Challenges of Recruiting Patients Into Group-Based Stroke Rehabilitation Research: Reflections on Clinician Equipoise Within the Singing for People With Aphasia (SPA) Pilot Trial.
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SUBMITTER: Calitri R
PROVIDER: S-EPMC8209260 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesPilot feasibility randomised controlled trial (RCT) for the singing groups for people with aphasia (SPA) intervention to assess: (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and participant burden; (5) fidelity of intervention delivery; (6) SPA intervention costs; (7) acceptability and feasibility of trial and intervention to participants and others involved.DesignA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation.SettingThree community-based cohorts in the South-West of England.ParticipantsEligible participants with post-stroke aphasia were randomised 1:1 to SPA or control.InterventionThe manualised SPA intervention was delivered over 10 weekly singing group sessions, led by a music facilitator and assisted by an individual with post-stroke aphasia. The intervention was developed using the Information-Motivation-Behavioural skills model of behaviour change and targeted psychosocial outcomes. Control and intervention participants all received an aphasia information resource pack.Outcome measuresCollected at baseline, 3 and 6 months post-randomisation, candidate primary outcomes were measured (well-being, quality of life and social participation) as well as additional clinical outcomes. Feasibility, acceptability and process outcomes included recruitment and retention rates, and measurement burden; and trial experiences were explored in qualitative interviews.ResultsOf 87 individuals screened, 42 participants were recruited and 41 randomised (SPA=20, control=21); 36 participants (SPA=17, control=19) completed 3-month follow-up, 34 (SPA=18, control=16) completed 6-month follow-up. Recruitment and retention (83%) were acceptable for a definitive RCT, and participants did not find the study requirements burdensome. High fidelity of the intervention delivery was shown by high attendance rates and facilitator adherence to the manual, and participants found SPA acceptable. Sample size estimates for a definitive RCT and primary/secondary outcomes were identified.ConclusionsThe SPA pilot RCT fulfilled its objectives, and demonstrated that a definitive RCT of the intervention would be both feasible and acceptable.Trial registration numberNCT03076736.
| S-EPMC7812101 | biostudies-literature
Project description:IntroductionThe singing for people with aphasia (SPA) intervention aims to improve quality of life and well-being for people with poststroke aphasia. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost effectiveness of SPA. The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design.Methods and analysisA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation. Forty-eight participants discharged from clinical speech and language therapy will be individually randomised 1:1 to SPA (10 group sessions plus a resource booklet) or control (resource booklet only). Outcome assessment at baseline, 3 and 6 months postrandomisation include: ICEpop CAPability measure for adults, Stroke and Aphasia Quality of Life, EQ-5D-5L, modified Reintegration into Normal Living Index, Communication Outcome After Stroke, Very Short Version of the Minnesota Aphasia Test, Service Receipt Inventory and Care Related Quality of Life. Feasibility, acceptability and process outcomes include recruitment and retention rates, with measurement burden and trial experiences being explored in qualitative interviews (15 participants, 2 music facilitators and 2 music champions). Analyses include: descriptive statistics, with 95% CIs where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis.Ethics and disseminationNHS National Research Ethics Service and the Health Research Authority confirmed approval in April 2017; recruitment commenced in June 2017. Outputs will include: pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised intervention manual for multicentre replication of SPA; presentations at conferences, public involvement events; internationally recognised peer reviewed journal publications, open access sources and media releases.Trial registration numberNCT03076736.
| S-EPMC6144319 | biostudies-literature
Project description:It has been reported for more than 100 years that patients with severe nonfluent aphasia are better at singing lyrics than they are at speaking the same words. This observation led to the development of melodic intonation therapy (MIT). However, the efficacy of this therapy has yet to be substantiated in a randomized controlled trial. Furthermore, its underlying neural mechanisms remain unclear. The two unique components of MIT are the intonation of words and simple phrases using a melodic contour that follows the prosody of speech and the rhythmic tapping of the left hand that accompanies the production of each syllable and serves as a catalyst for fluency. Research has shown that both components are capable of engaging fronto-temporal regions in the right hemisphere, thereby making MIT particularly well suited for patients with large left hemisphere lesions who also suffer from nonfluent aphasia. Recovery from aphasia can happen in two ways: either through the recruitment of perilesional brain regions in the affected hemisphere, with variable recruitment of right-hemispheric regions if the lesion is small, or through the recruitment of homologous language and speech-motor regions in the unaffected hemisphere if the lesion of the affected hemisphere is extensive. Treatment-associated neural changes in patients undergoing MIT indicate that the unique engagement of right-hemispheric structures (e.g., the superior temporal lobe, primary sensorimotor, premotor and inferior frontal gyrus regions) and changes in the connections across these brain regions may be responsible for its therapeutic effect.
| S-EPMC2982746 | biostudies-literature
Project description:(1) Background: Individuals with pulmonary disease need intensive and consistent rehabilitation due to their high risk for serious illness and long-term complications. The purpose of this scoping review was to provide a comprehensive analysis of relevant research regarding the use of singing in pulmonary rehabilitation. (2) Methods: A systematic literature search was performed using the PsycINFO, CINAHL, PubMed, and Web of Science databases. A search for studies that employed singing in pulmonary rehabilitation for patients with pulmonary disease was conducted. (3) Results: Studies that met the selection criteria were summarized and analyzed. Twenty-seven studies were included in the final analysis. Results showed that research using singing in pulmonary rehabilitation generally employed an intervention with structured tasks and additional home practice or socialization time. However, the singing procedure in each intervention was not always specifically described and the findings were inconsistent. (4) Conclusions: Programmed singing interventions can support lung health and be an effective component of pulmonary rehabilitation. The therapeutic singing method in relation to respiratory exercises should be integrated into the main activity in the intervention. Overall, singing has physical and psychosocial effects, leading to improvements in symptoms, but more research is necessary to ensure that the respiratory needs of people with pulmonary disease are adequately met.
| S-EPMC9858886 | biostudies-literature
Project description:IntroductionTreatment manuals play an essential role in clinical trials that aim to determine the efficacy of an intervention. Yet, the idea of needing to adhere to a treatment manual may seem counterintuitive to many music therapy clinicians. The purpose of this article is to offer clinician, supervisor, and researcher perspectives on the process of developing and executing a manualized music therapy treatment protocol in a randomized controlled trial.MethodAfter describing the purpose of treatment manuals in clinical trials, we present the experience of developing a treatment manual through clinician and researcher collaborations. The concept of treatment fidelity and quality assurance monitoring within clinical trials is detailed to provide an inside look at an integral aspect of enacting treatment manuals in efficacy research. We then share reflections from a research clinician and supervisor to demonstrate the opportunities and challenges when working within the guidelines of manualized clinical practice.ResultsProviding a reflective perspective on implementation of a manualized treatment protocol allows for a more thorough understanding of the clinical and research processes in the conduct of randomized controlled trials.DiscussionCollaboration of researchers, clinicians and supervisors is of critical importance for the successful implementation of treatment manuals in clinical trials.
| S-EPMC9416937 | biostudies-literature
Project description:A classical observation in neurology is that aphasic stroke patients with impairments in speech production can nonetheless sing the same utterances. This preserved ability suggests a distinctive neural architecture for singing that could contribute to speech recovery. However, to date, these structural correlates remain unknown. Here, we combined a multivariate lesion-symptom mapping and voxel-based morphometry approach to analyse the relationship between lesion patterns and grey matter volume and production rate in speech and singing tasks. Lesion patterns for spontaneous speech and cued repetition extended into frontal, temporal and parietal areas typically reported within the speech production network. Impairment in spontaneous singing was associated with damage to the left anterior-posterior superior and middle temporal gyri. Preservation of grey matter volume in the same regions where damage led to poor speech and singing production supported better performance in these tasks. When dividing the patients into fluent and dysfluent singers based on the singing performance from demographically matched controls, we found that the preservation of the left middle temporal gyrus was related to better spontaneous singing. These findings provide insights into the structural correlates of singing in chronic aphasia and may serve as biomarkers to predict treatment response in clinical trials using singing-based interventions for speech rehabilitation.
| S-EPMC8842683 | biostudies-literature
Project description:Repetitive transcranial magnetic stimulation (rTMS) has been reported to improve naming in chronic stroke patients with nonfluent aphasia since 2005. In part 1, we review the rationale for applying slow, 1-Hz, rTMS to the undamaged right hemisphere in chronic nonfluent aphasia patients after a left hemisphere stroke; and we present a transcranial magnetic stimulation (TMS) protocol used with these patients that is associated with long-term, improved naming post-TMS. In part 2, we present results from a case study with chronic nonfluent aphasia where TMS treatments were followed immediately by speech therapy (constraint-induced language therapy). In part 3, some possible mechanisms associated with improvement after a series of TMS treatments in stroke patients with aphasia are discussed.
| S-EPMC3589757 | biostudies-literature
Project description:The objective of the study was to demonstrate the non-inferiority of low-frequency spa therapy combined with rehabilitation (Spa-rehab) versus standard spa therapy at 6 months for symptomatic knee osteoarthritis (KOA). A prospective, randomized, monocenter, non-inferiority trial with recruitment of community-based symptomatic KOA patients was performed. Standard spa therapy comprised standardized spa treatment, 6 days a week for 3 weeks, and Spa-rehab therapy comprised spa sessions, 3 days a week for 3 weeks, followed by a dedicated rehabilitation program, 3 days a week for 3 weeks. The primary endpoint was achieving at 6 months a minimal clinically important improvement (MCII) for pain on a visual analog scale and/or an MCII for function on the WOMAC index and no knee surgery (composite MCII). Secondary endpoints were composite MCII at 3 months and achieving a Patient Acceptable Symptom State (PASS) for pain and function at 3 and 6 months. Among 283 patients included, 145 were allocated to standard spa therapy and 138 to Spa-rehab therapy. We could not demonstrate the non-inferiority of Spa-rehab therapy for the primary endpoint: difference for responders - 0.08 [90% CI (- 0.18 to 0.02), p = 0.14]. However, the difference test between the groups was not significant (p = 0.18). Spa-rehab therapy was not inferior to standard spa therapy for the composite MCII at 3 months or the PASS at 3 and 6 months. Spa-rehab therapy can reasonably be proposed to patients with symptomatic KOA. This protocol may be more cost-effective than standard spa therapy and avoid absenteeism from work and accommodation costs for patients who live close to a centre.
| S-EPMC7334225 | biostudies-literature
Project description:IntroductionThe Psychosocial Cardiological Schedule (PCS) was developed as a screening tool for patients undergoing cardiac rehabilitation (CR) to detect clinically relevant psychosocial/cognitive problems requiring psychological assessment/intervention. Filled out by a trained nurse, it classifies patients according to their need or not for a psychological interview and intervention provided by the psychologist (PCS-Yes vs. PCS-No).AimsThe main aim was to compare PCS data collected, respectively, in 2010 and 2017, regarding patients' socio-demographic characteristics, clinical variables, and the inclusion criteria for psychological counseling. Subsequently, the original Italian PCS was revised and an English version of the schedule was provided [PCS-Revised (PCS-R)].Results28 patients (aged 53.5 + 12.6 years, M = 20) of the 87 recruited in 2010 vs. 35 (aged 64.9 + 12.7 years, M = 28) of the 83 recruited in 2017 met the criteria for PCS-Yes: age < 55 years, social problems (living alone, no social support), manifest psychological/behavioral problems, suspected neuropsychological disorders, low prescription adherence, inadequate disease awareness. Comparing the two samples (2010 vs. 2017), clinical variables were similar, and the need for a psychological interview did not differ substantially (32.2 vs. 42.2%), but age increased significantly (PCS-Yes: 53.5 ± 12.6 vs. 64.9 ± 12.7 years, p = 0.001; PCS-No: 68.3 ± 8.0 vs. 75.0 ± 7.7 years, p = 0.0001). A significant increase was observed in the recommendation for neuropsychological assessment (3.6 vs. 25.7%, p = 0.02) to confirm eventual cognitive deficits. These results, the clinical experience, and the recent evidences from literature led to the PCS-R, incorporating a psychosocial screening, a psychological/neuropsychological deeper assessment, and a recommendation for a specific intervention to be carried out either during rehabilitation or in outpatient services.ConclusionThe data comparison highlight changes in the cardiac population, which is aging and more frequently requires neuropsychological assessment. The PCS-R could be considered in clinical practice as a useful screening tool to implement a timely coordinated interdisciplinary intervention, comprehensive of specific and tailored psychotherapeutic techniques.
| S-EPMC7381208 | biostudies-literature
Project description:BackgroundDeveloped countries' gains in health human resources (HHR) from developing countries with significantly lower ratios of health workers have raised questions about the ethics or fairness of recruitment from such countries. By attracting and/or facilitating migration for foreign-trained HHR, notably those from poorer, less well-resourced nations, recruitment practices and policies may be compromising the ability of developing countries to meet the health care needs of their own populations. Little is known, however, about actual recruitment practices. In this study we focus on Canada (a country with a long reliance on internationally trained HHR) and recruiters working for Canadian health authorities.MethodsWe conducted interviews with health human resources recruiters employed by Canadian health authorities to describe their recruitment practices and perspectives and to determine whether and how they reflect ethical considerations.Results and discussionWe describe the methods that recruiters used to recruit foreign-trained health professionals and the systemic challenges and policies that form the working context for recruiters and recruits. HHR recruiters' reflections on the global flow of health workers from poorer to richer countries mirror much of the content of global-level discourse with regard to HHR recruitment. A predominant market discourse related to shortages of HHR outweighed discussions of human rights and ethical approaches to recruitment policy and action that consider global health impacts.ConclusionsWe suggest that the concept of corporate social responsibility may provide a useful approach at the local organizational level for developing policies on ethical recruitment. Such local policies and subsequent practices may inform public debate on the health equity implications of the HHR flows from poorer to richer countries inherent in the global health worker labour market, which in turn could influence political choices at all government and health system levels.
| S-EPMC3032656 | biostudies-literature