A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson's disease: a study protocol for a randomised controlled trial.

BACKGROUND: Parkinson's disease (PD) affects approximately 145,519 people in the UK. Speech impairments are common with a reported prevalence of 68%, which increase physical and mental demands during conversation, reliance on family and/or carers, and the likelihood of social withdrawal reducing quality of life. In the UK, two approaches to Speech and Language Therapy (SLT) intervention are commonly available: National Health Service (NHS) SLT or Lee Silverman Voice Treatment (LSVT LOUD®). NHS SLT is tailored to the individuals' needs per local practice typically consisting of six to eight weekly sessions; LSVT LOUD® comprises 16 sessions of individual treatment with home-based practice over 4 weeks. The evidence-base for their effectiveness is inconclusive. METHODS/DESIGN: PD COMM is a phase III, multicentre, three-arm, unblinded, randomised controlled trial. Five hundred and forty-six people with idiopathic PD, reporting speech or voice problems will be enrolled. We will exclude those with a diagnosis of dementia, laryngeal pathology or those who have received SLT for speech problems in the previous 2 years. Following informed consent and completion of baseline assessments, participants will be randomised in a 1:1:1 ratio to no-intervention control, NHS SLT or LSVT LOUD® via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Participants randomised to the intervention groups will start treatment within 4 (NHS SLT) or 7 (LSVT LOUD®) weeks of randomisation. PRIMARY OUTCOME: Voice Handicap Index (VHI) total score at 3 months. Secondary outcomes include: VHI subscales, Parkinson's Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5 L; ICECAP-O; resource utilisation; adverse events and carer quality of life. Mixed-methods process and health economic evaluations will take place alongside the trial. Assessments will be completed before randomisation and at 3, 6 and 12 months after randomisation. The trial started in December 2015 and will run for 77 months. Recruitment will take place in approximately 42 sites around the UK. DISCUSSION: The trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with PD compared to no SLT. It will further test whether NHS SLT or LSVT LOUD® provide greater benefit and determine the cost-effectiveness of both interventions. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ID: 12421382. Registered on 18 April 2016.

The inpatient neurology consultation service: value and cost.

Neurological conditions comprise a significant proportion of patient admissions to hospital but, in the majority of cases, are admitted under the care of non-neurological physicians. As a consequence, neurological ward consultations are commonly requested by the admitting medical teams to review diagnoses and management plans. The outcomes of neurological ward consultations were examined and the time required for the referral process recorded by performing a detailed prospective three-month audit of inpatient referrals to the neurology service. The consultations of 120 patients were recorded, categorised and analysed. These consultations were beneficial in the vast majority of cases, with a clear impact on patient diagnoses or management plans. The consultation process was time consuming, however, both in respect of the initial review, but also with follow-up visits. This audit highlights the importance of neurological input in the diagnosis and management of hospital inpatients. The time taken for this process should be resourced appropriately.

Pilot randomised controlled trial of occupational therapy to optimise independence in Parkinson's disease: the PD OT trial.

OBJECTIVE: To perform a pilot trial of occupational therapy (OT) to optimise functional independence in Parkinson disease (PD) to assess accrual/withdrawal rates, acceptability, outcome measures, and inform sample-size calculation. METHOD: Non-demented patients with idiopathic PD and difficulties with activities of daily living (ADL) were recruited provided they had not received OT in the last 2 years and/or physiotherapy in the last year. Patients were randomised to immediate OT or OT after completion of the trial. Patients randomised to OT were assessed at home by an experienced therapist and then received six home treatment sessions over 2 months. Interventions were targeted at functional independence and mobility goals. Outcome measures were: Nottingham Extended Activity of Daily Living Scale, Rivermead Mobility Index, Unified Parkinson's Disease Rating Scale ADL scale, Parkinson's Disease Questionnaire 39, EuroQol-EQ-5D, Hospital Anxiety and Depression Scale, and health economics analysis. RESULTS: 39 patients (25 male; mean age 73 years) were recruited from four centres over 16 months. The mean difference in NEADL at 8 months was 3.5 (95% CI -3.2 to 10.2). The mean difference in PDQ-39 Summary Score was 3.8 (95% CI -4.94 to 12.6). There were strong correlations between the PDQ-39 and other outcomes. The intervention was acceptable to patients, with a low withdrawal rate and good questionnaire completion. CONCLUSION: Randomisation to a trial of OT in PD is feasible. NEADL and PDQ-39 are relevant outcomes and provided data to inform sample size for an adequately powered randomised trial for which there is pressing need.

Effects of dyskinesias in Parkinson's disease on quality of life and health-related costs: a prospective European study.

The treatment of Parkinson's disease (PD) with l-DOPA leads to involuntary movements (dyskinesias). This 6-month observational study in three European countries in PD patients with various degrees of motor complications examined the effects of dyskinesias on the quality of life (QoL) of patients and health care costs. Retrospective and prospective health economic data were collected, and QoL of patients was measured using the Short Form-36 (SF-36) and the PD Quality of Life (PDQL) Scale. Regression analysis was used to estimate the adjusted effects of dyskinesias on QoL and costs, whilst accounting for the potentially confounding effects of disease progression, motor fluctuations and country. Increasing dyskinesia scores on either the Unified PD Rating Scale or the Goetz Dyskinesia Rating Scale were associated with significant reductions in QoL scores on the SF-36 and PDQL Scale. Increasing dyskinesia severity was also associated with increased depression scores on the Montgomery-Asberg Depression Rating Scale along with significant increases in health care costs. The effects of dyskinesia on QoL, depression and costs decreased but remained significant after adjustment for the confounding effects of disease progression and motor fluctuations. In conclusion, dyskinesias may adversely affect QoL and increase health care costs in patients with PD. Future studies should evaluate the potentially beneficial effects in terms of QoL and health care costs of strategies to delay the onset of, or the treatment of, dyskinesias.

Referral criteria for speech and language therapy assessment of dysphagia caused by idiopathic Parkinson's disease.

OBJECTIVE: To examine the prevalence of dysphagia in idiopathic Parkinson's disease (IPD) in the outpatient setting and to determine what assessment criteria to use to select patients with dysphagia for referral to speech and language therapists. MATERIAL AND METHODS: Sixty-four patients with IPD and 80 age-matched controls were interviewed in clinic about their swallowing history and an objective swallowing test administered. All patients were assessed over the next few weeks by an experienced speech and language therapist and dysphagia rated according to a modified Rehabilitation Institute of Chicago Dysphagia Rating Scale and a novel global rating scale. The ability of various clinic criteria to predict patients with severe dysphagia were examined. RESULTS: Dysphagia for food was found in 30% of patients, significantly more than in controls. Swallowing speed and bolus volume were significantly lower in patients compared with controls and were correlated with declining Hoehn and Yahr score. Swallowing speed fell significantly on withdrawal of medication. The therapist's global rating score and Chicago score declined with Hoehn and Yahr score and duration of disease. However, only 10% of patients required dietary advice and none needed gastrostomy or tracheostomy. Discriminant analysis showed that various combinations of clinic selection criteria were no better than the presence of dysphagia for food at predicting which patients had significant dysphagia requiring advice from a therapist. CONCLUSIONS: Patients with idiopathic Parkinson's disease should be questioned about dysphagia for food on a regular basis and, if present, should be referred to a speech and language therapist for further assessment and treatment. The outcome of this protocol should be tested prospectively.

Economic and social impact of migraine.

We sent an anonymous self-administered questionnaire to 4200 employees of a Trust hospital, 1903 of whom returned it. We identified 158 migraine sufferers according to International Headache Society (IHS) criteria. These sufferers estimated 2.0 days/year absence from work, and an equivalent of 5.5 days/year lost by reduced effectiveness at work, caused by their migraine at an estimated financial cost of over 50,000 pounds to the Trust. An additional 220 individuals who had received a diagnosis of migraine from a doctor but fulfilled only 3/4 IHS criteria lost the equivalent of 6.7 days off work at a further cost of 63,000 pounds). Few patients had consulted their general practitioner about their migraines in the last 3 months. Most (78%) were using only over-the-counter medication. Migraine patients should be encouraged to seek medical attention.