Is it time to study routine car seat tolerance screening in a randomized controlled trial? An international survey of current practice and clinician equipoise

Abstract Background Malnutrition is present in 30% of hospitalized patients and has adverse outcomes for the patient and the healthcare system. The current practice for nutritional care is associated with many barriers. The MyFood decision support system was developed to prevent and treat malnutrition. Methods This paper reports on a process evaluation that was completed within an effectiveness trial. MyFood is a digital tool with an interface consisting of an app and a website. MyFood includes functions to record and evaluate dietary intake. It also provides reports to nurses, including tailored recommendations for nutritional treatment. We used an effectiveness-implementation hybrid design in a randomized controlled trial. The RE-AIM (Reach, Efficiency, Adoption, Implementation, Maintenance) framework was used to perform a process evaluation alongside the randomized controlled trial, using a combination of quantitative and qualitative methods. An implementation plan, including implementation strategies, was developed to plan and guide the study. Results Reach: In total, 88% of eligible patients consented to participate (n = 100). Adoption: Approximately 75% of the nurses signed up to use MyFood and 50% used the reports. Implementation: MyFood empowered the patients in their nutritional situation and acted as a motivation to eat to reach their nutritional target. The compliance of using MyFood was higher among the patients than the nurses. A barrier for use of MyFood among the nurses was different digital systems which were not integrated and the log-in procedure to the MyFood website. Despite limited use by some nurses, the majority of the nurses claimed that MyFood was useful, better than the current practice, and should be implemented in the healthcare system. Conclusions This study used a process evaluation to interpret the results of a randomized controlled trial more in-depth. The patients were highly compliant, however, the compliance was lower among the nurses. MyFood empowered the patients in their nutritional situation, the usability was considered as high, and the experiences and attitudes towards MyFood were primarily positive. Focus on strategies to improve the nurses’ compliance may in the future improve the MyFood system’s potential. Trial registration The trial was registered in ClinicalTrials.gov 26/01/2018 (NCT03412695).

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The comparison of access to an eHealth resource to current practice on mother and co-parent teamwork and breastfeeding rates: A randomized controlled trial

Midwifery ◽

10.1016/j.midw.2020.102812 ◽

2020 ◽

Vol 90 ◽

pp. 102812

Author(s):

Jennifer Abbass-Dick ◽

Winnie Sun ◽

Amber Newport ◽

Fangli Xie ◽

Debbie Godfrey ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Current Practice ◽

Controlled Trial ◽

Randomized Controlled ◽

Breastfeeding Rates

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Minilaparoscopic Total Hysterectomy in Current Practice Feasibility and Benefits: A Unicentric, Randomized Controlled Trial

Journal of Minimally Invasive Gynecology ◽

10.1016/j.jmig.2019.05.016 ◽

2020 ◽

Vol 27 (3) ◽

pp. 673-680

Author(s):

Marie Béguinot ◽

Revaz Botchorishvili ◽

Aurélie Comptour ◽

Sandra Curinier ◽

Sandrine Campagne-Loiseau ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Current Practice ◽

Controlled Trial ◽

Total Hysterectomy ◽

Randomized Controlled

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Car seat education: A randomized controlled trial of teaching methods

Injury ◽

10.1016/j.injury.2018.05.003 ◽

2018 ◽

Vol 49 (7) ◽

pp. 1272-1277 ◽

Cited By ~ 3

Author(s):

Erin Kuroiwa ◽

Rebecca L. Ragar ◽

Crystal S. Langlais ◽

Angelica Baker ◽

Maria E. Linnaus ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Teaching Methods ◽

Controlled Trial ◽

Car Seat ◽

Randomized Controlled

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

American Journal of Speech-Language Pathology ◽

10.1044/2019_ajslp-cac48-18-0227 ◽

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.

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

Journal of Speech Language and Hearing Research ◽

10.1044/2019_jslhr-l-18-0257 ◽

2019 ◽

Vol 62 (12) ◽

pp. 4464-4482 ◽

Cited By ~ 9

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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