Performance of the Patient-Reported Outcomes Measurement Information System-29 in scleroderma: a Scleroderma Patient-centered Intervention Network Cohort Study.

Objective: The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 assesses seven health-related quality of life domains plus pain intensity. The objective was to examine PROMIS-29v2 validity and explore clinical associations in patients with SSc. Methods: English-speaking SSc patients in the Scleroderma Patient-centered Intervention Network Cohort from 26 sites in Canada, the USA and the UK completed the PROMIS-29v2 between July 2014 and November 2015. Enrolling physicians provided medical data. To examine convergent validity, hypotheses on the direction and magnitude of correlations with legacy measures were tested. For clinical associations, t -tests were conducted for dichotomous variables and PROMIS-29v2 domain scores. Effect sizes (ESs) were labelled as small (<0.25), small to moderate (0.25-0.45), moderate (0.46-0.55), moderate to large (0.56-0.75) and large (>0.75). Results: There were 696 patients (87% female), mean ( s . d .) disease duration 11.6 (8.7) years, 57% with limited cutaneous subtype. Validity indices were consistent with seven of nine hypotheses (| r | =0.51-0.87, P < 0.001), with minor divergence for two hypotheses. Gastrointestinal involvement was associated with significantly worse outcomes for all eight PROMIS-29v2 domains (moderate or moderate to large ES in six of eight). Presence of joint contractures was associated with significant decrements in seven domains (small or small to moderate ESs). Skin thickening, diffuse cutaneous subtype and presence of overlap syndromes were significantly associated (small or small to moderate ESs) with five or six domains. Conclusion: This study further establishes the validity of the PROMIS-29v2 in SSc and underlines the importance of gastrointestinal symptoms and joint contractures in reduced health-related quality of life.

A randomized, noninferiority, controlled trial of two doses of intravenous subdissociative ketamine for analgesia in the emergency department.

OBJECTIVE: This study aimed to determine if 0.15 mg/kg intravenous (IV) subdissociative ketamine is noninferior to 0.3 mg/kg in emergency department (ED) patients with acute pain. METHODS: This randomized, prospective, double-blinded, noninferiority trial included patients' age 18 to 59 years presenting to the ED with acute moderate to severe pain. Subjects were randomized to IV subdissociative ketamine, 0.15 mg/kg ("low" dose) or 0.30 mg/kg ("high" dose), over 15 minutes. The primary endpoint was the 11-point numeric rating scale (NRS) pain score between groups at 30 minutes. Secondary endpoints included NRS pain scores at 15 and 60 minutes; change in NRS at 15, 30, and 60 minutes; rescue analgesia; and adverse effects. The noninferiority limit, δ0 , was set to 1.3. RESULTS: Forty-nine patients were included in each group. After the differences in the baseline NRS score were adjusted for, the mean NRS score at 30 minutes was 4.7 (95% confidence interval [CI] = 3.8 to 5.5) in the low-dose group and 5.0 (95% CI = 4.2 to 5.8) in the high-dose group (mean difference = 0.4, 95% CI = -0.8 to 1.5), indicating that the low-dose subdissociative ketamine was noninferior to the high dose (lower limit of 95% CI = -0.8 to ≥1.3 = -δ0 ). Adverse effects were similar at 30 minutes. At 15 minutes, the high-dose group experienced greater change in NRS; however, more adverse effects occurred. CONCLUSION: Our data did not detect a large difference in analgesia or adverse effect profile between 0.15 mg/kg IV ketamine and 0.30 mg/kg in the short-term treatment of acute pain in the ED.

Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations.

Introduction Transparent collaborations between patient organisations (POs) and clinical research sponsors (CRS) can identify and address the unmet needs of patients and caregivers. These insights can improve clinical trial participant experience and delivery of medical innovations necessary to advance health outcomes and standards of care. We share our experiences from such a collaboration undertaken surrounding the SENSCIS® clinical trial (NCT02597933), and discuss its impact during, and legacy beyond, the trial.Summary We describe the establishment of a community advisory board (CAB): a transparent, multiyear collaboration between the scleroderma patient community and a CRS. We present shared learnings from the collaboration, which is split into three main areas: (1) the implementation and conduct of the clinical trial; (2) analysis and dissemination of the results; and (3) aspects of the collaboration not related to the trial.1. The scleroderma CAB reviewed and provided advice on trial conduct and reporting. This led to the improvement and optimisation of trial procedures; meaningful, patient-focused adaptations were made to address challenges relevant to scleroderma-associated interstitial lung disease patients.2. To ensure that results of the trial were accessible to lay audiences and patients, written lay summaries were developed by the trial sponsor with valuable input from the CAB to ensure that language and figures were understandable.3. The CAB and the CRS also collaborated to co-develop opening tools for medication blister packs and bottles. In addition, to raise disease awareness among physicians, patients and caregivers, educational materials to improve diagnosis and management of scleroderma were co-created and delivered by the CAB and CRS.Conclusions This collaboration between POs and a CRS, in a rare disease condition, led to meaningful improvements in patient safety, comfort and self-management and addressed information needs. This collaboration may serve as a template of best practice for future collaborations between POs, research sponsors and other healthcare stakeholders.

Shock index in the emergency department: utility and limitations.

Shock index (SI) is defined as the heart rate (HR) divided by systolic blood pressure (SBP). It has been studied in patients either at risk of or experiencing shock from a variety of causes: trauma, hemorrhage, myocardial infarction, pulmonary embolism, sepsis, and ruptured ectopic pregnancy. While HR and SBP have traditionally been used to characterize shock in these patients, they often appear normal in the compensatory phase of shock and can be confounded by factors such as medications (eg, antihypertensives, beta-agonists). SI >1.0 has been widely found to predict increased risk of mortality and other markers of morbidity, such as need for massive transfusion protocol activation and admission to intensive care units. Recent research has aimed to study the use of SI in patients immediately on arrival to the emergency department (ED). In this review, we summarize the literature pertaining to use of SI across a variety of settings in the management of ED patients, in order to provide context for use of this measure in the triage and management of critically ill patients.

Development of Trauma Level Prediction Models Using Emergency Medical Service Vital Signs to Reduce Over- and Undertriage Rates in Penetrating Wounds and Falls of the Elderly.

Determining triage activation levels in geriatric patients who fall (GF), and patients with penetrating wounds can be difficult and inaccurate, resulting in excessive overtriage (OT) and undertriage (UT) rates. We developed trauma activation prediction models using field data to predict with greater accuracy trauma activation level and triage rates consistent with the ACS recommendations. Using data from the 2014 National Trauma Data Bank, we created binary regression equations for each type of injury (GF and penetrating wounds). The 2014 data were randomized and divided into two halves. The first half for each injury type was used to generate prediction models, whereas the second half of the 2014 data were combined with 2013 and 2015 National Trauma Data Bank data for model verification. Binary regression equations were generated from vital signs collected by EMS. A Cribari grid with ISS ≥ 15 was used to determine the appropriateness of activation level. Chi-square analysis was used to determine significant differences between OT, UT, and accuracy predictions. Using our triage models, we were able to obtain UT rates of less than 4 per cent for GF with OT rates of less than 40 per cent, UT rates less than 4.1 per cent and OT of less than 50 per cent for patients with gunshot wounds, and UT rates less than 4 per cent and OT rates less than 25 per cent for patients who had stab wounds. Our developed trauma level prediction models enable health providers to predict trauma activation levels that can result in OT and UT rates in the recommended ranges by the ACS.

Randomized Controlled Trial to Evaluate an Internet-Based Self-Management Program in Systemic Sclerosis.

OBJECTIVE: In a pilot study, our group showed that an internet-based self-management program improves self-efficacy in systemic sclerosis (SSc). The objective of the current study was to compare an internet-based self-management program to a patient-focused educational book developed to assess measures of self-efficacy and other patient-reported outcomes in patients with SSc. METHODS: We conducted a 16-week randomized, controlled trial. RESULTS: Of the 267 participants who completed baseline questionnaires and were randomized to the intervention (internet: www.selfmanagescleroderma.com) or control (book) group, 123 participants (93%) in the internet group and 124 participants (94%) in the control group completed the 16-week randomized controlled trial (RCT). The mean ± SD age of all participants was 53.7 ± 11.7 years, 91% were women, and 79.4% had some college or a higher degree. The mean ± SD disease duration after diagnosis of SSc was 8.97 ± 8.50 years. There were no statistical differences between the 2 groups for the primary outcome measure (Patient-Reported Outcomes Measurement Information System Self-Efficacy for Managing Symptoms: mean change of 0.35 in the internet group versus 0.94 in the control group; P = 0.47) and secondary outcome measures, except the EuroQol 5-domain instrument visual analog scale score (P = 0.05). Internet group participants agreed that the self-management modules were of importance to them, the information was presented clearly, and the website was easy to use and at an appropriate reading level. CONCLUSION: Our RCT showed that the internet-based self-management website was not statistically superior to an educational patient-focused book in improving self-efficacy and other measures. The participants were enthusiastic about the content and presentation of the self-management website.

Use of a Video Module to Improve Faculty Understanding of the Pharmacists' Patient Care Process.

OBJECTIVE: To evaluate change in faculty's knowledge and perceptions after an online video module on the Pharmacists' Patient Care Process (PPCP). INNOVATION: An educational video module on the PPCP was developed and disseminated to full-time faculty members at Samford University, McWhorter School of Pharmacy. Voluntary and anonymous pre- and post-test assessments were evaluated and analyzed. CRITICAL ANALYSIS: Thirty faculty completed the pre-assessment, and 31 completed the post-assessment (73% and 75% response rates, respectively). A significant improvement in faculty perceptions was indicated by an increase in agreement with the majority (80%) of questions on attitudes toward the PPCP on the post-test. Faculty's knowledge of the introduction and assessment of PPCP within the school's curriculum was significantly increased after viewing the video module. After viewing the module, more faculty were also able to correctly identify the majority of the PPCP components and their corresponding practice activities. NEXT STEPS: A short video module was effective at improving faculty knowledge and perceptions of the PPCP. Development of a similar faculty development module is feasible for implementation in other Schools of Pharmacy.

Isolation, Selection, and Efficacy of Pochonia chlamydosporia for Control of Rotylenchulus reniformis on Cotton.

ABSTRACT The reniform nematode, Rotylenchulus reniformis, is a serious threat to cotton (Gossypium hirsutum) production in the United States, causing an annual loss of about $80 million. The objective of this study was to isolate fungi from eggs of R. reniformis and select potential biocontrol agents for R. reniformis on cotton. We focused on the fungus Pochonia chlamydosporia because it suppresses root-knot and cyst nematodes and because preliminary data indicated that it was present in Arkansas cotton fields. Soil samples were collected from six cotton fields in Jefferson County, Arkansas. A total of 117 isolates of the nematophagous fungus P. chlamydosporia were obtained. In an in vitro test, 105 of the 117 isolates parasitized fewer than 15% of R. reniformis eggs, but 12 isolates parasitized between 16 and 35% of the eggs. These 12 isolates produced from 6.8 x 10(4) to 6.9 x 10(5) chlamydospores per gram of medium in vitro, and chlamydospore production was similar on rice grain and corn grain media. In two greenhouse experiments, a single application of isolate 37 (5,000 chlamydospores per gram of soil) significantly reduced the numbers of R. reniformis on cotton roots and in soil. The three isolates (37, 26, and 14) that parasitized the most eggs in vitro were also the most effective in suppressing numbers of R. reniformis and in increasing cotton growth in the greenhouse.

Perceived Stress, Stressors, and Coping Mechanisms among Doctor of Pharmacy Students.

The primary purpose of this study was to examine perceived stress in doctor of pharmacy students during their first, second, and third years of their program in a fully implemented new curriculum. The secondary objectives were to determine if there is a relationship between perceived stress and certain demographic variables, to compare student pharmacist perceived stress to the perceived stress in the general population, and to examine student reported stressors during pharmacy school and coping strategies employed for those stressors. A previously validated survey (Perceived Stress Scale-10) was given to first, second, and third year student pharmacists. Females exhibited higher mean stress scores than males. The under 22 years and over 32 years age categories exhibited higher mean stress scores than the 22 to 26 year old student population. There was no significant difference in perceived stress scores between classes of the program. Only a portion of the variation in stress scores was predicted by gender, age, marital status, race, and year in curriculum. Stress scores among these student pharmacists are higher overall than those in previously published probability samples in the general population. Class assignments and completing electronic portfolios were the top stressors reported. Spending time with family and friends was the most frequent coping mechanism reported. Programming related to stress reduction (particularly among female and nontraditional age students) appears warranted.

A quantitative assessment of a medicinal chemistry problem-based learning sequence.

OBJECTIVES: To establish an aggressive problem-based learning (PBL) format for the medicinal chemistry course and assess the outcomes of student learning. METHODS: To assess learning in the new format, precourse and postcourse examinations were given to students enrolled before and after problem-based learning was implemented, and appropriate statistical analyses were conducted. RESULTS: The PBL cohort did not learn the same amount of factual content yet performed the same on higher-order thought questions as the non-PBL cohort. CONCLUSIONS: Problem-based learning may not be the ideal method for teaching medicinal chemistry. This may be due to several factors including: student learning type, the lack of a cognitive framework for learning in the basic sciences, and time constraints.

Synthesis and stability of two indomethacin prodrugs.

The purpose of this study was to synthesize and study the in vitro enzymatic and non-enzymatic hydrolysis of indomethacin-TEG ester and amide prodrugs. It was found that the ester conjugate 10 was comparatively stable between pH 3 and 6 (half-life>90h), with a half-life equal to 5.2h in 80% buffered plasma. In contrast, the amide conjugate 12 appeared to be stable over the entire pH range studied with the only observed degradation being cleavage of the indolic N-4-chlorobenzoyl moiety.