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1.
N Z Vet J ; 70(1): 49-54, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34499591

ABSTRACT

AIMS: To determine the level and timing of lamb loss that occurs during the first year of life on a typical hill country sheep and beef farm in the central North Island of New Zealand and to determine how much of this loss can be prevented through vaccination against the five main clostridial diseases using a commercially available multivalent clostridial vaccine. METHODS: The study was conducted on a single commercial hill country sheep and beef farm in the central North Island of New Zealand, with a history of never vaccinating their stock against clostridial disease. Lambs were blocked on sex and randomly selected at docking into treatment (n = 1,705 lambs) and control (n = 1,709 lambs) groups. Treated lambs were vaccinated at docking and 4 weeks later with 1 mL of multivalent clostridial vaccine. Control lambs were not vaccinated. Different coloured ear tags were used to identify the lambs in the treatment and control groups. All lambs were counted at docking (October 2019) and at six other management event times between docking and when the replacement hoggets were set stocked for lambing (August 2020). The number of lambs sold between each management event, from each group was also counted. The difference in the number of lambs from one management event to another, minus the lambs sold between these events was regarded as the lamb losses for that period. RESULTS: The total percentage of lamb losses from docking to pre-lamb was 4.8% (81/1,705) and 6.2% (106/1,709) in the vaccinated and unvaccinated lambs respectively OR = 0.75 (95% CI = 0.56-1.02; p = 0.06). Most lamb loss occurred in the period after docking, followed by the period between weaning and the first post-weaning drench. Less lamb loss occurred in the vaccinated lambs (27/1,705; 1.6%) after docking than in the unvaccinated lambs (66/1,709; 3.9%). This was mainly due to lower female lamb losses in the vaccinated (5/868; 0.6%) compared to the unvaccinated (38/868; 4.4%) group (p < 0.001). CONCLUSIONS: Vaccination of lambs at docking and 4 weeks later, with a multivalent 5-in-1 clostridial vaccine was associated with a 23.6% (25/106) reduction in total lamb loss from docking to pre-lambing. In female lambs, vaccination was associated with an 87% (33/38) reduction in lamb loss after docking and a 37% (22/59) reduction over the total trial period.


Subject(s)
Cattle Diseases , Red Meat , Sheep Diseases , Animals , Cattle , Cattle Diseases/prevention & control , Female , New Zealand/epidemiology , Sheep , Sheep Diseases/prevention & control , Vaccination/veterinary , Weaning
3.
Phys Rev Lett ; 124(3): 032502, 2020 Jan 24.
Article in English | MEDLINE | ID: mdl-32031845

ABSTRACT

Radioactive ^{129}Sb, which can be treated as a proton plus semimagic ^{128}Sn core within the particle-core coupling scheme, was studied by Coulomb excitation. Reduced electric quadrupole transition probabilities, B(E2), for the 2^{+}⊗πg_{7/2} multiplet members and candidate πd_{5/2} state were measured. The results indicate that the total electric quadrupole strength of ^{129}Sb is a factor of 1.39(11) larger than the ^{128}Sn core, which is in stark contrast to the expectations of the empirically successful particle-core coupling scheme. Shell-model calculations performed with two different sets of nucleon-nucleon interactions suggest that this enhanced collectivity is due to constructive quadrupole coherence in the wave functions stemming from the proton-neutron residual interactions, where adding one nucleon to a core near a double-shell closure can have a pronounced effect. The enhanced electric quadrupole strength is an early signal of the emerging nuclear collectivity that becomes dominant away from the shell closure.

4.
Qual Life Res ; 27(9): 2443-2451, 2018 Sep.
Article in English | MEDLINE | ID: mdl-29797175

ABSTRACT

PURPOSE: Fatigue is frequent and often severe and disabling in RA, and there is no consensus on how to measure it. We used online surveys and in-person interviews to evaluate PROMIS Fatigue 7a and 8a short forms (SFs) in people with RA. METHODS: We recruited people with RA from an online patient community (n = 200) and three academic medical centers (n = 84) in the US. Participants completed both SFs then rated the comprehensiveness and comprehensibility of the items to their fatigue experience. Cognitive debriefing of items was conducted in a subset of 32 clinic patients. Descriptive statistics were calculated, and associations were evaluated using Pearson and Spearman correlation coefficients. RESULTS: Mean SF scores were similar (p ≥ .61) among clinic patients reflecting mild fatigue (i.e., 54.5-55.9), but were significantly higher (p < .001) in online participants. SF Fatigue scores correlated highly (r ≥ 0.82; p < .000) and moderately with patient assessments of disease activity (r ≥ 0.62; p = .000). Most (70-92%) reported that the items "completely" or "mostly" reflected their experience. Almost all (≥ 94%) could distinguish general fatigue from RA fatigue. Most (≥ 85%) rated individual items questions as "somewhat" or "very relevant" to their fatigue experience, averaged their fatigue over the past 7 days (58%), and rated fatigue impact versus severity (72 vs. 19%). 99% rated fatigue as an important symptom they considered when deciding how well their current treatment was controlling their RA. CONCLUSIONS: Results suggest that items in the single-score PROMIS Fatigue SFs demonstrate content validity and can adequately capture the wide range of fatigue experiences of people with RA.


Subject(s)
Arthritis, Rheumatoid/complications , Education, Distance/methods , Fatigue/etiology , Interview, Psychological/methods , Arthritis, Rheumatoid/pathology , Fatigue/pathology , Female , Humans , Male , Middle Aged , Quality of Life , Reproducibility of Results , Surveys and Questionnaires
5.
Ann Rheum Dis ; 76(1): 96-104, 2017 Jan.
Article in English | MEDLINE | ID: mdl-27165179

ABSTRACT

OBJECTIVES: To assess the efficacy and safety of certolizumab pegol (CZP)+dose-optimised methotrexate (MTX) versus placebo (PBO)+dose-optimised MTX in inducing and sustaining clinical remission in DMARD-naïve patients with moderate-to-severe, active, progressive rheumatoid arthritis (RA), with poor prognostic factors over 52 weeks. METHODS: DMARD-naïve patients with ≤1 year of active RA were randomised (3:1) in a double-blind manner to CZP (400 mg Weeks 0, 2, 4, then 200 mg Q2W to Week 52)+MTX or PBO+MTX (the mean optimised-MTX dose=21 and 22 mg/week, respectively). Sustained remission (sREM) and sustained low disease activity (sLDA; DAS28(ESR)<2.6 and DAS28(ESR)≤3.2, respectively, at both Weeks 40 and 52) were the primary and secondary endpoints. RESULTS: Patients were randomised to CZP+MTX (n=660) and PBO+MTX (n=219). At Week 52, significantly more patients assigned to CZP+MTX compared with PBO+MTX achieved sREM (28.9% vs 15.0%, p<0.001) and sLDA (43.8% vs 28.6%, p<0.001). Inhibition of radiographic progression and improvements in physical functioning were significantly greater for CZP+MTX versus PBO+MTX (van der Heijde modified total Sharp score (mTSS) mean absolute change from baseline (CFB): 0.2 vs 1.8, p<0.001, rate of mTSS non-progressors: 70.3% vs 49.7%, p<0.001; least squares (LS) mean CFB in Health Assessment Questionnaire-Disability Index (HAQ-DI): -1.00 vs -0.82, p<0.001). Incidence of adverse events (AEs) and serious AEs was similar between treatment groups. Infection was the most frequent AE, with higher incidence for CZP+MTX (71.8/100 patient-years (PY)) versus PBO+MTX (52.7/100 PY); the rate of serious infection was similar between CZP+MTX (3.3/100 PY) and PBO+MTX (3.7/100 PY). CONCLUSIONS: CZP+dose-optimised MTX treatment of DMARD-naïve early RA resulted in significantly more patients achieving sREM and sLDA, improved physical function and inhibited structural damage compared with PBO+dose-optimised MTX. TRIAL REGISTRATION NUMBER: NCT01519791.


Subject(s)
Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , Certolizumab Pegol/therapeutic use , Methotrexate/therapeutic use , Adult , Antirheumatic Agents/administration & dosage , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/diagnostic imaging , Certolizumab Pegol/adverse effects , Double-Blind Method , Drug Therapy, Combination/adverse effects , Female , Humans , Infections/chemically induced , Male , Methotrexate/administration & dosage , Methotrexate/adverse effects , Middle Aged , Prognosis , Radiography , Remission Induction
6.
Phys Rev Lett ; 118(9): 092503, 2017 Mar 03.
Article in English | MEDLINE | ID: mdl-28306272

ABSTRACT

Radioactive ^{136}Te has two valence protons and two valence neutrons outside of the ^{132}Sn double shell closure, providing a simple laboratory for exploring the emergence of collectivity and nucleon-nucleon interactions. Coulomb excitation of ^{136}Te on a titanium target was utilized to determine an extensive set of electromagnetic moments for the three lowest-lying states, including B(E2;0_{1}^{+}→2_{1}^{+}), Q(2_{1}^{+}), and g(2_{1}^{+}). The results indicate that the first-excited state, 2_{1}^{+}, composed of the simple 2p⊕2n system, is prolate deformed, and its wave function is dominated by excited valence neutron configurations, but not to the extent previously suggested. It is demonstrated that extreme sensitivity of g(2_{1}^{+}) to the proton and neutron contributions to the wave function provides unique insight into the nature of emerging collectivity, and g(2_{1}^{+}) was used to differentiate among several state-of-the-art theoretical calculations. Our results are best described by the most recent shell model calculations.

7.
Am J Public Health ; 107(1): 166-172, 2017 01.
Article in English | MEDLINE | ID: mdl-27854530

ABSTRACT

OBJECTIVES: To evaluate the impact of the partial repeal of Michigan's universal motorcycle helmet law on helmet use, fatalities, and head injuries. METHODS: We compared helmet use rates and motorcycle crash fatality risk for the 12 months before and after the April 13, 2012, repeal with a statewide police-reported crash data set. We linked police-reported crashes to injured riders in a statewide trauma registry. We compared head injury before and after the repeal. Regression examined the effect of helmet use on fatality and head injury risk. RESULTS: Helmet use decreased in crash (93.2% vs 70.8%; P < .001) and trauma data (91.1% vs 66.2%; P < .001) after the repeal. Although fatalities did not change overall (3.3% vs 3.2%; P = .87), head injuries (43.4% vs 49.6%; P < .05) and neurosurgical intervention increased (3.7% vs 6.5%; P < .05). Male gender (adjusted odds ratio [AOR] = 1.65), helmet nonuse (AOR = 1.84), alcohol intoxication (AOR = 11.31), intersection crashes (AOR = 1.62), and crashes at higher speed limits (AOR = 1.04) increased fatality risk. Helmet nonuse (AOR = 2.31) and alcohol intoxication (AOR = 2.81) increased odds of head injury. CONCLUSIONS: Michigan's helmet law repeal resulted in a 24% to 27% helmet use decline among riders in crashes and a 14% increase in head injury.


Subject(s)
Accidents, Traffic/statistics & numerical data , Craniocerebral Trauma/epidemiology , Head Protective Devices/statistics & numerical data , Motorcycles/legislation & jurisprudence , Accidents, Traffic/mortality , Adolescent , Adult , Craniocerebral Trauma/mortality , Female , Humans , Male , Michigan/epidemiology , Middle Aged , Retrospective Studies
8.
N Z Vet J ; 65(3): 152-155, 2017 May.
Article in English | MEDLINE | ID: mdl-27750502

ABSTRACT

AIM: To determine if there was a benefit from treating ewes with a low body condition score (BCS) with long acting anthelmintic products pre-lambing and to compare the effects of two commonly used treatment options. METHODS: The study was conducted on a single commercial hill country sheep and beef property in the central North Island of New Zealand. Mixed age twin-bearing ewes were preselected by the farmer as being in poor condition 4 weeks before the planned start of lambing, and were sequentially drafted into three equal groups identified with coloured ear tags. The negative control group (n=199) received no anthelmintic treatment; the other two groups received either a controlled release capsule (CRC) containing abamectin, albendazole, Se and Co (n=200) or a long-acting injection of moxidectin (n=200). All ewes were body condition scored (1-5 scale) and weighed at pre-lambing, docking (65 days after treatment) and at weaning (127 days after treatment). Faecal nematode egg counts (FEC) were carried out on 10 ewes from each group at these three times. Most lambs were matched to the ewe treatment groups at weaning, and weighed. RESULTS: At weaning the mean body weight of ewes treated with moxidectin was 3.2 (95% CI=2.3-4.3) kg heavier than controls, and of ewes treated with CRC was 3.6 (95% CI=2.5-4.5) kg heavier than control ewes (p<0.001). At the start of the trial only 61/599 (10.2%) ewes had a BCS≥3. At weaning, more ewes treated with CRC (140/194; 72%) or moxidectin (122/187; 65%) had a BCS≥3 than control ewes (55/179 (31%); p<0.001). In lambs that were matched with ewes from the treatment groups, the mean weight at weaning of lambs from ewes treated with moxidectin was 2.6 (95% CI=1.9-3.3) kg heavier, and from ewes treated with CRC was 2.6 (95% CI=1.9-3.4) kg heavier than lambs from control ewes (p<0.001). CONCLUSIONS AND CLINICAL RELEVANCE: Treating twin-bearing ewes with low BCS pre-lambing with long acting anthelmintic treatments (moxidectin long acting injection or CRC) resulted in an increase in mean body weight of the ewes and lambs at weaning. There were no significant differences between the two pre-lambing treatments used. These results were based on a single property and thus cannot be generalised to all properties where management conditions and parasite populations may differ.


Subject(s)
Anthelmintics/pharmacology , Body Composition , Nematode Infections/veterinary , Sheep/physiology , Animals , Anthelmintics/administration & dosage , Body Weight , Female , Nematode Infections/drug therapy , Parasite Egg Count , Pregnancy , Sheep/growth & development
9.
N Engl J Med ; 368(23): 2169-81, 2013 Jun 06.
Article in English | MEDLINE | ID: mdl-23738544

ABSTRACT

BACKGROUND: Atypical hemolytic-uremic syndrome is a genetic, life-threatening, chronic disease of complement-mediated thrombotic microangiopathy. Plasma exchange or infusion may transiently maintain normal levels of hematologic measures but does not treat the underlying systemic disease. METHODS: We conducted two prospective phase 2 trials in which patients with atypical hemolytic-uremic syndrome who were 12 years of age or older received eculizumab for 26 weeks and during long-term extension phases. Patients with low platelet counts and renal damage (in trial 1) and those with renal damage but no decrease in the platelet count of more than 25% for at least 8 weeks during plasma exchange or infusion (in trial 2) were recruited. The primary end points included a change in the platelet count (in trial 1) and thrombotic microangiopathy event-free status (no decrease in the platelet count of >25%, no plasma exchange or infusion, and no initiation of dialysis) (in trial 2). RESULTS: A total of 37 patients (17 in trial 1 and 20 in trial 2) received eculizumab for a median of 64 and 62 weeks, respectively. Eculizumab resulted in increases in the platelet count; in trial 1, the mean increase in the count from baseline to week 26 was 73×10(9) per liter (P<0.001). In trial 2, 80% of the patients had thrombotic microangiopathy event-free status. Eculizumab was associated with significant improvement in all secondary end points, with continuous, time-dependent increases in the estimated glomerular filtration rate (GFR). In trial 1, dialysis was discontinued in 4 of 5 patients. Earlier intervention with eculizumab was associated with significantly greater improvement in the estimated GFR. Eculizumab was also associated with improvement in health-related quality of life. No cumulative toxicity of therapy or serious infection-related adverse events, including meningococcal infections, were observed through the extension period. CONCLUSIONS: Eculizumab inhibited complement-mediated thrombotic microangiopathy and was associated with significant time-dependent improvement in renal function in patients with atypical hemolytic-uremic syndrome. (Funded by Alexion Pharmaceuticals; C08-002 ClinicalTrials.gov numbers, NCT00844545 [adults] and NCT00844844 [adolescents]; C08-003 ClinicalTrials.gov numbers, NCT00838513 [adults] and NCT00844428 [adolescents]).


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Complement C5/antagonists & inhibitors , Hemolytic-Uremic Syndrome/drug therapy , Thrombotic Microangiopathies/prevention & control , Adolescent , Adult , Aged , Antibodies, Monoclonal, Humanized/adverse effects , Antibodies, Monoclonal, Humanized/blood , Antibodies, Monoclonal, Humanized/pharmacokinetics , Combined Modality Therapy , Female , Hemolytic-Uremic Syndrome/blood , Hemolytic-Uremic Syndrome/genetics , Hemolytic-Uremic Syndrome/therapy , Humans , Kidney Diseases/drug therapy , Kidney Diseases/etiology , Male , Middle Aged , Mutation , Plasma Exchange , Platelet Count , Quality of Life , Young Adult
10.
Phys Rev Lett ; 116(12): 122502, 2016 Mar 25.
Article in English | MEDLINE | ID: mdl-27058074

ABSTRACT

The lifetimes of the first excited 2^{+} and 4^{+} states in ^{72}Ni were measured at the National Superconducting Cyclotron Laboratory with the recoil-distance Doppler-shift method, a model-independent probe to obtain the reduced transition probability. Excited states in ^{72}Ni were populated by the one-proton knockout reaction of an intermediate energy ^{73}Cu beam. γ-ray-recoil coincidences were detected with the γ-ray tracking array GRETINA and the S800 spectrograph. Our results provide evidence of enhanced transition probability B(E2;2^{+}→0^{+}) as compared to ^{68}Ni, but do not confirm the trend of large B(E2) values reported in the neighboring isotope ^{70}Ni obtained from Coulomb excitation measurement. The results are compared to shell model calculations. The lifetime obtained for the excited 4_{1}^{+} state is consistent with models showing decay of a seniority ν=4, 4^{+} state, which is consistent with the disappearance of the 8^{+} isomer in ^{72}Ni.

11.
Transp Res Part F Traffic Psychol Behav ; 41(A): 124-137, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27818610

ABSTRACT

OBJECTIVE: Serious crashes are more likely when teenage drivers have teenage passengers. One likely source of this increased risk is social influences on driving performance. This driving simulator study experimentally tested the effects of peer influence (i.e., risk-accepting compared to risk-averse peer norms reinforced by pressure) on the driving risk behavior (i.e., risky driving behavior and inattention to hazards) of male teenagers. It was hypothesized that peer presence would result in greater driving risk behavior (i.e., increased driving risk and reduced latent hazard anticipation), and that the effect would be greater when the peer was risk-accepting. METHODS: Fifty-three 16- and 17-year-old male participants holding a provisional U.S., State of Michigan driver license were randomized to either a risk-accepting or risk-averse condition. Each participant operated a driving simulator while alone and separately with a confederate peer passenger. The simulator world included scenarios designed to elicit variation in driving risk behavior with a teen passenger present in the vehicle. RESULTS: Significant interactions of passenger presence (passenger present vs. alone) by risk condition (risk-accepting vs. risk-averse) were observed for variables measuring: failure to stop at yellow light intersections (Incident Rate Ratio (IRR)=2.16; 95% Confidence Interval [95CI]=1.06, 4.43); higher probability of overtaking (IRR=10.17; 95CI=1.43, 73.35); shorter left turn latency (IRR=0.43; 95CI=0.31,0.60); and, failure to stop at an intersection with an occluded stop sign (IRR=7.90; 95CI=2.06,30.35). In all cases, greater risky driving by participants was more likely with a risk-accepting passenger versus a risk-averse passenger present and a risk-accepting passenger present versus driving alone. CONCLUSIONS: Exposure of male teenagers to a risk-accepting confederate peer passenger who applied peer influence increased simulated risky driving behavior compared with exposure to a risk-averse confederate peer passenger or driving alone. These results are consistent with the contention that variability in teenage risky driving is in part explained by social influences.

12.
J Cogn Neurosci ; 27(1): 83-95, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25100217

ABSTRACT

Adolescence is a period characterized by increased sensitivity to social cues, as well as increased risk-taking in the presence of peers. For example, automobile crashes are the leading cause of death for adolescents, and driving with peers increases the risk of a fatal crash. Growing evidence points to an interaction between neural systems implicated in cognitive control and social and emotional context in predicting adolescent risk. We tested such a relationship in recently licensed teen drivers. Participants completed an fMRI session in which neural activity was measured during a response inhibition task, followed by a separate driving simulator session 1 week later. Participants drove alone and with a peer who was randomly assigned to express risk-promoting or risk-averse social norms. The experimentally manipulated social context during the simulated drive moderated the relationship between individual differences in neural activity in the hypothesized cognitive control network (right inferior frontal gyrus, BG) and risk-taking in the driving context a week later. Increased activity in the response inhibition network was not associated with risk-taking in the presence of a risky peer but was significantly predictive of safer driving in the presence of a cautious peer, above and beyond self-reported susceptibility to peer pressure. Individual differences in recruitment of the response inhibition network may allow those with stronger inhibitory control to override risky tendencies when in the presence of cautious peers. This relationship between social context and individual differences in brain function expands our understanding of neural systems involved in top-down cognitive control during adolescent development.


Subject(s)
Automobile Driving/psychology , Brain/physiology , Inhibition, Psychological , Peer Group , Psychomotor Performance/physiology , Social Behavior , Adolescent , Adolescent Behavior/physiology , Adolescent Behavior/psychology , Brain/growth & development , Brain Mapping , Computer Simulation , Executive Function/physiology , Humans , Individuality , Magnetic Resonance Imaging , Male , Neural Pathways/growth & development , Neural Pathways/physiology , Risk-Taking , Self Report
13.
Am J Public Health ; 105(5): 1028-35, 2015 May.
Article in English | MEDLINE | ID: mdl-25790385

ABSTRACT

OBJECTIVES: We estimated the injury prevention impact and cost savings associated with alcohol interlock installation in all new US vehicles. METHODS: We identified fatal and nonfatal injuries associated with drinking driver vehicle crashes from the Fatality Analysis Reporting System and National Automotive Sampling System's General Estimates System data sets (2006-2010). We derived the estimated impact of universal interlock installation using an estimate of the proportion of alcohol-related crashes that were preventable in vehicles < 1 year-old. We repeated this analysis for each subsequent year, assuming a 15-year implementation. We applied existing crash-induced injury cost metrics to approximate economic savings, and we used a sensitivity analysis to examine results with varying device effectiveness. RESULTS: Over 15 years, 85% of crash fatalities (> 59 000) and 84% to 88% of nonfatal injuries (> 1.25 million) attributed to drinking drivers would be prevented, saving an estimated $342 billion in injury-related costs, with the greatest injury and cost benefit realized among recently legal drinking drivers. Cost savings outweighed installation costs after 3 years, with the policy remaining cost effective provided device effectiveness remained above approximately 25%. CONCLUSIONS: Alcohol interlock installation in all new vehicles is likely a cost-effective primary prevention policy that will substantially reduce alcohol-involved crash fatalities and injuries, especially among young vulnerable drivers.


Subject(s)
Accidents, Traffic/prevention & control , Alcoholic Intoxication/prevention & control , Automobile Driving/legislation & jurisprudence , Breath Tests/instrumentation , Protective Devices/economics , Adult , Aged , Cost Savings , Cost-Benefit Analysis , Female , Humans , Male , Middle Aged , Models, Econometric , Wounds and Injuries/economics , Wounds and Injuries/prevention & control
14.
Phys Rev Lett ; 112(17): 172701, 2014 May 02.
Article in English | MEDLINE | ID: mdl-24836240

ABSTRACT

Single-neutron states in (133)Sn and (209)Pb, which are analogous to single-electron states outside of closed atomic shells in alkali metals, were populated by the ((9)Be, (8)Be) one-neutron transfer reaction in inverse kinematics using particle-γ coincidence spectroscopy. In addition, the s(1/2) single-neutron hole-state candidate in (131)Sn was populated by ((9)Be, (10)Be). Doubly closed-shell (132)Sn (radioactive) and (208)Pb (stable) beams were used at sub-Coulomb barrier energies of 3 MeV per nucleon. Level energies, γ-ray transitions, absolute cross sections, spectroscopic factors, asymptotic normalization coefficients, and excited-state lifetimes are reported and compared with shell-model expectations. The results include a new transition and precise level energy for the 3p(1/2) candidate in (133)Sn, new absolute cross sections for the 1h(9/2) candidate in (133)Sn and 3s(1/2) candidate in (131)Sn, and new lifetimes for excited states in (133)Sn and (209)Pb. This is the first report on excited-state lifetimes of (133)Sn, which allow for a unique test of the nuclear shell model and (132)Sn double-shell closure.

15.
Semin Arthritis Rheum ; 64: 152339, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38141522

ABSTRACT

BACKGROUND: A series of qualitative studies conducted by the OMERACT Myositis Working Group identified pain interference, fatigue, and physical function as highly important life impact domains for adults with idiopathic inflammatory myositis (IIM). In this study, our goal was to assess the responsiveness and minimal important difference of PROMIS pain interference (6a), fatigue (7a), and physical function (8b). METHODS: Adults with IIM from USA, Netherlands, Korea, Sweden, and Australia with two "clinical" visits were enrolled in this prospective study. Anchor questions on a Likert scale were collected at baseline, and manual muscle testing (MMT), physician and patient reported global disease activity, and PROMIS instruments were collected at both visits. Responsiveness was assessed with i) ANOVA, ii) paired t-test, effect size and standardized response mean, and iii) Pearson correlation. Minimal important difference (MID), minimal important change (MIC) and minimal detectable change (MDC) values were calculated. RESULTS: 114 patients with IIM (median age 60, 60 % female) completed both visits. Changes in PROMIS instruments were significantly different among anchor categories. Patients who reported improvement had a significant improvement in their PROMIS scores with at least medium effect size, while patients who reported worsening and stability did not show a significant change with weak effect size. PROMIS instruments had weak to moderate correlations with MMT, patient and physician global disease activity. MID was approximately 2-3 points for Pain Interference and 3-4 points for Fatigue and Physical Function forms based on the method used. MIC was approximately 4-5 for improvement of all the instruments, while MDC was 1.7-2 points for Pain Interference and Physical Function and 3.2-3.9 for Fatigue. CONCLUSION: This study provides evidence towards the responsiveness of the PROMIS instruments in a large international prospective cohort of adults with IIM supporting their use as PROMs in adult myositis.


Subject(s)
Myositis , Patient Reported Outcome Measures , Adult , Humans , Female , Male , Prospective Studies , Pain , Myositis/complications , Myositis/diagnosis , Fatigue/diagnosis , Fatigue/etiology
16.
Arthritis Rheum ; 64(2): 360-70, 2012 Feb.
Article in English | MEDLINE | ID: mdl-22389919

ABSTRACT

OBJECTIVE: To evaluate the safety and efficacy of ocrelizumab plus methotrexate (MTX) or leflunomide (LEF) in patients with active rheumatoid arthritis (RA) and an inadequate response to tumor necrosis factor α inhibitors. METHODS: This was a multicenter randomized, double-blind, placebo-controlled, parallel-group study that continued over 48 weeks. Patients receiving stable doses of MTX or LEF were randomized to receive 2 infusions of placebo (n = 277), ocrelizumab 200 mg (n = 278), or ocrelizumab 500 mg (n = 285) on days 1 and 15 as well as at weeks 24 and 26. Coprimary end points were the proportion of patients with response according to the American College of Rheumatology 20% improvement criteria (ACR20) at weeks 24 and 48. Secondary end points included the change from baseline in the modified Sharp/van der Heijde score (SHS) and the ACR50/70 responses. RESULTS: ACR20 responses were 22.0% in the placebo group, 42.2% in the ocrelizumab 200 mg group, and 47.9% in the ocrelizumab 500 mg group at 24 weeks and 19.5%, 48.7%, and 50.7%, respectively, at 48 weeks (P < 0.0001 versus placebo for each comparison at each time point). At 48 weeks, patients receiving both doses of ocrelizumab showed significantly improved ACR50 and ACR70 responses of ~3-fold versus placebo. Only those in the ocrelizumab 500 mg group showed statistically significant (P = 0.0017) inhibition of joint damage progression (mean change in the SHS) relative to placebo (61% inhibition) at 48 weeks. Overall adverse events and infections during the 48 weeks of study were comparable in all treatment groups. Serious infections were observed more frequently in patients taking ocrelizumab (5.1% and 4.3%) than in those taking placebo (2.5%). CONCLUSION: Patients in both of the ocrelizumab groups met the clinical primary efficacy end points. Inhibition of change in the SHS was statistically significant at 48 weeks for those in the ocrelizumab 500 mg group. The rate of serious infections in this trial was higher for both ocrelizumab doses as compared with placebo.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Adult , Aged , Antibodies, Monoclonal, Humanized/adverse effects , Antirheumatic Agents/adverse effects , Double-Blind Method , Female , Humans , Male , Middle Aged , Treatment Outcome
17.
Osteoarthritis Cartilage ; 20(2): 93-101, 2012 Feb.
Article in English | MEDLINE | ID: mdl-22178465

ABSTRACT

OBJECTIVE: Total joint replacement has been proposed as an endpoint in disease modifying osteoarthritis drug (DMOAD) randomized clinical trials (RCTs); however, disparities have generated concerns regarding this outcome. A combined Osteoarthritis Research Society International (OARSI)/Outcome Measures in Rheumatology (OMERACT) initiative was launched in 2004 to develop a composite index ['virtual total joint replacement' (VJR)] as a surrogate outcome for osteoarthritis (OA) progression in DMOAD RCTs. Our objective was to evaluate the prevalence of patients fulfilling different thresholds of sustained pain, reduced function, and X-ray change in existing DMOAD RCTs. DESIGN: Post hoc analysis of summary data from the placebo arm of eight DMOAD RCTs. RESULTS: Eight OA RCTs representing 1379 patients were included. Pain was assessed by WOMAC and/or VAS and function by WOMAC and/or Lequesne. Among six knee and two hip studies, 248 (22%) and 132 (51%) patients respectively had X-ray progression [decrease joint space width (JSW) ≥0.5 mm]. The prevalence of patients fulfilling clinical and radiographic criteria was highest (n = 163, 12%) in the least stringent scenario (pain + function ≥80 at ≥2 visits); with few patients (n = 129, 2%) in the most stringent scenario (pain + function ≥80 at ≥4 visits). Using these prevalence data, a sample size of 352-2144 per group would be needed to demonstrate a 50% difference between groups. CONCLUSIONS: The prevalence of patients with sustained symptomatic OA of at least a moderate degree with X-ray progression is low. Even using lenient criteria to define VJR, large patient numbers would be required to detect differences between groups in DMOAD RCTs. Investigation of the optimal cutoff threshold and combination of symptoms and radiographic change should be pursued.


Subject(s)
Antirheumatic Agents/therapeutic use , Osteoarthritis/drug therapy , Randomized Controlled Trials as Topic/methods , Severity of Illness Index , Arthroplasty, Replacement , Disease Progression , Endpoint Determination , Humans , Osteoarthritis/diagnostic imaging , Osteoarthritis/physiopathology , Pain Measurement/methods , Pain Threshold , Placebos , Radiography , Treatment Outcome
18.
Phys Rev Lett ; 109(3): 032504, 2012 Jul 20.
Article in English | MEDLINE | ID: mdl-22861842

ABSTRACT

The nucleus 49Sc, having a single f(7/2) proton outside doubly magic 48Ca (Z=20, N=28), is one of the very few isotopes which makes possible testing of the fundamental theory of nuclear magnetism. The magnetic moment has been measured by online ß NMR of nuclei oriented at milli-Kelvin temperatures to be (+)5.616(25) µ(N). The result is discussed in terms of a detailed theory of the structure of the magnetic moment operator, showing excellent agreement with calculated departure from the f(7/2) Schmidt limit extreme single-particle value. The measurement completes the sequence of moments of Sc isotopes with even numbers of f(7/2) neutrons: the first such isotopic chain between two major shells for which a full set of moment measurements exists. The result further completes the isotonic sequence of ground-state moments of nuclei with an odd number of f(7/2) protons coupled to a closed subshell of f(7/2) neutrons. Comparison with a recent shell-model calculation of the latter sequence is made.

20.
Int J Behav Nutr Phys Act ; 8: 96, 2011 Sep 14.
Article in English | MEDLINE | ID: mdl-21917136

ABSTRACT

BACKGROUND: Active transportation including walking and bicycling is an important source of physical activity. Promoting active transportation is a challenge for the fields of public health and transportation. Descriptive data on the predictors of active transportation, including seasonal patterns in active transportation in the US as a whole, is needed to inform interventions and policies. METHODS: This study analyzed monthly variation in active transportation for the US using National Household Travel Survey 2001 data. For each age group of children, adolescents, adults and elderly, logistic regression models were used to identify predictors of the odds of active transportation including gender, race/ethnicity, household income level, geographical region, urbanization level, and month. RESULTS: The probability of engaging in active transportation was generally higher for children and adolescents than for adults and the elderly. Active transportation was greater in the lower income groups (except in the elderly), was lower in the South than in other regions of the US, and was greater in areas with higher urbanization. The percentage of people using active transportation exhibited clear seasonal patterns: high during summer months and low during winter months. Children and adolescents were more sensitive to seasonality than other age groups. Women, non-Caucasians, persons with lower household income, who resided in the Midwest or Northeast, and who lived in more urbanized areas had greater seasonal variation. CONCLUSIONS: These descriptive results suggest that interventions and policies that target the promotion of active transportation need to consider socio-demographic factors and seasonality.


Subject(s)
Bicycling/statistics & numerical data , Seasons , Transportation/statistics & numerical data , Walking/statistics & numerical data , Adolescent , Adult , Age Factors , Aged , Child , Child, Preschool , Female , Health Promotion , Humans , Income , Logistic Models , Male , Middle Aged , Public Health , Racial Groups , Sex Factors , Travel , United States , Urban Population , Young Adult
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