Browsing by Subject "randomized trial"

Now showing 1 - 5 of 5
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    Identification of subgroups with differential treatment effects for longitudinal and multiresponse variables
    (Wiley, 2016-11-20) Loh, Wei-Yin; Man, Michael; Fu, Haoda; Champion, Victoria L.; Yu, Menggang; School of Nursing
    We describe and evaluate a regression tree algorithm for finding subgroups with differential treatments effects in randomized trials with multivariate outcomes. The data may contain missing values in the outcomes and covariates, and the treatment variable is not limited to two levels. Simulation results show that the regression tree models have unbiased variable selection and the estimates of subgroup treatment effects are approximately unbiased. A bootstrap calibration technique is proposed for constructing confidence intervals for the treatment effects. The method is illustrated with data from a longitudinal study comparing two diabetes drugs and a mammography screening trial comparing two treatments and a control.
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    Inhaled nitric oxide to treat intermediate risk pulmonary embolism: A multicenter randomized controlled trial
    (Elsevier, 2019-03) Kline, Jeffrey A.; Puskarich, Michael A.; Jones, Alan E.; Mastouri, Ronald A.; Hall, Cassandra L.; Perkins, Anthony; Gundert, Emily; Lahm, Tim; Emergency Medicine, School of Medicine
    Objective To test the hypothesis that adjunctive inhaled NO would improve RV function and viability in acute PE. Methods This was a randomized, placebo-controlled, double blind trial conducted at four academic hospitals. Eligible patients had acute PE without systemic arterial hypotension but had RV dysfunction and a treatment plan of standard anticoagulation. Subjects received either oxygen plus 50 parts per million nitrogen (placebo) or oxygen plus 50 ppm NO for 24 h. The primary composite endpoint required a normal RV on echocardiography and a plasma troponin T concentration <14 pg/mL. The secondary endpoint required a blood brain natriuretic peptide concentration <90 pg/mL and a Borg dyspnea score ≤ 2. The sample size of N = 76 tested if 30% more patients treated with NO would achieve the primary endpoint with 80% power and alpha = 5%. Results We randomized 78 patients and after two withdrawals, 38 were treated per protocol in each group. Patients were well matched for baseline conditions. At 24 h, 5/38 (13%) of patients treated with placebo and 9/38 (24%) of patients treated with NO reached the primary endpoint (P = 0.375). The secondary endpoint was reached in 34% with placebo and 13% of the NO (P = 0.11). In a pre-planned post-hoc analysis, we examined how many patients with RV hypokinesis or dilation at enrollment resolved these abnormalities; 29% more patients treated with NO resolved both abnormalities at 24 h (P = 0.010, Cochrane's Q test). Conclusions In patients with severe submassive PE, inhaled nitric oxide failed to increase the proportion of patients with a normal troponin and echocardiogram but increased the probability of eliminating RV hypokinesis and dilation on echocardiography.
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    Issues in Conducting Randomized Controlled Trials of Health Services Research Interventions in Nonacademic Practice Settings: The Case of Retail Pharmacies
    (2002-08) Weinberger, Morris; Murray, Michael D.; Marrero, David G.; Brewer, Nancy; Lykens, Michael; Harris, Lisa E.; Newell, A Jeffrey; Collins, Joyce; Tierney, William M.
    Objective. To describe unexpected challenges and strategies to overcome them when conducting randomized controlled trials (RCT) of health services research interventions in retail pharmacies. Study Setting. Thirty-six retail drug stores in Indianapolis. Study Design. We conducted an RCT to evaluate the effectiveness of an intervention to increase pharmacists’ involvement in caring for customers. We describe: (1) our RCT as originally designed, (2) unexpected challenges we faced; and (3) how we resolved those challenges. Data Collection/Extraction Methods. Randomized controlled trial. Principal Findings. Major modifications in research design were necessitated by factors such as corporate restructuring, heightened sensitivity to patient confidentiality, and difficulties altering employees’ behavior. We overcame these barriers by conducting research that is consistent with corporate goals, involving appropriate corporate administrators and technical personnel early in the process, and being flexible. Conclusions. Health services researchers should conduct RCTs in a variety of nonacademic practice settings to increase generalizability and better reflect the true impact of interventions. Pragmatic problems, although significant, can be successfully overcome.
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    Menopausal Quality of Life: A RCT of Yoga, Exercise and Omega-3 Supplements
    (Elsevier B.V., 2014-03) Reed, Susan D.; Guthrie, Katherine A.; Newton, Katherine M.; Anderson, Garnet L.; Booth-LaForce, Cathryn; Caan, Bette; Carpenter, Janet S.; Cohen, Lee S.; Dunn, Andrea L.; Ensrud, Kristine E.; Freeman, Ellen W.; Hunt, Julie R.; Joffe, Hadine; Larson, Joseph C.; Learman, Lee A.; Rothenberg, Robin; Seguin, Rebecca A.; Sherman, Karen J.; Sternfeld, Barbara S.; LaCroix, Andrea Z.; IU School of Nursing
    Objective— Determine efficacy of three non-hormonal therapies for improving menopause- related quality of life (QOL) in women with vasomotor symptoms (VMS). Methods— 12-week 3×2 randomized, controlled, factorial design trial. Peri- and postmenopausal women, ages 40-62 years, were randomized to yoga (n=107), exercise (n=106), or usual activity (n=142), and also randomized to double-blind comparison of omega-3 (n=177) or placebo (n=178) capsules. Interventions: 1) weekly 90-minute yoga classes with daily at-home practice; 2) individualized facility-based aerobic exercise training 3 times/week; and 3) 0.615 gram omega-3 supplement, 3 times/day. Outcomes: Menopausal Quality of Life Questionnaire (MENQOL) total and domain (VMS, psychosocial, physical and sexual) scores. Results— Among 355 randomized women, average age 54.7 years, 338 (95%) completed 12- week assessments. Mean baseline VMS frequency was 7.6/day and mean baseline total MENQOL score was 3.8 (range 1-8 from better to worse) with no between-group differences. For yoga compared to usual activity, baseline to 12-week improvements were seen for MENQOL total -0.3 (95% CI -0.6 to 0.0, p=0.02), and VMS (p=0.02) and sexuality (p=0.03) domain scores. For exercise and omega-3 compared to controls, improvements in baseline to 12-week total MENQOL scores were not observed. Exercise showed benefit in the MENQOL physical domain score at 12- weeks (p=0.02). Conclusion— All women become menopausal and many seek medical advice on ways to improve quality of life; little evidence-based information exists. We found, among healthy sedentary menopausal women, yoga appears to improve menopausal QOL - the clinical significance of our finding is uncertain due to modest effect.
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    Triggered Palliative Care for Late-stage Dementia: a Pilot Randomized Trial
    (Elsevier, 2018) Hanson, Laura C.; Kistler, Christine E.; Lavin, Kyle; Gabriel, Stacey L.; Ernecoff, Natalie C.; Lin, Feng-Chang; Sachs, Greg A.; Mitchell, Susan L.; Medicine, School of Medicine
    Context Persons with late-stage dementia have limited access to palliative care. Objective To test dementia-specific specialty palliative care triggered by hospitalization. Methods This pilot randomized controlled trial enrolled 62 dyads of persons with late-stage dementia and family decision-makers on admission to hospital. Intervention dyads received dementia-specific specialty palliative care consultation plus post-acute transitional care. Control dyads received usual care and educational information. The primary outcome was 60-day hospital or emergency department visits. Secondary patient and family-centered outcomes were patient comfort, family distress, palliative care domains addressed in the treatment plan, and access to hospice or community-based palliative care. Secondary decision-making outcomes were discussion of prognosis, goals of care, completion of Medical Orders for Scope of Treatment (MOST), and treatment decisions. Results Of 137 eligible dyads, 62 (45%) enrolled. The intervention proved feasible, with protocol completion ranging from 77% (family 2-week call) to 93% (initial consultation). Hospital and emergency department visits did not differ (intervention vs control, 0.68 vs 0.53 transfers per 60 days, p=0.415). Intervention patients had more palliative care domains addressed, and were more likely to receive hospice (25% vs 3%, p<0.019). Intervention families were more likely to discuss prognosis (90% vs 3%, p<0.001) and goals of care (90% vs 25%, p<0.001), and to have a MOST at 60-day follow-up (79% vs 30%, p<0.001). More intervention families made decisions to avoid re-hospitalization (13% vs 0%, p=0.033). Conclusion Specialty palliative care consultation for hospitalized patients with for late-stage dementia is feasible and promising to improve decision-making and some treatment outcomes.