Realities of trial registration: the Glaxo Wellcome experience

2000 ◽  
Vol 14 (4) ◽  
pp. 203-205 ◽  
Author(s):  
T.G. Gibbs ◽  
E. Wager
Keyword(s):  
Author(s):  
I. Joa ◽  
J. O. Johannessen ◽  
K. S. Heiervang ◽  
A. A. Sviland ◽  
H. A. Nordin ◽  
...  

Abstract This study examined psychometric properties and feasibility of the Family Psychoeducation (FPE) Fidelity Scale. Fidelity assessors conducted reviews using the FPE fidelity scale four times over 18 months at five sites in Norway. After completing fidelity reviews, assessors rated feasibility of the fidelity review process. The FPE fidelity scale showed excellent interrater reliability (.99), interrater item agreement (88%), and internal consistency (mean = .84 across four time points). By the 18-month follow-up, all five sites increased fidelity and three reached adequate fidelity. Fidelity assessors rated feasibility as excellent. The FPE fidelity scale has good psychometric properties and is feasible for evaluating the implementation of FPE programs. Trial registration ClinicalTrials.gov Identifier: NCT03271242.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Guy A. Prochilo ◽  
Ricardo J.S. Costa ◽  
Craig Hassed ◽  
Richard Chambers ◽  
Pascal Molenberghs

Abstract Objectives Researchers have begun delivering mindfulness and aerobic exercise training concurrently on the premise that a combination intervention will yield salutary outcomes over and above each intervention alone. An estimate of the effect of combination training on chronic psychosocial stress in a nonclinical population has not been established. The objective of this study was to establish protocol feasibility in preparation of a definitive RCT targeting healthy individuals, and to explore the preliminary effect of combination training on reducing chronic psychosocial stress in this population. Methods Twenty-four participants were allocated to a single-arm pre-post study and subjected to 16 weeks of concurrent mindfulness psychoeducation and aerobic exercise training. Feasibility criteria were collected and evaluated. Within-group changes in chronic psychosocial stress, mindfulness, emotion regulation, and cardiorespiratory fitness were also assessed. Primary analyses were based on 17 participants. Results Retention rate, response rate, recruitment rate, and sample size analyses indicate a definitive trial is feasible for detecting most effects with precision. There was also a decline in our primary dependent measure of chronic psychosocial stress (dpretest = −0.56, 95% CI [ −1.14,−0.06]). With regard to secondary measures, there was an increase in the use of cognitive reappraisal, and a reduction in use of maladaptive emotion regulation strategies. We are insufficiently confident to comment on changes in mindfulness and aerobic capacity $\left (\dot {V}O_{2max}\right)$ V ̇ O 2 max . However, there were subgroup improvements in aerobic economy at submaximal exercise intensities. Conclusions We recommend a definitive trial is feasible and should proceed. Trial registration ANZCTR (ID: ACTRN12619001726145). Retrospectively registered December 9, 2019.


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