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.

Sponsor/contract laboratory communication: a team approach to quality.

The true measure of any successful quality endeavor is the final product. The final product generated at contract facilities conducting nonclinical studies is the final report. This should be accurate, complete, and consistent with regard to the raw data, and in compliance itself. The final report resulting from studies conducted at contract laboratories should be reflective of the collaborative efforts of sponsor and laboratory staffs. The dual interaction of the respective Quality Assurance Units (QAUs) in ensuring that optimal study performance is maintained from initiation through final report submission is of paramount importance. Key to any productive sponsor/contract laboratory relationship is communication. The multidirectional flow of information inherent in the conduct of nonclinical studies must be managed to maximize the strengths of the principals involved, while at the same time assuring that consistent emphasis is placed on team focus. Although the role of the QAUs representing the contract facilities and the sponsor both ensure the quality of study conduct, and ultimately the final product, their respective approaches may be from different perspectives. The contract QAU's primary focus is the specific study conduct, including appropriate inspections of ongoing critical phases and audits of raw data and reports, along with compliance to site Standard Operating Procedures (SOPs), protocols and sponsor requirements. On the other hand, sponsor QAUs focus mainly on overall study conduct, assurance that contract QAUs are operating effectively, and ensuring that sponsor monitors are communicating adequately with contract facility personnel. Open communication between the respective QAUs is the most productive and useful way of ensuring that all quality criteria are met.(ABSTRACT TRUNCATED AT 250 WORDS)