Engaging Refugees With a Culturally Adapted Digital Intervention to Improve Sleep: A Randomized Controlled Pilot Trial.

Refugees are exposed to multiple stressors affecting their mental health. Given various barriers to mental healthcare in the arrival countries, innovative healthcare solutions are needed. One such solution could be to offer low-threshold treatments, for example by culturally adapting treatments, providing them in a scalable format, and addressing transdiagnostic symptoms. This pilot trial examined the feasibility, acceptance, and preliminary effectiveness of a culturally adapted digital sleep intervention for refugees. Sixty-six refugees participated, with 68.2% of them seeking psychological help for the first time. Only three participants did not show clinically significant insomnia severity, 93.9% reported past traumatic experiences. Participants were randomly assigned to the intervention group (IG) or the waitlist control group (CG). Insomnia severity, measured by the Insomnia Severity Index, and secondary outcomes (sleep quality, fear of sleep, fatigue, depression, wellbeing, mental health literacy) were assessed at baseline, 1 and 3 months after randomization. The self-help intervention included four modules on sleep hygiene, rumination, and information on mental health conditions associated with sleep disturbances. 66.7% of the IG completed all modules. Satisfaction with the intervention and its perceived cultural appropriateness were high. Linear multilevel analyses revealed a small, non-significant intervention effect on insomnia severity of Hedge's g = 0.28 at 3-months follow-up, comparing the IG to the CG [F 2, 60 = 0.88, p = 0.421]. This non-confirmatory pilot trial suggests that low-threshold, viable access to mental healthcare can be offered to multiple burdened refugees by culturally adapting an intervention, providing it in a scalable format, and addressing a transdiagnostic symptom.

Effectiveness of an internet-based intervention to improve sleep difficulties in a culturally diverse sample of international students: A randomised controlled pilot study.

Sleep difficulties are widespread among international students. Internet-based interventions are suggested as a low-threshold treatment option but may require cultural adaptation among culturally diverse populations. The present pilot study investigated the effectiveness and acceptance of an internet-based intervention to improve sleep difficulties in international students. A total of 81 international students of 36 nationalities were randomly assigned to the intervention (n = 41) or waitlist control group (n = 40). The intervention group received immediate access to a culturally non-adapted unguided internet-based sleep intervention consisting of three modules based on sleep hygiene and cognitive techniques to reduce rumination. At baseline, 4 and 12 weeks after randomisation, insomnia severity, measured by the Insomnia Severity Index, and secondary outcomes (sleep quality, depression, anxiety, perceived stress, well-being, presenteeism, mental health literacy) were assessed. Data were analysed using linear multi-level analyses. Additionally, satisfaction and perceived cultural appropriateness of the intervention were evaluated by international students after 4 weeks, and compared with ratings of German students, who represent the original target group. Insomnia severity improved over time in the intervention group compared to the control group, revealing a significant estimated mean difference of -5.60 (Hedges' g = 0.84, p < 0.001) after 12 weeks. Satisfaction and perceived cultural appropriateness was high and comparable to that of German students. The present study shows that a culturally non-adapted internet-based sleep intervention can be a low-threshold treatment option to help meet the high demand for mental healthcare among international students. It thus indicates that cultural adaptation might not represent a precondition for providing effective internet-based sleep interventions to this target group.

Cultural adaptation of internet- and mobile-based interventions for mental disorders: a systematic review.

Providing accessible and effective healthcare solutions for people living in low- and middle-income countries, migrants, and indigenous people is central to reduce the global mental health treatment gap. Internet- and mobile-based interventions (IMI) are considered scalable psychological interventions to reduce the burden of mental disorders and are culturally adapted for implementation in these target groups. In October 2020, the databases PsycInfo, MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Web of Science were systematically searched for studies that culturally adapted IMI for mental disorders. Among 9438 screened records, we identified 55 eligible articles. We extracted 17 content, methodological, and procedural components of culturally adapting IMI, aiming to consider specific situations and perspectives of the target populations. Adherence and effectiveness of the adapted IMI seemed similar to the original IMI; yet, no included study conducted a direct comparison. The presented taxonomy of cultural adaptation of IMI for mental disorders provides a basis for future studies investigating the relevance and necessity of their cultural adaptation.PROSPERO registration number: CRD42019142320.

Cultural adaptation of Internet- and mobile-based interventions for mental disorders: a systematic review protocol.

BACKGROUND: Internet- and mobile-based interventions (IMI) are an effective and scalable low-threshold solution to reach people who are undersupplied by current healthcare. Adapting interventions to the cultural and ethnic background of the target group enhances their acceptance and effectiveness. However, no systematic approach to cultural adaptation of IMI has been established so far. Therefore, this review aims to summarise components and procedures commonly used in the cultural adaptation of IMI for mental disorders, as well as the current evidence base on whether such a cultural adaptation leads to an increased acceptance, adherence, and effectiveness of IMI for mental disorders. METHODS: A systematic literature search will be performed using the following databases: MEDLINE, Embase, PsycINFO, CENTRAL, and WoS. The search term will include keywords related to cultural adaptation, IMI, and mental disorders/disturbances. Two independent reviewers will evaluate studies against inclusion and exclusion criteria and extract study and intervention characteristics, details on the cultural adaptation approach, and outcome data. Quality of evidence will be assessed using the Quality Assessment Tool for Reviewing Studies with Diverse Designs, and results will be synthesised qualitatively. DISCUSSION: Providing adequate mental healthcare regardless of cultural backgrounds is a major global health challenge. The planned systematic review will lay the foundation for the further development of the cultural adaptation of IMI for mental disorders by summarising the current state and providing recommendations for future research. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019142320.

Assessing Communication Skills in Real Medical Encounters in Oncology: Development and Validation of the ComOn-Coaching Rating Scales.

One of the challenges in research on teaching physician-patient communication is how to assess communication, necessary for evaluating training, the learning process, and for feedback. Few instruments have been validated for real physician-patient consultations. Real consultations involve unique contexts, different persons, and topics, and are difficult to compare. The aim of this study is to develop and validate a rating scale for assessment of such consultations. For the evaluation study of a communication skills training for physicians in oncology, real consultations were recorded in three assessment points. Based on earlier work and on current studies, a new instrument was developed for assessment of these consultations. Two psychologists were trained in using the instrument and assessed 42 consultations. For inter-rater reliability, interclass correlation (ICC) was calculated. The final version of the rating scales consists of 13 items evaluated on a 5-point scale. The items are grouped in seven areas: "Start of conversation," "assessment of the patient's perspective," "structure of conversation," "emotional issues," "end of conversation," "general communication skills," and "overall evaluation." ICC coefficients for the domains ranged from .44 to .77. An overall coefficient of all items resulted in an ICC of .66. The ComOn-Coaching Rating Scales are a short, reliable, and applicable instrument for the assessment of real physician-patient consultations in oncology. If adapted, they could be used in other areas. They were developed for research and teaching purposes and meet the required methodological criteria. Rater training should be considered more deeply by further research.

Cultural adaptation of internet interventions for refugees: Results from a user experience study in Germany.

BACKGROUND: The estimated number of refugees worldwide resulting from persecution, conflict, violence, or human rights violations reached 25.4 million in 2017. An increased prevalence of mental disorders combined with language and socio-cultural barriers pose a challenge for healthcare systems. Internet-based interventions can help to meet this challenge. For the effective use of such interventions in refugees, cultural adaptations are necessary. The variety of their cultural backgrounds thereby is particularly challenging. METHODS: We conducted this explorative qualitative study in order to identify elements of Internet-based interventions that need cultural adaptation to be suitable for refugees. Six refugees from Syria, Iran, Eritrea, Algeria, and Iraq, and six healthcare providers (two social workers, two psychologists, one physiotherapist, one physician) working with refugees went through an intervention for individuals with sleeping problems (eSano Sleep-e). Possible threats to user experience were identified using the Think Aloud method and semi-structured interviews. Statements were analysed based on the grounded theory method. RESULTS: Results indicate the necessity to adapt the intervention to the specifics of refugees including aspects related to the flight (i.e., past and current stressors) and non-western characteristics (i.e., habits, disease and treatment concepts). Elements of adaptation should include pictures, role models, language, psychoeducational elements, structure of modules, and format of presentation. CONCLUSIONS: Cultural adaptation can be used to facilitate the identification with an intervention, which seems crucial to increase the acceptance among refugees. In spite of their diverse cultural backgrounds, it appears feasible to create interventions that allow identification by refugees from different home countries.

Cognitive behavioral group therapy for patients with physical diseases and comorbid depressive or adjustment disorders on a waiting list for individual therapy: results from a randomized controlled trial.

BACKGROUND: Depressive and adjustment disorders are highly prevalent in patients with physical diseases and are associated with poorer quality of life, increased morbidity and mortality, as well as higher healthcare costs. Access to mental health care holds strong importance for these patients, although waiting times for outpatient individual psychotherapy in Germany are often long. Attending an intervention while waiting for individual therapy could improve this problem. For this purpose, we developed an eight-session cognitive behavioral group therapy (STEpS) and tested its efficacy in a randomized controlled trial. METHODS: Seventy-six patients with chronic physical diseases and comorbid depressive or adjustment disorders were randomized to either STEpS or a waiting list control group. The primary outcome was self-reported depression measured by the Hospital Anxiety and Depression Scale (HADS-D), while the secondary outcomes included global psychological distress and health-related quality of life. Data was assessed at baseline, post-treatment and 2-month follow-up and was analyzed based on intention-to-treat. RESULTS: Compared to the control group, the STEpS group showed significantly less depression (d = 0.37; p = .009) and significantly higher quality of life (mental: d = 0.47; p = .030; physical: d = 0.70; p = .001) at post-treatment. The groups did not differ in global psychological distress. At 2-month follow-up, the STEpS group indicated significantly higher subjective physical health (d = 0.43; p = .046), but did not differ from the control group in the remaining outcomes. CONCLUSIONS: STEpS proved effective in improving depression and health-related quality of life in the short term but did not reveal effects on mental outcomes at 2-month follow-up. Nonetheless, the implementation of STEpS as a waiting list intervention prior to individual therapy could help patients to handle long waiting periods in outpatient care. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005140 (27 August 2013).

Effect of individualized communication skills training on physicians' discussion of clinical trials in oncology: results from a randomized controlled trial.

BACKGROUND: Discussing randomized clinical trials (RCTs) with cancer patients is one of the most challenging communication tasks a physician faces. Only two prior Communication Skills Trainings (CSTs) focused on RCTs in oncology have been reported. Their results demonstrated the need for further improvement. We developed and evaluated an enhanced, individually-tailored CST focused on improving physicians' communication during discussions of RCTs. METHODS: The CST focused on personal learning goals derived from video pre-assessment that were addressed in a 1.5-day group workshop and one-on-one coaching sessions. Forty physicians were recruited and randomly assigned to intervention and control groups. Video-recorded standardized consultations with actor-patients were utilized. As a primary outcome (1), training success was evaluated by blinded raters using a previously developed checklist. Change in checklist items was evaluated between pre- and post-training assessment and compared against control group results. As a secondary outcome (2), the physicians' feeling of confidence was assessed by a questionnaire. RESULTS: (1) Significant improvements in the intervention group were observed for the score on all items (p = 0.03), for the subgroup of content-specific items (p = 0.02), and for the global rating of communication competence (p = 0.04). The improvement observed for the subgroup of general communication skill items did not achieve significance (p = 0.20). (2) The feeling of confidence improved in nine out of ten domains. CONCLUSION: While the individually-tailored CST program significantly improved the physicians' discussions of RCTs, specifically related to discussion content, what remains unknown is the influence of such programs in practice on participant recruitment rates. The study was registered retrospectively in 2010/07/22 under DRKS-ID: DRKS00000492 .

Development and validation of parallel short forms PaSA-cardio for the assessment of general anxiety in cardiovascular rehabilitation patients using Rasch analysis.

OBJECTIVE: To develop and validate parallel short forms for the assessment of general anxiety in cardiovascular rehabilitation patients, that facilitate repeated measurement over time without contamination from residual practice effect variance. DESIGN: Development of the parallel short forms using Rasch analysis. Validation study. SETTING: Cardiac rehabilitation centres in Germany. SUBJECTS: Cardiovascular rehabilitation patients. INTERVENTIONS: Not applicable. MAIN MEASURES: Parallel short forms PaSA-cardio, Hospital Anxiety and Depression Scale, Short Form Health Survey SF-12 and Structured Clinical Interview for DSM-IV Axis I Disorders. RESULTS: Each version of the parallel short forms (PaSA-cardio-I and PaSA-cardio-II) comprises ten items. The two forms fitted to the Rasch model with a non-significant item-trait interaction (PaSA-cardio-I: chi-square = 39.49, degrees of freedom = 30, probability = 0.12; PaSA-cardio-II: chi-square = 26.56, degrees of freedom = 30, probability = 0.65). Person-separation reliability was 0.75/0.76. Unidimensionality could be verified. Correlation between the two models was 0.94 and 0.95, and correlations with the underlying item bank were 0.95 and 0.93. Validity could be confirmed. The area under the curve was between 0.88 and 0.97 for PaSA-cardio-I and between 0.92 and 0.95 for PaSA-cardio-II. CONCLUSIONS: Assessment of general anxiety in cardiovascular rehabilitation patients with the PaSA-cardio was valid, economical and accurate. The two forms of the PaSA-cardio are equivalent and allow retest without contamination from residual practice effect variance.

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

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.

Immediate help through group therapy for patients with somatic diseases and depressive or adjustment disorders in outpatient care: study protocol for a randomized controlled trial.

BACKGROUND: One in three people with a chronic somatic disease suffer from a comorbid mental disorder. Most common comorbidities are depressive, anxiety and adjustment disorders. These lead to an increase in morbidity and mortality, and a deterioration of quality of life and healthcare costs. Treatment of mental disorders is of great importance, but the waiting time for outpatient individual psychotherapy can be up to six months in Germany. Group therapy has comparable treatment effects and is considerably more economic than individual therapy; however, it is still almost unused in the outpatient care system. The introduction of a stepped care approach, such as attending a group program before individual therapy, could improve this issue. For this purpose we developed a group program (STEpS), and its efficacy will be evaluated in this study. METHODS/DESIGN: A randomized controlled trial will be conducted to evaluate the efficacy of a cognitive behavioral therapy (CBT) group program for patients with somatic diseases and depressive or adjustment disorders, compared to a wait-list control group. A total of 128 adults with any chronic somatic disease and comorbid depression or adjustment disorder will be recruited in our outpatient clinic, and will be randomly assigned to participate in the group program immediately after contacting the clinic (intervention group) or after a waiting period of four months (wait-list control group). Primary outcomes will be self-reported depressive and anxiety symptoms. Secondary outcomes will be self-reported psychological distress, changes in experience and behavior, health-related quality of life, state of self-esteem and subjective need for therapy. Assessments will take place at baseline, 10 weeks (post-treatment) and 18 weeks (follow-up) after randomization. Additionally, treatment acceptance and psychotherapeutic process will be assessed after each session. DISCUSSION: This study investigates whether the CBT group program is an effective treatment to reduce depressive and anxiety symptoms and psychological distress in these patients. If the group program is effective, it could be implemented as a treatment option prior to individual outpatient therapy. These results will contribute to improving outpatient care for mental disorders in patients with somatic diseases. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005140 (27 August 2013).

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.

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

BACKGROUND: To 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). METHODS: After 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. RESULTS: Results 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. CONCLUSIONS: The 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.

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.

The calibrated, unidimensional anxiety item bank for cardiovascular patients provided the basis for anxiety assessment in cardiovascular rehabilitation patients.

OBJECTIVE: Computer adaptive tests (CATs) offer a flexible, test fair, and economic opportunity for accurate measurement of anxiety in patients with cardiovascular diseases (CVDs). The objective of this study was to develop and calibrate an item bank [anxiety item bank for cardiovascular patients (AIB-cardio)] as a prerequisite for an anxiety-CAT in CVD patients. STUDY DESIGN AND SETTING: After pretesting for relevance and comprehension, a pool of 155 anxiety items was answered on a five-point Likert scale. Sample consisted of 715 CVD patients, who were recruited in 14 German cardiac rehabilitation centers. A confirmatory factor analysis (CFA), Mokken analysis, and Rasch analysis were conducted. RESULTS: The results of CFA and Mokken analysis confirmed 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 AIB-cardio to 37 items. The AIB-cardio fitted to the Rasch model with a nonsignificant item-trait interaction (chi-square, 133.89; degrees of freedom, 111; P = 0.07). Person separation reliability was 0.85, and unidimensionality could be verified. CONCLUSION: The calibrated, unidimensional AIB-cardio provides the basis for a CAT to assess anxiety in rehabilitation patients with CVD with good psychometric properties. Further testing in other cardiovascular patients is needed to increase generalizability.

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.

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

BACKGROUND: Restless 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. METHODS: In 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. RESULTS: Untreated 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). CONCLUSION: Severely affected RLS patients show psychological impairment in multiple psychological domains which has to be taken into account in the treatment regimen.

Information and decision making: patients' needs and experiences in the course of breast cancer treatment.

OBJECTIVE: This study explored breast cancer patients' preferences and experiences in receiving information and decision making in the course of the first 6 months of cancer treatment. METHODS: Participants were 135 German breast cancer patients, recruited within a week of either surgery or the beginning of neo-adjuvant chemotherapy. Women were asked to complete a self-explanatory questionnaire at baseline and 3 and 6 months later. RESULTS: There was a significant decrease in the importance of specific information needs. The quality of received information through the physician was rated significantly better at baseline than 6 months later. Nearly half of all patients changed their decision making preference at least at one assessment point. Shared decision making rarely took place in the first 6 months of treatment. CONCLUSION: Breast cancer patients' information needs and decision making preferences can change during treatment. Future research should analyse which patients change their decision making preference under which circumstances. PRACTICE IMPLICATIONS: Physicians need to investigate the decision making preferences and information needs of their patients in the course of treatment. Patient oriented communication skills might be helpful to meet patients' preferences and needs.