A scattered landscape: assessment of the evidence base for 71 patient decision aids developed in a hospital setting.

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.

Training doctors briefly and in situ to involve their patients in making medical decisions-Preliminary testing of a newly developed module.

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 self-assessed 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.

Patient-reported effects of hospital-wide implementation of shared decision-making at a university medical centre in Germany: a pre-post trial.

OBJECTIVES: To evaluate the feasibility and effectiveness of the SHARE TO CARE (S2C) programme, a complex intervention designed for hospital-wide implementation of shared decision-making (SDM). DESIGN: Pre-post study. SETTING: University Hospital Schleswig-Holstein (UKSH), Kiel Campus. PARTICIPANTS: Healthcare professionals as well as inpatients and outpatients from 22 departments of the Kiel Campus of UKSH. INTERVENTIONS: The S2C programme is a comprehensive implementation strategy including four core modules: (1) physician training, (2) SDM support training for and support by nurses as decision coaches, (3) patient activation and (4) evidence-based patient decision aid development and integration into patient pathways. After full implementation, departments received the S2C certificate. MAIN OUTCOME MEASURES: In this paper, we report on the feasibility and effectiveness outcomes of the implementation. Feasibility was judged by the degree of implementation of the four modules of the programme. Outcome measures for effectiveness are patient-reported experience measures (PREMs). The primary outcome measure for effectiveness is the Patient Decision Making subscale of the Perceived Involvement in Care Scale (PICSPDM). Pre-post comparisons were done using t-tests. RESULTS: The implementation of the four components of the S2C programme was able to be completed in 18 of the 22 included departments within the time frame of the study. After completion of implementation, PICSPDM showed a statistically significant difference (p<0.01) between the means compared with baseline. This difference corresponds to a small to medium yet clinically meaningful positive effect (Hedges' g=0.2). Consistent with this, the secondary PREMs (Preparation for Decision Making and collaboRATE) also showed statistically significant, clinically meaningful positive effects. CONCLUSIONS: The hospital-wide implementation of SDM with the S2C-programme proved to be feasible and effective within the time frame of the project. The German Federal Joint Committee has recommended to make the Kiel model of SDM a national standard of care.

Comprehensive Implementation of Shared Decision Making in a Neuromedical Center Using the SHARE TO CARE Program.

Purpose: 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.

Turning signals into meaning--'shared decision making' meets communication theory.

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 SDM-goal setting, and for clinical practice of SDM are described.

[Evaluation of the Padua and R.E.N.A.L. scores regarding their validity and implication in the perioperative management during partial nephrectomy]. / Evaluation von Padua- und R.E.N.A.L.-Score hinsichtlich ihrer Aussagekraft und Implikationen auf das perioperative Management bei der partiellen Nephrektomie.

BACKGROUND: 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. PATIENTS AND METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Moving towards patient-centered care and shared decision-making in Germany.

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.

Sustainability of large-scale implementation of shared decision making with the SHARE TO CARE program.

Introduction: SHARE TO CARE (S2C) is a comprehensive implementation program for shared decision making (SDM). It is run at the University Hospital Schleswig-Holstein (UKSH) in Kiel, Germany, and consists of four combined intervention modules addressing healthcare professionals and patients: (1) multimodal training of physicians (2) patient activation campaign including the ASK3 method, (3) online evidence-based patient decision aids (4) SDM support by nurses. This study examines the sustainability of the hospital wide SDM implementation by means of the Neuromedical Center comprising the Departments of Neurology and Neurosurgery. Methods: Between 2018 and 2020, the S2C program was applied initially within the Neuromedical Center: We implemented the patient activation campaign, trained 89% of physicians (N = 56), developed 12 patient decision aids and educated two decision coaches. Physicians adjusted the patients' pathways to facilitate the use of decision aids. To maintain the initial implementation, the departments took care that new staff members received training and decision aids were updated. The patient activation campaign was continued. To determine the sustainability of the initial intervention, the SDM level after a maintenance phase of 6-18 months was compared to the baseline level before implementation. Therefore, in- and outpatients received a questionnaire via mail after discharge. The primary endpoint was the "Patient Decision Making" subscale of the Perceived Involvement in Care Scale (PICSPDM). Secondary endpoints were an additional scale measuring SDM (CollaboRATE), and the PrepDM scale, which determines patients' perceived health literacy while preparing for decision making. Mean scale scores were compared using t-tests. Results: Patients reported a significantly increased SDM level (PICSPDM p = 0.02; Hedges' g = 0.33; CollaboRATE p = 0.05; Hedges' g = 0.26) and improved preparation for decision making (PrepDM p = 0.001; Hedges' g = 0.34) 6-18 months after initial implementation of S2C. Discussion: The S2C program demonstrated its sustainability within the Neuromedical Center at UKSH Kiel in terms of increased SDM and health literacy. Maintaining the SDM implementation required a fraction of the initial intensity. The departments took on the responsibility for maintenance. Meanwhile, an additional health insurance-based reimbursement for S2C secures the continued application of the program. Conclusion: SHARE TO CARE promises to be suitable for long-lasting implementation of SDM in hospitals.

The effect of a scalable online training module for shared decision making based on flawed video examples - a randomized controlled trial.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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; p < 0.001; 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. CONCLUSION: 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. PRACTICE IMPLICATIONS: SDM can be trained effectively and efficiently with this easily scalable online training.

Enhancing Specific Health Literacy with a Digital Evidence-Based Patient Decision Aid for Hypertension: A Randomized Controlled Trial.

INTRODUCTION: 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.

Challenges and Controversies in the Surgical Treatment of Cervical Cancer: Open Radical Hysterectomy versus Minimally Invasive Radical Hysterectomy.

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.

Strategies for involving patients and the public in scaling-up initiatives in health and social services: protocol for a scoping review and Delphi survey.

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 search 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. SYSTEMATIC REVIEW REGISTRATION: We registered this protocol with the Open Science Framework on August 19, 2020 ( https://osf.io/zqpx7/ ).

Making shared decision-making (SDM) a reality: protocol of a large-scale long-term SDM implementation programme at a Northern German University Hospital.

INTRODUCTION: Shared 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 ANALYSIS: S2C 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 DISSEMINATION: Ethics 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.

Radical dose escalation by high-dose-rate brachytherapy for localized prostate cancer-Significance of prostate-specific antigen nadir level within 18 months as correlation for long-term biochemical control.

PURPOSE: 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. METHODS AND MATERIALS: Combined pelvis-external beam radiation/HDR-BT boost to EQD2 >100 Gy (α/ß = 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. RESULTS: 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 group <0.5 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). CONCLUSIONS: 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.

Efficacy of the doktormitSDM training module in supporting shared decision making - Results from a multicenter double-blind randomized controlled trial.

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 (15min) 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.

Validation of the Norwegian version of MAPPIN'SDM, an observation-based instrument to measure shared decision-making in clinical encounters.

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 OPTION5 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 (MAPPINdoctor=0.77, MAPPINpatient=0.82, MAPPINdyad=0.77). Patient involvement was detected accurately (MAPPINdyad: mean sensitivity/specificity 93/91%). Comparison with OPTION5 showed weak to moderate correlation (Spearman's ρ/p-value: MAPPINdoctor:=0.44/0.009, MAPPINpatient: 0.38/0.024, MAPPINdyad 0.40/0.016) and little content overlap. CONCLUSION: MAPPIN'SDMnorge is capable of assessing SDM highly reliably and accurately. Divergence from OPTION5 reflects explicit disagreement regarding the concept's assumptions. PRACTICE IMPLICATIONS: MAPPIN'SDMnorge is ready for use in Norway. In-depth debate on the SDM concept's essentials is urgently needed.

Neuropsychological performance of school-aged children after staged surgical palliation of hypoplastic left heart syndrome.

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.

The 15-year outcomes of high-dose-rate brachytherapy for radical dose escalation in patients with prostate cancer - a benchmark for high-tech external beam radiotherapy alone?

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/ß = 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.