Re-assessing the validity of the Moral Sensitivity Questionnaire (MSQ): Two new scales for moral deliberation and paternalism.

RATIONALE, AIMS, AND OBJECTIVES: The current study and previous research have called the six-component model of Lützen's 30-item Moral Sensitivity Questionnaire (MSQ) into question. For this reason, we re-examined the construct validity of this instrument. METHODS: In this cross-sectional study, which was based on a convenience sample of Dutch nurse practitioners (NPs) and physician assistants (PAs), we tested the validity of MSQ items using exploratory and confirmatory factor analyses (EFA and CFA, respectively). RESULTS: The EFA revealed a two-component model, which was then tested as a target model with CFA and was found to have good model fit. Some items were correlated with two uncorrelated latent constructs, which we labelled as "paternalistic" and "deliberate" attitudes towards patients. CONCLUSIONS: As in previous studies, the analyses in the current study, which was conducted among PAs and NPs, did not reveal six dimensions for the 30 items. Two new latent dimensions of moral sensitivity were psychometrically tested and confirmed. These two components relate to studies investigating ethical behaviour, and they can be used to describe the moral climate in healthcare organizations. The scales are indicators of the extent to which health professionals behave in a deliberate (sensitive) or paternalistic (insensitive) manner towards the opinions of patients within the context of medical decision-making.

Anterior Thoracic Spinal Cord Herniation: Surgical Treatment and Postoperative Course. An Individual Participant Data Meta-Analysis of 246 Cases.

BACKGROUND: Anterior thoracic spinal cord herniation (ATSCH) is a rare cause of progressive myelopathy. Early surgery is essential, but there is no agreement about the best surgical approach. OBJECTIVE: To identify factors that determine surgical results and to find evidence for the most favorable technique to correct ATSCH. METHODS: To find relevant literature, computed databases of PubMed, EMBASE, and ISI Web of Science were searched. The study comprised case reports published between 1974 and 2018, and the data set was completed with 12 cases treated in our own institute. Patient characteristics were analyzed following the principles of an individual participant data meta-analysis. RESULTS: Brown-Séquard-like neurologic deficit before surgery was associated with postoperative motor function improvement compared with patients with paraparesis (P = 0.04). In the univariate analysis, widening of the dura defect (WDD) was more prevalent among improved patients, whereas anterior dura patch and application of intraoperative neurophysiologic monitoring were not. In the multivariate analysis, the favorable association with WDD disappeared, which is explained by the dominant influence of a Brown-Séquard-like deficit on outcome. CONCLUSIONS: In general, postoperative results after surgery for ATSCH are favorable, with a high percentage of patients experiencing postoperative improvement. Postoperative motor function improvement is more likely to occur in patients with a Brown-Séquard-like neurologic deficit. The WDD should be favored above the application of a patch as the technique of choice in surgical treatment of ATSCH.

Moral reasoning explained by personality traits and moral disengagement: A study among Dutch nurse practitioners and physician assistants.

AIM: To explore the direct and indirect effect of the personality meta-traits 'Stability' and 'Plasticity' on moral reasoning among nurse practitioners (NPs) and physician assistants (PAs). BACKGROUND: Moral reasoning is influenced by being prone to moral disengagement and personality traits. Moral disengagement is observed among professionals in many fields, including healthcare providers. Moral disengagement is known to be provoked by environmental stressors and influenced by certain personality traits. DESIGN: A cross-sectional approach was used including self-report questionnaires. METHODS: A convenience sample of Dutch NPs (N = 67) and PAs (N = 88) was surveyed via online questionnaires between January and March 2015, using (a) the Defining Issues Test; (b) the BIG five inventory; and (c) the Moral Disengagement Scale. Structural equation modelling (SEM) was employed for estimating the construct validity of two meta-traits of personality and to test unidirectional influences on moral reasoning. RESULTS: Only the Stability trait was a direct predictor of moral reasoning whereas both Stability and Plasticity were precursors of moral disengagement. Both personality meta-traits had statistically significant indirect effects on moral reasoning through a low level of moral disengagement. The influence of both personality traits on the level of moral reasoning was increased by strong self-censure on entering into morally disengaged interactions. CONCLUSION: The personality meta-trait 'Stability' is an indicator of moral reasoning and is explained by a lower propensity to morally disengage among highly stable people. Although the meta-trait Plasticity exerts an indirect effect through moral disengagement on moral reasoning, it is not a direct indicator of moral reasoning.

Differences between Slovak and Dutch patients scheduled for coronary artery bypass graft surgery regarding clinical and psychosocial predictors of physical and mental health-related quality of life.

BACKGROUND: Differences in health-related quality of life in coronary artery disease patients and associated factors between patients of central and western European descent are rarely investigated. We aim to test differences between Dutch and Slovak health-related quality of life, whether nationality predicted health-related quality of life and if standardised beta weights of health-related quality of life determinants differ across countries. DESIGN: An observational multicentre study at university cardiac centres in the Netherlands and Slovakia. METHODS: In 226 coronary artery disease patients, health-related quality of life was measured by the Short Form Health Survey 36, anxiety and depression were measured using the Hospital Anxiety and Depression Scale, and type D personality was assessed with the 14-item Type D Scale. Multivariate analysis was used to explore the effect of patient characteristics on the physical and mental component summaries. Estimates of each predictor's beta value of the physical and mental component summaries in the Slovak and Dutch patient sample were separately calculated using the Cummings criterion for comparison of two independent betas. RESULTS: Stronger predictors of physical health-related quality of life in Slovak patients were educational level, current smoking, poor functional status, history of diabetes and amount of social support. In Dutch patients, only more symptoms of depression was a stronger predictor ( P<0.05). Regarding Slovak mental health-related quality of life, stronger predictors were educational level, current smoking and amount of social support. Female gender, history of myocardial infarction and more symptoms of depression were stronger predictors in Dutch patients ( P<0.05). CONCLUSION: Descent and differences between both populations in determinants of health-related quality of life should be considered while planning care, follow-up, health education and rehabilitation.

Seven years' mortality in Roma and non-Roma patients after coronary angiography.

BACKGROUND: Ethnicity is associated with differences in clinical course and outcomes of cardiac disease, often in association with a poorer socioeconomic position. The aim of this study was to compare the mortality after coronary angiography (CAG) of Roma and non-Roma patients matched for education and adjusted for gender and age. METHODS: In total, 816 patients were included in the study (167 Roma and 649 non-Roma). Data on socio-demographic background, disease history, use of drugs, coronary findings and type of treatment were obtained from medical records. Mortality was assessed up to seven years after CAG. Kaplan-Meier curves of mortality were plotted, and differences between the Roma and non-Roma patients were assessed using log-rank tests, matched for education and adjusted for gender and age. RESULTS: Mortality after CAG was significantly higher among Roma than non-Roma (log-rank test χ(2) = 7.59, P < 0.01) and remained so after matching for education and adjustment for gender, age, history of previous myocardial infarction and abnormal CAG (hazard ratio: 2.07, 95% confidence interval: 1.13-3.82). CONCLUSION: Mortality after CAG is higher among Roma, and this is not due to differences in age, gender or education. These results warrant further reconsideration of the management of Roma cardiac patients.

The Geriatric ICF Core Set reflecting health-related problems in community-living older adults aged 75 years and older without dementia: development and validation.

PURPOSE: The aim of the present study was to develop a valid Geriatric ICF Core Set reflecting relevant health-related problems of community-living older adults without dementia. METHODS: A Delphi study was performed in order to reach consensus (≥70% agreement) on second-level categories from the International Classification of Functioning, Disability and Health (ICF). The Delphi panel comprised 41 older adults, medical and non-medical experts. Content validity of the set was tested in a cross-sectional study including 267 older adults identified as frail or having complex care needs. RESULTS: Consensus was reached for 30 ICF categories in the Delphi study (fourteen Body functions, ten Activities and Participation and six Environmental Factors categories). Content validity of the set was high: the prevalence of all the problems was >10%, except for d530 Toileting. The most frequently reported problems were b710 Mobility of joint functions (70%), b152 Emotional functions (65%) and b455 Exercise tolerance functions (62%). No categories had missing values. CONCLUSION: The final Geriatric ICF Core Set is a comprehensive and valid set of 29 ICF categories, reflecting the most relevant health-related problems among community-living older adults without dementia. This Core Set may contribute to optimal care provision and support of the older population. Implications for Rehabilitation The Geriatric ICF Core Set may provide a practical tool for gaining an understanding of the relevant health-related problems of community-living older adults without dementia. The Geriatric ICF Core Set may be used in primary care practice as an assessment tool in order to tailor care and support to the needs of older adults. The Geriatric ICF Core Set may be suitable for use in multidisciplinary teams in integrated care settings, since it is based on a broad range of problems in functioning. Professionals should pay special attention to health problems related to mobility and emotional functioning since these are the most prevalent problems in community-living older adults.

Determinants of physical and mental health complaints in dentists: a systematic review.

Occupational determinants of ill health in dentists were systematically reviewed in literature. The methodological quality of the studies was evaluated. Studies were included if they evaluated health-related risk factors in dental practice by means of quantitative methods and statistical analysis of collected data. Despite all the factors affecting dentists' physical and mental health, evidence of the predictive value of all these risk factors remains scarce. More than one-third (37%) of the studies appraised were found to be low quality research (weak or invalid). Results from studies investigating the factors associated with ill health in dentists do not allow for conclusions at the meta-level. More prospective and retrospective case-control studies should be conducted and attention should be paid to measuring outcomes with validated instruments to enable comparative studies and statistical summation of findings.

Decline in health-related quality of life 6 months after coronary artery bypass graft surgery: the influence of anxiety, depression, and personality traits.

BACKGROUND: Although coronary artery bypass graft (CABG) is known to improve health-related quality of life (HRQoL), this improvement does not seem to be realized in all patients who had undergone CABG surgery. OBJECTIVE: The aim of this study was to test the direct and indirect influence of personality trait Type D on no change-deterioration trajectories HRQoL and the mediating influence of increased symptoms of anxiety and depression. METHODS: The hypothesized influence of personality trait Type D on the relationship between increased anxiety and depression and no change-deterioration trajectories in HRQoL was tested with path analysis using structural equation modeling. RESULTS: The results of the current study show that Type D personality comprised a vulnerability factor for poor patient-reported outcomes (ie, HRQoL and distress), and despite significant and clinically relevant benefits also for Type D patients after CABG, their well-being remained poorer than that of non-Type D participants at 6 months. Increased levels of anxiety largely mediated the influence of Type D personality on no change-deterioration trajectories in both physical and mental HRQoL, whereas increased symptoms of depression explained deterioration in physical and mental HRQoL without the influence of Type D personality. CONCLUSION: There is evidence that increased symptoms of psychological distress is a strong predictor of no change-deterioration trajectories in HRQoL and that this relationship is influenced by personality trait Type D. We conclude that mediating factors, especially increased anxiety and depression, should be treated adequately in post-CABG clinical routine.

Influence of disease severity on fatigue in patients with Parkinson's disease is mainly mediated by symptoms of depression.

PURPOSE: Fatigue is a frequent non-motor complaint of patients with Parkinson's disease (PD). Despite increasing knowledge on fatigue, the factors leading to its development are still not recognised. The aim of this investigation was to test, using structural equation modelling, the hypothesis that the influence of disease severity on fatigue is mediated by symptoms of depression in patients with PD. METHOD: The sample consisted of 190 PD patients (93 men, 48.9%, mean age 68.2±9.3 years, mean disease duration 6.4±4.7 years) recruited from hospitals and outpatient clinics in the East Slovakia region. The Multidimensional Fatigue Inventory, the Hospital Anxiety and Depression Scale and the Unified Parkinson's Disease Rating Scale were used. LISREL was used to analyse the data. RESULTS: Disease severity was directly associated with symptoms of depression (ß=0.26) and directly affected fatigue in terms of increased levels of general fatigue (ß=0.35), physical fatigue (ß=0.22), reduced activity (ß=0.31) and mental fatigue (ß=0.29), but did not directly influence reduced motivation. Symptoms of depression mediated the impact of disease severity on general fatigue (ß=0.25), on reduced activity (ß=0.31) and on mental fatigue (ß=0.28), but not on physical fatigue. Reduced motivation was not mediated, but directly influenced by more symptoms of depression (ß=0.82). DISCUSSION: Since increased symptoms of depression mediate the impact of disease severity on three domains of fatigue in PD patients, disease management should focus on the treatment of PD and symptoms of depression.

Experienced stigmatization reduced quality of life of patients with a neuromuscular disease: a cross-sectional study.

OBJECTIVE: To examine the influence of stigma on the quality of life of patients with a neuromuscular disease. DESIGN: Cross-sectional postal survey. SETTING: Outpatient clinic of the Department of Neurology, University Hospital Groningen, the Netherlands. SUBJECTS: Patients diagnosed with a neuromuscular disease. MEASURES: The Stigma Scale for Chronic Illness, the World Health Organization Quality of Life - abbreviated version questionnaires and some background and disease-related questions. The Stigma Scale for Chronic Illness was translated into Dutch according to international guidelines. The impact of stigma on quality of life was estimated using hierarchical multiple regression analysis after controlling for the extent of limitations and patient characteristics. RESULTS: In total 235 patients (75% response rate) were diagnosed with neuromuscular disease and represented all four categories of the approximately 600 neuromuscular diseases. Most patients (86%) reported self stigma, while 64% reported to experience enacted stigma. Experienced quality of life was moderate to good. Stigma contributed to a unique and substantial extent to all domains of quality of life: explained variance for the impact of stigma on quality ranged from 0.13 (social relations) to 0.34 (physical functioning) for self stigma and from 0.09 (social relations) to 0.11 (physical and psychological health, and quality of the environment). CONCLUSION: Self stigma was a stronger predictor for poorer quality of life compared with enacted stigma. In other words: patients suffered more from shame and fear for discrimination (self stigma) than from the really experienced discrimination and exclusion (enacted stigma).

Embrace, a model for integrated elderly care: study protocol of a randomized controlled trial on the effectiveness regarding patient outcomes, service use, costs, and quality of care.

BACKGROUND: Ongoing growth in health care expenditures and changing patterns in the demand for health care challenge societies worldwide. The Chronic Care Model (CCM), combined with classification for care needs based on Kaiser Permanente (KP) Triangle, may offer a suitable framework for change. The aim of the present study is to investigate the effectiveness of Embrace, a population-based model for integrated elderly care, regarding patient outcomes, service use, costs, and quality of care. METHODS/DESIGN: The CCM and the KP Triangle were translated to the Dutch setting and adapted to the full elderly population living in the community. A randomized controlled trial with balanced allocation was designed to test the effectiveness of Embrace. Eligible elderly persons are 75 years and older and enrolled with one of the participating general practitioner practices. Based on scores on the INTERMED-Elderly Self-Assessment and Groningen Frailty Indicator, participants will be stratified into one of three strata: (A) robust; (B) frail; and (C) complex care needs. Next, participants will be randomized per stratum to Embrace or care as usual. Embrace encompasses an Elderly Care Team per general practitioner practice, an Electronic Elderly Record System, decision support instruments, and a self-management support and prevention program - combined with care and support intensity levels increasing from stratum A to stratum C. Primary outcome variables are patient outcomes, service use, costs, and quality of care. Data will be collected at baseline, twelve months after starting date, and during the intervention period. DISCUSSION: This study could provide evidence for the effectiveness of Embrace. TRIAL REGISTRATION: The Netherlands National Trial Register NTR3039.

Type D, anxiety and depression in association with quality of life in patients with Parkinson's disease and patients with multiple sclerosis.

PURPOSE: The present study examines the role of Type D personality, anxiety and depression in quality of life (QoL) in patients with two chronic neurological diseases--Parkinson's disease (PD) and multiple sclerosis (MS). METHODS: This cross-sectional study included 142 PD patients (73 % males; mean age 67.6 ± 9.2 years) and 198 patients with MS (32.3 % males; 38.4 ± 10.8 years). Multiple regression analyses were used to analyze the association of UDPRS (PD patients) or EDSS (MS patients), Type D personality (DS-14) and anxiety and depression (HADS) with the physical (PCS) and mental summary (MCS) of QoL, as measured by the SF-36. RESULTS: In PD patients, Type D was significantly associated with MCS only; in MS patients, Type D was significantly associated with both dimensions--MCS and PCS. After adding anxiety and depression, the importance of Type D for the QoL model dramatically decreased. Anxiety and depression were strongly associated with lower scores in MCS and PCS in both PD and MS patients. CONCLUSIONS: The actual mood of PD and MS patients--the level of anxiety or depression--might have a greater impact on patients' QoL than their personality. Further longitudinal research should focus on how the pathway consisting of personality traits, anxiety and depression, and QoL might be constructed.

Social support and psychological distress in rheumatoid arthritis: a 4-year prospective study.

INTRODUCTION: The objective of the study was to investigate the course of psychological distress in early rheumatoid arthritis patients and to explore the strength of its associations with disease-related variables over time. A further aim focused specifically on the associations between social support and psychological distress. METHODS: The study had a longitudinal design, with four annual measurements over consecutive years. The course and stability of psychological distress on the individual level were investigated via test-retest correlation coefficients and changes over time were studied using the Friedman test for repeated measurements. Hierarchical regression analysis was performed to analyze the multilinear associations of disease activity, functional disability, joint tenderness, pain and social support with psychological distress. RESULTS: Significant cross-sectional associations were found among functional disability, joint tenderness, pain, emotional support, instrumental support and psychological distress. However, after controlling for the erratic pattern of the disease and the relevant variables, only initial psychological distress and emotional support retained a significant relationship with psychological distress. The final regression model, in which functional disability, pain, emotional support and initial psychological distress were significant variables, explained 36% of the variance in psychological distress. CONCLUSION: The study stresses the importance of initial psychological distress, which was found to have the highest correlation with psychological distress experienced 4 years later. In addition, higher emotional support and lower pain were found to be the only variables independently associated with lower levels of psychological distress after controlling for the relevant variables.

Employment status and perceived health status in younger and older people with multiple sclerosis.

This study explores how employment is associated with perceived physical and mental health status in people with multiple sclerosis (MS) adjusted for sociodemographic and clinical variables stratified by age. The sample consisted of 184 MS patients divided into a younger (<45 years) and an older (≥45 years) age group. Respondents underwent an interview, a neurological examination on disability [Expanded Disability Status Scale (EDSS)], and completed the Short Form-36 Health Survey. Of the respondents (mean age 40.5±6.2 years), 43.5% were employed. Significant differences between younger and older patients were found in employment, EDSS, disease duration, and five Short Form-36 Health Survey dimensions. Block-step multiple regression explained 32.4% of the variance in physical health and 14.5% in mental health in the younger group. Being employed was significantly related to good physical health, whereas EDSS diminished the effect of being employed on physical health. The most important variable for mental health was employment status in the younger group. For the older age group, 19.1% of the variance in physical health and 14.0% of the variance in mental health was explained by the studied variables. Male gender and a lower EDSS were significant explanatory variables of better physical health. Male gender significantly explained mental health in the older age group. In conclusion, employment status was an explanatory variable for physical health and mental health in the younger patients. EDSS played a significant role in physical health for all patients. A vocational rehabilitation program could prevent eventual nonemployment and improve health outcomes in older MS people.

The impact of sleep and mood disorders on quality of life in Parkinson's disease patients.

Sleep disturbances are common and often severe in patients with Parkinson's disease (PD) and their symptoms can be present at any time of day. The purpose of our study was to examine how excessive daytime sleepiness or poor nocturnal sleep quality and mood disorders influence the quality of life (QoL) in PD patients. Ninety-three PD patients from eastern Slovakia were recruited (49.5% males, mean age 68.0 ± 9.5 years, mean disease duration 6.1 ± 5.9 years). Sleep disturbances were measured using the Epworth Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index (PSQI); QoL with the Parkinson's Disease Quality of Life Questionnaire (PDQ-39); depression and anxiety with the Hospital Anxiety and Depression Scale (HADS) and disease severity with the Unified Parkinson's Disease Rating Scale (UPDRS). χ (2) test, bivariate correlations and multiple linear regressions were performed. PSQI and ESS had significant correlations with worse QoL (p < 0.01, p < 0.05, respectively). HADS-D (p < 0.01), HADS-A (p < 0.01), UPDRS (p < 0.01) and disease duration (p < 0.05) were also significantly related to worse QoL. In the linear regression analysis, however, only PSQI (p < 0.01), anxiety (p < 0.001) and UPDRS (p < 0.001) remained significant. The model with PSQI explained 74% of the variance, and the model with ESS explained 63% of the variance in PDQ-39 when analyses were performed separately. In an overall model, however, only PSQI remained significant, accounting for 82% of the variance in PDQ-39. Nighttime poor sleep and anxiety are important contributors leading to a worse QoL. As these are treatable conditions, they should be recognized by clinicians and managed properly.

Construct and criterion validity of the DUFS and DEFS4 in Lithuanian patients with coronary artery disease.

BACKGROUND: Fatigue has become an important symptom in clinical diagnosis and clinical trials among subjects with cardiovascular diseases and disease-specific fatigue scales were developed in a Dutch and English version. OBJECTIVE: Various questionnaires for measuring fatigue have been developed, but currently no validated questionnaire targeted at subjects with cardiovascular disease and heart failure exists in the Lithuanian language. METHODS: Despite the rigor of the exploratory factor analysis and analyses of the psychometric properties of the disease-specific Dutch Fatigue Scale and the Dutch Exertion Fatigue Scale (DUFS-DEFS) we adopted a confirmatory approach considered as the gold standard method for the evaluation of construct validity in psychometric inventories. To test the criterion validity of the DUFS and DEFS structural equation modelling was employed with the widely used and validated Multidimensional Fatigue Inventory (MFI). RESULTS: The a priori specification of a hypothesized five-factor model of the MFI-20 and a two-factor model of the DUFS and DEFS appeared to have a good fit to the data in Lithuanian patients. The hypothesized model of the criterion validity of the DUFS and DEFS had a good fit and classes of disease severity showed statistically significant and clinically relevant differences on fatigue scores. CONCLUSION: The construct validity and criterion validity of the DUFS and DEFS were confirmed in a Lithuanian sample of cardiac patients. The construct validity of the MFI was also supported and this fatigue measure can be used in Lithuanian settings of clinical practice and research.

Psychosocial predictors of change in quality of life in patients after coronary interventions.

OBJECTIVE: Health-related quality of life (HRQOL) after coronary interventions (coronary artery bypass grafting, percutaneous transluminal coronary angioplasty) usually improves in patients, but not in all patients. Some patients actually show a significant decline in HRQOL. Our aim was to explore the potential of psychologic well-being (anxiety, depression), vital exhaustion, Type D personality, and socioeconomic position as predictors of HRQOL in patients with coronary disease. METHODS: A total of 106 patients scheduled for coronary angiography were interviewed before (baseline) and 12 to 24 months after coronary angiography. Socioeconomic status was evaluated by education. The General Health Questionnaire 28 was used for measuring psychologic well-being (anxiety, depression), the Maastricht interview was used for measuring vital exhaustion, and the Type D questionnaire was used for measuring personality. HRQOL was assessed using the Short Form-36 (physical and mental components) questionnaire. Functional status was assessed with a combination of New York Heart Association and Canadian Cardiovascular Society classifications. Linear regressions were used to analyze data. RESULTS: A change in physical HRQOL was predicted by baseline psychologic well-being (ß = -.39; 95% confidence interval [CI], -1.00 to -.16) and baseline HRQOL (ß = -.61; 95% CI, -.83 to -.34). A change in mental HRQOL was predicted by (baseline) psychologic well-being (ß = -.37; 95% CI, -.99 to -.09), vital exhaustion (ß = -.21; 95% CI, -.69 to -.03), and baseline HRQOL (ß = -.76; 95% CI, -1.03 to -.44). Ejection fraction did not significantly predict HRQOL. CONCLUSION: Psychosocial factors (psychologic well-being, vital exhaustion) seem to be more important predictors of change in HRQOL compared with some objective medical indicators (ejection fraction) among patients with coronary disease.

Design of a Randomised Controlled Trial (RCT) on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients.

BACKGROUND: Case management has been suggested as an innovative strategy that facilitates the improvement of a patient's quality of life, reduction of hospital length of stay, optimization of self-care and improvement of satisfaction of patients and professionals involved. However, there is little evidence about the effectiveness of the patient advocacy case management model in clinical practice.Therefore, the objective of our study was to examine the effects of the Dutch patient advocacy case management model for severely disabled Multiple Sclerosis (MS) patients and their caregivers compared to usual care. METHODS/DESIGN: In this randomized controlled trial the effectiveness of casemanagement on quality of life of patients and their caregivers, quality of care, service use and economic aspects were evaluated. The primary outcomes of this study were quality of life of MS-patients and caregiver burden of caregivers.Furthermore, we examined quality of life of caregivers, quality of care, service use and costs. DISCUSSION: This is a unique trial in which we examined the effectiveness of case management from a broad perspective. We meticulously prepared this study and applied important features and created important conditions for both intervention and research protocol to increase the likelihood of finding evidence for the effectiveness of patient advocacy case management. Concerning the intervention we anticipated to five important conditions: 1) the contrast between the case management intervention compared to the usual care seems to be large enough to detect intervention effects; 2) we included patients with complex care situations and/or were at risk for critical situations; 3) the case managers were familiar with disease specific health-problems and a broad spectrum of solutions; 4) case managers were competent and authorized to perform a medical neurological examination and worked closely with neurologists specialized in MS; and 5) the case managers had a regional network of professionals and health care organisations at their disposal, and were accepted as a coordinator of care. We also put a lot of effort on the selection of eligible patients, randomization and statistical methods, but also on power analysis, selection of reliable, validated and sensitive outcome measures, and (statistical) control of confounders. TRIAL REGISTRATION: Dutch Trial Register http://www.trialregister.nl. Trial ID: NTR762.