[On the Way to Culture-Sensitive Patient Information Materials: Results of a Focus Group Study]. / Auf dem Weg zu kultursensitiven Patienteninformationsmaterialien: Ergebnisse einer Fokusgruppenuntersuchung.

AIM: This study was part of a double-blind randomised controlled trial aimed to evaluate the effects of culture-sensitive patient information materials (PIM) compared with standard translated material. The study aimed to obtain the data for the development of culture sensitive PIM about unipolar depression for the 4 largest migrant groups in Germany (Turkish, Polish, Russian and Italian migration background). METHOD: A qualitative study using 4 manual-based focus groups (FG), one for each migrant group, with 29 participants (9 with a Turkish (TüG), 8 with a Polish (PoG), 5 with a Russian (RuG) and 7 with an Italian (ItG) migration background) was conducted. The discussions were recorded, transcribed and analyzed using qualitative content analysis. RESULTS: 7 categories were identified. For the (1.) development of a good culture-sensitive PIM an easy language, a clear structure, an assessable extent of information and the avoidance of stereotypes were highlighted cross-culturally in all four FG. RuG and PoG had the largest (2.) lack of information about the German health care system. Concerning the (3.) illness perception RuG named problems with recognizing and understanding depression. PoG, RuG and TüG thematized (4.) feared consequences of the illness and of professional helpseeking. ItG, PoG, RuG had fears concerning (5.) psychotropic drugs as a result from insufficient knowledge about medication. For (6.) doctor-patient relationship cultural specifics were identified in RuG and TüG and for (7.) migration or culture specific reasons for depression in RuG, ItG and TüG. CONCLUSION: Although the identified categories were relevant for all or for the majority of migrant groups, for most categories specific cultural aspects were discovered. These findings show the importance of a culture sensitive adaptation of PIM.

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.

[Psychoeducation for Relatives of Persons with Depressive Disorders: A Focus Group Study on Information Demands]. / Psychoedukative Gruppen für Angehörige von depressiv Erkrankten: Analyse des Informationsbedarfs durch eine Fokusgruppenuntersuchung.

BACKGROUND: Depressive disorders place a high burden on patients and their relatives. Psychoeducational groups for relatives may reduce relatives' burden and improve the course of disease in patients. To foster the development of psychoeducational interventions which meet relatives' needs, information demands in relatives of patients with depressive disorders were examined. METHODS: A qualitative study using 3 focus groups was conducted among adult relatives of patients with depressive disorders (N=17). Discussions were audio-taped, transcribed and analyzed using qualitative content analysis. RESULTS: Information demands are based on information gaps, emotional burden as well as strains in everyday living and were identified with regard to illness-specific (symptoms, course and etiology), treatment-specific (treatment options and health care system) and - as central aspects - interaction-specific issues (dealing with the patient, difficulties in everyday living and relationship problems) as well as support options for relatives themselves and self-care. CONCLUSIONS: Information brokerage within psychoeducational groups for relatives should consider the burden of relatives as well as strains in everyday living on which information demands are based. To consider interaction-specific issues, specific skills - e. g. in problemsolving - should be trained.

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.

Development and testing of culturally sensitive patient information material for Turkish, Polish, Russian and Italian migrants with depression or chronic low back pain (KULTINFO): study protocol for a double-blind randomized controlled trial.

BACKGROUND: Many of the approximately 15 million people with a migration background living in Germany (19% of the population) are inadequately reached by existing healthcare provision. In the literature, the necessity for cultural adaptation of information material for patients with a migration background is often cited as a measure for improving healthcare.In this study, culturally sensitive information material will be developed and evaluated for patients with a migration background and depression or chronic low back pain. In this respect, it will be examined whether culturally sensitive information material is judged as more useful by the patients than standard translated patient information without cultural adaptation. METHODS/DESIGN: The implementation and evaluation of culturally sensitive patient information material will occur in the framework of a double-blind randomized controlled parallel-group study in four study centres in Germany. Primary care patients with a Turkish, Polish, Russian or Italian migration background with a diagnosis of depressive disorder or chronic low back pain will be included and randomly allocated to the intervention group or the control group. In the intervention group, culturally sensitive patient information will be handed to the patient at the end of the physician consultation, while in the control group, standard translated patient information material will be provided. The patients will be surveyed by means of questionnaires following the consultation as well as after 8 weeks and 6 months. In addition to the primary outcome (subjective usefulness), several patient- and physician-rated secondary outcomes will be considered. DISCUSSION: The study will provide an empirical answer to the question of whether persons with a migration background perceive culturally sensitive patient information material as more useful than translated information material without cultural adaptation. TRIAL REGISTRATION: Deutsches Register Klinischer Studien (DRKS-ID) DRKS00004241 and Universal Trial Number (UTN) U1111-1135-8043.