The Interactive Web-Based Program MSmonitor for Self-Management and Multidisciplinary Care in Persons With Multiple Sclerosis: Quasi-Experimental Study of Short-Term Effects on Patient Empowerment.

BACKGROUND: Empowerment helps persons with a chronic disease to self-manage their condition and increase their autonomy and participation. MSmonitor (Curavista bv) is an interactive Web-based program for self-management and multidisciplinary care in multiple sclerosis (MS). It includes, among others, short questionnaires on fatigue (Modified Fatigue Impact Scale-5 [MFIS-5]) and health-related quality of life (HRQoL, Leeds Multiple Sclerosis Quality of Life [LMSQoL]); long questionnaires on disabilities, perception of disabilities (Multiple Sclerosis Impact Profile), and HRQoL (Multiple Sclerosis Quality of Life-54); a Medication and Adherence Inventory and an Activity Diary. The combination MFIS-5, LMSQoL, and Medication and Adherence Inventory constitutes the Quick Scan. OBJECTIVE: This study aimed to investigate the short-term effects of MSmonitor on empowerment in patients with MS. METHODS: We conducted a quasi-experimental study in a general hospital. Of the 180 patients with MS, 125 were eligible, 30 used MSmonitor, and 21 participated in the study (mean age 45.4 years, SD 10.2 years). A total of 24 eligible patients who did not use MSmonitor constituted the control group (mean age 49.3 years, SD 11.4 years). At baseline and at 4 months, we assessed self-efficacy (Multiple Sclerosis Self-Efficacy Scale [MSSES]), participation and autonomy (Impact on Participation and Autonomy [IPA] questionnaire), and self-management (Partners In Health [PIH] questionnaire). Differences between time points and groups were tested with paired t tests and χ² tests. RESULTS: In the MSmonitor group, follow-up values remained unchanged for MSSES control (P=.19), MSSES function (P=.62), IPA limitations (P=.26), IPA problems (P=.40), PIH recognition and management of symptoms (P=.52), PIH adherence to treatment (P=.80), and PIH coping (P=.73), whereas the PIH knowledge score had improved (mean 27.8, SD 1.7 vs mean 28.7, SD 2.0; P=.02). The overall utilization rate of the program components was 83% and that of the Quick Scan was 95%. In the control group, all outcomes had remained unchanged. CONCLUSIONS: The results suggest that for first-time users of the MSmonitor program and their health care providers, it may not be justified to expect a short-term improvement in empowerment in terms of self-efficacy, self-management, autonomy, or participation. Furthermore, a lack of effect on empowerment is not because of nonusage of the program components.

Glatiramer acetate treatment persistence - but not adherence - in multiple sclerosis patients is predicted by health-related quality of life and self-efficacy: a prospective web-based patient-centred study (CAIR study).

BACKGROUND: In patients with relapsing remitting multiple sclerosis (RRMS) the persistence of and adherence to disease modifying drug (DMD) treatment is inadequate. To take individualised measures there is a need to identify patients with a high risk of non-persistence or non-adherence. As patient-related factors have a major influence on persistence and adherence, we investigated whether health-related quality of life (HRQoL) and self-efficacy could predict persistence or adherence. METHODS: In a prospective web-based patient-centred study in 203 RRMS patients, starting treatment with glatiramer acatete (GA) 20 mg subcutaneously daily, we measured physical and mental HRQoL (Multiple Sclerosis Quality of Life-54 questionnaire), functional and control self-efficacy (Multiple Sclerosis Self-Efficacy Scale), the 12-month persistence rate and, in persistent patients, the percentage of missed doses. HRQoL and self-efficacy were compared between persistent and non-persistent patients, and between adherent and non-adherent patients. Logistic regression analysis was used to assess whether persistence and adherence were explained by HRQoL and self-efficacy. RESULTS: Persistent patients had higher baseline physical (mean 58.1 [standard deviation, SD] 16.9) and mental HRQoL (63.8 [16.8]) than non-persistent patients (49.5 [17.6]; 55.9 [20.4]) (P = 0.001; P = 0.003) with no differences between adherent and non-adherent patients (P = 0.46; P = 0.54). Likewise, in persistent patients function (752 [156]) and control self-efficacy (568 [178]) were higher than in non-persistent patients (689 [173]; 491 [192]) (P = 0.009; P = 0.004), but not in adherent vs. non-adherent patients (P = 0.26; P = 0.82). Logistic regression modelling identified physical HRQoL and control self-efficacy as factors that explained persistence. Based on predicted scores from the model, patients were classified into quartiles and the percentage of non-persistent patients per quartile was calculated: non-persistence in the highest quartile was 23.4 vs. 53.2% in the lowest quartile. Risk differentiation with respect to adherence was not possible. Based on these findings we propose a practical work-up scheme to identify patients with a high risk of non-persistence and to identify persistence-related factors. CONCLUSIONS: Findings suggest that pre-treatment physical HRQoL and control self-efficacy may identify RRMS patients with a high risk of early discontinuation of injectable DMD treatment. Targeting of high-risk patients may enable the efficient use of persistence-promoting measures. TRIAL REGISTRATION: Nederlands Trial Register code: NTR2432 .

An intensive social cognitive program (can do treatment) in people with relapsing remitting multiple sclerosis and low disability: a randomized controlled trial protocol.

BACKGROUND: In people with multiple sclerosis (MS) disabilities and limitations may negatively affect self-efficacy. Lowered self-efficacy has been associated with decreases in health-related quality of life, physical activity and cognitive performance. In an explorative observational study we found that a 3-day intensive social cognitive program (Can Do Treatment [CDT]) with the participation of support partners was followed by substantial increases in self-efficacy control and health-related quality of life 6 months after treatment in those people with MS who had relapsing remitting disease and low disability. METHODS/DESIGN: CDT is a sociologically oriented approach, its goal is to uncover and promote existing capabilities, and the notion "stressor" is the central concept. CDT's components are plenary group sessions, small group sessions, consultations, a theatre evening, and start of the day with a joint activity. The small group sessions form the actual training. Depending on their individual goals the participants join the training groups 'Body', 'Feeling' or 'Life', to work out their aims and to reduce their stressors. The multidisciplinary team includes a psychiatrist, psychiatric nurse, neurologist, specialized MS nurse, physiotherapist, dance therapist, and a person with MS. To evaluate the (cost)effectiveness of CDT in persons with relapsing remitting MS and low disability we perform a single-centre, randomized controlled trial in 140 patients, with or without support partners. The primary outcome is self-efficacy control. The secondary outcomes are self-efficacy function, health-related quality of life, autonomy and participation, anxiety, depression, cost effectiveness and cost utility. The tertiary outcome is care-related strain to support partners. Outcomes are assessed at baseline and at 1, 3 and 6 months after CDT. DISCUSSION: This randomized controlled trial will adequately evaluate the clinical and cost effectiveness of a 3-day intensive social cognitive program in people with relapsing remitting MS and low disability, with self-efficacy control as primary outcome. DUTCH TRIAL REGISTRY: Application number: 22444.

A prospective web-based patient-centred interactive study of long-term disabilities, disabilities perception and health-related quality of life in patients with multiple sclerosis in The Netherlands: the Dutch Multiple Sclerosis Study protocol.

BACKGROUND: In the past two decades the widespread use of disease modifying drugs with moderate to strong efficacy has changed the natural course of multiple sclerosis (MS). Health care professionals, researchers, patient organizations and health authorities are in need of recent information about the objectified and subjective long-term clinical outcomes in MS patients. Such information is scarce. METHODS/DESIGN: We started a prospective, web-based, patient-centred, interactive study of long-term disabilities, disabilities perception and health-related quality of life (HRQoL) in MS patients in The Netherlands (Dutch Multiple Sclerosis Study). The study has an on online patient-driven inclusion and online acquisition of patient-reported outcomes (PROs). At six-months intervals participants complete the Multiple Sclerosis Impact Profile (MSIP) (disabilities and disabilities perception in seven domains and four symptoms), the Multiple Sclerosis Quality of Life-54 items (MSQoL-54), the Modified Fatigue Impact Scale-5 items (MFIS-5) and the Leeds Multiple Sclerosis Quality of Life-8 items (LMSQoL) questionnaires, and a Medication and Adherence Inventory. Every three years the Expanded Disability Status Scale (EDSS) score is assessed by phone. The monthly completion of the MFIS-5, LMSQoL and Medication and Adherence Inventory is optional. Completed questionnaires and inventories, and automatically generated scores are made available online to patients for self-monitoring and self-management purposes, and to authorized health care professionals for the evaluation of disease activity and of the effectiveness of treatments. Study duration is planned to be 15 years. Results will be analyzed periodically using means and standard deviations for continuous variables, and frequencies for categorical variables. Relations between time points, variables, patient and treatment characteristics will be evaluated in random effects repeated measures models. DISCUSSION: The Dutch Multiple Sclerosis Study is characterized by online patient-driven inclusion; online data acquisition; the use of PROs; the optional monthly completion of short questionnaires; the interactive use of personal study data by patients and authorized health care professionals for self-monitoring, self-management and multidisciplinary care; the expected representativeness of the study sample; and a long-term time horizon. The study will provide valuable data on long-term disabilities, disabilities perceptions and HRQoL in MS patients in The Netherlands.

Validation of a Dutch version of the Actionable 8-item screening questionnaire for neurogenic bladder overactivity in multiple sclerosis: an observational web-based study.

BACKGROUND: In patients with multiple sclerosis (MS) the impact of urological symptoms on quality of life and daily activities is considerable. Yet, a substantial percentage of patients may not be urologically evaluated and thus fail to be treated concordantly. The 8-item Actionable questionnaire is a validated English screening tool for the detection of neurogenic bladder overactivity in MS. To enable the use of the 8-item Actionable in The Netherlands and Belgium we translated the questionnaire into the Dutch language and investigated the test-retest reliability and the concurrent validity of the Dutch version. METHODS: The process of translating the English Actionable questionnaire into the Dutch language included forward translations and back-translations. Then, in an online observational study, MS patients completed the Dutch Actionable at Days 1 and 8, and the Multiple Sclerosis Quality of Life 54-Items (MSQoL-54) and Multiple Sclerosis Impact Profile (MSIP) questionnaires at Day 1; the Expanded Disability Status Scale (EDSS) score was assessed by phone at Day 1. For assessment of the test-retest reliability Pearson's correlation coefficient (r) between the Day 1 and Day 8 Actionable scores was calculated. For assessment of the concurrent validity r values were calculated between the Day 1 Actionable score and the EDSS score, the Physical and Mental MSQoL-54 composites, and the MSIP domain and symptom disability scores. STUDY POPULATION: N = 141 (106 female, 35 male) (80 relapsing remitting, 48 progressive, 13 unknown), mean age 47.8 (standard deviation [SD] 10.4) years, mean EDSS score 4.7 (SD 1.8); 137 patients completed the Day 8 assessment. Pearson's r between Actionable scores Day 1 and Day 8: 0.85 (P < .0001). Pearson's r between Actionable score Day 1 and scores for EDSS 0.41 (P < 0.0001), MSQoL-54 Physical -0.31 (P = 0.0002), MSQoL-54 Mental -0.29 (P = 0.0005), MSIP Excretion and Reproductive Functions 0.44 (P < 0.0001), Muscle and Movement Functions 0.39 (P < .0001), Basic Movement Activities 0.37 (P < 0.0001), Activities of Daily Living 0.32 (P < 0.0001), Participation in Life Situations 0.29 (P = 0.0006) and Mental Functions 0.20 (P = 0.0189). CONCLUSIONS: The Dutch version of the Actionable urological screening tool for MS shows a good test-retest reliability and a good concurrent validity with disabilities and HRQoL.

Simplified scoring of the Actionable 8-item screening questionnaire for neurogenic bladder overactivity in multiple sclerosis: a comparative analysis of test performance at different cut-off points.

BACKGROUND: The Actionable questionnaire is an 8-item tool to screen patients with multiple sclerosis (MS) for neurogenic bladder problems, identifying those patients who might benefit from urological referral and bladder-specific treatment. The original scoring yields a total score of 0 to 24 with cut-off point 6. A simplified scoring, yielding a total score of 0 to 8 with cut-off point 3, has been developed in urogynaecological patients, but has not been investigated in MS. METHODS: One-hundred-and-forty-one MS patients completed the Actionable on two occasions. We compared the test performance of the simplified scoring with cut-off point 3 with that of cut-off point 2, using the original scoring with cut-off point 6 as a gold standard. The following measures were calculated: True Positives (TP), True Negatives (TN), False Positives (FP), False Negatives (FN), Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), and Accuracy. The associations between positive test result and urological treatment, and bladder-specific drug treatment were calculated. RESULTS: For cut-off point 3 the outcomes (Test 1, Test 2) were: TP 43.26 %, 40.88 %; TN 29.79 %, 32.85 %; FP 0.00 %, 0.00 %; FN 26.95 %, 26.28 %; Sensitivity 0.62, 0.61; Specificity 1.00, 1.00; PPV 1.00, 1.00; NPV 0.53, 0.55; Accuracy 0.73, 0.74; and for cut-off point 2: TP 59.57 %, 59.85 %; TN 26.95 %, 31.39 %; FP 2.84 %, 1.46 %; FN 10.63 %, 7.30 %; Sensitivity 0.85, 0.89; Specificity 0.90, 0.96; PPV 0.95, 0.98; NPV 0.72, 0.81; Accuracy 0.87, 0.91. Cut-off 3 completely prevented FP outcomes, but wrongly classified 26 % of the patients as negative (FN). Cut-off 2 reduced the FN to 7-10 %, with low FP values (2.84-1.46 %). With cut-off 2, the percentage of patients screened positive was higher in the Progressive group (75.00 %) than in the Relapsing Remitting group (56.25 %) (P = 0.0331), which was not the case with cut-off 3. Only a positive test according to the original scoring was associated with both urological treatment (P = 0.0119) and bladder-specific medication (P = 0.0328). CONCLUSIONS: Our findings suggest that in MS patients the simplified Actionable scoring is more accurate with cut-off point 2 than with cut-off point 3, especially by substantially reducing FN outcomes; and that in MS the original Actionable scoring seems preferable.

Improved self-efficacy in persons with relapsing remitting multiple sclerosis after an intensive social cognitive wellness program with participation of support partners: a 6-months observational study.

BACKGROUND: For persons with multiple sclerosis (MS) it is important to preserve their autonomy, in spite of increasing disability. A major factor mediating autonomy is self-efficacy. According to the social cognitive theory stressors are crucial determinants of self-efficacy, as well as the interaction with partners. METHODS: In an explorative observational study we assessed in 47 persons with MS (PwMS) the effect of an intense, multidisciplinary, 3-day, social cognitive wellness program with the participation of support partners, after 1, 3 and 6 months. PRIMARY OUTCOMES: self-efficacy-control and -function (Multiple Sclerosis Self-Efficacy Scale [MSSES]),limitations to and problems with participation and autonomy (Impact on Participation and Autonomy [IPA] scale). SECONDARY OUTCOMES: health-related quality of life (HRQoL) (MS Quality of Life-54 Items [MSQoL-54] questionnaire), anxiety, depression (Hospital Anxiety and Depression Scale [HADS]), and fatigue (Modified Fatigue Impact Scale-5 Items [MFIS-5]). Disability was measured with the Expanded Disability Status Scale (EDSS). Percentage changes from baseline were tested with T-tests, level of significance 0.05. RESULTS: In the whole group the MSQoL-54 Mental score was increased at 1, 3 and 6 months (+16.0%, +13.2%, +12.2%), and the MSQoL-54 Physical (+10.2%) at 6 months, with no changes in other outcomes. The relapsing remitting (RR) subgroup (n = 20) had at 6 months an increase in the MSSES-Control score (+24.8%) and in the MSQoL54 Mental and Physical scores (+22.3%, +17.6%). Progressive patients (n = 22) only showed an increase in the MSQoL-54 Mental score (+11.5%) at 1 month. In the low-disability (EDSS < 4.0) subgroup the MSSES-Control score was increased (+23.8%) at 6 months, and the IPA-Limitations and -Problems scores decreased at 3 months (-6.1%, -8.8%); the MSQoL-54 Mental score had increased at 1, 3 and 6 months (+19.3%, +21.5%, +19.3%). In the high-disability (EDSS > =4.0) subgroup no significant changes occurred. CONCLUSIONS: Results from this observational study suggest that 6 months after an intense, 3-day, multidisciplinary, social cognitive wellness program with support partners, PwMS with a RR course or low disability may experience an improved self-efficacy-control and HRQoL.

Outcome of first line systemic treatment in elderly compared to younger patients with metastatic colorectal cancer: a retrospective analysis of the CAIRO and CAIRO2 studies of the Dutch Colorectal Cancer Group (DCCG).

BACKGROUND: Metastatic colorectal cancer (CRC) is predominantly a disease of the elderly, therefore the current standards should be evaluated in this population. MATERIAL AND METHODS: We evaluated in different age groups the outcome in terms of median overall and progression-free survival, response rate, disease control rate, relative dose intensity (RDI), tolerability, and global quality of life (QoL) of first-line capecitabine monotherapy (CAP) versus capecitabine + irinotecan (CAPIRI) and capecitabine + oxaliplatin + bevacizumab (CAPOX + BEV) in the CAIRO and CAIRO2 study, respectively. Patients were categorized into three age groups: age > 75, 70-75 and < 70 years. RESULTS: Clinical outcomes were not significantly different among age groups, with the exception of a higher response rate from CAP treatment in the elderly. Elderly patients treated with CAPOX + BEV showed a trend towards a worse median overall survival compared to younger patients. Only treatment with CAP resulted in a higher incidence of grade 3-4 toxicity and a lower RDI in elderly versus younger patients. Treatment with CAP and CAPOX + BEV in elderly patients was significantly more often discontinued due to toxicity instead of progression to disease compared to younger patients. The increase in global QoL was comparable for the three age groups for each treatment regimen. CONCLUSION: We did not observe significant differences in survival outcomes between elderly and younger metastatic CRC patients with three different first-line systemic treatment regimens. Our data suggest that initial dose reduction of CAP monotherapy may be indicated in elderly patients.

A simple sample size formula for analysis of covariance in randomized clinical trials.

OBJECTIVE: Randomized clinical trials that compare two treatments on a continuous outcome can be analyzed using analysis of covariance (ANCOVA) or a t-test approach. We present a method for the sample size calculation when ANCOVA is used. STUDY DESIGN AND SETTING: We derived an approximate sample size formula. Simulations were used to verify the accuracy of the formula and to improve the approximation for small trials. The sample size calculations are illustrated in a clinical trial in rheumatoid arthritis. RESULTS: If the correlation between the outcome measured at baseline and at follow-up is rho, ANCOVA comparing groups of (1-rho(2))n subjects has the same power as t-test comparing groups of n subjects. When on the same data, ANCOVA is used instead of t-test, the precision of the treatment estimate is increased, and the length of the confidence interval is reduced by a factor 1-rho(2). CONCLUSION: ANCOVA may considerably reduce the number of patients required for a trial.

Cerebrospinal fluid IgM index correlates with cranial MRI lesion load in patients with multiple sclerosis.

In multiple sclerosis intrathecal IgM synthesis correlates with an unfavourable disease course. Whether this reflects a pathogenic role of IgM, possibly in conjunction with complement, is a matter of debate. In a cross-sectional study we measured intrathecal synthesis of IgM and the complement component C3, and on cranial MRI lesion load and central brain atrophy in clinically active patients, 17 relapsing-remitting, 16 secondary progressive. Correlative analysis showed that in relapsing-remitting patients CSF IgM index correlated with cranial MRI T2 and T1 lesion load, and central brain atrophy; and the C3 index correlated with T2 lesion load. In secondary progressive patients CSF IgM index correlated with periventricular T2 lesion load. Our data are in favour of a pathogenic role of IgM in multiple sclerosis.

Persistence and adherence in multiple sclerosis patients starting glatiramer acetate treatment: assessment of relationship with care received from multiple disciplines.

BACKGROUND: In multiple sclerosis patients, the persistence of, and adherence to, disease-modifying treatment are often insufficient. The degree of persistence and adherence may relate to the care received from various disciplines. METHODS: In an observational study of 203 patients treated with glatiramer acetate 20 mg subcutaneous daily, we assess the persistence and adherence in relation to the amount of care received in various disciplines. The frequencies and durations of care per discipline were reported by patients online, as were missed doses and eventual treatment discontinuation. The associations between the care provided by neurologists, nurses, psychologists, pharmacists, and rehabilitative doctors and persistence and adherence were the primary outcomes; the associations between care received from general practitioners, occupational therapists, physiotherapists, social workers, dieticians, home caregivers, informal caregivers, other medical specialists, and other caregivers and persistence and adherence were secondary outcomes. RESULTS: It was found that the 12-month persistence rate was 62% and that 85% of the persistent patients were 95% adherent (missed <5% of doses). Patients who discontinued treatment in the fourth quarter (Q) had received less-frequent and shorter psychological care in Q3 than persistent patients (P=0.0018 and P=0.0022). Adherent patients had received more frequent home care and informal care than nonadherent patients (P=0.0074 and P=0.0198), as well as longer home care and informal care (P=0.0074 and P=0.0318). Associations between care in other disciplines and persistence or adherence were not observed. As to the relationship between adherence and persistence, nonadherence in Q2 was related to discontinuation after Q2 (P=0.0001). CONCLUSION: We obtained no evidence that, in multiple sclerosis patients, persistence of and adherence to disease-modifying treatment are associated with the amount of neurological, nursing, pharmaceutical, or rehabilitative care. However, findings suggest that the treatment of psychological problems in Q3 may relate to persistence and that home care and informal care may relate to adherence.

Intensive social cognitive treatment (can do treatment) with participation of support partners in persons with relapsing remitting multiple sclerosis: observation of improved self-efficacy, quality of life, anxiety and depression 1 year later.

BACKGROUND: In persons with multiple sclerosis (MS) self-efficacy positively affects health-related quality of life (HRQoL) and physical activity. In a previous study we observed that 6 months after an intensive 3-day social cognitive treatment (Can Do treatment) with the participation of support partners, self-efficacy and HRQoL had improved in persons with relapsing remitting MS (RRMS). Given the chronic nature of the disease, it is important to know whether these beneficial changes may last. METHODS: Can Do treatment was given to 60 persons with MS and their support partners. At baseline and 12 months after treatment self-efficacy control, self-efficacy function, physical and mental HRQoL, anxiety, depression and fatigue were assessed via self-report questionnaires. Differences were tested via a paired t test. RESULTS: Of the 57 persons with MS that completed the baseline assessment and the 3-day treatment, 38 filled in the 12th month questionnaires (response rate 66.7 %), 22 with RRMS and 14 with progressive MS. In the RR group self-efficacy control had increased by 20.2 % and physical HRQoL by 15.0 %, and depression and anxiety had decreased by 29.8 and 25.9 %, respectively (all P < 0.05); the changes in mental HRQoL (+17 %) and fatigue (-20 %) failed to be statistically significant (P = 0.087, P = 0.080, respectively). In the progressive group no changes suggestive of improvement were seen. CONCLUSIONS: The findings suggest that a 3-day intensive social cognitive treatment (Can Do treatment) with the participation of support partners may have long lasting beneficial effects on the self-efficacy and HRQoL in persons with RRMS; and that improvements in anxiety and depression, not seen in the 6-month study, may yet develop at 12 months.

Risk of Disabling Response Fluctuations and Dyskinesias for Dopamine Agonists Versus Levodopa in Parkinson's Disease.

BACKGROUND: Response fluctuations and dyskinesias develop during the use of both levodopa (LD) and dopamine agonists (DA), but may not be equally disabling. OBJECTIVE: To compare the risk and time of onset of disabling response fluctuations and dyskinesias (DRFD) among patients with Parkinson's disease (PD) who were initially treated with either LD or DA. METHODS: Open cohort study of all consecutive de-novo PD patients in routine clinical practice, included over a period of 15 years (median follow-up: 8.1 years, range 1.1-17.7), since embarking on LD or DA. Older patients and patients with more severe PD were started on LD (n = 77), younger patients on a DA (n = 50). Therapy was adjusted according to generally accepted guidelines. The primary endpoints were: the onset of response fluctuations, dyskinesias, and the moment when these complications became disabling (DRFD). RESULTS: LD-starters developed response fluctuations 0.8 years earlier than DA-starters (p = 0.07), while dyskinesias appeared around 2.5 years earlier (p = 0.003). However, the risk and time of onset of DRFD did not differ statistically between the groups (LD-starters: 60% , median interval 7.3 years, DA-starters: 52% , 6.1 years, p = 0.63). DA-starters displayed a 0.19 points lower adjusted mean improvement in motor scores than LD-starters (p = 0.002). Adjustments for age and severity of PD at start of dopaminergic therapy did not change these results. CONCLUSIONS: In routine clinical practice, the risk and time of onset of DRFD is comparable for LD-starters versus DA-starters, but motor functioning is worse in DA-starters. These results support the use of LD as initial therapy for PD.

The interactive web-based program MSmonitor for self-management and multidisciplinary care in multiple sclerosis: concept, content, and pilot results.

BACKGROUND: There is a growing need to offer persons with multiple sclerosis (PwMS) possibilities for self-management and to integrate multidisciplinary health data. In 2009-2014 we developed a patient-reported outcome based, interactive, web-based program (MSmonitor) for (self-)monitoring, self-management and integrated, multidisciplinary care in MS. METHODS: The notions underlying the MSmonitor concept and the program's elements are described. We analyze MSmonitor's role in the self-management of fatigue by retrospective comparison of fatigue and health-related quality of life (HRQoL) before and after usage of specific elements of MSmonitor, and by a correlative analysis between frequency of usage and fatigue change. RESULTS: After a step-wise development the program comprises six validated questionnaires: Multiple Sclerosis Impact Profile, Modified Fatigue Impact Scale-5 items (MFIS-5), Hospital Anxiety and Depression Scale, Multiple Sclerosis Quality of Life-54 items, and the 8-item Leeds Multiple Sclerosis Quality of Life (LMSQoL) questionnaires; two inventories: Medication and Adherence Inventory, Miction Inventory; two diaries: Activities Diary, Miction Diary; and two functionalities: e-consult and personal e-logbook. The program is now used in 17 hospitals by 581 PwMS and their neurologists, MS nurses, physical therapists, rehabilitative doctors, continence nurses, and family doctors. Those PwMS (N=105) who used the LMSQoL and MFIS-5 questionnaires at least twice in a period of up to 6 months, showed improved HRQoL (P<0.026). In the subgroup (N=56) who had also used the Activities Diary twice or more, the frequency of diary usage correlated modestly with the degree of fatigue improvement (r=0.292; P=0.028). CONCLUSION: MSmonitor is an interactive web-based program for self-management and integrated care in PwMS. Pilot data suggest that the repeated use of the short MFIS-5 and LMSQoL questionnaires is associated with an increase in HRQoL, and that a repeated use of the Activities Diary might contribute to the self-management of fatigue.

Improvement of health-related quality of life in relapsing remitting multiple sclerosis patients after 2 years of treatment with intramuscular interferon-beta-1a.

In patients with relapsing remitting multiple sclerosis (RRMS), the effect of interferon-beta (INFb) on health-related quality of life (HR-QoL) is not firmly documented. The objective of this study is to assess HR-QoL during 2 years of treatment with intramuscular INFb and its correlation with disability. In 36 neurological practices in the Netherlands (17), Belgium (16), United Kingdom (2) and Luxemburg (1), 284 RRMS patients were treated with intramuscular INFb-1a. Physical and mental domains of HR-QoL were measured by the MS54 Quality of Life (MS54QoL) questionnaire, and disability was assessed by the Multiple Sclerosis Functional Composite (MSFC) (Timed 25-Foot Walk Test [Timed 25-FWT], 9 Hole Peg Test [9-HPT], Paced Auditory Serial Addition Test [PASAT]) at baseline and at months 3, 6, 12, 18 and 24. Expanded Disability Status Scale (EDSS) score was assessed at baseline and month 24. Pearson's correlation coefficients were determined and predefined factors were analyzed for relation to HR-QoL after baseline by stepwise regression analyses on physical and mental scores. 204 patients (71.8%) completed 2 years of treatment. Mean values for MS54QoL increased from 56.6 to 61.0 for physical (p < 0.05) and from 57.2 to 61.1 for mental domain (p = 0.07). Correlations between physical domain and MSFC was -0.40 (p < 0.05), and between mental domain and MSFC -0.24 (p < 0.05). MSFC and EDSS did not change. Increase of physical MS54QoL was associated with lower age, lower EDSS, less time for Timed 25-FWT, and higher PASAT score at baseline. Increase of mental MS54QoL was associated with higher PASAT and lower EDSS. Patients who discontinued INFb had lower physical or mental HR-QoL at baseline. In RRMS patients, 2 years of treatment with intramuscular INFb-1a is associated with an increase in HR-QoL, especially in younger patients with low disability.

The impact of intensive antileukaemic treatment strategies on prognosis of myelodysplastic syndrome patients aged less than 61 years according to International Prognostic Scoring System risk groups.

The present study applied the International Prognostic Scoring System (IPSS) to 306 consecutive myelodysplastic syndrome (MDS) patients diagnosed between August 1977 and September 2000 at the University Medical Centre Nijmegen. The aim was to investigate whether the IPSS could be used as a prognostic tool in MDS patients aged less than 61 years who were treated with acute myeloid leukaemia (AML)-like chemotherapy with or without transplantation, and whether the scoring system discriminated between the subgroups of patients who benefit from intensive treatment strategies. The patients were retrospectively assigned to the IPSS risk categories and compared with the IPSS workshop patients. Eighty-three of 159 patients aged < 61 years, classified as intermediate 1, intermediate 2 and high risk according to the IPSS, received intensive treatment consisting of chemotherapy only (n = 30), chemotherapy followed by either autologous stem cell transplantation (n = 7) or allogeneic stem cell transplantation (n = 46). After intensive treatment, the median survival was 2.6 years for the intermediate 1 risk group (n = 33), 3.4 years for the intermediate 2 risk group (n = 27) and 0.9 years for the high-risk group (n = 23). We conclude that the IPSS is an improved scoring system for patients receiving supportive care. Nevertheless, the scoring system does not seem to be the best method for predicting outcome after intensive antileukaemic treatment. In particular, intermediate 2 risk patients may benefit from intensive treatment.