Stimulation of the tibial nerve: a protocol for a multicentred randomised controlled trial for urinary problems associated with Parkinson's disease-STARTUP.

INTRODUCTION: Parkinson's disease is the second most common chronic neurodegenerative condition with bladder dysfunction affecting up to 71%. Symptoms affect quality of life and include urgency, frequency, hesitancy, nocturia and incontinence. Addressing urinary dysfunction is one of the top 10 priority research areas identified by the James Lind Alliance and Parkinson's UK. OBJECTIVES: Conduct a randomised controlled trial (RCT) targeting people with Parkinson's disease (PwP) who have self-reported problematic lower urinary tract symptoms, investigating the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared with sham TTNS. Implement a standardised training approach and package for the correct application of TTNS. Conduct a cost-effectiveness analysis of TTNS compared with sham TTNS. METHODS AND ANALYSIS: An RCT of 6 weeks with twice weekly TTNS or sham TTNS. Participants will be recruited in 12 National Health Service neurology/movement disorder services, using a web-based randomisation system, and will be shown how to apply TTNS or sham TTNS. Participants will receive a weekly telephone call from the researchers during the intervention period. The trial has two coprimary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score. Secondary outcomes include a 3-day bladder diary, quality of life, acceptability and fidelity and health economic evaluation. Outcomes will be measured at 0, 6 and 12 weeks.A sample size of 208 randomised in equal numbers to the two arms will provide 90% power to detect a clinically important difference of 2.52 points on the Internatioanl Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and of 3 points in the International Prostate Symptom Score total score at 12 weeks at 5% significance level, based on an SD of 4.7 in each arm and 20% attrition at 6 weeks. Analysis will be by intention to treat and pre defined in a statistical analysis plan ETHICS AND DISSEMINATION: East of Scotland Research Ethics Service (EoSRES), 18/ES00042, obtained on 10 May 2018. The trial will allow us to determine effectiveness, safety, cost and acceptability of TTNS for bladder dysfunction in PWP. Results will be published in open access journals; lay reports will be posted to all participants and presented at conferences. TRIAL REGISTRATION NUMBER: ISRCTN12437878; Pre-results.

Cognitive stimulation therapy as a sustainable intervention for dementia in sub-Saharan Africa: feasibility and clinical efficacy using a stepped-wedge design.

BACKGROUND: Cognitive stimulation therapy (CST) is a psychosocial group-based intervention for dementia shown to improve cognition and quality of life with a similar efficacy to cholinesterase inhibitors. Since CST can be delivered by non-specialist healthcare workers, it has potential for use in low-resource environments, such as sub-Saharan Africa (SSA). We aimed to assess the feasibility and clinical effectiveness of CST in rural Tanzania using a stepped-wedge design. METHODS: Participants and their carers were recruited through a community dementia screening program. Inclusion criteria were DSM-IV diagnosis of dementia of mild/moderate severity following detailed assessment. No participant had a previous diagnosis of dementia and none were taking a cholinesterase inhibitor. Primary outcomes related to the feasibility of conducting CST in this setting. Key clinical outcomes were changes in quality of life and cognition. The assessing team was blind to treatment group membership. RESULTS: Thirty four participants with mild/moderate dementia were allocated to four CST groups. Attendance rates were high (85%) and we were able to complete all 14 sessions for each group within the seven week timeframe. Substantial improvements in cognition, anxiety, and behavioral symptoms were noted following CST, with smaller improvements in quality of life measures. The number needed to treat was two for a four-point cognitive (adapted Alzheimer's Disease Assessment Scale-Cognitive) improvement. CONCLUSIONS: This intervention has the potential to be low-cost, sustainable, and adaptable to other settings across SSA, particularly if it can be delivered by non-specialist health workers.

Electrocardiographic assessment of coronary artery disease and stroke risk factors in rural and urban Tanzania: a case-control study.

BACKGROUND: Although the association between cerebrovascular and coronary artery disease (CAD) is well known in high-income countries, this association is not well documented in black Africans. AIMS: The aim of this study was to document electrocardiographic (ECG) evidence of CAD in stroke cases and controls and to identify other common ECG abnormalities related to known stroke risk factors in a community-based population of incident stroke cases in Tanzania, East Africa. METHODS: This was a case-control study. Incident stroke cases were identified by the Tanzanian Stroke Incidence Project. Age- and sex-matched controls were randomly selected from the background population. Electrocardiograms were manually analyzed using the Minnesota Coding System, looking for evidence of previous myocardial infarction (MI), atrial fibrillation (AF) or atrial flutter (AFl), and left ventricular hypertrophy (LVH). RESULTS: In Hai, there were 93 cases and 241 controls with codable electrocardiograms, and in Dar-es-Salaam, there were 39 cases and 72 controls with codable electrocardiograms. Comparing cases and controls, there was a higher prevalence of MI and AF or AFl (but not LVH) in cases compared with controls. CONCLUSIONS: This is the first published study of ECG assessment of CAD and other stroke risk factors in an incident population of stroke cases in sub-Saharan Africa. It suggests that concomitant CAD in black African stroke cases is more common than previously suggested.

Experience of care home residents with Parkinson's disease: Reason for admission and service use.

AIM: The care needs of people with Parkinson's disease (PD) are poorly understood. We aimed to investigate the factors that precipitate entry to institutional care, and on-going care needs once in care, within a representative cohort of community-dwelling people with PD. METHOD: All people with idiopathic PD, Parkinson's plus syndromes and vascular parkinsonism under the care of the Northumbria Healthcare NHS Foundation Trust PD service who were living in care homes on 1 January 2013 were included. Disease severity (Hoehn and Yahr stage) and demographic data were collected. Admissions to hospital over the previous 2 years and in the year before institutional care admission were documented. RESULTS: A total of 90 patients (51 females) with a mean age of 81.3 years were included. During care home stay, the median number of emergency department attendances, the median number of hospital admissions and the median length of stay for those admitted per year were significantly lower than before care home admission. Both before care home admission and during care home stay, falls were the most common diagnoses in people attending emergency departments, with 32 of 65 (49.2%) admissions before and 34 of 59 (57.6%) admissions during care home stay having falls recorded as a cause of attendance. CONCLUSIONS: Hospital attendances and admissions were relatively common, even after institutional care home placement. Events precipitating admission, such as falls, might be preventable. PD nurse specialists could be an effective way to help train staff in homes where someone is known to have PD.

Geriatric medicine: services and training in Africa.

BACKGROUND: the population is ageing globally and developing countries are experiencing the most rapid increase in the number of older persons. By 2045 the United Nations estimate that for the first time in history more people will be over 65, than under 15, years of age. The World Health Organization predicts that deaths from non-communicable diseases will rise by 24% in Africa in the next decade. The aim of this survey was to determine the specialist medical services available for older persons and the undergraduate and postgraduate training systems in place for geriatrics in each African country. METHODS: a short survey was developed and sent to representatives from every country. Where appropriate, French and Portuguese translations were available. RESULTS: responses were received from 40/54 countries (74%). Data were obtained via an internet search for a further three countries. Out of 43, 25 countries had no geriatricians. Out of 40, 35 countries had no formal undergraduate training for medical students on geriatrics and 33 of 40 countries reported no national postgraduate training scheme for geriatrics. Having at least one geriatrician in the country was associated with a World Bank upper middle-income status (P = 0.04), but there was no significant association with the population size (P = 0.395). CONCLUSION: despite increasing numbers of older people and the increasing burden of chronic disease there are few geriatricians in Africa. Without undergraduate training, even general medical physicians will have limited knowledge of specialist geriatric needs. This is an area that will require development and investment in the future.

A cross-sectional study of quality of life in incident stroke survivors in rural northern Tanzania.

The aim of this study was to evaluate changes to, and predictors of, quality of life (QOL) in a community-based cohort of stroke survivors from an earlier stroke incidence study in rural northern Tanzania. Patients were assessed 1-5 years after their incident stroke. The study cohort was compared with an age- and sex-matched control group from the same rural district within a cross-sectional design. Patients and controls were asked a series of questions relating to their QOL [World Health Organization quality of life, abbreviated version (WHOQOL-BREF)], levels of anxiety and depression [hospital anxiety and depression (HAD) scale], cognitive function [community screening instrument for dementia (CSI-D) screening tool], socioeconomic status and demographic characteristics (e.g. age, sex, education and abode). Patients were further assessed for functional outcome and disability (Barthel index, modified Rankin scale), post-stroke care and psychosocial functioning. Patients (n = 58) were found to have significantly lower QOL than controls (n = 58) in all six domains of the WHOQOL-BREF. Gender, socioeconomic status, cognitive function and time elapsed since stroke were not associated with QOL. Older patients and those with more impaired motor function and disability (Barthel index, modified Rankin score) had significantly poorer physical health-related QOL. Greater anxiety and depression, reduced muscle power and less involvement in social events were significantly correlated with lower physical and psychological health-related QOL. To our knowledge, this is the first long-term study of QOL in survivors of incident stroke in Sub-Saharan Africa (SSA). Poorer QOL was associated with greater levels of physical disability, anxiety and depression and reduced social interaction. Demographic factors appear to be much less significant. Modifying these QOL predictors could be important in planning effective post-stroke care within a stretched healthcare system.

Care requirements of a prevalent population of people with idiopathic Parkinson's disease.

BACKGROUND: Parkinson's disease (PD) is the second most common neurodegenerative condition in the UK. Care needs increase as the disease progresses, but there are very few published data in relation to this. OBJECTIVE: the aim of this study was to elicit the care requirements for a prevalent PD population and compare these to a similarly aged background population. METHODS: all people diagnosed with idiopathic PD from within a defined area of north-east England were asked to participate in this study. Those who agreed to participate were assessed using a number of standard rating scales including Hoehn and Yahr stage, Unified Parkinson's Disease Rating Scale (UPDRS), Hospital Anxiety and Depression Scale, Parkinson's Disease Questionaire-39 and Mini-Mental State Examination (MMSE). In addition, participants were asked whether they had experienced hallucinations. Social and demographic information (e.g. age, sex and place of abode) was also recorded. RESULTS: from all cases (n = 161), 135 people (83.8%) agreed to participate. Of these, 19 (14.1%) were living in residential or nursing homes, representing 1.6% of the total nursing/residential home residents in the study area. Participants had a mean age of 74.8 years and disease duration of 5.6 years. Those in care were significantly older and had significantly poorer Hoehn and Yahr, MMSE and UPDRS scores. CONCLUSION: PD patients in institutional care have poorer cognitive function, are older, have later stage disease and worse functional ability than those living at home.

Physical assessment as a predictor of mortality in people with Parkinson's disease: a study over 7 years.

The primary aim of this study was to ascertain whether a battery of physical function measures in a Parkinson's disease (PD) patient cohort predicted mortality status at 7-year follow-up. Secondary aims were establishing which specific tests were the most useful, and whether PD phenotype was a predictor. A retrospective correlation design was used in this study. A cohort of 109 PD patients underwent baseline physiotherapy assessment of gait, balance, posture, muscle strength, and ability to change postural set. We compared mortality status at 7-year follow-up and baseline physical assessment tests. Tinetti gait and balance scores, UPDRS score, 10-m walk test (time, velocity, and number of strides), posture in standing, lying to sitting, sitting to standing, getting up from floor assessments, and time to ascend and descend four steps were found to be statistically significant physical predictors of mortality at 7-year follow-up. In addition, age, sex, and mini-mental state examination were significant nonphysical predictors of mortality. Using Cox regression, a survival model was constructed with age, sex, and Tinetti gait score as independent predictors of mortality. The results of this study suggest that there is a link between reduced physical function and an increased mortality risk in PD populations.

Demonstration of cognitive decline in Parkinson's disease using the Cambridge Cognitive Assessment (Revised) (CAMCOG-R).

BACKGROUND: Cognitive impairment is well recognised in Parkinson's Disease (PD) but few studies have examined cognitive decline over time in such subjects. Standard clinical assessments of cognitive function, such as the MMSE, do not measure all cognitive domains and often have a ceiling effect. CAMCOG-R provides a more comprehensive cognitive assessment allowing several different domains of cognition to be compared. It also features the ability to test 'executive function'. CAMCOG-R has only been reported on one previous occasion in PD subjects and this is the first study to report a follow-up CAMCOG-R to assess cognitive decline. METHODS: In a previously published study CAMCOG-R was administered to a prevalent community-based population of 94 subjects with PD with a MMSE of 25 or above. In this subsequent study 85 of the subjects (two declined and seven were deceased) underwent a follow-up CAMCOG-R after a mean delay of 13.1 months. RESULTS: The initial, and follow-up mean total CAMCOG-R scores were 88.65/104 and 84.75/104 respectively, demonstrating a significant decline (p < 0.05). Significant cognitive decline (p < 0.05) was also seen across every CAMCOG-R cognitive domain and in the executive function scores. CONCLUSIONS: A wide range of cognitive ability was again demonstrated using CAMCOG-R in this PD population. The decline of 3.9 CAMCOG-R points over the 13-month period compares to other previous studies showing an annual decline of 1.6 CAMCOG points in normal elderly individuals and 12 CAMCOG points annually in those with established dementia. This study suggests that CAMCOG-R is a useful and appropriate tool for use in follow-up cognitive screening in PD subjects.

Individualized assessment of quality of life in idiopathic Parkinson's disease.

The purpose of this study was to assess quality of life (QoL) of patients with idiopathic Parkinson's disease (IPD). The Parkinson's Disease Questionnaire (PDQ-39) was compared with an individualized QoL tool: the Schedule for Evaluation of Individual Quality of Life Direct Weighting (SEIQoL-DW). One hundred twenty-three patients underwent interviews using these tools, together with the Mini Mental State examination, Beck Depression Inventory, a qualitative pain assessment, and the Palliative Care Assessment tool (for symptoms). The SEIQoL-DW was well tolerated and demonstrated that QoL not only was broad and highly individualistic but also was determined more by psychosocial than physical issues. Of the 87 domains nominated by patients, the most common were family (87.8%), health (52.8%), leisure activities (36.6%), marriage (35%), and friends (30.9%). The SEIQoL index score was predicted by depression but not by disease stage. However, the PDQ-39 was predicted by disease stage, the number of symptoms, and depression. Direct comparison of the tools confirmed that the SEIQoL index score was predicted by the PDQ-39 domains of social support, cognitive impairment, and emotion. The use of the SEIQoL-DW challenges current thinking within IPD research regarding QoL and its assessment using the PDQ-39.

Cognitive assessment of a representative community population with Parkinson's disease (PD) using the Cambridge Cognitive Assessment-Revised (CAMCOG-R).

BACKGROUND: cognitive decline is well recognised in Parkinson's disease (PD) but the best cognitive assessment tool for use in such patients remains unclear. The 30-point Mini-Mental State Examination (MMSE), while quick and straightforward to use, fails to cover a full range of cognitive domains and is recognised to have a ceiling effect. The Cambridge Cognitive Assessment-Revised (CAMCOG-R) is a cognitive screening tool allowing the assessment of a number of different domains of cognition. It has not previously been used specifically on PD subjects. METHODS: a prevalent community population of 135 PD patients were assessed cognitively using the MMSE. Those scoring 25 or above on the MMSE were subsequently further assessed using CAMCOG-R. Demographic and disease factors including disease duration, symptom severity, anxiety, depression and the presence of hallucinations were recorded for each participant. RESULTS: 31/135 (23%) demonstrated cognitive impairment on the MMSE (score < 25). Ninety-four of the remaining group (10 were excluded) achieved a median total CAMCOG-R score of 89/104. The results were widely distributed. The subjects scored particularly highly in the cognitive domains of orientation, comprehension and perception but relatively poorly at memory and abstract thinking. Significantly poorer scores (P < 0.05) were seen throughout the cognitive domains with increasing age, increasing PD symptom severity and increasing disease duration, but not with the presence of anxiety, depression or hallucinations in the subjects. DISCUSSION: CAMCOG-R was found to be a viable and useful cognitive screening tool for use in PD. A wide range of cognitive ability was demonstrated in subjects who had been assessed previously by the MMSE as not having significant cognitive impairment. The group performed worse in certain cognitive domains than others and those who were older, with more severe PD symptoms and with symptoms for longer, scored less well.