. RESULTS Patients who were nonwhite, had less education, used tobacco, had less continuity of care, and had lower rates of preventive care and cancer screening were more likely to be nonparticipants. Patients reporting never having received any type of CRC testing or screening were also more likely not to participate (62% of nonparticipants vs 46% of participants; adjusted RR=1.58, 95% CI=1.47, 1.70). Reasons for refusal included costs, risks of procedures, and not wanting their medical records reviewed. CONCLUSIONS Patients eligible for but not participating in the trial were more likely to be from minority socioeconomic and racial groups and had behaviors that can negatively affect cancer outcomes. Additional efforts are needed to recruit patients who need CRC screening the most. TRIAL REGISTRATION This trial is registered at clinicaltrials.gov NCT 00697047.

A cross-sectional study of equol producer status and self-reported vasomotor symptoms.

ObjectiveThis study aims to evaluate the associations of vasomotor symptom (VMS) frequency, bother, and severity with equol producer status and dietary daidzein intake. MethodsThis is an observational study. This study included women aged 45 to 55 years, in postmenopause or in the menopausal transition, who had soy food intake of three or more servings per week. Exclusion criteria included severe concurrent disease, pregnancy or planned pregnancy, and current use of oral or transdermal hormones or selective estrogen receptor modulators. After screening, 375 participants completed a 3-day VMS diary and a 24-hour urine collection. Women with a urine daidzein or genistein concentration of 100 ng/mL or higher were included. We evaluated the association of VMS—dichotomized as lower than or equal to versus higher than the mean number of VMS per day (<2.33, ≥2.33)—with quartiles of daidzein intake. ResultsOverall, 129 (35%) of 365 women were equol producers. The mean (SD) urinary equol excretion was 0.67 (1.57) mg/day (50th percentile, 0 mg/d; 95th percentile, 4.12 mg/d). Among equol producers, the mean (SD) urinary equol excretion was 1.91 (2.15) mg/day (50th percentile, 1.09 mg/d; 95th percentile, 6.27 mg/d). Among equol producers, compared with those in the lowest quartile of dietary daidzein intake (mean, 4.9 mg/d), those in the highest quartile (mean, 28.5 mg/d) were 76% less likely to have VMS higher than the mean number of VMS (odds ratio, 0.24; 95% CI, 0.07-0.83; trend test across all daidzein levels, P = 0.06). Among equol nonproducers, there were no associations between daidzein intake and VMS frequency. There were no differences in VMS bother or severity among equol producers or nonproducers by dietary daidzein level. ConclusionsAmong equol producers, higher equol availability attributable to higher soy consumption contributes to decreased VMS.

Premenopausal vasomotor symptoms in an ethnically diverse population.

ObjectiveThe prevalence of vasomotor symptoms (VMS) among women aged 45 years or older who report regular menses has not been described well. Variability by race/ethnicity is expected. MethodsA cross-sectional analysis of Group Health enrollees was performed among women ages 45-56 y with regular and no skipped menses, and not taking hormones. Data were collected from electronic databases and mailed surveys, including a soy food questionnaire. Associations between race/ethnicity and VMS (ever/never; past 2 wk) were assessed using generalized linear models, controlling for age and body mass index. The prevalence of headache and joint pain, and VMS associations within race by soy intake were explored. ResultsA total of 1,513 premenopausal women with a mean age of 48.5 years responded to the survey; 75% were white. Native American women were most likely to report ever having VMS (66.7%), followed by black (61.4%), white (58.3%), Hawaiian/Pacific Islander (45.5%), mixed-ethnicity (42.1%), Vietnamese (40.0%), Filipino (38.9%, P < 0.05), Japanese (35.9%, P < 0.01), East Indian (31.3%, P < 0.05), Chinese (29.0%, P < 0.001), and other Asian (25.6%, P < 0.001) women, as compared with white women. Hispanic women were less likely to have VMS (41.7%) than non-Hispanic white women (58.8%, P < 0.001). Among white women, but not among other women, soy intake was associated with VMS (P = 0.03). ConclusionsAmong a diverse population of premenopausal women, VMS prevalence is high at 55%. Asian (vs white) and Hispanic (vs non-Hispanic white) women are less likely to report ever having VMS, a pattern similar to that observed during the menopausal transition and early postmenopause in our studies. White women with more VMS seem to include more soy in their diet.

A population-based, shared decision-making approach to recruit for a randomized trial of bariatric surgery versus lifestyle for type 2 diabetes

BACKGROUND Randomized trials of bariatric surgery versus lifestyle treatment likely enroll highly motivated patients, which may limit the interpretation and generalizability of study findings. The objective of this study was to assess the feasibility of a population-based shared decision-making (SDM) approach to recruitment for a trial comparing laparoscopic Roux-en-Y gastric bypass surgery with intensive lifestyle intervention among adults with mild to moderate obesity and type 2 diabetes. METHODS Adult members with a body mass index (BMI) between 30 and 45 kg/m(2) taking diabetes medications were identified in electronic databases and underwent a multiphase screening process. Candidates were given a telephone survey, education about treatment options for obesity and diabetes using decision aids, and an SDM phone call with a nurse practitioner, in addition to standard office-based consent. RESULTS We identified 1808 members, and 828 (45.7%) had a BMI of 30-34.9 kg/m(2). Among these, 1063 (59%) agreed to the telephone survey, 416 (23%) expressed interest in education about treatment options, and 277 (15%) completed the SDM process. The preferred treatment options were surgery (21 [8%]), diet and exercise (149 [53.8%]), pharmacotherapy (5 [2%]), none of the above (8 [3%]), and unsure (94 [34%]). Ultimately, 43 participants were randomly assigned to the trial. Significant differences, mainly related to sex, disease severity, and hypoglycemic medication use, were observed among people who did and did not agree to participate in our trial. CONCLUSION This population-based, SDM-based recruitment strategy successfully identified, enrolled, and randomly assigned patients who had balanced views of surgery and lifestyle management. Even with this approach, selection biases may remain, highlighting the need for careful characterization of nonparticipants in all future studies.

How the Provenance of Electronic Health Record Data Matters for Research: A Case Example Using System Mapping

Introduction: The use of electronic health records (EHRs) for research is proceeding rapidly, driven by computational power, analytical techniques, and policy. However, EHR-based research is limited by the complexity of EHR data and a lack of understanding about data provenance, meaning the context under which the data were collected. This paper presents system flow mapping as a method to help researchers more fully understand the provenance of their EHR data as it relates to local workflow. We provide two specific examples of how this method can improve data identification, documentation, and processing. Background: EHRs store clinical and administrative data, often in unstructured fields. Each clinical system has a unique and dynamic workflow, as well as an EHR customized for local use. The EHR customization may be influenced by a broader context such as documentation required for billing. Methods: We present a case study with two examples of using system flow mapping to characterize EHR data for a local colorectal cancer screening process. Findings: System flow mapping demonstrated that information entered into the EHR during clinical practice required interpretation and transformation before it could be accurately applied to research. We illustrate how system flow mapping shaped our knowledge of the quality and completeness of data in two examples: (1) determining colonoscopy indication as recorded in the EHR, and (2) discovering a specific EHR form that captured family history. Discussion: Researchers who do not consider data provenance risk compiling data that are systematically incomplete or incorrect. For example, researchers who are not familiar with the clinical workflow under which data were entered might miss or misunderstand patient information or procedure and diagnostic codes. Conclusions: Data provenance is a fundamental characteristic of research data from EHRs. Given the diversity of EHR platforms and system workflows, researchers need tools for evaluating and reporting data availability, quality, and transformations. Our case study illustrates how system mapping can inform researchers about the provenance of their data as it pertains to local workflows.

Impact of Continued Mailed Fecal Tests in the Patient-Centered Medical Home: Year 3 of the Systems of Support to Increase Colon Cancer Screening and Follow-Up Randomized Trial

The current study was conducted to determine the effect of continuing a centralized fecal occult blood test (FOBT) mailed program on screening adherence.