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

Abstract: 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

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

Abstract: 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

Difficulties encountered by nursing students in practices and their views about nurses [Ögrenci hemşirelerin klinik uygulamada karşi{dotless}laşti{dotless}klari{dotless} güçlükler ve klinik hemşireler hakki{dotless}ndaki görüşleri]

AIM: The clinical setting is a significant learning environment for nursing students. This crosssectional study was conducted to determine the problems experienced in clinical practices by the students studying in the Nursing Department of the Health Sciences Faculty of Gaziantep University and their views about clinic nurses. METHOD: Study consisted of 296 students who agreed to take part in the study and were attending the classes at the time when the questionnaire was administered became the sample of the study. Data were collected between 2-13 May 2011 using a questionnaire which was prepared by searching through the literature. The data obtained was electronically evaluated using quantification, percentage calculations and chi-square test. RESULTS: Most of the students stated that they worked with nurses (44.3%) and their friends (44.3%) during clinical practices, the major reason for their having problems was because they could not put into practice the theoretical knowledge they received in school (33.8%), 59.1% stated that nurses partially helped them use their conceptual knowledge in practice, and 53.0% said that they did not have any support from nurses when they experienced a problem during practice. When the students were compared by their grades, it was found that the 1st grade students received support from nurses in solving the problems they had in the clinic and in using the conceptual knowledge they had in practice, but this support decreased as their grades went up (p<0.001). CONCLUSION: The students stated that they did not receive sufficient support from nurses in solving the problems they had in practice and nurses did not help them develop themselves professionally. As the students' grade went up, their expectations from nurses significantly decreased in relation to their desire to be evaluated by, and be under the responsibility of, nurses

Listening to Turkish Classical Music Decreases Patients\u27 Anxiety, Pain, Dissatisfaction and the Dose of Sedative and Analgesic Drugs During Colonoscopy: A Prospective Randomized Controlled Trial

AIM: To determine whether listening to music decreases the requirement for dosages of sedative drugs, patients\u27 anxiety, pain and dissatisfaction feelings during colonoscopy and makes the procedure more comfortable and acceptable. METHODS: Patients undergoing elective colonoscopy between October 2005 and February 2006 were randomized into either listening to music (Group 1, n = 30) or not listening to music (Group 2, n = 30). Anxiolytic and analgesic drugs (intravenous midazolam and meperidine) were given according to the patients\u27 demand. Administered medications were monitored. We determined their levels of anxiety using the State-Trait Anxiety Inventory Test form. Patients\u27 satisfaction, pain, and willingness to undergo a repeated procedure were self-assessed using a visual analog scale. RESULTS: The mean dose of sedative and analgesic drugs used in group 1 (midazolam: 2.1 +/- 1.4, meperidine: 18.1 +/- 11.7) was smaller than group 2 (midazolam: 2.4 +/- 1.0, meperidine: 20.6 +/- 11.5), but without a significant difference (P \u3e 0.05). The mean anxiety level in group 1 was lower than group 2 (36.7 +/- 2.2 vs 251.0 +/- 1.9, P \u3c 0.001). The mean satisfaction score was higher in group 1 compared to group 2 (87.8 +/- 3.1 vs 58.1 +/- 3.4, P \u3c 0.001). The mean pain score in group 1 was lower than group 2 (74.1 +/- 4.7 vs 39.0 +/- 3.9, P \u3c 0.001). CONCLUSION: Listening to music during colonoscopy helps reduce the dose of sedative medications, as well as patients\u27 anxiety, pain, dissatisfaction during the procedure. Therefore, we believe that listening to music can play an adjunctive role to sedation in colonoscopy. It is a simple, inexpensive way to improve patients\u27 comfort during the procedure