Katherine H. O. Deane

Fatigue is one of the most disabling symptoms experienced by people with Parkinson's disease, yet few evidence-based non-pharmacological interventions are available. This study evaluated the feasibility, acceptability, and exploratory clinical signals of the Rebalancing Fatigue and Enhancing Self-Help (ReFresh) online fatigue management programme for people with Parkinson's disease. A pilot randomized controlled trial with a wait-list control group was conducted. Participants with Parkinson's disease experiencing fatigue were randomized to either the six-week ReFresh online programme or a wait-list control. Feasibility outcomes included recruitment, retention, adherence, and participant engagement. Secondary outcomes included fatigue severity, fatigue self-efficacy, sleep quality, mood, and occupational performance. A total of 118 participants were randomized. Recruitment targets were achieved; however, retention and adherence were modest. Participants who completed the programme reported improvements in fatigue self-efficacy and perceived ability to manage fatigue, while changes in fatigue severity were smaller. Qualitative feedback indicated that participants valued the flexibility and accessibility of the online format. The ReFresh programme demonstrated feasibility and acceptability as a digitally delivered fatigue management intervention for people with Parkinson's disease. Future research should explore strategies to improve engagement and evaluate the programme in a fully powered randomized controlled trial. ISRCTN Registry, ISRCTN62114944, https://www.isrctn.com/ISRCTN62114944.

PurposeAnxiety is a prevalent symptom of Parkinson's disease, but is often under-recognised and challenging to characterise. The present study aimed to develop a comprehensive new scale that characterised the specific and nuanced experience of anxiety in people living with Parkinson's disease. A shortened version of the scale was also developed. The psychometric properties of both versions of the scale were assessed for reliability and validity.MethodsSecondary analyses were conducted on data from 254 people with Parkinson's disease and anxiety collected in a modified Nominal Group Technique ranking survey. Secondary analyses included exploratory factor analysis, reliability and validity analyses, and confirmatory factor analysis.ResultsA standardised scale of anxiety and Parkinson's disease, in its long Comprehensive Anxiety and Parkinson's Scale - 54 (CAPS-54) and short versions (CAPS-24), was developed. Reliability and validity analyses of the scales demonstrated excellent factorial and internal consistency, as well as good convergent validity.ConclusionsThe CAP Scales offer researchers and clinicians a more comprehensive means of assessing the experience of anxiety in the context of Parkinson's disease than is currently available. Initial validation of the scales is promising. Future validation and identification of clinical boundaries with an independent sample is recommended.

Medication adherence is a multi-faceted construct associated with several positive consequences in people with chronic conditions. However, non-adherence currently represents a major issue in Parki...

Perceived control is an important construct for the psychological well-being of people affected by chronic conditions, and higher perceived control is associated with better outcomes. Psychosocial ...

Background: non-motor symptoms such as bladder dysfunction are common (80%) in people with Parkinson’s increasing the risk for falls with a negative impact on health-related costs and quality of life. We undertook STARTUP to evaluate the clinical and cost-effectiveness of using an adhesive electrode to stimulate the transcutaneous tibial nerve stimulation (TTNS) to treat bladder dysfunction in people with Parkinson’s disease (PD). Study design, materials and methods: STARTUP was a parallel two-arm, multi-centre, pragmatic, double-blind, randomised controlled trial. Each participant attended one clinic visit to complete consent, be randomised using a computer-generated system and to be shown how to use the device. The trial had two co-primary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score (IPSS). These were completed at baseline, 6 and 12 weeks. A bladder frequency chart and resource questionnaire were also completed. Results: two hundred forty two participants were randomised. About 59% of participants were male, the mean age was 69 years and mean time since diagnosis was 6 years. Questionnaire return rate was between 79 and 90%. There was a statistically significantly lower score in the active group at 6 weeks in the IPSS questionnaire (mean difference (Standard deviation, SD) 12.5 (6.5) vs 10.9 (5.5), effect size −1.49, 95% CI −2.72, −0.25). There was no statistically significant change in any other outcome. Conclusion: TTNS was demonstrated to be safe with a high level of compliance. There was a significant change in one of the co-primary outcome measures at the end of the treatment period (i.e. 6 weeks), which could indicate a benefit. Further fully powered RCTs are required to determine effective treatments.

Introduction Parkinson’s disease is the second most common chronic neurodegenerative condition with bladder dysfunction affecting up to 71%. Symptoms affect quality of life and include urgency, frequency, hesitancy, nocturia and incontinence. Addressing urinary dysfunction is one of the top 10 priority research areas identified by the James Lind Alliance and Parkinson’s UK. Objectives Conduct a randomised controlled trial (RCT) targeting people with Parkinson’s disease (PwP) who have self-reported problematic lower urinary tract symptoms, investigating the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared with sham TTNS. Implement a standardised training approach and package for the correct application of TTNS. Conduct a cost-effectiveness analysis of TTNS compared with sham TTNS. Methods and analysis An RCT of 6 weeks with twice weekly TTNS or sham TTNS. Participants will be recruited in 12 National Health Service neurology/movement disorder services, using a web-based randomisation system, and will be shown how to apply TTNS or sham TTNS. Participants will receive a weekly telephone call from the researchers during the intervention period. The trial has two coprimary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score. Secondary outcomes include a 3-day bladder diary, quality of life, acceptability and fidelity and health economic evaluation. Outcomes will be measured at 0, 6 and 12 weeks. A sample size of 208 randomised in equal numbers to the two arms will provide 90% power to detect a clinically important difference of 2.52 points on the Internatioanl Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and of 3 points in the International Prostate Symptom Score total score at 12 weeks at 5% significance level, based on an SD of 4.7 in each arm and 20% attrition at 6 weeks. Analysis will be by intention to treat and pre defined in a statistical analysis plan Ethics and dissemination East of Scotland Research Ethics Service (EoSRES), 18/ES00042, obtained on 10 May 2018. The trial will allow us to determine effectiveness, safety, cost and acceptability of TTNS for bladder dysfunction in PWP. Results will be published in open access journals; lay reports will be posted to all participants and presented at conferences. Trial registration number ISRCTN12437878; Pre-results.

Objective: To create a database of long-term randomised controlled trials (RCTs) comparing higher with lower omega-3, omega-6 or total polyunsaturated fatty acid (PUFA), regardless of reported outcomes, and to develop methods to assess effects of increasing omega-6, alpha-linolenic acid (ALA), long-chain omega-3 (LCn3) and total PUFA on health outcomes. Design: Systematic review search, methodology and meta-analyses. Data sources: Medline, Embase, CENTRAL, WHO International Clinical Trials Registry Platform, Clinicaltrials.gov and trials in relevant systematic reviews. Eligibility criteria: RCTs of ≥24 weeks' duration assessing effects of increasing ALA, LCn3, omega-6 or total PUFAs, regardless of outcomes reported. Data synthesis: Methods included random-effects meta-analyses and sensitivity analyses. Funnel plots were examined, and subgrouping assessed effects of intervention type, replacement, baseline diabetes risk and use of diabetic medications, trial duration and dose. Quality of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE). Results: Electronic searches generated 37 810 hits, de-duplicated to 19 772 titles and abstracts. We assessed 2155 full-text papers, conference abstracts and trials registry entries independently in duplicate. Included studies were grouped into 363 RCTs comparing higher with lower omega-3, omega-6 and/or total PUFA intake of at least 6 months’ duration—the Database. Of these 363 included RCTs, 216 RCTs were included in at least one of our reviews of health outcomes, data extracted and risk of bias assessed in duplicate. Ninety five RCTs were included in the Database but not included in our current reviews. Of these 311 completed trials, 27 altered ALA intake, 221 altered LCn3 intake and 16 trials altered omega-3 intake without specifying whether ALA or LCn3. Forty one trials altered omega-6 and 59 total PUFA.The remaining 52 trials are ongoing though 13 (25%) appear to be outstanding, or constitute missing data. Conclusions: This extensive database of trials is available to allow assessment of further health outcomes.