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A mixed-methods study to explore the modifiable aspects of treatment burden in Parkinson’s disease and develop recommendations for improvement

by Qian Yue Tan, Kinda Ibrahim, Helen C. Roberts, Khaled Amar, Simon D.S. Fraser

Background

People with Parkinson’s (PwP) and their caregivers have to manage multiple daily healthcare tasks (treatment burden). This can be challenging and may lead to poor health outcomes.

Objective

To assess the extent of treatment burden in Parkinson’s disease(PD), identify key modifiable factors, and develop recommendations to improve treatment burden.

Methods

A mixed-methods study was conducted consisting of: 1) a UK-wide cross-sectional survey for PwP and caregivers using the Multimorbidity Treatment Burden Questionnaire (MTBQ) to measure treatment burden levels and associated factors and 2) focus groups with key stakeholders to discuss survey findings and develop recommendations.

Results

160 PwP (mean age = 68 years) and 30 caregivers (mean age = 69 years) completed the surveys. High treatment burden was reported by 21% (N = 34) of PwP and 50% (N = 15) of caregivers using the MTBQ. Amongst PwP, higher treatment burden was significantly associated with advancing PD severity, frailty, a higher number of non-motor symptoms, and more frequent medication timings (>3 times/day). Caregivers reporting higher treatment burden were more likely to care for someone with memory issues, had lower mental well-being scores and higher caregiver burden. Three online focus groups involved 11 participants (3 PwP, 1 caregiver and 7 healthcare professionals) recruited from the South of England. Recommendations to reduce treatment burden that were discussed in the focus groups include improving communication. clear expectation setting, and better signposting from healthcare professionals, increasing education and awareness of PD complexity, flexibility of appointment structures, increasing access to healthcare professionals, and embracing the supportive role of technology.

Conclusions

Treatment burden is common amongst PwP and caregivers and could be identified in clinical practice using the MTBQ. There is a need for change at individual provider and system levels to recognise and minimise treatment burden to improve health outcomes in PD.

Experience-based co-design informed development of a toolbox to help optimise primary care support during transition from childrens hospice care: HOPSCOTCH study protocol

Por: Chapman · E. · Mitchell · S. · Fraser · L. K. · Wozencroft · J. · Morris · B. · Peat · G. · Charles · T. · Elverson · J. · Carder · P. · Tallowin · K. · Magnusson · J. · Ziegler · L.
Introduction

The HOPSCOTCH study ‘Helping Optimise Primary Care Support During Transition From Children’s Hospice Care’ aims to develop a toolbox to enable engagement of primary care services in the care of young people with life-limiting conditions (LLC) with a specific focus on the point of transition from children’s hospice services.

Methods and analysis

Individual interviews will be held with young people with LLC, their families and healthcare professionals (HCPs). In alignment with Experience Based Co-Design (EBCD) methodology, extracts of film and audio from young people and family interviews will be combined to professionally produce a ‘catalyst film’ highlighting key points and experiences before, during and after the transition from children’s hospice care. Role-specific workshops will be held with young people with LLC, their families and HCPs working in primary care, children’s hospices and adult hospice services. The catalyst film will be used in feedback workshops to prompt prioritisation of key issues to take forward into toolbox development in a shared young people, family and HCP workshop. A documentary analysis of resources currently used to support transition and communication between care settings will support contextual understanding of the transition process. Young people, parents and professionals have shaped and continue to have influence over the study delivery as advisors alongside a multidisciplinary steering committee.

The study design has been guided by the UK Medical Research Council complex intervention framework. Intervention development draws on the principles of EBCD and is theoretically driven by the Behaviour Change Wheel.

Ethics and dissemination

The study is registered with the UK’s Clinical Study Registry (ISCTRN75964234).

Ethical approval was obtained from Wales 3 ethics board on 2 July 2025 (IRAS ID 334486). This study will include ongoing dissemination and knowledge transfer to key audiences (young people, parents, service providers, commissioners) via publications, national bodies, knowledge exchange events, web-based platforms, social media and clinical/academic forums.

Personalised exercise-rehabilitation for people with multiple long-term conditions (PERFORM): a randomised feasibility study

Por: Evans · R. A. · Simpson · S. A. · Manifield · J. R. · Ahmed · Z. · Barber · S. · Barwell · G. · Brown · S. E. · Daw · P. · Dean · S. G. · Doherty · P. J. · Fraser · H. · Gardiner · N. · Greaves · C. · Ibbotson · T. · Jani · B. · Jolly · K. · Mair · F. · McIntosh · E. · Megaritis · D. · Mille
Objective

Existing exercise-based rehabilitation services, such as cardiac and pulmonary rehabilitation, are traditionally commissioned around single long-term conditions (LTCs) and therefore may not meet the complex needs of adults with multiple long-term conditions (MLTCs) or multimorbidity. The aim of this study was to assess the feasibility and acceptability of the newly developed personalised exercise-rehabilitation programme for people with multiple long-term conditions (PERFORM) and the trial methods.

Design

A parallel two-group mixed-methods feasibility randomised controlled trial (RCT) with embedded process and economic evaluation.

Setting

Three UK sites (two acute hospital settings, one community-based healthcare setting).

Participants

60 adults with MLTCs (defined as the presence of ≥2 LTCs) with at least one known to benefit from exercise therapy were randomised 2:1 to PERFORM intervention plus usual care (PERFORM group) or usual care alone (control group).

Intervention

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

Primary and secondary outcome measures

Primary feasibility outcomes included: trial recruitment (percentage of a target of 60 participants recruited within 4.5 months), retention (percentage of participants with complete EuroQol data at 3 months) and intervention adherence (percentage of intervention group attending ≥60% sessions). Other feasibility measures included completion of outcome measures at baseline (pre-randomisation), 3 months post-randomisation (including patient-reported outcomes, exercise capacity and collection of health and social care resource use) and intervention fidelity.

Results

Target recruitment (40 PERFORM group, 20 control group) was met within the timeframe. Participants were 57% women with a mean (SD) age of 62 (13) years, body mass index of 30.8 (8.0) kg/m2 and a median of 4 LTCs (most common: diabetes (41.7%), hypertension (38.3%), asthma (36.7%) and a painful condition (35.0%)). We achieved EuroQol outcome retention of 76.7% (95% CI: 65.9% to 87.1%; 46/60 participants) and intervention adherence of 72.5% (95% CI: 56.3% to 84.4%; 29/40 participants). Data completion for attendees was over 90% for 11/18 outcome measures.

Conclusions

Our findings support the feasibility and rationale for delivering the PERFORM comprehensive self-management and exercise-based rehabilitation intervention for people living with MLTCs and progression to a full multicentre RCT to formally assess clinical effectiveness and cost-effectiveness.

Trial registration number

ISRCTN68786622.

Pubertal timing, body dissatisfaction and self-image: a prospective cohort study

Por: Tarif · D. · Heron · J. · Fraser · A. · Joinson · C.
Objective

Early pubertal timing has been linked to heightened body dissatisfaction, but previous studies have focused on girls, with small sample sizes and lacking objective measures of pubertal timing. The objective of this study was to examine the association between pubertal timing (age at peak height velocity [aPHV] and age at menarche [AAM] for girls) and body dissatisfaction and self-image in mid-adolescence (age 14).

Design and setting

Prospective cohort study in the UK.

Participants

6644 participants (41% male) from the Avon Longitudinal Study of Parents and Children.

Outcome measures

Outcomes were measured using the Satisfaction and Dissatisfaction with Body Parts Scale and Self-Image Profile at age 14. Multivariable regression models were adjusted for socioeconomic status and prepubertal body mass index (BMI).

Results

In boys, later aPHV was associated with higher body dissatisfaction (b=0.13 (95% CI 0.09 to 0.18)). In girls, later aPHV was associated with lower body dissatisfaction, but this was attenuated after adjusting for BMI (b=–0.03 (95% CI –0.07 to 0.01)). A negative association was found between AAM and body dissatisfaction (b=–0.06 (95% CI –0.09 to –0.02)). Later aPHV in girls was associated with increased odds of feeling good-looking (OR=1.09 (95% CI 1.01 to 1.19)) and lower odds of feeling different from others (OR=0.91 (95% CI 0.83 to 1.00)). No associations between aPHV and self-image were found in boys.

Conclusions

These findings highlight the need for targeted interventions for adolescent body dissatisfaction.

Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol

Por: Howe · B. D. · Macdonald · S. P. J. · Arendts · G. · Bellomo · R. · Burcham · J. · Delaney · A. · Egerton-Warburton · D. · Fatovich · D. · Fraser · J. F. · Higgins · A. · Jones · P. · Keijzers · G. · Milford · E. · Udy · A. A. · Williams · P. · Young · P. · Peake · S. L.
Introduction

International consensus guidelines support the initial administration of 30 mL/kg of intravenous fluids for haemodynamic resuscitation of newly diagnosed septic shock. Practice variation exists between the volume of fluids administered and timing of vasopressor commencement. The optimal approach in patients with septic shock is uncertain.

Methods and analysis

Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis is a 1000-participant multicentre, randomised, open-label, parallel group clinical trial conducted in patients with septic shock presenting to the emergency department in participating sites in Australia, New Zealand and Ireland. Participants are randomised (1:1) to either restricted fluids and early vasopressors or a larger initial intravenous fluid volume and later vasopressors. The primary outcome is days alive and out of hospital at day 90 postrandomisation. Secondary outcomes are all-cause mortality at day 90, time from randomisation until death (to day 90), days alive and at home at day 90 and ventilator-free, vasopressor-free and renal replacement-free days to day 28 postrandomisation and death or disability at 6-month and 12-month postrandomisation. Health-related quality of life will be assessed at day 180 and 12 months following randomisation.

Ethics and dissemination

The study was approved by Northern Sydney Local Health District Human Research Ethics Committee (HREC2020/ETH02874) on 21 January 2021. Patients will be enrolled under a waiver of prior consent. The patient or next-of-kin (or equivalent according to local jurisdiction) is approached at the first available opportunity and given a trial information sheet. According to local approvals, the patient or next-of-kin chooses to either continue in the trial or opt-out/decline continued participation. Results will be disseminated in peer-reviewed journals and presented at academic conferences.

Trial registration number

NCT04569942

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