Jesse Chittams

A Two-Year Randomized Trial of Obesity Treatment in Primary Care Practice

BACKGROUND Calls for primary care providers (PCPs) to offer obese patients behavioral weight-loss counseling have not been accompanied by adequate guidance on how such care could be delivered. This randomized trial compared weight loss during a 2-year period in response to three lifestyle interventions, all delivered by PCPs in collaboration with auxiliary health professionals (lifestyle coaches) in their practices. METHODS We randomly assigned 390 obese adults in six primary care practices to one of three types of intervention: usual care, consisting of quarterly PCP visits that included education about weight management; brief lifestyle counseling, consisting of quarterly PCP visits combined with brief monthly sessions with lifestyle coaches who instructed participants about behavioral weight control; or enhanced brief lifestyle counseling, which provided the same care as described for the previous intervention but included meal replacements or weight-loss medication (orlistat or sibutramine), chosen by the participants in consultation with the PCPs, to potentially increase weight loss. RESULTS Of the 390 participants, 86% completed the 2-year trial, at which time, the mean (±SE) weight loss with usual care, brief lifestyle counseling, and enhanced brief lifestyle counseling was 1.7±0.7, 2.9±0.7, and 4.6±0.7 kg, respectively. Initial weight decreased at least 5% in 21.5%, 26.0%, and 34.9% of the participants in the three groups, respectively. Enhanced lifestyle counseling was superior to usual care on both these measures of success (P=0.003 and P=0.02, respectively), with no other significant differences among the groups. The benefits of enhanced lifestyle counseling remained even after participants given sibutramine were excluded from the analyses. There were no significant differences between the intervention groups in the occurrence of serious adverse events. CONCLUSIONS Enhanced weight-loss counseling helps about one third of obese patients achieve long-term, clinically meaningful weight loss. (Funded by the National Heart, Lung, and Blood Institute; POWER-UP ClinicalTrials.gov number, NCT00826774.).

Weight Lifting for Women at Risk for Breast Cancer–Related Lymphedema: A Randomized Trial

CONTEXT Clinical guidelines for breast cancer survivors without lymphedema advise against upper body exercise, preventing them from obtaining established health benefits of weight lifting. OBJECTIVE To evaluate lymphedema onset after a 1-year weight lifting intervention vs no exercise (control) among survivors at risk for breast cancer-related lymphedema (BCRL). DESIGN, SETTING, AND PARTICIPANTS A randomized controlled equivalence trial (Physical Activity and Lymphedema trial) in the Philadelphia metropolitan area of 154 breast cancer survivors 1 to 5 years postunilateral breast cancer, with at least 2 lymph nodes removed and without clinical signs of BCRL at study entry. Participants were recruited between October 1, 2005, and February 2007, with data collection ending in August 2008. INTERVENTION Weight lifting intervention included a gym membership and 13 weeks of supervised instruction, with the remaining 9 months unsupervised, vs no exercise. MAIN OUTCOME MEASURES Incident BCRL determined by increased arm swelling during 12 months (≥5% increase in interlimb difference). Clinician-defined BCRL onset was also evaluated. Equivalence margin was defined as doubling of lymphedema incidence. RESULTS A total of 134 participants completed follow-up measures at 1 year. The proportion of women who experienced incident BCRL onset was 11% (8 of 72) in the weight lifting intervention group and 17% (13 of 75) in the control group (cumulative incidence difference [CID], -6.0%; 95% confidence interval [CI], -17.2% to 5.2%; P for equivalence = .04). Among women with 5 or more lymph nodes removed, the proportion who experienced incident BCRL onset was 7% (3 of 45) in the weight lifting intervention group and 22% (11 of 49) in the control group (CID, -15.0%; 95% CI, -18.6% to -11.4%; P for equivalence = .003). Clinician-defined BCRL onset occurred in 1 woman in the weight lifting intervention group and 3 women in the control group (1.5% vs 4.4%, P for equivalence = .12). CONCLUSION In breast cancer survivors at risk for lymphedema, a program of slowly progressive weight lifting compared with no exercise did not result in increased incidence of lymphedema. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00194363.

CPAP, Weight Loss, or Both for Obstructive Sleep Apnea

BACKGROUND Obesity and obstructive sleep apnea tend to coexist and are associated with inflammation, insulin resistance, dyslipidemia, and high blood pressure, but their causal relation to these abnormalities is unclear. METHODS We randomly assigned 181 patients with obesity, moderate-to-severe obstructive sleep apnea, and serum levels of C-reactive protein (CRP) greater than 1.0 mg per liter to receive treatment with continuous positive airway pressure (CPAP), a weight-loss intervention, or CPAP plus a weight-loss intervention for 24 weeks. We assessed the incremental effect of the combined interventions over each one alone on the CRP level (the primary end point), insulin sensitivity, lipid levels, and blood pressure. RESULTS Among the 146 participants for whom there were follow-up data, those assigned to weight loss only and those assigned to the combined interventions had reductions in CRP levels, insulin resistance, and serum triglyceride levels. None of these changes were observed in the group receiving CPAP alone. Blood pressure was reduced in all three groups. No significant incremental effect on CRP levels was found for the combined interventions as compared with either weight loss or CPAP alone. Reductions in insulin resistance and serum triglyceride levels were greater in the combined-intervention group than in the group receiving CPAP only, but there were no significant differences in these values between the combined-intervention group and the weight-loss group. In per-protocol analyses, which included 90 participants who met prespecified criteria for adherence, the combined interventions resulted in a larger reduction in systolic blood pressure and mean arterial pressure than did either CPAP or weight loss alone. CONCLUSIONS In adults with obesity and obstructive sleep apnea, CPAP combined with a weight-loss intervention did not reduce CRP levels more than either intervention alone. In secondary analyses, weight loss provided an incremental reduction in insulin resistance and serum triglyceride levels when combined with CPAP. In addition, adherence to a regimen of weight loss and CPAP may result in incremental reductions in blood pressure as compared with either intervention alone. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT0371293 .).

Flaxseed and Cardiovascular Risk Factors: Results from a Double Blind, Randomized, Controlled Clinical Trial

Objective: Flaxseed is a rich source of alpha linolenic acid (ALA), fiber and lignans, making it a potentially attractive functional food for modulating cardiovascular risk. We studied the effects of flaxseed on markers of cardiovascular risk in hypercholesterolemic adults. Methods: Sixty-two men and post-menopausal women with pre-study low density lipoprotein cholesterol (LDL-C) between 130 and 200 mg/dl were randomized to 40g/day of ground flaxseed-containing baked products or matching wheat bran products for 10 weeks while following a low fat, low cholesterol diet. Fasting lipoproteins, measures of insulin resistance, inflammation, oxidative stress, and safety were assessed at 0, 5 and 10 weeks. Results: Flaxseed was well-tolerated, and increased serum levels of ALA (p < 0.001). Compared to wheat, flaxseed significantly reduced LDL-C at 5 weeks (−13%, p < 0.005), but not at 10 weeks (−7%, p = 0.07). Flaxseed reduced lipoprotein a (Lp[a]) by a net of 14% (p = 0.02), and reduced the homeostatic model assessment of insulin resistance (HOMA-IR) index by 23.7% (p = 0.03) compared to wheat at 10 weeks, but did not affect markers of inflammation (IL-6, Hs-CRP) or oxidative stress (ox LDL, urinary isoprostanes) at any time points. In men, flaxseed reduced HDL-C concentrations by a net of 16% (p = 0.03) and 9% (p = 0.05) at 5 and 10 weeks, respectively. Conclusions: Ground flaxseed has a modest but short lived LDL-C lowering effect, yet reduces Lp(a) and improves insulin sensitivity in hyperlipidemic adults. The HDL-C lowering effect of flaxseed in men warrants additional study.

Effects of Pioglitazone on Lipoproteins, Inflammatory Markers, and Adipokines in Nondiabetic Patients with Metabolic Syndrome

Objective—The purpose of this research was to evaluate the short-term effects of pioglitazone (PIO) on high-density lipoprotein cholesterol (HDL-C) and other metabolic parameters in nondiabetic patients with metabolic syndrome (MetSyn). Methods and Results—Sixty nondiabetic adults with low HDL-C and MetSyn were randomized to PIO or matching placebo for 12 weeks. PIO increased HDL-C by 15% and 14% at 6 and 12 weeks, respectively, compared with placebo (P<0.001). Changes in HDL-C were correlated to changes in adiponectin (r=0.34; P=0.01) but not to changes in insulin resistance. PIO did not affect serum triglycerides or low-density lipoprotein (LDL) cholesterol concentrations but reduced the number of small LDL particles by 18% (P<0.001). PIO reduced median C-reactive protein levels by 31% (P<0.001) and mean resistin levels by 10% (P=0.02) while increasing mean serum levels of adiponectin by 111% (P<0.001) compared with placebo. PIO did not affect weight and modestly decreased insulin resistance. Conclusions—In nondiabetic patients with low HDL-C and MetSyn, PIO significantly raised HDL-C and favorably affected lipoprotein particle size, markers of inflammation, and adipokines without changes in triglycerides, LDL-C, or weight. These results suggest that PIO has direct effects on HDL, which may contribute to its antiatherogenic effects.

Pharmacy refill adherence compared with CD4 count changes for monitoring HIV-infected adults on antiretroviral therapy

Background World Health Organization (WHO) guidelines for monitoring HIV-infected individuals taking combination antiretroviral therapy (cART) in resource-limited settings recommend using CD4+ T cell (CD4) count changes to monitor treatment effectiveness. In practice, however, falling CD4 counts are a consequence, rather than a cause, of virologic failure. Adherence lapses precede virologic failure and, unlike CD4 counts, data on adherence are immediately available to all clinics dispensing cART. However, the accuracy of adherence assessments for predicting future or detecting current virologic failure has not been determined. The goal of this study therefore was to determine the accuracy of adherence assessments for predicting and detecting virologic failure and to compare the accuracy of adherence-based monitoring approaches with approaches monitoring CD4 count changes. Methodology and Findings We conducted an observational cohort study among 1,982 of 4,984 (40%) HIV-infected adults initiating non-nucleoside reverse transcriptase inhibitor-based cART in the Aid for AIDS Disease Management Program, which serves nine countries in southern Africa. Pharmacy refill adherence was calculated as the number of months of cART claims submitted divided by the number of complete months between cART initiation and the last refill prior to the endpoint of interest, expressed as a percentage. The main outcome measure was virologic failure defined as a viral load > 1,000 copies/ml (1) at an initial assessment either 6 or 12 mo after cART initiation and (2) after a previous undetectable (i.e., < 400 copies/ml) viral load (breakthrough viremia). Adherence levels outperformed CD4 count changes when used to detect current virologic failure in the first year after cART initiation (area under the receiver operating characteristic [ROC] curves [AUC] were 0.79 and 0.68 [difference = 0.11; 95% CI 0.06 to 0.16; χ2 = 20.1] respectively at 6 mo, and 0.85 and 0.75 [difference = 0.10; 95% CI 0.05 to 0.14; χ2 = 20.2] respectively at 12 mo; p < 0.001 for both comparisons). When used to detect current breakthrough viremia, adherence and CD4 counts were equally accurate (AUCs of 0.68 versus 0.67, respectively [difference = 0.01; 95% CI −0.06 to 0.07]; χ2 = 0.1, p > 0.5). In addition, adherence levels assessed 3 mo prior to viral load assessments were as accurate for virologic failure occurring approximately 3 mo later as were CD4 count changes calculated from cART initiation to the actual time of the viral load assessments, indicating the potential utility of adherence assessments for predicting future, rather than simply detecting current, virologic failure. Moreover, combinations of CD4 count and adherence data appeared useful in identifying patients at very low risk of virologic failure. Conclusions Pharmacy refill adherence assessments were as accurate as CD4 counts for detecting current virologic failure in this cohort of patients on cART and have the potential to predict virologic failure before it occurs. Approaches to cART scale-up in resource-limited settings should include an adherence-based monitoring approach.

Clinical Outcomes Related to Protein Delivery in a Critically Ill Population A Multicenter, Multinational Observation Study

OBJECTIVE Optimal intake of energy and protein is associated with improved outcomes, although outcomes relative to protein intake are very limited. Our purpose was to evaluate the impact of prescribed protein delivery on mortality and time to discharge alive (TDA) using data from the International Nutrition Survey 2013. We hypothesized that greater protein delivery would be associated with lower mortality and shorter TDA. METHODS The sample included patients in the intensive care unit (ICU) ≥ 4 days (n = 2828) and a subsample in the ICU ≥ 12 days (n = 1584). Models were adjusted for evaluable nutrition days, age, body mass index, sex, admission type, acuity scores, and geographic region. Percentages of prescribed protein and energy intake were compared with mortality outcomes using logistic regression and with Cox proportional hazards for TDA. RESULTS Mean intake for the 4-day sample was protein 51 g (60.5% of prescribed) and 1100 kcal (64.1% of prescribed); for the 12-day sample, mean intake was protein 57 g (66.7% of prescribed) and 1200 kcal (70.7% of prescribed). Achieving ≥ 80% of prescribed protein intake was associated with reduced mortality (4-day sample: odds ratio [OR], 0.68; 95% confidence interval [CI], 0.50-0.91; 12-day sample: OR, 0.60; 95% CI, 0.39-0.93), but ≥ 80% of prescribed energy intake was not. TDA was shorter with ≥ 80% prescribed protein (hazard ratio [HR], 1.25; 95% CI, 1.04-1.49) in the 12-day sample but longer with ≥ 80% prescribed energy in the 4-day sample (HR, 0.82; 95% CI, 0.69-0.96). CONCLUSION Achieving at least 80% of prescribed protein intake may be important to survival and shorter TDA in ICU patients. Efforts to achieve prescribed protein intake should be maximized.

Relationship between Chest Port Catheter Tip Position and Port Malfunction after Interventional Radiologic Placement

PURPOSE The relationship between catheter tip position of implanted subcutaneous chest ports and subsequent port malfunction was investigated. Tip movement from initial supine position to subsequent erect position was also evaluated. MATERIALS AND METHODS Patients who underwent imaging-guided internal jugular chest port placement between July 2001 and May 2003 were identified with use of a quality-assurance database. Sixty-two patients were included in the study (22 men and 40 women), with a mean age of 58 years (range, 27-81 years). Catheter tip location on the intraprocedural chest radiograph was determined with use of two methods. First, the distance from the right tracheobronchial angle (TBA) was recorded (TBA distance). Second, tip location was classified into six anatomic regions: 1, internal jugular veins; 2, brachiocephalic veins; 3, superior vena cava (SVC; n = 11); 4, SVC/right atrial junction (n = 22); 5, upper half of right atrium (n = 25); and 6, lower half of right atrium (n = 4). For the duration of follow-up, catheter tip location was documented, as were all episodes of catheter malfunction. RESULTS Patients with catheter tips initially placed in position 3 had a higher risk of port malfunction (four of 11; 36%) than patients with catheter tips located in position 5 (two of 25; 8%). This difference narrowly fell short of statistical significance (P =.057). When comparing intraprocedural chest radiographs to the first erect chest radiographs, significant upward tip movement was noted. The tips migrated cephalad an average of 20 mm (P =.003) and 1.0 position units (P =.001). DISCUSSION Catheter tips placed in the SVC tended to have a greater risk of port malfunction compared with those positioned in the right atrium. Chest ports migrated cephalad between the supine and erect positions.

Predictors of dropout from psychosocial treatment of cocaine dependence.

The current study assessed demographic, drug and psychiatric predictors of dropout in the pilot/training phase of a large, multi-site psychotherapy outcome study for patients with cocaine dependence. The different predictors of dropout were assessed throughout the phases of the study: screening, intake, stabilization and assessment phase, and following randomization to treatment. Results showed that (1) younger patients were less likely to keep their intake appointment. (2) Of the patients who had an intake visit, those who did not complete high school and with more days of cocaine use in the previous month were less likely to complete an initial stabilization and assessment phase requiring 1 week of abstinence from all drugs. A survival analysis was used to examine time to dropout for the 286 patients randomized to individual treatment. (3) Again, younger age was associated with dropout after randomization. (4) Drug use variables did not predict time to dropout. (5) Presence of any current Axis I disorder was associated with later dropout from treatment. Minority treatment information seekers and treatment initiators were less likely to go on to complete the full treatment program.

Single-center Experience with the Arrow-Trerotola Percutaneous Thrombectomy Device in the Management of Thrombosed Native Dialysis Fistulas

PURPOSE The present study sought to evaluate the performance of the Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) in the treatment of native fistula thrombosis in a U. S. hemodialysis population. Specifically, the technical success, clinical success, complication rate and type, primary and secondary patency rates, effect of adjunctive thrombolytic therapy, and any variables that affected outcomes of procedures in which this device was used were analyzed. MATERIALS AND METHODS Forty-two patients with 44 thrombosed native fistulas (17 radiocephalic, 10 brachiocephalic, 10 transposed or superficialized, five graft/fistula hybrids, and two leg fistulas) were treated with 62 mechanical thrombolysis procedures with use of the PTD. All patients had large clot burden. The device type was recorded in 43 procedures: standard (n = 21), over-the-wire (OTW; n = 19), or both (n = 3). No device was used in two cases because of inability to cross the anastomosis. Adjunctive therapies (n = 18) included the use of tissue plasminogen activator (tPA; n = 16) and deployment of the AngioJet device with (n = 1) or without tPA (n = 1). Stents were inserted in four procedures. Outcome variables included technical and clinical success, complications, and primary and secondary patency. Cox proportional-hazards regression and Kaplan-Meier analyses were performed. RESULTS The technical success rate was 87% (54 of 62) and the clinical success rate was 79% (49 of 62). Percutaneous transluminal angioplasty was performed in all but two procedures. Complications occurred in 13% of procedures (n = 8); three resulted in technical failure. The primary patency rates were 38% at 6 months and 18% at 12 months; secondary patency rates were 74% and 69%, respectively. Outcomes were not affected by adjunctive techniques, fistula type, age of fistula, device type (ie, OTW vs standard), or patient sex. Secondary patency was superior when no residual clot or stenosis was present (P = .003). CONCLUSIONS The PTD is effective for percutaneous treatment of thrombosed hemodialysis fistulas, with good short- and long-term outcomes in a U.S. population. Within the limitations of a retrospective study with a small sample size, use of an adjunctive thrombolytic agent did not appear to improve results compared with the use of the device alone.