scholarly journals The next step in translational research: lessons learned from the first preclinical randomized controlled trial

2016 ◽  
Vol 139 ◽  
pp. 271-279 ◽  
Author(s):  
Gemma Llovera ◽  
Arthur Liesz
Keyword(s):  
Randomized Controlled Trial ◽  
Translational Research ◽  
Controlled Trial ◽  
Lessons Learned ◽  
Randomized Controlled

scholarly journals The ACHIEVE Trial: Lessons Learned From Nesting a Randomized Controlled Trial Within an Observational Cohort Study

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 811-811
Author(s):  
Jennifer Deal ◽  
Nicholas Reed ◽  
David Couper ◽  
Kathleen Hayden ◽  
Thomas Mosley ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Observational Study ◽  
Cognitive Decline ◽  
Controlled Trial ◽  
Lessons Learned ◽  
Community Dwelling ◽  
Randomized Controlled ◽  
Study Staff ◽  
Increased Risk

Abstract Hearing impairment in older adults is linked to accelerated cognitive decline and a 94% increased risk of incident dementia in population-based observational studies. Whether hearing treatment can delay cognitive decline is unknown but could have substantial clinical and public health impact. The NIH-funded ACHIEVE randomized controlled trial of 977 older adults aged 70-84 years with untreated mild-to-moderate hearing loss, is testing the efficacy of hearing treatment versus health education on cognitive decline over 3 years in community-dwelling older adults (Clinicaltrials.gov Identifier: NCT03243422.) This presentation will describe lessons learned from ACHIEVE’s unique study design. ACHIEVE is nested within a large, well-characterized multicenter observational study, the Atherosclerosis Risk in Communities Study. Such nesting within an observational study maximizes both operational and scientific efficiency. With trial results expected in 2022, this presentation will focus on the benefits gained in design and recruitment/retention, including dedicated study staff, well-established protocols, and established study staff-participant relationships. Part of a symposium sponsored by Sensory Health Interest Group.

Warfarin Cessation Before Cardiopulmonary Bypass: Lessons Learned from a Randomized Controlled Trial of Oral Vitamin K

2007 ◽  
Vol 84 (1) ◽  
pp. 103-108 ◽  
Author(s):  
Richard P. Whitlock ◽  
Mark A. Crowther ◽  
Theodore E. Warkentin ◽  
Mary-Helen Blackall ◽  
Forough Farrokhyar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiopulmonary Bypass ◽  
Vitamin K ◽  
Controlled Trial ◽  
Lessons Learned ◽  
Oral Vitamin ◽  
Randomized Controlled

Peritoneal Ultrafiltration for Heart Failure: Lessons from a Randomized Controlled Trial

2019 ◽  
Vol 39 (5) ◽  
pp. 486-489
Author(s):  
Hari Dukka ◽  
Philip A. Kalra ◽  
Martin Wilkie ◽  
Sunil Bhandari ◽  
Simon J. Davies ◽  
...  
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Short Form ◽  
Controlled Trial ◽  
Severe Heart Failure ◽  
Lessons Learned ◽  
Randomized Controlled ◽  
Ckd Stage ◽  
Patient Reported

Peritoneal ultrafiltration (PuF) has been employed for severe heart failure (HF), but evidence for its benefit is lacking. The Peritoneal Dialysis for Heart Failure (PDHF) study was a multicenter prospective randomized controlled trial which aimed to investigate this issue. The trial stopped early due to inadequate recruitment. We describe methods, trial activity, and lessons learned. The trial aimed to recruit 130 participants with severe diuretic-resistant HF (New York Heart Association [NYHA] 3/4) and chronic kidney disease (CKD) stage 3/4 on optimal medical treatment for ≥ 4 weeks from 6 UK centers. Participants were randomized to either continuation of conventional HF treatment or to additionally receiving PuF (1 overnight exchange using Icodextrin dialysate). Primary outcome was change in 6-minute walk test (6MWT) between baseline and 28 weeks (end of trial). Secondary outcomes were changes in patient reported quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire, short form 36 (SF 36) health survey results, hospitalization, and mortality. Over a 2-year period, 290 patients were screened from which only 20 met inclusion criteria and 10 were recruited. Reasons for ineligibility were fluctuating estimated glomerular filtration rate (eGFR), suboptimal HF treatment, frailty, and patients being too unwell for randomization. Barriers to recruitment included patient frailty, with some participants considered only when they were at end of life, unwillingness to engage in an invasive therapy, and suboptimal coordination between cardiology and renal services. This is a challenging patient group in which to perform research, and lessons learned from the peritoneal dialysis (PD)-HF trial will be helpful in the planning of future studies in this area.

scholarly journals Methodological Challenges of Multiple-Component Intervention: Lessons Learned from a Randomized Controlled Trial of Functional Recovery After Hip Fracture

2006 ◽  
Vol 3 (1) ◽  
pp. 63-70 ◽  
Author(s):  
John P. Allegrante ◽  
Margaret G. E. Peterson ◽  
Charles N. Cornell ◽  
C. Ronald MacKenzie ◽  
Laura Robbins ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hip Fracture ◽  
Functional Recovery ◽  
Controlled Trial ◽  
Lessons Learned ◽  
Randomized Controlled ◽  
Methodological Challenges ◽  
Multiple Component

Financial Incentives for Medicaid Beneficiaries With Diabetes: Lessons Learned From HI-PRAISE, an Observational Study and Randomized Controlled Trial

2017 ◽  
Vol 32 (7) ◽  
pp. 1498-1501 ◽  
Author(s):  
Ritabelle Fernandes ◽  
Chuan C. Chinn ◽  
Dongmei Li ◽  
Timothy Halliday ◽  
Timothy B. Frankland ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Observational Study ◽  
Clinical Outcomes ◽  
Financial Incentives ◽  
Controlled Trial ◽  
Lessons Learned ◽  
Kaiser Permanente ◽  
Randomized Controlled ◽  
Medicaid Beneficiaries ◽  
The Impact

Purpose: The Hawaii Patient Reward and Incentives to Support Empowerment (HI-PRAISE) project examined the impact of financial incentives on Medicaid beneficiaries with diabetes. Design: Observational pre–post study and randomized controlled trial (RCT). Setting: Federally qualified health centers (FQHCs) and Hawaii Kaiser Permanente. Participants: The observational study included 2003 Medicaid beneficiaries with diabetes from FQHCs. The RCT included 320 participants from Kaiser Permanente. Intervention: Participants could earn up to $320/year of financial incentives for a minimum of 1 year. Measures: (1) Clinical outcomes of change in hemoglobin A1c (HbA1c), blood pressure, and cholesterol; (2) compliance with American Diabetes Association (ADA) standards of diabetes care; and (3) cost effectiveness. Analysis: Generalized estimating equation models were used to assess differences in clinical outcomes. General linear models were utilized to estimate the medical costs per patient/day. Results: Changes in clinical outcomes in the observational study were statistically significant. Mean HbA1c decreased from 8.56% to 8.24% ( P < .0001) and low-density lipoprotein decreased from 106.17 mg/dL to 98.55 mg/dL ( P < .0001). No significant differences were found between groups in the RCT. Improved ADA compliance was observed. No reduction in total health cost during the project period was demonstrated. Conclusion: The HI-PRAISE found no conclusive evidence that financial incentives had beneficial effect on diabetes clinical outcomes or cost saving measures.

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