Memory rehabilitation for people with multiple sclerosis.

BACKGROUND: Problems with cognition, particularly memory, are common in people with multiple sclerosis (MS) and can affect their ability to complete daily activities and can negatively affect quality of life. Over the last few years, there has been considerable growth in the number of randomised controlled trials (RCTs) of memory rehabilitation in MS. To guide clinicians and researchers, this review provides an overview of the effectiveness of memory rehabilitation for people with MS. OBJECTIVES: To determine whether people with MS who received memory rehabilitation compared to those who received no treatment, or an active control showed better immediate, intermediate, or longer-term outcomes in their: 1. memory functions, 2. other cognitive abilities, and 3. functional abilities, in terms of activities of daily living, mood, and quality of life. SEARCH METHODS: We searched CENTRAL which includes Clinicaltrials.gov, World Health Organization (The Whoqol) International Clinical Trials Registry Portal, Embase and PubMed (MEDLINE), and the following electronic databases (6 September 2020): CINAHL, LILACS, the NIHR Clinical Research Network Portfolio database, The Allied and Complementary Medicine Database, PsycINFO, and CAB Abstracts. SELECTION CRITERIA: We selected RCTs or quasi-RCTs of memory rehabilitation or cognitive rehabilitation for people with MS in which a memory rehabilitation treatment group was compared with a control group. Selection was conducted independently first and then confirmed through group discussion. We excluded studies that included participants whose memory deficits were the result of conditions other than MS, unless we could identify a subgroup of participants with MS with separate results. DATA COLLECTION AND ANALYSIS: Eight review authors were involved in this update in terms of study selection, quality assessment, data extraction and manuscript review. We contacted investigators of primary studies for further information where required. We conducted data analysis and synthesis in accordance with Cochrane methods. We performed a 'best evidence' synthesis based on the methodological quality of the primary studies included. Outcomes were considered separately for 'immediate' (within the first month after completion of intervention), 'intermediate' (one to six months), and 'longer-term' (more than six months) time points. MAIN RESULTS: We added 29 studies during this update, bringing the total to 44 studies, involving 2714 participants. The interventions involved various memory retraining techniques, such as computerised programmes and training on using internal and external memory aids. Control groups varied in format from assessment-only groups, discussion and games, non-specific cognitive retraining, and attention or visuospatial training. The risk of bias amongst the included studies was generally low, but we found eight studies to have high risk of bias related to certain aspects of their methodology. In this abstract, we are only reporting outcomes at the intermediate timepoint (i.e., between one and six months). We found a slight difference between groups for subjective memory (SMD 0.23, 95% CI 0.11 to 0.35; 11 studies; 1045 participants; high-quality evidence) and quality of life (SMD 0.30, 95% CI 0.02 to 0.58; 6 studies; 683 participants; high-quality evidence) favoring the memory rehabilitation group. There was a small difference between groups for verbal memory (SMD 0.25, 95% CI 0.11 to 0.40; 6 studies; 753 participants; low-quality evidence) and information processing (SMD 0.27, 95% CI 0.00 to 0.54; 8 studies; 933 participants; low-quality evidence), favoring the memory rehabilitation group.  We found little to no difference between groups for visual memory (SMD 0.20, 95% CI -0.11 to 0.50; 6 studies; 751 participants; moderate-quality evidence), working memory (SMD 0.16, 95% CI -0.09 to 0.40; 8 studies; 821 participants; moderate-quality evidence), or activities of daily living (SMD 0.06, 95% CI -0.36 to 0.24; 4 studies; 400 participants; high-quality evidence).  AUTHORS' CONCLUSIONS: There is evidence to support the effectiveness of memory rehabilitation on some outcomes assessed in this review at intermediate follow-up. The evidence suggests that memory rehabilitation results in between-group differences favoring the memory rehabilitation group at the intermediate time point for subjective memory, verbal memory, information processing, and quality of life outcomes, suggesting that memory rehabilitation is beneficial and meaningful to people with MS. There are differential effects of memory rehabilitation based on the quality of the trials, with studies of high risk of bias inflating (positive) outcomes. Further robust, large-scale, multi-centre RCTs, with better quality reporting, using ecologically valid outcome assessments (including health economic outcomes) assessed at longer-term time points are still needed to be certain about the effectiveness of memory rehabilitation in people with MS.

Cognitive rehabilitation for attention and memory in people with multiple sclerosis: a randomized controlled trial (CRAMMS).

OBJECTIVE: To assess the clinical and cost-effectiveness of cognitive rehabilitation for attention and memory problems in people with multiple sclerosis. DESIGN: Multicentre, pragmatic, randomized controlled trial. SETTING: Community. PARTICIPANTS: People with multiple sclerosis aged 18-69 years, who reported cognitive problems in daily life and had cognitive problems on standardized assessment. INTERVENTIONS: A group cognitive rehabilitation programme delivered in 10 weekly sessions in comparison with usual care. MAIN MEASURES: The primary outcome was the Multiple Sclerosis Impact Scale Psychological subscale at 12 months after randomization. Secondary outcomes included measures of everyday memory problems, mood, fatigue, cognitive abilities and employment at 6 and 12 months after randomization. RESULTS: In all, 245 participants were allocated to cognitive rehabilitation and 204 to usual care. Mean Multiple Sclerosis Impact Scale Psychological at 12 months was 22.2 (SD = 6.1) for cognitive rehabilitation and 23.4 (SD = 6.0) for usual care group; adjusted difference -0.6, 95% confidence interval (CI) = -1.5 to 0.3, P = 0.20. No differences were observed in cognitive abilities, fatigue or employment. There were small differences in favour of cognitive rehabilitation for the Multiple Sclerosis Impact Scale Psychological at 6 months and everyday memory and mood at 6 and 12 months. There was no evidence of an effect on costs (-£808; 95% CI = -£2248 to £632) or on quality-adjusted life year gain (0.00; 95% CI = -0.01 to 0.02). CONCLUSION: This rehabilitation programme had no long-term benefits on the impact of multiple sclerosis on quality of life, but there was some evidence of an effect on everyday memory problems and mood.

Evaluation of NeuroPage as a memory aid for people with multiple sclerosis: A randomised controlled trial.

Memory problems are reported in 40%-60% of people with multiple sclerosis (MS). These problems affect independence and may limit the ability to benefit from rehabilitation. Our aim was to evaluate the effectiveness of NeuroPage for people with MS living in the community. A multicentre, single-blind, randomised controlled crossover trial was conducted. The intervention comprised the NeuroPage service, which sends reminder messages to mobile phones at pre-arranged times. In the control condition participants received "non-memory texts", that is, messages not aimed at providing a reminder; for example, supplying news headlines or sport updates. Outcome measures were completed using postal questionnaires after each condition. There were 38 participants aged 28 to 72 (mean 48, SD 11) and 10 (26%) were men. There were no significant differences between NeuroPage and control conditions on the Everyday Memory Questionnaire (p = 0.41, d = 0.02). The number of daily diary items forgotten in the NeuroPage condition was significantly less than in the control (9% vs. 31%, p = 0.01, d = -0.64). Psychological distress was less in the NeuroPage condition than control (p = 0.001, d = -0.84). Further evaluation of the effect on everyday memory is required.

Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial.

OBJECTIVE: To evaluate the clinical and cost effectiveness of a group-based memory rehabilitation programme for people with traumatic brain injury. DESIGN: Multicentre, pragmatic, observer-blinded, randomized controlled trial in England. SETTING: Community. PARTICIPANTS: People with memory problems following traumatic brain injury, aged 18-69 years, able to travel to group sessions, communicate in English, and give consent. INTERVENTIONS: A total of 10 weekly group sessions of manualized memory rehabilitation plus usual care (intervention) vs. usual care alone (control). MAIN MEASURES: The primary outcome was the patient-reported Everyday Memory Questionnaire (EMQ-p) at six months post randomization. Secondary outcomes were assessed at 6 and 12 months post randomization. RESULTS: We randomized 328 participants. There were no clinically important differences in the primary outcome between arms at six-month follow-up (mean EMQ-p score: 38.8 (SD 26.1) in intervention and 44.1 (SD 24.6) in control arms, adjusted difference in means: -2.1, 95% confidence interval (CI): -6.7 to 2.5, p = 0.37) or 12-month follow-up. Objectively assessed memory ability favoured the memory rehabilitation arm at the 6-month, but not at the 12-month outcome. There were no between-arm differences in mood, experience of brain injury, or relative/friend assessment of patient's everyday memory outcomes, but goal attainment scores favoured the memory rehabilitation arm at both outcome time points. Health economic analyses suggested that the intervention was unlikely to be cost effective. No safety concerns were raised. CONCLUSION: This memory rehabilitation programme did not lead to reduced forgetting in daily life for a heterogeneous sample of people with traumatic brain injury. Further research will need to examine who benefits most from such interventions.

Home-based pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): a feasibility randomized controlled trial.

OBJECTIVE: To determine the feasibility of conducting a trial of a pre-surgical psychological intervention on pain, function, and mood in people with knee osteoarthritis listed for total knee arthroplasty. DESIGN: Multi-centre, mixed-methods feasibility randomized controlled trial of intervention plus usual care versus usual care. SETTING: Participants' homes or hospital. PARTICIPANTS: Patients with knee osteoarthritis listed for total knee arthroplasty and score >7 on either subscales of Hospital Anxiety and Depression Scale. INTERVENTION: Up-to 10 sessions of psychological intervention (based on cognitive behavioural therapy). MAIN MEASURES: Feasibility outcomes (recruitment and retention rates, acceptability of trial procedures and intervention, completion of outcome measures), and standardized questionnaires assessing pain, function, and mood at baseline, and four and six months post-randomisation. RESULTS: Of 222 people screened, 81 did not meet inclusion criteria, 64 did not wish to participate, 26 were excluded for other reasons, and 51 were randomized. A total of 30 completed 4-month outcomes and 25 completed 6-month outcomes. Modal number of intervention sessions completed was three (range 2-8). At 6-month follow-up, mood, pain, and physical function scores were consistent with clinically important benefits from intervention, with effect sizes ranging from small ( d = 0.005) to moderate ( d = 0.74), and significant differences in physical function between intervention and usual care groups ( d = 1.16). Feedback interviews suggested that participants understood the rationale for the study, found the information provided adequate, the measures comprehensive, and the intervention acceptable. CONCLUSION: A definitive trial is feasible, with a total sample size of 444 people. Pain is a suitable primary outcome, but best assessed 6 and 12 months post-surgery.

Examining the relationship between fatigue and cognition after stroke: A systematic review.

Many stroke survivors experience fatigue, which is associated with a variety of factors including cognitive impairment. A few studies have examined the relationship between fatigue and cognition and have obtained conflicting results. The aim of the current study was to review the literature on the relationship between fatigue and cognition post-stroke. The following databases were searched: EMBASE (1980-February, 2014), PsycInfo (1806-February, 2014), CINAHL (1937-February, 2014), MEDLINE (1946-February, 2014), Ethos (1600-February, 2014) and DART (1999-February, 2014). Reference lists of relevant papers were screened and the citation indices of the included papers were searched using Web of Science. Studies were considered if they were on adult stroke patients and assessed the following: fatigue with quantitative measurements (≥ 3 response categories), cognition using objective measurements, and the relationship between fatigue and cognition. Overall, 413 papers were identified, of which 11 were included. Four studies found significant correlations between fatigue and memory, attention, speed of information processing and reading speed (r = -.36 to .46) whereas seven studies did not. Most studies had limitations; quality scores ranged from 9 to 14 on the Critical Appraisal Skills Programme Checklists. There was insufficient evidence to support or refute a relationship between fatigue and cognition post-stroke. More robust studies are needed.

Measurement of confidence: the development and psychometric evaluation of a stroke-specific, measure of confidence.

OBJECTIVE: To design, develop and psychometrically evaluate a stroke-specific measure of confidence, the Confidence after Stroke Measure (CaSM). DESIGN: Cross-sectional. SETTING: Adults in the community. PARTICIPANTS: Stroke survivors and healthy elderly participants. METHODS: Questionnaire items were generated based on the literature and qualitative interviews and piloted with expert groups to establish face validity. A 53-item CaSM was administered to stroke survivors and healthy elderly participants in the community. A second copy was posted four weeks later. Completed questionnaires were analysed for extreme responses, missing values, construct validity (factor analysis), convergent validity, divergent validity, reliability (internal consistency and temporal stability) and comparing responses according to age and gender. RESULTS: Stroke ( n = 101) and healthy elderly participants ( n = 101) returned questionnaires. Eight items were removed that had extreme responses and large numbers of missing values. Six items had item total correlations <0.3 and were removed. A further item was removed demonstrating gender difference. An exploratory factor analysis was conducted on the remaining 38 items. A 27-item three factor solution was derived assessing Self-Confidence, Positive Attitude and Social Confidence, which explained 52% of variance. Cronbach's alpha coefficient demonstrated good internal consistency ( α = 0.94). A test re-test on the 27 items indicated good temporal stability ( r = 0.85, P = 0.001). CONCLUSION: The 27-item CaSM was a valid and reliable measure for assessing confidence in stroke survivors.

The Nottingham Fatigue after Stroke (NotFAST) study: factors associated with severity of fatigue in stroke patients without depression.

OBJECTIVE: To identify factors associated with post-stroke fatigue in a sample of stroke survivors without depression. DESIGN: Cross-sectional cohort study. SETTING: Recruitment was from four stroke units in the UK. SUBJECTS: Participants were assessed within four to six weeks of first stroke; those with high levels of depressive symptoms (score ⩾7 Brief Assessment Schedule Depression Cards) were excluded. MAIN MEASURES: Participants were assessed after stroke on the Fatigue Severity Scale of the Fatigue Assessment Inventory, the Rivermead Mobility Index, Nottingham Extended Activities of Daily Living scale, Beck Anxiety Index, Sleep Hygiene Index, 6m walk test, and measures of cognitive ability. RESULTS: Of the 371 participants recruited, 103 were excluded and 268 were assessed. Of the latter, the mean age was 67.7 years (SD 13.5) and 168 (63%) were men. The National Institutes of Health Stroke Scale mean score was 4.96 (SD 4.12). Post-stroke fatigue was reported by 115 (43%) of participants, with 71 (62%) reporting this to be a new symptom since their stroke. Multivariate analysis using the Fatigue Severity Scale as the outcome variable found pre-stroke fatigue, having a spouse/partner, lower Rivermead Mobility Index score, and higher scores on both the Brief Assessment Schedule Depression Cards and Beck Anxiety Index were independently associated with post-stroke fatigue, accounting for approximately 47% of the variance in Fatigue Severity Scale scores. CONCLUSIONS: Pre-stroke fatigue, lower mood, and poorer mobility were associated with post-stroke fatigue.

External memory aids for memory problems in people with multiple sclerosis: A systematic review.

Approximately 40-60% of people with multiple sclerosis (MS) have memory problems, which adversely impact on their everyday functioning. Evidence supports the use of external memory aids in people with stroke and brain injury, and suggests they may reduce everyday memory problems in people with MS. Previous reviews of people with MS have only evaluated randomised trials; therefore this review included other methodologies. The aim was to assess the efficacy of external memory aids for people with MS for improving memory functioning, mood, quality of life, and coping strategies. Seven databases were systematically searched. Intervention studies that involved training in the use of external memory aids, e.g., personal digital assistants, with at least 75% of people with MS, were included. Based on study design, quality was rated with the SCED or PEDro scale. Nine studies involving 540 participants were included. One single case experimental design (mean of 8 on SCED scale) and eight group studies (mean of 5 on PEDro scale) were included. One study reported a significant treatment effect on subjective memory functioning, two on mood, and two on coping strategies. There is insufficient evidence to support or refute the effectiveness of external memory aids for improving memory function in people with MS.

Using image J to document healing in ulcers of the foot in diabetes.

The aim of the study was to assess the reliability of measuring the cross-sectional area of diabetic foot ulcers using Image J software. The inter- and intra-rater reliability of ulcer area measures were assessed using digital images of acetate tracings of ulcers of the foot affecting 31 participants in an off-loading randomised trial. Observations were made independently by five specialist podiatrists, one of whom was experienced in the use of Image J software and educated the other four in a single session. The mean (±SD) of the mean cross-sectional areas of the 31 ulcers determined independently by the five observers was 1386·7 (±22·7) mm2 . The correlation between all pairs of observers was >0·99 (P < 0·001). There was no significant difference overall between the five observers (ANOVA F1.538; P = 0·165) and no difference between any two (paired samples test t = -0·787-1·396; P ≥ 0·088). The correlation between the areas determined by two observers on two occasions separated by not less than 1 week was very high (0·997 and 0·999; P < 0·001 and <0·001, respectively). The inter- and intra-reliability of the Image J software is very high, with no evidence of a difference either between or within observers. This technique should be considered for both research and clinical use in order to document changes in ulcer area.

Memory rehabilitation for people with multiple sclerosis.

BACKGROUND: This is an update of the Cochrane review 'Memory rehabilitation for people with multiple sclerosis' (first published in the Cochrane Library 14 March 2012, Issue 3). Impairments in cognitive function, particularly memory, are common in people with multiple sclerosis (MS) and can potentially affect their ability to complete functional activities. There is evidence from single-case or small group studies that memory rehabilitation can be beneficial for people with MS, but findings from randomised controlled trials (RCTs) and systematic reviews have been inconclusive. OBJECTIVES: To determine whether people with MS who received memory rehabilitation showed: 1. better outcomes in their memory functions compared to those given no treatment or receiving a placebo control; and 2. better functional abilities, in terms of activities of daily living, mood, and quality of life, than those who received no treatment or a placebo. SEARCH METHODS: We searched the Trials Specialised Register of the Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group (2 June 2015) and the following electronic databases: The NIHR Clinical Research Network Portfolio database (NIHR CRN) (from 2010 to June 2015), The Allied and Complementary Medicine Database (AMED) (2010 to June 2015), British Nursing Index (BNI) (2010 to June 2015), PsycINFO (2011 to June 2015), and CAB Abstracts (2010 to June 2015). Start dates for the electronic databases coincided with the last search for the previous review. We handsearched relevant journals and reference lists. SELECTION CRITERIA: We selected RCTs or quasi-randomised trials of memory rehabilitation or cognitive rehabilitation for people with MS in which a memory rehabilitation treatment group was compared to a control group. Selection was conducted independently first and then confirmed through group discussion. We excluded studies that included participants whose memory deficits were the result of conditions other than MS unless we could identify a subgroup of participants with MS with separate results. DATA COLLECTION AND ANALYSIS: Three review authors were involved in this update in terms of study selection, quality assessment, and data extraction. We contacted investigators of primary studies for further information where required. We conducted data analysis and synthesis in accordance with the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We performed a 'best evidence' synthesis based on the methodological quality of the primary studies included. MAIN RESULTS: We added seven studies during this update, bringing the total to 15 studies, involving 989 participants. The interventions involved various memory retraining techniques, such as computerised programmes and training on internal and external memory aids. Control groups varied in format from assessment-only groups, discussion and games, non-specific cognitive retraining, and attention or visuospatial training. The risk of bias of the included studies was generally low, but we found eight studies to have high risk of bias related to certain aspects of their methodology.We found significant effect of intervention on objective assessments of memory in both the immediate and long-term follow-ups: standardised mean difference (SMD) 0.23 (95% confidence interval (CI) 0.05 to 0.41) and SMD 0.26 (95% CI 0.03 to 0.49), respectively. We also found significant effect of intervention for quality of life in the immediate follow-up (SMD 0.23 (95% CI 0.05 to 0.41)). These findings showed that the intervention group performed significantly better than the control group. We also found a significant difference for activities of daily living (ADL) in the long-term follow-up (SMD -0.33 (95% CI -0.63 to -0.03)), showing that the control groups had significantly less difficulty completing ADLs than the intervention groups. We found no significant effects, either immediate or long-term, on subjective reports of memory problems (SMD 0.04 (95% CI -0.19 to 0.27) and SMD 0.04 (95% CI -0.19 to 0.27)); on mood (SMD 0.02 (95% CI -0.16 to 0.20) and SMD -0.01 (95% CI -0.21 to 0.20)); and on immediate follow-up for ADL (SMD -0.13 (95% CI -0.60 to 0.33)) and in the long term for quality of life (SMD 0.16 (95% CI -0.03 to 0.36)). We could not complete a sensitivity analysis of intention-to-treat in comparison with per-protocol analysis, due to insufficient information from the included papers. However, a sensitivity analysis of high- versus low-risk studies suggested that while quality of the trials did not affect most outcomes, differences were seen in the objective memory outcomes (both at immediate and long term) and quality of life (immediate) outcome, with studies with higher risk of bias inflating the overall effect size estimates for these outcomes, and the test of overall effect changing from being statistically significant to not significant when studies at high risk of bias were excluded. This suggests that lower-quality studies may have positively influenced the outcomes. AUTHORS' CONCLUSIONS: There is some evidence to support the effectiveness of memory rehabilitation on memory function, as well as on quality of life. However, the evidence is limited and does not extend to subjective reports of memory functioning or mood. Furthermore, the objective measures used are not ecologically valid measures, and thus potentially limit generalisability of these findings into daily life. Further robust RCTs of high methodological quality and better quality of reporting, using ecologically valid outcome assessments, are still needed.

Cognitive rehabilitation for memory deficits after stroke.

BACKGROUND: Memory problems are a common cognitive complaint following stroke and can potentially affect ability to complete functional activities. Cognitive rehabilitation programmes either attempt to retrain lost or poor memory functions, or teach patients strategies to cope with them.Some studies have reported positive results of cognitive rehabilitation for memory problems, but the results obtained from previous systematic reviews have been less positive and they have reported inconclusive evidence. This is an update of a Cochrane review first published in 2000 and most recently updated in 2007. OBJECTIVES: To determine whether participants who have received cognitive rehabilitation for memory problems following a stroke have better outcomes than those given no treatment or a placebo control.The outcomes of interest were subjective and objective assessments of memory function, functional ability, mood, and quality of life. We considered the immediate and long-term outcomes of memory rehabilitation. SEARCH METHODS: We used a comprehensive electronic search strategy to identify controlled studies indexed in the Cochrane Stroke Group Trials Register (last searched 19 May 2016) and in the Cochrane Central Register of Controlled Trials (CENTRAL2016, Issue 5), MEDLINE (2005 to 7 March 2016), EMBASE 2005 to 7 March 2016), CINAHL (2005 to 5 February 2016), AMED (2005 to 7 March 2016), PsycINFO (2005 to 7 March 2016), and nine other databases and registries. Start dates for the electronic databases coincided with the last search for the previous review. We handsearched reference lists of primary studies meeting the inclusion criteria and review articles to identify further eligible studies. SELECTION CRITERIA: We selected randomised controlled trials in which cognitive rehabilitation for memory problems was compared to a control condition. We included studies where more than 75% of the participants had experienced a stroke, or if separate data were available from those with stroke in mixed aetiology studies. Two review authors independently selected trials for inclusion, which was then confirmed through group discussion. DATA COLLECTION AND ANALYSIS: We assessed study risk of bias and extracted data. We contacted the investigators of primary studies for further information where required. We conducted data analysis and synthesis in accordance with the Cochrane Handbook for Systematic Reviews of Interventions. We performed a 'best evidence' synthesis based on the risk of bias of the primary studies included. Where there were sufficient numbers of similar outcomes, we calculated and reported standardised mean differences (SMD) using meta-analysis. MAIN RESULTS: We included 13 trials involving 514 participants. There was a significant effect of treatment on subjective reports of memory in the short term (standard mean difference (SMD) 0.36, 95% confidence interval (CI) 0.08 to 0.64, P = 0.01, moderate quality of evidence), but not the long term (SMD 0.31, 95% CI -0.02 to 0.64, P = 0.06, low quality of evidence). The SMD for the subjective reports of memory had small to moderate effect sizes.The results do not show any significant effect of memory rehabilitation on performance in objective memory tests, mood, functional abilities, or quality of life.No information was available on adverse events. AUTHORS' CONCLUSIONS: Participants who received cognitive rehabilitation for memory problems following a stroke reported benefits from the intervention on subjective measures of memory in the short term (i.e. the first assessment point after the intervention, which was a minimum of four weeks). This effect was not, however, observed in the longer term (i.e. the second assessment point after the intervention, which was a minimum of three months). There was, therefore, limited evidence to support or refute the effectiveness of memory rehabilitation. The evidence was limited due to the poor quality of reporting in many studies, lack of consistency in the choice of outcome measures, and small sample sizes. There is a need for more robust, well-designed, adequately powered, and better-reported trials of memory rehabilitation using common standardised outcome measures.

Comparing individual and group intervention for psychological adjustment in people with multiple sclerosis: a feasibility randomised controlled trial.

OBJECTIVE: To modify a published group intervention for adjustment to multiple sclerosis (MS) to suit an individual format, and to assess the feasibility of a randomised controlled trial (RCT) to compare individual and group intervention for people with multiple sclerosis and low mood. DESIGN: Feasibility randomised controlled trial. SETTING: Participants were recruited through healthcare professionals at a hospital-based multiple sclerosis service and the MS Society. SUBJECTS: People with multiple sclerosis. INTERVENTIONS: Adjustment to multiple sclerosis in individual or group delivery format. MAIN MEASURES: Participants completed mood and quality of life assessments at baseline and at four-month follow-up. Measures of feasibility included: recruitment rate, acceptability of randomisation and the intervention (content and format), and whether the intervention could be adapted for individual delivery. Participants were screened for inclusion using the General Health Questionnaire-12 and Hospital Anxiety and Depression Scale, and were randomly allocated to receive either individual or group intervention, with the same content. RESULTS: Twenty-one participants were recruited (mean age 48.5 years, SD 10.5) and were randomly allocated to individual (n=11) or group (n=10) intervention. Of those offered individual treatment, nine (82%) completed all six sessions. Of those allocated to group intervention, two (20%) attended all six sessions and three (30%) attended five sessions. There were no statistically significant differences between the groups on the outcome measures of mood and quality of life. CONCLUSIONS: The intervention could be provided on an individual basis and the trial design was feasible. There were lower attendance rates at group sessions compared to individual sessions.

A study of the validity and the reliability of the Geriatric Anxiety Inventory in screening for anxiety after stroke in older inpatients.

OBJECTIVES: To investigate the validity and reliability of the Geriatric Anxiety Inventory in screening for anxiety in older inpatients post-stroke. DESIGN: Longitudinal. SUBJECTS: A total of 81 inpatients with stroke aged 65 years or older were recruited at four centres in England. MAIN MEASURES: At phase 1 the Geriatric Anxiety Inventory and the Hospital Anxiety and Depression Scale were administered and then the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 4th edition (phase 2). The Geriatric Anxiety Inventory was repeated a median of seven days later (phase 3). RESULTS: Internal reliability of the Geriatric Anxiety Inventory was high (α = 0.95) and test-retest reliability acceptable (τB = 0.53). Construct validity was evident relative to the Hospital Anxiety and Depression Scale - Anxiety subscale (τB = 0.61). At a cut off of 6/7, sensitivity of the Geriatric Anxiety Inventory was 0.88, specificity 0.84, with respect to the Structured Clinical Interview anxiety diagnosis. Hospital Anxiety and Depressions Scale - Anxiety subscale sensitivity was 0.88, specificity 0.54 at the optimum cut off of 5/6. A comparison of the areas under the curve of the Receiver Operating Characteristics for the two instruments indicated that the area under the curve of the Geriatric Anxiety Inventory was significantly larger than that of the Hospital Anxiety and Depressions Scale - Anxiety subscale, supporting its superiority. CONCLUSIONS: The Geriatric Anxiety Inventory is an internally consistent, reliable (stable) and valid instrument with acceptable sensitivity and specificity to screen for anxiety in older inpatients with stroke.

Functional and motor outcome 5 years after stroke is equivalent to outcome at 2 months: follow-up of the collaborative evaluation of rehabilitation in stroke across Europe.

BACKGROUND AND PURPOSE: Recovery of patients within the first 6 months after stroke is well documented, but there has been little research on long-term recovery. The aim of this study was to analyze functional and motor recovery between admission to rehabilitation centres and 5 years after stroke. METHODS: This follow-up of the Collaborative Evaluation of Rehabilitation in Stroke Across Europe study, included patients from 4 European rehabilitation centres. Patients were assessed on admission, at 2 and 6 months, and 5 years after stroke, using the Barthel Index, Rivermead Motor Assessment Gross Function, Leg and Trunk function, and Arm function. Linear mixed models were used, corrected for baseline characteristics. To account for the drop-out during follow-up, the analysis is likelihood-based (assumption of missingness at random). RESULTS: A total of 532 patients were included in this study, of which 238 were followed up at 5 years post stroke. Mean age at stroke onset was 69 (±10 SD) years, 53% were men, 84% had ischemic strokes, and 53% had left-sided motor impairment. Linear mixed model analysis revealed a significant deterioration for all 4 outcomes between 6 months and 5 years (P<0.0001). Scores at 2 months were not statistically significant different from scores at 5 years after stroke. Higher age (P<0.0001) and increasing stroke severity on admission (P<0.0001) negatively affected long-term functional and motor recovery. CONCLUSIONS: Five-year follow-up revealed deterioration in functional and motor outcome, with a return to the level measured at 2 months. Increasing age and increasing stroke severity negatively affected recovery up to 5 years after stroke.

Cost analysis of the Communication and Low Mood (CALM) randomised trial of behavioural therapy for stroke patients with aphasia.

OBJECTIVE: To evaluate the cost effectiveness of a behavioural therapy intervention shown to be clinically effective in comparison with usual care for stroke patients with aphasia. DESIGN: Randomised controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. SETTING: Community. PARTICIPANTS: Participants identified as having low mood on either the Visual Analog Mood Scale sad item (≥50) or Stroke Aphasic Depression Questionnaire Hospital version 21 (SADQH21) (≥6) were recruited. INTERVENTIONS: Participants were randomly allocated to behavioural therapy or usual care using internet-based randomisation generated in advance of the study by a clinical trials unit. MAIN MEASURES: Outcomes were assessed at six months after randomisation, blind to group allocation. The costs were assessed from a service use questionnaire. Effectiveness was defined as the change in SADQH21 scores and a cost-effectiveness analysis was performed comparing the behavioural group with the usual care control group. The cost analysis was undertaken from the perspective of the UK NHS and Social Services. RESULTS: The greatest difference was in home help costs where there was a saving of £56.20 in the intervention group compared to an increase of £61.40 in the control group. At six months the SADQH21 score for the intervention group was 17.3 compared to the control group value of 20.4. This resulted in a mean increase of 0.7 in the control group, compared to a mean significant different decrease of 6 in the intervention group (P = 0.003). The Incremental Cost-Effectiveness Ratio indicated that the cost per point reduction on the SADQH21 was £263. CONCLUSION: Overall the behavioural therapy was found to improve mood and resulted in some encouraging savings in resource utilisation over the six months follow-up.

An evaluation of treatment integrity in a randomised controlled trial of memory rehabilitation for people with multiple sclerosis.

OBJECTIVE: To assess the treatment integrity of a memory rehabilitation programme for people with multiple sclerosis. SUBJECTS: Data were drawn from the intervention group of a randomised controlled trial of memory rehabilitation. This comprised 24 participants with multiple sclerosis. MEASURES: Four core session components were identified from the treatment manual: recap, activities, take-home activity and other. One video-recording of each of ten intervention sessions was transcribed and amount of time spent on components recorded. RESULTS: There were no significant differences between early and late stages of the programme in time spent on the core components (recap Z= -0.87, P=0.49; activities Z = -0.29, P=0.89; take-home activity Z = -0.59, P=0.69; other Z = -0.58, P=0.69). Thus, adherence to the manual was good with no evidence of programme drift. CONCLUSIONS: Good adherence indicates the intervention was delivered as described in the manual and strengthens confidence in the findings of the randomised controlled trial.

What does confidence mean to people who have had a stroke? A qualitative interview study.

OBJECTIVE: To explore the meaning of confidence to stroke patients after stroke in order to inform the development of a measurement tool. DESIGN: Qualitative interview study using interpretative phenomenological analysis (IPA). METHODS: Ten stroke survivors were purposively selected from those participating in a multi-centre randomised trial of outdoor mobility rehabilitation. Interviews about confidence were conducted in participants' homes, audio recorded and transcribed verbatim. RESULTS: Six themes emerged from the analysis. These were loss of identity, fear, social confidence, role confidence, mastering skill and attitudes and beliefs. Loss of identity was particularly evident in the early stages of stroke recovery. Fear was a barrier to regaining confidence and was associated with avoidance behaviours. Lack of social confidence was a common problem which appeared difficult to resolve. Life roles motivated participants to re-engage in daily life activities. Personal attitudes and beliefs, combined with the attitudes of significant others, contributed to personal feelings of competence. CONCLUSION: This study provides a coherent definition of the meaning of confidence through the experiences of stroke survivors. Being successful in gradually re-engaging in activities, including social activities and life roles helped to establish a positive self-belief. The influence of others, such as family and friends reinforce self-beliefs. Confidence and self-efficacy appear to be a similar construct. However, participants in this study also identified a relationship between confidence and self-esteem. The findings indicate that all six themes need to be included in a confidence measure to encompass the meaning of confidence as described by participants with stroke.

Group memory rehabilitation for people with multiple sclerosis: a feasibility randomized controlled trial.

OBJECTIVE: To assess the feasibility and effectiveness of a group memory rehabilitation programme combining compensation and restitution strategies. DESIGN: Randomized controlled trial. SETTING: Community. PARTICIPANTS: People with multiple sclerosis who reported memory difficulties were recruited. INTERVENTIONS: A group memory rehabilitation programme, comprising ten 1.5-hour sessions, was compared with a waiting list control. MAIN MEASURES: The primary outcome was the Everyday Memory Questionnaire. Secondary outcomes included the General Health Questionnaire 28 and MS Impact Scale administered four and eight months after randomization. In addition, those in the intervention group gave feedback about the intervention. RESULTS: Forty-eight participants were recruited. They were aged 34-72 years (mean 54.3, SD 11.0) and 33 (69%) were women. There were no significant differences between the two groups on the Everyday Memory Questionnaire or MS Impact Scale (P > 0.05) at four or eight months after randomization. However, the intervention group reported significantly better mood than controls on the GHQ-28 at eight months (P = 0.04). Participants showed minimal benefit from the memory rehabilitation programme on quantitative measures but the intervention was well received, as indicated by positive feedback at the end of the intervention. CONCLUSIONS: There was no significant effect of the intervention on memory but there was a significant effect on mood. The results suggest a larger scale study is justified.

Comparison of assessments of fitness to drive for people with dementia.

Cognitive tests are used to inform recommendations about the fitness to drive of people with dementia. The Rookwood Driving Battery (RDB) and Dementia Drivers' Screening Assessment (DDSA) are neuropsychological batteries designed to assist in this process. The aim was to assess the concordance between the classifications (pass/fail) of the RDB and DDSA in individuals with dementia, and to compare any discordant classifications against on-road driving ability. Participants were identified by community mental health teams and psychiatrists. Twenty four participants were recruited. The mean age was 74.1 (SD 8.9) years and 18 (75%) were men. Each participant was assessed on the RDB and DDSA in an order determined by random allocation. Those with discrepant results also had an on-road assessment. The agreement between the tests was 54% using a cut-off of > 6 on the RDB, and 75% using the cut-off to > 10 on the RDB. Three participants with discrepant results agreed to be assessed on the road and all were found to be safe to drive. The findings suggested that there was poor concurrent validity between the RDB and DDSA. This raises questions about the choice of assessments in making clinical recommendations about fitness to drive in people with dementia.