Is the Human Touch Always Therapeutic? Patient Stimulation and Spreading Depolarization after Acute Neurological Injuries.

Touch and other types of patient stimulation are necessary in critical care and generally presumed to be beneficial. Recent pre-clinical studies as well as randomized trials assessing early mobilization have challenged the safety of such routine practices in patients with acute neurological injury such as stroke. We sought to determine whether patient stimulation could result in spreading depolarization (SD), a dramatic pathophysiological event that likely contributes to metabolic stress and ischemic expansion in such patients. Patients undergoing surgical intervention for severe acute neurological injuries (stroke, aneurysm rupture, or trauma) were prospectively consented and enrolled in an observational study monitoring SD with implanted subdural electrodes. Subjects also underwent simultaneous video recordings (from continuous EEG monitoring) to assess for physical touch and other forms of patient stimulation (such as suctioning and positioning). The association of patient stimulation with subsequent SD was assessed. Increased frequency of patient stimulation was associated with increased risk of SD (OR = 4.39 [95%CI = 1.71-11.24]). The overall risk of SD was also increased in the 60 min following patient stimulation compared to times with no stimulation (OR = 1.19 [95%CI = 1.13-1.26]), though not all subjects demonstrated this effect individually. Positioning of the subject was the subtype of stimulation with the strongest overall effect on SD (OR = 4.92 [95%CI = 3.74-6.47]). We conclude that in patients with some acute neurological injuries, touch and other patient stimulation can induce SD (PS-SD), potentially increasing the risk of metabolic and ischemic stress. PS-SD may represent an underlying mechanism for observed increased risk of early mobilization in such patients.

Spreading Depolarization as a Therapeutic Target in Severe Ischemic Stroke: Physiological and Pharmacological Strategies.

BACKGROUND: Spreading depolarization (SD) occurs nearly ubiquitously in malignant hemispheric stroke (MHS) and is strongly implicated in edema progression and lesion expansion. Due to this high burden of SD after infarct, it is of great interest whether SD in MHS patients can be mitigated by physiologic or pharmacologic means and whether this intervention improves clinical outcomes. Here we describe the association between physiological variables and risk of SD in MHS patients who had undergone decompressive craniectomy and present an initial case of using ketamine to target SD in MHS. METHODS: We recorded SD using subdural electrodes and time-linked with continuous physiological recordings in five subjects. We assessed physiologic variables in time bins preceding SD compared to those with no SD. RESULTS: Using multivariable logistic regression, we found that increased ETCO2 (OR 0.772, 95% CI 0.655-0.910) and DBP (OR 0.958, 95% CI 0.941-0.991) were protective against SD, while elevated temperature (OR 2.048, 95% CI 1.442-2.909) and WBC (OR 1.113, 95% CI 1.081-1.922) were associated with increased risk of SD. In a subject with recurrent SD, ketamine at a dose of 2 mg/kg/h was found to completely inhibit SD. CONCLUSION: Fluctuations in physiological variables can be associated with risk of SD after MHS. Ketamine was also found to completely inhibit SD in one subject. These data suggest that use of physiological optimization strategies and/or pharmacologic therapy could inhibit SD in MHS patients, and thereby limit edema and infarct progression. Clinical trials using individualized approaches to target this novel mechanism are warranted.

Cerebral Autoregulation Correlation With Outcomes and Spreading Depolarization in Aneurysmal Subarachnoid Hemorrhage.

BACKGROUND: Delayed cerebral ischemia remains one of the principal therapeutic targets after aneurysmal subarachnoid hemorrhage. While large vessel vasospasm may contribute to ischemia, increasing evidence suggests that physiological impairment through disrupted impaired cerebral autoregulation (CA) and spreading depolarizations (SDs) also contribute to delayed cerebral ischemia and poor neurological outcome. This study seeks to explore the intermeasure correlation of different measures of CA, as well as correlation with SD and neurological outcome. METHODS: Simultaneous measurement of 7 continuous indices of CA was calculated in 19 subjects entered in a prospective study of SD in aneurysmal subarachnoid hemorrhage undergoing surgical aneurysm clipping. Intermeasure agreement was assessed, and the association of each index with modified Rankin Scale score at 90 days and occurrence of SD was assessed. RESULTS: There were 4102 hours of total monitoring time across the 19 subjects. In time-resolved assessment, no CA measures demonstrated significant correlation; however, most demonstrate significant correlation averaged over 1 hour. Pressure reactivity (PRx), oxygen reactivity, and oxygen saturation reactivity were significantly correlated with modified Rankin Scale score at 90 days. PRx and oxygen reactivity also were correlated with the occurrence of SD events. Across multiple CA measure reactivity indices, a threshold between 0.3 and 0.5 was most associated with intervals containing SD. CONCLUSIONS: Different continuous CA indices do not correlate well with each other on a highly time-resolved basis, so should not be viewed as interchangeable. PRx and oxygen reactivity are the most reliable indices in identifying risk of worse outcome in patients with aneurysmal subarachnoid hemorrhage undergoing surgical treatment. SD occurrence is correlated with impaired CA across multiple CA measurement techniques and may represent the pathological mechanism of delayed cerebral ischemia in patients with impaired CA. Optimization of CA in patients with aneurysmal subarachnoid hemorrhage may lead to decreased incidence of SD and improved neurological outcomes. Future studies are needed to evaluate these hypotheses and approaches.

Spreading Depolarization After Chronic Subdural Hematoma Evacuation: Associated Clinical Risk Factors and Influence on Clinical Outcome.

BACKGROUND: Chronic subdural hematoma (cSDH) is a common neurosurgical condition responsible for excess morbidity, particularly in the geriatric population. Recovery after evacuation is complicated by fluctuating neurological deficits in a high proportion of patients. We previously demonstrated that spreading depolarizations (SDs) may be responsible for some of these events. In this study, we aim to determine candidate risk factors for probable SD and assess the influence of probable SD on outcome. METHODS: We used two cohorts who underwent surgery for cSDH. The first cohort (n = 40) had electrocorticographic monitoring to detect SD. In the second cohort (n = 345), we retrospectively identified subjects with suspected SD based on the presence of transient neurological symptoms not explained by structural etiology or ictal activity on electroencephalography. We extracted standard demographic and outcome variables for comparisons and modeling. RESULTS: Of 345 subjects, 80 (23%) were identified in the retrospective cohort as having probable SD. Potential risk factors included history of hypertension, worse clinical presentation on the Glasgow Coma Scale, and lower Hounsfield unit density and volume of the preoperative subdural hematoma. Probable SD was associated with multiple worse-outcome measures, including length of stay and clinical outcomes, but not increased mortality. On a multivariable analysis, probable SD was independently associated with worse outcome, determined by the Glasgow Outcome Scale score at the first clinic follow-up (odds ratio 1.793, 95% confidence interval 1.022-3.146) and longer hospital length of stay (odds ratio 7.952, 95% confidence interval 4.062-15.563). CONCLUSIONS: Unexplained neurological deficits after surgery for cSDH occur in nearly a quarter of patients and may be explained by SD. We identified several potential candidate risk factors. Patients with probable SD have worse outcomes, independent of other baseline risk factors. Further data with gold standard monitoring are needed to evaluate for possible predictors of SD to target therapies to a high-risk population.

Incidence and outcomes of intracerebral haemorrhage with mechanical compression hydrocephalus.

INTRODUCTION: Intracerebral haemorrhage (ICH) within deep structures adjacent to the third ventricle is associated with worse outcomes when compared with lobar ICH due to the critical role of deep nuclei in normal neurological functioning. New evidence suggests another contributing factor to poor outcome is obstruction of cerebrospinal fluid outflow by clot burden causing mechanical compression of the third ventricle. The authors reviewed the incidence and outcomes of mechanical compression ICH in order to identify this high-risk group which may potentially benefit from minimally invasive evacuation. METHODS: Patients with spontaneous, non-traumatic, supratentorial ICH were identified retrospectively over a 30-month period. CT imaging was reviewed to assess location of the ICH, volume of the ICH, presence of hydrocephalus requiring external ventricular drain (EVD) placement, and time to clearing of the third ventricle. Hydrocephalus was then categorised as due to 'primarily intraventricular haemorrhage (IVH)', 'primarily mechanical compression' or 'mixed'. Functional outcomes at discharge were assessed using the modified Rankin Score (mRS). RESULTS: 287 patients met inclusion criteria, of which 39 (13.5%) patients developed hydrocephalus that required EVD. EVD patients had significantly higher mRS at discharge (p≤0.001) when compared with the non-EVD group. Lobar location was associated with lower odds of poor outcome compared with thalamic location (OR 0.107-0.560). Mechanical compression hydrocephalus was associated with poor outcome when compared with the primary IVH hydrocephalus subgroup (p=0.037) as well as longer time to clearing of the third ventricle (p=0.006). CONCLUSIONS: Mechanical obstruction requiring EVD occurs in approximately (21/287) 7.3% of all patients with spontaneous supratentorial ICH. It is unknown if the worse morbidity in these subjects is purely related to damage to deep structures surrounding the third ventricle or if secondary damage from hydrocephalus could be mitigated with targeted minimally invasive clot evacuation.

Enhancing Collaborative Learning for Quality Improvement: Evidence from the Improving Clinical Flow Project, a Breakthrough Series Collaborative with Project ECHO.

BACKGROUND: This project engaged teams from Federally Qualified Health Centers (FQHCs) in a quality improvement (QI) collaborative to improve clinical flow (increase quality and efficiency of operations), using a novel combination of Breakthrough Series Collaborative tools with Project ECHO's telementoring model. This mixed methods study describes the collaborative and evaluates its success in generating improvement and developing QI capacity at participating FQHCs. METHODS: The 18-month collaborative used three in-person/virtual learning session workshops and weekly telementoring sessions with brief lectures and case-based learning. Participants engaged in QI work (for example, PDSAs [Plan-Do-Study-Act]) and tracked data for 10 care system measures to evaluate progress. These data were averaged across consistently reporting sites for standard run chart analysis. Semistructured interviews assessed the effectiveness and value of the approach for participants. RESULTS: Fifteen sites across the United States participated for one year (Cohort 1); 10 sites continued to 18 months (Cohort 2). Cohort 2 evidenced improvement for 6 measures: Patient/Family Experience, Patient Time Valued, Empanelment, Cycle Time, Colorectal Cancer Screening Rate, and Third Next Available Appointment. Progress varied across sites and measures. Participant interviews indicated value from both in-person and virtual activities, increased QI knowledge, and professional growth, as well as challenges when participants lacked time, engagement, leadership support, and consistent and committed staff. CONCLUSION: This novel collaborative structure is promising. Evidence indicates progress in building QI capacity and improving processes and patient experience across participating FQHCs. Future iterations should address barriers to improvement identified here. Additional work is needed to compare the efficacy of this approach to other collaborative modes.

Association of Sleep Apnea with Mortality in Patients with Advanced Kidney Disease.

BACKGROUND AND OBJECTIVES: In the general population, sleep disorders are associated with mortality. However, such evidence in patients with CKD and ESKD is limited and shows conflicting results. Our aim was to examine the association of sleep apnea with mortality among patients with CKD and ESKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this prospective cohort study, 180 patients (88 with CKD stage 4 or 5, 92 with ESKD) underwent in-home polysomnography, and sleep apnea measures such as apnea hypopnea index (AHI) and nocturnal hypoxemia were obtained. Mortality data were obtained from the National Death Index. Cox proportional hazard models were used for survival analysis. RESULTS: Among the 180 patients (mean age 54 years, 37% women, 39% with diabetes, 49% CKD with mean eGFR 18±7 ml/min per 1.73 m2), 71% had sleep apnea (AHI>5) and 23% had severe sleep apnea (AHI>30). Median AHI was 13 (range, 4-29) and was not significantly different in patients with advanced CKD or ESKD. Over a median follow-up of 9 years, there were 84 (47%) deaths. AHI was not significantly associated with mortality after adjusting for age, sex, race, diabetes, body mass index, CKD/ESKD status, and kidney transplant status (AHI>30: hazard ratio [HR], 1.5; 95% confidence interval [95% CI], 0.6 to 4.0; AHI >15 to 30: HR, 2.3; 95% CI, 0.9 to 5.9; AHI >5 to 15: HR, 2.1; 95% CI, 0.8 to 5.4, compared with AHI≤5). Higher proportion of sleep time with oxygen saturation <90% and lower mean oxygen saturation were significantly associated with higher mortality in adjusted analysis (HR, 1.4; 95% CI, 1.1 to 1.7; P=0.007 for every 15% higher proportion, and HR, 1.6; 95% CI, 1.2 to 2.1; P=0.003 for every 2% lower saturation, respectively). Sleep duration, sleep efficiency, or periodic limb movement index were not associated with mortality. CONCLUSIONS: Hypoxemia-based measures of sleep apnea are significantly associated with increased risk of death among advanced CKD and ESKD.

A Novel Intervention for High-Need, High-Cost Medicaid Patients: a Study of ECHO Care.

BACKGROUND: A small number of high-need patients account for a disproportionate amount of Medicaid spending, yet typically engage little in outpatient care and have poor outcomes. OBJECTIVE: To address this issue, we developed ECHO (Extension for Community Health Outcomes) Care™, a complex care intervention in which outpatient intensivist teams (OITs) provided care to high-need high-cost (HNHC) Medicaid patients. Teams were supported using the ECHO model™, a continuing medical education approach that connects specialists with primary care providers for case-based mentoring to treat complex diseases. DESIGN: Using an interrupted time series analysis of Medicaid claims data, we measured healthcare utilization and expenditures before and after ECHO Care. PARTICIPANTS: ECHO Care served 770 patients in New Mexico between September 2013 and June 2016. Nearly all had a chronic mental illness, and over three-quarters had a chronic substance use disorder. INTERVENTION: ECHO Care patients received care from an OIT, which typically included a nurse practitioner or physician assistant, a registered nurse, a licensed mental health provider, and at least one community health worker. Teams focused on addressing patients' physical, behavioral, and social issues. MAIN MEASURES: We assessed the effect of ECHO Care on Medicaid costs and utilization (inpatient admissions, emergency department (ED) visits, other outpatient visits, and dispensed prescriptions. KEY RESULTS: ECHO Care was associated with significant changes in patients' use of the healthcare system. At 12 months post-enrollment, the odds of a patient having an inpatient admission and an ED visit were each reduced by approximately 50%, while outpatient visits and prescriptions increased by 23% and 8%, respectively. We found no significant change in overall Medicaid costs associated with ECHO Care. CONCLUSIONS: ECHO Care shifts healthcare utilization from inpatient to outpatient settings, which suggests decreased patient suffering and greater access to care, including more effective prevention and early intervention for chronic conditions.

Combining rhetoric and role-play to introduce and develop patient presentation skills in third year pharmacy students.

BACKGROUND AND PURPOSE: To implement a mock rounds activity designed to introduce and develop patient presentation skills in pharmacy students. EDUCATIONAL ACTIVITY AND SETTING: The sample population included third-year pharmacy students enrolled at the University of New Mexico (UNM) and Virginia Commonwealth University (VCU) during Fall 2011, 2012, and 2013. A mock rounds activity was developed and implemented in the Pharmaceutical Care Lab setting. Students were assigned an infectious disease case and asked to create an assessment and plan to present orally to an acting preceptor in a small group laboratory setting. Summative assessment of student performance was evaluated using a standardized rubric. FINDINGS: A total of 621 students (VCU: 371; UNM: 250) from both universities participated in the mock rounds activity. Data was collected using the rubric. Students scored highest in the areas of respectfulness (94.8% exceeds expectations) and completion time (86.9% exceeds expectations). The lowest ratings were in the areas of logical flow and organization (73.7% exceeds expectations) and ability to answer preceptors' questions (73.3% exceeds expectations). DISCUSSION AND SUMMARY: A simulated mock rounds activity enabled students to practice patient case presentation skills and receive summative feedback prior to Advanced Pharmacy Practice Experiences.

Vascular Access Site for Renal Replacement Therapy in Acute Kidney Injury: A Post hoc Analysis of the ATN Study.

BACKGROUND: Acute kidney injury requiring renal replacement therapy (RRT) in the intensive care unit portends a poor prognosis. The decisions regarding dialysis catheter placement is based mainly on physician discretion with little evidence to support the choice of dialysis catheter location. METHODS: The Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study was a multicenter, prospective, randomized trial of intensive vs. less intensive RRT in critically ill patients with AKI. We assessed the association of dialysis catheter location with dialysis catheter-related outcomes including catheter-related complications, mortality, dialysis dependence, and dialysis dose delivered. RESULTS: Of the 1,124 patients enrolled in the ATN study, catheter data were available in 1,016 (90.39%) patients. A total of 91 (8.96%) subclavian, 387 (38.09%) internal jugular, and 538 (52.95%) femoral dialysis catheters were inserted. The femoral group was younger (58.39 ± 16.27), had greater bleeding tendency [lower platelet count (96.00 ± 109.35) with higher INR (2.01 ± 2.19)], and had a higher baseline sequential organ failure assessment score on admission (14.59 ± 3.61) compared to the other two groups. Dialysis catheter-related complications were low in this study with no significant difference in the rates of complications among all catheter locations. Mortality and dialysis dependence was lowest in the subclavian group, while the dose of dialysis delivered (Kt/V) remained lowest in the femoral group, after propensity score and center adjustments. CONCLUSION: Patient characteristics influence the choice of dialysis catheter location with a tendency to place femoral catheters in younger, sicker, and more coagulopathic patients. There were no statistically significant differences in complication rates among the three catheter locations, although femoral catheters may be associated with a lower delivered dose of dialysis during intermittent hemodialysis. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.gov, identifier NCT00076219.

Mortality Among Patients Hospitalized With Heart Failure and Diabetes Mellitus: Results From the National Inpatient Sample 2000 to 2010.

BACKGROUND: Case fatality and hospitalization rates for US patients with heart failure (HF) have steadily decreased during the past several decades. Diabetes mellitus (DM), a risk factor for, and frequent coexisting condition with, HF continues to increase in the general population. METHODS AND RESULTS: We used the National Inpatient Sample to estimate overall as well as age-, sex-, and race/ethnicity-specific trends in HF hospitalizations, DM prevalence, and in-hospital mortality among 2.5 million discharge records from 2000 to 2010 with HF as primary discharge diagnosis. Multivariable logistic and Poisson regression were used to assess the impact of the above demographic characteristics on in-hospital mortality. Age-standardized hospitalizations decreased significantly in HF overall and in HF with DM. Age-standardized in-hospital mortality with HF declined from 2000 to 2010 (4.57% to 3.09%, Ptrend<0.0001), whereas DM prevalence in HF increased (38.9% to 41.9%, Ptrend<0.0001) as did comorbidity burden. Age-standardized in-hospital mortality in HF with DM also decreased significantly (3.53% to 2.27%, Ptrend<0.0001). After adjusting for year, age, and comorbid burden, males remained at 17% increased risk versus females, non-Hispanics remained at 12% increased risk versus Hispanics, and whites had a 30% higher mortality versus non-white minorities. Absolute mortality rates were lower in younger versus older patients, although the rate of decline was attenuated in younger patients. CONCLUSIONS: In-hospital mortality in HF patients with DM significantly decreased during the past decade, despite increases in DM prevalence and comorbid conditions. Mortality rate decreases among younger patients were significantly attenuated, and mortality disparities remain among important demographic subgroups.

Sexual Function and Pessary Management among Women Using a Pessary for Pelvic Floor Disorders.

INTRODUCTION: Pessaries are commonly used to treat pelvic floor disorders, but little is known about the sexual function of pessary users. AIM: We aimed to describe sexual function among pessary users and pessary management with regard to sexual activity. METHODS: This is a secondary analysis of a randomized trial of new pessary users, where study patients completed validated questionnaires on sexual function and body image at pessary fitting and 3 months later. MAIN OUTCOME MEASURES: Women completed the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire, International Urogynecological Association Revised (PISQ-IR), a validated measure that evaluates the impact of pelvic floor disorders on sexual function, a modified female body image scale (mBIS), and questions regarding pessary management surrounding sexual activity. RESULTS: Of 127 women, 54% (68/127) were sexually active at baseline and 42% (64/114) were sexually active at 3 months. Sexual function scores were not different between baseline and 3 months on all domains except for a drop of 0.15 points (P = 0.04) for sexually active women, and a drop of 0.34 points for non-sexually active women (P = 0.02) in the score related to the sexual partner. Total mBIS score did not change (P = 0.07), but scores improved by 0.2 points (P = 0.03) in the question related to self-consciousness. Pessary satisfaction was associated with improved sexual function scores in multiple domains and improved mBIS scores. The majority (45/64, 70%) of sexually active women removed their pessary for sex, with over half stating their partner preferred removal for sex (24/45, 53%). CONCLUSION: Many women remove their pessary during sex for partner considerations, and increased partner concerns are the only change seen in sexual function in the first 3 months of pessary use. Pessary use may improve self-consciousness and pessary satisfaction is associated with improvements in sexual function and body image.

In-hospital mortality among patients with type 2 diabetes mellitus and acute myocardial infarction: results from the national inpatient sample, 2000-2010.

BACKGROUND: Case-fatality rates in acute myocardial infarction (AMI) have significantly decreased; however, the prevalence of diabetes mellitus (DM), a risk factor for AMI, has increased. The purposes of the present study were to assess the prevalence and clinical impact of DM among patients hospitalized with AMI and to estimate the impact of important clinical characteristics associated with in-hospital mortality in patients with AMI and DM. METHODS AND RESULTS: We used the National Inpatient Sample to estimate trends in DM prevalence and in-hospital mortality among 1.5 million patients with AMI from 2000 to 2010, using survey data-analysis methods. Clinical characteristics associated with in-hospital mortality were identified using multivariable logistic regression. There was a significant increase in DM prevalence among AMI patients (year 2000, 22.2%; year 2010, 29.6%, Ptrend<0.0001). AMI patients with DM tended to be older and female and to have more cardiovascular risk factors. However, age-standardized mortality decreased significantly from 2000 (8.48%) to 2010 (4.95%) (Ptrend<0.0001). DM remained independently associated with mortality (adjusted odds ratio 1.069, 95% CI 1.051 to 1.087; P<0.0001). The adverse impact of DM on in-hospital mortality was unchanged over time. Decreased death risk over time was greatest among women and elderly patients. Among younger patients of both sexes, there was a leveling off of this decrease in more recent years. CONCLUSIONS: Despite increasing DM prevalence and disease burden among AMI patients, in-hospital mortality declined significantly from 2000 to 2010. The adverse impact of DM on mortality remained unchanged overall over time but was age and sex dependent.

The effectiveness of screening and brief intervention on reducing driving while intoxicated citations.

The purpose of this study was to use retrospective data, including citations for driving while intoxicated (DWI), to assess the long-term effectiveness of a program consisting of Screening and Brief Intervention (SBI) for at-risk alcohol users and its impact on traffic safety. A second objective was to study ethnic differences in response to SBI. During the time period of 1998-1999, LCF Research, together with the Lovelace Health System, participated in the Cutting Back SBI study for at-risk drinkers. A total of 426 subjects exhibiting at-risk drinking behaviors from the New Mexico cohort were examined for the study, including 211 subjects who received a brief counseling intervention and 215 in the no intervention control group. This study examined DWI citations for all 426 subjects during the 5 years following the Cutting Back study. The brief interventions were shown to have had a significant impact on reducing DWI citations for at-risk drinkers, with the added benefit lasting for the 5-year duration of the study. The SBI was found to be most effective at reducing DWI citations for Hispanic at-risk drinkers. Evidence is presented to show that screening to identify at-risk drinkers followed by a brief intervention has a statistically significant lasting impact on improving traffic safety.

Comparative effectiveness of patient education methods for type 2 diabetes: a randomized controlled trial.

BACKGROUND: Group education for patients with suboptimally controlled diabetes has not been rigorously studied. METHODS: A total of 623 adults from Minnesota and New Mexico with type 2 diabetes and glycosylated hemoglobin (HbA(1c)) concentrations of 7% or higher were randomized to (1) group education (using the US Diabetes Conversation Map program), (2) individual education, or (3) usual care (UC; ie, no assigned education). Both education methods covered content as needed to meet national standards for diabetes self-management education and were delivered through accredited programs from 2008 to 2009. General linear mixed-model methods assessed patient-level changes between treatment groups in mean HbA(1c) levels from baseline to follow-up at 6.8 months. Secondary outcomes included mean change in general health status (Medical Outcomes Study 12-Item Short Form Health Survey [SF-12]), Problem Areas in Diabetes (PAID), Diabetes Self-Efficacy (DES-SF), Recommended Food Score (RFS), and Physical Activity (PA, min/wk). RESULTS: Mean HbA(1c) concentration decreased in all groups but significantly more with individual (-0.51%) than group education (-0.27%) (P = .01) and UC (-0.24%) (P = .01). The proportion of subjects with follow-up HbA(1c) concentration lower than 7% was greater for individual education (21.2%) than for group (13.9%) and UC (12.8%) (P = .03). Compared with UC, individual education (but not group) improved SF-12 physical component score (+1.88) (P = .04), PA (+42.95 min/wk) (P = .03), and RFS (+0.63) (P = .05). Compared with group education, individual education reduced PAID (-3.62) (P = .02) and increased self-efficacy (+0.1) (P = .04). CONCLUSIONS: Individual education for patients with established suboptimally controlled diabetes resulted in better glucose control outcomes than did group education using Conversation Maps. There was also a trend toward better psychosocial and behavioral outcomes with individual education. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00652509.

A comparative analysis of recruitment methods used in a randomized trial of diabetes education interventions.

Recruitment methods heavily impact budget and outcomes in clinical trials. We conducted a post-hoc examination of the efficiency and cost of three different recruitment methods used in Journey for Control of Diabetes: the IDEA Study, a randomized controlled trial evaluating outcomes of group and individual diabetes education in New Mexico and Minnesota. Electronic databases were used to identify health plan members with diabetes and then one of the following three methods was used to recruit study participants: 1. Minnesota Method 1--Mail only (first half of recruitment period). Mailed invitations with return-response forms. 2. Minnesota Method 2--Mail and selective phone calls (second half of recruitment period). Mailed invitations with return-response forms and subsequent phone calls to nonresponders. 3. New Mexico Method 3--Mail and non-selective phone calls (full recruitment period): Mailed invitations with subsequent phone calls to all. The combined methods succeeded in meeting the recruitment goal of 623 subjects. There were 147 subjects recruited using Minnesota's Method 1, 190 using Minnesota's Method 2, and 286 using New Mexico's Method 3. Efficiency rates (percentage of invited patients who enrolled) were 4.2% for Method 1, 8.4% for Method 2, and 7.9% for Method 3. Calculated costs per enrolled subject were $71.58 (Method 1), $85.47 (Method 2), and $92.09 (Method 3). A mail-only method to assess study interest was relatively inexpensive but not efficient enough to sustain recruitment targets. Phone call follow-up after mailed invitations added to recruitment efficiency. Use of return-response forms with selective phone follow-up to non-responders was cost effective.

Multiscale AM-FM methods for diabetic retinopathy lesion detection.

In this paper, we propose the use of multiscale amplitude-modulation-frequency-modulation (AM-FM) methods for discriminating between normal and pathological retinal images. The method presented in this paper is tested using standard images from the early treatment diabetic retinopathy study. We use 120 regions of 40 x 40 pixels containing four types of lesions commonly associated with diabetic retinopathy (DR) and two types of normal retinal regions that were manually selected by a trained analyst. The region types included microaneurysms, exudates, neovascularization on the retina, hemorrhages, normal retinal background, and normal vessels patterns. The cumulative distribution functions of the instantaneous amplitude, the instantaneous frequency magnitude, and the relative instantaneous frequency angle from multiple scales are used as texture feature vectors. We use distance metrics between the extracted feature vectors to measure interstructure similarity. Our results demonstrate a statistical differentiation of normal retinal structures and pathological lesions based on AM-FM features. We further demonstrate our AM-FM methodology by applying it to classification of retinal images from the MESSIDOR database. Overall, the proposed methodology shows significant capability for use in automatic DR screening.

Cardiometabolic risk and health care utilization and cost for Hispanic and non-Hispanic women.

Cardiometabolic risk (CMR) is a specific set of risk factors that are associated with an increased chance of developing diabetes and cardiovascular disease. We conducted a retrospective study of female members of a health maintenance organization in the southwestern United States to: determine the prevalence of CMR for 4 different groupings of CMR factors, identify differences between Hispanics and non-Hispanics, and quantify differences in 2-year health care utilization and costs of CMR. Subjects were females who had bone mineral density tests during 2003-2004, and thus a measure of height and weight, allowing body mass index (BMI) calculation (n = 2578; 27.6% Hispanic). Risk factors used to define CMR groupings were: obesity (BMI), triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, and fasting glucose. Results showed that Hispanics had higher prevalence rates than non-Hispanics (65.8% versus 52.3%, respectively; P < 0.0001). Adjusting for age and ethnicity, total costs for CMR patients in the groupings that required the presence of diabetes were twice the costs of those without CMR (approximately $11,500 versus $5500, respectively; P < 0.0001). In all other groupings, costs for patients with and without CMR were approximately $7000 versus $5500, respectively (P < 0.0001). Non-Hispanics had significantly higher visit costs than Hispanics. There were no differences in pharmacy costs. Higher utilization and costs associated with CMR suggest the need to identify and monitor patients with CMR. Our findings suggest diabetes prevention could yield substantial cost savings. Higher costs for non-Hispanics, despite higher prevalence among Hispanics, may indicate underutilization of health care resources by Hispanics. Future research in CMR should explore ethnic differences in access to care and disease management programs.