Reusing a prepaid health plan's fecal immunochemical tests for microbiome associations with colorectal adenoma.

An altered colonic microbiota probably increases colorectal adenoma (CRA) and cancer (CRC) risk, but large, unbiased fecal collections are needed to examine the relationship of gut microbiota diversity and composition to colorectal carcinogenesis. This study assessed whether fecal immunochemical tests (FITs) from CRA/CRC screening may fulfill this requirement. Using FIT, self-collected by members of Kaiser Permanente Hawaii (KPH), as well as interspersed quality control (QC) specimens, DNA was extracted and amplified to generate 16S rRNA microbiome profiles rarified at 10,000 reads. CRA/CRC were diagnosed by colonoscopy and histopathology. Covariates were from electronic KPH records. Of 921 participants' FIT devices, 538 (58%) yielded at least 10,000 rRNA reads and 1016 species-level variants mapped to 46 genera. Of the 538 evaluable participants, 63 (11.7%) were FIT-negative per protocol, and they were considered negative for CRA/CRC. Of the 475 FIT + participants, colonoscopy and pathologic review revealed that 8 (1.7%) had CRC, 71 (14.9%) had high-risk CRA, 107 (22.5%) had low-risk CRA, and 289 (60.8%) did not have CRA/CRC. Men were 2.27-fold [95% confidence interval (CI) 1.32-3.91] more likely than women to be FIT+ . Men also had 1.96-fold (CI 1.24-3.07) higher odds of low-risk CRA, with similar trends for high-risk CRA and CRC. CRA/CRC were not associated with overweight, obesity, diabetes, or antibiotic prescriptions in this study. QC analysis across 24 batches of FIT devices revealed QC outliers in four batches. With or without exclusion of the four QC-outlier batches, as well as lenient (1000-read) rarefaction, CRA/CRC had no consistent, statistically significant associations with fecal microbiome alpha diversity, beta diversity or genera relative abundance. CRA/CRC had expected associations with male sex but not with microbiome metrics. Fecal microbiome profiling using DNA extracted from at-home collected, re-used FIT devices is feasible, albeit with substantial challenges. Using FITs for prospective microbiome studies of CRA/CRC risk should consider the impact of the current findings on statistical power and requisite sample sizes.

Developing an algorithm across integrated healthcare systems to identify a history of cancer using electronic medical records.

OBJECTIVE: Tumor registries in integrated healthcare systems (IHCS) have high precision for identifying incident cancer but often miss recently diagnosed cancers or those diagnosed outside of the IHCS. We developed an algorithm using the electronic medical record (EMR) to identify people with a history of cancer not captured in the tumor registry to identify adults, aged 40-65 years, with no history of cancer. MATERIALS AND METHODS: The algorithm was developed at Kaiser Permanente Colorado, and then applied to 7 other IHCS. We included tumor registry data, diagnosis and procedure codes, chemotherapy files, oncology encounters, and revenue data to develop the algorithm. Each IHCS adapted the algorithm to their EMR data and calculated sensitivity and specificity to evaluate the algorithm's performance after iterative chart review. RESULTS: We included data from over 1.26 million eligible people across 8 IHCS; 55 601 (4.4%) were in a tumor registry, and 44848 (3.5%) had a reported cancer not captured in a registry. The common attributes of the final algorithm at each site were diagnosis and procedure codes. The sensitivity of the algorithm at each IHCS was 90.65%-100%, and the specificity was 87.91%-100%. DISCUSSION: Relying only on tumor registry data would miss nearly half of the identified cancers. Our algorithm was robust and required only minor modifications to adapt to other EMR systems. CONCLUSION: This algorithm can identify cancer cases regardless of when the diagnosis occurred and may be useful for a variety of research applications or quality improvement projects around cancer care.

Improving Adherence to Cardiovascular Therapies: An Economic Evaluation of a Randomized Pragmatic Trial.

OBJECTIVE: Preplanned economic analysis of a pragmatic trial using electronic-medical-record-linked interactive voice recognition (IVR) reminders for enhancing adherence to cardiovascular medications (i.e., statins, angiotensin-converting enzyme inhibitors [ACEIs], and angiotensin receptor blockers [ARBs]). METHODS: Three groups, usual care (UC), IVR, and IVR plus educational materials (IVR+), with 21,752 suboptimally adherent patients underwent follow-up for 9.6 months on average. Costs to implement and deliver the intervention (from a payer perspective) were tracked during the trial. Medical care costs and outcomes were ascertained using electronic medical records. RESULTS: Per-patient intervention costs ranged from $9 to $17 for IVR and from $36 to $47 for IVR+. For ACEI/ARB, the incremental cost-effectiveness ratio for each percent adherence increase was about 3 times higher with IVR+ than with IVR ($6 and $16 for IVR and IVR+, respectively). For statins, the incremental cost-effectiveness ratio for each percent adherence increase was about 7 times higher with IVR+ than with IVR ($6 and $43 for IVR and IVR+, respectively). Considering potential cost offsets from reduced cardiovascular events, the probability of breakeven was the highest for UC, but the IVR-based interventions had a higher probability of breakeven for subgroups with a baseline low-density lipoprotein (LDL) level of more than 100 mg/dl and those with two or more calls. CONCLUSIONS: We found that the use of an automated voice messaging system to promote adherence to ACEIs/ARBs and statins may be cost-effective, depending on a decision maker's willingness to pay for unit increase in adherence. When considering changes in LDL level and downstream medical care offsets, UC is the optimal strategy for the general population. However, IVR-based interventions may be the optimal choice for those with elevated LDL values at baseline.

Improving adherence to cardiovascular disease medications with information technology.

OBJECTIVES: Evaluate the utility of 2 electronic medical record (EMR)-linked, automated phone reminder interventions for improving adherence to cardiovascular disease medications. STUDY DESIGN: A 1-year, parallel arm, pragmatic clinical trial in which 21,752 adults were randomized to receive either usual care (UC) or 1 of 2 interventions in the form of interactive voice recognition calls-regular (IVR) or enhanced (IVR+). The interventions used automated phone reminders to increase adherence to cardiovascular disease medications. The primary outcome was medication adherence; blood pressure and lipid levels were secondary outcomes. METHODS: The study took place in 3 large health maintenance organizations. We enrolled participants who were 40 years or older, had diabetes mellitus or atherosclerotic cardiovascular disease, and were suboptimally adherent. IVR participants received automated phone calls when they were due or overdue for a refill. IVR+ participants received these phone calls, plus personalized reminder letters, live outreach calls, EMR-based feedback to their primary care providers, and additional mailed materials. RESULTS: Both interventions significantly increased adherence to statins and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEIs/ARBs) compared with UC (1.6 to 3.7 percentage points). Adherence to ACEIs/ARBs was also significantly higher for IVR+ relative to IVR participants. These differences persisted across subgroups. Among statin users, IVR+ participants had significantly lower low-density lipoprotein (LDL) levels at follow-up compared with UC (Δ = -1.5; 95% CI, -2.7 to -0.2 mg/dL); this effect was seen mainly in those with baseline LDL levels ≥ 100 mg/dL (Δ = -3.6; 95% CI, -5.9 to -1.3 mg/dL). CONCLUSIONS: Technology-based tools, in conjunction with an EMR, can improve adherence to chronic disease medications and measured cardiovascular disease risk factors.

The virtual hospital: treating acute infections in the home by telemedicine.

The growth and aging of the population of Hawaii mandates a need for more effective utilization of hospital beds. One approach is early hospital discharge and outpatient treatment. However, as the acuity of illness increases, satisfactory outcomes of outpatient treatment maybe difficult to achieve. We have utilized telemedicine to closely monitor acutely ill patients with infections, such as community-acquired pneumonia, skin and soft tissue infections, and urinary tract infection, in the home setting. Our treatment paradigm achieved satisfactory outcomes, cost savings, and at the same time resulted in more rapid convalescence than hospitalization.

Treating acute infections by telemedicine in the home.

Patients with community-acquired pneumonia, cellulitis, or urinary tract infection may be treated either in the hospital or as outpatients, depending on the severity of their disease, comorbidities, and Karnofsky performance status. To more efficiently use hospital beds, we discharge many moderately to severely ill patients with acute infections directly from the emergency department or early in the course of hospitalization. To insure satisfactory clinical outcomes, we use telemedicine in the home to monitor patients who would normally be hospitalized. Patients treated with telemedicine have satisfactory clinical outcomes, and their recovery appears to be more rapid than comparable hospitalized patients. Telemedicine in the home results in considerable savings by averting or shortening hospital stays.

Malignant melanoma in non-Caucasians: experience from Hawaii.

Data from the Hawaii Tumor Registry suggest that the incidence of melanoma in the non-Caucasian population of Hawaii is not substantially different from that of the remainder of the United States. Our experience indicates that melanoma in this population, although unusual, is not rare. Although lesions on the palms and soles are more common. as are subungal melanomas, primary tumors on other skin sites account for the majority of patients with cutaneous melanoma in the non-Caucasian population. The substantial difference in primary tumor thickness suggests the reported poorer outcomes for non-Caucasian patients with cutaneous melanoma may be explained, at least in part, by a delay in diagnosis. Given the evidence that preventive measures and educational efforts have dramatically impacted the diagnosis and outcome of melanoma patients, it is critical to recognize that similar efforts should be directed at the non-Caucasian population.

Timing of sentinel lymphadenectomy in cutaneous melanoma.

PURPOSE: The conduct of sentinel lymphadenectomy for cutaneous melanoma varies substantially among the medical disciplines. The authors sought to characterize the number of hot spots identified during preoperative lymphoscintigraphy for cutaneous melanoma and to determine its relation to the harvesting of sentinel lymph nodes. METHODS: Sixty-nine patients with cutaneous melanoma underwent lymphoscintigraphy with filtered Tc-99m sulfur colloid before sentinel lymphadenectomy. The lymphoscintigrams were reviewed and the number of hot spots visualized over time and the number of sentinel nodes harvested were determined. RESULTS: Lymphoscintigraphy identified 79 patients with 87 lymphatic basins at risk for metastatic disease. Lymphoscintigraphy was performed in a mean time of 30 minutes (range, 15 to 40 minutes). The mean number of hot spots increased from 0.2 to 2.0 hot spots 40 minutes after the initial static image, but the number of hot spots stabilized between 20 and 40 minutes. The same number of sentinel nodes as hot spots visualized were harvested in 58% of patients. Fewer sentinel nodes were identified at the time of surgery than were visualized by lymphoscintigrams in 39% of patients. CONCLUSIONS: More hot spots were identified up to 40 minutes after the initiation of lymphoscintigraphy. Sentinel lymphadenectomy can be performed as near to 40 minutes after the initiation of lymphoscintigraphy as is logistically reasonable. However, there may be substantial latitude in delayed performance of sentinel lymphadenectomy.