Effect of Lower Extremity Nerve Decompression in Patients With Painful Diabetic Peripheral Neuropathy: The Diabetic Neuropathy Nerve Decompression Randomized, Observation Group and Placebo Surgery-Controlled Clinical Trial.

OBJECTIVE: To evaluate the effect of nerve decompression on pain in patients with lower extremity painful diabetic peripheral neuropathy (DPN). BACKGROUND: Currently, no treatment provides lasting relief for patients with DPN. The benefits of nerve decompression remain inconclusive. METHODS: This double-blinded, observation and same-patient sham surgery-controlled randomized trial enrolled patients aged 18 to 80 years with lower extremity painful DPN who failed 1 year of medical treatment. Patients were randomized to nerve decompression or observation group (2:1). Decompression-group patients were further randomized and blinded to nerve decompression in either the right or left leg and sham surgery in the opposite leg. Pain (11-point Likert score) was compared between decompression and observation groups and between decompressed versus sham legs at 12 and 56 months. RESULTS: Of 2987 screened patients, 78 were randomized. At 12 months, compared with controls (n=37), both the right-decompression group (n=22) and left-decompression group (n=18) reported lower pain (mean difference for both: -4.46; 95% CI: -6.34 to -2.58 and -6.48 to -2.45, respectively; P < 0.0001). Decompressed and sham legs equally improved. At 56 months, compared with controls (n=m 14), pain was lower in both the right-decompression group (n=20; mean difference: -7.65; 95% CI: -9.87 to -5.44; P < 0.0001) and left-decompression group (n=16; mean difference: -7.26; 95% CI: -9.60 to -4.91; P < 0.0001). The mean pain score was lower in decompressed versus sham legs (mean difference: 1.57 95% CI: 0.46 to 2.67; P =0.0002). CONCLUSIONS: Although nerve decompression was associated with reduced pain, the benefit of surgical decompression needs further investigation as a placebo effect may be responsible for part or all of these effects.

Characterizing Measurement-Based Care in the Texas Youth Depression and Suicide Research Network (TX-YDSRN).

Integration of measurement-based care (MBC) into clinical practice has shown promise in improving treatment outcomes for depression. Yet, without a gold standard measure of MBC, assessing fidelity to the MBC model across various clinical settings is difficult. A central goal of the Texas Youth Depression and Suicide Research Network (TX-YDSRN) was to characterize MBC across the state of Texas through the development of a standardized tool to assess the use of MBC strategies when assessing depression, anxiety, side effects, and treatment adherence. A chart review of clinical visits indicated standardized depression measures (71.2%) and anxiety measures (64%) were being utilized across sites. The use of standardized measures to assess medication adherence and side effects was limited to less than six percent for both, with the majority utilizing clinical interviews to assess adherence and side effects; yet medication was changed in nearly half. Rates of utilization of standardized measures for participants with multiple MBC forms were similar to those who only provided one form.

Crossroads between Autoimmunity and COVID-19 in Lung Transplant Recipients.

The presence of a certain group of auto-antibodies (AAbs) is known to correlate with the severity of COVID-19. It is, however, unknown if such AAbs are prevalent and impact COVID-19-related outcomes in lung transplant recipients (LTRs) who are immunosuppressed. We performed a retrospective study of LTRs with COVID-19 and analyzed samples before and after COVID-19 for IgG AAbs. AAbs analysis was carried out using autoimmune and coronavirus microarray and the resulting cross-sectional differences in Ab-scores and clinical variables were analyzed using Fischer's Exact test for categorical variables and a paired t-test for continuous variables. Linear regression was used to analyze the differences in Ab-scores and COVID-19 severity. LTRs with non-severe [NS gp (n = 10)], and severe [S gp (n = 8)] COVID-19 disease were included. Ferritin and acute respiratory failure were higher in the S group (p = 0.03; p < 0.0001). Among the AAbs analyzed, interferon-related AAbs (IFN-alpha2, IFN-beta, IFN lamba, IFN-epsilon), eight interleukin-related AAbs, and several tissue-related AAbs were also found to be changed significantly from pre- to post-COVID-19 (p < 0.05). IFN-lambda (p = 0.03) and IL-22 (p = 0.002) were significantly associated with COVID-19 severity and remained significant in linear regression analysis while controlling for other variables. AAbs are common in LTRs, and certain groups of antibodies are particularly enhanced in LTRs with severe COVID-19. Preliminary observations of this study need to be confirmed by a larger sample size.

Acutely decompensated heart failure in a county emergency department: a double-blind randomized controlled comparison of nesiritide versus placebo treatment.

STUDY OBJECTIVE: Acutely decompensated congestive heart failure is a major cause of emergency department (ED) visits in county hospitals. This often underserved population has a high rate of return visits to the ED for heart failure. Nesiritide has been demonstrated to relieve symptoms of acutely decompensated congestive heart failure. We examined the effect of an 8-hour infusion of nesiritide on the composite of return to the ED or hospitalization at 30 days. METHODS: A prospective, randomized, double-blinded, placebo-controlled trial of nesiritide plus protocol-specified standard therapy versus standard therapy done in the ED for acutely decompensated congestive heart failure. RESULTS: One hundred one patients were randomized during a 16-month enrollment period. Sixty-six percent of the patients were men and 34% were women. Fifty-six percent were black; all patients had New York Heart Association class II to IV heart failure and most had dyspnea at rest or with minimal exertion. Complete follow-up data were available in 97 of 101 patients. After the 8-hour treatment period, acute symptom relief was experienced in 95.7% of the nesiritide group (95% confidence interval [CI] 88.9% to 100%) versus 86.8% of the placebo group (95% CI 72% to 98.9%), with an absolute difference between the 2 groups of 8.9% (95% CI -3.3% to 24.2%). Diuresis was similar between the 2 groups, but hypotension occurred more frequently in the nesiritide-treated group. The primary outcome measure of return visit to the ED or hospitalization at 30 days was higher for nesiritide (41.5%) than placebo (39.6%; absolute difference 1.9%; 95% CI -17.2% to 21.1%). There was only 1 death. No measurable change in renal function was observed. CONCLUSION: Administration of nesiritide for acutely decompensated congestive heart failure in a county ED was no better than standard therapy alone for return to the ED or hospitalization at 30 days.

Increasing Adherence to Brain Trauma Foundation Guidelines for Hospital Care of Patients With Traumatic Brain Injury.

BACKGROUND: The Brain Trauma Foundation has developed treatment guidelines for the care of patients with acute traumatic brain injury. The Adam Williams Initiative is a program established to provide education and resources to encourage hospitals across the United States to incorporate the guidelines into practice. OBJECTIVE: To explore the relationship in hospitals between participation in the Adam Williams Initiative and adherence to the Brain Trauma Foundation guidelines for patients with acute traumatic brain injury. METHOD: Hospitals that participated in the Adam Williams Initiative entered data into an online tracking system of patients with traumatic brain injury for at least 2 years after the initial site training. Data included baseline hospital records and daily records on hospital care of patients with traumatic brain injury, including blood pressure, intracranial pressure, cerebral perfusion pressure, oxygenation, and other data relevant to the 15 key metrics in the Brain Trauma Foundation guidelines. RESULTS: The 16 hospitals funded by the Adam Williams Initiative had good overall adherence to the 15 key metrics of the recommendations detailed in the Brain Trauma Foundation guidelines. Variability in results was primarily due to data collection methods and analysis. CONCLUSIONS: The Adam Williams Initiative helps promote adherence to the Brain Trauma Foundation guidelines for hospital care of patients with traumatic brain injury by providing a platform for developing and standardizing best practices. Participation in the initiative is associated with high adherence to clinical guidelines, a situation that may subsequently improve care and outcomes for patients with traumatic brain injury.

Serum apoptosis markers in acute liver failure: a pilot study.

BACKGROUND & AIMS: We sought to determine whether circulating apoptotic markers are altered in acute liver failure (ALF), differ with etiology, or predict clinical outcome in this condition. METHODS: Serum levels of soluble Fas (sFas), tumor necrosis factor-alpha (TNF-alpha), hepatocyte growth factor (HGF), and interleukin-6 (IL-6) were measured in 67 acute liver failure patients, as well as controls. In a subset of the groups, we measured serum M-30 antigen, an exposed neoepitope from caspase cleavage. We also assessed M-30 immunoreactivity in liver tissue of ALF patients and controls. RESULTS: Median levels for TNF-alpha, HGF, IL-6, and M-30 antigen were at least 10-fold greater in ALF than in hepatitis C virus or normal controls (P < .0001). Median day 1 sFas, day 3 sFas, and day 1 HGF levels varied according to etiology of acute liver failure (P = .004, P = .011, and P = .019, respectively), with values for drug-induced liver injury and acetaminophen-related ALF higher than other etiologies. Median M-30 antigen levels were significantly higher in patients who were transplanted and/or died (2183 U/L) than spontaneous survivors (1004 U/L) (P = .026). M-30 immunoreactivity in liver tissue was significantly greater in ALF patients than HCV controls (P = .004). CONCLUSIONS: TNF-alpha, HGF, IL-6, and M-30 antigen were significantly elevated in ALF. High levels of sFas and HGF might help to confirm a diagnosis of drug-induced liver injury or acetaminophen-related ALF. Higher levels of M-30 antigen are associated with poor clinical outcomes in ALF.

Outcomes after deep full-thickness hand burns.

OBJECTIVE: To measure hand-specific functional performance after deep full-thickness dorsal hand burns. DESIGN: Descriptive, cross-sectional study. SETTING: The 2005 Phoenix Society's World Burn Congress, Baltimore, MD. PARTICIPANTS: Volunteer sample of burn survivors (N=32) with full-thickness dorsal hand burns with extensor mechanism involvement, who consented to participate. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Total active motion of joints, Jebsen-Taylor Hand Function Test (JTHFT), and Michigan Hand Questionnaire (MHQ). RESULTS: Subjects had large burns (mean percentage total body surface area, 58%). Digit involvement was severe, with more than 50% having amputations and 22% with a boutonnière deformity. Forty percent of subjects had poor functional range with total active motion of less than 180 degrees . Scores on the JTHFT were lower than normative scores, and subjects reported most difficulty in performing MHQ activities of daily living (ADLs). CONCLUSIONS: Even with partial amputation or loss of extensor mechanisms, the intact flexor muscles facilitate function by allowing for a modified grasp and enable patients to be independent in most ADL tasks. Training programs can be developed to meet specific goals despite residual hand deformities caused by deep full-thickness burns.

Association Between Method of Prescribing and Primary Nonadherence to Dermatologic Medication in an Urban Hospital Population.

Importance: Prescription underuse is associated with poorer clinical outcomes. A significant proportion of underuse is owing to primary nonadherence, defined as the rate at which patients fail to fill and pick up new prescriptions. Although electronic prescribing increases coordination of care and decreases errors, its effect on primary nonadherence is less certain. Objectives: To analyze factors associated with primary nonadherence to dermatologic medications and study whether electronic prescribing affects rates of primary nonadherence. Design, Setting, and Participants: A retrospective review of medical records was conducted from January 1, 2011, to December 31, 2013, among a cohort of new patients prescribed dermatologic medications at a single, urban, safety-net hospital outpatient dermatology clinic. Main Outcomes and Measures: The primary outcome was the overall rate of primary nonadherence, defined as filling and picking up all prescribed medications within a 1-year period, and the difference in primary nonadherence between patients who received electronic prescriptions and those who received paper prescriptions. Secondary outcomes included the association of primary nonadherence with sex, age, relationship status, primary language, race/ethnicity, and number of prescriptions. Results: A total of 4318 prescriptions were written for 2496 patients (mean [SD] age, 47.7 [13.2] years; 849 men and 1647 women). The overall rate of primary nonadherence was 31.6% (n = 788). Based on multivariable analysis, the risk of primary nonadherence was 16 percentage points lower among patients given an electronic prescription (15.2%) than patients given a paper prescription (31.5%). Primary nonadherence decreased with age (<30 y, 38.9%; 30-49 y, 35.3%; and 50-69 y, 26.3%), and then increased in elderly patients 70 years and older (31.9%). Of patients who were given 1, 2, 3, 4, or 5 prescriptions, rates of primary nonadherence were 33.1%, 28.8%, 26.4%, 39.8%, and 38.1%, respectively. Primary nonadherence decreased with age but then increased in elderly patients. Patients identifying English as their primary language had the highest rate of primary nonadherence (33.9%) compared with Spanish (29%) or other speakers (20.4%). Conclusions and Relevance: Compared with paper prescriptions, electronic prescriptions were associated with less primary nonadherence. Number of prescriptions, language, race/ethnicity, and age were associated with increased rates of primary nonadherence. Efforts must be made to understand why primary nonadherence occurs, identify patients prone to primary nonadherence, and simplify medication regimens to maximize adherence and quality of care.

A randomized, placebo-controlled trial of citicoline add-on therapy in outpatients with bipolar disorder and cocaine dependence.

INTRODUCTION: Bipolar disorder is associated with the highest rates of substance abuse of any psychiatric disorder. Cocaine use is particularly common in patients with bipolar disorder. Both cocaine use and bipolar disorder are associated with mood symptoms and cognitive impairment. Therefore, treatments that stabilize mood, improve cognition, and reduce cocaine use would be useful. Citicoline modulates phospholipids metabolism and neurotransmitter levels and appears to improve cognition in some central nervous system disorders. A 12-week, randomized, placebo-controlled, parallel-group, add-on, proof-of-concept trial of citicoline was conducted in 44 outpatients with a history of mania or hypomania and cocaine dependence. The primary aim was to examine memory, but mood and cocaine use were also assessed. METHOD: Participants were evaluated with a structured diagnostic interview; Inventory of Depressive Symptomatology-Self-Report, Young Mania Rating Scale, and Rey Auditory Verbal Learning Test. Cocaine use was assessed with urine drug screens. Data were analyzed using mixed-model analysis of covariance, generalized estimating equations, and logistic regression analyses that used all of the available data. RESULTS: A significant group effect (P = 0.006) favoring citicoline was observed on the Rey Auditory Verbal Learning Test alternative word list. No significant between-group differences were found on the Inventory of Depressive Symptomatology-Self-Report or Young Mania Rating Scale. The citicoline group had a significantly lower probability of a cocaine-positive urine at exit (P = 0.026). The covariate-adjusted odds ratio estimate was 6.41, suggesting that those who took placebo had 6.41-times higher odds of testing positive for cocaine at exit than those who took citicoline. Citicoline was well tolerated, with no participants to our knowledge discontinuing because of medication side effects. CONCLUSIONS: The use of citicoline was associated with improvement relative to placebo in some aspects of declarative memory and cocaine use, but not mood. The findings are promising and suggest that larger trials of citicoline are warranted.

Convergence of connected language and SPECT in variants of frontotemporal lobar degeneration.

The characterization of frontotemporal lobar degeneration (FTLD) is complicated and not widely recognized. Connected language measures (ie, discourse) and functional neuroimaging may advance knowledge specifying early distinctions among frontal dementias. The present study examined the correspondence of discourse measures with (1) clinical diagnosis and (2) single photon emission computed tomography (SPECT) imaging. Nineteen subjects were selected from Alzheimer's Disease Center (ADC) participants if they were diagnosed with early-stage frontotemporal lobar degeneration and also underwent single photon emission computed tomography and discourse evaluation. First, clinical diagnoses given by specialists at an Alzheimer's Disease Center were compared with the discourse-based diagnostic profiles. Secondly, compromised brain regions that were predicted from discourse profiles were compared with SPECT findings. Results revealed a significant correspondence between the ADC diagnosis and the discourse-based diagnoses. Also, the discourse profiles across frontotemporal lobar degeneration subtypes were consistently associated with distinctive patterns of SPECT hypometabolism in the right frontal, left frontal, or left temporal lobes. These findings suggest that discourse methods may be systematized to provide an efficient adjunct measure beyond the traditional word and sentential level measures. Objectifying complex language performance may contribute to early detection and differentiation among frontotemporal lobar degeneration variants because consensus in the literature states that language is a core disturbance of frontotemporal lobar degeneration.