Information and Communication Technology Medicine: Integrative Specialty for the Future of Medicine.

The impact of information and communication technology (ICT) on medicine is unprecedented and ever-increasing. This has made it more and more difficult for doctors to keep pace with ICT developments and to adequately match the input of ICT experts. As a result, medical disciplines may not be able to take full advantage of growing possibilities. In this personal viewpoint paper, I argue for the establishment of a novel medical specialty, ICT medicine. ICT medicine is needed to optimally face the challenges of ICT-based developments, including artificial intelligence (AI), and to ensure their efficient and beneficial use. ICT medicine is rooted in both medicine and ICT, and in contrast to existing medical specialties it is integrative in nature, as long-standing structural collaborations with ICT and other stakeholders cross the boundaries between disciplines. Thus, new concepts and theories may evolve that are better suited to addressing ICT-related issues in medicine. ICT doctors will be instrumental in the conception, development, implementation, and evaluation of digital tools, systems, and services. They provide a bridge between ICT professionals and clinical users and educate doctors in digital applications and services. Notably, ICT doctors may have a pivotal role in the validation, verification, and evaluation of AI models. ICT medicine institutes offer a home to these new professionals, enhancing their independence within health care organizations and in relation to ICT companies. Importantly, in an era of growing technicalization and use of AI algorithms, ICT doctors may safeguard the human factor in medicine. And, from a societal perspective, they may promote digital inclusion and the continuing high quality of digital services and provide leadership in the future digitalization of medicine.

Sexual Motivation in Persons with Multiple Sclerosis: A Controlled Cross-Sectional Study.

Purpose: Sexual motives are major determinants of sexual behaviour. It has been known that sexual motives may vary according to circumstances. Multiple sclerosis (MS) is a chronic disease causing a broad range of symptoms and disabilities, that often interfere with sexual activities. We aimed to investigate the sexual motives in persons with MS. Patients and Methods: Cross-sectional study in 157 persons with MS and 157 controls matched for age, gender, relationship, duration of relationship and educational status via propensity score matching. The Reasons for Having Sex (YSEX) questionnaire assessed the proportion with which a person had engaged in sexual intercourse for each of 140 distinct motives to have sex. Estimated mean differences in scores for four primary factors (Physical, Goal attainment, Emotional, Insecurity) and 13 sub-factors, and sexual satisfaction and importance of sex were calculated as Average Treatment Effect of the Treated using 99% confidence intervals. Results: Persons with MS reported a lower proportion of engaging in sex compared with the controls for the factors Physical (-0.29), Emotional (-0.23) and Insecurity (-0.10); and for the physical sub-factors Pleasure (-0.48), Experience seeking (-0.32), Stress reduction (-0.24), and Physical desirability (-0.16), the emotional sub-factors Love and commitment (-0.27) and Expression (-0.17), and the insecurity sub-factor Self-esteem boost (-0.23). In the control group seven of the top 10 sexual motives were physical versus five in the MS group. The importance of sex was lower in the MS group (-0.68). Conclusion: Findings of this controlled cross-sectional study suggest a reduction in the number of sexual motives in persons with MS, especially of physical motives related to pleasure and experience seeking. Health care professionals may consider assessing sexual motivation when dealing with persons with MS who suffer from decreased sexual desire or another sexual dysfunction.

A Two-Minute Walking Test With a Smartphone App for Persons With Multiple Sclerosis: Validation Study.

BACKGROUND: Walking disturbances are a common dysfunction in persons with multiple sclerosis (MS). The 2-Minute Walking Test (2MWT) is widely used to quantify walking speed. We implemented a smartphone-based 2MWT (s2MWT) in MS sherpa, an app for persons with MS. When performing the s2MWT, users of the app are instructed to walk as fast as safely possible for 2 minutes in the open air, while the app records their movement and calculates the distance walked. OBJECTIVE: The aim of this study is to investigate the concurrent validity and test-retest reliability of the MS sherpa s2MWT. METHODS: We performed a validation study on 25 persons with relapsing-remitting MS and 79 healthy control (HC) participants. In the HC group, 21 participants were matched to the persons with MS based on age, gender, and education and these followed the same assessment schedule as the persons with MS (the HC-matched group), whereas 58 participants had a less intense assessment schedule to determine reference values (the HC-normative group). Intraclass correlation coefficients (ICCs) were determined between the distance measured by the s2MWT and the distance measured using distance markers on the pavement during these s2MWT assessments. ICCs were also determined for test-retest reliability and derived from 10 smartphone tests per study participant, with 3 days in between each test. We interviewed 7 study participants with MS regarding their experiences with the s2MWT. RESULTS: In total, 755 s2MWTs were completed. The adherence rate for the persons with MS and the participants in the HC-matched group was 92.4% (425/460). The calculated distance walked on the s2MWT was, on average, 8.43 m or 5% (SD 18.9 m or 11%) higher than the distance measured using distance markers (n=43). An ICC of 0.817 was found for the concurrent validity of the s2MWT in the combined analysis of persons with MS and HC participants. Average ICCs of 9 test-retest reliability analyses of the s2MWT for persons with MS and the participants in the HC-matched group were 0.648 (SD 0.150) and 0.600 (SD 0.090), respectively, whereas the average ICC of 2 test-retest reliability analyses of the s2MWT for the participants in the HC-normative group was 0.700 (SD 0.029). The interviewed study participants found the s2MWT easy to perform, but they also expressed that the test results can be confronting and that a pressure to reach a certain distance can be experienced. CONCLUSIONS: The high correlation between s2MWT distance and the conventional 2MWT distance indicates a good concurrent validity. Similarly, high correlations underpin a good test-retest reliability of the s2MWT. We conclude that the s2MWT can be used to measure the distance that the persons with MS walk in 2 minutes outdoors near their home, from which both clinical studies and clinical practice can benefit.

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.

Effect of an intensive 3-day social cognitive treatment (can do treatment) on control self-efficacy in patients with relapsing remitting multiple sclerosis and low disability: A single-centre randomized controlled trial.

In patients with chronic disorders, control self-efficacy is the confidence with managing symptoms and coping with the demands of illness. Can do treatment (CDT) is an intensive, 3-day, social cognitive theory-based, multidisciplinary treatment that focuses on identification of stressors, goal setting, exploration of boundaries, and establishment of new boundaries. An uncontrolled study showed that patients with relapsing remitting multiple sclerosis (RRMS) and low-disability had improved control self-efficacy six months after CDT. Hence, in a 6-month, single-centre, randomized (1:1), unmasked, controlled trial in RRMS patients with Expanded Disability Status Scale (EDSS) score ≤4.0, we compared CDT with no intervention and the option to receive CDT after completion of study participation. Follow-up assessments were at one, three and six months. Primary endpoint was control self-efficacy (Multiple Sclerosis Self-Efficacy Scale Control [MSSES-C] (minimum 90, maximum 900) at six months. Secondary endpoints were functional self-efficacy (MSSES-F), participation and autonomy (Impact on Participation and Autonomy questionnaire [IPA]), health-related quality of life (MS Quality of Life-54 Items questionnaire [MSQoL-54]), anxiety, depression (Hospital Anxiety and Depression Scale [HADS]) and coping skills (Utrecht Coping List [UCL]) at six months. Tertiary endpoint was care-related strain on support partners (Caregiver Strain Index) at six months. Of the 158 patients that were included, 79 were assigned to CDT and 79 to the control group. Two CDT patients discontinued treatment prematurely. Sixty-one (77%) control patients chose to receive CDT after study participation. Intention-to-treat ANCOVA analyses were performed with follow-up values as dependent, and condition, baseline values, disease duration and gender as independent variables. The mean (standard deviation [SD]) MSSES-C score in the CDT group vs. control group at baseline was 468 (162) vs. 477 (136), and at six months 578 (166) vs. 540 (135) (p = 0.100). Secondary and tertiary endpoints did not differ between groups, except for the UCL palliative reaction score being slightly higher in the CDT group (p = 0.039). On post hoc analyses the MSSES-C score at one and three months was higher in the CDT vs. control group: 597 (114) vs. 491 (131) (p<0.0001) and 561 (160) vs. 514 (143) (p = 0.018), respectively; and at one month the MSSES-F, IPA Limitations, HADS Anxiety and Depression, and MSQoL-54 Mental and Physical scores were also in favour of the CDT group. We conclude that in low-disability RRMS patients, the intensive 3-day social cognitive theory-based CDT did not improve control self-efficacy at six months follow-up compared to waitlist controls. The absence of a between-group difference at six months relates to a gradual improvement in the control group. In all, this social cognitive theory-based approach for improving self-efficacy needs further investigation before being broadly applied in RRMS patients.

Observational designs in clinical multiple sclerosis research: Particulars, practices and potentialities.

Observational studies investigate a wide range of topics in multiple sclerosis research. This paper presents an overview of the various observational designs and their applications in clinical studies. Observational studies are well suited for making discoveries and assessing new explanations of phenomena, but less so for establishing causal relationships, due to confounding by indication (selection bias), co-morbidity, socio-economic or other factors. Whether observational findings are demonstrative, indicative or only suggestive, depends on the research question, whether and how the design fits this question, analytical techniques, and the quality of data. Observational studies may be cross-sectional vs. longitudinal, and prospective vs. retrospective. The term 'retrograde' is proposed to explicate that cross-sectional studies may obtain data that cover (long) preceding periods. Case reports and case series are usually based on accidental observations or routinely collected data. Cross-sectional studies, by simultaneously assessing clinical phenomena and external factors, enable the discovery and quantification of associations. In ecological studies the unit of analysis is population or group, and relationships on patient level cannot be established. A cohort study is a longitudinal study that investigates patients with a defining characteristic, e.g. diagnosis or specific treatment, by analyzing data acquired at various intervals. Prospective cohort studies use (some) data that are not yet available at the time the research is conceived, whereas in retrospective studies the data already exist. In a case-control study a representative group of patients with a specific clinical feature is compared with controls, and the frequencies at which an external factor, e.g. infection, has occurred in each group is compared; in a nested case-control study controls are drawn from a fully known cohort. Randomized controlled trial (RCT)-extension studies are informative because, due to RCT randomization, they are free from confounding by indication. Patient or disease registries are organised systems for the long-term collection of uniform data on a population that is defined by a particular disease, condition or exposure, with the purpose to study changes over time. In pharmacotherapeutic research, accidental observations of unexpected beneficial effects may lead to further research into a drug's efficacy in other conditions. Uncontrolled phase 1 studies investigate safety and dosing aspects. Observational studies are alternatives to RCTs when these are not feasible for ethical or practical reasons. Phase 4 observational studies play a crucial role in the evaluation of the effectiveness of treatments in daily practice, the validation of RCT-based side effect profiles, and the discovery of late occurring or rare, potentially life-threatening side effects. Combinations of multidisciplinary longitudinal data bases into large data sets enable the development of algorithms for personalized treatments. To improve the reporting of observational findings on treatment effectiveness, it is proposed that abstracts define the research question(s) the study was meant to answer, study design and analytical methods, and identify and quantify the patient population, treatment of interest, relevant outcomes and the study's strengths and limitations. The development of guidelines for Strengthening the Reporting of Observational Studies in Effectiveness Research (STROBER), as an extension of the guidelines used in epidemiology, is wanted.

Toward Digital Self-monitoring of Multiple Sclerosis: Investigating First Experiences, Needs, and Wishes of People with MS.

BACKGROUND: Digital self-monitoring, such as through smartphone applications (apps) or activity trackers, could be applied to monitor the health of people with multiple sclerosis (MS). This self-monitoring could facilitate personalized therapies and self-management of MS. The acceptance of digital self-monitoring tools by patients depends on them being able and willing to use these tools in their daily lives. METHODS: In-depth interviews were conducted with seven adults with MS before and after participation in a study in which they used an activity tracker and an MS-specific smartphone app for 4 weeks. We inquired about experiences with the tools in daily life and needs and wishes regarding further development and implementation of digital self-monitoring for people with MS. RESULTS: The smartphone app and the activity tracker increased respondents' awareness of their physical status and stimulated them to act on the data. Challenges, such as confrontation with their MS and difficulties with data interpretation, were discussed. The respondents desired 1) adaptation of digital self-monitoring tools to a patient's personal situation, 2) guidance to increase the value of the data, and 3) integration of digital self-monitoring into treatment plans. CONCLUSIONS: These findings show that patients can provide detailed descriptions of their daily life experiences with new technologies. Mapping these experiences could help in better aligning the development and implementation of digital self-monitoring tools, in this case smartphones and activity trackers, with the needs and wishes of people with MS.

Risk knowledge of people with relapsing-remitting multiple sclerosis - Results of an international survey.

BACKGROUND: Adequate disease and treatment-related risk knowledge of people with Multiple Sclerosis (pwMS) is a prerequisite for informed choices in medical encounters. Previous work showed that MS risk knowledge is low among pwMS and role preferences are different in Italy and Germany. OBJECTIVE: We investigated the level of risk knowledge and role preferences in 8 countries and assessed putative variables associated with risk knowledge. METHODS: An online-survey was performed based on the Risk knowledge questionnaire for people with relapsing-remitting MS (RIKNO 2.0), the electronic Control Preference Scale (eCPS), and other patient questionnaires. Inclusion criteria of participants were: (1) age ≥18 years, (2) a diagnosis of relapsing-remitting MS (RRMS), (3) being in a decision making process for a disease modifying drug. RESULTS: Of 1939 participants from Germany, Italy, the Netherlands, Serbia, Spain and Turkey, 986 (51%) (mean age 38.6 years [range 18-67], 77% women, 7.8 years of disease duration) completed the RIKNO 2.0, with a mean of 41% correct answers. There were less than 50 participants in the UK and Estonia and data were not analysed. Risk knowledge differed across countries (p < 0.001). Variables significantly associated with higher risk knowledge were higher education (p < 0.001), previous experience with disease modifying drugs (p = 0.001), correct answer to a medical data interpretation question (p < 0.001), while higher fear for wheelchair dependency was negatively associated to risk knowledge (p = 0.001). CONCLUSION: MS risk knowledge was overall low and differed across participating countries. These data indicate that information is an unmet need of most pwMS.

Improved health-related quality of life, participation, and autonomy in patients with treatment-resistant chronic pain after an intensive social cognitive intervention with the participation of support partners.

Despite the availability of various specific treatments, most patients with chronic pain (CP) consider their pain problem as undertreated. Recently, multiple sclerosis (MS) patients who were given an intensive 3-day social cognitive treatment with the participation of support partners experienced lasting improvements in health-related quality of life (HRQoL) and self-efficacy. In this study, a similar intervention was given to treatment-resistant CP patients with stressors, relational problems with support partner, and distress, anxiety or depression. Before and 1, 3, and 6 months after the intervention, patients completed the Euro-Qol 5 Dimensions 5 Levels (EQ-5D-5L) and Impact on Participation and Autonomy (IPA) questionnaires (primary outcomes), and the Survey Of Pain Attitudes (SOPA), the Four-Dimensional Symptom Questionnaire (4DSQ) (distress, depression, anxiety, and somatization), and Visual Analog Scale for pain intensity, whereas the support partners completed the Caregiver Strain Index (CSI) questionnaire. Differences between baseline and post-treatment were tested via paired t-tests (significance level 0.05). Of the 39 patients who were included, 34 (87.2%) completed the 3-day treatment. At 1, 3, and 6 months, improvements were seen in EQ-5D-5L-Index (+40.6%; +22.4%; +31.7%), Health Today (+61.8%; +36.3%; +46.8%), Control attitude (+45.8%; not significant [NS]; +55.0%) and decreases in IPA-Problems (-14.8%; NS; -20.4%), Harm attitude (-18.9%; -15.0%; -17.7%), Distress (-17.7%; -31.8%; -37.1%), and Depression (-37.4%; -31.4%; -35.7%) scores. The CSI score had decreased by -29.0%, -21.4%, and -25.9%, respectively. In conclusion, after an intensive 3-day social cognitive intervention, treatment-resistant CP patients experienced substantial and lasting improvements in HRQoL and in problematic limitations to participation and autonomy, in association with improvements in pain attitudes, depression, and distress. To assess whether this innovative approach may be an effective treatment for this subgroup of CP patients, future randomized controlled studies are needed.

Adherence to Web-Based Self-Assessments in Long-Term Direct-to-Patient Research: Two-Year Study of Multiple Sclerosis Patients.

BACKGROUND: Direct-to-patient research via Web-based questionnaires is increasingly being used. Missed data or delayed reporting of data may negatively affect the quality of study results. It is insufficiently known to what degree patients adhere to agreed self-assessment schedule over the long term and whether questionnaires are filled out in a timely manner. OBJECTIVE: The objective of this study was to investigate patients' adherence to a self-assessment schedule with low-frequency long questionnaires versus that with a high-frequency short questionnaire. METHODS: In this study, the 36-item MS Impact Profile (MSIP) questionnaire measured (perceived) disabilities and the 54-item MS Quality of Life-54 (MSQoL-54) questionnaire measured health-related quality of life at 6-month intervals. Additionally, the 2-item Medication and Adherence (MA) questionnaire documented medication and adherence to disease-modifying medication every month. An experienced MS nurse assessed the Expanded Disability Status Scale (EDSS) score via phone. For both the self-assessment schedules, we calculated the percentage of patients who had completed all the questionnaires in the first 2 years (completion adherence), the percentage of patients who completed all the questionnaires within set time frames (interval adherence), the relationship between adherence and the EDSS score, and the timing of EDSS assessment. RESULTS: Of the 331 patients who enrolled themselves, 301 patients completed at least one questionnaire. At month six (M6), M12, M18, and M24, the MSIP was completed by 83.4% (251/301), 71.8% (216/301), 68.1% (205/301), and 58.5% (176/301) of the patients, respectively; the MSQoL-54 by 82.1% (247/301), 71.8% (216/301), 66.8% (201/301), and 57.1% (172/301), respectively; and the MA questionnaire by 80.1% (241/301), 70.4% (212/301), 62.1% (187/301), and 53.5% (161/301), respectively. For the MSIP, 56.8% (171/301) of the patients were 2-year completion adherent; 55.5% (167/301) and 53.5% (161/301) of the patients were completion adherent for the MSQoL-54 and MA questionnaires, respectively. Whereas 85.5% (142/166) of the patients were interval adherent for the MSIP and MSQoL-54, 25.5% (41/161) were interval adherent for the MA questionnaire, with 73.9% (119/161) exceeding the maximum MA monthly interassessment interval. Completion adherence for the monthly short MA questionnaire was higher in patients with moderately high disability (EDSS 5.0-5.5) than for those with no or minimal disability (EDSS 0-2.5) (OR 5.47, 95% CI 1.08-27.69; P=.040). Completion adherence was also higher in patients with EDSS assessment within 6 months after baseline than in those with later assessment (OR 1.810, 95% CI 0.999-3.280; P=.050). CONCLUSIONS: The 2-year completion adherence to Web-based self-assessments did not differ between the low-frequency long questionnaires and a high-frequency short questionnaire, but the interval adherence was substantially higher for the low-frequency long questionnaires. Personal contact with a member of the research team regarding a clinically relevant professional-reported outcome early in the study might positively affect the long-term completion adherence in direct-to-patient studies.

Health-Related Quality of Life in Patients with Multiple Sclerosis: Impact of Disease-Modifying Drugs.

Multiple sclerosis (MS) has a profound impact on health-related quality of life (HRQoL), a comprehensive subjective measure of the patient's health status. Assessment of HRQoL informs on the potential advantages and disadvantages of disease-modifying drugs (DMDs) beyond their effects on observer-based disability and magnetic resonance imaging abnormalities. This article reviews published data from randomized controlled trials and observational studies regarding the effects of currently available DMDs on HRQoL. Data indicate that DMD treatment is associated with prevention of worsening or with improvement of HRQoL, and that, in general, second-line DMDs may have a greater impact on HRQoL than first-line DMDs. In clinical practice, monitoring of HRQoL provides clinicians with unique information regarding disease impact and potential benefits and adverse effects of DMD treatment that may not be obtained otherwise; it might also permit early detection of an unfavorable disease course. It is suggested to assess HRQoL at the time of diagnosis and before starting or switching DMD treatment. Regular HRQoL measurements contribute to a comprehensive clinical evaluation, and may help to elucidate and quantify the patient's contribution to shared decision making regarding DMD treatment. Further studies are needed to better determine the role of HRQoL assessments in daily MS care.

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 .

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.

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.

Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse.

In a prospective multi-center observational study, we evaluated the frequency, severity, and impact on activities of daily living (ADL) of adverse effects (AEs) of high-dose intravenous methylprednisolone (IVMP) in relapsing remitting multiple sclerosis (MS) patients with a relapse. Online self-report questionnaires stating IVMP's most common AEs were completed at baseline, the 2nd day of treatment, and 1 day and 1 week after treatment. Eighty-five patients were included, 66 completed the baseline questionnaire, and 59 completed at least one post-baseline questionnaire. Patients reported on average 4 (median) AEs; two (3.4 %) reported no AE. Most frequent was change in taste (61 %), facial flushing (61 %), sick/stomach pain (53 %), sleep disturbance (44 %), appetite change (37 %), agitation (36 %), and behavioral changes (36 %). Of all AEs, 34.3 % were severe and 37.9 % impacted on ADL. A 3-day course resulted in 4 (median) AEs and a 5-day course in 7. All patients with high disease impact had two or more AEs, compared with 79 % of those with low impact (p < 0.01). Of patients with high disability, 45 % had severe AEs, compared with 16 % of those with low disability. Severe central nervous system (CNS)-related AEs occurred two times more frequently in patients with high disease impact, and two-and-a-half times more frequently in patients with high disability. Therefore, in virtually all patients, high-dose IVMP leads to AEs, with about one of three AEs being severe with impact on ADL. Patients with high disease impact or high disability may experience more (severe) AEs, due to a higher occurrence of severe CNS-related AEs.

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.

The interactive web-based program MSmonitor for self-management and multidisciplinary care in multiple sclerosis: utilization and valuation by patients.

BACKGROUND: MSmonitor is an interactive web-based program for self-management and integrated, multidisciplinary care in multiple sclerosis. METHODS: To assess the utilization and valuation by persons with multiple sclerosis, we held an online survey among those who had used the program for at least 1 year. We evaluated the utilization and meaningfulness of the program's elements, perceived use of data by neurologists and nurses, and appreciation of care, self-management, and satisfaction. RESULTS: Fifty-five persons completed the questionnaire (estimated response rate 40%). The Multiple Sclerosis Impact Profile (MSIP), Medication and Adherence Inventory, Activities Diary, and electronic consultation (e-consult) were used by 40%, 55%, 47%, and 44% of respondents and were considered meaningful by 83%, 81%, 54%, and 88%, respectively. During out-patient consultations, nurses reportedly used the MSmonitor data three to six times more frequently than neurologists. As to nursing care, more symptoms were dealt with (according to 54% of respondents), symptoms were better discussed (69%), and the overall quality of care had improved (60%) since the use of the program. As to neurological care, these figures were 24%, 31%, and 27%, respectively. In 46% of the respondents, the insight into their symptoms and disabilities had increased since the use of the program; the MSIP, Activities Diary, and e-consult had contributed most to this improvement. The overall satisfaction with the program was 3.5 out of 5, and 73% of the respondents would recommend the program to other persons with multiple sclerosis. CONCLUSION: A survey among persons with multiple sclerosis using the MSmonitor program showed that the MSIP, Medication and Adherence Inventory, Activities Diary, and e-consult were frequently used and that the MSIP, Medication and Adherence Inventory, and e-consult were appreciated the most. Moreover, the quality of nursing care, but not so neurological care, had improved, which may relate to nurses making more frequent use of the MSmonitor data than neurologists.

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.

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.