With stroke being one of the leading causes of adult disability worldwide, the challenge of supporting individuals in their recovery extends beyond physical rehabilitation. Post-stroke aphasia, a common impairment affecting language and communication, can be a source of significant psychological distress, often leading to depression. The Action Success Knowledge (ASK) trial represents a pivotal step towards addressing this concern. This trial, as presented in BMJ Open (DOI: 10.1136/bmjopen-2018-023560), employs a psychosocial intervention designed to minimize depression in those struggling with post-stroke aphasia. Its unique aspect, however, lies in its commitment to treatment fidelity—a concept that has been sparsely reported in aphasia intervention studies despite its critical role in validating clinical research.
Treatment fidelity, broadly defined, is the methodological safeguard that ensures an intervention is delivered as planned. It is a multifaceted process that correlates closely with the reliability and validity of findings in clinical trials. In fact, as acknowledged by various researchers including Borrelli et al. (2005) and Bellg et al. (2004), maintaining fidelity not only serves to enhance the quality of an intervention but also bolsters the interpretability of treatment outcomes. More importantly, by adhering to these stringent methodological standards, practitioners are better positioned to replicate these interventions in real-world settings, echoing the imperatives set forth by the TiDIER (Template for Intervention Description and Replication) checklist.
A recent article published in BMJ Open elaborates on the development of a fidelity protocol within the ASK trial, a cluster randomized trial that capitalizes on early mood interventions delivered by speech and language therapists. The protocol, devised in congruence with the National Institutes of Health Behaviour Change Consortium framework, meticulously outlines the processes to enhance fidelity within the two arms of the study—the experimental treatment and the attention control groups.
The study protocol secured approval from the Darling Downs Hospital and Health Service Human Research Ethics Committee in Queensland, Australia, under the National Mutual Acceptance scheme for multicentre human research projects. This endorsement ensures the study’s governance aligns with national norms for conducting human research ethically.
One of the pioneering features of the ASK study is the use of a novel fidelity tool tailored to monitor adherence to the intervention’s protocol. This instrument is pivotal in identifying potential divergences from the planned treatment course, enabling real-time adjustments to maintain fidelity. This is especially pertinent given the complexity of delivering interventions in aphasia, where patient engagement and communication are inherently challenging.
According to Carragher et al., the fidelity protocol for the ASK trial includes rigorous training for therapists, standardization of therapy materials, and methods to monitor and rate therapist adherence. These checks and balances are envisaged to provide critical feedback and uphold the integrity of the intervention, giving robustness to potential findings that could shape future treatment paradigms for aphasia patients dealing with depression post-stroke.
Once the ASK trial concludes, findings from the fidelity reviews, alongside the trial outcomes, will be disseminated through academic publications and conference presentations. Such transparency is key in fostering an evidence-based approach to aphasia treatment, one that could revolutionize the support provided to individuals and families affected by stroke.
The publication of the fidelity protocol in the BMJ Open (DOI: 10.1136/bmjopen-2018-023560) is a progressive step in clinical trial reporting. It highlights the need for transparency and methodological rigor in intervention research, particularly in the domain of health behavior. This emphasis on treatment fidelity is a testament to the growing recognition that the benefits of an intervention depend not only on its inherent therapeutic potential but also on how faithfully it is executed.
As the ASK trial progresses, the implications will extend beyond its immediate findings. It sets a precedent for future exploration into aphasia interventions and underlines the demand for innovation in speech and language therapy, geared towards holistic recovery post-stroke.
References
1. Carragher, M., Ryan, B., Worrall, L., Thomas, S., Rose, M., Simmons-Mackie, N., … & Hoffmann, T. (2019). Fidelity protocol for the Action Success Knowledge (ASK) trial: a psychosocial intervention administered by speech and language therapists to prevent depression in people with post-stroke aphasia. BMJ Open, 9(5), e023560. doi:10.1136/bmjopen-2018-023560
2. Borrelli, B., Sepinwall, D., Ernst, D., et al. (2005). A new tool to assess treatment fidelity and evaluation of treatment fidelity across 10 years of health behavior research. J Consult Clin Psychol, 73, 852-60. doi:10.1037/0022-006X.73.5.852
3. Bellg, A. J., Borrelli, B., Resnick, B., et al. (2004). Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol, 23, 443-51. doi:10.1037/0278-6133.23.5.443
4. Hoffmann, T. C., Glasziou, P. P., Boutron, I., et al. (2014). Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ, 348, g1687. doi:10.1136/bmj.g1687
5. Hinckley, J. J., & Douglas, N. F. (2013). Treatment fidelity: its importance and reported frequency in aphasia treatment studies. Am J Speech Lang Pathol, 22, S279-S284. doi:10.1044/1058-0360(2012/12-0092)
Keywords
1. ASK trial post-stroke depression
2. Treatment fidelity in aphasia
3. Early mood intervention stroke
4. Speech therapy for aphasia
5. Psychological impact of aphasia