Randomized pilot trial of bariatric surgery versus intensive medical weight management on diabetes remission in type 2 diabetic patients who do NOT meet NIH criteria for surgery and the role of soluble RAGE as a novel biomarker of success.

OBJECTIVE: To compare bariatric surgery versus intensive medical weight management (MWM) in patients with type 2 diabetes mellitus (T2DM) who do not meet current National Institutes of Health criteria for bariatric surgery and to assess whether the soluble form of receptor for advanced glycation end products (sRAGE) is a biomarker to identify patients most likely to benefit from surgery. BACKGROUND: There are few studies comparing surgery to MWM for patients with T2DM and BMI less than 35. METHODS: Fifty-seven patients with T2DM and BMI 30 to 35, who otherwise met the criteria for bariatric surgery were randomized to MWM versus surgery (bypass, sleeve or band, based on patient preference). The primary outcomes assessed at 6 months were change in homeostatic model of insulin resistance (HOMA-IR) and diabetes remission. Secondary outcomes included changes in HbA1c, weight, and sRAGE. RESULTS: The surgery group had improved HOMA-IR (-4.6 vs +1.6; P = 0.0004) and higher diabetes remission (65% vs 0%, P < 0.0001) than the MWM group at 6 months. Compared to MWM, the surgery group had lower HbA1c (6.2 vs 7.8, P = 0.002), lower fasting glucose (99.5 vs 157; P = 0.0068), and fewer T2DM medication requirements (20% vs 88%; P < 0.0001) at 6 months. The surgery group lost more weight (7. vs 1.0 BMI decrease, P < 0.0001). Higher baseline sRAGE was associated with better weight loss outcomes (r = -0.641; P = 0.046). There were no mortalities. CONCLUSIONS: Surgery was very effective short-term in patients with T2DM and BMI 30 to 35. Baseline sRAGE may predict patients most likely to benefit from surgery. These findings need to be confirmed with larger studies.ClinicalTrials.gov ID: NCT01423877.

Medicaid managed care: how to target efforts to reduce costs.

BACKGROUND: To be successful, cost control efforts must target Medicaid Managed Care (MMC) beneficiaries likely to incur high costs. The critical question is how to identify potential high cost beneficiaries with simple, reproducible, transparent, auditable criteria. Our objective in this analysis was to evaluate whether the total burden of comorbidity, assessed by the Charlson comorbidity index, could identify MMC beneficiaries who incurred high health care costs. METHODS: The MetroPlus MMC claims database was use to analyze six months of claims data from 07/07-12/07; the analysis focused on the total amount paid. Age, gender, Charlson comorbidity score, serious mental illness and pregnancy were analyzed as predictors of total costs. RESULTS: We evaluated the cost profile of 4,614 beneficiaries enrolled at MetroPlus, an MMC plan. As hypothesized, the comorbidity index was a key correlate of total costs (p < .01). Yearly costs were more related to the total burden of comorbidity than any specific comorbid disease. For adults, in addition to comorbidity (p < .01) both serious mental illness (p < .01) and pregnancy (p < .01) were also related to total costs, while age, drug addiction and gender were not. The model with age, gender, comorbidity, serious mental illness, pregnancy and addiction explained 20% of the variance in total costs. In children, comorbidity (p < .01), serious mental illness (p < .01), addiction (p < .03) and pregnancy (p < .01) were associated with log cost; the model with those variables explained 6% of the variance in costs. CONCLUSIONS: Comorbidity can be used to identify MMC beneficiaries most likely to have high costs.

Telephone outreach to increase colon cancer screening in medicaid managed care organizations: a randomized controlled trial.

PURPOSE: Health Plans are uniquely positioned to deliver outreach to members. We explored whether telephone outreach, delivered by Medicaid managed care organization (MMCO) staff, could increase colorectal cancer (CRC) screening among publicly insured urban women, potentially reducing disparities. METHODS: We conducted an 18-month randomized clinical trial in 3 MMCOs in New York City in 2008-2010, randomizing 2,240 MMCO-insured women, aged 50 to 63 years, who received care at a participating practice and were overdue for CRC screening. MMCO outreach staff provided cancer screening telephone support, educating patients and helping overcome barriers. The primary outcome was the number of women screened for CRC during the 18-month intervention, assessed using claims. RESULTS: MMCO staff reached 60% of women in the intervention arm by telephone. Although significantly more women in the intervention (36.7%) than in the usual care (30.6%) arm received CRC screening (odds ratio [OR] = 1.32; 95% CI, 1.08-1.62), increases varied from 1.1% to 13.7% across the participating MMCOs, and the overall increase was driven by increases at 1 MMCO. In an as-treated comparison, 41.8% of women in the intervention arm who were reached by telephone received CRC screening compared with 26.8% of women in the usual care arm who were not contacted during the study (OR = 1.84; 95% CI, 1.38, 2.44); 7 women needed to be reached by telephone for 1 to become screened. CONCLUSIONS: The telephone outreach intervention delivered by MMCO staff increased CRC screening by 6% more than usual care among randomized women, and by 15.1% more than usual care among previously overdue women reached by the intervention. Our research-based intervention was successfully translated to the health plan arena, with variable effects in the participating MMCOs.

The relation of stroke admissions to recent weather, airborne allergens, air pollution, seasons, upper respiratory infections, and asthma incidence, September 11, 2001, and day of the week.

BACKGROUND AND PURPOSE: Some previous research links stroke incidence to weather, some links strokes to air pollution, and some report seasonal effects. Alveolar inflammation was proposed as the mechanistic link. We present a unified model of time, weather, pollution, and upper respiratory infection (URI) incidence. METHODS: We combined existing databases: US Environmental Protection Agency pollution levels, National Weather Service data, counts of airborne allergens, and New York City Health and Hospitals Corporation counts of stroke, asthma, and URI patients. We used autoregressive integrated moving average modeling (a statistical time series modeling technique) with stroke admissions as the response variable and day of week, holidays, September 11th, and other counts and levels as explanatory variables. RESULTS: Using a broad definition of stroke, there were 5.1+/-2.3 stroke admissions per day: narrowly defined, 4.2+/-2.1 strokes per day. There are relatively fewer strokes on Sundays (0.50 strokes; P=0.0011), Saturdays (0.62; P<0.0001), Fridays (0.38; P=0.0009) and holidays (0.875; P=0.0016). We found relatively small, independent exacerbating effects of higher air temperature (P=0.0211), dry air (P=0.0187), URIs, (P<0.0001), grass pollen (P=0.0341), sulfur dioxide (SO2; P=0.0471), and suspended particles <10 microm in size (P=0.0404). These effects are modest: < or =0.6, 0.6, 2.4, 1, 0.9, and 0.7 strokes per day, respectively. We did not find statistically significant exacerbating effects of other variables. CONCLUSIONS: We found statistically significant, independent exacerbating effects of warmer, drier air, URIs, grass pollen, SO2, and particulate air pollution. The model supports the theory that links pulmonary inflammation to stroke.

Three-year follow-up comparing metabolic surgery versus medical weight management in patients with type 2 diabetes and BMI 30-35. The role of sRAGE biomarker as predictor of satisfactory outcomes.

BACKGROUND: Patients with type 2 diabetes (T2D) and body mass index (BMI)<35 may benefit from metabolic surgery. The soluble form of the receptor for advanced glycation end products (sRAGE) may identify patients at greater chance for T2D remission. OBJECTIVES: To study long-term outcomes of patients with T2D and BMI 30-35 treated with metabolic surgery or medical weight management (MWM) and search for predictors of T2D remission. SETTING: University METHODS: Retrospective review of the original cohort, including patients who crossed over from MWM to surgery. Repeated-measures linear models were used to model weight loss (%WL), change in glycated hemoglobin (HbA1C) and association with baseline sRAGE. RESULTS: Fifty-seven patients with T2D and BMI 30-35 were originally randomly assigned to metabolic surgery versus MWM. Mean BMI and HbA1C was 32.6% and 7.8%, respectively. A total of 30 patients underwent surgery (19 sleeves, 8 bypasses, 3 bands). Three-year follow-up in the surgery group and MWM group was 75% and 86%, respectively. Surgery resulted in higher T2D remission (63% versus 0%; P<.001) and lower HbA1C (6.9% versus 8.4%; P<.001) for up to 3 years. There was no difference in %WL in those with versus those without T2D remission (21.7% versus 20.6%, P = .771), suggesting that additional mechanisms other than %WL play an important role for the studied outcome. Higher baseline sRAGE was associated with greater change in HbA1C and greater %WL after surgery (P< .001). CONCLUSION: Metabolic surgery was effective in promoting remission of T2D in 63% of patients with BMI 30-35; higher baseline sRAGE predicted T2D remission with surgery. Larger-scale randomly assigned trials are needed in this patient population.

Ponseti casting: a new soft option.

We have modified the Ponseti casting technique by using a below-knee Softcast instead of an above-knee plaster of Paris cast. Treatment was initiated as soon as possible after birth and the Pirani score was recorded at each visit. Following the manipulation techniques of Ponseti, a below-knee Softcast was applied directly over a stockinette for a snug fit and particular attention was paid to creating a deep groove above the heel to prevent slippage. If necessary, a percutaneous Achilles tenotomy was performed and casting continued until the child was fitted with Denis Browne abduction boots. Between April 2003 and May 2007 we treated 51 consecutive babies with 80 idiopathic club feet with a mean age at presentation of 4.5 weeks (4 days to 62 weeks). The initial mean Pirani score was 5.5 (3 to 6). It took a mean of 8.5 weeks (4 to 53) of weekly manipulation and casting to reach the stage of percutaneous Achilles tenotomy. A total of 20 feet (25%) did not require a tenotomy and for the 60 that did, the mean Pirani score at time of operation was 2.5 (0.5 to 3). Denis Browne boots were applied at a mean of 10 weeks (4 to 56) after presentation. The mean time from tenotomy to boots was 3.3 weeks (2 to 10). We experienced one case of cast-slippage during a period of non-attendance, which prolonged the casting process. One case of prolonged casting required repeated tenotomy, and three feet required repeated tenotomy and casting after relapsing while in Denis Browne boots. We believe the use of a below-knee Softcast in conjunction with Ponseti manipulation techniques shows promising initial results which are comparable to those using above-knee plaster of Paris casts.