S. Patel

Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial

Summary Background Surgical intervention for advanced Parkinsons disease is an option if medical therapy fails to control symptoms adequately. We aimed to assess whether surgery and best medical therapy improved self-reported quality of life more than best medical therapy alone in patients with advanced Parkinsons disease. Methods The PD SURG trial is an ongoing randomised, open-label trial. At 13 neurosurgical centres in the UK, between November, 2000, and December, 2006, patients with Parkinsons disease that was not adequately controlled by medical therapy were randomly assigned by use of a computerised minimisation procedure to immediate surgery (lesioning or deep brain stimulation at the discretion of the local clinician) and best medical therapy or to best medical therapy alone. Patients were analysed in the treatment group to which they were randomised, irrespective of whether they received their allocated treatment. The primary endpoint was patient self-reported quality of life on the 39-item Parkinsons disease questionnaire (PDQ-39). Changes between baseline and 1 year were compared by use of t tests. This trial is registered with Current Controlled Trials, number ISRCTN34111222. Findings 366 patients were randomly assigned to receive immediate surgery and best medical therapy (183) or best medical therapy alone (183). All patients who had surgery had deep brain stimulation. At 1 year, the mean improvement in PDQ-39 summary index score compared with baseline was 5·0 points in the surgery group and 0·3 points in the medical therapy group (difference −4·7, 95% CI −7·6 to −1·8; p=0·001); the difference in mean change in PDQ-39 score in the mobility domain between the surgery group and the best medical therapy group was −8·9 (95% CI −13·8 to −4·0; p=0·0004), in the activities of daily living domain was −12·4 (−17·3 to −7·5; p<0·0001), and in the bodily discomfort domain was −7·5 (−12·6 to −2·4; p=0·004). Differences between groups in all other domains of the PDQ-39 were not significant. 36 (19%) patients had serious surgery-related adverse events; there were no suicides but there was one procedure-related death. 20 patients in the surgery group and 13 in the best medical therapy group had serious adverse events related to Parkinsons disease and drug treatment. Interpretation At 1 year, surgery and best medical therapy improved patient self-reported quality of life more than best medical therapy alone in patients with advanced Parkinsons disease. These differences are clinically meaningful, but surgery is not without risk and targeting of patients most likely to benefit might be warranted. Funding UK Medical Research Council, Parkinsons UK, and UK Department of Health.

The Prevalence of Joint Contractures, Pressure Sores, Painful Shoulder, Other Pain, Falls, and Depression in the Year After a Severely Disabling Stroke

Background and Purpose— Complications after stroke have been shown to impede rehabilitation, lead to poor functional outcome, and increase cost of care. This inception cohort study sought to investigate the prevalence of immobility-related complications during the first year after severely disabling stroke in relation to functional independence and place of residence. Methods— Over a 7-month period, 600 stroke survivors were identified in the hospital through the Nottingham Stroke Register. Those who had a Barthel Index score ≤10 3 months poststroke and did not have a primary diagnosis of dementia were eligible to participate in the study. Assessments of complications were carried out at 3, 6, and 12 months poststroke. Results— Complications were recorded for 122 stroke survivors (mean age, 76 years; 57% male). Sixty-three (52%) had significant language impairment and of the remaining 59 who were able to complete an assessment of cognitive function, 10 (8%) were cognitively impaired. The numbers of reported complications over 12 months, in rank order, were falls, 89 (73%); contracture, 73 (60%); pain, 67 (55%); shoulder pain, 64 (52%); depression, 61 (50%); and pressure sores, 26 (22%). A negative correlation was found between Barthel Index score and the number of complications experienced (low scores on the Barthel Index correlate with a high number of complications). The highest relative percentages of complications were experienced by patients who were living in a nursing home at the time of their last completed assessment. Conclusions— Immobility-related complications are very common in the first year after a severely disabling stroke. Patients who are more functionally dependent in self-care are likely to experience a greater number of complications than those who are less dependent. Trials of techniques to limit and prevent complication are required.

A pilot study using nabilone for symptomatic treatment in Huntington's disease.

Pilot study of nabilone in Huntingtons disease (HD). Double‐blind, placebo‐controlled, cross‐over study of nabilone versus placebo. Primary outcome, Unified Huntingtons Disease Rating Scale (UHDRS) total motor score. Secondary measures: UHDRS subsections for chorea, cognition and behavior, and neuropsychiatric inventory (NPI). 44 randomized patients received either nabilone (1 or 2 mg) followed by placebo (n = 22), or placebo followed by nabilone (n = 22). Recruiting was straightforward. Nabilone safe and well tolerated, no psychotic episodes. Assessment of either dose of nabilone versus placebo showed a treatment difference of 0.86 (95% CI: −1.8 to 3.52) for total motor score; 1.68 (95% CI: 0.44 to 2.92) for chorea; 3.57 (95% CI: −3.41 to 10.55) for UHDRS cognition; 4.01 (95% CI: −0.11 to 8.13) for UHDRS behavior, and 6.43 (95% CI: 0.2 to 12.66) for the NPI. Larger longer RCT of nabilone in HD is feasible and warranted.

Effects of a physiotherapy and occupational therapy intervention on mobility and activity in care home residents: a cluster randomised controlled trial

Objective To compare the clinical effectiveness of a programme of physiotherapy and occupational therapy with standard care in care home residents who have mobility limitations and are dependent in performing activities of daily living. Design Cluster randomised controlled trial, with random allocation at the level of care home. Setting Care homes within the NHS South Birmingham primary care trust and the NHS Birmingham East and North primary care trust that had more than five beds and provided for people in the care categories “physical disability” and “older people.” Participants Care home residents with mobility limitations, limitations in activities of daily living (as screened by the Barthel index), and not receiving end of life care were eligible to take part in the study. Intervention A targeted three month occupational therapy and physiotherapy programme. Main outcome measures Scores on the Barthel index and the Rivermead mobility index. Results 24 of 77 nursing and residential homes that catered for residents with mobility limitations and dependency for activities of daily living were selected for study: 12 were randomly allocated to the intervention arm (128 residents, mean age 86 years) and 12 to the control arm (121 residents, mean age 84 years). Participants were evaluated by independent assessors blind to study arm allocation before randomisation (0 months), three months after randomisation (at the end of the treatment period for patients who received the intervention), and again at six months after randomisation. After adjusting for home effect and baseline characteristics, no significant differences were found in mean Barthel index scores at six months post-randomisation between treatment arms (mean effect 0.08, 95% confidence interval −1.14 to 1.30; P=0.90), across assessments (−0.01, −0.63 to 0.60; P=0.96), or in the interaction between assessment and intervention (0.42, −0.48 to 1.32; P=0.36). Similarly, no significant differences were found in the mean Rivermead mobility index scores between treatment arms (0.62, −0.51 to 1.76; P=0.28), across assessments (−0.15, −0.65 to 0.35; P=0.55), or interaction (0.71, −0.02 to 1.44; P=0.06). Conclusions The three month occupational therapy and physiotherapy programme had no significant effect on mobility and independence. On the other hand, the variation in residents’ functional ability, the prevalence of cognitive impairment, and the prevalence of depression were considerably higher in this sample than expected on the basis of previous work. Further research to clarify the efficacy of occupational therapy and physiotherapy is required if access to therapy services is to be recommended in this population. Trial registration ISRCTN79859980

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.

Is non-invasive testing for sexually transmitted infections an efficient and acceptable alternative for patients? A randomised controlled trial

Objectives A randomised controlled trial was conducted to assess and quantify the efficacy and acceptability of non-invasive testing (NIT) for sexually transmitted infections (STI) in asymptomatic patients within a genitourinary medicine clinic. Methods Patients were randomly assigned to either standard of care (SOC—STI testing with genital examination) or NIT. The length of time patients spent in the clinic was recorded and patients were asked to complete a satisfaction survey. Results 391 participants were randomly assigned. The length of time male and female patients spent in the clinic was significantly shorter with NIT (men 26u2005min; women 23u2005min) compared with SOC (men 41u2005min; women 45u2005min, p<0.0001), but most of this decrease was due to reduced patient waiting time within the clinic, rather than less time spent with medical or nursing staff. Those randomly assigned to NIT were significantly more likely to state they were in clinic for less time than expected (p<0.01) and report that the tests were less uncomfortable than expected (p≤0.04). For both men and women, more patients in the SOC group declined testing for syphilis (14%) and HIV (20%) compared with NIT (7% and 13%, respectively), but this was only significantly different between treatments for female patients (p≤0.02). Conclusions NIT for STI in asymptomatic patients can reduce the time patients spend in the clinic when combined with appropriate patient care pathways, and is an acceptable alternative to physician-taken genital swabs.