Development and first validation of the shared decision-making questionnaire (SDM-Q).

OBJECTIVE: Due to a lack of valid German instruments measuring shared decision-making (SDM), a theory-driven questionnaire (SDM-Q) to measure the process of SDM was developed and validated. METHODS: As a theoretical basis steps of the SDM process were defined in an expert panel. Item formulation was then conducted according to the Delphi method. For the first validation on a mixed sample Rasch analysis was used to eliminate items not fitting the construct thus receiving a unidimensional scale. RESULTS: After eliminating 4 items the remaining 11 form a unidimensional scale with an acceptable reliability for person measures (0.77) and very good reliability for item difficulties (0.95). Analysis of subgroups revealed a different use of items in different conditions. Furthermore the scale showed high ceiling effects. CONCLUSION: A new theory-driven instrument to measure the process of SDM has been developed and validated by use of a rigorous method revealing first promising results. Yet the ceiling effects require the addition of more discriminating items, and the different use of items in different conditions demands an in depth analysis. PRACTICE IMPLICATIONS: While the concept of SDM is constantly receiving more attention in medical practice, its valid and reliable measurement remains challenging.

[Evaluation of the decision aid "Entscheidungshilfe Prostatakrebs" from the patients' view : Results from the first three months]. / Evaluation der Entscheidungshilfe Prostatakrebs aus Patientensicht : Ergebnisse der ersten 3 Monate.

BACKGROUND: The decision aid "Entscheidungshilfe Prostatakrebs" is available online free of charge since June 2016. It is designed to support patients with their treatment decision-making and to lighten the burden on their treating urologists. This study evaluates usage data from the first 3 months. MATERIALS AND METHODS: The ICHOM standard set was applied to allow a personalised presentation and to collect relevant data for subsequent counselling. Additionally, personal preferences and psychological burden were assessed amongst others. We collected anonymous data. A multivariate model evaluated predictors for high user satisfaction. RESULTS: From June through August 2016 a total of 319 patients used the decision aid, showing a continuous monthly increase in the number of users. There were n = 219 (68.7%) complete questionnaires. Median age was 66.1 ± 8.0 years. The oncological risk was low in 30.3%, intermediate in 43.6% and high in 26.1%. A majority of 57.5% used the decision aid together with their partner, 35.1% alone and 5.5% with their children. In all, 54.8% were "very satisfied" and 32.0% were "satisfied" with the decision aid for a total satisfaction rate of about 87%. The only predictors of total satisfaction were the usage mode and reported distress level. CONCLUSIONS: As shown by the continuously increasing number of users this decision aid is becoming well established in German urology. Patients' overall ratings are very positive. The majority of patients use the decision aid with their partner. This represents a significant advantage of a multimedia approach compared to print media.

[Treatment of nonmetastatic prostate cancer: a systematic review of interactive, personalized patient decision aids]. / Therapie des nichtmetastasierten Prostatakarzinoms : Eine systematische Übersicht interaktiv personalisierter patientenorientierter Entscheidungshilfen.

BACKGROUND: Patients with nonmetastatic prostate cancer face a complex treatment decision. To support them with personalized information, a variety of interactive computerized decision aids have been developed in Anglo-Saxon countries. Our goal was to identify relevant decision aids and investigate their didactic strengths and limitations. MATERIALS AND METHODS: We included decision aids that derived individualized content from personal and clinical data provided by the patient. By conducting a systematic literature and internet research through November 2013 supplemented by expert interviews, we identified 10 decision aids of which 6 had been investigated scientifically. We compared their individual characteristics as well as the design and results of the evaluation studies. RESULTS: The decision aids present two to seven therapy choices, whereby radical prostatectomy and percutaneous radiotherapy are always included. Number and type of parameters provided by the patient also vary considerably. Two decision aids derive a therapeutic recommendation from the patient's input. Evaluation studies showed higher disease-related knowledge and greater confidence in the treatment decision after using one of six decision aids. Satisfaction with the decision aid was predominantly high. CONCLUSIONS: Currently personalized patient decision aids for treatment of nonmetastatic prostate cancer are only available in English. These tools can facilitate the shared decision making process for patients and physicians. Therefore, comparable decision aids should be developed in German.

Trying to optimise the German version of the OPTION scale regarding the dyadic aspect of shared decision making.

OBJECTIVES: The OPTION scale ("observing patient involvement in decision making") assesses the extent to which clinicians involve patients in decisions across a range of situations in clinical practice. It so far just covers physician behavior. We intended to modify the scoring of the OPTION scale to incorporate active patient behavior in consultations. METHODS: Modification was done on scoring level, attempting a dyadic, relationship-centred approach in that high ratings can be evoked also by the behaviour of active patients. The German version of the OPTION scale was compared with a modified version by analysing video recordings of primary care consultations dealing with cardiovascular prevention. Fifteen general practitioners provided 40 videotaped consultations. Videos were analysed by two rater pairs and two experts in shared decision making (SDM). RESULTS: Reliability measures of the modified version were lower than those of the original scale. Significant associations of the dichotomised scale with the expert SDM rating as well as with physicians' expertise in SDM were only found for the modified OPTION scale. Receiver Operating Characteristic (ROC) analyses confirmed a valid differentiation between the presence of SDM (yes/no) on total score level, even though the cut-off point was quite low. Standard deviations of the single items in the modified version were higher compared to the original OPTION scale, while the means of total scores were similar. CONCLUSIONS: The original OPTION scale is physician-centered and neglects the activity and a possible self-involvement of the patient. Our modified instruction was able to capture the dyadic element partially. The development of a separate dyadic instrument might be more promising.

[Brain drain in stem cell research? The views and attitudes of stem cell researchers in Germany]. / Brain Drain in der Stammzellforschung? Erste Ergebnisse einer Befragung von Wissenschaftlern zur Lage der Stammzellforschung in Deutschland.

The legal status of stem cell research in Germany has most recently been debated at the highest political level. Stakeholders have argued referring to the situation of stem cell researchers in past debates; however, a survey of the views and attitudes of German stem cell researchers is currently being performed by the University of Marburg also involving a team at Exeter University. Here, we present some of the first findings from this study on the basis of 14 qualitative interviews and 117 responses to the quantitative survey. The data suggest that the motives for engaging in particular areas of research are multilayered. Respondents take a critical view towards the way in which research on human embryonic stem cells has been regulated. The majority of interviewees rejected a change in legislation involving the amendment of the cut-off date for the import of human embryonic stem cells lines. Also, the recent changes in the German regulation of stem cell research that, among other changes, include a change of the cut off date for the production of lines which could become used in the country from January 2002 to May 2007 appear not to be received as a satisfactory solution of the constraints experienced by science through the law in Germany.

Attitudes of patients, healthcare professionals and ethicists towards embryonic stem cell research and donation of gametes and embryos in Germany.

Due to the Embryo Protection Act, creation of supernumerary embryos, as well as egg and embryo donation, is prohibited in Germany. Human stem cell research is regulated through the Act on stem cells that came into force in 2002. A cross-sectional survey of 101 IVF couples (n=202) in two fertility centres, and representative samples of healthcare professionals and ethicists (n=879), was carried out, and their attitudes towards embryonic stem cell research and donation of gametes and embryos compared. A clear majority of IVF couples favoured legalization of egg and embryo donation and embryonic stem cell research for various purposes. The willingness of couples to donate was related to purpose and to other independent influences. The majority of physicians voted for legalization of embryonic stem cell production from surplus embryos. Most human geneticists and obstetricians approved egg, but not embryo, donation to other couples. Ethicists and midwives were opposed to every kind of donation and research on surplus embryos. The IVF couples surveyed have positive attitudes towards donation and research using surplus embryos, whereas the healthcare professionals and ethicists are predominantly sceptical about most research activities destroying human embryos. This difference should be considered carefully in legal and ethical discussions on reprogenetics.