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 ◽  
...  
Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Bruce C Campbell ◽  
Wim van Zwam ◽  
Mayank Goyal ◽  
Bijoy K Menon ◽  
Diederik W Dippel ◽  
...  

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.


2017 ◽  
Vol 19 (S1) ◽  
pp. 60-73 ◽  
Author(s):  
Ahnalee Brincks ◽  
Samantha Montag ◽  
George W. Howe ◽  
Shi Huang ◽  
Juned Siddique ◽  
...  

2021 ◽  
Vol 39 (Supplement 1) ◽  
pp. e53
Author(s):  
Dexter Canoy ◽  
Emma Copland ◽  
Rema Ramakrishnan ◽  
Ana -Catarina Pinho-Gomes ◽  
Milad Nazarzadeh ◽  
...  

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0255361
Author(s):  
Mahesh Ramanan ◽  
Laurent Billot ◽  
Dorrilyn Rajbhandari ◽  
John Myburgh ◽  
Balasubramanian Venkatesh

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.


1973 ◽  
Vol 38 (1) ◽  
pp. 15-24 ◽  
Author(s):  
Linda Lynch ◽  
Annette Tobin

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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