Prevalence, symptomatology, risk factors and healthcare services utilization regarding paternal depression in Germany: study protocol of a controlled cross-sectional epidemiological study.

BACKGROUND: While postpartum depression is a well-researched disorder in mothers, there is growing evidence indicating that some fathers also develop depressive symptoms (paternal postpartum depression, PPD). A recent meta-analysis revealed a total prevalence of paternal depression during pregnancy and up to one year postpartum of 8.4%, with significant heterogeneity observed among prevalence rates. International studies suggest that PPD is characterized by additional symptoms compared to maternal postpartum depression. Furthermore, various risk factors of PPD have been identified. However, the prevalence, symptomatology, risk factors and healthcare situation of fathers affected by PPD in Germany are unknown. METHODS/DESIGN: This study comprises a controlled, cross-sectional epidemiological survey administered via postal questionnaires. The primary objective is to compare the prevalence of depressive symptoms in fathers with a 0-12-month-old infant to the prevalence of depressive symptoms in men without recent paternity. Two structurally differing regions (concerning birthrate, employment status, socioeconomic structure, and nationality of inhabitants) will be included. A random sample of 4600 fathers (2300 in each region) in the postpartum period and 4600 men without recent paternity matched by age, nationality and marital status will be assessed regarding depressive symptoms using the PHQ-9. Contact data will be extracted from residents' registration offices. As secondary objectives, the study aims to provide insights into symptoms and risk factors of PPD in fathers and to assess the current healthcare situation of fathers with PPD in Germany. In an add-on study, genetic and epigenetic mechanisms of PPD will be explored. DISCUSSION: This study will conduct the first direct comparison between fathers in the postpartum period of one year after childbirth and a matched sample of men without a newborn child. Besides closing this research gap, the findings will provide prevalence estimates as well as insights into specific symptomatology, risk factors, and the current healthcare situation regarding fathers with PPD in Germany. The results will identify low-threshold approaches as a relevant issue for healthcare. Moreover, the findings should inform the development of PPD-specific screening instruments and healthcare offers addressing fathers with PPD. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00013339 ; Trial registration date: August 20, 2018; Universal Trial Number (UTN): U1111-1218-8185.

Education and employment status of adults with autism spectrum disorders in Germany - a cross-sectional-survey.

BACKGROUND: Adults with autism spectrum disorders (ASD) experience challenges in participating in the labour market and struggle to achieve and maintain appropriate professional positions, possibly due to impairments of communication and social interaction. Studies have shown high rates of unemployment as well as evidence of inadequate employment. As knowledge on the participation in the German labour market is scarce, the aim of our study was to examine employment status, type of occupation and inadequate employment in a sample of clinically mostly late-diagnosed and most likely not intellectually disabled adults with ASD in Germany. METHODS: We conducted a cross-sectional-survey in clinically mostly late-diagnosed adults with ASD. Employment status, type of occupation, and the level of formal education and training were examined through a postal questionnaire. Inadequate employment regarding participants' current and longest practised occupation was assessed by transforming participants' information into skill levels of the "Classification of Occupations 2010" of the German Federal Employment Agency, and comparing these with participants' level of formal education and training. RESULTS: The response rate was 43.2% (N = 185 of N = 428 potential participants). 94.6% were first-time diagnosed when being 18 years of age or older. 56.8% held a general university entrance-level qualification and 24.9% had obtained a Masters' or diploma degree as their highest vocational qualification. 94.1% had been employed at some time. Of these, 68.4% reported being currently employed, 13.5% being currently unemployed and 17.0% being retired for health reasons. Regarding the longest-practised and the current occupation, the highest proportion of participants was found in the occupational area "health and social sector, teaching and education" (22.4% and 23.3%, respectively). With respect to inadequate employment, 22.1% were found to be overeducated in relation to their longest-practised occupation and 31.3% in relation to their current occupation. This is significantly higher than the percentage of overeducation in the general population. CONCLUSIONS: Despite largely high formal qualifications, the clinically mostly late-diagnosed adults with ASD represented in our sample are disadvantaged regarding their participation in the German labour market, especially with respect to rates of unemployment, early retirement and overeducation. Employment support programs should be developed to improve employment outcomes.

Effectiveness of a brief psychoeducational group intervention for relatives on the course of disease in patients after inpatient depression treatment compared with treatment as usual--study protocol of a multisite randomised controlled trial.

BACKGROUND: Relapses and rehospitalisations are common after acute inpatient treatment in depressive disorders. Interventions for stabilising treatment outcomes are urgently needed. Psychoeducational group interventions for relatives were shown to be suitable for improving the course of disease in schizophrenia and bipolar disorders. A small Japanese monocentre randomised controlled trial also showed promising results for depressive disorders. However, the evidence regarding psychoeducation for relatives of patients with depressive disorders is unclear. METHODS/DESIGN: The study is conducted as a two-arm multisite randomised controlled trial to evaluate the incremental effect of a brief psychoeducational group intervention for relatives as a maintenance treatment on the course of disease compared to treatment as usual. Primary outcome is the estimated number of depression-free-days in patients within one year after discharge from inpatient treatment. 180 patients diagnosed with unipolar depressive disorders as well as one key relative per patient will be included during inpatient treatment and randomly allocated to the conditions at discharge. In the intervention group, relatives will participate in a brief psychoeducational group intervention following the patient's discharge. The intervention consists of four group sessions lasting 90 to 120 min each. Every group session contains informational parts as well as structured training in problem-solving. In both study conditions, patients will receive treatment as usual. Patients as well as relatives will be surveyed by means of questionnaires at discharge and three, six, nine and twelve months after discharge. In addition to the primary outcome, several patient-related and relative-related secondary outcomes will be considered and health economics will be investigated. DISCUSSION: Our study will provide evidence on the incremental effect of a brief psychoeducational intervention for relatives as a maintenance treatment after inpatient depression treatment. Positive results may have a major impact on health care for depression. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00006819; Trial registration date: 2014 Oktober 31; Universal Trial Number (UTN): U1111-1163-5391.

Usefulness scale for patient information material (USE) - development and psychometric properties.

BACKGROUND: One economical way to inform patients about their illness and medical procedures is to provide written health information material. So far, a generic and psychometrically sound scale to evaluate cognitive, emotional, and behavioral aspects of the subjectively experienced usefulness of patient information material from the patient's perspective is lacking. The aim of our study was to develop and psychometrically test such a scale. METHODS: The Usefulness Scale for Patient Information Material (USE) was developed using a multistep approach. Ultimately, three items for each subscale (cognitive, emotional, and behavioral) were selected under consideration of face validity, discrimination, difficulty, and item content. The final version of the USE was subjected to reliability analysis. Structural validity was tested using confirmatory factor analysis, and convergent and divergent validity were tested using correlation analysis. The criterion validity of the USE was tested in an experimental design. To this aim, patients were randomly allocated to one of two groups. One group received a full version of an information brochure on depression or chronic low back pain depending on the respective primary diagnosis. Patients in the second group received a reduced version with a lower design quality, smaller font size and less information. Patients were recruited in six hospitals in Germany. After reading the brochure, they were asked to fill in a questionnaire. RESULTS: Analyzable data were obtained from 120 questionnaires. The confirmatory factor analysis supported the structural validity of the scale. Reliability analysis of the total scale and its subscales showed Cronbach's α values between .84 and .94. Convergent and divergent validity were supported. Criterion validity was confirmed in the experimental condition. Significant differences between the groups receiving full and reduced information were found for the total score (p<.001) and its three subscales (cognitive p<.001, emotional p=.001, and behavioral p<.001), supporting criterion validity. CONCLUSIONS: We developed a generic scale to measure the subjective usefulness of written patient information material from a patient perspective. Our construct is defined in line with current theoretical models for the evaluation of written patient information material. The USE was shown to be a short, reliable and valid psychometric scale.

Efficacy and acceptability of acute treatments for persistent depressive disorder: a network meta-analysis.

BACKGROUND: We aimed to synthesize the available evidence on the relative efficacy and acceptability of specific treatments for persistent depressive disorder. METHODS: We searched several databases up to January 2013 and included randomized controlled trials that compared acute pharmacological, psychotherapeutic, and combined interventions with each other or placebo. The outcome measures were the proportion of patients who responded to (efficacy) or dropped out from (acceptability) the allocated treatment. Data synthesis was performed with network meta-analysis. RESULTS: A network of 45 trials that tested 28 drugs included data from 5,806 and 5,348 patients concerning efficacy and acceptability, respectively. A second network of 15 trials that tested five psychotherapeutic and five combined interventions included data from 2,657 and 2,719 patients concerning efficacy and acceptability, respectively. Among sufficiently tested treatments, fluoxetine (odds ratio (OR) 2.94), paroxetine (3.79), sertraline (4.47), moclobemide (6.98), imipramine (4.53), ritanserin (2.35), amisulpride (5.63), and acetyl-l-carnitine (5.67) were significantly more effective than placebo. Pairwise comparisons showed advantages of moclobemide (2.38) and amisulpride (1.92) over fluoxetine. Sertraline (0.57) and amisulpride (0.53) showed a lower dropout rate than imipramine. Interpersonal psychotherapy with medication outperformed medication alone in chronic major depression but not in dysthymia. Evidence on cognitive behavioral analysis system of psychotherapy plus medication was partly inconclusive. Interpersonal psychotherapy was less effective than medication (0.48) and cognitive behavioral analysis system of psychotherapy (0.45). Several other treatments were tested in single studies. CONCLUSIONS: Several evidence-based acute pharmacological, psychotherapeutic, and combined treatments for persistent depressive disorder are available with significant differences between them.

Provision of group psychoeducation for relatives of persons in inpatient depression treatment--a cross-sectional survey of acute care hospitals in Germany.

BACKGROUND: Depressive disorders are often recurrent and place a high burden on patients and their relatives. Psychoeducational groups for relatives may reduce relatives' burden, help prevent relapses in patients, and are recommended by the German "National Disease Management Guideline Unipolar Depression". Since there is limited knowledge on the provision of psychoeducational groups for relatives of persons in inpatient depression treatment, we conducted a survey among acute care hospitals in Germany. METHODS: We conducted a two-step cross-sectional survey. Step I consisted of a questionnaire asking the heads of all psychiatric/psychosomatic acute care hospitals in Germany (N = 512) whether psychoeducational groups for relatives were provided within depression treatment, and if not, the reasons for not implementing them. In group offering hospitals the person responsible for conducting psychoeducational groups received a detailed questionnaire on intervention characteristics (step II). We performed descriptive data analysis. RESULTS: The response rate was 50.2% (N = 257) in step I and 58.4% in step II (N = 45). 35.4% of the responding hospitals offered psychoeducational groups for relatives of patients with depressive disorders. According to the estimates of the respondents, relatives of about one in five patients took part in psychoeducational groups in 2011. Groups were mostly provided by two moderators (62.2%) as continuous groups (77.8%), without patients' participation (77.8%), with up to ten participants (65.9%), consisting of four or fewer sessions (51.5%) which lasted between one and one and a half hours each (77.8%). The moderators in charge were mostly psychologists (43.9%) or physicians (26.8%). Approximately one third used published manuals. Reasons for not conducting such psychoeducational groups were lack of manpower (60.1%), time (44.9%) and financial constraints (24.1%). 25.3% mentioned adequate concepts of intervention as a required condition for initiating such groups. CONCLUSIONS: Only a small proportion of relatives of patients with depressive disorders participated in psychoeducational groups in 2011 in Germany. Mostly short interventions were favoured and main implementation barriers were scarce resources. Brief interventions that fit with healthcare routine should be developed and tested within randomised controlled trials. This could promote the provision of psychoeducational groups for relatives as evidence-based practice in inpatient depression treatment in Germany.

Freiburg Questionnaire of linguistic pragmatics (FQLP): psychometric properties based on a psychiatric sample.

BACKGROUND: Asperger's Syndrome (AS) is an autism spectrum disorder that is characterized by significant difficulties in social interaction and nonverbal communication, and restricted and repetitive patterns of behavior and interests. Difficulties with respect to pragmatic speech, reading emotional and social cues, differentiating between fact and fiction, and taking into account the influence of context on a statement are commonly described features. However, hitherto established questionnaires did not focus on these symptoms. METHODS: In this study we present a short (11 questions) questionnaire which focuses on self-rated pragmatic speech abilities, the Freiburg Questionnaire of linguistic pragmatics (FQLP). Psychometric properties of the questionnaire were explored in a sample of 57 patients with Asperger's Syndrome, 66 patients with other psychiatric disorders, and a convenience sample of 56 people. RESULTS: Reliability analysis showed a high Cronbach's α. Strong correlations could be demonstrated for the FQLP with the Autism Quotient and the Empathy Quotient. Concerning divergent validity a moderate correlation was found between the FQLP and self-rated symptoms of personality disorders. No significant correlation was found between the FQLP and the vocabulary skills. The receiver operating characteristics curve showed an excellent diagnostic accuracy of the FQLP (.97). CONCLUSIONS: As the control group consisted of people without mental disorder and patients with different psychiatric disorders, the results indicate that the construct examined by the FQLP is quite specific to the peculiarities of AS. The FQLP is a reliable, brief and valid instrument. First results regarding sensitivity and specificity are highly promising.

Patient preference for involvement, experienced involvement, decisional conflict, and satisfaction with physician: a structural equation model test.

BACKGROUND: A comprehensive model of the relationships among different shared decision-making related constructs and their effects on patient-relevant outcomes is largely missing. Objective of our study was the development of a model linking decision-making in medical encounters to an intermediate and a long-term endpoint. The following hypotheses were tested: physicians are more likely to involve patients who have a preference for participation and are willing to take responsibility in the medical decision-making process, increased patient involvement decreases decisional conflict, and lower decisional conflict favourably influences patient satisfaction with the physician. METHODS: This model was tested in a German primary care sample (N = 1,913). Psychometrically tested instruments were administered to assess the following: patients' preference for being involved in medical decision-making, patients' experienced involvement in medical decision-making, decisional conflict, and satisfaction with the primary care provider. Structural equation modelling was used to explore multiple associations. The model was tested and adjusted in a development sub-sample and cross-validated in a confirmatory sample. Demographic and clinical characteristics were accounted for as possible confounders. RESULTS: Local and global indexes suggested an acceptable fit between the theoretical model and the data. Increased patient involvement was strongly associated with decreased decisional conflict (standardised regression coefficient Β = -.73). Both high experienced involvement (Β = .34) and low decisional conflict (B = -.28) predicted higher satisfaction with the physician. Patients' preference for involvement was negatively associated with the experienced involvement (B = -.24). CONCLUSION: Altogether, our model could be largely corroborated by the collected empirical data except the unexpected negative association between preference for involvement and experienced involvement. Future research on the associations among different SDM-related constructs should incorporate longitudinal studies in order to strengthen the hypothesis of causal associations.

Combination of pharmacotherapy and psychotherapy in the treatment of chronic depression: a systematic review and meta-analysis.

BACKGROUND: Chronic depression represents a substantial portion of depressive disorders and is associated with severe consequences. This review examined whether the combination of pharmacological treatments and psychotherapy is associated with higher effectiveness than pharmacotherapy alone via meta-analysis; and identified possible treatment effect modifiers via meta-regression-analysis. METHODS: A systematic search was conducted in the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, ISI Web of Science, BIOSIS, PsycINFO, and CINAHL. Primary efficacy outcome was a response to treatment; primary acceptance outcome was dropping out of the study. Only randomized controlled trials were considered. RESULTS: We identified 8 studies with a total of 9 relevant comparisons. Our analysis revealed small, but statistically not significant effects of combined therapies on outcomes directly related to depression (BR = 1.20) with substantial heterogeneity between studies (I² = 67%). Three treatment effect modifiers were identified: target disorders, the type of psychotherapy and the type of pharmacotherapy. Small but statistically significant effects of combined therapies on quality of life (SMD = 0.18) were revealed. No differences in acceptance rates and the long-term effects between combined treatments and pure pharmacological interventions were observed. CONCLUSIONS: This systematic review could not provide clear evidence for the combination of pharmacotherapy and psychotherapy. However, due to the small amount of primary studies further research is needed for a conclusive decision.

The latent factor structure of Young's early maladaptive schemas: are schemas organized into domains?

OBJECTIVE: In previous research it has not been clarified whether the first-order schema factors of the Young Schema Questionnaire (YSQ) can be structured into higher order domains. We examined whether investigators' subjective choices between complex models of the YSQ or chance as opposed to clinical diversity of the samples may be responsible for the heterogeneity of results reported in the literature. METHOD: We used confirmatory factor analysis to compare several a priori defined domain models in a sample of 542 undergraduate students (82.8% female; mean age 24.1 years) and 590 nonstudent adults (73.9% female; mean age 34.5 years) form an Internet survey. An additional Monte Carlo simulation study was performed to gain further insights on model selection. RESULTS: The analyses did not provide unequivocal support for the presence of a second-order domain structure. However, study findings suggested that the structure of the YSQ could be represented by a bifactor model including a first-order generic factor on which all items load and correlated first-order specific schema factors on which only the items load that were meant to measure the respective schemas. CONCLUSION: In the YSQ either several second-order domain structures are present that cannot be ranked by statistical measures alone or a first-order generic factor is present making second-order domains dispensable. Future research should include theoretical arguments and incorporate the clinical experience of practitioners.

COVID-19 vaccination rates in hospitalized mentally ill patients compared to the general population in Germany: Results from the COVID Ψ Vac study.

BACKGROUND: Mental illness is known to come along with a large mortality gap compared to thegeneral population and it is a risk for COVID-19 related morbidity andmortality. Achieving high vaccination rates in people with mental illness is therefore important. Reports are conflicting on whether vaccination rates comparable to those of the general population can be achieved and which variables represent risk factors for nonvaccination in people with mental illness. METHODS: The COVID Ψ Vac study collected routine data on vaccination status, diagnostic groups, sociodemographics, and setting characteristics from in- and day-clinic patients of 10 psychiatric hospitals in Germany in August 2021. Logistic regression modeling was used to determine risk factors for nonvaccination. RESULTS: Complete vaccination rates were 59% (n = 776) for the hospitalized patients with mental illness versus 64% for the regionally and age-matched general population. Partial vaccination rates were 68% (n = 893) for the hospitalised patients with mental illness versus 67% for the respective general population and six percentage (n = 74) of this hospitalized population were vaccinated during the hospital stay. Rates showed a large variation between hospital sites. An ICD-10 group F1, F2, or F4 main diagnosis, younger age, and coercive accommodation were further risk factors for nonvaccination in the model. CONCLUSIONS: Vaccination rates were lower in hospitalized people with mental illness than in the general population. By targeting at-risk groups with low-threshold vaccination programs in all health institutions they get in contact with, vaccination rates comparable to those in the general population can be achieved.

Challenges in the Transition from In-Patient to Out-Patient Treatment in Depression.

BACKGROUND: Few data are available on the characteristics of inpatient treatment and subsequent outpatient treatment for depression in Germany. In this study, we aimed to characterize the inpatient and outpatient treatment phases, to determine the rates of readmission and mortality, and to identify risk factors. METHODS: We carried out a descriptive statistical analysis of routine administrative data from a large health-insurance carrier (BARMER). All insurees aged 18 to 65 who were treated in 2015 as inpatients on a psychiatry and psychotherapy service or on a psychosomatic medicine and psychotherapy service with a main diagnosis of depression were included in the analysis. Risk factors for readmission and death were determined with the aid of mixed logistic regression. RESULTS: Of the 22 893 patients whose data were analyzed, 78% had been hospitalized on a psychiatry and psychotherapy service and 22% on a psychosomatic medicine and psychotherapy service. The median length of hospital stay was 42 days. Follow-up care in the outpatient setting failed to conform with the recommendations of the pertinent guidelines in 92% of the patients with a main diagnosis of severe depression during hospitalization, and in 50% of those with moderate depression. 21% of the patients were readmitted within a year. The mortality at one year was 961 per 100 000 individuals (adjusted for the age and sex structure of the German population), or 3.4 times the mortality of the population at large. In the regression model, more treatment units during hospitalization and subsequent treatment with psychotherapy were associated with a lower probability of readmission, while longer hospitalization with subsequent pharmacotherapy or psychotherapy was associated with lower mortality. CONCLUSION: The recommendations of the national (German) S3 guidelines for the further care of patients who have been hospitalized for depression are inadequately implemented at present in the sectored structures of in- and outpatient care in the German health care system. This patient group has marked excess mortality.

Cost-effectiveness analysis of collaborative treatment of late-life depression in primary care (GermanIMPACT).

BACKGROUND: Late-life depression is a highly prevalent disorder that causes a large economic burden. A stepped collaborative care program was set up in order to improve care for patients with late-life depression in primary care in Germany: GermanIMPACT is the adaption of the Improving Mood-Promoting Access to Collaborative Treatment (IMPACT) program that has already been established in primary care in the USA. The aim of this study was to determine the cost-effectiveness of GermanIMPACT compared with treatment as usual from a societal perspective. METHODS: This study is part of a 12-month bi-centric cluster-randomized controlled trial aiming to assess the effectiveness of GermanIMPACT compared with treatment as usual among patients with late-life depression. A cost-effectiveness analysis using depression-free days (DFDs) was performed. Net-monetary benefit (NMB) regressions adjusted for baseline differences for different willingness-to-pay (WTP) thresholds were conducted and cost-effectiveness acceptability curves were constructed. RESULTS: In total, n = 246 patients (intervention group: n = 139; control group: n = 107) with a mean age of 71 from 71 primary care practices were included in the analysis. After 12 months, adjusted mean differences in costs and DFDs between intervention group and control group were +€354 and +21.4, respectively. Only the difference in DFDs was significant (p = 0.022). According to the unadjusted incremental cost-effectiveness ratio, GermanIMPACT was dominant compared with treatment as usual. The probability of GermanIMPACT being cost-effective was 80%, 90% or 95% if societal WTP per DFD was ≥€70, ≥€110 or ≥€180, respectively. CONCLUSION: Evidence for cost-effectiveness of GermanIMPACT relative to treatment as usual is not clear. Only if societal WTP was ≥€180 for an additional DFD, GermanIMPACT could be considered cost-effective with certainty.

Coordinated Treatment of Depression in Elderly People in Primary Care.

BACKGROUND: Depression in the elderly is mainly treated by primary care physicians; the treatment is often suboptimal because of the limited resources available in pri- mary care. New models of care in which treatment by a primary care physician is supplemented by the provision of brief, low-threshold interventions mediated by care managers are showing themselves to be a promising approach. METHODS: In this open, cluster-randomized, controlled study, we sought to determine the superiority of a model of this type over the usual form of treatment by a primary care physician. Patients in primary care aged 60 and above with moderate depres- sive manifestations (PHQ-9: 10-14 points) were included in the study. The primary endpoint was the percentage of patients in remission (score <5 on the Patient Health Questionnaire, PHQ-9) after the end of the intervention (12 months after baseline). The study was registered in the German Clinical Studies Registry (Deutsches Register für Klinische Studien) with the number DRKS00003589. RESULTS: 71 primary care physicians entered 248 patients in the study, of whom 109 were in the control group and 139 in the intervention group. In an intention-to-treat analysis, the remission rate at 12 months was 25.6% (95% confidence interval [18.3; 32.8]) in the intervention group and 10.9% [5.4; 16.5]) in the control group (p = 0.004). CONCLUSION: This study demonstrates the superiority of the new care model in the primary care setting in Germany, as has been found in other countries.

[What Determines Treatment Recommendations of Relatives: The Role of Expectations, Negative Consequences and Control Attributions for the Treatment of Patients with Psychosis]. / Was führt zu Behandlungsempfehlungen von Angehörigen: Die Rolle von Erfolgserwartung, negativen Folgen und Kontrollattributionen bei der Behandlung von Patienten mit Psychosen.

Objective Therapy recommendations of relatives of individuals with psychotic disorders. Method A total of n = 52 inpatient relatives were interviewed about their attitude towards psychotherapy and antipsychotics. Results Over 80 % of the relatives recommended psycho- and pharmacotherapy. Concerns reduced recommendations for pharmacotherapy, poor/lack of hope for improvement reduced recommendations for psychotherapy. Conclusion The relatives' therapy recommendations could be influenced by discussing their concerns and expectations of success.

Effects of culture-sensitive adaptation of patient information material on usefulness in migrants: a multicentre, blinded randomised controlled trial.

OBJECTIVES: To evaluate the usefulness of culture-sensitive patient information material compared with standard translated material. DESIGN: Multicentre, double-blind randomised controlled trial. SETTING: 37 primary care practices. PARTICIPANTS: 435 adult primary care patients with a migration background with unipolar depressive disorder or non-specific chronic low back pain were randomised. Patients who were unable to read in the language of their respective migration background were excluded. Sufficient data were obtained from 203 women and 106 men. The largest group was of Russian origin (202 patients), followed by those of Turkish (52), Polish (30) and Italian (25) origin. INTERVENTIONS: Intervention group: provision of culture-sensitive adapted material. CONTROL GROUP: provision of standard translated material. MAIN OUTCOME MEASURES: Primary outcome: patient-rated usefulness (USE) assessed immediately after patients received the material. SECONDARY OUTCOMES: patient-rated usefulness after 8 weeks and 6 months, symptoms of depression (PHQ-9), back pain (Back Pain Core Set) and quality of life (WHO-5) assessed at all time points. RESULTS: Usefulness was found to be significantly higher (t=1.708, one-sided p=0.04) in the intervention group (USE-score=65.08, SE=1.43), compared with the control group (61.43, SE=1.63), immediately after patients received the material, in the intention-to-treat analysis, with a mean difference of 3.65 (one-sided 95% lower confidence limit=0.13). No significant differences were found for usefulness at follow-up (p=0.16, p=0.71). No significant effect was found for symptom severity in depression (p=0.95, p=0.66, p=0.58), back pain (p=0.40, p=0.45, p=0.32) or quality of life (p=0.76, p=0.86, p=0.21), either immediately after receiving the material, or at follow-up (8 weeks; 6 months). Patients with a lower level of dominant society immersion benefited substantially and significantly more from the intervention than patients with a high level of immersion (p=0.005). CONCLUSION: Cultural adaptation of patient information material provides benefits over high quality translations. Clinicians are encouraged to use culture-sensitive material in their consultations, particularly with low-acculturated patients. TRIAL REGISTRATION NUMBER: German Register for Clinical Trials: DRKS00004241, Universal Trial Number: U1111-1135-8043, Results.

Efficiency and contribution of strategies for finding randomized controlled trials: a case study from a systematic review on therapeutic interventions of chronic depression.

BACKGROUND: Identifying all existing evidence is a crucial aspect in conducting systematic reviews. Since the retrieval of electronic database searches alone is limited, guidelines recommend the use of additional search strategies. The aim of this investigation was to assess the efficiency and contribution of additional search strategies for identifying randomized controlled trials in conducting a systematic review on interventions after performing a sensitive electronic database search. DESIGN AND METHODS: Seven electronic databases, 3 journals and 11 systematic reviews were searched. All first authors of the included studies were contacted; citation tracking and a search in clinical trial registers were performed. A priori defined evaluation criteria were calculated for each search strategy. RESULTS: A total of 358 full-text articles were identified; 50 studies were included in the systematic review, wherefrom 84.0% (42) were acquired by the sensitive electronic database search and 16.0% (8) through additional search strategies. Screening reference lists of related systematic reviews was the most beneficial additional search strategy, with an efficiency of 31.3% (5) and a contribution of 10.0% (5/50), whereas hand-searching and author contacts contributed two and one additional studies, respectively. Citation tracking and searching clinical trial registers did not lead to any further inclusion of primary studies. CONCLUSIONS: Based on our findings, hand-searching contents of relevant journals and screening reference lists of related systematic reviews may be helpful additional strategies to identify an extensive body of evidence. In case of limited resources, a sensitive electronic database search may constitute an appropriate alternative for identifying relevant trials. Significance for public healthSystematic reviews provide the strongest form of evidence synthesis for therapeutic interventions and are of high relevance for decision makers in public health. Preparing high quality systematic reviews can be very time-consuming since all existing evidence should be identified, but the retrieval of electronic database searches is limited and therefore additional search strategies are recommended. However, the time needed for conducting full systematic reviews does often not address the need for urgent evidence. Thus, priorities of summarizing all available evidence and providing fast evidence-based recommendations may conflict. So far, no consensus exists regarding which additional search strategies are beneficial and sparsely time-consuming for conducting systematic reviews. We examined the efficiency and contribution of additional search strategies performed after a sensitive electronic database search. Our results provide highly relevant information for researchers conducting systematic reviews in various fields of public health research and for establishing guidelines for conducting rapid reviews.

Generalizability of findings from efficacy trials for chronic depression: an analysis of eligibility criteria.

OBJECTIVES: Concerns have been raised that the rigorous eligibility criteria used to select patients for randomized controlled trials (RCTs) limit the generalizability of trial findings. The objectives of this study were to identify commonly used eligibility criteria in RCTs for chronic depression, to examine whether these criteria are met by patients with chronic depression who are in routine care, and to identify differences between patients who would and would not meet RCT criteria. METHODS: Thirteen eligibility criteria were extracted from eight RCTs of combined psychotherapeutic and pharmacological interventions for patients with chronic depression. These criteria were then applied to a sample of patients with chronic depression receiving care in one of ten German hospitals (N=231). Demographic, clinical, and treatment characteristics of those who met the RCT criteria and those who did not were compared in univariate and multivariate analyses. RESULTS: Only 25% of the 231 inpatients met all RCT eligibility criteria. Patients were ineligible mainly because of suicide risk, low severity of depression at admission, and concurrent psychiatric or somatic disorders. No statistically significant differences were found between those who met the criteria and those who did not in demographic characteristics, length of inpatient stay, treatment outcome, and efficacy of certain antidepressants, except that slightly more patients meeting RCT criteria received selective serotonin reuptake inhibitors. CONCLUSIONS: Findings suggest that the generalizability of RCT findings to routine health care is less limited than frequently supposed.