Association Between Bariatric Surgery and Macrovascular Disease Outcomes in Patients With Type 2 Diabetes and Severe Obesity.

Importance: Macrovascular disease is a leading cause of morbidity and mortality for patients with type 2 diabetes, and medical management, including lifestyle changes, may not be successful at lowering risk. Objective: To investigate the relationship between bariatric surgery and incident macrovascular (coronary artery disease and cerebrovascular diseases) events in patients with severe obesity and type 2 diabetes. Design, Setting, and Participants: In this retrospective, matched cohort study, patients with severe obesity (body mass index ≥35) aged 19 to 79 years with diabetes who underwent bariatric surgery from 2005 to 2011 in 4 integrated health systems in the United States (n = 5301) were matched to 14 934 control patients on site, age, sex, body mass index, hemoglobin A1c, insulin use, observed diabetes duration, and prior health care utilization, with follow-up through September 2015. Exposures: Bariatric procedures (76% Roux-en-Y gastric bypass, 17% sleeve gastrectomy, and 7% adjustable gastric banding) were compared with usual care for diabetes. Main Outcomes and Measures: Multivariable-adjusted Cox regression analysis investigated time to incident macrovascular disease (defined as first occurrence of coronary artery disease [acute myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting] or cerebrovascular events [ischemic stroke, hemorrhagic stroke, carotid stenting, or carotid endarterectomy]). Secondary outcomes included coronary artery disease and cerebrovascular outcomes separately. Results: Among a combined 20 235 surgical and nonsurgical patients, the mean (SD) age was 50 (10) years; 76% of the surgical and 75% of the nonsurgical patients were female; and the baseline mean (SD) body mass index was 44.7 (6.9) and 43.8 (6.7) in the surgical and nonsurgical groups, respectively. At the end of the study period, there were 106 macrovascular events in surgical patients (including 37 cerebrovascular and 78 coronary artery events over a median of 4.7 years; interquartile range, 3.2-6.2 years) and 596 events in the matched control patients (including 227 cerebrovascular and 398 coronary artery events over a median of 4.6 years; interquartile range, 3.1-6.1 years). Bariatric surgery was associated with a lower composite incidence of macrovascular events at 5 years (2.1% in the surgical group vs 4.3% in the nonsurgical group; hazard ratio, 0.60 [95% CI, 0.42-0.86]), as well as a lower incidence of coronary artery disease (1.6% in the surgical group vs 2.8% in the nonsurgical group; hazard ratio, 0.64 [95% CI, 0.42-0.99]). The incidence of cerebrovascular disease was not significantly different between groups at 5 years (0.7% in the surgical group vs 1.7% in the nonsurgical group; hazard ratio, 0.69 [95% CI, 0.38-1.25]). Conclusions and Relevance: In this observational study of patients with type 2 diabetes and severe obesity who underwent surgery, compared with those who did not undergo surgery, bariatric surgery was associated with a lower risk of macrovascular outcomes. The findings require confirmation in randomized clinical trials. Health care professionals should engage patients with severe obesity and type 2 diabetes in a shared decision making conversation about the potential role of bariatric surgery in the prevention of macrovascular events.

Microvascular Outcomes in Patients With Diabetes After Bariatric Surgery Versus Usual Care: A Matched Cohort Study.

Background: Bariatric surgery improves glycemic control in patients with type 2 diabetes mellitus (T2DM), but less is known about microvascular outcomes. Objective: To investigate the relationship between bariatric surgery and incident microvascular complications of T2DM. Design: Retrospective matched cohort study from 2005 to 2011 with follow-up through September 2015. Setting: 4 integrated health systems in the United States. Participants: Patients aged 19 to 79 years with T2DM who had bariatric surgery (n = 4024) were matched on age, sex, body mass index, hemoglobin A1c level, insulin use, diabetes duration, and intensity of health care use up to 3 nonsurgical participants (n = 11 059). Intervention: Bariatric procedures (76% gastric bypass, 17% sleeve gastrectomy, and 7% adjustable gastric banding) compared with usual care. Measurements: Adjusted Cox regression analysis investigated time to incident microvascular disease, defined as first occurrence of diabetic retinopathy, neuropathy, or nephropathy. Results: Median follow-up was 4.3 years for both surgical and nonsurgical patients. Bariatric surgery was associated with significantly lower risk for incident microvascular disease at 5 years (16.9% for surgical vs. 34.7% for nonsurgical patients; adjusted hazard ratio [HR], 0.41 [95% CI, 0.34 to 0.48]). Bariatric surgery was associated with lower cumulative incidence at 5 years of diabetic neuropathy (7.2% for surgical vs. 21.4% for nonsurgical patients; HR, 0.37 [CI, 0.30 to 0.47]), nephropathy (4.9% for surgical vs. 10.0% for nonsurgical patients; HR, 0.41 [CI, 0.29 to 0.58]), and retinopathy (7.2% for surgical vs. 11.2% for nonsurgical patients; HR, 0.55 [CI, 0.42 to 0.73]). Limitation: Electronic health record databases could misclassify microvascular disease status for some patients. Conclusion: In this large, multicenter study of adults with T2DM, bariatric surgery was associated with lower overall incidence of microvascular disease (including lower risk for neuropathy, nephropathy, and retinopathy) than usual care. Primary Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases.

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.

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.

A multisite study of long-term remission and relapse of type 2 diabetes mellitus following gastric bypass.

BACKGROUND: Gastric bypass has profound effects on glycemic control in adults with type 2 diabetes mellitus. The goal of this study was to examine the long-term rates and clinical predictors of diabetes remission and relapse among patients undergoing gastric bypass. METHODS: We conducted a retrospective cohort study of adults with uncontrolled or medication-controlled type 2 diabetes who underwent gastric bypass from 1995 to 2008 in three integrated health care delivery systems in the USA. Remission and relapse events were defined by diabetes medication use and clinical laboratory measures of glycemic control. We identified 4,434 adults with uncontrolled or medication-controlled type 2 diabetes who had gastric bypass. RESULTS: Overall, 68.2 % (95 % confidence interval [CI], 66 and 70 %) experienced an initial complete diabetes remission within 5 years after surgery. Among these, 35.1 % (95 % CI, 32 and 38 %) redeveloped diabetes within 5 years. The median duration of remission was 8.3 years. Significant predictors of complete remission and relapse were poor preoperative glycemic control, insulin use, and longer diabetes duration. Weight trajectories after surgery were significantly different for never remitters, relapsers, and durable remitters (p = 0.03). CONCLUSIONS: Gastric bypass surgery is associated with durable remission of type 2 diabetes in many but not all severely obese diabetic adults, and about one third experience a relapse within 5 years of initial remission. More research is needed to understand the mechanisms of diabetes relapse, the optimal timing of surgery in effecting a durable remission, and the relationship between remission duration and incident microvascular and macrovascular events.

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.

Reiki for the treatment of fibromyalgia: a randomized controlled trial.

OBJECTIVE: Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. DESIGN: This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. SETTING/LOCATION: The study setting was private medical offices in the Seattle, Washington metropolitan area. SUBJECTS: The subjects were comprised 100 adults with fibromyalgia. INTERVENTION: Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). OUTCOME MEASURES: The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. RESULTS: Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. CONCLUSION: Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.