Real-world effectiveness of risankizumab in patients with moderate-to-severe psoriasis using the CorEvitas Psoriasis Registry.

BACKGROUND: Psoriasis, an inflammatory skin disease, is often treated with biologic therapeutics. OBJECTIVE: To determine the real-world treatment effectiveness of risankizumab, an interleukin-23 inhibitor, in the treatment of moderate-to-severe plaque psoriasis. METHODS: A retrospective, observational study was conducted using the CorEvitas Psoriasis Registry for eligible adults with a diagnosis of moderate-to-severe psoriasis and persistent use of risankizumab at 12 (±3) months after initiation. Skin clearance measures and patient-reported outcomes were analyzed for the entire study population and by prior biologic treatment. RESULTS: Among 287 patients with persistent risankizumab use at 1 year, most achieved clear or clear/almost clear skin and reported significant reductions in Dermatology Life Quality Index scores, psoriasis symptoms (fatigue, skin pain, and overall itch), and work and activity impairment. LIMITATIONS: The CorEvitas Psoriasis Registry is not necessarily representative of all adults with psoriasis in the United States and Canada and does not measure patient adherence. CONCLUSION: Patients treated with risankizumab, regardless of prior treatment, achieved high levels of clear and clear/almost clear skin, Dermatology Life Quality Index scores of 0/1, and significant reductions in psoriasis symptoms (fatigue, skin pain, and overall itch) and work and activity impairment 1 year after initiation.

Impact of psoriasis disease severity and special area involvement on patient-reported outcomes in the real world: an analysis from the CorEvitas psoriasis registry.

BACKGROUND: The impact of psoriasis in special areas (i.e., scalp, nails, palms, soles, genitals) on patient physical functioning, health-related quality of life (HRQoL), and work abilities has not been fully characterized. We assessed associations between disease severity and special area involvement in psoriasis symptoms, HRQoL, and work/activity impairment. METHODS: Patients with psoriasis from the CorEvitas Psoriasis Registry who initiated systemic treatment between 04/2015-06/2020 were included. Outcomes were change from baseline in psoriasis symptoms, Dermatology Life Quality Index (DLQI), and work/activity impairment at 6 months stratified by baseline disease severity and special area involvement. RESULTS: Among 2620 patients, increasing disease severity was associated with worsening patient-reported outcomes. Patients with (46.0%; N = 1205) versus without (54.0%; N = 1415) psoriasis in special areas reported greater HRQoL and work/activity impairment. Over 6 months, patients with unchanged or worsening disease severity had reduced HRQoL and increased symptom severity; incremental increases in patient HRQoL and decreases in symptom severity were associated with improved disease severity. CONCLUSIONS: Higher disease severity and special area involvement was associated with worse outcomes and impaired work abilities. These data highlight the significant impact that adequate treatment of severe psoriasis and/or special area involvement may have on patient HRQoL and function.

Effects of two different paradigms of electrical stimulation exercise on cardio-metabolic risk factors after spinal cord injury. A randomized clinical trial.

Objective: To examine the combined effects of neuromuscular electrical stimulation-resistance training (NMES-RT) and functional electrical stimulation-lower extremity cycling (FES-LEC) compared to passive movement training (PMT) and FES-LEC in adults with SCI on (1) oxygen uptake (VO2), insulin sensitivity and glucose disposal in adults with SCI; (2) Metabolic and inflammatory biomarkers; (3) skeletal muscle, intramuscular fat (IMF) and visceral adipose tissue (VAT) cross-sectional areas (CSAs). Materials and methods: Thirty-three participants with chronic SCI (AIS A-C) were randomized to 24 weeks of NMES-RT + FES or PMT + FES. The NMES-RT + FES group underwent 12 weeks of evoked surface NMES-RT using ankle weights followed by an additional 12 weeks of progressive FES-LEC. The control group, PMT + FES performed 12 weeks of passive leg extension movements followed by an additional 12 weeks of FES-LEC. Measurements were performed at baseline (BL; week 0), post-intervention 1 (P1; week 13) and post-intervention 2 (P2; week 25) and included FES-VO2 measurements, insulin sensitivity and glucose effectiveness using the intravenous glucose tolerance test; anthropometrics and whole and regional body composition assessment using dual energy x-ray absorptiometry (DXA) and magnetic resonance imaging to measure muscle, IMF and VAT CSAs. Results: Twenty-seven participants completed both phases of the study. NMES-RT + FES group showed a trend of a greater VO2 peak in P1 [p = 0.08; but not in P2 (p = 0.25)] compared to PMT + FES. There was a time effect of both groups in leg VO2 peak. Neither intervention elicited significant changes in insulin, glucose, or inflammatory biomarkers. There were modest changes in leg lean mass following PMT + FES group. Robust hypertrophy of whole thigh muscle CSA, absolute thigh muscle CSA and knee extensor CSA were noted in the NMES-RT + FES group compared to PMT + FES at P1. PMT + FES resulted in muscle hypertrophy at P2. NMES-RT + FES resulted in a decrease in total VAT CSA at P1. Conclusion: NMES-RT yielded a greater peak leg VO2 and decrease in total VAT compared to PMT. The addition of 12 weeks of FES-LEC in both groups modestly impacted leg VO2 peak. The addition of FES-LEC to NMES-RT did not yield additional increases in muscle CSA, suggesting a ceiling effect on signaling pathways following NMES-RT. Clinical trial registration: identifier NCT02660073.

Durability of Near-Complete Skin Clearance in Patients with Psoriasis Using Systemic Biologic Therapies: Real-World Evidence from the CorEvitas Psoriasis Registry.

INTRODUCTION: Near-complete skin clearance has become a rapidly achievable treatment goal for patients with psoriasis receiving systemic biologic therapies. However, real-world evidence for durability of near-complete skin clearance and risk factors associated with loss of near-complete skin clearance is limited. METHODS: This study described durability of near-complete skin clearance (≥ 90% improvement in Psoriasis Area and Severity Index from initiation; PASI90) and identified clinical factors or patient characteristics associated with loss of PASI90 among patients with psoriasis from the CorEvitas Psoriasis Registry (April 2015-August 2021). Included patients had PASI > 5 at biologic initiation and achieved PASI90 at approximately 6 months from initiation (index). A Kaplan-Meier estimate described time to loss of treatment response over 24 months follow-up from index. Proportional hazards regression was used to identify independent predictors of loss of treatment response. RESULTS: This study included 687 patient initiations (instances of patients initiating a biologic). Following achievement of PASI90, treatment response was maintained in more than half of patient initiations (54%). Treatment response was maintained at 6, 12, and 18 months from index in an estimated 73% (95% [confidence interval] CI 70-77%), 60% (95% CI 56-63%), and 50% (95% CI 47-54%) of patient initiations, respectively. Adjusted hazards regression suggested non-White race, full-time employment, greater body weight, concomitant psoriatic arthritis, prior use of biologics, and clinically meaningful skin symptoms were associated with loss of treatment response. CONCLUSIONS: Among real-world patients with psoriasis who achieved PASI90 with biologic therapy, about one-quarter lost response at 6 months, and half lost response at 18 months. Prior use of a biologic therapy and clinically meaningful skin symptoms at index, including itch and skin pain, were associated with loss of treatment response. Therefore, dermatologists may consider focusing on patient-reported symptoms as part of any intervention designed to reduce the likelihood of loss of response to biologic therapies. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02707341.

Many people with psoriasis are treated with biologic medications that work to improve symptoms associated with psoriasis, including inflammation. These medications can lead to almost clear skin for many people. However, there is limited information available about how long almost clear skin can be maintained with biologic medications, and what predicts who is likely to lose it. To explore these questions, we examined a database of patients with psoriasis (the CorEvitas Psoriasis Registry) that records how clear patients' skin is and the medications they take. Out of every 100 patients, 54 maintained almost clear skin and stayed on their original medication for 2 years after first having almost clear skin. Out of every 100 patients, 73, 60, and 50 maintained almost clear skin and remained on their original medication at 6, 12, and 18 months after they had achieved this response. The results indicated that patients who were not White, worked full time, previously used a biologic medication, or had itchy and/or painful skin after they had achieved almost-clear skin were more likely to change their medication and/or no longer have almost-clear skin. These results suggest that dermatologists may consider focusing on patient-reported characteristics when deciding how to treat their patients, to reduce the likelihood that they lose their response to the medication they are prescribed.

Skin Clearance is Associated with Reduced Treatment Failure in Patients with Psoriasis: Real-World Evidence from the CorEvitas Psoriasis Registry.

INTRODUCTION: Complete and near-complete skin clearance have become achievable treatment goals for patients with psoriasis receiving systemic biologic therapies. However, there is limited real-world evidence regarding the impact of the degree of skin clearance on biologic treatment patterns among these patients. METHODS: This longitudinal cohort study assessed the relationship between degree of skin clearance following initiation of a systemic biologic therapy and treatment failure among patients from the CorEvitas Psoriasis Registry (April 2015-August 2021). Patients had Psoriasis Area and Severity Index (PASI) score > 5 at systemic biologic therapy initiation and ≥ 1 follow-up visit(s) within 15 months of initiation. Treatment failure (discontinuation due to poor response/adverse event; addition of non-biologic therapy) and degree of skin clearance (measured by PASI) were assessed following biologic initiation. Proportional hazards regression was used to estimate the association between PASI response level and treatment failure over follow-up. RESULTS: This study included 2701 patient initiations from 2516 unique patients with 3846 total visits over follow-up. Over half of the patient initiations (n = 1412; 52.3%) were among patients with PASI >10. Treatment failure occurred in 1.3% of visits at which PASI100 was achieved, while those achieving PASI90 - < 100 and PASI75 - < 90 had treatment failure rates of 3.4% and 3.5%, respectively. After adjustment for confounders, the risk of treatment failure was two to three times higher in the PASI90 - < 100 (hazard ratio [HR] = 2.61; 95% confidence interval [CI] 1.35, 5.02; p = 0.004) and PASI75 < 90 (HR = 2.97; CI 1.58, 5.58; p = 0.001) groups compared to the PASI100 group. The risk of treatment failure was more than 20 times higher in the < PASI75 group versus the PASI100 group (HR = 22.26; CI 13.32, 37.21; p < 0.001). CONCLUSIONS: The results suggest that patients are more likely to remain on a systemic biologic therapy if they achieve near-complete or complete skin clearance, supporting the continued need to target skin clearance as a treatment goal in psoriasis. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02707341.

Many people with psoriasis are often treated with biologic medications that work to improve symptoms associated with psoriasis, including inflammation. These medications can lead to clear or almost-clear skin for many people. However, there is limited information available about how achieving this goal affects whether patients continue taking their biologic medication or add a new non-biologic medication. The data source for this study was a database of patients with psoriasis (the CorEvitas Psoriasis Registry) that records how clear patients' skin is and what medications they take. Over 1 year after starting a biologic medication, approximately 1 out of every 100 patients that achieved clear skin after taking a biologic medication stopped using that medication, and approximately 3 out of every 100 patients with almost-clear skin after taking a biologic medication stopped using that medication. Meanwhile, around 20 out of every 100 patients that did not have clear or almost-clear skin after taking a biologic medication stopped using that medication. Furthermore, patients who did not have clear or almost-clear skin after taking a biologic medication had more than 20 times greater risk of stopping their medication than those who did have clear or almost-clear skin after taking a biologic medication. These results suggest that patients are more likely to remain on their biologic medication if they experience clear or almost-clear skin after taking a biologic medication and that patients and their providers should aim for this goal when taking a biologic medication.

The Running Readiness Scale as an Assessment of Kinematics Related to Knee Injury in Novice Female Runners.

CONTEXT: Frontal- and transverse-plane kinematics have been prospectively identified as risk factors for running-related injuries in females. The Running Readiness Scale (RRS) may allow for clinical evaluation of these kinematics. OBJECTIVES: To determine the reliability and validity of the RRS as an assessment of frontal- and transverse-plane running kinematics. DESIGN: Cross-sectional study. SETTING: University research laboratory. PATIENTS OR OTHER PARTICIPANTS: A total of 56 novice female runners (median [interquartile range] age = 34 years [26-47 years]). MAIN OUTCOME MEASURE(S): We collected 3-dimensional kinematics during running and RRS tasks: hopping, plank, step-ups, single-legged squats, and wall sit. Five clinicians assessed RRS performances 3 times each. Interrater and intrarater reliabilities of the total RRS score and individual tasks were calculated using the intraclass correlation coefficient and Fleiss κ, respectively. Pearson product moment correlation coefficients between peak joint angles measured during running and the same angles measured during RRS tasks were computed. Peak joint angles of high- and low-scoring participants were compared. RESULTS: Interrater and intrarater reliabilities of assessment of the total RRS scores were good (intraclass correlation coefficients = 0.75 and 0.80, respectively). Reliability of assessing individual tasks was moderate to almost perfect (κ = 0.58-1.00). Peak hip adduction, contralateral pelvic drop, and knee abduction during running were correlated with the same angles measured during hopping, step-ups, and single-legged squats (r = 0.537-0.939). Peak knee internal rotation during running was correlated with peak knee internal rotation during step-ups (r = 0.831). Runners who scored high on the RRS demonstrated less knee abduction during running (P ≤ .01). CONCLUSIONS: The RRS may effectively assess knee abduction in novice runners, but evaluation criteria or tasks may need to be modified to effectively characterize pelvic and transverse-plane knee kinematics.

Growth Analysis of Untreated Meningiomas under Observation.

BACKGROUND: When meningiomas are small or asymptomatic, the decision to observe rather than treat requires balancing the growth potential of the lesion with the outcome and side effects of treatment. The aim of this study is to characterize the growth patterns of untreated meningiomas to better inform the clinical decision-making process. METHODS: Patients with meningiomas were identified from 2005 to 2015. Those without treatment who had been followed for 1.5 years, with three magnetic resonance imaging (MRI) scans, were identified. Scans were measured with orthogonal diameters, geometric mean diameters, and volumes using the ABC/2 method. Regression modeling determined what growth pattern these parameters best approximated. RESULTS: Two hundred and fifteen MRI scans for 34 female (82.9%) and 7 male (17%) patients with 43 tumors were evaluated. Initial tumor volumes ranged from 0.13 to 9.98 mL. The mean and median initial volumes were 2.44 and 1.52 mL, respectively. Follow-up times ranged from 21 to 144 months, with a median of 70 months. There were 12 tumors (28%) whose growth rates were significantly greater than zero. For all tumors, use of a linear regression model allowed accurate prediction of the future size using prior data. CONCLUSION: Three-quarters of presumptive meningiomas managed conservatively do not grow significantly. The remainder have significant growth over time, and the behavior could be approximated with linear regression models.

Azithromycin versus erythromycin infusions prior to endoscopy in upper gastrointestinal bleeding.

Background: Intravenous erythromycin prior to endoscopy for upper gastrointestinal bleeding (GIB) improves outcomes but requires immediate preparation delaying administration in emergency cases. Azithromycin is readily available and does not require prolonged preparation. The aim of the study was to assess the effect of azithromycin in improving the quality of endoscopic visualization in upper GIB compared to erythromycin. Methods: Patients admitted with upper GIB who received erythromycin or azithromycin before urgent endoscopy were included. Primary outcome of the quality of visualization was assessed by two gastroenterologists, blinded to the choice of infusion, using a scoring system ranging from 0 to 8, with a maximum of 2 points assigned to the fundus, body, antrum and bulb. Results: Sixty-six patients were included; 25 received azithromycin and 41 received erythromycin. Mean total visualization score was significantly higher with azithromycin compared to that with erythromycin (6.8±1.4 vs. 5.5±2.2, respectively; P=0.01) and remained significant after adjusting for confounders (Diff: 0.01, 1.88; P=0.05). Secondary outcomes analyses showed a shorter LOS when given azithromycin compared to erythromycin [6 (3 to 9) vs. 8 (7 to 16) days, respectively, 95% CI: 1.03, 3.89; P=0.04]. Time between initiating the infusion and endoscopy was longer with azithromycin (Diff: 40.64 min; 95% CI: 7.23, 74.05; P=0.02). Need for second look endoscopy, procedure time, blood transfusion requirements and procedure-related complications did not differ between the groups. Conclusions: Azithromycin infusion before endoscopy for upper GIB was associated with better visualization than that of erythromycin. Randomized trials are needed to validate these findings.

Current Life Experiences in Veterans with Limb Loss: A Description of Survey Methods and Summary Results.

PURPOSE: To present the methods and summary findings of a nationwide survey on the current life experiences of Operation Iraqi Freedom/Operation Enduring Freedom (OEF/OIF) Veterans with limb loss. METHODS: A questionnaire was sent to Veterans with items covering sample demographics, summaries of health status, prosthesis usage and fit, employment experience, and use and satisfactions with support services and providers. RESULTS: 158 Veterans completed the survey. Approximately 40% perceived their overall status, function and problems related to the prosthesis as "Average". 58% wore a prosthesis over 10 hours per day and 74% did not use additional walking aids. Approximately 75% had at least "Moderate" pain and residual limb health problems. 37% were employed though conditions often changed. Over 80% used healthcare, mental health counseling and education services. The Departments of Defense and VA were primary service providers. CONCLUSIONS: Respondents generally exhibited satisfactory life experiences. Results suggest a positive current status despite challenges that could impair health, functioning and quality of life. Support services were available as needed. Satisfaction with services and providers varied.

The effect of intermittent theta burst stimulation on corticomotor excitability of the biceps brachii in nonimpaired individuals.

Intermittent theta burst stimulation (iTBS) is a form of repetitive transcranial magnetic stimulation (TMS) that can increase corticomotor excitability in distal upper limb muscles, but the effect on the more proximal biceps is unknown. The study objective was to determine the effect of iTBS on corticomotor excitability of the biceps brachii in non-impaired individuals. Ten individuals completed three sessions, and an additional ten individuals completed one session in a secondary study; each session included sham and active iTBS. Resting and active motor thresholds (RMT, AMT) were determined prior to sham and active iTBS. Motor evoked potentials (MEPs) in response to single pulse TMS served as our measure of corticomotor excitability. In our primary cohort, MEPs were recorded with biphasic stimulation to accurately capture the same neurons affected by biphasic iTBS. MEPs were recorded at an intensity of 120% of RMT, or for instances of high RMTs, 100% of the maximum stimulator output (MSO), at baseline, and 10, 20, and 30 minutes after iTBS. MEPs were normalized by the maximum voluntary isometric muscle activity. In the secondary, MEPs were recorded with monophasic stimulation, which increased our ability to record MEPs at 120% of RMT. Linear mixed effects models were used to determine the effect of iTBS on normalized MEPs (nMEPs), with analyses to evaluate the interaction of the biceps AMT:RMT ratio as a measure of corticomotor conductance. Change in nMEPs from baseline did not differ for the active and sham conditions (p = 0.915 ) when MEPs were assessed with biphasic stimulation. With MEPs assessed by monophasic stimulation, there was an increase in biceps nMEPs after active iTBS, and no change in nMEPs after sham. Our results suggest that when RMTs are expected to be high when measured with biphasic stimulation, monophasic stimulation can better capture changes in MEPs induced by iTBS, and biphasic stimulation appears limited in its ability to capture changes in biceps MEPs in nonimpaired individuals. In both cohorts, increased corticomotor excitability after iTBS occurred when the biceps AMT:RMT ratio was high. Thus, the AMT:RMT ratio may be a predictive measure to evaluate the potential for iTBS to increase biceps corticomotor excitability.

Severe Sepsis: The Fragile Anatomy of Crude Mortality.

Clinical trials of severe sepsis that target crude mortality are underpowered to detect mortality differences due to intervention. We discuss the importance of including subcomponents of crude mortality in study design; how the proportion of attributable mortality affects sample size requirements; and how minor changes from predicted outcomes affect interpretation.

Social Media and Academic Impact: Do Early Tweets Correlate With Future Citations?

OBJECTIVE: Determine whether social media platforms can influence article impact as measured by citations. METHODS: Cross-sectional study that analyzed articles published in the top 10 otolaryngology journals by Eigenfactor score in January 2015. Total accumulated Twitter mentions and citations were recorded in 2021. The main outcomes examined the difference in citations, tweets, article types, and author counts accumulated over a 5-year period for all articles that were either tweeted or nontweeted. RESULTS: A total of 3094 articles were included for analysis. The average article was cited 11.2 ± 13.2 times and tweeted 2.10 ± 4.0 times. Sixty-four percent of the articles had at least one tweet. Over the study period, there was a statistically significant difference in mean number of citations between tweeted articles (12.1 ± 15.0) versus nontweeted articles (9.6 ± 10.5) citations, representing a 26% difference (P < .001). Review articles had the highest mean citations (19.4 ± 23.4) while editorials had the lowest mean citations (2.8 ± 6.9). Tweets peaked in the year of publication, but citations continued to rise in the subsequent years. Tweeted articles' peak citation rate change was +1.27 mean citations per year, compared to +0.99 mean citations per year in nontweeted articles. The mean author count in tweeted articles (5.40 ± 3.1) was not significantly different than the mean author count in nontweeted articles (5.19 ± 2.65, P = .0794). CONCLUSION: These data suggest a moderate correlation between tweets and article citations, but a clear difference in the number of citations in articles tweeted versus those with no tweets. Thus, dissemination of knowledge may be impacted by social medial platforms such as Twitter.

Aging with Traumatic Brain Injury: Deleterious Effects of Injury Chronicity Are Most Pronounced in Later Life.

Understanding the effects of age on longitudinal traumatic brain injury (TBI) outcomes requires attention to both chronic and evolving TBI effects and age-related changes in health and function. The present study examines the independent and interactive effects of aging and chronicity on functional outcomes after TBI. We leveraged a well-defined cohort of individuals who sustained a moderate/severe TBI and received acute inpatient rehabilitation at specialized centers with high follow up rate as part of their involvement in the TBI Model Systems longitudinal study. We selected individuals at one of two levels of TBI chronicity (either 2 or 10 years post-injury) and used an exact matching procedure to obtain balanced chronicity groups based on age and other characteristics (N = 1993). We found that both older age and greater injury chronicity were related to greater disability, reduced functional independence, and less community participation. There was a significant age by chronicity interaction, indicating that the adverse effects of greater time post-injury were most pronounced among survivors who were age 75 or older. The inflection point at roughly 75 years of age was corroborated by post hoc analyses, dividing the sample by age at 75 years and examining the interaction between age group and chronicity. These findings point to a need for provision of rehabilitation services in the chronic injury period, particularly for those who are over 75 years old. Future work should investigate the underlying mechanisms of this interaction towards the goal of developing interventions and models of care to promote healthy aging with TBI.

Tobacco Use and Skin Reactivity in Patients With Percutaneous Auditory Osseointegrated Implants.

OBJECTIVES: To determine if there is an association between tobacco use and the development of postoperative skin reactions in patients undergoing percutaneous osseointegrated auditory implant (pOAI) surgery. STUDY DESIGN: Single surgeon retrospective cohort study. SETTING: Academic medical center. SUBJECTS AND METHODS: Retrospective chart review was performed on all patients who underwent pOAI. Smoking status (current and former users versus never-users) was recorded as were numerous demographic and surgical variables. The primary outcome measure was skin reactivity as measured by Holgers score. Secondary outcomes studied included total number of problem visits, minor interventions, and major interventions. RESULTS: 126 patients, 73 with no tobacco history (NT) and 53 with a positive smoking tobacco history (T) underwent pOAI surgery in this study. The T group was found to have higher rates of first postoperative visit soft tissue reactions compared with the NT group (24.5% versus 6.8%, p 1/4 0.011, odds ratio [OR] 4.42, 95% confidence interval [CI]: 1.5, 13.3), but not at long-term follow-up. When former smokers were eliminated from analysis, differences were also found at long- term follow-up (40.9% versus 19.2%, p 1/4 0.037, OR 2.92, 95% CI [1.0 - 8.1]). There were no differences in total number of problem visits or total number of minor or major interventions. CONCLUSIONS: Patients with a history of tobacco use have a significantly higher rates of skin reactivity compared with patients without, though smoking cessation may partially mitigate long-term risks. Surgeons should be aware of the risks of early skin reactivity and should counsel patients accordingly.

Research Letter: Performance of the Brief Test of Adult Cognition by Telephone in a National Sample.

OBJECTIVE: To create a larger, more representative community comparison sample of the Brief Test of Adult Cognition by Telephone (BTACT) data to facilitate assessment of cognitive function in research studies. SETTING: National US community-based survey. PARTICIPANTS: In total, 6747 healthy adults aged 23 to 84 years (53% female; mean age = 55 years, SD = 13). DESIGN: Secondary data analysis of BTACT data collected from the National Survey of Midlife Development in the United States (MIDUS) II and MIDUS Refresher cohorts. MAIN MEASURES: The BTACT, a brief (15-20 minute) measure of global cognitive function validated for telephone administration. RESULTS: This article provides BTACT community comparison sample data based on age, sex, and education from a national sample. Similar to other cognitive measures, BTACT scores decreased with age and increased with education. CONCLUSIONS: The BTACT community comparison sample will facilitate investigation of cognitive functioning in large-scale traumatic brain injury research studies and will support secondary analysis of existing BTACT data gathered through the MIDUS study.

Comparison of Frontal and Transverse Plane Kinematics Related to Knee Injury in Novice Versus Experienced Female Runners.

Novice runners experience a higher incidence of knee injury than experienced runners, which may be related to aberrant frontal and transverse plane kinematics. However, differences in kinematics between novice and experienced runners have not been fully explored. For this study, 10 novice and 10 experienced female runners ran on a treadmill at 2.68 m/s. Ankle, knee, and hip joint angles during the stance phase were measured using a 3-dimensional motion capture system and modeled using cubic splines. Spline models were compared between groups using a generalized linear model (α = .05). Ninety-five percent confidence intervals of the difference between joint angles throughout stance were constructed to identify specific periods of stance where groups differed in joint position. Angle-angle diagrams of ankle and hip position in the frontal and transverse planes were constructed to depict joint coordination. Novice runners displayed less hip adduction, but greater knee abduction and knee internal rotation compared to experienced runners. Differences in knee joint position may be explained by coordination of hip and ankle motion. Greater knee abduction and knee internal rotation displayed by novice runners compared with experienced runners may help to explain their higher risk for injury.

An adaptive method for assigning clinical trials wait-times for controls.

Wait-list control clinical trials are popular among psychologists and rehabilitation specialists partly because all participants receive the intervention. In 2 arm wait-list control trials, individuals randomized to the treatment group receive immediate treatment whereas individuals randomized to the control group wait a fixed amount of time before intervention is initiated. For interventions that have varying durations, careful consideration must be given to the period that participants in the control group have a delay until treatment begins, as incongruent wait times compared to the intervention durations of the treatment group may introduce confounding into the evaluation of the treatment differences. To alleviate this issue, we propose to adaptively assign wait times to individuals randomized to the control group based on the intervention duration of those in the treatment group. Simulations demonstrate the that our method not only results in similar timing distributions between participants in the treatment and control groups, but also allows participants in the control group to initiate treatment earlier than the traditional design. The latter characteristic may reduce dropout and result in more efficient study enrollment.

Combination therapy with methadone and duloxetine for cancer-related pain: a retrospective study.

BACKGROUND: A comprehensive approach to pain management often requires multimodal therapy and a combination of medications. Oncology patients may be prescribed methadone and duloxetine as single agents or in combination for cancer-related pain, particularly neuropathic pain. Duloxetine is also prescribed for depression or anxiety in patients with cancer. METHODS: A retrospective chart review on patients with cancer-related pain prescribed duloxetine and methadone combination therapy at the Virginia Commonwealth University supportive care clinic (SCC) between 2012 and 2019. Edmonton Symptom Assessment System (ESAS) scores reported by patients on monotherapy were compared to scores after they started combination therapy. Of 131 patients identified on combination therapy, 43 met study criteria (2 with incomplete ESAS scores). RESULTS: ESAS total and subscores after combination therapy were lower than on monotherapy. Combination therapy decreased total, pain, and emotion subscores by 5.6 (SD =17.3, dz =-0.32, P=0.046), 0.9 (SD =3.0, dz =-0.30, P=0.052), and 1.8 (SD =5.1, dz =-0.36, P=0.023), respectively. On combination therapy, 28% of patients reported at least a two-point reduction in pain scores. All study participants reported cancer pain with neuropathic components; most had mixed pain syndromes comprising nociceptive and neuropathic components. Adherence rates were high as 81% of patients with follow-up appointments continued therapy. CONCLUSIONS: These results suggest the combination of duloxetine and methadone reduces cancer-related pain and emotional symptom burden compared to either medication as a single agent.