Emily Jane Henderson
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Research Subjects
Emily Jane Henderson has a total of 440 co-authors. Here are the top co-authors by number of shared publications:
- Emma Tenison
Ageing and Movement Research Group, Population Health Sciences, Bristol Medical School University of Bristol Bristol UK
16 shared publications - Yoav Ben-Shlomo
Population Health Sciences, University of Bristol, Bristol, UK
12 shared publications - Fiona Eileen Lithander
Liggins Institute, University of Auckland, Auckland, New Zealand
9 shared publications - Matthew D. Smith
Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
9 shared publications Yoav Ben-Shlomo
Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
6 shared publications- Daisy Gaunt
Population Health Sciences, University of Bristol, Bristol, UK
5 shared publications
Latest Publications
- Open Access
- 10 May 2026
- Published by Wiley in Movement Disorders Clinical Practice
- Vol. 13 (10) , 2474-2499
Mind the Gap: Predictors of Osteoporosis Treatment Following Fragility Fracture in Parkinsonism
Background: Fracture risk is increased in Parkinson's yet this risk is often not addressed. Objectives: Our objective was to study the extent to which osteoporosis was treated, and predictors of treatment in a large representative cohort with parkinsonism. Methods: The clinical practice research datalink ( CPRD ) GOLD data contains anonymized UK primary care data. We identified fragility fractures (hip, vertebrae, wrist/distal radius, humerus, rib, pelvis and unspecified osteoporotic) amongst prevalent parkinsonism patients between 2010 and 2019, and ascertained whether bone protective medications and/or vitamin D/calcium supplements were prescribed in the pre‐fracture period or in the 48‐weeks post‐fracture. Logistic regression was used to determine predictors of prescriptions. Results: There were 21,581 people with parkinsonism (mean age 74.7 ± 9.8 years, 40% female), with a mean of 3.1 ± 2.5 years of available data. One thousand eight hundred twenty‐three experienced at least one fragility fracture. Prior to a fragility fracture 12% had a prescription for bone protective medication. This increased to 38% and 53% in the 16 and 48‐weeks post‐fracture, respectively. 24% already had a prescription for vitamin D/calcium which increased to 73% at 48‐weeks post‐fracture. Female gender (OR = 2.06 [1.69–2.51], p < 0.001) and sustaining a vertebral fracture (OR = 2.06 [1.53–2.77], p < 0.001) increased the odds of bone protection prescriptions. However, sustaining a rib fracture (OR = 0.34 [0.19–0.60], p < 0.001) or residing in a care home (OR = 0.58 [0.38–0.88], p = 0.01) decreased the odds. Conclusions: There is an osteoporosis treatment gap in Parkinson's rendering an already high‐risk population at further risk of fracture. Men and those with rib fractures are two groups who are least likely to receive potentially beneficial treatment.
- 10 May 2026
- Published by Wiley in Movement Disorders Clinical Practice
- Vol. 13 (10) , 2474-2499
Open AccessMind the Gap: Predictors of Osteoporosis Treatment Following Fragility Fracture in Parkinsonism
Background: Fracture risk is increased in Parkinson's yet this risk is often not addressed. Objectives: Our objective was to study the extent to which osteoporosis was treated, and predictors of treatment in a large representative cohort with parkinsonism. Methods: The clinical practice research datalink ( CPRD ) GOLD data contains anonymized UK primary care data. We identified fragility fractures (hip, vertebrae, wrist/distal radius, humerus, rib, pelvis and unspecified osteoporotic) amongst prevalent parkinsonism patients between 2010 and 2019, and ascertained whether bone protective medications and/or vitamin D/calcium supplements were prescribed in the pre‐fracture period or in the 48‐weeks post‐fracture. Logistic regression was used to determine predictors of prescriptions. Results: There were 21,581 people with parkinsonism (mean age 74.7 ± 9.8 years, 40% female), with a mean of 3.1 ± 2.5 years of available data. One thousand eight hundred twenty‐three experienced at least one fragility fracture. Prior to a fragility fracture 12% had a prescription for bone protective medication. This increased to 38% and 53% in the 16 and 48‐weeks post‐fracture, respectively. 24% already had a prescription for vitamin D/calcium which increased to 73% at 48‐weeks post‐fracture. Female gender (OR = 2.06 [1.69–2.51], p < 0.001) and sustaining a vertebral fracture (OR = 2.06 [1.53–2.77], p < 0.001) increased the odds of bone protection prescriptions. However, sustaining a rib fracture (OR = 0.34 [0.19–0.60], p < 0.001) or residing in a care home (OR = 0.58 [0.38–0.88], p = 0.01) decreased the odds. Conclusions: There is an osteoporosis treatment gap in Parkinson's rendering an already high‐risk population at further risk of fracture. Men and those with rib fractures are two groups who are least likely to receive potentially beneficial treatment.
- 9 February 2026
- Published by Springer Nature in European Geriatric Medicine
- Vol. 17 (3) , 1665-1670
Patient activation among patients with Parkinsonism and informal caregivers: results from the PRIME-UK cross-sectional study
Key summary points AbstractSection Aim The aim of this study was to describe activation levels, and determinants of activation, amongst patients with parkinsonism and their informal caregivers within the PRIME-UK cross-sectional study. AbstractSection Findings The majority (64% of patients and 59% of caregivers) were categorised in the lowest two levels of activation. Increasing age, frailty, non-motor symptom burden, depression, worse quality of life and four or more comorbidities were associated with lower patient activation. AbstractSection Message Proactive management of non-motor symptoms and targeted, tailored interventions to improve self-management capability may improve outcomes for people with parkinsonism.
- 9 February 2026
- Published by Springer Nature in European Geriatric Medicine
- Vol. 17 (3) , 1665-1670
Patient activation among patients with Parkinsonism and informal caregivers: results from the PRIME-UK cross-sectional study
Key summary points AbstractSection Aim The aim of this study was to describe activation levels, and determinants of activation, amongst patients with parkinsonism and their informal caregivers within the PRIME-UK cross-sectional study. AbstractSection Findings The majority (64% of patients and 59% of caregivers) were categorised in the lowest two levels of activation. Increasing age, frailty, non-motor symptom burden, depression, worse quality of life and four or more comorbidities were associated with lower patient activation. AbstractSection Message Proactive management of non-motor symptoms and targeted, tailored interventions to improve self-management capability may improve outcomes for people with parkinsonism.
- Open Access
- 1 August 2025
- Published by Oxford University Press (OUP) in Age and Ageing
- Vol. 54 (8)
What are we teaching UK medical students about ageing and geriatric medicine? Results of the third British Geriatrics Society national curriculum and teaching survey
Introduction: The ageing population means all newly qualified doctors will need knowledge, skills and attitudes to care for older people with complex health conditions. An essential component of preparing the medical workforce to care for older people is including teaching on ageing and geriatric medicine in undergraduate medical curricula. We present results of the British Geriatrics Society national curriculum survey 2021–22, highlighting progress in undergraduate teaching in geriatric medicine. Methods: All 35 UK General Medical Council–registered medical schools at the time of data collection were invited to participate in an online survey on the content, methodology, timing and duration of teaching in ageing and geriatric medicine. Results: Thirty out of the thirty-five (83%) UK medical schools responded, all of which provided some teaching in geriatric medicine. Most teaching occurred in the fourth year of study (n = 21). The majority (n = 15) reported a discrete module for geriatric medicine lasting 4–8 weeks, an increase on previous surveys. Three schools reported geriatric medicine exposure lasting >12 weeks, of which two were integrated clerkships. We observed a reduction in interprofessional education but identified several examples combining simulated teaching with other healthcare professions (n = 7). Every school (n = 30) incorporated small-group or case-based learning. Conclusion: There is increased exposure to geriatric medicine compared to previous surveys in 2008 and 2013. Generally, programmes reported a move towards clinically framed small-group and case-based learning, employing a wider variety of assessment methods than previously. We also identified key gaps in teaching provision for targeted improvement and ongoing research.
- 1 August 2025
- Published by Oxford University Press (OUP) in Age and Ageing
- Vol. 54 (8)
Open AccessWhat are we teaching UK medical students about ageing and geriatric medicine? Results of the third British Geriatrics Society national curriculum and teaching survey
Introduction: The ageing population means all newly qualified doctors will need knowledge, skills and attitudes to care for older people with complex health conditions. An essential component of preparing the medical workforce to care for older people is including teaching on ageing and geriatric medicine in undergraduate medical curricula. We present results of the British Geriatrics Society national curriculum survey 2021–22, highlighting progress in undergraduate teaching in geriatric medicine. Methods: All 35 UK General Medical Council–registered medical schools at the time of data collection were invited to participate in an online survey on the content, methodology, timing and duration of teaching in ageing and geriatric medicine. Results: Thirty out of the thirty-five (83%) UK medical schools responded, all of which provided some teaching in geriatric medicine. Most teaching occurred in the fourth year of study (n = 21). The majority (n = 15) reported a discrete module for geriatric medicine lasting 4–8 weeks, an increase on previous surveys. Three schools reported geriatric medicine exposure lasting >12 weeks, of which two were integrated clerkships. We observed a reduction in interprofessional education but identified several examples combining simulated teaching with other healthcare professions (n = 7). Every school (n = 30) incorporated small-group or case-based learning. Conclusion: There is increased exposure to geriatric medicine compared to previous surveys in 2008 and 2013. Generally, programmes reported a move towards clinically framed small-group and case-based learning, employing a wider variety of assessment methods than previously. We also identified key gaps in teaching provision for targeted improvement and ongoing research.
- Open Access
- 17 April 2025
- Published by Wiley in Movement Disorders
- Vol. 40 (7) , 1291-1296
Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Symptoms in Parkinson's Disease: Results from a Phase II Randomized Control Trial (STRIPE)
Background: Lower urinary tract symptoms (LUTS) are common Parkinson's disease (PD), causing great impact.Objective: The goal was to undertake a phase II randomized control trial of transcutaneous tibial nerve stimulation (TTNS) delivered by Geko device for LUTS related to overactive bladder (OAB) in PD, an easy to use of the shelf solution.Methods: Participants were randomized to active/sham stimulation. Primary outcome measure was the International Consultation on Incontinence Questionnaire‐Overactive Bladder score (ICIQ‐OAB) at 12 weeks.Results: A total of 148 participants were allocated to active (73) and sham arms (75). No difference was seen between arms (coefficient, 0.48; 95% CI, −0.2 to 1.2; P = 0.17), although both active and sham showed improvements over baseline. Pain was the most common adverse event.Conclusion: No difference was seen between active and sham arms. Symptom improvements seen in both groups are consistent with a placebo effect, however, we cannot exclude a biological effect from the sham intervention. Although negative, this result should be taken only in context of Geko use rather TTNS in general. © 2025 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
- 17 April 2025
- Published by Wiley in Movement Disorders
- Vol. 40 (7) , 1291-1296
Open AccessTranscutaneous Tibial Nerve Stimulation for Overactive Bladder Symptoms in Parkinson's Disease: Results from a Phase II Randomized Control Trial (STRIPE)
Background: Lower urinary tract symptoms (LUTS) are common Parkinson's disease (PD), causing great impact.Objective: The goal was to undertake a phase II randomized control trial of transcutaneous tibial nerve stimulation (TTNS) delivered by Geko device for LUTS related to overactive bladder (OAB) in PD, an easy to use of the shelf solution.Methods: Participants were randomized to active/sham stimulation. Primary outcome measure was the International Consultation on Incontinence Questionnaire‐Overactive Bladder score (ICIQ‐OAB) at 12 weeks.Results: A total of 148 participants were allocated to active (73) and sham arms (75). No difference was seen between arms (coefficient, 0.48; 95% CI, −0.2 to 1.2; P = 0.17), although both active and sham showed improvements over baseline. Pain was the most common adverse event.Conclusion: No difference was seen between active and sham arms. Symptom improvements seen in both groups are consistent with a placebo effect, however, we cannot exclude a biological effect from the sham intervention. Although negative, this result should be taken only in context of Geko use rather TTNS in general. © 2025 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
- Open Access
- 24 March 2025
- Published by Cambridge University Press (CUP) in Psychological Medicine
- Vol. 55, e93
Minimal clinically important differences for treatment of hallucinations in Parkinson’s disease and dementia with Lewy bodies
Background: Hallucinations are common and distressing symptoms in Parkinson’s disease (PD). Treatment response in clinical trials is measured using validated questionnaires, including the Scale for Assessment of Positive Symptoms-Hallucinations (SAPS-H) and University of Miami PD Hallucinations Questionnaire (UM-PDHQ). The minimum clinically important difference (MCID) has not been determined for either scale. This study aimed to estimate a range of MCIDs for SAPS-H and UM-PDHQ using both consensus-based and statistical approaches. Methods: A Delphi survey was used to seek opinions of researchers, clinicians, and people with lived experience. We defined consensus as agreement ≥75%. Statistical approaches used blinded data from the first 100 PD participants in the Trial for Ondansetron as Parkinson’s Hallucinations Treatment (TOP HAT, NCT04167813). The distribution-based approach defined the MCID as 0.5 of the standard deviation of change in scores from baseline at 12 weeks. The anchor-based approach defined the MCID as the average change in scores corresponding to a 1-point improvement in clinical global impression-severity scale (CGI-S). Results: Fifty-one researchers and clinicians contributed to three rounds of the Delphi survey and reached consensus that the MCID was 2 points on both scales. Sixteen experts with lived experience reached the same consensus. Distribution-defined MCIDs were 2.6 points for SAPS-H and 1.3 points for UM-PDHQ, whereas anchor-based MCIDs were 2.1 and 1.3 points, respectively. Conclusions: We used triangulation from multiple methodologies to derive the range of MCID estimates for the two rating scales, which was between 2 and 2.7 points for SAPS-H and 1.3 and 2 points for UM-PDHQ.
- 24 March 2025
- Published by Cambridge University Press (CUP) in Psychological Medicine
- Vol. 55, e93
Open AccessMinimal clinically important differences for treatment of hallucinations in Parkinson’s disease and dementia with Lewy bodies
Background: Hallucinations are common and distressing symptoms in Parkinson’s disease (PD). Treatment response in clinical trials is measured using validated questionnaires, including the Scale for Assessment of Positive Symptoms-Hallucinations (SAPS-H) and University of Miami PD Hallucinations Questionnaire (UM-PDHQ). The minimum clinically important difference (MCID) has not been determined for either scale. This study aimed to estimate a range of MCIDs for SAPS-H and UM-PDHQ using both consensus-based and statistical approaches. Methods: A Delphi survey was used to seek opinions of researchers, clinicians, and people with lived experience. We defined consensus as agreement ≥75%. Statistical approaches used blinded data from the first 100 PD participants in the Trial for Ondansetron as Parkinson’s Hallucinations Treatment (TOP HAT, NCT04167813). The distribution-based approach defined the MCID as 0.5 of the standard deviation of change in scores from baseline at 12 weeks. The anchor-based approach defined the MCID as the average change in scores corresponding to a 1-point improvement in clinical global impression-severity scale (CGI-S). Results: Fifty-one researchers and clinicians contributed to three rounds of the Delphi survey and reached consensus that the MCID was 2 points on both scales. Sixteen experts with lived experience reached the same consensus. Distribution-defined MCIDs were 2.6 points for SAPS-H and 1.3 points for UM-PDHQ, whereas anchor-based MCIDs were 2.1 and 1.3 points, respectively. Conclusions: We used triangulation from multiple methodologies to derive the range of MCID estimates for the two rating scales, which was between 2 and 2.7 points for SAPS-H and 1.3 and 2 points for UM-PDHQ.
- Open Access
- 3 March 2025
- Published by Oxford University Press (OUP) in Age and Ageing
- Vol. 54 (3)
Assessing and managing bone health and fracture risk in Parkinson’s disease: the BONE PARK 2 protocol
Background: In Parkinson’s disease (PD), the propensity to fall and the higher risk of osteoporosis converge yielding a high fracture risk. Updated National Osteoporosis Guideline Group (NOGG) guidance recommends that PD should trigger a risk assessment, for example using the FRAX tool, yet clinical pathways remain sub-optimal. To address this, we generated an algorithm for the assessment and management of bone health specifically in PD. Methods: Within the Proactive and Integrated Management and Empowerment in Parkinson’s Disease randomised controlled trial (PRIME-UK RCT), bone-health metrics were collected, and all participants were offered a dual X-ray absorptiometry scan. The FRAX tool was used to obtain the 10-year probability of hip and major osteoporotic fracture (MOF), and the resulting NOGG risk-category recorded. Probabilities were recalculated including femoral-neck bone mineral density (FN-BMD) and/or with numeric adjustment for recurrent falls, and results compared. Results: Among 182 people with parkinsonism (mean age 73.8 years, 65% male, median disease duration 5 years), 28% reported a prior fragility fracture, and 40.7% recurrent falls over the previous year. 28.6% had MOF above NOGG intervention thresholds (IT); whilst 12.1% had a FN-BMD T-Score ≤ −2.5. Recalculation of FRAX with FN-BMD (n = 182) reduced fracture MOF and hip fracture probabilities; 12 (6.6%) deescalated below the IT, and 16 (8.8%) moved above the IT. Conclusions: This 2024 BONE-PARK algorithm is informed by both the latest NOGG Guidelines and novel findings in a ‘real-world’ population. The algorithm will aid bone health assessment for people with PD.
- 3 March 2025
- Published by Oxford University Press (OUP) in Age and Ageing
- Vol. 54 (3)
Open AccessAssessing and managing bone health and fracture risk in Parkinson’s disease: the BONE PARK 2 protocol
Background: In Parkinson’s disease (PD), the propensity to fall and the higher risk of osteoporosis converge yielding a high fracture risk. Updated National Osteoporosis Guideline Group (NOGG) guidance recommends that PD should trigger a risk assessment, for example using the FRAX tool, yet clinical pathways remain sub-optimal. To address this, we generated an algorithm for the assessment and management of bone health specifically in PD. Methods: Within the Proactive and Integrated Management and Empowerment in Parkinson’s Disease randomised controlled trial (PRIME-UK RCT), bone-health metrics were collected, and all participants were offered a dual X-ray absorptiometry scan. The FRAX tool was used to obtain the 10-year probability of hip and major osteoporotic fracture (MOF), and the resulting NOGG risk-category recorded. Probabilities were recalculated including femoral-neck bone mineral density (FN-BMD) and/or with numeric adjustment for recurrent falls, and results compared. Results: Among 182 people with parkinsonism (mean age 73.8 years, 65% male, median disease duration 5 years), 28% reported a prior fragility fracture, and 40.7% recurrent falls over the previous year. 28.6% had MOF above NOGG intervention thresholds (IT); whilst 12.1% had a FN-BMD T-Score ≤ −2.5. Recalculation of FRAX with FN-BMD (n = 182) reduced fracture MOF and hip fracture probabilities; 12 (6.6%) deescalated below the IT, and 16 (8.8%) moved above the IT. Conclusions: This 2024 BONE-PARK algorithm is informed by both the latest NOGG Guidelines and novel findings in a ‘real-world’ population. The algorithm will aid bone health assessment for people with PD.
- Open Access
- 17 February 2025
- Published by Wiley in Neurourology and Urodynamics
- Vol. 44 (6) , 1389-1391
Using a Back‐Worn Accelerometer to Capture Nocturia Frequency in Parkinson's: An Exploratory Study
- 17 February 2025
- Published by Wiley in Neurourology and Urodynamics
- Vol. 44 (6) , 1389-1391
Open AccessUsing a Back‐Worn Accelerometer to Capture Nocturia Frequency in Parkinson's: An Exploratory Study
- Open Access
Exploring how PRIME-Parkinson care is implemented and whether, how and why it produces change, for who and under what conditions: a protocol for an embedded process evaluation within the PRIME-UK randomised controlled trial
Introduction: The PRIME-UK randomised controlled trial (RCT) aims to establish whether a model of care that seeks to be proactive, integrated and empower participants, caregivers and healthcare professionals can improve outcomes in people with parkinsonism. Given that this intervention is novel and complex, understanding whether and how the intervention will be acceptable, implementable, cost-effective and scalable across contexts are key questions beyond that of whether ‘it works’. We describe an embedded process evaluation to answer these questions, which aims to support interpretation of the trial results, refinement of the intervention and support future scaling of the PRIME-Parkinson model of care. Methods and analysis: A mixed-methods approach will be used to collect data across four process evaluation domains: implementation, mechanism of change, acceptability and context. Quantitative data will be collected prospectively from all participants and analysed descriptively with exploratory tests of relationships as power allows. Qualitative data will be collected through semistructured interviews with a purposively sampled subpopulation of participants, caregivers and staff members as well as case studies where relevant. Interview transcripts will be analysed thematically using interpretive qualitative analysis. Synthesis of quantitative and qualitative data will also be performed to draw conclusions. Ethics and dissemination: The quantitative data will be collected as part of the main PRIME-UK RCT which was been granted NHS REC approval (21/LO/0387) on 27 July 2021. The qualitative data will be collected as part of a substudy, ‘PRIME-Qual’, which was granted NHS REC approval (21/LO/0388) on 14 July 2021. The mixed-methods process evaluation will be published after the conclusion of the trial in addition to the main trial findings. Trial registration number: NCT05127057 .
Open AccessExploring how PRIME-Parkinson care is implemented and whether, how and why it produces change, for who and under what conditions: a protocol for an embedded process evaluation within the PRIME-UK randomised controlled trial
Introduction: The PRIME-UK randomised controlled trial (RCT) aims to establish whether a model of care that seeks to be proactive, integrated and empower participants, caregivers and healthcare professionals can improve outcomes in people with parkinsonism. Given that this intervention is novel and complex, understanding whether and how the intervention will be acceptable, implementable, cost-effective and scalable across contexts are key questions beyond that of whether ‘it works’. We describe an embedded process evaluation to answer these questions, which aims to support interpretation of the trial results, refinement of the intervention and support future scaling of the PRIME-Parkinson model of care. Methods and analysis: A mixed-methods approach will be used to collect data across four process evaluation domains: implementation, mechanism of change, acceptability and context. Quantitative data will be collected prospectively from all participants and analysed descriptively with exploratory tests of relationships as power allows. Qualitative data will be collected through semistructured interviews with a purposively sampled subpopulation of participants, caregivers and staff members as well as case studies where relevant. Interview transcripts will be analysed thematically using interpretive qualitative analysis. Synthesis of quantitative and qualitative data will also be performed to draw conclusions. Ethics and dissemination: The quantitative data will be collected as part of the main PRIME-UK RCT which was been granted NHS REC approval (21/LO/0387) on 27 July 2021. The qualitative data will be collected as part of a substudy, ‘PRIME-Qual’, which was granted NHS REC approval (21/LO/0388) on 14 July 2021. The mixed-methods process evaluation will be published after the conclusion of the trial in addition to the main trial findings. Trial registration number: NCT05127057 .
- Open Access
Exploring how PRIME-Parkinson care is implemented and whether, how and why it produces change, for who and under what conditions: a protocol for an embedded process evaluation within the PRIME-UK randomised controlled trial
Introduction The PRIME-UK randomised controlled trial (RCT) aims to establish whether a model of care that seeks to be proactive, integrated and empower participants, caregivers and healthcare professionals can improve outcomes in people with parkinsonism. Given that this intervention is novel and complex, understanding whether and how the intervention will be acceptable, implementable, cost effective and scalable across contexts are key questions beyond that of whether ‘it works’. We describe an embedded process evaluation to answer these questions, which aims to support interpretation of the trial results, refinement of the intervention and support future scaling of the PRIME-Parkinson model of care. Methods and analysis A mixed methods approach will be used to collect data across four process evaluation domains: implementation, mechanism of change, acceptability and context. Quantitative data will be collected prospectively from all participants and analysed descriptively with exploratory tests of relationships as power allows. Qualitative data will be collected through semi-structured interviews with a purposively sampled sub-population of participants, caregivers and staff members as well as case studies where relevant. Interview transcripts will be analysed thematically using interpretive qualitative analysis. Synthesis of quantitative and qualitative data will also be performed to draw conclusions. Ethics and dissemination The quantitative data will be collected as part of the main PRIME-UK RCT which was been granted NHS REC approval (21/LO/0387) on 27th July 2021. The qualitative data will be collected as part of a sub-study, ‘PRIME-Qual’, which was granted NHS REC approval (21/LO/0388) on 14th July 2021. The mixed methods process evaluation will be published after the conclusion of the trial in addition to the main trial findings. Trial registration number NCT05127057 Data availability statement Access to the data will be available through application to the Chief Investigator. Pseudo-anonymised data may be shared with other researchers to enable knowledge synthesis. Strengths and limitations of this study This is a pre-planned process evaluation of a complex intervention, which uses robust mixed methodology to support understanding and interpretation of the main trial findings This process evaluation is embedded within a RCT which aims to recruit a representative sample of people living with parkinsonism, meaning the process evaluation has potential to gather a broad range of perspectives Our mixed methods approach provides breadth of data across the study population and more in-depth exploration of themes in a purposively sampled sub-population The main limitation is that statistical power will limit the use of statistical tests in the analysis of quantitative data across subgroups.
Open AccessExploring how PRIME-Parkinson care is implemented and whether, how and why it produces change, for who and under what conditions: a protocol for an embedded process evaluation within the PRIME-UK randomised controlled trial
Introduction The PRIME-UK randomised controlled trial (RCT) aims to establish whether a model of care that seeks to be proactive, integrated and empower participants, caregivers and healthcare professionals can improve outcomes in people with parkinsonism. Given that this intervention is novel and complex, understanding whether and how the intervention will be acceptable, implementable, cost effective and scalable across contexts are key questions beyond that of whether ‘it works’. We describe an embedded process evaluation to answer these questions, which aims to support interpretation of the trial results, refinement of the intervention and support future scaling of the PRIME-Parkinson model of care. Methods and analysis A mixed methods approach will be used to collect data across four process evaluation domains: implementation, mechanism of change, acceptability and context. Quantitative data will be collected prospectively from all participants and analysed descriptively with exploratory tests of relationships as power allows. Qualitative data will be collected through semi-structured interviews with a purposively sampled sub-population of participants, caregivers and staff members as well as case studies where relevant. Interview transcripts will be analysed thematically using interpretive qualitative analysis. Synthesis of quantitative and qualitative data will also be performed to draw conclusions. Ethics and dissemination The quantitative data will be collected as part of the main PRIME-UK RCT which was been granted NHS REC approval (21/LO/0387) on 27th July 2021. The qualitative data will be collected as part of a sub-study, ‘PRIME-Qual’, which was granted NHS REC approval (21/LO/0388) on 14th July 2021. The mixed methods process evaluation will be published after the conclusion of the trial in addition to the main trial findings. Trial registration number NCT05127057 Data availability statement Access to the data will be available through application to the Chief Investigator. Pseudo-anonymised data may be shared with other researchers to enable knowledge synthesis. Strengths and limitations of this study This is a pre-planned process evaluation of a complex intervention, which uses robust mixed methodology to support understanding and interpretation of the main trial findings This process evaluation is embedded within a RCT which aims to recruit a representative sample of people living with parkinsonism, meaning the process evaluation has potential to gather a broad range of perspectives Our mixed methods approach provides breadth of data across the study population and more in-depth exploration of themes in a purposively sampled sub-population The main limitation is that statistical power will limit the use of statistical tests in the analysis of quantitative data across subgroups.
- Open Access
Assessing and managing bone-health and fracture risk in Parkinson’s disease: the BONE PARK 2 protocol
Background: In Parkinson’s disease (PD) the propensity to fall and the higher risk of osteoporosis converge yielding a high fracture risk. Updated National Osteoporosis Guideline Group (NOGG) guidance recommends that PD should trigger a risk assessment, for example using the FRAX tool, yet clinical pathways remain sub-optimal. To address this, we generated an algorithm for the assessment and management of bone-health specifically in PD. Methods: Within the Proactive and Integrated Management and Empowerment in Parkinson’s Disease randomised controlled trial (PRIME-UK RCT), bone-health metrics were collected, and all participants were offered a DXA scan. The FRAX tool was used to obtain the 10-year probability of hip and major osteoporotic fracture (MOF), and the resulting NOGG risk- category recorded. Probabilities were recalculated including femoral-neck bone mineral density (FN-BMD) and/or with numeric adjustment for recurrent falls, and results compared. Results: Among 182 people with parkinsonism (mean age 73.8 years, 65% male, median disease duration 5-years), 28.0% reported a prior fragility fracture, and 40.7% recurrent falls over the previous year. 28.6% had MOF above NOGG intervention thresholds (IT); whilst 12.1% had a FN-BMD T-Score ≤-2.5. Recalculation of FRAX with FN-BMD (n=182) reduced fracture MOF and hip fracture probabilities; 12 (6.6%) deescalated below the IT, and 16 (8.8%) moved above the IT. Conclusions: This 2024 BONE-PARK algorithm is informed by both the latest NOGG Guidelines and novel findings in a ‘real-world’ population. The algorithm will aid bone health assessment people with PD. Key points: Bone-health in Parkinson’s is under-recognised and under-treated, and we have demonstrated an ongoing treatment gap. In this population, we have demonstrated DXA is feasible but infrequently changes treatment. Our Parkinson’s specific guidance supports clinicians and patients to recognise, investigate and treat fracture risk.
Open AccessAssessing and managing bone-health and fracture risk in Parkinson’s disease: the BONE PARK 2 protocol
Background: In Parkinson’s disease (PD) the propensity to fall and the higher risk of osteoporosis converge yielding a high fracture risk. Updated National Osteoporosis Guideline Group (NOGG) guidance recommends that PD should trigger a risk assessment, for example using the FRAX tool, yet clinical pathways remain sub-optimal. To address this, we generated an algorithm for the assessment and management of bone-health specifically in PD. Methods: Within the Proactive and Integrated Management and Empowerment in Parkinson’s Disease randomised controlled trial (PRIME-UK RCT), bone-health metrics were collected, and all participants were offered a DXA scan. The FRAX tool was used to obtain the 10-year probability of hip and major osteoporotic fracture (MOF), and the resulting NOGG risk- category recorded. Probabilities were recalculated including femoral-neck bone mineral density (FN-BMD) and/or with numeric adjustment for recurrent falls, and results compared. Results: Among 182 people with parkinsonism (mean age 73.8 years, 65% male, median disease duration 5-years), 28.0% reported a prior fragility fracture, and 40.7% recurrent falls over the previous year. 28.6% had MOF above NOGG intervention thresholds (IT); whilst 12.1% had a FN-BMD T-Score ≤-2.5. Recalculation of FRAX with FN-BMD (n=182) reduced fracture MOF and hip fracture probabilities; 12 (6.6%) deescalated below the IT, and 16 (8.8%) moved above the IT. Conclusions: This 2024 BONE-PARK algorithm is informed by both the latest NOGG Guidelines and novel findings in a ‘real-world’ population. The algorithm will aid bone health assessment people with PD. Key points: Bone-health in Parkinson’s is under-recognised and under-treated, and we have demonstrated an ongoing treatment gap. In this population, we have demonstrated DXA is feasible but infrequently changes treatment. Our Parkinson’s specific guidance supports clinicians and patients to recognise, investigate and treat fracture risk.