Operationalizing goal setting as an outcome measure in trials involving patients with frailty, multimorbidity or complexity
Background/aims: In the absence of disease-modifying therapies for Parkinson's disease, much research focuses on improving quality of life, health and wellbeing. It is important to evaluate potential treatments and innovative care models in a robust and standardised way. Disease-specific outcom...
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| Language: | English |
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Elsevier
2025-02-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865424001583 |
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| author | Emma Tenison Katherine Lloyd Yoav Ben-Shlomo Emily J. Henderson |
| author_facet | Emma Tenison Katherine Lloyd Yoav Ben-Shlomo Emily J. Henderson |
| author_sort | Emma Tenison |
| collection | DOAJ |
| description | Background/aims: In the absence of disease-modifying therapies for Parkinson's disease, much research focuses on improving quality of life, health and wellbeing. It is important to evaluate potential treatments and innovative care models in a robust and standardised way. Disease-specific outcomes have limitations in older people, those with cognitive impairment, multimorbidity, disability or short life expectancy. We aimed to select, and adapt as needed, a primary outcome to evaluate a multicomponent intervention for people with parkinsonism. Methods: The multicomponent Proactive and Integrated Management and Empowerment (PRIME) model of care is being evaluated in the UK within a randomized controlled trial (RCT). We needed a meaningful outcome measure which could capture effects across multiple symptoms and domains; be suitable across the spectrum of disease stage/phenotype, including for participants with multimorbidity and/or cognitive impairment. Results: We have chosen the Bangor Goal-setting Interview and adapted it for use within the PRIME-UK RCT. This includes 4 steps: participants 1) identify an area to work on; 2) describe a specific goal; 3) rate current attainment, readiness to change and goal importance; and 4) attainment is followed up 3-monthly. Change in ratings across three to five individualised goals on a standardised scale can be compared between trial arms. Conclusion: We demonstrate how a goal-orientated outcome can be operationalized within a complex intervention trial for parkinsonism. Parkinsonism is an exemplar multisystem, heterogeneous condition, predominantly affecting older people. There is scope to use goal-orientated outcome measures more widely in trials involving patients living with frailty, multimorbidity and/or clinical complexity. |
| format | Article |
| id | doaj-art-36c88d739f874aa2ba0e930dd58e64b3 |
| institution | Kabale University |
| issn | 2451-8654 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-36c88d739f874aa2ba0e930dd58e64b32025-01-12T05:25:30ZengElsevierContemporary Clinical Trials Communications2451-86542025-02-0143101411Operationalizing goal setting as an outcome measure in trials involving patients with frailty, multimorbidity or complexityEmma Tenison0Katherine Lloyd1Yoav Ben-Shlomo2Emily J. Henderson3Ageing and Movement Research Group, Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom; Older People's Unit, Royal United Hospitals Bath NHS Foundation Trust, Combe Park, Bath, United Kingdom; Corresponding author. Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, United Kingdom.Ageing and Movement Research Group, Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United KingdomAgeing and Movement Research Group, Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom; The National Institute for Health and Care Research Applied Research Collaboration West (NIHR ARC West) at University Hospitals Bristol and Weston NHS Foundation Trust, United KingdomAgeing and Movement Research Group, Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom; Older People's Unit, Royal United Hospitals Bath NHS Foundation Trust, Combe Park, Bath, United KingdomBackground/aims: In the absence of disease-modifying therapies for Parkinson's disease, much research focuses on improving quality of life, health and wellbeing. It is important to evaluate potential treatments and innovative care models in a robust and standardised way. Disease-specific outcomes have limitations in older people, those with cognitive impairment, multimorbidity, disability or short life expectancy. We aimed to select, and adapt as needed, a primary outcome to evaluate a multicomponent intervention for people with parkinsonism. Methods: The multicomponent Proactive and Integrated Management and Empowerment (PRIME) model of care is being evaluated in the UK within a randomized controlled trial (RCT). We needed a meaningful outcome measure which could capture effects across multiple symptoms and domains; be suitable across the spectrum of disease stage/phenotype, including for participants with multimorbidity and/or cognitive impairment. Results: We have chosen the Bangor Goal-setting Interview and adapted it for use within the PRIME-UK RCT. This includes 4 steps: participants 1) identify an area to work on; 2) describe a specific goal; 3) rate current attainment, readiness to change and goal importance; and 4) attainment is followed up 3-monthly. Change in ratings across three to five individualised goals on a standardised scale can be compared between trial arms. Conclusion: We demonstrate how a goal-orientated outcome can be operationalized within a complex intervention trial for parkinsonism. Parkinsonism is an exemplar multisystem, heterogeneous condition, predominantly affecting older people. There is scope to use goal-orientated outcome measures more widely in trials involving patients living with frailty, multimorbidity and/or clinical complexity.http://www.sciencedirect.com/science/article/pii/S2451865424001583Clinical trialsGoal attainmentOutcome measuresComplex interventionsParkinson's diseaseFrailty |
| spellingShingle | Emma Tenison Katherine Lloyd Yoav Ben-Shlomo Emily J. Henderson Operationalizing goal setting as an outcome measure in trials involving patients with frailty, multimorbidity or complexity Contemporary Clinical Trials Communications Clinical trials Goal attainment Outcome measures Complex interventions Parkinson's disease Frailty |
| title | Operationalizing goal setting as an outcome measure in trials involving patients with frailty, multimorbidity or complexity |
| title_full | Operationalizing goal setting as an outcome measure in trials involving patients with frailty, multimorbidity or complexity |
| title_fullStr | Operationalizing goal setting as an outcome measure in trials involving patients with frailty, multimorbidity or complexity |
| title_full_unstemmed | Operationalizing goal setting as an outcome measure in trials involving patients with frailty, multimorbidity or complexity |
| title_short | Operationalizing goal setting as an outcome measure in trials involving patients with frailty, multimorbidity or complexity |
| title_sort | operationalizing goal setting as an outcome measure in trials involving patients with frailty multimorbidity or complexity |
| topic | Clinical trials Goal attainment Outcome measures Complex interventions Parkinson's disease Frailty |
| url | http://www.sciencedirect.com/science/article/pii/S2451865424001583 |
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