Understanding results from randomized trials: use of program- and client-level data to study medical and nonmedical treatment programs.

2005 ◽  
Vol 66 (5) ◽  
pp. 682-687 ◽  
Author(s):  
Lee Ann Kaskutas ◽  
Lyndsay Ammon ◽  
Jane Witbrodt ◽  
Karen Graves ◽  
Sarah Zemore ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Treatment Programs ◽  
Level Data ◽  
Nonmedical Treatment

Abstract 29: The Association Between General Anesthesia and Outcome of Endovascular Thrombectomy in Pooled Data From Five Randomized Trials

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Bruce C Campbell ◽  
Wim van Zwam ◽  
Mayank Goyal ◽  
Bijoy K Menon ◽  
Diederik W Dippel ◽  
...  
Keyword(s):  
General Anesthesia ◽  
Standard Care ◽  
Randomized Trials ◽  
Random Effect ◽  
Prognostic Variables ◽  
Anterior Circulation ◽  
Endovascular Thrombectomy ◽  
Pooled Data ◽  
Mixed Effects Modeling ◽  
Level Data

Background and purpose: General anesthesia (GA) during endovascular thrombectomy has been associated with worse patient outcomes in observational studies. We examined the association between GA and thrombectomy outcomes in pooled data from five randomized trials. Methods: Patient-level data were pooled from trials comparing endovascular thrombectomy (predominantly using stent retrievers) with standard care in anterior circulation ischemic stroke patients (HERMES Collaboration): MR CLEAN, ESCAPE, REVASCAT, SWIFT PRIME, and EXTEND IA. The primary outcome was ordinal analysis of modified Rankin scale (mRS) at 90 days in the GA and non-GA subgroups, adjusted for baseline prognostic variables. To account for between-trial variance we used mixed-effects modeling with a random effect for trial incorporated in all models. Results: Of 1287 patients, 634 were allocated to endovascular thrombectomy and general anesthesia was used in 153/609 (25%) of endovascular-treated patients with anesthesia information available. Although dysphasic patients are sometimes felt to be less co-operative and require GA, the rate of GA was 25% in both right and left hemisphere patients. At baseline, GA and non-GA patients had similar age, NIHSS and time to randomization. Endovascular thrombectomy was associated with increased odds of improved functional outcome at 3 months, regardless of whether GA (cOR 1.73 95%CI 1.10-2.72, p=0.02) or non-GA (cOR 2.61 95%CI 2.01-3.40, p<0.001) was used. The odds of improved outcome were, however, significantly greater for those treated under non-GA (OR 1.59 95%CI 1.12-2.26, p=0.01). Pneumonia was more common in the GA group (16% vs 9% p=0.03). Rates of vessel perforation were similar in GA (0.7%) vs non-GA patients (1.8%, p=0.52). Delay between randomization and reperfusion was greater in GA versus non-GA patients (median 98 vs 75 min, p<0.001). Conclusions: Worse outcomes after endovascular thrombectomy were associated with GA, after adjustment for baseline prognostic variables. These data support avoidance of GA whenever possible. The procedure did, however, remain effective versus standard care in patients treated under GA, indicating that treatment is still worthwhile in those who require anesthesia for medical reasons.

scholarly journals Addressing Methodologic Challenges and Minimizing Threats to Validity in Synthesizing Findings from Individual-Level Data Across Longitudinal Randomized Trials

2017 ◽  
Vol 19 (S1) ◽  
pp. 60-73 ◽  
Author(s):  
Ahnalee Brincks ◽  
Samantha Montag ◽  
George W. Howe ◽  
Shi Huang ◽  
Juned Siddique ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Individual Level ◽  
Threats To Validity ◽  
Level Data

scholarly journals STRATIFIED EFFECTS OF BLOOD PRESSURE-LOWERING TREATMENT ON LONG-TERM BLOOD PRESSURE: A META-ANALYSIS OF INDIVIDUAL-LEVEL DATA OF 334,219 PARTICIPANTS FROM 50 RANDOMIZED TRIALS

2021 ◽  
Vol 39 (Supplement 1) ◽  
pp. e53
Author(s):  
Dexter Canoy ◽  
Emma Copland ◽  
Rema Ramakrishnan ◽  
Ana -Catarina Pinho-Gomes ◽  
Milad Nazarzadeh ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Trials ◽  
Meta Analysis ◽  
Blood Pressure Lowering ◽  
Individual Level ◽  
Level Data ◽  
Pressure Lowering

scholarly journals An evaluation of factors that may influence clinicians’ decisions not to enroll eligible patients into randomized trials in critical care

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0255361
Author(s):  
Mahesh Ramanan ◽  
Laurent Billot ◽  
Dorrilyn Rajbhandari ◽  
John Myburgh ◽  
Balasubramanian Venkatesh
Keyword(s):  
Intensive Care ◽  
Randomized Trials ◽  
Controlled Trial ◽  
Mixed Effects ◽  
Multivariable Model ◽  
Academic Status ◽  
Regression Modelling ◽  
Level Data ◽  
Research Coordinator ◽  
Logistic Regression Modelling

Objectives To determine the association between intensive care unit (ICU) characteristics and clinicians’ decision to decline eligible patients for randomization into a multicentered pragmatic comparative-effectiveness controlled trial. Methods Screening logs from the Adjunctive Glucocorticoid Therapy in Septic Shock Trial (ADRENAL) and site-level data from the College of Intensive Care Medicine and Australia New Zealand Intensive Care Society were examined. The effects of ICU characteristics such as tertiary academic status, research coordinator availability, number of admissions, and ICU affiliations on clinicians declining to randomize eligible patients were calculated using mixed effects logistic regression modelling. Results There were 21,818 patients screened for inclusion in the ADRENAL trial at 69 sites across five countries, out of which 5,501 were eligible, 3,800 were randomized and 659 eligible patients were declined for randomization by the treating clinician. The proportion of eligible patients declined by clinicians at individual ICUs ranged from 0 to41%. In the multivariable model, none of the ICU characteristics were significantly associated with higher clinician decline rate. Conclusions Neither tertiary academic status, nor other site-level variables were significantly associated with increased rate of clinicians declining eligible patients.

The Development of Language-Training Programs for Postrubella Hearing-Impaired Children

1973 ◽  
Vol 38 (1) ◽  
pp. 15-24 ◽  
Author(s):  
Linda Lynch ◽  
Annette Tobin
Keyword(s):  
Hearing Impaired ◽  
Treatment Programs ◽  
Individual Treatment ◽  
Target Behaviors ◽  
Systematic Fashion ◽  
Development Of Language ◽  
The Individual ◽  
Impaired Children ◽  
Hearing Impaired Children

This paper presents the procedures developed and used in the individual treatment programs for a group of preschool, postrubella, hearing-impaired children. A case study illustrates the systematic fashion in which the clinician plans programs for each child on the basis of the child’s progress at any given time during the program. The clinician’s decisions are discussed relevant to (1) the choice of a mode(s) for the child and the teacher, (2) the basis for selecting specific target behaviors, (3) the progress of each program, and (4) the implications for future programming.

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