Juergen Bengel

What treatment works best for restless legs syndrome? Meta-analyses of dopaminergic and non-dopaminergic medications

BACKGROUND At the time of writing only dopamine agonists are licensed for the treatment of restless legs syndrome (RLS) in various countries, but randomized controlled trials (RCTs) have been performed with other treatments. We performed comprehensive meta-analyses and indirect comparisons of RCTs for all currently recommended treatments of RLS. METHODS We searched the Central, Medline, Embase, PsycINFO and CINAHL databases. Outcome measures were the international RLS study group severity scale (IRLS), clinical global impression-improvement, (CGI-I), periodic limb movement index (PLMI), and psychosocial parameters such as quality of life (QoL). We also conducted indirect comparisons by testing for heterogeneity between the substance groups. RESULTS Placebo (58 trials) and actively (4 trials) controlled RCTs with dopamine agonists (38 trials), levodopa (4 trials), anticonvulsants (13 trials), most of them with α₂δ ligands (11 trials), opioids (1 trial), and iron treatments (6 trials) were included (9596 patients). Although treatment effects showed large variations, changes in the IRLS in the substance groups were comparable (P = 0.78), with a mean reduction in the IRLS of -5.47 points for dopamine agonists, -5.12 points for anticonvulsants (α₂δ ligands and levetiracetam), and -4.59 points for iron treatments. The CGI-I indicated slightly different treatment effects between the substance groups, while PLMI changes during treatment differed (P = 0.002), showing a marked decrease with dopamine agonists (-22.50/h), levodopa (-26.01/h), and oxycodone (-34.46/h) compared with a slight decrease for anticonvulsants (α₂δ ligands and levetiracetam; -8.48/h) and iron treatments (-13.10/h). Quality of sleep and QoL improved moderately in most of the RCTs investigating these parameters (standardized mean difference, SMD) 0.40 and 0.33, respectively). In the few studies evaluating the change of depressive (n = 4) or anxiety symptoms (n = 3), these symptoms improved slightly (SMD -0.24, and -0.21). Adverse effects and dropouts were comparable in number across all substance groups. In meta-regressions, the treatment effect was predicted by the design of the trial (the more sites involved in a trial the lower the effect) and by the duration of action of a medication (the longer the duration of action, expressed as the half-life time of a substance, the greater the improvement), the latter indicating potential superiority of treatments with stable blood concentration. CONCLUSION This first meta-analysis of all RCTs for the pharmacological treatment of RLS provides evidence that, besides the well-defined efficacy of dopaminergic treatment, other treatments with different pharmacological principles show efficacy in small samples and may be well-tolerated alternatives for the treatment of RLS. In the group of anticonvulsants, only the trials performed with α₂δ ligands such as gabapentin, gabapentin enacarbil, and pregabalin showed good efficacy. This indicates a specific mechanism of action of these substances in RLS. The group of iron treatments consisted of a few trials with different compounds in oral and intravenous application form, respectively. For a more differentiated evaluation of the efficacy of iron treatments further studies are necessary. The large efficacy of one opioid RCT in RLS has to be confirmed in further studies.

Psychological distress of patients suffering from restless legs syndrome: a cross-sectional study

BackgroundRestless legs syndrome (RLS) is a chronic disorder with substantial impact on quality of life similar to that seen in diabetes mellitus or osteoarthritis. Little is known about the psychological characteristics of RLS patients although psychological factors may contribute to unfavourable treatment outcome.MethodsIn an observational cross-sectional design, we evaluated the psychological features of 166 consecutive RLS patients from three outpatient clinics, by means of the Symptom Checklist 90-R (SCL-90-R) questionnaire. Additionally, the Beck Depression Inventory-II (BDI-II) and the International RLS Severity Scale (IRLS) were measured. Both treated and untreated patients were included, all patients sought treatment.ResultsUntreated patients (n = 69) had elevated but normal scores on the SCL-90-R Global Severity Index (GSI; p = 0.002) and on the sub-scales somatisation (p < 0.001), compulsivity (p = 0.003), depression (p = 0.02), and anxiety (p = 0.004) compared with a German representative sample. In the treated group, particularly in those patients who were dissatisfied with their actual treatment (n = 62), psychological distress was higher than in the untreated group with elevated scores for the GSI (p = 0.03) and the sub-scales compulsivity (p = 0.006), depression (p = 0.012), anxiety (p = 0.031), hostility (p = 0.013), phobic anxiety (p = 0.024), and paranoid ideation (p = 0.012). Augmentation, the most serious side effect of dopaminergic, i.e. first-line treatment of RLS, and loss of efficacy were accompanied with the highest psychological distress, as seen particularly in the normative values of the sub-scales compulsivity and anxiety. Generally, higher RLS severity was correlated with higher psychological impairment (p < 0.001).ConclusionSeverely affected RLS patients show psychological impairment in multiple psychological domains which has to be taken into account in the treatment regimen.

Development and Evaluation of a Computer Adaptive Test to Assess Anxiety in Cardiovascular Rehabilitation Patients

OBJECTIVE To develop and evaluate a computer adaptive test for the assessment of anxiety in cardiovascular rehabilitation patients (ACAT-cardio) that tailors an optimal test for each patient and enables precise and time-effective measurement. DESIGN Simulation study, validation study (against the anxiety subscale of the Hospital Anxiety and Depression Scale and the physical component summary scale of the 12-Item Short-Form Health Survey), and longitudinal study (beginning and end of rehabilitation). SETTING Cardiac rehabilitation centers. PARTICIPANTS Cardiovascular rehabilitation patients: simulation study sample (n=106; mean age, 57.8y; 25.5% women) and validation and longitudinal study sample (n=138; mean age, 58.6 and 57.9y, respectively; 16.7% and 12.1% women, respectively). INTERVENTIONS Not applicable. MAIN OUTCOME MEASURES Hospital Anxiety and Depression Scale, 12-Item Short-Form Health Survey, and ACAT-cardio. RESULTS The mean number of items was 9.2 with an average processing time of 1:13 minutes when an SE ≤.50 was used as a stopping rule; with an SE ≤.32, there were 28 items and a processing time of 3:47 minutes. Validity could be confirmed via correlations between .68 and .81 concerning convergent validity (ACAT-cardio vs Hospital Anxiety and Depression Scale anxiety subscale) and correlations between -.47 and -.30 concerning discriminant validity (ACAT-cardio vs 12-Item Short-Form Health Survey physical component summary scale). Sensitivity to change was moderate to high with standardized response means between .45 and .82. CONCLUSIONS The ACAT-cardio shows good psychometric properties and provides the opportunity for an innovative and time-effective assessment of anxiety in cardiovascular rehabilitation. A more flexible stopping rule might further improve the ACAT-cardio. Additionally, testing in other cardiovascular populations would increase generalizability.

Development and calibration of an item bank for the assessment of activities of daily living in cardiovascular patients using Rasch analysis.

BackgroundTo develop and calibrate the activities of daily living item bank (ADLib-cardio) as a prerequisite for a Computer-adaptive test (CAT) for the assessment of ADL in patients with cardiovascular diseases (CVD).MethodsAfter pre-testing for relevance and comprehension a pool of 181 ADL items were answered on a five-point Likert scale by 720 CVD patients, who were recruited in fourteen German cardiac rehabilitation centers. To verify that the relationship between the items is due to one factor, a confirmatory factor analysis (CFA) was conducted. A Mokken analysis was computed to examine the double monotonicity (i.e. every item generates an equivalent order of person traits, and every person generates an equivalent order of item difficulties). Finally, a Rasch analysis based on the partial credit model was conducted to test for unidimensionality and to calibrate the item bank.ResultsResults of CFA and Mokken analysis confirmed a one factor structure and double monotonicity. In Rasch analysis, merging response categories and removing items with misfit, differential item functioning or local response dependency reduced the ADLib-cardio to 33 items. The ADLib-cardio fitted to the Rasch model with a nonsignificant item-trait interaction (chi-square=105.42, df=99; p=0.31). Person-separation reliability was 0.81 and unidimensionality could be verified.ConclusionsThe ADLib-cardio is the first calibrated, unidimensional item bank that allows for the assessment of ADL in rehabilitation patients with CVD. As such, it provides the basis for the development of a CAT for the assessment of ADL in patients with cardiovascular diseases. Calibrating the ADLib-cardio in other than rehabilitation cardiovascular patient settings would further increase its generalizability.

Aus-, Fort- und Weiterbildung „Psychologie in der Rehabilitation“

The commission for vocational training, training and further education of the German Society of Rehabilitation Science tends to discuss and to give recommendations for various professions in rehabilitation. The working group, which is led by J. Bengel/Freiburg and M. Morfeld/Magdeburg-Stendal created an inventory of Rehabilitation Psychology. The training programs for Rehabilitation Psychology at universities and universities of applied science in Germany are based on a job profile of psychologists in medical and vocational rehabilitation. The different universities have diverse priorities focusing on Rehabilitation Psychology. The offer changes because of the adaption of requirements and implementation of Bologna Reform. The training and further education offers are specific and available for large indication areas. Finally outstanding issues and problems are pointed out.

Is there a role of depressive symptoms in the fear-avoidance model? A structural equation approach

Abstract The fear-avoidance (FA) model has gained widespread acceptance as a conceptual framework for investigating psychological factors such as FA beliefs and avoidance behavior, which contribute to chronic back pain and reduced functioning. Depressive symptoms are supposed to be related to FA beliefs and to foster avoidance behavior. This study aims to investigate the multivariate assumptions of the FA model with a focus on the role of depressive symptoms. A total of N = 360 patients with chronic nonspecific low back pain at admission of inpatient orthopedic rehabilitation participated in the survey. Measures included a numeric pain rating scale, Fear-Avoidance Beliefs Questionnaire, Pain Anxiety Symptoms Scale, Hannover Functional Ability Questionnaire and Patient Health Questionnaire. Using structural equation modeling (SEM), we construed a basic FA model and subsequently extended it by adding symptoms of depression as a covariate. The results of SEM indicated a good model fit for a basic FA model (χ²(263) = 431.069, p < .001, RMSEA = .042, CFI = .964, WRMR = .986). They confirmed the hypothesized relations and supported single mediations of the relationship between pain and functioning by FA beliefs and avoidance behavior. A second model including symptoms of depression as additional covariate (χ²(511) = 722.761, p < .001, RMSEA = .034, CFI = .956, WRMR = .949) showed a high impact of depressive symptoms on all FA model variables leading to a decrease of the FA mediations. The findings provide empirical support for the multivariate FA model and underline the importance of considering depressive symptoms in a multiple-target approach to understand the mechanisms of chronic pain.

Inanspruchnahmebereitschaft und Inanspruchnahmeverhalten von Behandlungen aufgrund psychischer Belastungen bei Patienten der somatischen Rehabilitation

BACKGROUND AND OBJECTIVES Somatically ill patients in somatic rehabilitation often show comorbid psychological distress and mental disorders. In the framework of the implementation of a stepwise psychodiagnostic procedure, the present study investigated the intention to use and the use of treatment due to psychological distress. METHODOLOGY Cohort study with a 6-months follow-up in 5 orthopedic, cardiologic and oncologic inpatient rehabilitation clinics (n=1 374). Psychological distress, sociodemographic data, intention to use psychotherapeutic or psychiatric treatments and the use of health care offers due to psychological distress were assessed by means of questionnaires. RESULTS Every third patient (34%) was psychologically distressed at the beginning of rehabilitation. A positive intention to use psychotherapeutic or psychiatric treatment was reported by 79% of the psychologically distressed patients. 6 months after the end of rehabilitation, 26% of the patients who were psychologically distressed at the beginning of rehabilitation, had received treatment for mental health reasons. Reasons for non-utilization of treatment included lack of subjective need (45%) and lack of interest in treatment despite a perceived need (30%). Further 25% were considering treatment or were seeking appropriate treatment. CONCLUSIONS Psychologically distressed rehabilitation patients show a high intention to undergo treatment. However, they show a clearly diminished use of post-rehabilitative treatments due to mental health problems. Hence, the promotion of motivation as well as the management of treatment barriers for improving post-rehabilitative use in psychologically distressed rehabilitants are of particular importance.

Development of Rasch-Based Item Banks for the Assessment of Work Performance in Patients with Musculoskeletal Diseases

Purpose This study aimed to develop a self-description assessment instrument to measure work performance in patients with musculoskeletal diseases. In terms of the International Classification of Functioning, Disability and Health (ICF), work performance is defined as the degree of meeting the work demands (activities) at the actual workplace (environment). To account for the fact that work performance depends on the work demands of the job, we strived to develop item banks that allow a flexible use of item subgroups depending on the specific work demands of the patients’ jobs. Methods Item development included the collection of work tasks from literature and content validation through expert surveys and patient interviews. The resulting 122 items were answered by 621 patients with musculoskeletal diseases. Exploratory factor analysis to ascertain dimensionality and Rasch analysis (partial credit model) for each of the resulting dimensions were performed. Results Exploratory factor analysis resulted in four dimensions, and subsequent Rasch analysis led to the following item banks: ‘impaired productivity’ (15 items), ‘impaired cognitive performance’ (18), ‘impaired coping with stress’ (13) and ‘impaired physical performance’ (low physical workload 20 items, high physical workload 10 items). The item banks exhibited person separation indices (reliability) between 0.89 and 0.96. Conclusions The assessment of work performance adds the activities component to the more commonly employed participation component of the ICF-model. The four item banks can be adapted to specific jobs where necessary without losing comparability of person measures, as the item banks are based on Rasch analysis.