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.

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.

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.

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.

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.

Relationship between pain-related comorbidities and quality of life in patients with symptoms of chronic rhinosinusitis.

INTRODUCTION: Facial pain is a common manifestation of sinonasal disease but may be due to a variety of other conditions. Misattribution of pain to chronic rhinosinusitis may result in worse quality of life in populations both with and without objective evidence of sinonasal disease. The purpose of this study was to determine if there is an association between pain-related comorbidities and worse chronic rhinosinusitis specific quality of life in patients with and without objective evidence of sinonasal inflammation. METHODS: Retrospective cohort study of 299 patients meeting diagnostic criteria for sinusitis evaluated at a tertiary academic medical center from 2017 to 2018. Objective evidence was measured using the Lund-Kennedy and Lund-MacKay scoring systems; for the purposes of this study a score >3 on either scale was considered indicative of disease. Quality of life was determined by the rhinosinusitis disability index. RESULTS: A total of 191 patients were included in the study, with an average age of 52.7. (SD=15.3). The average Lund-Kennedy and Lund-MacKay scores were 4.7 and 8.3, respectively. The average rhinosinusitis disability index was 32.1. When stratified by the presence of pain-related comorbidities, there was no significant difference in Lund-Kennedy (p = 0.203), Lund-MacKay (p = 0.101), or rhinosinusitis disability index (p = 0.421). CONCLUSION: Although prior studies have suggested a correlation between the presence of pain-related comorbidities and worse chronic rhinosinusitis specific quality of life, this relationship was not evident within the current cohort of patients. The relationship between pain and sinusitis specific quality of life is likely complex and requires further research to fully elucidate.

Patterns of transaminase elevation in rhabdomyolysis versus acetaminophen toxicity.

BACKGROUND: Transaminase elevations can occur from liver injury or in the setting of rhabdomyolysis. The goal of this study is to evaluate indices that could differentiate acetaminophen toxicity from muscle injury in the setting of transaminase elevations. METHODS: A retrospective chart review of consecutive cases reported to our regional poison center. Patients with transaminase (AST and ALT) elevation were grouped as those with acetaminophen exposure (AT) and those with elevated creatine phosphokinase (CPK) without evidence of acetaminophen exposure (RHB). RESULTS: Of the 345 patients included in the study, elevated AST/ALT levels were attributed to rhabdomyolysis in 168 patients and attributed to acetaminophen toxicity in 177 patients. The median AST: ALT values also differed between groups, with patients in the RHB group had higher median ratios (p < 0.001). Using an AST: ALT value of 2.02 as a diagnostic cutoff produced a specificity of 0.52 (95% CI: 0.37, 0.64) and sensitivity of 0.84 (95% CI: 0.73, 0.94) for acetaminophen detection in the test dataset (N = 104). CONCLUSIONS: Elevated transaminases due to liver injury from acetaminophen ingestion had a different pattern than elevated transaminases due to rhabdomyolysis. Lower AST:ALT ratios were found in acetaminophen cases, however, the specificity using a ratio threshold of ≤1 would be 83%.

Impact of Traumatic Brain Injury on Clinical Institute Withdrawal Assessment Use in Trauma Patients: A Descriptive Study.

BACKGROUND: Alcohol withdrawal syndrome (AWS) and traumatic brain injury (TBI) present with similar signs and symptoms, yet their treatment strategies differ greatly. AWS treatment includes the Clinical Institute Withdrawal Assessment (CIWA) protocol, which grades withdrawal signs and symptoms. A major purpose of CIWA is to guide the addition and titration of central nervous system (CNS) depressants, most commonly benzodiazepines. Conversely, best practice is to avoid these same CNS depressants in the setting of TBI. Thus, patients with TBI presenting with AWS risk may receive undesirable interventions that could worsen outcome. OBJECTIVE: To describe the relationship of TBI diagnosis with CIWA protocol scores and intervention implementation. DESIGN: Retrospective cohort observational study. SETTING: Single university-based, level one trauma center. PATIENTS: Three hundred seventy-five patients with head trauma or AWS classification, identified through the trauma center's trauma registry. INTERVENTIONS: CIWA protocol and related medication use. MAIN OUTCOME MEASURES: Frequency of elevated CIWA score, length of CIWA administration, and medication administration incidence were abstracted from patients' medical records. RESULTS: The percentage of elevated CIWA scores increased significantly with TBI severity, from 4.5%(0-60) in the No TBI group, up to 12.5% (0-36) in the Mild TBI group, 27.1% (0-57) in the Moderate TBI group, and 50.0% (14-77) in the Severe TBI group. Nominally, lorazepam use showed a similar pattern of escalation with TBI severity, but it did not reach statistical significance. Haloperidol use did significantly escalate with higher TBI severity. No group differences were observed for total lorazepam equivalents or length on the CIWA protocol. CONCLUSIONS: TBI diagnosis and higher TBI severity level correlate with higher CIWA scores, but neither increased nor decreased benzodiazepine usage was observed. Antipsychotic use did escalate with TBI diagnosis and severity. The risks versus benefits of minimizing benzodiazepines in patients with TBI who are at risk for AWS warrant future study.

The Effect of Business Internships Model and Employment on Enhancing the Independence of Young Adults With Significant Impact From Autism.

This article presents findings from a multisite randomized clinical trial measuring the impact of employment on independence in 18 to 22 year old youth with significant impact from autism spectrum disorder (ASD). The treatment condition was Project SEARCH plus ASD Supports (PS+ASD) where 73.4% of participants gained competitive integrated employment (CIE) within 1 year of graduation compared to control participants who acquired CIE at 17%. Within group analysis revealed that PS+ASD participants demonstrated improvement in all domains whereas control group participants demonstrated improvement in one domain only. Between groups analysis indicated that participants in PS+ASD demonstrated nominally better rates of improvement than control group participants at graduation and 1-year follow-up. Results provide evidence that employment provides therapeutic benefits to individuals with ASD.

Effect of Surgery for Stress Incontinence on Female Sexual Function.

OBJECTIVE: To evaluate the effects of four different surgical interventions for stress urinary incontinence (SUI) on 2-year postoperative sexual function. METHODS: This is a combined secondary analysis of SISTEr (Stress Incontinence Surgical Treatment Efficacy Trial) and TOMUS (Trial of Mid-Urethral Slings). Women in the original trials were randomized to receive surgical treatment for SUI with an autologous fascial sling or Burch colposuspension (SISTEr), or a retropubic or transobturator midurethral sling (TOMUS). Sexual function (assessed by the short version of the PISQ-12 [Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire]) was compared between groups at baseline, 12 and 24 months. Secondarily, the effects of subjective and objective surgical cure rates and the effect of concomitant surgical procedures on 24-month sexual function was explored. RESULTS: Nine hundred twenty-four women were included in this study: 249 (26.9%) had an autologous fascial sling, 239 (25.9%) underwent Burch colposuspension, 216 (23.3%) had a retropubic midurethral sling placed, and 220 (23.8%) had transobturator midurethral sling placed. Baseline characteristics (including PISQ-12 scores) were similar between the four treatment arms, with notable exceptions including race-ethnicity, prolapse stage, concomitant surgery, and number of vaginal deliveries. After adjustment for differences between the groups, there was a clinically important improvement in PISQ-12 scores over the 24-month postoperative period for all treatment groups, with no significant differences attributed to the type of anti-incontinence procedure (baseline PISQ-12: 32.6, 33.1, 31.9, 31.4; 24-month PISQ-12: 37.7, 37.8, 36.9, 37.1, P<.01). There was no significant difference in mean PISQ-12 scores between 12 months and 24 months (12-month PISQ-12: 37.7, 37.8, 36.9, 37.1; 24 months as above, P=.97). Multivariable analysis showed independent associations between objective and subjective cure rates as well as concomitant procedures with a 24-month PISQ-12 score. CONCLUSION: Women undergoing anti-incontinence surgery show overall improvement in sexual function from baseline to 24 months postoperatively, without significant differences based on surgical procedure performed. The majority of this improvement occurs in the first 12 months and is maintained over 24 months.

Incorporating professional recommendations into a graduate-level statistical consulting laboratory: A case study.

INTRODUCTION: There has been a recent trend in medical research towards a more collaborative relationship between statisticians and clinical investigators. This has led to an increased focus on the most efficient and effective ways to structure, conduct, and measure the impact of organizations that provide statistical services to clinical investigators. Several recent guidelines and recommendations on the conduct of statistical consulting services(SCSs) have been made in response to this need, focusing on larger SCSs consisting primarily of faculty and staff statisticians. However, the application of these recommendations to consulting services primarily staffed by graduate students, which have the dual role of providing a professional service and training, remains unclear. METHODS: Guidelines and recommendations, primarily from the Clinical and Translational Science (CTSA) consortium, were applied to a SCS staffed primarily by graduate students in an academic health center. A description of the organizational structure and outcomes after 3 years of operation is presented. RESULTS: The guidelines recommended by the CTSA consortium and other groups were successfully incorporated into the graduate consulting laboratory. At almost one new project request per week, the consulting laboratory demonstrated a large bandwidth and had an excellent feedback from investigators. CONCLUSIONS: Guidelines developed for larger statistical consulting organizations are able to be applied in student-led consultation organizations. Outcomes and recommendations from 3.5 years of operation are used to describe the successes and challenges we have encountered.

Cold Compress for Intrauterine Device Insertional Pain: A Randomized Control Trial.

Background: Pain with intrauterine device (IUD) insertion is identified as a barrier to uptake of this highly effective long-acting reversible contraceptive. Several studies have assessed the efficacy of interventions to alleviate patient discomfort associated with IUD insertion, but no interventions have been clearly shown to improve procedural pain. The aim of this study was to determine whether use of a cold compress on the abdomen during IUD insertion reduces pain. Materials and Methods: This was a prospective randomized control trial of women presenting to Virginia Commonwealth University for insertion of IUD from September 2016 to October 2017. A power analysis determined that 69 subjects were needed in each arm to detect a 30% reduction in pain with a power of 80%, significance value of p < 0.05. One hundred forty-two participants were consented for the study, 69 were randomized to the control group, which received the usual management, and 73 were randomized to the study group, which received a cold compress to the abdomen before the procedure. In addition to data on the difference from pre- to postprocedure pain scales, we collected information regarding inserting provider type, gravidity/parity, body mass index, demographic information (age, race, insurance type, and level of education), history of IUD placement or cervical procedure, history of chronic pain, and the use of regular pain medications (defined as more than once per week). Statistical analysis was accomplished using t-test and chi square tests. Results: There was no difference in pre and postinsertional pain in those who received a cold compress versus the control during insertion of an IUD (3.4 vs. 3.5). The insertional pain was rated at 4.3 and 4.6 for patients who received the cold compress and the control group, respectively (p = 0.805). Conclusion: Although a cold compress is a simple, inexpensive, and safe method of pain control, this study shows no reduction in insertional pain for IUD placement.

Characterizing Comorbid Cerebrovascular Insults Among Patients With TBI at a TBI Model Systems Rehabilitation Center.

OBJECTIVE: Determine incidence and predictors of comorbid cerebrovascular injuries in patients with moderate to severe traumatic brain injury (TBI) and whether it influences rehabilitation outcomes. SETTING: Inpatient Rehabilitation Facility (IRF) brain injury unit participating in NIDILRR TBI Model Systems (TBIMS). PARTICIPANTS: A total of 663 patients with moderate to severe TBI. DESIGN: Observational study with prospective and retrospective data collection. MAIN MEASURES: New traumatic cerebral artery injury (TCAI) lesions of head/neck and new cerebral infarcts (CIs) abstracted from neuroimaging reports and clinical notes. RESULTS: The incidence of comorbid CI was 8%, among whom 19% also had TCAI identified. The incidence of TCAI increased over time from 2% before 2008 to 10% after, probably from greater screening. Both CI and TCAI were associated with longer acute care stay. Cerebral infarct was also associated with longer posttraumatic amnesia and lower rate of functional gains. CONCLUSIONS: Using in-depth abstraction of imaging findings, the incidence of traumatic head/neck artery injuries, and CIs in patients with moderate to severe TBI were both higher than a recent TBIMS-wide study utilizing ICD coding. Cerebral infarct was associated with longer posttraumatic amnesia duration and slower functional gains. Further research is recommended on the outcome implications of concomitant cerebrovascular injury in patients with TBI.