Validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with somatoform disorders.

BACKGROUND: The EQ-5D is a generic questionnaire providing a preference-based index score applicable to cost-utility analysis. This is the first study to validate the EQ-5D in patients with somatoform disorders. METHODS: Data of the EQ-5D descriptive system, the British and the German EQ-5D index and the EQ Visual Analogue Scale, the Patient Health Questionnaire 15, the Patient Health Questionnaire 9, the Whiteley Index 7 and the Short Form 36 were collected from 294 patients at baseline, 244 at 6 months and 256 at 12 months after baseline. The discriminative ability of the EQ-5D was evaluated by comparison with a general population sample and by the ability to distinguish between different symptom severities. Convergent validity was analysed by assessing associations between the EQ-5D and the other instruments. Responsiveness was evaluated by analysing the effects on scores between two measurements in groups of patients reporting worse, same or better health. The Bonferroni correction was employed. RESULTS: For all items of the EQ-5D except 'self-care', patients with somatoform disorders reported more problems than the general population. The EQ-5D showed discriminative ability in patients with different symptom severities. For nearly all reference instruments there were significant differences in mean scores between respondents with and without problems in the various EQ-5D items and strong correlations with the EQ Visual Analogue Scale and the EQ-5D index scores. Evidence for the responsiveness of the EQ-5D could only be found for patients with better health; effects were medium at the utmost. CONCLUSIONS: The EQ-5D showed a considerable validity and a limited responsiveness in patients with somatoform disorders. TRIAL REGISTRATION: Current Controlled Trials ISRCTN55280791.

[New ways in caring for patients with functional syndromes - interdisciplinary group intervention in the primary care setting: a qualitative study]. / Neue Wege in der Versorgung von Patienten mitfunktionellen Syndromen - Interdisziplinäre Gruppen-behandlung in der Hausarztpraxis: Eine qualitative Studie.

Interface problems between health care sectors hinder collaborative care in functional syndromes. The speciAL trial investigated a disorder-oriented group intervention conducted by the general practitioner (GP) and a psychosomatic specialist (PS) in the GP's office. To evaluate the GP-PS cooperation, our qualitative study analysed free text statements about collaborative group leading of all 18 intervention GPs. In the GPs' view, all sessions should structuredly be prepared and reviewed together for 20 min. Functions of the preparatory communication were gaining distance from daily business, attunement to the group and to each other, and preparing for the session topics. Functions of the communication after the sessions were professional exchange, reflection of the session and further treatment planning. The GPs saw the PS's role as a group leader and expert, their own role as a reference person for the patient, a link between all dimensions and a cotherapist. Crucial seemed a succeeding role splitting.

Economics of medically unexplained symptoms: a systematic review of the literature.

OBJECTIVE: To review cost-of-illness studies (COI) and economic evaluations (EE) conducted for medically unexplained symptoms and to analyze their methods and results. METHODS: We searched the databases PubMed, PsycINFO and National Health Service Economic Evaluations Database of the University of York. Cost data were inflated to 2006 using country-specific gross domestic product inflators and converted to 2006 USD purchasing power parities. RESULTS: We identified 5 COI and 8 EE, of which 6 were cost-minimization analyses and 2 were cost-effectiveness analyses. All studies used patient level data collected between 1980 and 2004 and were predominantly conducted in the USA (n = 10). COI found annual excess health care costs of somatizing patients between 432 and 5,353 USD in 2006 values. Indirect costs were estimated by only one EE and added up to about 18,000 USD per year. In EE, educational interventions for physicians as well as cognitive-behavioral therapy approaches for patients were evaluated. For both types of interventions, effectiveness was either shown within EE or by previous studies. Most EE found (often insignificant) cost reductions resulting from the interventions, but only two studies explicitly combined changes in costs with data on effectiveness to cost-effectiveness ratios (ratio of additional costs to additional effects). CONCLUSIONS: Medically unexplained symptoms cause relevant annual excess costs in health care that are comparable to mental health problems like depression or anxiety disorders and which may be reduced by interventions targeting physicians as well as patients. More extensive research on indirect costs and cost-effectiveness is needed.

Maternal mental healthcare needs of refugee women in a State Registration and Reception Centre in Germany: A descriptive study.

Pregnant refugees and new mothers are at high risk of developing mental health problems. Previous research has highlighted an increase in adverse pre-, peri- and postpartum outcomes in refugee women and their newborns. This descriptive study aimed to present the characteristics and needs of refugee women who attended a psychosocial walk-in clinic addressing pregnant refugees' and new mothers' maternity mental healthcare needs in a state registration and reception centre in Germany. We assessed all patients that consulted the clinic and received interventions during the first 28 weeks after it opened, collecting information on symptoms, diagnoses, attitudes towards and experience of pregnancy, birth, obstetric care and applied psychosocial interventions during consultations. Between November 2017 and May 2018, N = 120 pregnant refugees and new mothers attended the clinic. Most patients were diagnosed with post-traumatic stress-, adjustment- or depressive disorder. While 69.6% of the women reported physical and mental health problems during pregnancy, 87.4% experienced obstetric complications. Trauma-informed and psychoeducational interventions were primarily used during counselling sessions. Our data underpin the glaring disparities in refugee maternal healthcare in Germany. Maternal care designed to meet the specific needs of pregnant refugees and mothers is essential. More targeted, evidence-based and cost-effective interventions are needed. Our psychosocial walk-in clinic is a first step towards ensuring primary care delivery for refugee women during the particularly vulnerable period of pregnancy and early motherhood.

Stabilizing Techniques and Guided Imagery for Traumatized Male Refugees in a German State Registration and Reception Center: A Qualitative Study on a Psychotherapeutic Group Intervention.

Refugees have an increased risk of developing mental health problems. Due to the unstable setting in refugee state registration and reception centers, recommended trauma-focused treatment approaches are often not applicable. For this purpose, we devised a suitable therapeutic approach to treat traumatized refugees in a German state registration and reception center: Group therapy, focusing on stabilizing techniques and guided imagery according to Reddemann (2017). From May 2017 to April 2018, we conducted semi-structured interviews with n = 30 traumatized refugees to assess their experiences with the stabilizing techniques and guided imagery in group sessions and self-practice. Participants mainly reported that they had more pleasant feelings, felt increasingly relaxed, and could better handle recurrent thoughts. Additionally, the participants noticed that their psychosocial functioning had improved. The main difficulties that participants encountered were feeling stressed, having difficulties staying focused, or concentrating on the techniques. During self-practice, the participants found it most challenging that they did not have any verbal guidance, were often distracted by the surroundings in the accommodation, and had recurrent thoughts about post-migratory stressors, such as insecurity concerning the future or the application for asylum. Our results show that stabilizing techniques and guided imagery according to Reddemann (2017) are a suitable approach to treat traumatized refugees living in volatile conditions.

Positive impact of retrograde autologous priming in adult patients undergoing cardiac surgery: a randomized clinical trial.

BACKGROUND: Adult cardiac surgery with extracorporeal circulation is known to be associated with increased risk of blood transfusion leading to adverse outcomes. Procedures like retrograde autologous priming (RAP) may reduce these negative side effects. This randomized prospective study was initiated to assess whether RAP using specifically designed RAP bag (Terumo) has immediate effects on patient outcome. METHODS: One hundred eighteen adults undergoing elective CABG or elective aortic valve replacement were randomly assigned by a computer program into two groups: the RAP group (n = 54) in which the retrograde autologous priming was applied and the non-RAP (n = 64) group in which the same setting was used without the possibility to save priming volume. Patient demographics, preoperative characteristics and postoperative outcomes were analyzed for both groups. RESULTS: The primary endpoint defined as rate of intraoperative blood transfusion was significantly reduced in the RAP-group (p = 0.04). The absolute risk reduction for RAP managed patients was 13.5 percent points. There were no significant differences in operation time and blood loss. No deaths and no myocardial infarctions were observed. The number of patients needed to treat to prevent at least one red blood cell transfusion was around 8 (NNT = 7.42). CONCLUSIONS: Retrograde autologous priming is a safe and less invasive procedure which achieves clear benefits for adult cardiac surgery patients. In the light of increasing red blood cell transfusion risks and costs and the wish of patients to avoid a transfusion implementation of retrograde autologous priming is an interesting option. TRIAL REGISTRATION: German Clinical Trials Register ID: DRKS00013512 , registered 04 December 2017.

Psychotherapeutic Group Intervention for Traumatized Male Refugees Using Imaginative Stabilization Techniques-A Pilot Study in a German Reception Center.

Background: Due to persecution, human rights violations and armed conflicts, the prevalence of post-traumatic stress disorder (PTSD) is high in refugee populations. Previous studies indicate that trauma-focused treatments are highly effective in treating PTSD in refugees. However, these approaches rely on the stability of the therapeutic setting, treatment continuity, and safe housing. Although early treatment of PTSD is recommended, these requirements are not met in reception centers. Therefore, we conducted a pilot study to examine the effect of imaginative stabilization techniques derived from psychodynamic psychotraumatology therapy for the early stabilization of traumatized refugees in a reception center. Methods: From May 2017 to April 2018, 86 imaginative stabilization group therapy sessions have taken place. A sample of 43 out of 46 traumatized refugees completed self-report questionnaires assessing PTSD, depression, and anxiety symptoms prior to attending open imaginative stabilization group therapy sessions. Furthermore, participants filled in self-report questionnaires on distress and emotional state (valence/arousal/dominance) before and after each session. After having participated in four consecutive sessions, a sub-group of 17 participants completed a follow-up assessment of PTSD, depression, and anxiety symptoms. Follow-up interviews were conducted with 25 participants 2 weeks after their last session attendance to explore self-practice habits post intervention. Results: The pre-post-intervention comparison of scores indicated a significant reduction of distress (z = -3.35, p < 0.001, r = -0.51) and an improvement of affective reports for valence (z = -4.79, p < 0.001, r = -0.82) and dominance (z = -3.89, p < 0.001, r = -0.59), whereas arousal scores were not affected. We found a significant reduction of anxiety symptoms (z = -2.04, p < 0.05, r = -0.49), whereas PTSD and depression scores remained unchanged. Follow-up interviews revealed that 80% of the participants continued to practice the imaginative stabilization techniques after redistribution to other accommodation. Conclusion: The results indicate that imaginative stabilization techniques are a promising and feasible approach to treat refugees in unstable reception center settings. In regular imaginative stabilization group therapy sessions, we were able to reduce the participants' distress and anxiety symptoms while strengthening their internal resources and increasing their emotional stability.

Abnormal N400 Semantic Priming Effect May Reflect Psychopathological Processes in Schizophrenia: A Twin Study.

OBJECTIVE: Activation of semantic networks is indexed by the N400 effect. We used a twin study design to investigate whether N400 effect abnormalities reflect genetic/trait liability or are related to psychopathological processes in schizophrenia. METHODS: We employed robust linear regression to compare N400 and behavioral priming effects across 36 monozygotic twin pairs (6 pairs concordant for schizophrenia/schizoaffective disorder, 11 discordant pairs, and 19 healthy control pairs) performing a lexical decision task. Moreover, we examined the correlation between Brief Psychiatric Rating Scale (BPRS) score and the N400 effect and the influence of medication status on this effect. RESULTS: Regression yielded a significant main effect of group on the N400 effect only in the direct priming condition (p = 0.003). Indirect condition and behavioral priming effect showed no significant effect of group. Planned contrasts with the control group as a reference group revealed that affected concordant twins had significantly reduced N400 effect compared to controls, and discordant affected twins had a statistical trend for reduced N400 effect compared to controls. The unaffected twins did not differ significantly from the controls. There was a trend for correlation between reduced N400 effect and higher BPRS scores, and the N400 effect did not differ significantly between medicated and unmedicated patients. CONCLUSIONS: Reduced N400 effect may reflect disease-specific processes in schizophrenia implicating frontotemporal brain network in schizophrenia pathology.

Excess costs from functional somatic syndromes in Germany - An analysis using entropy balancing.

AIM: The aim of this study was to calculate disorder-specific excess costs in patients with functional somatic syndromes (FSS). METHODS: We compared 6-month direct and indirect costs in a patient group with FSS (n=273) to a control group of the general adult population in Germany without FSS (n=2914). Data on the patient group were collected between 2007 and 2009 in a randomized controlled trial (speciAL). Data on the control group were obtained from a telephone survey, representative for the general German population, conducted in 2014. Covariate balance between the patient group and the control group was achieved using entropy balancing. Excess costs were calculated by estimating generalized linear models and two-part models for direct costs and indirect costs. Further, we estimated excess costs according to the level of somatic symptom severity (SSS). RESULTS: FSS patients differed significantly from the control group regarding 6-month costs of outpatient physicians (+€280) and other outpatient providers (+€74). According to SSS, significantly higher outpatient physician costs were found for mild (+€151), moderate (+€306) and severe (+€376) SSS. We also found significantly higher costs of other outpatient providers in patients with mild, moderate and severe SSS. Regarding costs of rehabilitation and hospital treatments, FSS patients did not differ significantly from the control group for any level of SSS. Indirect costs were significantly higher in patients with severe SSS (+€760). CONCLUSION: FSS were of major importance in the outpatient sector. Further, we found significantly higher indirect costs in patients with severe SSS.

Association of behavioral inhibition with hair pigmentation in a European sample.

Behavioral inhibition, a temperamental trait signalling a predisposition to childhood and adolescent anxiety disorders, is slightly more frequent in America among Caucasian children having blue irises. This paper examines a community sample of 101 German toddlers assessed for behavioral inhibition in a standardized laboratory procedure. Hair pigmentation was found to be significantly associated with behavioral inhibition in the sense that blond children exhibited higher fear scores. As in American samples, blue-eyed children had a higher fear score than did other children, but this difference was not statistically significant.

Cost-utility of a specific collaborative group intervention for patients with functional somatic syndromes.

BACKGROUND: Collaborative group intervention (CGI) in patients with functional somatic syndromes (FSS) has been shown to improve mental quality of life. OBJECTIVE: To analyse incremental cost-utility of CGI compared to enhanced medical care in patients with FSS. METHODS: An economic evaluation alongside a cluster-randomised controlled trial was performed. 35 general practitioners (GPs) recruited 300 FSS patients. Patients in the CGI arm were offered 10 group sessions within 3months and 2 booster sessions 6 and 12months after baseline. Costs were assessed via questionnaire. Quality adjusted life years (QALYs) were calculated using the SF-6D index, derived from the 36-item short-form health survey (SF-36). We calculated patients' net-monetary-benefit (NMB), estimated the treatment effect via regression, and generated cost-effectiveness acceptability curves. RESULTS: Using intention-to-treat analysis, total costs during the 12-month study period were 5777EUR in the intervention, and 6858EUR in the control group. Controlling for possible confounders, we found a small, but significant positive intervention effect on QALYs (+0.017; p=0.019) and an insignificant cost saving resulting from a cost-increase in the control group (-10.5%; p=0.278). NMB regression showed that the probability of CGI to be cost-effective was 69% for a willingness to pay (WTP) of 0EUR/QALY, increased to 92% for a WTP of 50,000EUR/QALY and reached the level of 95% at a WTP of 70,375EUR/QALY. Subgroup analyses yielded that CGI was only cost-effective in severe somatic symptom severity (PHQ-15≥15). CONCLUSION: CGI has a high probability to be a cost-effective treatment for FSS, in particular for patients with severe somatic symptom severity.

Association of costs with somatic symptom severity in patients with medically unexplained symptoms.

OBJECTIVE: To analyse the association of direct and indirect costs in patients with medically unexplained symptoms (MUS) with somatic symptom severity (SSS). METHODS: A cross-sectional cost analysis for retrospective 6 months was conducted in 294 primary care patients with MUS. Health care utilisation and loss of productivity were measured by questionnaires. SSS was measured using the "Patient Health Questionnaire 15" (PHQ-15). Direct and indirect costs and the association of costs with SSS were analysed via multiple linear regression analysis. RESULTS: Patients with MUS had average 6-month direct costs of 1098 EUR and indirect costs of 7645 EUR. For direct costs, outpatient physician visits were the most expensive single cost category (36%), followed by pharmaceuticals (25%) and hospital stays (19%). Indirect costs were predominantly caused by productivity reduction at work (56%) followed by early retirement (29%) and acute sickness absence (14%). As compared to mild SSS, moderate SSS was not significantly associated with direct, but with indirect costs (+2948 EUR; p<.001); severe SSS was associated with increased direct cost (+658 EUR; p=.001) and increased indirect costs (+4630 EUR; p<.001). Age was positively associated with direct cost (+15 EUR for each additional year; p=.015) as well as indirect cost (+104 EUR for each additional year; p<.001). CONCLUSIONS: MUS are associated with relevant direct and even much higher indirect costs that strongly depend on SSS.

Diagnosing somatisation disorder (P75) in routine general practice using the International Classification of Primary Care.

OBJECTIVE: (i) To analyze general practitioners' diagnosis of somatisation disorder (P75) using the International Classification of Primary Care (ICPC)-2-E in routine general practice. (ii) To validate the distinctiveness of the ICD-10 to ICPC-2 conversion rule which maps ICD-10 dissociative/conversion disorder (F44) as well as half of the somatoform categories (F45.0-2) to P75 and codes the other half of these disorders (F45.3-9), including autonomic organ dysfunctions and pain syndromes, as symptom diagnoses plus a psychosocial code in a multiaxial manner. METHODS: Cross-sectional analysis of routine data from a German research database comprising the electronic patient records of 32 general practitioners from 22 practices. For each P75 patient, control subjects matched for age, gender, and practice were selected from the 2007 yearly contact group (YCG) without a P75 diagnosis using a propensity-score algorithm that resulted in eight controls per P75 patient. RESULTS: Of the 49,423 patients in the YCG, P75 was diagnosed in 0.6% (302) and F45.3-9 in 1.8% (883) of cases; overall, somatisation syndromes were diagnosed in 2.4% of patients. The P75 coding pattern coincided with typical characteristics of severe, persistent medically unexplained symptoms (MUS). F45.3-9 was found to indicate moderate MUS that otherwise showed little clinical difference from P75. Pain syndromes exhibited an unspecific coding pattern. Mild and moderate MUS were predominantly recorded as symptom diagnoses. Psychosocial codes were rarely documented. CONCLUSIONS: ICPC-2 P75 was mainly diagnosed in cases of severe MUS. Multiaxial coding appears to be too complicated for routine primary care. Instead of splitting P75 and F45.3-9 diagnoses, it is proposed that the whole MUS spectrum should be conceptualized as a continuum model comprising categorizations of uncomplicated (mild) and complicated (moderate and severe) courses. Psychosocial factors require more attention.