Faculty Opinions recommendation of Effect of dexmedetomidine versus lorazepam on outcome in patients with sepsis: an a priori-designed analysis of the MENDS randomized controlled trial.

2010 ◽  
Author(s):  
John Kress
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
A Priori ◽  
Randomized Controlled

Feasibility randomized controlled trial of a mind-body activity program for older adults with chronic pain and cognitive decline: The virtual “Active Brains” study

2021 ◽  
Author(s):  
James D Doorley ◽  
Ryan A Mace ◽  
Paula J Popok ◽  
Victoria A Grunberg ◽  
Anya Ragnhildstveit ◽  
...  
Keyword(s):  
Older Adults ◽  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Cognitive Decline ◽  
Controlled Trial ◽  
A Priori ◽  
Exit Interviews ◽  
Randomized Controlled ◽  
Activity Program ◽  
Body Activity

Abstract Background and Objectives Chronic pain (CP) and cognitive decline (CD) are highly co-morbid and debilitating among older adults. We iteratively developed Active Brains–Fitbit (AB-F), a group mind-body activity program aided by a Fitbit that is feasible and associated with improvements in physical, cognitive, and emotional functioning when delivered in person to older adults with CP and CD. We adapted our intervention and methodology for remote delivery to bypass barriers to participation. Here we report on a feasibility randomized controlled trial of the virtual AB-F versus a Health Enhancement Program (HEP) educational control followed by qualitative exit interviews. Research Design and Methods Older adults (age ≥ 60) with CP and CD (2 cohorts) completed eight weeks of AB-F (n = 8) or HEP (n = 11). Study procedures were fully remote via live video. Quantitative analyses explored feasibility and acceptability markers and within group improvements in outcomes. Qualitative analyses were primarily deductive using the Framework Method. Results AB-F met a-priori set feasibility benchmarks, similar to our in-person pilot. Participation in AB-F was associated with preliminary signals of improvement in multimodal physical function, emotional function (anxiety), cognitive function, pain intensity, and coping (e.g., pain self-efficacy, catastrophizing). Participation in HEP was associated with smaller or negligible improvements. Exit interviews confirmed feasibility and satisfaction with our completely remote interventions and methodology. Discussion and Implications Results provide evidence for the feasibility of our completely remote study, and for initial markers of improvement after AB-F. The results will inform a fully powered remote efficacy trial.

scholarly journals Effect of dexmedetomidine versus lorazepam on outcome in patients with sepsis: an a priori-designed analysis of the MENDS randomized controlled trial

Critical Care ◽  
2010 ◽  
Vol 14 (2) ◽  
pp. R38 ◽  
Author(s):  
Pratik P Pandharipande ◽  
Robert D Sanders ◽  
Timothy D Girard ◽  
Stuart McGrane ◽  
Jennifer L Thompson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
A Priori ◽  
Randomized Controlled

scholarly journals An Evaluation of Strategies Used to Maximize Intervention Fidelity in a Randomized Controlled Trial of a Sexual Assault Resistance Program for University Women

2021 ◽  
Author(s):  
Karen L. Hobden ◽  
Wilfreda E. Thurston ◽  
Gail L. McVey ◽  
Charlene Y. Senn
Keyword(s):  
Randomized Controlled Trial ◽  
Sexual Assault ◽  
Sexual Coercion ◽  
Controlled Trial ◽  
A Priori ◽  
Intervention Fidelity ◽  
University Women ◽  
Randomized Controlled ◽  
Core Elements ◽  
High Level

AbstractIn this paper, we describe and evaluate the strategies used to maximize intervention fidelity in a randomized controlled trial to examine the efficacy of a sexual assault resistance intervention. The EAAA program was based on the best available theory and evidence on how women can successfully resist sexual coercion from male acquaintances. Extensive protocols for hiring, training, and supervising facilitators were established a priori. Detailed intervention manuals were developed that clearly described program goals, learning objectives, core elements, troubleshooting tips, sections that must be delivered verbatim, adaptations that could be made if necessary, and the ideal and minimum dose. Program sessions were audio-recorded, and a subsample of recordings were scored for adherence to the manuals using detailed Intervention Fidelity Checklists (IFC) developed specifically for this research. The Gearing et al. (2011) Comprehensive Intervention Fidelity Guide (CFIG) was employed retrospectively to provide objectivity to our analysis and help identify what we did well and what we could have done better. The SARE (Sexual Assault Resistance Education) Trial received high scores (38 out of 44 (86%) from each of the first two authors on the CFIG, suggesting a high level of intervention fidelity. Although a potential for bias on the part of the two raters was an obvious limitation, as was our neglection to include measures of implementation receipt, which Gearing et al. (2011) recommended, our analysis underscores the utility in employing methods recommended to enhance intervention fidelity when developing and evaluating evidence-based interventions.

A Randomized Controlled Trial of Implant-retained Mandibular Overdentures

2006 ◽  
Vol 85 (6) ◽  
pp. 547-551 ◽  
Author(s):  
P.F. Allen ◽  
J.M. Thomason ◽  
N.J.A. Jepson ◽  
F. Nohl ◽  
D.G. Smith ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Oral Health ◽  
Randomized Clinical Trials ◽  
Controlled Trial ◽  
A Priori ◽  
Health Impact ◽  
Post Treatment ◽  
Complete Dentures ◽  
Satisfaction Scale ◽  
Randomized Controlled

Evidence from randomized clinical trials of implant-retained overdentures is very limited at the present time. The aim of this study was to compare implant-retained mandibular overdentures and conventional complete dentures in a randomized controlled trial (RCT). Our a priori hypothesis was that implant-retained mandibular overdentures would be significantly better than conventional complete dentures. Edentulous patients (n = 118) were randomly allocated to either an Implant Group (n = 62) or a Denture Group (n = 56). Patients completed the Oral Health Impact Profile (OHIP) and a denture satisfaction scale pre-treatment and three months post-treatment. Upon completion of treatment, both groups reported improvement (p < 0.001, Wilcoxon Ranks Sum test) in oral-health-related quality of life and denture satisfaction. There were no significant post-treatment differences between the groups, but a treatment effect may be masked by application of “intention to treat” analysis. The OHIP change scores were significantly greater for patients receiving implants than for those who refused them.

scholarly journals Correction: Effect of dexmedetomidine versus lorazepam on outcome in patients with sepsis: an a priori-designed analysis of the MENDS randomized controlled trial

Critical Care ◽  
2011 ◽  
Vol 15 (1) ◽  
Author(s):  
Pratik P Pandharipande ◽  
◽  
Robert D Sanders ◽  
Timothy D Girard ◽  
Stuart McGrane ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
A Priori ◽  
Randomized Controlled ◽  
Correction Effect

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

Phonomotor Versus Semantic Feature Analysis Treatment for Anomia in 58 Persons With Aphasia: A Randomized Controlled Trial

2019 ◽  
Vol 62 (12) ◽  
pp. 4464-4482 ◽  
Author(s):  
Diane L. Kendall ◽  
Megan Oelke Moldestad ◽  
Wesley Allen ◽  
Janaki Torrence ◽  
Stephen E. Nadeau
Keyword(s):  
Randomized Controlled Trial ◽  
Response Latency ◽  
Controlled Trial ◽  
Semantic Knowledge ◽  
Semantic Feature ◽  
Feature Analysis ◽  
Group Differences ◽  
Randomized Controlled ◽  
Confrontation Naming ◽  
Semantic Feature Analysis

Purpose The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session, as well as generalization to untrained exemplars and contexts. The purpose of this study was to test the efficacy of phonomotor treatment, a treatment focusing on enhancement of phonological sequence knowledge, against semantic feature analysis (SFA), a lexical-semantic therapy that focuses on enhancement of semantic knowledge and is well known and commonly used to treat anomia in aphasia. Method In a between-groups randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56–60 hr of intensively delivered treatment over 6 weeks with testing pretreatment, posttreatment, and 3 months posttreatment termination. Results There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment. Significant within-group immediately posttreatment acquisition effects for confrontation naming and response latency were observed for both groups. Treatment-specific generalization effects for confrontation naming were observed for both groups immediately and 3 months posttreatment; a significant decrease in response latency was observed at both time points for the SFA group only. Finally, significant within-group differences on the Comprehensive Aphasia Test–Disability Questionnaire ( Swinburn, Porter, & Howard, 2004 ) were observed both immediately and 3 months posttreatment for the SFA group, and significant within-group differences on the Functional Outcome Questionnaire ( Glueckauf et al., 2003 ) were found for both treatment groups 3 months posttreatment. Discussion Our results are consistent with those of prior studies that have shown that SFA treatment and phonomotor treatment generalize to untrained words that share features (semantic or phonological sequence, respectively) with the training set. However, they show that there is no significant generalization to untrained words that do not share semantic features or phonological sequence features.

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