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  • Article
    Huhn GD, Sigman A, Livak B.
    Antivir Ther. 2015;20(8):849-54.
    BACKGROUND: DRIVESHAFT is a randomized, open-label, 48-week clinical trial that examined virological outcomes and safety of antiretroviral simplification among virologically suppressed, treatment-experienced HIV-infected patients switching from darunavir/ritonavir (DRV/r) twice-daily-based regimens to a once-daily DRV/r component.
    METHODS: HIV-infected adults with a stable antiretroviral regimen including DRV/r 600/100 mg twice daily plus a minimum of two other antiretrovirals, <2 historical DRV-associated mutations and HIV RNA<40 copies/ml for at least 12 weeks prior to entry were eligible. Participants were randomized 1:1 to switch DRV/r to 800/100 mg once daily or maintain their current regimen. The primary end point was HIV-1 RNA<40 copies/ml at week 48 using the Snapshot algorithm.
    RESULTS: Demographics and baseline characteristics were similar between arms. Virological suppression was greater in the DRV/r once-daily (n=30) versus twice-daily (n=30) arm at week 48 (90.0% versus 83.3%; 95% CI: -11.5, 24.8). Three subjects discontinued the once-daily arm, with four discontinuations and one virological failure in the twice-daily arm. No discontinuations were related to adverse events. Reduction in LDL was significantly greater in the once-daily arm at week 24 (-8.0 mg/dl versus 3.3 mg/dl; P=0.04). There was a trend towards suboptimal adherence <90% to antiretrovirals among subjects taking twice-daily versus once-daily DRV/r by week 48 (12.0% versus 0.0%; P=0.06).
    CONCLUSIONS: Switching from twice-daily to once-daily DRV/r in virologically suppressed patients maintains virological control, with greater reduction in LDL cholesterol by 24 weeks. This study provides pilot data that could be used to design a non-inferiority study to definitively answer the question of whether switching from twice-daily to once-daily DRV/r maintains viral suppression. ClinicalTrials.gov number: NCT01423812.
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  • Article
    Lee EQ, Muzikansky A, Drappatz J, Kesari S, Wong ET, Fadul CE, Reardon DA, Norden AD, Nayak L, Rinne ML, Alexander BM, Arvold ND, Doherty L, Stefanik J, LaFrankie D, Ruland SF, Pulverenti J, Smith KH, Gaffey SC, Hammond S, Wen PY.
    Neuro Oncol. 2016 06;18(6):849-54.
    BACKGROUND: Fatigue is common among glioma patients undergoing radiotherapy (RT) and impacts quality of life (QOL). We evaluated whether armodafinil, a wakefulness-promoting medication, improves fatigue in glioma patients undergoing RT.
    METHODS: Eligibility criteria included age ≥18 years, Karnofsky performance status ≥60, and grade 2-4 glioma undergoing RT to a total dose of 50-60 Gy. Patients were randomized 1:1 to armodafinil or placebo for 8 weeks beginning within 10 days of starting RT. Fatigue and QOL were assessed at baseline, day 22, day 43, and day 56 with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), the Functional Assessment of Cancer Therapy - General (FACT-G), the Brief Fatigue Inventory (BFI), and the Cancer Fatigue Scale (CFS). The primary aim was to detect a difference in the 42-day change in FACIT-F fatigue subscale between the 2 groups using a 2-sample Wilcoxon statistic.
    RESULTS: We enrolled 81 patients total (42 armodafinil and 39 placebo). Armodafinil did not significantly improve fatigue or QOL based on the 42-day change in FACIT-F fatigue subscale, FACT-G, CFS, or BFI. Further analysis suggests no difference between the arms even after accounting for the potential bias of missing data. Treatment was well tolerated with few grade 3 or 4 toxicities.
    CONCLUSIONS: While treatment was well-tolerated, an 8-week course of armodafinil did not improve fatigue or QOL in glioma patients undergoing RT in this pilot study. Further studies are needed to determine whether pharmacologic treatment improves fatigue in glioma patients undergoing RT.
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  • Article
    Lawler M, Kaplan R, Wilson RH, Maughan T, S-CORT Consortium.
    Oncologist. 2015 Aug;20(8):849-51.
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  • Article
    Hoang A, Shen C, Zheng J, Taylor S, Groh WJ, Rosenman M, Buxton AE, Chen PS.
    Heart Rhythm. 2014 May;11(5):849-55.
    BACKGROUND: Utilization rates (URs) for implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden cardiac death (PPSCD) are lacking in the community.
    OBJECTIVE: The purpose of this study was to establish the ICD UR in central Indiana.
    METHODS: A query run on 2 hospitals in a health information exchange database in Indianapolis identified patients between 2011 and 2012 with left ventricular ejection fraction (EF) ≤0.35. ICD eligibility and utilization were determined from chart review.
    RESULTS: We identified 1863 patients with at least 1 low EF study. Two cohorts were analyzed: 1672 patients without and 191 patients with International Classification of Diseases, Ninth Revision, Clinical Modification procedure code 37.94 for ICD placement. We manually reviewed a stratified (by hospital) random sample of 300 patients from the no-ICD procedure code cohort and found that 48 (16%) had no ICD but had class I indications for ICD. Eight of 300 (2.7%) actually had ICD implantation for PPSCD. Review of all 191 patients in the ICD procedure code cohort identified 70 with ICD implantation for PPSCD. The ICD UR (ratio between patients with ICD for PPSCD and all with indication) was 38% overall (95% confidence interval [CI] 28%-49%). URs were 48% for males (95% CI 34%-61%), 21% for females (95% CI 16%-26%, P = .0002 vs males), 40% for whites (95% CI 27%-53%), and 37% for blacks (95% CI 28%-46%, P = .66 vs whites).
    CONCLUSION: ICD UR is 38% among patients meeting class I indications, suggesting further opportunities for improving guideline compliance. This study also illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review.
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  • Article
    Brose LS, Chong CB, Aspinall E, Michie S, McEwen A.
    Psychol Health. 2014;29(7):849-60.
    OBJECTIVE: To assess whether standardised packs of the form introduced in Australia are associated with a reduction in acute craving and/or an increase in motivation to stop, and to replicate previous findings on perceptions of packaging, perceptions of smokers using it and perceived effects on behaviour.
    DESIGN: Following abstinence of at least 12 h, 98 regular and occasional smokers were randomised to exposure to their own cigarette package, another branded package or a standardised package.
    MAIN OUTCOME MEASURES: Craving (QSU-brief), motivation to stop, both at baseline and post-exposure. Ratings of 10 attributes concerning package design, perceived smoker characteristics and effects on behaviour, post-exposure only.
    RESULTS: For craving, a mixed model ANCOVA showed a significant interaction of packaging and time of measurement (F(2,94) = 8.77, p < .001, partial η(2) = .16). There was no significant main effect or interaction for motivation to stop smoking (p = .9). The standardised pack was perceived to be significantly less appealing and less motivating to buy cigarettes, smokers using them were perceived as less popular and cigarettes from them expected to taste worse.
    CONCLUSION: Standardised cigarette packaging may reduce acute (hedonic) craving and is associated with more negative perceptions than branded packaging with less prominent health warnings.
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  • Article
    Seimon RV, Espinoza D, Finer N, James WP, Legler UF, Coutinho W, Sharma AM, Van Gaal L, Maggioni AP, Sweeting A, Torp-Pedersen C, Gebski V, Caterson ID.
    Int J Obes (Lond). 2015 May;39(5):849-57.
    BACKGROUND/OBJECTIVES: The Sibutramine Cardiovascular OUTcomes (SCOUT) trial showed a significantly increased relative risk of nonfatal cardiovascular events, but not mortality, in overweight and obese subjects receiving long-term sibutramine treatment with diet and exercise. We examined the relationship between early changes (both increases and decreases) in pulse rate, and the impact of these changes on subsequent cardiovascular outcome events in both the placebo and sibutramine groups.
    SUBJECTS/METHODS: 9804 males and females, aged ⩾55 years, with a body mass index of 27-45 kg m(-)(2) were included in this current subanalysis of the SCOUT trial. Subjects were required to have a history of cardiovascular disease and/or type 2 diabetes mellitus with at least one cardiovascular risk factor, to assess cardiovascular outcomes. The primary outcome event (POE) was a composite of nonfatal myocardial infarction, nonfatal stroke, resuscitated cardiac arrest or cardiovascular death. Time-to-event analyses of the POE were performed using Cox regression models.
    RESULTS: During the initial 6-week sibutramine treatment period, the induced pulse rate increase was related to weight change (1.9±7.7 beats per minute (bpm)  with weight increase; 1.4±7.3 bpm, 0-5 kg weight loss; 0.6±7.4 bpm, ⩾5 kg weight loss). Throughout the subsequent treatment period, those continuing on sibutramine showed a consistently higher mean pulse rate than the placebo group. There was no difference in POE rates with either an increase or decrease in pulse rate over the lead-in period, or during lead-in baseline to 12 months post randomization. There was also no relationship between pulse rate at lead-in baseline and subsequent cardiovascular events in subjects with or without a cardiac arrhythmia.
    CONCLUSION: Baseline pulse rate and changes in pulse rate may not be an important modifier nor a clinically useful predictor of outcome in an individual elderly cardiovascular obese subject exposed to weight management.
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  • Article
    Bondonno CP, Downey LA, Croft KD, Scholey A, Stough C, Yang X, Considine MJ, Ward NC, Puddey IB, Swinny E, Mubarak A, Hodgson JM.
    Food Funct. 2014 May;5(5):849-58.
    Flavonoids and nitrate in a fruit and vegetable diet may be protective against cardiovascular disease and cognitive decline through effects on nitric oxide (NO) status. The circulating NO pool is increased via distinct pathways by dietary flavonoids and nitrate. Our aim was to investigate the acute effects of apples, rich in flavonoids, and spinach, rich in nitrate, independently and in combination on NO status, cognitive function and mood in a randomised, controlled, cross-over trial with healthy men and women (n = 30). The acute effects of four energy-matched treatments (control, apple, spinach and apple + spinach) were compared. Endpoints included plasma nitric oxide status (determined by measuring S-nitrosothiols + other nitroso species (RXNO)), plasma nitrate and nitrite, salivary nitrate and nitrite, urinary nitrate and nitrite as well as cognitive function (determined using the Cognitive Drug Research (CDR) computerized cognitive assessment battery) and mood. Relative to control, all treatments resulted in higher plasma RXNO. A significant increase in plasma nitrate and nitrite, salivary nitrate and nitrite as well as urinary nitrate and nitrite was observed with spinach and apple + spinach compared to control. No significant effect was observed on cognitive function or mood. In conclusion, flavonoid-rich apples and nitrate-rich spinach augmented NO status acutely with no concomitant improvements or deterioration in cognitive function and mood.
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  • Article
    Barillà F, Pannarale G, Torromeo C, Paravati V, Acconcia MC, Tanzilli G, Mangieri E, Dominici T, Martino F, Pannitteri G, Gaudio C.
    Clin Drug Investig. 2016 Oct;36(10):849-56.
    BACKGROUND AND OBJECTIVE: An elevated heart rate (HR) is an independent risk factor for mortality and morbidity in patients with acute heart failure (HF). The purpose of this study was to evaluate the impact of ivabradine, a selective HR-lowering agent, in patients with cardiogenic shock (CS) complicating ST-elevation acute myocardial infarction (AMI).
    METHODS: Patients with post-AMI CS were randomized to standard treatment (SDT, 28 patients) or to standard treatment plus ivabradine (I + SDT, 30 patients). In the presence of orotracheal intubation (OTI), ivabradine was administered by nasogastric intubation. HR, BP, New York Heart Association (NYHA) class, NT-proBNP, left ventricular ejection fraction (LVEF) and diastolic function (LVDF) were monitored at specific times after the onset of AMI. The primary (surrogate) end-point was the in-hospital halving of plasma NT-proBNP levels. The secondary end-points were cardiovascular death, hospital re-admission for worsening HF, and clinical and haemodynamic improvement.
    RESULTS: Treatment groups were statistically similar with regard to age, gender distribution, cardiovascular risk factors, number of diseased vessels and overall treated lesions, AMI site and occurrence of OTI. In-hospital mortality was double in the SDT group in comparison with the I + SDT group (14.3 vs. 6.7 %), but the difference was not statistically significant. HR, BP, NT-proBNP and LVEF favorably changed in both groups, but the change was more relevant in the I + SDT group. LVDF significantly changed only in the I + SDT group (p < 0.01). Patients in the I + SDT group did not experience adverse effects.
    CONCLUSION: Ivabradine in CS complicating AMI is safe, is associated with a short-term favourable outcome and can be effectively administered by nasogastric intubation.
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  • Article
    Krieger JM, Hagele AM, Orr LS, Walden KE, Gross KN, Mumford PW, Kerksick CM.
    J Diet Suppl. 2023;20(6):832-849.
    L-Beta-amino isobutyric acid (L-BAIBA) is a myokine produced in skeletal muscle during exercise and has been shown to impact carbohydrate and fat metabolism in both animals and humans. This study was designed to determine the rate and extent to which L-BAIBA appeared in human plasma after oral ingestion. In a randomized, double-blind, placebo-controlled, crossover fashion, six males and 6 females (N = 12; 24 ± 5 yrs; 173.6 ± 12.0 cm; 72.3 ± 11.3 kg; 21.0 ± 7.0 body fat %) completed a single-dose supplementation protocol of placebo (PLA), L-BAIBA at 250 mg (B250), 500 mg (B500), 1,500mg (B1500), and 1,500mg of valine (V1500). Participants fasted overnight (8-10 h) and consumed their dose with 8-12 fluid ounces of cold water. Venous blood samples were collected 0, 30, 60, 90, 120, 180, 240 and 300 min after ingestion and analyzed for L-BAIBA. Complete blood counts and comprehensive metabolic panels were analyzed 0 and 300 min after ingestion. Peak concentration (CMax) and area under the curve (AUC) were calculated for all variables. Baseline L-BAIBA levels were not different between conditions (p = 0.46). The observed AUC for B1500 (30,513 ± 9190 µM•300 min) was significantly higher than B500 (11,087 ± 3378 µM•300 min, p < 0.001), B250 (7081 ± 2535 µM•300 min, p < 0.001), V1500 (2837 ± 2107 µM•300 min, p < 0.001), and PLA (2836 ± 2061 µM•300 min, p < 0.001). Similarly, L-BAIBA CMax for B1500 (278.1 ± 52.1 µM) was significantly higher than all other supplement conditions: B500 (95.4 ± 33.5 µM, p < 0.001), B250 (63.3 ± 61.1 µM, p < 0.001), V1500 (10.1 ± 7.2 µM, p < 0.001), PLA (11.0 ± 7.1 µM, p = 0.001). AUC and CMax for B500 was significantly higher than B250 (p < 0.001), V1500 (p < 0.001), and PLA (p < 0.001). BAIBA AUC for B250 was significantly higher than V1500 (p < 0.001) and PLA (p < 0.001). No clinically significant changes in blood-based markers of health or adverse events were observed across the study protocol. L-BAIBA doses of 250 mg, 500 mg, and 1500 mg produced significantly greater concentrations of plasma L-BAIBA across a five-hour measurement window when compared to a 1500 mg dose of valine or a placebo. Follow-up efficacy studies on resting and exercise metabolism should be completed to assess the impact of L-BAIBA supplementation in normal weight and overweight individuals. Retrospectively registered on April 22, 2022 at ClinicalTrials.gov as NCT05328271.
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  • Article
    Beer L, Szerafin T, Mitterbauer A, Kasiri MM, Debreceni T Palotás L, Dworschak M, Roth GA, Ankersmit HJ.
    J Cardiovasc Surg (Torino). 2014 Dec;55(6):849-56.
    AIM: Cardiopulmonary bypass (CPB), utilized in on-pump coronary artery bypass graft procedures (CABG) induces generalized immune suppression, release of heat shock proteins (HSP), inflammatory markers and apoptosis-specific proteins. We hypothesized that continued mechanical ventilation during cardiopulmonary bypass attenuates immune response and HSP liberation.
    METHODS: Thirty patients undergoing conventional coronary artery bypass graft (CABG) operation were randomized into a ventilated on CPB (VG; N.=15) and a non-ventilated CPB group (NVG; N.=15). Blood samples were drawn at the beginning and end of surgery, as well as on the five consecutive postoperative days (POD). Molecular markers were measured by ELISA. Data are given as mean ± (SD). Mann-Whitney-U-test was used for statistical analysis.
    RESULTS: Serum concentrations of HSP70 were significantly lower in VG compared to NVG on POD-1 (VG: 1629±608 vs. NVG: 5203±2128.6 pg/mL, P<0.001). HSP27 and HSP60 depicted a minor increase in both study groups at the end of surgery without any intergroup differences (HSP27: VG 6207.9±1252.5 vs. NVG 7424.1±2632.5; HSP60: VG 1046.2±478.8 vs. NVG 1223.5±510.1). IL-8 and CK-18 M30 evidenced the highest serum concentrations at the end of surgery (IL-8: VG 119.5±77.9 vs. NVG 148.0±184.55; CK-18 M30: VG 62.1±39.2 vs. NVG 67.5±33.9) with no differences between groups. Decreased ICAM-1 serum concentrations were detected postoperatively, however ICAM-1 concentrations on POD-1 to POD-5 showed slightly elevated concentrations in both study groups with no intergroup differences.
    CONCLUSION: Significantly less HSP70 was detectable in patients receiving uninterrupted mechanical lung ventilation on CPB, indicating either different inflammatory response, cellular stress or cell damage between the ventilated and non-ventilated group. These data suggest that continued mechanical ventilation has a modulatory effect on the immune response in patients after CABG surgery.
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  • Article
    Harrison MJ, Hassell A, Dawes PT, Scott DL, Knight SM, Davis MJ, Mulherin D, Symmons DP.
    Rheumatology (Oxford). 2007 May;46(5):849-55.
    OBJECTIVES: The overall status in rheumatoid arthritis (OSRA) instrument is a simple summary of health status, including disease activity (OSRA-A) and damage (OSRA-D) scores. Despite evidence of the validity of the OSRA, uptake has been low. This study aimed to assess the responsiveness and re-examine the validity of the OSRA using the measures from the British Rheumatoid Outcome Study Group (BROSG) randomized controlled trial of aggressive vs symptomatic treatment of rheumatoid arthritis (RA) patients.
    METHODS: 466 patients were recruited. Outcome measures included the OSRA, the OMERACT core set and the DAS28, and were collected at baseline and annually for the 3 yrs of the trial. X-rays of the hands and feet were taken at baseline and 3 yrs. Patients were assigned a Townsend score (a measure of social deprivation) according to area of residence. Construct validity was assessed by correlating the OSRA with a range of outcome measures, and testing for the known inequality in RA outcome between patients classified by social deprivation. Responsiveness to change was assessed against self-reported change over the first year of the trial.
    RESULTS: The OSRA-A and OSRA-D measures demonstrated construct validity, performing as hypothesized. The OSRA-A was the most responsive measure in the BROSG trial in detecting patient reported improvement and deterioration. The OSRA-D demonstrated similar responsiveness to alternative measures.
    CONCLUSIONS: Our results demonstrate the validity and responsiveness of the OSRA, and its potential for inclusion in clinical trials. More important, as the OSRA is quick and easily calculated, uses routinely collected information, and provides useful quantitative information about a patient's status and progress it is suitable for use in the routine clinic.
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  • Article
    Yoshida K, Tanaka S, Watanabe K, Obara S, Murakawa M.
    J Anesth. 2020 12;34(6):849-856.
    PURPOSE: Quadratus lumborum block (QLB) has recently been used for postoperative analgesia after abdominal surgery. Although there are several approaches to QLB, the effectiveness of intramuscular QLB (QLBi) remains controversial. The aim of the present study was to examine the effectiveness of QLBi for postoperative analgesia after cesarean section with a vertical midline incision.
    METHODS: In this single-center, randomized, double-blinded placebo-controlled study, 36 women who were scheduled for elective cesarean section were randomly divided into a QLBi group (n = 18) and a placebo group (n = 18). In both groups, spinal anesthesia was performed with 10-11 mg hyperbaric bupivacaine and 15 µg fentanyl. After the surgery, in the QLBi group, 0.4 mL/kg of 0.25% ropivacaine was injected into the bilateral quadratus lumborum muscle under ultrasound guidance (the total volume was 0.8 mL/kg). In the placebo group, instead of ropivacaine, the subjects were injected with the same amount of normal saline. The primary outcome measure was elapsed time to first analgesic use from the QLBi block after cesarean section.
    RESULTS: The data from all 36 patients were analyzed. There were no significant differences between the QLBi and placebo groups regarding elapsed time to first postoperative analgesic use [mean 230 (standard deviation 103) vs 194 (89) min; 95% confidence interval - 101 to 30; p = 0.27].
    CONCLUSIONS: QLBi with the concentration and amount of local anesthetic used in the present study was clinically slightly effective, and the effect was limited for postoperative analgesia after cesarean section.
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  • Article
    Hoogervorst P, Knox R, Tanaka K, Working ZM, El Naga AN, Herfat S, Lee N.
    Hand (N Y). 2020 11;15(6):842-849.
    Background: The aim of this study was to quantify the stabilizing properties of a 3-dimensional (3D)-printed short-arm cast and compare those properties with traditional fiberglass casts in a cadaveric subacute distal radius fracture model. Methods: A cadaveric subacute fracture model was created in 8 pairs of forearms. The specimens were equally allocated to a fiberglass cast or 3D-printed cast group. All specimens were subjected to 3 biomechanical testing modalities simulating daily life use: flexion and extension of digits, pronation and supination of the hand, and 3-point bending. Between each loading modality, radiological evaluation of the specimens was performed to evaluate possible interval displacement. Interfragmentary motion was quantified using a 3D motion-tracking system. Results: Radiographic assessment did not reveal statistically significant differences in radiographic parameters between the 2 groups before and after biomechanical testing. A statistically significant difference in interfragmentary motion was calculated with the 3-point bending test, with a mean difference of 0.44 (±0.48) mm of motion. Conclusions: A statistically significant difference in interfragmentary motion between the 2 casting groups was only identified in 3-point bending. However, the clinical relevance of this motion remains unclear as the absolute motion is less than 1 mm. The results of this study show noninferiority of the 3D-printed casts compared with the traditional fiberglass casts in immobilizing a subacute distal radius fracture model. These results support the execution of a prospective randomized clinical trial comparing both casting techniques.
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  • Article
    Cairo F, Cortellini P, Pilloni A, Nieri M, Cincinelli S, Amunni F, Pagavino G, Tonetti MS.
    J Clin Periodontol. 2016 10;43(10):849-56.
    BACKGROUND: The aim of this study was to assess the clinical efficacy of coronally advanced flap (CAF) with or without connective tissue graft (CTG) for the treatment of multiple adjacent gingival recessions in the upper arch.
    MATERIAL AND METHODS: Thirty-two patients with a total of 74 gingival recessions were randomly allocated to the two groups. Outcome measures, collected by a blind examiner, included complete root coverage (CRC), recession reduction (RecRed), keratinized tissue (KT) gain, increase in gingival thickness (GT), patient satisfaction and root coverage esthetic score (RES).
    RESULTS: An interaction between treatment and baseline GT was detected. At 1 year, CAF + CTG resulted in better outcomes in terms of CRC (p = 0.0016) and RecRed (p < 0.0001) than CAF alone at sites with thin gingiva (thickness ≤ 0.8 mm). No difference was found between CAF alone and CAF + CTG at sites with thick gingiva (>0.8 mm). CAF resulted in higher aesthetic scores (RES) than CAF + CTG at sites with thick gingiva. CAF + CTG was associated with greater KT gain (p < 0.0001) and greater post-operative morbidity (p < 0.0001).
    CONCLUSION: Connective tissue graft under CAF results in increased probability of CRC only at sites with thin baseline gingiva. CAF alone is associated with similar clinical outcomes and better aesthetics at sites with thick baseline gingiva.
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  • Article
    Heley K, Kennedy-Hendricks A, Niederdeppe J, Barry CL.
    Health Commun. 2020 06;35(7):849-860.
    Public stigma characterizes three leading health issues: prescription opioid addiction, obesity, and cigarette smoking. Attributions of individual responsibility are often embedded in negative public attitudes around these issues and can be important to stigma's development and reduction. Research suggests that narrative messages may hold promise for influencing attributions and stigma in these health contexts. Using a national sample of American adults from an online panel (N = 5,007), we conducted a survey-embedded randomized experiment, assigning participants to read one of six messages about one of three health issues. All participants read a statement detailing the magnitude of their assigned health problem, after which some respondents received a short inoculation message (serving as a comparison group) or a narrative message emphasizing external factors while acknowledging personal responsibility for the issue. Some participants also read a counter message emphasizing personal responsibility for the health issue to replicate competitive messaging environments surrounding these issues. Relative to those who received only the magnitude of problem message (comparison group 1) or the magnitude of problem and inoculation messages (comparison group 2), the narrative message reduced prescription opioid addiction stigma and increased attributions of responsibility to groups beyond the individual. Narrative effects were mixed for obesity, had no effect on attributions or stigma around cigarette smoking, and were generally consistent whether or not respondents received a counter message. Narrative messages may be a promising approach for shifting responsibility attributions and reducing public stigma around prescription opioid addiction, and may have some relevance for obesity stigma-reduction efforts.
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  • Article
    Margolese RG, Cecchini RS, Julian TB, Ganz PA, Costantino JP, Vallow LA, Albain KS, Whitworth PW, Cianfrocca ME, Brufsky AM, Gross HM, Soori GS, Hopkins JO, Fehrenbacher L, Sturtz K, Wozniak TF, Seay TE, Mamounas EP, Wolmark N.
    Lancet. 2016 Feb 27;387(10021):849-56.
    BACKGROUND: Ductal carcinoma in situ is currently managed with excision, radiotherapy, and adjuvant hormone therapy, usually tamoxifen. We postulated that an aromatase inhibitor would be safer and more effective. We therefore undertook this trial to compare anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy.
    METHODS: The double-blind, randomised, phase 3 National Surgical Adjuvant Breast and Bowel Project (NSABP) B-35 trial was done in 333 participating NSABP centres in the USA and Canada. Postmenopausal women with hormone-positive ductal carcinoma in situ treated by lumpectomy with clear resection margins and whole-breast irradiation were enrolled and randomly assigned (1:1) to receive either oral tamoxifen 20 mg per day (with matching placebo in place of anastrozole) or oral anastrozole 1 mg per day (with matching placebo in place of tamoxifen) for 5 years. Randomisation was stratified by age (<60 vs ≥60 years) and patients and investigators were masked to treatment allocation. The primary outcome was breast cancer-free interval, defined as time from randomisation to any breast cancer event (local, regional, or distant recurrence, or contralateral breast cancer, invasive disease, or ductal carcinoma in situ), analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00053898, and is complete.
    FINDINGS: Between Jan 1, 2003, and June 15, 2006, 3104 eligible patients were enrolled and randomly assigned to the two treatment groups (1552 to tamoxifen and 1552 to anastrozole). As of Feb 28, 2015, follow-up information was available for 3083 patients for overall survival and 3077 for all other disease-free endpoints, with median follow-up of 9·0 years (IQR 8·2-10·0). In total, 212 breast cancer-free interval events occurred: 122 in the tamoxifen group and 90 in the anastrozole group (HR 0·73 [95% CI 0·56-0·96], p=0·0234). A significant time-by-treatment interaction (p=0·0410) became evident later in the study. There was also a significant interaction between treatment and age group (p=0·0379), showing that anastrozole is superior only in women younger than 60 years of age. Adverse events did not differ between the groups, except for thrombosis or embolism--a known side-effect of tamoxifen-for which there were 17 grade 4 or worse events in the tamoxifen group versus four in the anastrozole group.
    INTERPRETATION: Compared with tamoxifen, anastrozole treatment provided a significant improvement in breast cancer-free interval, mainly in women younger than 60 years of age. This finding means that women will benefit from having a choice of effective agents for ductal carcinoma in situ.
    FUNDING: US National Cancer Institute and AstraZeneca Pharmaceuticals LP.
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  • Article
    Ogoh S, Nakahara H, Ueda S, Okazaki K, Shibasaki M, Subudhi AW, Miyamoto T.
    Exp Physiol. 2014 Jun;99(6):849-58.
    In normoxic conditions, a reduction in arterial carbon dioxide tension causes cerebral vasoconstriction, thereby reducing cerebral blood flow and modifying dynamic cerebral autoregulation (dCA). It is unclear to what extent these effects are altered by acute hypoxia and the associated hypoxic ventilatory response (respiratory chemoreflex). This study tested the hypothesis that acute hypoxia attenuates arterial CO2 tension-mediated regulation of cerebral blood flow to help maintain cerebral O2 homeostasis. Eight subjects performed three randomly assigned respiratory interventions following a resting baseline period, as follows: (1) normoxia (21% O2); (2) hypoxia (12% O2); and (3) hypoxia with wilful restraint of the respiratory chemoreflex. During each intervention, 0, 2.0, 3.5 or 5.0% CO2 was sequentially added (8 min stages) to inspired gas mixtures to assess changes in steady-state cerebrovascular CO2 reactivity and dCA. During normoxia, the addition of CO2 increased internal carotid artery blood flow and middle cerebral artery mean blood velocity (MCA Vmean), while reducing dCA (change in phase = -0.73 ± 0.22 rad, P = 0.005). During acute hypoxia, internal carotid artery blood flow and MCA Vmean remained unchanged, but cerebrovascular CO2 reactivity (internal carotid artery, P = 0.003; MCA Vmean, P = 0.031) and CO2-mediated effects on dCA (P = 0.008) were attenuated. The effects of hypoxia were not further altered when the respiratory chemoreflex was restrained. These findings support the hypothesis that arterial CO2 tension-mediated effects on the cerebral vasculature are reduced during acute hypoxia. These effects could limit the degree of hypocapnic vasoconstriction and may help to regulate cerebral blood flow and cerebral O2 homeostasis during acute periods of hypoxia.
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  • Article
    Makhlouf T, Emil NS, Sibbitt WL, Fields RA, Bankhurst AD.
    Clin Rheumatol. 2014 Jun;33(6):849-58.
    This randomized controlled study addressed whether sonographic needle guidance affected the outcomes of corticosteroid injection for symptomatic carpal tunnel syndrome. Seventy-seven symptomatic carpal tunnels were randomized to injection by either (1) conventional anatomic landmark palpation-guided injection or (2) sonographic image-guided injection, each using a two-step technique where 3 ml of 1% lidocaine was first injected to hydrodissect and hydrodisplace critical intra-carpal tunnel structures followed by injection with 80 mg of triamcinolone acetonide (2 ml). Baseline pain, procedural pain, pain at outcome (2 weeks and 6 months), responders, therapeutic duration, total cost, and cost per responder were determined. There were no complications in either treatment group. Relative to conventional anatomic landmark palpation-guided methods, sonographic guidance for injection of the carpal tunnel resulted in 77.1% reduction in injection pain (p<0.01), a 63.3% reduction in pain scores at outcome (p<0.014), 93.5% increase in the responder rate (p<0.001), 84.6% reduction in the non-responder rate (p<0.001), a 71.0% increase in therapeutic duration (p<0.001), and a 59.3% ($150) reduction in cost/responder/year for a hospital outpatient (p<0.001). However, despite improved outcomes, cost per patient per year was significantly increased for an outpatient in a physician's office and was neutral for a hospital outpatient. Sonographic needle guidance significantly improves the performance and clinical outcomes of injection of the carpal tunnel and is cost-effective for a hospital-based practice, but based on current reimbursements, it significantly increases overall costs for medical care delivered in a non-hospital-based physician practice.
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  • Article
    Chounta V, Overton ET, Mills A, Swindells S, Benn PD, Vanveggel S, van Solingen-Ristea R, Wang Y, Hudson KJ, Shaefer MS, Margolis DA, Smith KY, Spreen WR.
    Patient. 2021 11;14(6):849-862.
    BACKGROUND: Advances in HIV-1 therapeutics have led to the development of a range of daily oral treatment regimens, which share similar high efficacy rates. Consequently, more emphasis is being placed upon the individual's experience of treatment and impact on quality of life. The first long-acting injectable antiretroviral therapy for HIV-1 (long-acting cabotegravir + rilpivirine [CAB + RPV LA]) may address challenges associated with oral treatment for HIV-1, such as stigma, pill burden/fatigue, drug-food interactions, and adherence. Patient-reported outcomes (PROs) collected in an HIV-1 clinical trial (ATLAS-2M; NCT03299049) comparing participants' experience with two dosing regimens (every 4 weeks [Q4W] vs. every 8 weeks [Q8W]) of CAB + RPV LA are presented herein.
    METHODS: PRO endpoints evaluated through 48 weeks of therapy included treatment satisfaction (HIV Treatment Satisfaction Questionnaire [HIVTSQ]), treatment acceptance ("General Acceptance" domain of the Chronic Treatment Acceptance [ACCEPT®] questionnaire), acceptability of injections (Perception of Injection [PIN] questionnaire), treatment preference (questionnaire), and reasons for switching to/continuing long-acting therapy (exploratory endpoint; questionnaire). Participants were randomized 1:1 to receive CAB + RPV LA Q8W or Q4W. Results were stratified by prior CAB + RPV exposure in either preplanned or post hoc analyses.
    RESULTS: Overall, 1045 participants were randomized to the Q8W (n = 522) and Q4W (n = 523) regimens; 37% (n = 391/1045) had previously received CAB + RPV in ATLAS. For participants without prior CAB + RPV exposure, large increases from baseline were reported in treatment satisfaction in both long-acting arms (HIVTSQ status version), with Q8W dosing statistically significantly favored at Weeks 24 (p = 0.036) and 48 (p = 0.004). Additionally, improvements from baseline were also observed in the "General Acceptance" domain of the ACCEPT questionnaire in both long-acting arms for participants without prior CAB + RPV exposure; however, no statistically significant difference was observed between arms at either timepoint (Week 24, p = 0.379; Week 48, p = 0.525). Significant improvements (p < 0.001) in the "Acceptance of Injection Site Reactions" domain of the PIN questionnaire were observed from Week 8 to Weeks 24 and 48 in both arms for participants without prior CAB + RPV exposure. Participants with prior CAB + RPV exposure reported high treatment satisfaction (mean [HIVTSQ status version]: Q8W 62.2/66.0; Q4W 62.0/66.0), treatment acceptance (mean: Q8W 89.3/100; Q4W 91.2/100), and acceptance of injection site reactions (mean [5 = not at all acceptable; 1 = totally acceptable]: Q8W 1.72; Q4W 1.59) at baseline/Week 8 that were maintained over time. Participants without prior CAB + RPV exposure who received Q8W dosing preferred this regimen over oral CAB + RPV (98%, n = 300/306). Among those with prior Q4W exposure, 94% (n = 179/191) preferred Q8W dosing versus Q4W dosing (3%, n = 6/191) or oral CAB + RPV (2%, n = 4/191).
    CONCLUSIONS: Both long-acting regimens provided high treatment satisfaction and acceptance, irrespective of prior CAB + RPV exposure, with most participants preferring Q8W dosing over both the Q4W regimen and their previous daily oral regimen. The PRO data collected at Week 48 support the therapeutic potential of CAB + RPV LA.
    FUNDING: ViiV Healthcare and Janssen.
    TRIAL REGISTRATION: ATLAS-2M: ClinicalTrials.gov NCT03299049, registered October 2, 2017.
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  • Article
    Price MJ, Gibson DN, Kar S.
    Circulation. 2022 04 26;145(17):e849.
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