Stakeholders\u27 views on data sharing in multicenter studies

AIM: To understand stakeholders\u27 views on data sharing in multicenter comparative effectiveness research studies and the value of privacy-protecting methods. MATERIALS and METHODS: Semistructured interviews with five US stakeholder groups. RESULTS: We completed 11 interviews, involving patients (n = 15), researchers (n = 10), Institutional Review Board and regulatory staff (n = 3), multicenter research governance experts (n = 2) and healthcare system leaders (n = 4). Perceptions of the benefits and value of research were the strongest influences toward data sharing; cost and security risks were primary influences against sharing. Privacy-protecting methods that share summary-level data were acknowledged as being appealing, but there were concerns about increased cost and potential loss of research validity. CONCLUSION: Stakeholders were open to data sharing in multicenter studies that offer value and minimize security risks

Examining the BMI-mortality relationship using fractional polynomials

<p>Abstract</p> <p>Background</p> <p>Many previous studies estimating the relationship between body mass index (BMI) and mortality impose assumptions regarding the functional form for BMI and result in conflicting findings. This study investigated a flexible data driven modelling approach to determine the nonlinear and asymmetric functional form for BMI used to examine the relationship between mortality and obesity. This approach was then compared against other commonly used regression models.</p> <p>Methods</p> <p>This study used data from the National Health Interview Survey, between 1997 and 2000. Respondents were linked to the National Death Index with mortality follow-up through 2005. We estimated 5-year all-cause mortality for adults over age 18 using the logistic regression model adjusting for BMI, age and smoking status. All analyses were stratified by sex. The multivariable fractional polynomials (MFP) procedure was employed to determine the best fitting functional form for BMI and evaluated against the model that includes linear and quadratic terms for BMI and the model that groups BMI into standard weight status categories using a deviance difference test. Estimated BMI-mortality curves across models were then compared graphically.</p> <p>Results</p> <p>The best fitting adjustment model contained the powers -1 and -2 for BMI. The relationship between 5-year mortality and BMI when estimated using the MFP approach exhibited a J-shaped pattern for women and a U-shaped pattern for men. A deviance difference test showed a statistically significant improvement in model fit compared to other BMI functions. We found important differences between the MFP model and other commonly used models with regard to the shape and nadir of the BMI-mortality curve and mortality estimates.</p> <p>Conclusions</p> <p>The MFP approach provides a robust alternative to categorization or conventional linear-quadratic models for BMI, which limit the number of curve shapes. The approach is potentially useful in estimating the relationship between the full spectrum of BMI values and other health outcomes, or costs.</p

Omega-3 Fatty Acids Modify Human Cortical Visual Processing—A Double-Blind, Crossover Study

While cardiovascular and mood benefits of dietary omega-3 fatty acids such as docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are manifest, direct neurophysiological evidence of their effects on cortical activity is still limited. Hence we chose to examine the effects of two proprietary fish oil products with different EPA∶DHA ratios (EPA-rich, high EPA∶DHA; DHA-rich) on mental processing speed and visual evoked brain activity. We proposed that nonlinear multifocal visual evoked potentials (mfVEP) would be sensitive to any alteration of the neural function induced by omega-3 fatty acid supplementation, because the higher order kernel responses directly measure the degree of recovery of the neural system as a function of time following stimulation. Twenty-two healthy participants aged 18–34, with no known neurological or psychiatric disorder and not currently taking any nutritional supplementation, were recruited. A double-blind, crossover design was utilized, including a 30-day washout period, between two 30-day supplementation periods of the EPA-rich and DHA-rich diets (with order of diet randomized). Psychophysical choice reaction times and multi-focal nonlinear visual evoked potential (VEP) testing were performed at baseline (No Diet), and after each supplementation period. Following the EPA-rich supplementation, for stimulation at high luminance contrast, a significant reduction in the amplitude of the first slice of the second order VEP kernel response, previously related to activation in the magnocellular pathway, was observed. The correlations between the amplitude changes of short latency second and first order components were significantly different for the two supplementations. Significantly faster choice reaction times were observed psychophysically (compared with baseline performance) under the EPA-rich (but not DHA-rich) supplementation, while simple reaction times were not affected. The reduced nonlinearities observed under the EPA-rich diet suggest a mechanism involving more efficient neural recovery of magnocellular-like visual responses following cortical activation

Clinical Outcomes of Metabolic Surgery: Microvascular and Macrovascular Complications

Understanding of the long-term clinical outcomes associated with bariatric surgery has recently been advanced. Research related to the sequelae of diabetes—in particular, long-term microvascular and macrovascular complications—in patients who undergo weight-loss surgery is imperative to this pursuit. While numerous randomized control trials have assessed glucose control with bariatric surgery compared with intensive medical therapy, bariatric surgery outcome data relating to microvascular and macrovascular complications have been limited to observational studies and nonrandomized clinical trials. As a result, whether bariatric surgery is associated with a long-term reduction in microvascular and macrovascular complications when compared with current intensive glycemic control therapy cannot be determined because the evidence is insufficient. However, the consistent salutary effects of bariatric surgery on diabetes remission and glycemic improvement support the opportunity (and need) to conduct high-quality studies of bariatric surgery versus intensive glucose control. This review provides relevant background information related to the treatment of diabetes, hyperglycemia, and long-term complications; reports clinical findings (to date) with bariatric surgery; and identifies ongoing research focusing on long-term vascular outcomes associated with bariatric surgery

Child obesity associated with social disadvantage of children's neighborhoods

Evidence suggests variability in adult obesity risk at a small-scale geographic area is associated with differences in neighborhood socioeconomic status (SES). However, the extent to which geographic variability in child obesity is associated with neighborhood SES is unknown. The objective of this paper was to estimate risk of child obesity associated with multiple census tract SES measures and race within a large urban U.S. county. Height, weight, age, sex, medical insurance type and census tract residence were obtained for 6-18 year old children (n = 8616) who received medical care at a health plan in King County, Washington, in 2006. Spatial analyses examined the individual risk of obesity (BMI >= 95th percentile) with 2000 US census tract measures of median household income, home ownership, adult female education level, single parent households, and race as predictors. Conditional autoregressive regression models that incorporated adjacent census tracts (spatial autocorrelation) were applied to each census tract variable, adjusting for individual variables. We found that in adjusted spatial models, child obesity risk was significantly associated with each census tract variable in the expected direction: lower household income, lower home ownership, and for each 10% increase in less educated women, and single parent households, as well as non-white residents. In a spatial model including all variables, the SES/race variables explained approximately 24% of geographic variability in child obesity. Results indicated that living in census tracts with social disadvantage defined by multiple different measures was associated with child obesity among insured children in a large U.S. urban county. These results contribute new information on relationships between broader social and economic context and child obesity risk using robust spatial analyses.USA Child obesity Neighborhood Socioeconomic status Spatial epidemiology Social inequality Children

The Feasibility of Reducing Sitting Time in Overweight and Obese Older Adults

Background. Overweight and obese older adults have high sedentary time. We tested the feasibility and preliminary effects of a sedentary time reduction intervention among adults over age 60 with a body mass index over 27 kg/m2 using a nonrandomized one-arm design. Methods. Participants (N = 25, mean age = 71.4, mean body mass index = 34) completed an 8-week theory-based intervention targeting reduced total sitting time and increased sit-to-stand transitions. An inclinometer (activPAL™) measured the primary outcomes, change in total sitting time and sit-to-stand transitions. Secondary outcomes included physical activity (ActiGraph GT3X+ accelerometer), self-reported sedentary behaviors, physical function (Short Physical Performance Battery), depressive symptoms (8-item Patient Health Questionnaire), quality of life (PROMIS), and study satisfaction. Paired t tests examined pre–post test changes in sitting time, sit-to-stand transitions, and secondary outcomes. Results. Inclinometer measured sitting time decreased by 27 min/day (p.05), while standing time increased by 25 min/day (

Factors associated with lack of effective contraception among obese women in the United States

ObjectiveTo identify factors associated with contraceptive nonuse and use of less effective methods among obese women in the US.Study designWe analyzed data from sexually active obese women (body mass index &gt;30 kg/m²) age 20-44 using the 2006-2010 National Survey of Family Growth. We conducted multinomial logistic regression to assess associations between current contraceptive use and demographic, reproductive and health services factors. Specifically, we compared contraceptive nonusers, behavioral method users (withdrawal and fertility awareness) and barrier method users (condoms) to prescription method users (pill, patch, ring, injection, implant and intrauterine device).ResultsOf 1345 obese respondents, 21.5% used no method, 10.3% behavioral methods, 20.8% barrier methods and 47.4% prescription methods. Only 42.4% of respondents overall and 20.4% of nonprescription method users reported discussing contraception with a provider in the past year. Similar to findings in the general population, behavioral method users were more likely to have previously discontinued a contraceptive method due to dissatisfaction [adjusted RR (aRR), 1.93; 95% confidence interval (CI), 1.09-3.44], and nonusers were more likely to perceive difficulty becoming pregnant (aRR, 3.86; 95% CI, 2.04-7.29), compared to prescription method users. Respondents using nonprescription methods were significantly less likely to have discussed contraception with a healthcare provider (nonusers: aRR, 0.16; 95% CI, 0.10-0.27; behavioral methods: aRR, 0.13; 95% CI, 0.06-0.25, barrier methods: aRR, 0.15; 95% CI, 0.09-0.25) than prescription method users.ConclusionsObese women who discuss contraception with a provider are more likely to use effective contraception and may be less likely to experience unintended pregnancy; however, over half report no recent discussion of contraception with a provider.ImplicationsEfforts are needed to increase contraceptive counseling for obese women, who face increased risks of morbidity from unintended pregnancy

Development and Pilot Testing of a Patient-Centered Web-Based Reproductive Decision Support Tool for Primary Care.

BackgroundPatient-centered counseling to help women achieve their reproductive goals is an essential yet often absent component of primary care.ObjectiveWe developed and piloted MyPath, a novel web-based decision support tool integrating reproductive goals assessment, information about optimizing health before pregnancy, and contraceptive decision support, for use prior to primary care visits in the Veterans Administration (VA).DesignWe created MyPath using best practices for decision tool development, including a conceptual framework informed by theory and user-centered design with input from patients, providers, and scientific experts. We conducted a non-randomized pilot in two VA Women's Health primary care clinics. A control group (n = 28) was recruited prior to and intervention group (n = 30) recruited after introduction of MyPath into clinics.ParticipantsWomen Veterans ages 18-44 with an upcoming visit scheduled with one of eight providers.InterventionsAfter recruitment of controls, providers and staff received a brief introduction to MyPath. Patients scheduled to see providers in the intervention phase used MyPath on an iPad in the waiting room prior to their visit.Main measuresAcceptability, feasibility, discussions about pregnancy and/or contraceptive needs, and contraceptive decision quality by a survey of participants and providers.Key resultsNearly all participants who used MyPath reported they learned new information (97%) and would recommend it to other Veterans (93%). No providers reported that MyPath significantly increased workload. A greater proportion of intervention participants reported having discussions about reproductive needs in their visit compared to controls (93% vs 68%; p = 0.02). Intervention participants also experienced greater increases in pre-/post-visit knowledge and communication self-efficacy and a trend towards greater reduction in contraceptive decision conflict compared to controls.ConclusionsMyPath was highly acceptable to women, increased the proportion of primary care visits addressing reproductive needs, and improved decision quality without increasing providers' perceived workload. A larger randomized evaluation of effectiveness is warranted