Browsing by Subject "Comparative effectiveness"

Now showing 1 - 4 of 4
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    Back Pain Consortium (BACPAC): Protocol and Pilot Study Results for a Randomized Comparative-Effectiveness Trial of Antidepressants, Fear Avoidance Rehabilitation, or the Combination for Chronic Low Back Pain and Comorbid High Negative Affect
    (Oxford University Press, 2023) Wasan, Ajay D.; Edwards, Robert R.; Kraemer, Kevin L.; Jeong, Jong; Kenney, Megan; Luong, Kevin; Cornelius, Marise C.; Mickles, Caitlin; Dharmaraj, Bhagya; Sharif, Essa; Stoltenberg, Anita; Emerick, Trent; Karp, Jordan F.; Bair, Matt J.; George, Steven Z.; Hooten, William M.; Medicine, School of Medicine
    Objective: Patients with chronic low back pain (CLBP) and comorbid depression or anxiety disorders are highly prevalent. Negative affect (NA) refers to a combination of negative thoughts, emotions, and behaviors. Patients with CLBP with high NA have greater pain, worse treatment outcomes, and greater prescription opioid misuse. We present the protocol for SYNNAPTIC (SYNergizing Negative Affect & Pain Treatment In Chronic pain). Design: A randomized comparative-effectiveness study of antidepressants, fear-avoidance rehabilitation, or their combination in 300 patients with CLBP with high NA. In the antidepressant- or rehabilitation-only arms, SYNNAPTIC includes an adaptive design of re-randomization after 4 months for nonresponders. Setting: A multisite trial conducted in routine pain clinical treatment settings: pain clinics and physical and occupational therapy treatment centers. Methods: Inclusion criteria include CLBP with elevated depression and anxiety symptoms. Antidepressant and rehabilitation treatments follow validated and effective protocols for musculoskeletal pain in patients with high NA. Power and sample size are based on superior outcomes of combination therapy with these same treatments in a 71-subject 4-arm pilot randomized controlled trial. Conclusions: SYNNAPTIC addresses the lack of evidence-based protocols for the treatment of the vulnerable subgroup of patients with CLBP and high NA. We hypothesize that combination therapy of antidepressants plus fear-avoidance rehabilitation will be more effective than each treatment alone.
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    Comparative Effectiveness of Carotid Stenting to Medical Therapy Among Patients With Asymptomatic Carotid Stenosis
    (Wolters Kluwer, 2022) Keyhani, Salomeh; Cheng, Eric M.; Hoggatt, Katherine; Austin, Peter C.; Madden, Erin; Hebert, Paul L.; Halm, Ethan A.; Naseri, Ayman; Johanning, Jason; Abraham, Ann; Bravata, Dawn M.; Medicine, School of Medicine
    Background: No completed trials have compared carotid artery stenting (CAS) to medical therapy (MT). We examined the effectiveness of CAS compared with MT in patients with asymptomatic carotid stenosis. Methods: We conducted a retrospective cohort study of 219 979 Veterans ≥65 years who received carotid imaging for asymptomatic carotid stenosis between 2005 and 2009 in the US Veterans Health Administration. We constructed a sample of patients who received MT (n=2509) and comparable patients who received CAS (n=551) and followed them for 5 years. Using target trial methodology, we computed weighted Kaplan-Meier curves and estimated the risk of fatal and nonfatal stroke in each group over 5 years of follow-up. We also estimated the cumulative incidence functions for fatal and nonfatal stroke accounting for nonstroke deaths as competing risks. Results: Five hundred fifty-one patients received CAS, and 2509 patients received MT. The observed rate of stroke or death (perioperative complications) within 30 days in the CAS arm was 2.2%. Using the target trial methodology, the 5-year risk of fatal and nonfatal stroke was similar among patients assigned to CAS (6.9%) compared with patients assigned to MT (7.1%; risk difference, -0.1% [95% CI, -2.6% to 2.7%]). In an analysis that incorporated the competing risk of death, the risk difference between the two arms remained nonsignificant (risk difference, -1.5% [95% CI, -3.0% to 0.3%]). Conclusions: In this sample of older male adults, we found no difference between MT and CAS in the treatment of asymptomatic carotid stenosis. Future studies in other settings are needed to confirm these findings.
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    Prevalence of Microvascular and Macrovascular Disease in the Glycemia Reduction Approaches in Diabetes - A Comparative Effectiveness (GRADE) Study Cohort
    (Elsevier, 2020-07) Mather, Kieren J.; Bebu, Ionut; Baker, Chelsea; Cohen, Robert M.; Crandall, Jill P.; DeSouza, Cyrus; Green, Jennifer B.; Kirkman, M. Sue; Krause-Steinrauf, Heidi; Larkin, Mary; Pettus, Jeremy; Seaquist, Elizabeth R.; Soliman, Elsayed Z.; Schroeder, Emily B.; Wexler, Deborah J.; Pop-Busui, Rodica; Medicine, School of Medicine
    Aims: The Glycemia Reduction Approaches in Diabetes - A Comparative Effectiveness (GRADE) trial is a randomized clinical trial comparing glycemic effects of four diabetes medications added to metformin in type 2 diabetes (T2D). Microvascular and macrovascular diseases are secondary outcomes. We evaluated the prevalence and risk factor relationships for microvascular and macrovascular complications in the GRADE cohort at study entry. Methods: Complication prevalence and risk factors were analyzed based on data from screening in all consenting participants meeting GRADE eligibility. Logistic regression and Z-statistics were used to assess risk factor relationships with complications. Results: We enrolled 5047 T2D participants [mean age 57 years; 36% female; mean known T2D duration 4 years (all < 10 years); mean HbA1c 8.0% (∼64 mmol/mol) at screening]. Urinary albumin/creatinine ratio (ACR) ≥ 30 mg/gram was present in 15.9% participants; peripheral neuropathy (by Michigan Neuropathy Screening Instrument) in 21.5%; cardiovascular autonomic neuropathy by electrocardiography-derived indices in 9.7%; self-reported retinopathy in 1.0%. Myocardial infarction ascertained by self-report or electrocardiogram was present in 7.3%, and self-reported history of stroke in 2.0%. Conclusions: In the GRADE cohort with < 10 years of T2D and a mean HbA1c of 8.0%, diabetes complications were present in a substantial fraction of participants, more so than might otherwise have been expected.
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    The Pain Outcomes Comparing Yoga vs. Structured Exercise (POYSE) Trial in Veterans With Fibromyalgia: Study Design and Methods
    (Frontiers Media, 2022-07-07) Allsop, Vivianne L.; Schmid, Arlene A.; Miller, Kristine K.; Slaven, James E.; Daggy, Joanne K.; Froman, Amanda; Kline, Matthew; Sargent, Christy; French, Dustin D.; Ang, Dennis; Van Puymbroeck, Marieke; Schalk, Nancy L.; Bair, Matthew J.; Medicine, School of Medicine
    Background: Fibromyalgia is a common pain condition that often leads to significant disability. Unfortunately, the effectiveness of most medications for fibromyalgia is limited, and there is a need for alternative, non-pharmacological therapies. Yoga and aerobic exercise are both evidence-based non-pharmacological treatments for fibromyalgia. However, no prior studies have directly compared the effectiveness of yoga vs. exercise. Objective: This article describes the study design and recruitment outcomes of the Pain Outcomes comparing Yoga vs. Structured Exercise (POYSE) Trial, a two-arm randomized comparative effectiveness trial. Methods: Veterans with fibromyalgia, defined by the 2010 American College of Rheumatology diagnostic criteria, who also experienced at least moderate pain severity were enrolled. The participants were randomized to a 12-week yoga-based or a structured exercise program (SEP) and will undergo comprehensive outcome assessments at baseline, 1, 3, 6, and 9 months by interviewers blinded to treatment assignment. The primary outcome will be the overall severity of fibromyalgia as measured by the total Fibromyalgia Impact Questionnaire-Revised. Secondary outcomes included depression, anxiety, health-related quality of life, pain beliefs, fatigue, sleep, and self-efficacy. Results: A total of 2,671 recruitment letters were sent to potential participants with fibromyalgia. Of the potential participants, 623 (23.3%) were able to be contacted by telephone and had their eligibility assessed. Three hundred seventy-one of those interviewed were found to be eligible (59.6%) and 256 (69.0%) agreed to participate and were randomized to the YOGA (n = 129) or the SEP (n = 127) arm of the trial. Conclusions: Clinicians are faced with numerous challenges in treating patients with fibromyalgia. The interventions being tested in the POYSE trial have the potential to provide primary care and other care settings with new treatment options for clinicians while simultaneously providing a much needed relief for patients suffering from fibromyalgia.