Carl E Clarke1,2, Smitaa Patel3, Natalie Ives3, Caroline E Rick3, Rebecca Woolley3, Keith Wheatley4, Marion F Walker5, Shihua Zhu6, Rebecca Kandiyali7, Guiqing Yao7, Catherine M Sackley8,9. 1. Institute for Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. 2. Department of Neurology, Sandwell and West Birmingham Hospitals NHS Trust, City Hospital, Birmingham, UK. 3. Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. 4. Cancer Research UK Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. 5. Rehabilitation and Ageing, Queen's Medical Centre, University of Nottingham, Nottingham, UK. 6. Primary Care Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. 7. Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK. 8. University of East Anglia, Norwich, UK. 9. Academic Department of Physiotherapy, Faculty of Life Sciences and Medicine, King's College London, London, UK.
Abstract
BACKGROUND: Cochrane reviews of physiotherapy (PT) and occupational therapy (OT) for Parkinson's disease found insufficient evidence of effectiveness, but previous trials were methodologically flawed with small sample size and short-term follow-up. OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of individualised PT and OT in Parkinson's disease. DESIGN: Large pragmatic randomised controlled trial. SETTING:Thirty-eight neurology and geriatric medicine outpatient clinics in the UK. PARTICIPANTS: Seven hundred and sixty-two patients with mild to moderate Parkinson's disease reporting limitations in activities of daily living (ADL). INTERVENTION: Patients were randomised online to either both PT and OT NHS services (n = 381) or no therapy (n = 381). Therapy incorporated a patient-centred approach with individual assessment and goal setting. MAIN OUTCOME MEASURES: The primary outcome was instrumental ADL measured by the patient-completed Nottingham Extended Activities of Daily Living (NEADL) scale at 3 months after randomisation. Secondary outcomes were health-related quality of life [Parkinson's Disease Questionnaire-39 (PDQ-39); European Quality of Life-5 Dimensions (EQ-5D)], adverse events, resource use and carer quality of life (Short Form questionnaire-12 items). Outcomes were assessed before randomisation and at 3, 9 and 15 months after randomisation. RESULTS: Data from 92% of the participants in each group were available at the primary time point of 3 months, but there was no difference in NEADL total score [difference 0.5 points, 95% confidence interval (CI) -0.7 to 1.7; p = 0.4] or PDQ-39 summary index (0.007 points, 95% CI -1.5 to 1.5; p = 1.0) between groups. The EQ-5D quotient was of borderline significance in favour of therapy (-0.03, 95% CI -0.07 to -0.002; p = 0.04). Contact time with therapists was for a median of four visits of 58 minutes each over 8 weeks (mean dose 232 minutes). Repeated measures analysis including all time points showed no difference in NEADL total score, but PDQ-39 summary index (curves diverging at 1.6 points per annum, 95% CI 0.47 to 2.62; p = 0.005) and EQ-5D quotient (0.02, 95% CI 0.00007 to 0.03; p = 0.04) showed significant but small differences in favour of the therapy arm. Cost-effective analysis showed that therapy was associated with a slight but not significant gain in quality-adjusted life-years (0.027, 95% CI -0.010 to 0.065) at a small incremental cost (£164, 95% CI -£141 to £468), resulting in an incremental cost-effectiveness ratio of under £4000 (£3493, 95% -£169,371 to £176,358). There was no difference in adverse events or serious adverse events. CONCLUSIONS: NHS PT and OT did not produce immediate or long-term clinically meaningful improvements in ADL or quality of life in patients with mild to moderate Parkinson's disease. This evidence does not support the use of low-dose, patient-centred, goal-directed PT and OT in patients in the early stages of Parkinson's disease. Future research should include the development and testing of more structured and intensive PT and OT programmes in patients with all stages of Parkinson's disease. TRIAL REGISTRATION: Current Controlled Trials ISRCTN17452402. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 63. See the NIHR Journals Library website for further project information. The Birmingham Clinical Trials Unit, University of Birmingham, received support from the UK Department of Health up to March 2012. Catherine Sackley was supported by a NIHR senior investigator award, Collaboration for Leadership in Applied Health Research and Care East of England and West Midlands Strategic Health Authority Clinical Academic Training award.
RCT Entities:
BACKGROUND: Cochrane reviews of physiotherapy (PT) and occupational therapy (OT) for Parkinson's disease found insufficient evidence of effectiveness, but previous trials were methodologically flawed with small sample size and short-term follow-up. OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of individualised PT and OT in Parkinson's disease. DESIGN: Large pragmatic randomised controlled trial. SETTING: Thirty-eight neurology and geriatric medicine outpatient clinics in the UK. PARTICIPANTS: Seven hundred and sixty-two patients with mild to moderate Parkinson's disease reporting limitations in activities of daily living (ADL). INTERVENTION: Patients were randomised online to either both PT and OT NHS services (n = 381) or no therapy (n = 381). Therapy incorporated a patient-centred approach with individual assessment and goal setting. MAIN OUTCOME MEASURES: The primary outcome was instrumental ADL measured by the patient-completed Nottingham Extended Activities of Daily Living (NEADL) scale at 3 months after randomisation. Secondary outcomes were health-related quality of life [Parkinson's Disease Questionnaire-39 (PDQ-39); European Quality of Life-5 Dimensions (EQ-5D)], adverse events, resource use and carer quality of life (Short Form questionnaire-12 items). Outcomes were assessed before randomisation and at 3, 9 and 15 months after randomisation. RESULTS: Data from 92% of the participants in each group were available at the primary time point of 3 months, but there was no difference in NEADL total score [difference 0.5 points, 95% confidence interval (CI) -0.7 to 1.7; p = 0.4] or PDQ-39 summary index (0.007 points, 95% CI -1.5 to 1.5; p = 1.0) between groups. The EQ-5D quotient was of borderline significance in favour of therapy (-0.03, 95% CI -0.07 to -0.002; p = 0.04). Contact time with therapists was for a median of four visits of 58 minutes each over 8 weeks (mean dose 232 minutes). Repeated measures analysis including all time points showed no difference in NEADL total score, but PDQ-39 summary index (curves diverging at 1.6 points per annum, 95% CI 0.47 to 2.62; p = 0.005) and EQ-5D quotient (0.02, 95% CI 0.00007 to 0.03; p = 0.04) showed significant but small differences in favour of the therapy arm. Cost-effective analysis showed that therapy was associated with a slight but not significant gain in quality-adjusted life-years (0.027, 95% CI -0.010 to 0.065) at a small incremental cost (£164, 95% CI -£141 to £468), resulting in an incremental cost-effectiveness ratio of under £4000 (£3493, 95% -£169,371 to £176,358). There was no difference in adverse events or serious adverse events. CONCLUSIONS: NHS PT and OT did not produce immediate or long-term clinically meaningful improvements in ADL or quality of life in patients with mild to moderate Parkinson's disease. This evidence does not support the use of low-dose, patient-centred, goal-directed PT and OT in patients in the early stages of Parkinson's disease. Future research should include the development and testing of more structured and intensive PT and OT programmes in patients with all stages of Parkinson's disease. TRIAL REGISTRATION: Current Controlled Trials ISRCTN17452402. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 63. See the NIHR Journals Library website for further project information. The Birmingham Clinical Trials Unit, University of Birmingham, received support from the UK Department of Health up to March 2012. Catherine Sackley was supported by a NIHR senior investigator award, Collaboration for Leadership in Applied Health Research and Care East of England and West Midlands Strategic Health Authority Clinical Academic Training award.
Authors: Lauren E Heusinkveld; Mallory L Hacker; Maxim Turchan; Thomas L Davis; David Charles Journal: Front Neurol Date: 2018-08-03 Impact factor: 4.003
Authors: Victoria A Goodwin; Jacqueline J Hill; James A Fullam; Katie Finning; Claire Pentecost; David A Richards Journal: BMJ Open Date: 2019-08-28 Impact factor: 2.692