scholarly journals Communicating the diagnosis of cancer or depression: Results of a randomized controlled online study using video vignettes

2021 ◽  
Author(s):  
Franziska Kühne ◽  
Henriette Fauth ◽  
Destina S. Ay‐Bryson ◽  
Leonie N. C. Visser ◽  
Florian Weck
Keyword(s):  
Online Study ◽  
Randomized Controlled ◽  
Diagnosis Of Cancer ◽  
Video Vignettes

Communicating prognosis to parents in the neonatal ICU: Optimistic vs. PEssimistic – “The “COPE”-Trial“ – Study protocol of a randomized controlled trial using scripted video-vignettes to explore communication preferences of parents of preterm infants

2021 ◽  
Author(s):  
Fiona A. Forth ◽  
Florian Hammerle ◽  
Jochem König ◽  
Michael S. Urschitz ◽  
Philipp Neuweiler ◽  
...  
Keyword(s):  
Online Survey ◽  
Medical Center ◽  
Controlled Trial ◽  
Patient Questionnaire ◽  
Online Questionnaire ◽  
Post Intervention ◽  
Parent Communication ◽  
Communication Preferences ◽  
Randomized Controlled ◽  
Video Vignettes

Abstract Background: One of the numerous challenges preterm birth poses for parents and physicians is prognostic disclosure. Prognoses are based on scientific evidence and medical experience. They are subject to individual assessment and, hence, will generally remain uncertain with regard to the individual. This can result in differences in prognostic framing and thus affect the recipients’ perception. In neonatology, data on the effects of prognostic framing are scarce. In particular, it is unclear whether parents prefer a more optimistic or a more pessimistic prognostic framing.Objective: To explore parents’ preferences concerning prognostic framing and its effects on parent reported outcomes and experiences. To identify predictors (demographic, psychological) of parents’ communication preferences.Design, setting, participants: Unblinded, randomized-controlled cross-over trial (RCT) at the Division of Neonatology of the University Medical Center Mainz, Germany, including German-speaking parents or guardians of infants born preterm between 2009 and 2019 with a birth weight <1500g. Inclusion of up to 204 families is planned, with possible reduction according to a blinded sample size reassessment after enrollment of 50 to 70 families, depending on the number of participants per family.Intervention: Embedded in an online-survey and in pre-specified order, participants will watch two video-vignettes depicting a more optimistic vs. a more pessimistic framing in prognostic disclosure to parents of a preterm infant. Apart from prognostic framing, all other aspects of physician-parent communication are standardized in both videos.Main outcomes and measures: At baseline and after each video, participants complete a two-part online-questionnaire (baseline and post-intervention). Primary outcome is the preference for either a more optimistic or a more pessimistic prognostic framing. Secondary outcomes include changes in state-anxiety (STAI-SKD), satisfaction with framing, evaluation of prognosis, future optimism and hope, preparedness for shared decision-making (each assessed using customized questions), and general impression (customized question), professionalism (adapted from GMC Patient Questionnaire) and compassion (Physician Compassion Questionnaire) of the consulting physician.Discussion: This RCT will explore parents’ preferences concerning prognostic framing and its effects on physician-parent communication. Results may contribute to a better understanding of parental needs in prognostic disclosure and will be instrumental for a broad audience of clinicians, scientists and ethicists.Trial registration: drks.de DRKS00024466. Registered on April 16, 2021

scholarly journals Bicycling campaigns promoting health versus campaigns promoting safety: A randomized controlled online study of ‘dangerization’

2015 ◽  
Vol 2 (3) ◽  
pp. 369-378 ◽  
Author(s):  
Tim Gamble ◽  
Ian Walker ◽  
Aleksandra Laketa
Keyword(s):  
Online Study ◽  
Randomized Controlled

scholarly journals Effective Information Provision About the Side Effects of Treatment for Malignant Lymphoma: Protocol of a Randomized Controlled Trial Using Video Vignettes

10.2196/12453 ◽  
2019 ◽  
Vol 8 (5) ◽  
pp. e12453 ◽  
Author(s):  
Nanon Labrie ◽  
Sandra van Dulmen ◽  
Marie José Kersten ◽  
Hanneke JCM de Haes ◽  
Arwen H Pieterse ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Malignant Lymphoma ◽  
Controlled Trial ◽  
Information Provision ◽  
Randomized Controlled ◽  
Video Vignettes

scholarly journals The COPE-Trial—Communicating prognosis to parents in the neonatal ICU: Optimistic vs. PEssimistic: study protocol for a randomized controlled crossover trial using two different scripted video vignettes to explore communication preferences of parents of preterm infants

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fiona A. Forth ◽  
Florian Hammerle ◽  
Jochem König ◽  
Michael S. Urschitz ◽  
Philipp Neuweiler ◽  
...  
Keyword(s):  
Online Survey ◽  
Crossover Trial ◽  
Medical Center ◽  
Patient Questionnaire ◽  
Online Questionnaire ◽  
Post Intervention ◽  
Parent Communication ◽  
Communication Preferences ◽  
Randomized Controlled ◽  
Video Vignettes

Abstract Background One of the numerous challenges preterm birth poses for parents and physicians is prognostic disclosure. Prognoses are based on scientific evidence and medical experience. They are subject to individual assessment and will generally remain uncertain with regard to the individual. This can result in differences in prognostic framing and thus affect the recipients’ perception. In neonatology, data on the effects of prognostic framing are scarce. In particular, it is unclear whether parents prefer a more optimistic or a more pessimistic prognostic framing. Objective To explore parents’ preferences concerning prognostic framing and its effects on parent-reported outcomes and experiences. To identify predictors (demographic, psychological) of parents’ communication preferences. Design, setting, participants Unblinded, randomized controlled crossover trial (RCT) at the Division of Neonatology of the University Medical Center Mainz, Germany, including German-speaking parents or guardians of infants born preterm between 2010 and 2019 with a birth weight < 1500 g. Inclusion of up to 204 families is planned, with possible revision according to a blinded sample size reassessment. Intervention Embedded in an online survey and in pre-specified order, participants will watch two video vignettes depicting a more optimistic vs. a more pessimistic framing in prognostic disclosure to parents of a preterm infant. Apart from prognostic framing, all other aspects of physician-parent communication are standardized in both videos. Main outcomes and measures At baseline and after each video, participants complete a two-part online questionnaire (baseline and post-intervention). Primary outcome is the preference for either a more optimistic or a more pessimistic prognostic framing. Secondary outcomes include changes in state-anxiety (STAI-SKD), satisfaction with prognostic framing, evaluation of prognosis, future optimism and hope, preparedness for shared decision-making (each assessed using customized questions), and general impression (customized question), professionalism (adapted from GMC Patient Questionnaire) and compassion (Physician Compassion Questionnaire) of the consulting physician. Discussion This RCT will explore parents’ preferences concerning prognostic framing and its effects on physician-parent communication. Results may contribute to a better understanding of parental needs in prognostic disclosure and will be instrumental for a broad audience of clinicians, scientists, and ethicists. Trial registration German Clinical Trials Register DRKS00024466. Registered on April 16, 2021.

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.

Principles for School-Age Language Intervention: Insights from a Randomized Controlled Trial

ASHA Leader ◽  
2010 ◽  
Vol 15 (1) ◽  
pp. 10-13 ◽  
Author(s):  
Ronald Gillam ◽  
Diane Frome Loeb
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Language Intervention ◽  
School Age ◽  
Randomized Controlled

Baclofen versus clonidine in the treatment of opiates withdrawal, side-effects aspect: a double-blind randomized controlled trial

2001 ◽  
Vol 26 (1) ◽  
pp. 67-71 ◽  
Author(s):  
S. A. Ahmadi-Abhari ◽  
S. Akhondzadeh ◽  
S. M. Assadi ◽  
O. L. Shabestari ◽  
Z. M. Farzanehgan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Controlled Trial ◽  
Double Blind ◽  
Randomized Controlled
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