Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trial
Abstract Background Treatment fidelity is inconsistently reported in aphasia research, contributing to uncertainty about the effectiveness of types of aphasia therapy following stroke. We outline the processes and outcomes of treatment fidelity monitoring in a pre-specified secondary analysis of the...
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| Format: | Article |
| Language: | English |
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BMC
2022-06-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-022-06433-3 |
| _version_ | 1811241199455961088 |
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| author | Erin Godecke Emily Brogan Natalie Ciccone Miranda L. Rose Elizabeth Armstrong Anne Whitworth Fiona Ellery Audrey Holland Sandy Middleton Tapan Rai Graeme J. Hankey Dominique Cadilhac Julie Bernhardt |
| author_facet | Erin Godecke Emily Brogan Natalie Ciccone Miranda L. Rose Elizabeth Armstrong Anne Whitworth Fiona Ellery Audrey Holland Sandy Middleton Tapan Rai Graeme J. Hankey Dominique Cadilhac Julie Bernhardt |
| author_sort | Erin Godecke |
| collection | DOAJ |
| description | Abstract Background Treatment fidelity is inconsistently reported in aphasia research, contributing to uncertainty about the effectiveness of types of aphasia therapy following stroke. We outline the processes and outcomes of treatment fidelity monitoring in a pre-specified secondary analysis of the VERSE trial. Methods VERSE was a 3-arm, single-blinded RCT with a 12-week primary endpoint comparing Usual Care (UC) to two higher intensity treatments: Usual Care-Plus (UC-Plus) and VERSE, a prescribed intervention. Primary outcome results were previously reported. This secondary analysis focused on treatment fidelity. Video-recorded treatment sessions in the higher intensity study arms were evaluated for treatment adherence and treatment differentiation. Treatment components were evaluated using a pre-determined fidelity checklist. Primary outcome: prescribed amount of therapy time (minutes); secondary outcomes: (i) adherence to therapy protocol (%) and (ii) treatment differentiation between control and high intensity groups. Results Two hundred forty-six participants were randomised to Usual Care (n=81), Usual Care-Plus (n=82), and VERSE (n=83). One hundred thirty-five (82%) participants in higher intensity intervention arms received the minimum prescribed therapy minutes. From 10,805 (UC 7787; UC-Plus 1450; VERSE 1568) service events, 431 treatment protocol deviations were noted in 114 participants. Four hundred thirty-seven videos were evaluated. The VERSE therapists achieved over 84% adherence to key protocol elements. Higher stroke and aphasia severity, older age, and being in the UC-Plus group predicted more treatment deviations. Conclusions We found high levels of treatment adherence and differentiation between the intervention arms, providing greater confidence interpreting our results. The comprehensive systems for intervention fidelity monitoring and reporting in this trial make an important contribution to aphasia research and, we argue, should set a new standard for future aphasia studies. Trial registration ACTRN 12613000776707 |
| first_indexed | 2024-04-12T13:32:59Z |
| format | Article |
| id | doaj.art-80fb137940914ac185d494f54be397ed |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T13:32:59Z |
| publishDate | 2022-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-80fb137940914ac185d494f54be397ed2022-12-22T03:31:07ZengBMCTrials1745-62152022-06-0123111110.1186/s13063-022-06433-3Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trialErin Godecke0Emily Brogan1Natalie Ciccone2Miranda L. Rose3Elizabeth Armstrong4Anne Whitworth5Fiona Ellery6Audrey Holland7Sandy Middleton8Tapan Rai9Graeme J. Hankey10Dominique Cadilhac11Julie Bernhardt12School of Medical and Health Sciences, Edith Cowan UniversitySchool of Medical and Health Sciences, Edith Cowan UniversitySchool of Medical and Health Sciences, Edith Cowan UniversityCentre of Research Excellence in Aphasia Rehabilitation RecoverySchool of Medical and Health Sciences, Edith Cowan UniversityCurtin UniversityStroke Division, The Florey Institute of Neuroscience and Mental HealthUniversity of ArizonaCentre of Research Excellence in Aphasia Rehabilitation RecoveryUniversity of Technology SydneySchool of Medicine and Pharmacology, The University of Western AustraliaCentre of Research Excellence in Aphasia Rehabilitation RecoveryCentre of Research Excellence in Aphasia Rehabilitation RecoveryAbstract Background Treatment fidelity is inconsistently reported in aphasia research, contributing to uncertainty about the effectiveness of types of aphasia therapy following stroke. We outline the processes and outcomes of treatment fidelity monitoring in a pre-specified secondary analysis of the VERSE trial. Methods VERSE was a 3-arm, single-blinded RCT with a 12-week primary endpoint comparing Usual Care (UC) to two higher intensity treatments: Usual Care-Plus (UC-Plus) and VERSE, a prescribed intervention. Primary outcome results were previously reported. This secondary analysis focused on treatment fidelity. Video-recorded treatment sessions in the higher intensity study arms were evaluated for treatment adherence and treatment differentiation. Treatment components were evaluated using a pre-determined fidelity checklist. Primary outcome: prescribed amount of therapy time (minutes); secondary outcomes: (i) adherence to therapy protocol (%) and (ii) treatment differentiation between control and high intensity groups. Results Two hundred forty-six participants were randomised to Usual Care (n=81), Usual Care-Plus (n=82), and VERSE (n=83). One hundred thirty-five (82%) participants in higher intensity intervention arms received the minimum prescribed therapy minutes. From 10,805 (UC 7787; UC-Plus 1450; VERSE 1568) service events, 431 treatment protocol deviations were noted in 114 participants. Four hundred thirty-seven videos were evaluated. The VERSE therapists achieved over 84% adherence to key protocol elements. Higher stroke and aphasia severity, older age, and being in the UC-Plus group predicted more treatment deviations. Conclusions We found high levels of treatment adherence and differentiation between the intervention arms, providing greater confidence interpreting our results. The comprehensive systems for intervention fidelity monitoring and reporting in this trial make an important contribution to aphasia research and, we argue, should set a new standard for future aphasia studies. Trial registration ACTRN 12613000776707https://doi.org/10.1186/s13063-022-06433-3Treatment fidelityBehavioural therapyStrokeAphasiaRehabilitationRandomised control trial |
| spellingShingle | Erin Godecke Emily Brogan Natalie Ciccone Miranda L. Rose Elizabeth Armstrong Anne Whitworth Fiona Ellery Audrey Holland Sandy Middleton Tapan Rai Graeme J. Hankey Dominique Cadilhac Julie Bernhardt Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trial Trials Treatment fidelity Behavioural therapy Stroke Aphasia Rehabilitation Randomised control trial |
| title | Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trial |
| title_full | Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trial |
| title_fullStr | Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trial |
| title_full_unstemmed | Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trial |
| title_short | Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trial |
| title_sort | treatment fidelity monitoring reporting and findings in a complex aphasia intervention trial a substudy of the very early rehabilitation in speech verse trial |
| topic | Treatment fidelity Behavioural therapy Stroke Aphasia Rehabilitation Randomised control trial |
| url | https://doi.org/10.1186/s13063-022-06433-3 |
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