OBJECTIVE — To systematically review the incidence of posttransplantation diabetes (PTD), risk factors for its development, prognostic implications, and optimal management. RESEARCH DESIGN AND METHODS — We searched databases (MEDLINE, EMBASE, the Cochrane Library, and others) from inception to September 2000, reviewed bibliographies in reports retrieved, contacted transplantation experts, and reviewed specialty journals. Two reviewers independently determined report inclusion (original studies, in all languages, of PTD in adults with no history of diabetes before transplantation), assessed study methods, and extracted data using a standardized form. Meta-regression was used to explain between-study differences in incidence. RESULTS — Nineteen studies with 3,611 patients were included. The 12-month cumulative incidence of PTD is lower (10% in most studies) than it was 3 decades ago. The type of immunosuppression explained 74% of the variability in incidence (P 0.0004). Risk factors were patient age, nonwhite ethnicity, glucocorticoid treatment for rejection, and immunosuppression with high-dose cyclosporine and tacrolimus. PTD was associated with decreased graft and patient survival in earlier studies; later studies showed improved outcomes. Randomized trials of treatment regimens have not been conducted. CONCLUSIONS — Physicians should consider modification of immunosuppressive regimens to decrease the risk of PTD in high-risk transplant recipients. Randomized trials are needed to evaluate the use of oral glucose-lowering agents in transplant recipients, paying particular attention to interactions with immunosuppressive drugs. Diabetes Care 25:583–592, 2002

A systematic review of the literature

Objectives: To establish: (1) inter-rater and test–retest reliability of standardized guidelines for the Fugl-Meyer upper limb section, Action Research Arm Test and Box and Block Test in patients with paresis secondary to stroke, multiple sclerosis or traumatic brain injury and (2) correlation between these arm motor scales and more general measures of impairment and activity limitationDesign: Multicentre cohort studySetting: Three European referral centres for neurorehabilitationSubjects: Thirty-seven stroke, 14 multiple sclerosis and five traumatic brain injury patientsMain measures: Scores of the Fugl-Meyer Test (arm section), Action Research Arm Test, and Box and Block Test derived from video informationResults: All three motor tests showed very high inter-rater and test–retest reliability (ICC and rho for main variables>095) Correlation between the motor scales was very high (rho>092) Motor scales correlated moderately highly with the Hemispheric Stroke Scale, a measure of impairment (rho=0

Reliability and validity of arm function assessment with standardized guidelines for the Fugl-Meyer Test, Action Research Arm Test and Box and Block Test: a multicentre study

Traumatic brain injury (TBI) is a leading cause of death, and in a recent analysis it was found that nearly one-third of all injury-related deaths in the US have at least one diagnosis of TBI (CDC-Quickstats, 2010). This chapter presents the burden of TBI as regards age group, gender, costs, race, emergency department (ED) visits, hospitalizations, and deaths. Injury trends over a 15 year period are examined. Rehabilitation estimates and disability estimates are also available. Through good epidemiology we can better understand the causes of TBI and design more effective intervention programs to reduce injury. Important sources of evidence for this chapter include mostly studies from the US because of their leading work in the epidemiology of this important injury.

Epidemiology of traumatic brain injury

Background and Purpose— There is no consensus concerning the number of patients developing spasticity or the relationship between spasticity and disabilities after acute stroke. The aim of the present study was to describe the extent to which spasticity occurs and is associated with disabilities (motor impairments and activity limitations). Methods— Ninety-five patients with first-ever stroke were examined initially (mean, 5.4 days) and 3 months after stroke with the Modified Ashworth Scale for spasticity; self-reported muscle stiffness; tendon reflexes; Birgitta Lindmark motor performance; Nine Hole Peg Test for manual dexterity; Rivermead Mobility Index; Get-Up and Go test; and Barthel Index. Results— Of the 95 patients studied, 64 were hemiparetic, 18 were spastic, 6 reported muscle stiffness, and 18 had increased tendon reflexes 3 months after stroke. Patients who were nonspastic (n=77) had statistically significantly better motor and activity scores than spastic patients (n=18). However, the correlat...

Spasticity After Stroke Its Occurrence and Association With Motor Impairments and Activity Limitations

Objective: To determine the frequency of disability in young people and adults admitted to hospital with a head injury and to estimate the annual incidence in the community. Design: Prospective, hospital based cohort study, with one year follow up of sample stratified by coma score. Setting: Five acute hospitals in Glasgow. Subjects: 2962 patients (aged 14 years or more) with head injury; 549 (71%) of the 769 patients selected for follow up participated. Main outcome measures: Glasgow outcome scale and problem orientated questionnaire. Results: Survival with moderate or severe disability was common after mild head injury (47%, 95% confidence interval 42% to 52%) and similar to that after moderate (45%, 35% to 56%) or severe injury (48%, 36% to 60%). By extrapolation from the population identified (90% of whom had mild injuries), it was estimated that annually in Glasgow (population 909 498) 1400 young people and adults are still disabled one year after head injury. Conclusion: The incidence of disability in young people and adults admitted with a head injury is higher than expected. This reflects the high rate of sequelae previously unrecognised in the large number of patients admitted to hospital with an apparently mild head injury.

https://www.bmj.com/content/bmj/320/7250/1631.full.pdf

Disability in young people and adults one year after head injury: prospective cohort study

Background: The Ashworth Scale and the modified Ashworth Scale are the primary clinical measures of spasticity. A prerequisite for using any scale is a knowledge of its characteristics and limitations, as these will play a part in analysing and interpreting the data. Despite the current emphasis on treating spasticity, clinicians rarely measure it.Objectives: To determine the validity and the reliability of the Ashworth and modified Ashworth Scales.Study design: A theoretical analysis following a structured literature review (key words: Ashworth; Spasticity; Measurement) of 40 papers selected from the BIDS-EMBASE, First Search and Medline databases.Conclusions: The application of both scales would suggest that confusion exists on their characteristics and limitations as measures of spasticity. Resistance to passive movement is a complex measure that will be influenced by many factors, only one of which could be spasticity. The Ashworth Scale (AS) can be used as an ordinal level measure of resistance to pa...

A review of the properties and limitations of the Ashworth and modified Ashworth Scales as measures of spasticity

The aim of this paper is to review briefly our understanding of the phenomenon of spasticity based in current evidence.

Spasticity: Clinical perceptions, neurological realities and meaningful measurement

Head injury is a common disabling condition but regrettably facilities for rehabilitation are sparse There is now increasing evidence of the efficacy of a comprehensive multidisciplinary rehabilitation team compared to natural recovery following brain injury. This chapter outlines some basic concepts of rehabilitatio n and emphasises the importance of valid and reliable outcome measures. The evidence of the efficacy of a rehabilitation programme is discussed in some detail. A number of specific rehabilitation problems are outlined including the management of spasticity, nutrition, pressure sores and urinary continence. The increasingly important role of assistive technology is illustrated, particularly in terms of communication aids and environmental control equipment. However, the major long-term difficulties after head injury focus around the cognitive, intellectual, behavioural and emotional problems. The complex management of these disorders is briefly addressed and the evidence of the efficacy of some techniques discussed. The importance of recognition of the vegetative state and avoidance of misdiagnosis is emphasised. Finally, the important, but often neglected, area of employment rehabilitation is covered.

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Rehabilitation after traumatic brain injury.

OBJECTIVE To compare the clinical effectiveness and cost-effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A plus an upper limb therapy programme with the upper limb therapy programme alone. DESIGN A multicentre open-label parallel-group randomised controlled trial and economic evaluation. SETTING Twelve stroke services in the north of England, UK. PARTICIPANTS Three hundred and thirty-three adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously. INTERVENTIONS The intervention group received botulinum toxin type A injection(s) plus a 4-week programme of upper limb therapy. The control group received the upper limb therapy programme alone. Participants were clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A injection(s) and/or therapy. MAIN OUTCOME MEASURES The primary outcome was upper limb function 1 month after study entry measured by the Action Research Arm Test (ARAT). A successful outcome was defined as: (1) a change of three or more points on the ARAT scale for a participant whose baseline ARAT score was between 0 and 3, (2) a change of six or more points on the ARAT scale for a participant whose baseline ARAT score was between 4 and 51, or (3) a final ARAT score of 57 for a participant whose baseline ARAT score was 52-56. Outcome assessments were undertaken at 1, 3 and 12 months by an assessor who was blinded to the study group allocation. Upper limb impairment and activity limitation were assessed by: Modified Ashworth Scale; Motricity Index; grip strength; ARAT; Nine-Hole Peg Test; upper limb basic functional activity questions and the Barthel Activities of Daily Living (ADL) Index. Stroke-related quality of life/participation restriction was measured using the Stroke Impact Scale, European Quality of Life-5 Dimensions (EQ-5D) and the Oxford Handicap Scale. Upper limb pain was assessed using numerical rating scales. Participant-selected upper limb goal achievement (1 month only) was measured using the Canadian Occupational Performance Measure. Adverse events were compared. Health-care and social services resource use was compared during the first 3 months postrandomisation. EQ-5D data were used to calculate the quality-adjusted life-years (QALYs) associated with intervention and control treatments, and the incremental cost per QALY gained of botulinum toxin type A plus therapy compared with therapy alone was estimated. The sensitivity of the base-case results to alternative assumptions was investigated, and cost-effectiveness acceptability curves, which summarise the evidence of botulinum toxin type A plus therapy being cost-effective for a range of societal willingness to pay for a QALY values, are presented. RESULTS Randomisation groups were well matched at baseline. There was no significant difference between the groups for the primary outcome of improved arm function at 1 month. This was achieved by 30/154 (19.5%) in the control group and 42/167 (25.1%) in the intervention group (p = 0.232). The relative risk of having a 'successful treatment' in the intervention group compared with the control group was 1.3 [95% confidence interval (CI) 0.9 to 2.0]. No significant differences in improved arm function were seen at 3 or 12 months. In terms of secondary outcomes, muscle tone/spasticity at the elbow was decreased in the intervention group compared with the control group at 1 month. The median change in the Modified Ashworth Scale was - 1 in the intervention group compared with zero in the control group (p < 0.001). No difference in spasticity was seen at 3 or 12 months. Participants treated with botulinum toxin type A showed improvement in upper limb muscle strength at 3 months. The mean change in strength from baseline (upper limb component of the Motricity Index) was 3.5 (95% CI 0.1 to 6.8) points greater in the intervention group compared with the control group. No differences were seen at 1 or 12 months. Participants in the intervention group were more likely to be able to undertake specific basic functional activities, e.g. dress a sleeve, clean the palm and open the hand for cutting fingernails. At 1 month, 109/144 (75.7%) of the intervention group and 79/125 (63.2%) of the control group had improved by at least one point on a five-point Likert scale for at least one of these tasks (p = 0.033). At 3 months the corresponding proportions were 102/142 (71.8%) of the intervention group and 71/122 (58.2%) of the control group (p = 0.027). Improvement was sustained at 12 months for opening the hand for cleaning the palm and opening the hand for cutting the nails but not for other activities. Pain rating improved by two points on a 10-point severity rating scale in the intervention group compared with zero points in the control group (p = 0.004) at 12 months, but no significant differences were seen at 1 or 3 months. There were a number of occasions when there were statistically significant differences in favour of the intervention group; however, these differences were small and of uncertain clinical relevance. These differences were: 3 months - upper limb function (change in ARAT score from baseline), pain (EQ-5D) and participation restriction (Oxford Handicap Scale); 12 months - anxiety/depression (EQ-5D) and participation restriction (Oxford Handicap Scale). No differences in grip strength, dexterity or the Barthel ADL Index were found at any time point. There were no differences between the groups for achievement of patient-selected goals. There was a higher incidence of general malaise/flu-like/cold symptoms in participants treated with botulinum toxin type A with a relative risk of 7.6 (95% CI 1.8 to 32.3). Only one serious adverse event (dysphagia) was potentially related to botulinum toxin type A. Time since stroke and severity of initial upper limb function were preplanned subgroup analyses. There was no significant difference in either subgroup for achievement of ARAT 'success' following treatment with botulinum toxin type A. The base-case incremental cost-effectiveness ratio was 93,500 pounds per QALY gained and estimation of the cost-effectiveness acceptability curve for botulinum toxin type A plus the upper limb therapy programme indicated that there was only a 0.36 probability of it being cost-effective at a threshold ceiling ratio of 20,000 pounds per QALY. CONCLUSIONS The addition of botulinum toxin type A to an upper limb therapy programme to treat spasticity due to stroke did not enhance improvement in upper limb function when assessed by the prespecified primary outcome measure at 1 month. However, improvements were seen in muscle tone at 1 month, upper limb strength at 3 months, upper limb functional activities related to undertaking specific basic functional tasks at 1, 3 and 12 months, and upper limb pain at 12 months. Botulinum toxin was well tolerated and side effects were minor. The addition of botulinum toxin type A to an upper limb therapy programme for the treatment of upper limb spasticity due to stroke was not estimated to be cost-effective at levels of willingness to pay for a QALY set by NHS decision-makers. TRIAL REGISTRATION ISRCTN78533119; EudraCT 2004-002427-40; CTA 17136/0230/001.

https://njl-admin.nihr.ac.uk/document/download/2001933

BoTULS: a multicentre randomised controlled trial to evaluate the clinical effectiveness and cost-effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A

The objective of this article is to establish the prevalence of spasticity in a random selection of people with multiple sclerosis (MS) in the city of Newcastle upon Tyne in the Northeast of England. A secondary aim was to assess the adequacy of current pharmacological intervention for spasticity and assess the relationship between spasticity and overall disability. The study design was a simple comparison that examined differences in functional independence in 2 random groups of people with MS subdivided by the presence of clinically significant spasticity. A total of 68 adults with a diagnosis of clinically definite MS were included in the study. Their level of functional independence was assessed using the Newcastle Independence Assessment Form (NIAF), the Functional Independence Measure (FIM), and the Kurtzke Extended Disability Status Scale (EDSS). Spasticity was assessed using the Modified Ashworth Scale. A subjective analysis was made of the appropriateness of oral antispastic medication by a rehab...

Michael P. Barnes

Papers

A review of the properties and limitations of the Ashworth and modified Ashworth Scales as measures of spasticity

Spasticity: Clinical perceptions, neurological realities and meaningful measurement

Rehabilitation after traumatic brain injury.

BoTULS: a multicentre randomised controlled trial to evaluate the clinical effectiveness and cost-effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A

Spasticity in Multiple Sclerosis