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Constanze Stolz-Klingenberg,1 Claudia Bünzen,1 Marie Coors,2 Charlotte Flüh,3 Klarissa Hanja Stürner,4 Kai Wehkamp,5,6 Marla L Clayman,7,8 Fueloep Scheibler,1,9 Jens Ulrich Rüffer,9,10 Wiebke Schüttig,2 Leonie Sundmacher,2 Daniela Berg,4 Friedemann Geiger1,9,11 1National Competency Center for Shared Decision Making, University Hospital Schleswig-Holstein, Kiel, Germany; 2Chair of Health Economics, Technical University of Munich, Munich, Germany; 3Department of Neurosurgery, University Hospital Schleswig-Holstein, Kiel, Germany; 4Department of Neurology, University Hospital Schleswig-Holstein, Kiel, Germany; 5Department of Internal Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany; 6Department of Medical Management, MSH Medical School Hamburg, Hamburg, Germany; 7Center for Healthcare Organization and Implementation Research (CHOIR), Veterans Administration, Bedford, MA, USA; 8Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA; 9SHARE TO CARE Patientenzentrierte Versorgung GmbH, Cologne, Germany; 10TakePart Media+Science GmbH, Cologne, Germany; 11Department of Psychology, MSH Medical School Hamburg, Hamburg, GermanyCorrespondence: Constanze Stolz-Klingenberg, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Arnold-Heller-Straße 3, Haus 9, Kiel, 24105, Germany, Tel +49 431 500 20208 ; +49 151 17271928, Email Constanze.Stolz-Klingenberg@uksh.dePurpose: SHARE TO CARE (S2C) is a comprehensive, multi-module implementation program for shared decision making (SDM). It is currently applied at the University Hospital Schleswig-Holstein in Kiel, Germany, and among general practitioners at the Federal State of Bremen. This study examines the results of the full implementation of S2C in terms of effectiveness within the Kiel Neuromedical Center comprising the departments of neurology and neurosurgery.Method and Design: The S2C program consists of four combined intervention modules: 1) multimodal training of physicians; 2) a patient activation campaign including the ASK-3 method; 3) digital evidence-based patient decision aids; and 4) SDM support by nurses, e.g., as decision coaches. The SDM level before and immediately after implementation was retrospectively assessed in consecutively selected patients on the subscale “Patient Decision Making” of the Perceived Involvement in Care Scale (PICSPDM). Mean scores were compared with t-tests.Results: Eighty-nine percent of all physicians (N = 56) completed the SDM training. We developed a total of 12 evidence-based digital decision aids in the center, educated two decision coaches to support patients’ decision processes by using decision aids. Physicians adjusted patients’ pathways to incorporate the use of decision aids. Patients (n = 261) reported a significant increase in participation (p< 0.001; Hedges’ g = 0.49) in medical decision making.Conclusion: The S2C program has been successfully implemented within the entire Neuromedical Center. Patients reported a medium to small increase of perceived involvement in decision making demonstrating the effectiveness of the implementation. For future research, it might be interesting to investigate the sustainability of the effects of S2C. In addition, it seems useful to complement the patient-based evaluation with observer-based data.Keywords: shared decision making intervention, decision aids, physician training, patient activation, neurology, neurosurgery, SDM

Shared Decision Making (SDM) is considered the gold standard of medical decision making as it provides a method to systematically integrate the patient's preferences, evidence-based medicine and the experience of health care professionals. Therefore, evidence-based training methods for a broad implementation into healthcare are needed. A new online training was designed, based on the concept of flawed/flawless video examples and additional educational concepts.In a single-blind randomized-controlled trial, medical students were randomly assigned to intervention group receiving the online training (n = 82) or waiting control group (n = 105). SDM-related knowledge and the ability to judge distinct levels of SDM were compared between both groups. Additionally, feedback regarding the intervention was collected.SDM-related knowledge and judging ability increased significantly in the intervention group compared to controls (SDM knowledge: mean difference: 12 %; 95 % CI: 7.3-18.5; p0.001; SDM judging ability (inter-rater concordance displayed by weighted t): mean difference: 0.07; 95 %CI: 0.03-0.11; p = 0.001). Feedback was positive.The online training with its distinctive methodology prove effective. As it shares the theoretical and didactical background with an already existing face-to-face training, both approaches may also be used complementarily.SDM can be trained effectively and efficiently with this easily scalable online training.

Kai Wehkamp,1– 3,* Felicia Beatrice Kiefer,4,* Friedemann Geiger,1,5 Fueloep Scheibler,1 Jens Ulrich Rueffer,6 Norbert Donner-Banzhoff,7 Cornelia Betsch4 1Department of Pediatrics/Project SHARE TO CARE, University Hospital Schleswig-Holstein, Kiel, Schleswig-Holstein, Germany; 2Department of Internal Medicine I, University Hospital Schleswig-Holstein, Kiel, Schleswig-Holstein, Germany; 3Department of Medical Management, MSH Medical School Hamburg, Hamburg, Germany; 4Center for Empirical Research in Economics and Behavioral Sciences, University of Erfurt, Erfurt, Thüringen, Germany; 5Department of Psychology, MSH Medical School Hamburg, Hamburg, Germany; 6Take Part Media & Science GmbH, Cologne, Nordrhein-Westfalen, Germany; 7Department of General Practice/Family Medicine, University of Marburg, Marburg, Hessen, Germany*These authors contributed equally to this workCorrespondence: Kai WehkampDepartment of Internal Medicine I, Project SHARE TO CARE, University Hospital Schleswig-Holstein (UKSH), Arnold-Heller-Straße 3, Kiel, 24105, GermanyTel +49 (0)431-500-0Email kai.wehkamp@uksh.deIntroduction: Health literacy is an important competency to make informed, shared decisions in line with patient’s preferences. On the other hand, lower health literacy is associated with poorer health outcomes. Evidence-based patient decision aids (EbPDA) are validated instruments to support informed medical decisions and empower patients for relevant involvement in their care. This study aimed to investigate the effect of a digital EbPDA for hypertension on health literacy.Methods: In a randomized controlled trial, 124 participants were presented with a web-based scenario related to a newly diagnosed condition of arterial hypertension. The intervention group was provided with an online decision aid, while the control group was prompted to search for related information without support. Specific health literacy for hypertension was operationalized based on the European survey for health literacy (HLS-EU-Q47).Results: The intervention group showed a statistically significant increase in subjectively perceived overall specific health literacy regarding hypertension (p=0.02, Cohen’s d=0.44). The effect was also statistically significant for the subcategories understanding, appraising, and applying health-related information (all p< 0.05). At least equal results could be shown for participants with a lower level of education compared to participants with a high level.Conclusion: The findings suggest that digital EbPDAs can be an effective and easily scalable instrument to improve populations’ specific health literacy. A possible advantage of the measure could be that patients are addressed concerning important and pressing personal decisions, fostering awareness of the individual’s need for health literacy to reflect one’s options and preferences. EbPDAs may also be a promising approach to target vulnerable populations, as the investigated EbPDA seems to perform equally in less versus more educated individuals. For future research, it may be interesting to investigate whether EbPDAs have effects on general health literacy that go beyond the disease specifically addressed.Keywords: shared decision-making, decision aids, health literacy, equity, preferences

The main focus of this paper is to describe the development and current state of policy, research and implementation of patient-centered care (PCC) and shared decision-making (SDM) in Germany. What is the current state in health policy? Since 2013, the Law on Patients' Rights has standardized all rights and responsibilities regarding medical care for patients in Germany. This comprises the right to informed decisions, comprehensive and comprehensible information, and decisions based on a clinician-patient partnership. In addition, reports and action plans such as the German Ethics Council's report on patient well-being, the National Health Literacy Action Plan, or the National Cancer Plan emphasize and foster PCC and SDM on a policy level. There are a number of public organizations in Germany that support PCC and SDM. How are patients and the public involved in health policy and research? Publishers and funding agencies increasingly demand patient and public involvement. Numerous initiatives and organizations are involved in publicizing ways to engage patients and the public. Also, an increasing number of public and research institutions have established patient advisory boards. How is PCC and SDM taught? Great progress has been made in introducing SDM into the curricula of medical schools and other health care providers' (HCPs) schools (e.g., nursing, physical therapy). What is the German research agenda? The German government and other public institutions have constantly funded research programs in which PCC and SDM are important topics. This yielded several large-scale funding initiatives and helped to develop SDM training programs for HCPs in different fields of health care and information materials. Recently, two implementation studies on SDM have been conducted. What is the current uptake of PCC and SDM in routine care, and what implementation efforts are underway? Compared to the last country report from 2017, PCC and SDM efforts in policy, research and education have been intensified. However, many steps are still needed to reliably implement SDM in routine care in Germany. Specifically, the further development and uptake of decision tools and countrywide SDM trainings for HCPs require further efforts. Nevertheless, an increasing number of decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care. Also, recent implementation efforts are promising. For example, reimbursement by health insurance companies of hospital-wide SDM implementation is being piloted. A necessary next step is to nationally coordinate the gathering and provision of the many PCC and SDM resources available.

Background Recent publications reveal shortcomings in evidence review and summarization methods for patient decision aids. In the large-scale “Share to Care (S2C)” Shared Decision Making (SDM) project at the University Hospital Kiel, Germany, one of 4 SDM interventions was to develop up to 80 decision aids for patients. Best available evidence on the treatments’ impact on patient-relevant outcomes was systematically appraised to feed this information into the decision aids. Aims of this paper were to (1) describe how PtDAs are developed and how S2C evidence reviews for each PtDA are conducted, (2) appraise the quality of the best available evidence identified and (3) identify challenges associated with identified evidence. Methods The quality of the identified evidence was assessed based on GRADE quality criteria and categorized into high-, moderate-, low-, very low-quality evidence. Evidence appraisal was conducted across all outcomes assessed in an evidence review and for specific groups of outcomes, namely mortality, morbidity, quality of life, and treatment harms. Challenges in evidence interpretation and summarization resulting from the characteristics of decision aids and the type and quality of evidence are identified and discussed. Results Evidence reviews assessed on average 25 systematic reviews/guidelines/studies and took about 3 months to be completed. Despite rigorous review processes, nearly 70% of outcome-specific information derived for decision aids was based on low-quality and mostly on non-directly comparative evidence. Evidence on quality of life and harms was often not provided or not in sufficient form/detail. Challenges in evidence interpretation for use in decision aids resulted from, e.g., a lack of directly comparative evidence or the existence of very heterogeneous evidence for the diverse treatments being compared. Conclusions Evidence reviews in this project were carefully conducted and summarized. However, the evidence identified for our decision aids was indeed a “scattered landscape” and often poor quality. Facing a high prevalence of low-quality, non-directly comparative evidence for treatment alternatives doesn’t mean it is not necessary to choose an evidence-based approach to inform patients. While there is an urgent need for high quality comparative trials, best available evidence nevertheless has to be appraised and transparently communicated to patients.

Objective: The aim of the study was to perform a systematic assessment of disease-free survival (DFS), overall survival, and morbidity rates after open radical hysterectomy (ORH) and minimally invasive surgery (MIS) for early-stage cervical cancer and discuss with experts the consequences of the LACC trial (published by Ramirez et al. in 2018) on clinical routine. Methods: A total of 5428 records were retrieved. After exclusion based on text screening, four records were identified for inclusion. Five experts from three independent large-volume medical centers in Europe were interviewed for their interpretation of the LACC trial. Results: The LACC trial showed a significantly higher risk of disease progression with MIS compared to ORH (HR 3.74, 95% CI 1.63 to 8.58). This was not seen in one epidemiological study and was contradicted by one prospective cohort study reported by Greggi et al. A systematic review by Zhang et al. mentioned a similar DFS for robot-assisted radical hysterectomy (RRH) and LRH. Recurrence rates were significantly higher with MIS compared to ORH in the LACC trial (HR 4.26, 95% CI 1.44 to 12.60). In contrast, four studies presented by Greggi reported no significant difference in recurrence rates between LRH/RRH and ORH, which concurred with the systematic reviews of Zhang and Zhao. The experts mentioned various limitations of the LACC trial and stated that clinicians were obliged to provide patients with detailed information and ensure a shared decision-making process. Conclusions: The surgical treatment of early-stage cervical cancer remains a debated issue. More randomized controlled trials (RCT) will be needed to establish the most suitable treatment for this condition.

Zusammenfassung Hintergrund Chirurgische Indikationen zum Nierenerhalt werden aufgrund der rasanten Entwicklung der minimalinvasiven Nierenchirurgie viel breiter gestellt. Die aktuelle Literatur hierzu legt nahe, dass neben der Tumorgröße auch die genaue anatomische Lage des Tumors für die Wahl der bestmöglichen operativen Therapie des Patienten beachtet werden muss. Zur präoperativen Risikoeinschätzung werden häufig 2 Nephrometrie-Scores, der Padua- und der R.E.N.A.L.-Score, erhoben. Zur Frage, welcher Score die nierenerhaltende Operabilität eines Nierentumors am besten einschätzt und intra- oder postoperative Komplikationen besser vorhersagen kann, möchten wir anhand unseres Patientenkollektivs einen Beitrag leisten. Material und Methoden Patientendaten von 117 Patienten, die sich von 2014 bis 2017 am Universitätsklinikum in Kiel einer Nierenteilresektion haben unterziehen müssen, wurden erfasst. Vorhandene Schnittbildgebung (Computertomografie und Magnetresonanztomografie) wurde retrospektiv nach Kriterien von Padua-, bzw. R.E.N.A.L.- Score ausgewertet. Es wurden die Fälle identifiziert, bei denen im Anschluss an den Versuch einer Nierenteilresektion eine radikale Nephrektomie durchgeführt wurde. Hierzu wurden Gruppenunterschiede in der Höhe der beiden Scores statistisch ausgewertet. Wir führten die Korrelationsanalysen zwischen der Höhe der beiden Scores und der Operationsdauer, intra- und postoperativen Komplikationen sowie Gesamtkomplikationen durch. Ergebnisse Für den R.E.N.A.L-Score zeigten sich signifikant höhere Werte der Tumore (Mittelwertsdifferenz 1,059, p Schlussfolgerung Beide Scores dienen der Risikoeinschätzung vor Nierenteilresektion. Für unsere Patienten hätte die Anwendung des R.E.N.A.L.-Scores Vorteile geboten. Eine präoperative Nephrometrie ist sinnvoll und sollte neben der subjektiven Einschätzung des Operateurs zur Anwendung kommen. Uns fehlen bislang noch prospektive Studien zu diesem Thema.

High-dose-rate brachytherapy (HDR-BT) for dose escalation in localized prostate cancer has been established as one standard treatment option. However, long-term results at followup (FU) ≥5 years are usually needed to ensure robustness of reported outcomes. Potential benefit of salvage therapy is, nevertheless, higher when relapse is diagnosed early. This study aimed to solve this dilemma by evaluating the prostate-specific antigen (PSA) nadir for early prediction of long-term biochemical control.Combined pelvis-external beam radiation/HDR-BT boost to EQD2100 Gy (α/β = 3) was performed in 459 consecutively treated patients. These patients with an FU ≥ 24 months were analyzed and stratified in PSA nadir (nPSA)-groups by PSA nadir within 18 months after radiotherapy (nPSA18). Kaplan-Meier/log-rank tests and Cox-regression models were used to compare the study endpoints.The mean FU was 77 months. A PSA nadir within 18 months (nPSA18)0.5 ng/mL was achieved in 222 patients with median time to reach nPSA18 of 7 months. The 5-year American Society of Therapeutic Radiology and Oncology (ASTRO) biochemical control (prostate-specific antigen disease-free survival) for the nPSA18 group0.5 ng/mL was 89% and for the group ≥ 0.5 ng/mL, it was 78.6% (p = 0.011). nPSA18 was an independent predictor of cancer-specific survival, distant metastasis-free survival, and biochemical control (ASTRO) (p = 0.026, p = 0.020, and p = 0.01, respectively).The present results suggest that the PSA nadir level within 18 months after radiotherapy may serve as an early parameter for long-term biochemical control according to ASTRO definitions following radical dose escalation by HDR-BT for prostate cancer. Excellent outcomes were associated with nPSA18 0.5 ng/mL.

Background: The scale-up of evidence-based innovations is required to reduce waste and inequities in health and social services (HSS). However, it often tends to be a top-down process initiated by policy-makers, and the values of the intended beneficiaries are forgotten. Involving multiple stakeholders including patients and the public in the scaling-up process is thus essential but highly complex. We propose to identify relevant strategies for meaningfully and equitably involving patients and the public in the science and practice of scaling up in HSS.Methods: We will adapt our overall method from the RAND/UCLA Appropriateness Method. Following this, we will perform a two-prong study design (knowledge synthesis and Delphi study) grounded in an integrated knowledge translation approach. This approach involves extensive participation of a network of stakeholders interested in patient and public involvement (PPI) in scaling up and a multidisciplinary steering committee. We will conduct a systematic scoping review following the methodology recommended in the Joanna Briggs Institute Reviewers Manual. We will use the following eligibility criteria: 1) Participants – any stakeholder involved in creating or testing a strategy for PPI; 2) Intervention – any PPI strategy proposed for scaling-up initiatives; 3) Comparator – no restriction; 4) Outcomes: any process or outcome metrics related to PPI; and 5) Setting – HSS. We will search electronic databases (e.g., Medline, Web of Science, Sociological Abstract) from inception onwards, hand searching relevant websites, screen the reference lists of included records, and consult experts in the field. Two reviewers will independently select and extract eligible studies. We will summarize data quantitatively and qualitatively and report results using the PRISMA extension for Scoping Reviews (PRISMA-ScR) checklist. We will conduct an online Delphi survey to achieve consensus on the relevant strategies for PPI in scaling-up initiatives in HSS. Participants will include stakeholders from low-, middle-, and high-income countries. We anticipate that three rounds will allow an acceptable degree of agreement on research priorities. Discussion: Our findings will advance understanding of how to meaningfully and equitably involve patients and the public in scaling-up initiatives for sustainable HSS.Registration: We registered this protocol with the Open Science Framework on August 19, 2020 (https://osf.io/zqpx7/).

IntroductionShared decision-making (SDM) is not yet widely used when making decisions in German hospitals. Making SDM a reality is a complex task. It involves training healthcare professionals in SDM communication and enabling patients to actively participate in communication, in addition to providing sound, easy to understand information on treatment alternatives in the form of evidence-based patient decision aids (EbPDAs). This project funded by the German Innovation Fund aims at designing, implementing and evaluating a multicomponent, large-scale and integrative SDM programme—called SHARE TO CARE (S2C)—at all clinical departments of a University Hospital Campus in Northern Germany within a 4-year time period.Methods and analysisS2C tackles the aforementioned components of SDM: (1) training physicians in SDM communication, (2) activating and empowering patients, (3) developing EbPDAs in the most common/relevant diseases and (4) training other healthcare professionals in SDM coaching. S2C is designed together with patients and providers. The physicians’ training programme entails an online and an in situ training module. The decision coach training is based on a similar but less comprehensive approach. The development of online EbPDAs follows the International Patient Decision Aid Standards and includes written, graphical and video-based information. Validated outcomes of SDM implementation are measured in a preintervention and postintervention evaluation design. Process evaluation accompanies programme implementation. Health economic impact of the intervention is investigated using a propensity-score-matched approach based on potentially preference-sensitive hospital decisions.Ethics and disseminationEthics committee review approval has been obtained from Medical Ethics Committee of the Medical Faculty of the Christian-Albrechts-University Kiel. Project information and results will be disseminated at conferences, on project-hosted websites at University Hospital Medical Center Schleswig Holstein and by S2C as well as in peer-reviewed and professional journals.

Background: The scale-up of evidence-based innovations is required to reduce waste and inequities in health and social services (HSS). However, it often tends to be a top-down process initiated by policy-makers, and the values of the intended beneficiaries are forgotten. Involving multiple stakeholders including patients and the public in the scaling-up process is thus essential but highly complex. We propose to identify relevant strategies for meaningfully and equitably involving patients and the public in the science and practice of scaling up in HSS.Methods: Design: We will adapt our overall method from the RAND Appropriateness Method. Following this, we will perform a two-component study design (knowledge synthesis and Delphi study) grounded in an integrated knowledge translation (iKT) approach. This approach involves extensive participation of a network of stakeholders interested in patient and public involvement (PPI) in scaling up and a multidisciplinary steering committee. Knowledge synthesis: We will conduct a systematic scoping review following the methodology recommended in the Joanna Briggs Institute Reviewers Manual. We will use the following eligibility criteria: 1) Participants - any stakeholder involved in creating or testing a strategy for PPI; 2) Intervention - any PPI strategy proposed for scaling-up initiatives; 3) Comparator - no restriction; 4) Outcomes: any process or outcome metrics related to PPI; and 5) Setting - HSS. We will search electronic databases (e.g., MEDLINE, Sociological Abstract), hand searching relevant websites, screen the reference lists of included records, and consult experts in the field. Two reviewers will independently select and extract eligible studies. We will summarize data quantitatively and qualitatively and report results using the PRISMA extension guidelines. Delphi study: We will conduct an online Delphi survey to achieve consensus on the relevant strategies for PPI in scaling-up initiatives in HSS. Participants will include stakeholders from low-, middle-, and high-income countries. We anticipate that three rounds will allow an acceptable degree of agreement on research priorities.Discussion: Our findings will advance understanding of how to meaningfully and equitably involve patients and the public in scaling-up initiatives for sustainable HSS.Registration: We registered this protocol with the Open Science Framework on August 19, 2020 (https://osf.io/zqpx7/).

Objective Training to improve physicians’ shared decision making (SDM) competencies with proven effectiveness and efficiency is rare. This study evaluated the brief in situ training module ‘doktormitSDM’. Methods In a multicenter RCT, each physician recorded four consultations, each of which included a diagnostic or treatment decision (N = 152 consultations from seven medical specialties). The doktormitSDM training module included two video-based individual coaching sessions (15 min) at the physicians’ workplaces, supplemented by a manual and a video tutorial. Primary endpoint was the compound measure SDMmass (based on the MAPPIN’SDM system) which incorporates patient and observer perceptions of involvement and doctor-patient concordance on perceived involvement. Results SDMmass increased significantly in the intervention group compared to the controls (effect size 0.58; p= 0.05; t -test). This effect tended to persist at follow-up (effect size 0.63; p=0.06). Patients’ perceived involvement increased accordingly (effect sizes 0.9/.58; p=0.01/.07). Conclusion The doktormitSDM training module is effective and efficient at improving SDM competencies. This is the first SDM training to be evaluated with a compound measure simultaneously considering doctor, patient and observer ratings. Practice implications Owing to its very brief form and its reference to the doctors’ own consultation videos, the doktormitSDM training module meets clinicians’ needs and time constraints.

Objective To validate the Norwegian version of MAPPIN'SDM observer scales with regard to reliability, accuracy and the extent to which the scales include the essentials of the shared decision-making concept. Methods Three MAPPIN'SDM scales, focusing on the skills of doctor, patient and dyad, were applied to audiovisual records of 35 decision sequences. Inter-rater reliabilities were determined based on kappa coefficients. Sensitivities and specificities were calculated with regard to an expert reference standard. Convergent validities were calculated with the OPTION 5 scale. MAPPIN'SDM was qualitatively compared to OPTION5 using Makoul & Clayman's Integrative Model structure. Results Inter-rater reliabilities were high on average over 11 items in each of three observer scales (MAPPIN doctor =0.77, MAPPIN patient =0.82, MAPPIN dyad =0.77). Patient involvement was detected accurately (MAPPIN dyad : mean sensitivity/specificity 93/91%). Comparison with OPTION 5 showed weak to moderate correlation (Spearman's ρ/p-value: MAPPIN doctor :=0.44/0.009, MAPPIN patient : 0.38/0.024, MAPPIN dyad 0.40/0.016) and little content overlap. Conclusion MAPPIN'SDM norge is capable of assessing SDM highly reliably and accurately. Divergence from OPTION 5 reflects explicit disagreement regarding the concept's assumptions. Practice implications MAPPIN'SDM norge is ready for use in Norway. In-depth debate on the SDM concept's essentials is urgently needed.

Due to the rapid development of minimally-invasive surgery, there is a broader indication for surgical preservation of renal tissue. Current research suggests that, apart from the size of the tumour, its exact anatomical position should be considered when seeking optimal surgical treatment for individual patients. Therefore, numerous nephrometry scores have emerged, the Padua score and the R.E.N.A.L. score being most commonly used. Based on our patient population, we aimed to shed light on the question which score is best suited to assess the feasibility of nephron-sparing surgery and which can predict complications most accurately.This study included 117 patients treated with partial nephrectomy at the University Hospital in Kiel (UKSH, Campus Kiel) between 2014 and 2017. The imaging results (computed tomography and magnetic resonance tomography) were retrospectively evaluated according to the Padua and R.E.N.A.L. score criteria. In some cases, radical nephrectomy became necessary despite the planned partial nephrectomy. We evaluated group differences regarding both nephrometry scores in these cases and the cases without radical nephrectomy. Then we performed correlation analyses regarding score outcome, operation time as well as perioperative, postoperative and overall complications.The tumours requiring treatment by radical nephrectomy (10 out of 117) had significantly higher scores only when the R.E.N.A.L. score was applied (mean difference 1.059, p 0.05). Both the Padua and the R.E.N.A.L. score were positive correlated with operation time (R.E.N.A.L. score: correlation coefficient 0.284, p 0.05, Padua score: coefficient 0.312, p 0.05) as well as perioperative, postoperative and overall complications (R.E.N.A.L. score: coefficient 0.216, p 0.05, Padua score: coefficient 0.192, p 0.05).Each of the examined scores can be used to assess the risk of partial nephrectomy. For our patients, the preoperative application of the R.E.N.A.L. score would have been advantageous. Preoperative nephrometry scores are a useful tool and should be applied in addition to the surgeon's subjective evaluation. There is a lack of prospective studies investigating this issue.Chirurgische Indikationen zum Nierenerhalt werden aufgrund der rasanten Entwicklung der minimalinvasiven Nierenchirurgie viel breiter gestellt. Die aktuelle Literatur hierzu legt nahe, dass neben der Tumorgröße auch die genaue anatomische Lage des Tumors für die Wahl der bestmöglichen operativen Therapie des Patienten beachtet werden muss. Zur präoperativen Risikoeinschätzung werden häufig 2 Nephrometrie-Scores, der Padua- und der R.E.N.A.L.-Score, erhoben. Zur Frage, welcher Score die nierenerhaltende Operabilität eines Nierentumors am besten einschätzt und intra- oder postoperative Komplikationen besser vorhersagen kann, möchten wir anhand unseres Patientenkollektivs einen Beitrag leisten.Patientendaten von 117 Patienten, die sich von 2014 bis 2017 am Universitätsklinikum in Kiel einer Nierenteilresektion haben unterziehen müssen, wurden erfasst. Vorhandene Schnittbildgebung (Computertomografie und Magnetresonanztomografie) wurde retrospektiv nach Kriterien von Padua-, bzw. R.E.N.A.L.- Score ausgewertet. Es wurden die Fälle identifiziert, bei denen im Anschluss an den Versuch einer Nierenteilresektion eine radikale Nephrektomie durchgeführt wurde. Hierzu wurden Gruppenunterschiede in der Höhe der beiden Scores statistisch ausgewertet. Wir führten die Korrelationsanalysen zwischen der Höhe der beiden Scores und der Operationsdauer, intra- und postoperativen Komplikationen sowie Gesamtkomplikationen durch.Für den R.E.N.A.L-Score zeigten sich signifikant höhere Werte der Tumore (Mittelwertsdifferenz 1,059, p 0,05), die im Anschluss an den Versuch einer Nierenteilresektion doch durch eine radikale Nephrektomie behandelt werden mussten (10 von 117). Zu beiden Scores konnte eine positive Korrelation mit OP-Dauer (für R.E.N.A.L.-Score: Korr.-Koeffizient 0,284, p 0,05; für Padua-Score: Koeffizient 0,312, p 0,05), intra- und postoperativen sowie Gesamtkomplikationen (für R.E.N.A.L.-Score: Korr.-Koeffizient 0,216, p 0,05; für Padua-Score: Koeffizient 0,192, p 0,05) gezeigt werden.Beide Scores dienen der Risikoeinschätzung vor Nierenteilresektion. Für unsere Patienten hätte die Anwendung des R.E.N.A.L.-Scores Vorteile geboten. Eine präoperative Nephrometrie ist sinnvoll und sollte neben der subjektiven Einschätzung des Operateurs zur Anwendung kommen. Uns fehlen bislang noch prospektive Studien zu diesem Thema.

Source at https://doi.org/10.1111/hex.12565. Accepted manuscript version, licensed CC BY-NC-ND 4.0. Objective: To carry out preliminary evaluation of a training module for doctors to enhance their ability to involve their patients in medical decision making. The training refers to the shared decision-making (SDM) communication concept. Methods: The training module includes a comprehensive manual, a corresponding video tutorial with communication examples and a 15-minute face-to-face feedback session based on an SDM analysis of a consultation recording provided by the trainee. Ten trainees (four neurologists, three dentists, and three general practitioners) participating in the pretest each recorded four clinical consultations (total sample: N=40) and received three training components. After the training, doctors provided feedback on the module’s feasibility in a questionnaire. Communication performance of doctors, patients and doctor–patient dyads was assessed by trained observers and selfassessed by doctors and patients using the MAPPIN’SDM approach. Training effects were determined using Wilcoxon signed-rank tests comparing baseline values with post-intervention performance as assessed in the fourth consultations. Results: The face-to-face training sessions were short and feasible with regard to clinical reality. Participants considered the training supportive for acquiring SDM skills and recommended more emphasis on the face-to-face feedback. Communication improved according to observers rating doctors (P=.05) and doctor–patient dyads (P=.07) and to doctors’ own judgements (P=.02). No improvement was observed in patients’ SDM behaviour (P=.11); accordingly, patients’ judgements did not indicate improvement (P=.14). Conclusions: The training is designed to meet clinicians’ needs. Improvement of risk communication after training encourages optimization according to doctors’ feedback. Following this study, the efficacy of the training is now being examined in a randomized controlled trial.

Summary Objective Shared decision making (SDM) between patient and physician is an interpersonal process. Most SDM measures use the view of one party (patient, physician or observer) as a proxy to capture this process although these views typically diverge. This study suggests the compound measure SDM MASS ( SDM M eeting its concept's ASS umptions) integrating these three perspectives in one single index. Methods SDM MASS was derived theoretically and compared empirically to unilateral perspectives of patients, physicians and observers by application to a data set of 10 physicians (40 consultations) receiving an SDM training. Results The constituting parts of SDM MASS were highly reliable (Cronbach's alpha .94; interrater reliability .74-.87). Unilateral appraisal of training effects was divergent. SDM MASS revealed no effect. Conclusion SDM MASS combines noteworthy information about SDM processes from different viewpoints and thereby delivers plausible assessments. It could overcome immanent shortcomings of unilateral approaches. However, it is a complex measure needing further validation.

The current study examined the relationship between psychopathy, intelligence and two variables describing the conviction history (length of conviction and number of prior convictions). It was hypothesized that psychopathy factors (interpersonal and antisocial factors assuming a 2-factor model or interpersonal, affective, lifestyle and antisocial factors assuming a 4-factor model) would be related in different ways to IQ scores, length of conviction and number of prior convictions. Psychopathy and IQ were assessed using the PCL:SV and the CFT 20-R respectively. Results indicated no association between interpersonal psychopathy features (Factor 1, two-factor model), IQ and the number of prior convictions but a positive association between Factor 1 and the length of conviction. Antisocial features (Factor 2, two-factor model) were negatively related to IQ and the length of conviction and positively related to the number of prior convictions. Results were further differentiated for the four-factor model of psychopathy. The relationship between IQ and psychopathy features was further assessed by statistically isolating the effects of the two factors of psychopathy. It was found that individuals scoring high on interpersonal features of psychopathy are more intelligent than those scoring high on antisocial features, but less intelligent than those scoring low on both psychopathy features. The results underpin the importance of allocating psychopathic individuals to subgroups on the basis of personality characteristics and criminological features. These subgroups may identify different types of offenders and may be highly valuable for defining treatment needs and risk of future violence.

Shared decision making (SDM) is being increasingly challenged for promoting an innovative role model while adhering to an archaic approach to patient-clinician communication, both in clinical practice and the research field. Too often, SDM has been studied at the individual level, which ignores the interpersonal system between patients and physicians. We aimed to encourage debate by reflecting on the essentials of SDM in terms of epistemology. We operationalized the SDM core concept of information exchange in terms of social systems theory. An epistemological analysis of the term information refers to its inherent process character. Exchange of information thereby becomes synonymous with social sense construction, indicating that, rather than just being a vehicle, the act of communication itself is the information. We plead for the adoption of existing dyadic analytical methods such as those offered by the interpersonal paradigm. Implications of an updated concept of information for the use of SDM-evaluation methods, for SDMgoal setting, and for clinical practice of SDM are described.

Shared decision-making (SDM) has the potential to overcome outdated social role models in the health care system. The concept, however, adheres to archaic epistemological assumptions as can be inferred from the rudimentary stage of the measurement methods used and from the information monopoly that the physician still holds in this concept. Advantages of an up-to-date model of knowledge for understanding and operationalising SDM are outlined. To this purpose, essential definitions of the concept are reflected in terms of epistemology. Accordingly, information emerges through a process of social construction. Likewise, interpersonal relations do not represent a static condition; rather, they develop anew with each interaction. Therefore, constructs suitable to focus on dyadic interaction processes can be used as indicators of sharing in SDM. Theories and methods of the interpersonal paradigm are advocated.

Objective: To consider the extent to which the presence of psychopathy, as indicated by the psychopathy checklist: screening version (PCL:SV), can predict intramural behaviour in offenders with mental disorders serving compulsory treatment at a German forensic psychiatric hospital. Method: The PCL:SV was used with 48 offenders detained at a forensic psychiatric hospital in Germany. In a prospective design, objective and subjective measures of behaviour were compared for those identified as high and low scorers on the PCL:SV. Data were obtained from hospital records of disciplinary incidents (objective) and from interviews with case managers and therapists (subjective), according to predefined criteria and in standardized forms. Results: The hospital records of the high scorers indicated they had been involved in significantly more disciplinary incidents than low scorers. Their behaviour was also rated significantly more negative by therapists than the low scorers. Conclusion: Numeorus studies found the psychopathy checklist (PCL) score to be a reliable predictor of recidivism in offenders after release. The present study has demonstrated that the PCL score has also predictive validity for intramural behaviour problems in individuals serving compulsory treatment at a forensic psychiatric hospital. As a result, we recommend the routine use of the PCL with offenders starting a period of compulsory detention to identify those at increased risk for problem behaviour.

Aim was to survey distinctive qualities of decision-related uncertainty in cancer. Assessment of differential perception of uncertainties is a prerequisite for the study of cognitive coping as mediated by risk communication. A theory building process was initiated. Using in-depth interviews with cancer patients subjective representations of uncertainty associated with medical decisions were explored. Grounded theory techniques were applied to extract categories out of the interview material. The qualitative process led to an eight-dimensional model. Five raters achieved a Fleiss agreement coefficient of 0.61 attributing raw material from interviews to the categories. Patients expressed uncertainties concerning (1) disease-related issues (prognosis/diagnosis, treatment), (2) risk communication issues (deciphering information, role in the medical dyad, physician's trustability) and (3) aspects of coping with life considering the disease (mastering requirements, social integration, causal attribution). We found support for a multidimensional model of uncertainty. This approach can be helpful in the investigation of further issues concerning communication and coping with uncertainty related to medical decisions in cancer and other diseases. It sharpens shared decision making theoretically and thereby provides the basis for a measurement concept. Copyright © 2007 John Wiley & Sons, Ltd.

Patient participation can be seen as an end in and of itself, and it can be seen as a way to foster further goals like quality and safety in healthcare, adherence and cost-effectiveness. Wide-scale implementation of interventions to increase patient participation without having confidence in its measures means being unable to determine if implementation was successful or the desired outcome was achieved. Therefore, we were pleased to see a review of measures assessing patient participation in healthcare. However, we have some major concerns about the conceptual approach, the method and the conclusions in the …

OBJECTIVES Despite advances in perioperative management during surgical treatment of hypoplastic left heart syndrome (HLHS), patients are still at risk for adverse neurodevelopmental sequelae including cognitive dysfunction. This study aimed to assess a neuropsychological profile of HLHS patients at school age who underwent the Norwood operation between 1996 and 2003 with deep hypothermic circulatory arrest (DHCA) or antegrade selective cerebral perfusion (ASCP), respectively. METHODS Forty HLHS patients (DHCA: n = 11 and ASCP: n = 29) were compared with healthy controls (DHCA controls: n = 10 and ASCP controls: n = 24), recruited according to age, sex and socioeconomic status. Neuropsychological assessment included non-verbal intelligence (IQ norms) and raw score measures of visual and verbal short- and long-term memory as well as executive functions, processing speed and concentration. Neuropsychological data were correlated with bypass and circulatory arrest times. RESULTS Compared with control subjects, both patient groups had average non-verbal intelligence scores [DHCA: 102 (72-112) and ASCP: 92 (70-127)], but showed reduced long-term memory capacities and decreased executive performance as well as reduced processing speed. DHCA patients, furthermore, had a reduced visual attention span, and ASCP patients scored less on the verbal learning task than controls. The duration of DHCA and cardiopulmonary bypass (CPB) was associated with visual executive functions and short-term memory. In the DHCA group, the duration of DHCA was correlated with the time to complete the Trail Making Test A measuring visual executive functions (Spearman rank correlation, rS = 0.867, P = 0.018). In patients provided with ASCP, the cumulated CPB duration was negatively correlated with the score of the block span test measuring visual short memory (rS = -0.476, P = 0.020) as well as with the copy score of the Rey Figure assessing visual executive functions (rS = -0.399, P = 0.032). CONCLUSIONS School-age children with HLHS who underwent the Norwood procedure either with DHCA or ASCP show cognitive impairments compared with healthy controls. Our data indicate deficits in specific cognitive domains such as memory, executive functions and processing speed rather than basic intellectual dysfunction.

Purpose Dose escalation using high-dose-rate brachytherapy (HDR-BT) is an established treatment method for prostate cancer. First, long-term results were previously published (specific Kiel method). This study aims to evaluate 10-/15-year outcomes of Kiel Protocol 1 (1986–1992). Methods and Materials Conformal external beam radiotherapy (EBRT) was delivered to the pelvis (50 Gy per conventional fractionation) along with an HDR boost to the prostate amounting to a combined biologic equivalent dose in 2 Gy per fraction of 117.25 Gy (α/β = 3). The HDR-BT was performed in two fractions of 15 Gy to the peripheral zone of McNeal. The EBRT-clinical target volume covered the full pelvis. The analyzed cohort totaled 122 patients. The reported end points were overall/cancer-specific survival, local recurrence/distant metastasis rates, and biochemical (BC) control rates according to American Society for Therapeutic Radiology and Oncology/Phoenix definitions. All end points were calculated using the Kaplan–Meier method and the log-rank test in univariate analyses. Results The mean follow-up time was 116.8 months. The 5-, 10-, and 15-year survival rates were 81%, 62.1%, and 45% for overall survival; 92.1%, 83.1%, and 75.3% for cancer-specific survival; 92.5%, 91.4%, and 83.9% for local recurrence–free survival; and 83.8%, 81.2%, and 69.8% for distant metastasis–free survival, respectively. American Society for Therapeutic Radiology and Oncology–defined BC tumor control rates at 5, 10, and 15 years were 81.1%, 74%, and 67.8%, respectively. According to Phoenix, the BC control rates at 5, 10, and 15 years were 77.8%, 69%, and 63.6%, respectively. Conclusions The long-term results for the combination of HDR-BT and EBRT continue to show excellent results, providing high equivalent dose in 2 Gy per fraction and high disease control rates. These outcomes were reproducible for the extended follow-up period ranging up to 21.9 years.

Summary Objective Shared decision making is based on the idea of cooperation and partnership between patients and doctors. In this concept both parties may initiate and perform specific decision-making steps. However, the common observation-based instruments focus solely on doctors’ behaviour. Content and quality of information provided to involve patients in medical decisions are hardly considered in evaluation of SDM. This study investigates the advantages of a revised observer inventory taking into account these aspects. Methods Based on the OPTION scale, a more comprehensive observation-based inventory was developed, additionally considering both the patient-sided indicators for patient involvement and the criteria of evidence-based patient information. The inventory comprises three scales (doctor, patient, doctor-patient dyad) and 15 indicators each. Rater training and re-analyses of 76 consultations previously analysed using the OPTION scale were conducted. Convergent validities were calculated between the observer-based scales and the patients’ ratings on the Shared Decision Making Questionnaire, the Decisional Conflict Scale and the Control Preference Scale. Results Interrater reliabilities of the revised scales were high (r = .87 to .74) and even higher when only the dyadic perspective was coded (.86). The revised inventory provided additional information on the involvement taking place. No substantive correlations were found between observation-based and patients’ subjective judgments. Conclusion The observers’ perspective on patient involvement needs to consider patient activities. Inconsistencies of patients’ and observers’ judgements concerning patient participation need further investigation.

Background Shared Decision Making (SDM) is regarded as the best practice model for the communicative challenge of decision making about treatment or diagnostic options. However, randomized controlled trials focusing the effectiveness of SDM trainings are rare and existing measures of SDM are increasingly challenged by the latest research findings. This study will 1) evaluate a new physicians' communication training regarding patient involvement in terms of SDM, 2) validate SDMMASS, a new compound measure of SDM, and 3) evaluate the effects of SDM on the perceived quality of the decision process and on the elaboration of the decision. Methods In a multi-center randomized controlled trial with a waiting control group, 40 physicians from 7 medical fields are enrolled. Each physician contributes a sequence of four medical consultations including a diagnostic or treatment decision. The intervention consists of two condensed video-based individual coaching sessions (15min.) supported by a manual and a DVD. The interventions alternate with three measurement points plus follow up (6 months). Realized patient involvement is measured using the coefficient SDMMASS drawn from the Multifocal Approach to the Sharing in SDM (MAPPIN'SDM) which includes objective involvement, involvement as perceived by the patient, and the doctor-patient concordance regarding their judges of the involvement. For validation purposes, all three components of SDMMASS are supplemented by similar measures, the OPTION observer scale, the Shared Decision Making Questionnaire (SDM-Q) and the dyadic application of the Decisional Conflict Scale (DCS). Training effects are analyzed using t-tests. Spearman correlation coefficients are used to determine convergent validities, the influence of involvement (SDMMASS) on the perceived decision quality (DCS) and on the elaboration of the decision. The latter is operationalised by the ELAB coefficient from the UP24 (Uncertainty Profile, 24 items version). Discussion Due to the rigorous blinded randomized controlled design, the current trial promises valid and reliable results. On the one hand, we expect this condensed time-saving training to be adopted in clinical routine more likely than previous trainings. On the other hand, the exhaustivity of the MAPPIN'SDM measurement system qualifies it as a reference measure for simpler instruments and to deepen understanding of decision-making processes. Trial registration Current Controlled Trials ISRCTN78716079

OBJECTIVE: Patient involvement into medical decisions as conceived in the shared decision making method (SDM) is essential in evidence based medicine. However, it is not conclusively evident how best to define, realize and evaluate involvement to enable patients making informed choices. We aimed at investigating the ability of four measures to indicate patient involvement. While use and reporting of these instruments might imply wide overlap regarding the addressed constructs this assumption seems questionable with respect to the diversity of the perspectives from which the assessments are administered. METHODS: The study investigated a nested cohort (N = 79) of a randomized trial evaluating a patient decision aid on immunotherapy for multiple sclerosis. Convergent validities were calculated between observer ratings of videotaped physician-patient consultations (OPTION) and patients' perceptions of the communication (Shared Decision Making Questionnaire, Control Preference Scale & Decisional Conflict Scale). RESULTS: OPTION reliability was high to excellent. Communication performance was low according to OPTION and high according to the three patient administered measures. No correlations were found between observer and patient judges, neither for means nor for single items. Patient report measures showed some moderate correlations. CONCLUSION: Existing SDM measures do not refer to a single construct. A gold standard is missing to decide whether any of these measures has the potential to indicate patient involvement. PRACTICE IMPLICATIONS: Pronounced heterogeneity of the underpinning constructs implies difficulties regarding the interpretation of existing evidence on the efficacy of SDM. Consideration of communication theory and basic definitions of SDM would recommend an inter-subjective focus of measurement. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN25267500.

We investigated possible age differences in the frequency of antisocial personality disorder (ASPD), and of psychopathy according to Hare's criteria and its constituent features: In a cross-sectional study 226 male violent offenders, detained in adult or youth custody, were investigated using the Psychopathy Checklist Screening Version (PCL:SV) and the SCID II Interview. Their ages ranged from 18 to 59 years. Total PCL:SV score was negatively correlated with age. ANOVA showed that total PCL scores for three age groups differed significantly. Both effects were due entirely to Factor 2 of the PCL. Factor 1 was not related to age. The frequency of ASPD was also lower among older prisoners. The relationship with age was similar to that of PCL:SV Factor 2. These results point to age-related effects in psychopathy and suggest that different aspects of psychopathy follow different developmental courses. The results of our group comparison suggest that the different subfacets of psychopathy are not stable over time to the same extent. In order to make statements about the course of intraindividual development, however, longitudinal studies would be required.

This study examines the relationship between DSM-cluster B personality disorders (PDs) and psychopaths according to Hare's criteria as detected by the Psychopathy Checklist (PCL:SV) in 299 violent offenders. To clarify some contradictions among several previous studies on this issue, individual cluster B PDs were looked at alone, excluding any cases of comorbidity with other PDs of this cluster. We found highly significant relationships between antisocial and borderline PD and Factor II of the PCL and a highly significant correlation between narcissistic PD and Factor I of the PCL. These results were to be expected from the theoretical basis of the development of the PCL and provide a contribution to the construct validity of the PCL, which until now has not been validated on such a large sample in Germany. Copyright © 2007 John Wiley & Sons, Ltd.

Objective: This study examined the predictive validity of the German translation of the Psychopathy Checklist-Screening Version (PCL-SV) for negative events during the course of the prison sentence of German prisoners. Method: Using the PCL-SV, we investigated 145 offenders in a German prison at the start of their sentences. We then compared the extreme groups identified by the PCL-SV—the high and low scorers—using a prospective design with respect to negative events and factors during the course of the sentences. This involved the standardized collection of data on both objective records of disciplinary incidents and subjective impressions from prison staff on the basis of operationalized criteria. Results: The high scorers were involved in significantly more disciplinary incidents and were also rated significantly less favourably by prison staff than the low scorers. Conclusion: Until now, the PCL has only been shown to predict recidivism following release from prison. The results of our study show that the PCL also has predictive validity for problems during the course of the sentence. It is therefore recommended that the PCL be used routinely at the start of the prison sentence to estimate the likelihood of subsequent difficulties.

Background The wide scale permeation of health care by the shared decision making concept (SDM) reflects its relevance and advanced stage of development. An increasing number of studies evaluating the efficacy of SDM use instruments based on various sub-constructs administered from different viewpoints. However, as the concept has never been captured in operable core definition it is quite difficult to link these parts of evidence. This study aims at investigating interrelations of SDM indicators administered from different perspectives. Method A comprehensive inventory was developed mapping judgements from different perspectives (observer, doctor, patient) and constructs (behavior, perception) referring to three units (doctor, patient, doctor-patient-dyad) and an identical set of SDM-indicators. The inventory adopted the existing approaches, but added additional observer foci (patient and doctor-patient-dyad) and relevant indicators hitherto neglected by existing instruments. The complete inventory comprising a doctor-patient-questionnaire and an observer-instrument was applied to 40 decision consultations from 10 physicians from different medical fields. Convergent validities were calculated on the basis of Pearson correlation coefficients. Results Reliabilities for all scales were high to excellent. No correlations were found between observer and patients or physicians neither for means nor for single items. Judgements of doctors and patients were moderately related. Correlations between the observer scales and within the subjective perspectives were high. Inter-perspective agreement was not related to SDM performance or patient activity. Conclusion The study demonstrates the contribution to involvement made by each of the relevant perspectives and emphasizes the need for an inter-subjective approach regarding SDM measurement.

Background Emesis and nausea are side effects induced by chemotherapy. These effects lead to enormous stress and strain on cancer patients. Further consequences may include restrictions in quality of life, cachexia or therapy avoidance. Evidence suggests that cancer patients develop the side effects of nausea and vomiting in anticipation of chemotherapy. Contextual cues such as smell, sounds or even the sight of the clinic may evoke anticipatory nausea and vomiting prior to infusion. Anticipatory nausea and vomiting are problems that cannot be solved by administration of antiemetica alone. The purpose of the proposed randomized placebo-controlled trial is to use an overshadowing technique to prevent anticipatory nausea and vomiting and to decrease the intensity and duration of post-treatment nausea and vomiting. Furthermore, the effect on anxiety, adherence and quality of life will be evaluated. Methods/Design Fifty-two pediatric cancer patients will be evenly assigned to two groups: an experimental group and a control group. The participants, hospital staff and data analysts will be kept blinded towards group allocation. The experimental group will receive during three chemotherapy cycles a salient piece of candy prior to every infusion, whereas the control group will receive flavorless placebo tablets. Discussion If an effectiveness of the overshadowing technique is proven, implementation of this treatment into the hospitals’ daily routine will follow. The use of this efficient and economic procedure should aid a reduced need for antiemetics. Trial registration Current Controlled Trials ISRCTN30242271/