7 research outputs found
Feasibility, safety and acceptability of select outcome measures in a physiotherapy study protocol for boys with haemophilia.
BACKGROUND: There is a lack of functional performance measures for children and young people with haemophilia (CYPwH) with associated control data from typically developing boys (TDB). The literature advocates development of a core set of outcome measures for different chronic conditions. As medical treatment improves, CYPwHÂ are experiencing better outcomes; therefore, more challenging measures are required to monitor physical performance. Such testing is not performed routinely, due to practical and safety concerns. AIM: Evaluate the feasibility, safety and acceptability of select outcome measures as part of a study protocol testing CYPwH; including myometry, 10Â metre incremental shuttle walk test (10-m ISWT), iSTEP (an incremental step test, with data from TDB), and 1 week of accelerometry-wear at home. METHODS: Sixty-six boys aged 6-15 years with mild, moderate or severe haemophilia A or B (including inhibitors) attending routine clinics at Great Ormond Street Hospital were approached to participate. Descriptive statistics and content analysis were used to assess outcomes of feasibility, safety and acceptability, which included recruitment/retention rates, protocol completion within routine appointment timeframes, performance testing without serious adverse events/reactions (SAE/SARs), and acceptability to CYPwH of high-level performance measures. RESULTS: Outcomes were met: 43 boys completed testing at clinic review (Jan-Nov 2018) within a 10-month timeframe, retention was 95% at completion of protocol and no SAE/SARs were reported throughout testing. CONCLUSION: Feasibility, safety and acceptability of the study protocol have been established in this population. Both high-level performance tests, iSTEP and 10-m ISWT, were an acceptable addition to boys' routine clinic appointments and could be safe, acceptable choices of outcome measure as part of a core set of tests for CYPwH. Further investigation of the psychometric properties for the iSTEP is now justified, in order for it to be used as a standardised, validated, reliable outcome measure in clinical or research settings. TRIAL REGISTRATION: Retrospectively registered on September 3, 2019, on ClinicalTrials.gov (ID: NCT04076306 )
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Adapting a participatory intervention for caregivers of children with complex neurodisability from low resource to high income settings: Moving from “Baby Ubuntu” to “Encompass”
Background: “Baby Ubuntu” is a community-based intervention for families of young children with cerebral palsy (CP), that has been developed and tested in low-resource settings globally. The programme provides caregivers with support to increase their skills and confidence to care for their child and promote development, enhancing the impact of early intervention.
Methods: “Baby Ubuntu” is being adapted for use in East London, UK as “Encompass”, in line with the ADAPT and MRC complex intervention development frameworks. Stakeholder engagement was achieved using an advisory group, including the original creators of the intervention, and a Patient and Public (PPI) Involvement group. The adaptation team consisted of the researchers, advisors, and PPI participants. Semi-structured interviews were conducted with 12 caregivers and 6 healthcare providers of children with CP.
Results: Data from the qualitative interviews were analysed and considered by the adaptation team. It was felt that content should include greater emphasis on caregiver mental health and well-being, signposting to third sector organisations, simplifying medical terminology, and educational support. Key programme delivery recommendations included joint facilitation with health specialists and expert parents, considerations of language and cultural diversity, and a blended face-to-face and online delivery. A logic model and adapted manual was drafted based on this feedback.
Conclusions: The adaptation described is one of few examples where an intervention is being adapted from a low-resource to a high-resource setting. “Encompass” has been co-developed with various professionals and parents with lived experience to improve its relevance and impact. Next steps include pilot implementation evaluation