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.

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.

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.

Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: a systematic literature review.

BACKGROUND: An effectiveness assessment on ASCT in locally advanced and metastatic breast cancer identified serious ethical issues associated with this intervention. Our objective was to systematically review these aspects by means of a literature analysis. METHODS: We chose the reflexive Socratic approach as the review method using Hofmann's question list, conducted a comprehensive literature search in biomedical, psychological and ethics bibliographic databases and screened the resulting hits in a 2-step selection process. Relevant arguments were assembled from the included articles, and were assessed and assigned to the question list. Hofmann's questions were addressed by synthesizing these arguments. RESULTS: Of the identified 879 documents 102 included arguments related to one or more questions from Hofmann's question list. The most important ethical issues were the implementation of ASCT in clinical practice on the basis of phase-II trials in the 1990s and the publication of falsified data in the first randomized controlled trials (Bezwoda fraud), which caused significant negative effects on recruiting patients for further clinical trials and the doctor-patient relationship. Recent meta-analyses report a marginal effect in prolonging disease-free survival, accompanied by severe harms, including death. ASCT in breast cancer remains a stigmatized technology. Reported health-related-quality-of-life data are often at high risk of bias in favor of the survivors. Furthermore little attention has been paid to those patients who were dying. CONCLUSIONS: The questions were addressed in different degrees of completeness. All arguments were assignable to the questions. The central ethical dimensions of ASCT could be discussed by reviewing the published literature.

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.

Transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis: a systematic review and meta-analysis.

OBJECTIVES: Patients undergoing surgery for severe aortic stenosis (SAS) can be treated with either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). The choice of procedure depends on several factors, including the clinical judgement of the heart team and patient preferences, which are captured by actively informing and involving patients in a process of shared decision making (SDM). We synthesised the most up-to-date and accessible evidence on the benefits and risks that may be associated with TAVI versus SAVR to support SDM in this highly personalised decision-making process. DESIGN: Systematic review and meta-analysis. DATA SOURCES: MEDLINE (Ovid), Embase (Ovid) and the Cochrane Central Register of Controlled Trials (CENTRAL; Wiley) were searched from January 2000 to August 2020 with no language restrictions. Reference lists of included studies were searched to identify additional studies. ELIGIBILITY CRITERIA: Randomised controlled trials (RCTs) that compared TAVI versus SAVR in patients with SAS and reported on all-cause or cardiovascular mortality, length of stay in intensive care unit or hospital, valve durability, rehospitalisation/reintervention, stroke (any stroke or major/disabling stroke), myocardial infarction, major vascular complications, major bleeding, permanent pacemaker (PPM) implantation, new-onset or worsening atrial fibrillation (NOW-AF), endocarditis, acute kidney injury (AKI), recovery time or pain were included. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers were involved in data extraction and risk of bias (ROB) assessment using the Cochrane tool (one reviewer extracted/assessed the data, and the second reviewer checked it). Dichotomous data were pooled using the Mantel-Haenszel method with random-effects to generate a risk ratio (RR) with 95% CI. Continuous data were pooled using the inverse-variance method with random-effects and expressed as a mean difference (MD) with 95% CI. Heterogeneity was assessed using the I2 statistic. RESULTS: 8969 records were retrieved and nine RCTs (61 records) were ultimately included (n=8818 participants). Two RCTs recruited high-risk patients, two RCTs recruited intermediate-risk patients, two RCTs recruited low-risk patients, one RCT recruited high-risk (≥70 years) or any-risk (≥80 years) patients; and two RCTs recruited all-risk or 'operable' patients. While there was no overall change in the risk of dying from any cause (30 day: RR 0.89, 95% CI 0.65 to 1.22; ≤1 year: RR 0.90, 95% CI 0.79 to 1.03; 5 years: RR 1.09, 95% CI 0.98 to 1.22), cardiovascular mortality (30 day: RR 1.03, 95% CI 0.77 to 1.39; ≤1 year: RR 0.90, 95% CI 0.76 to 1.06; 2 years: RR 0.96, 95% CI 0.83 to 1.12), or any type of stroke (30 day: RR 0.83, 95% CI 0.61 to 1.14;≤1 year: RR 0.94, 95% CI 0.72 to 1.23; 5 years: RR 1.07, 95% CI 0.88 to 1.30), the risk of several clinical outcomes was significantly decreased (major bleeding, AKI, NOW-AF) or significantly increased (major vascular complications, PPM implantation) for TAVI vs SAVR. TAVI was associated with a significantly shorter hospital stay vs SAVR (MD -3.08 days, 95% CI -4.86 to -1.29; 4 RCTs, n=2758 participants). Subgroup analysis generally favoured TAVI patients receiving implantation via the transfemoral (TF) route (vs non-TF); receiving a balloon-expandable (vs self-expanding) valve; and those at low-intermediate risk (vs high risk). All RCTs were rated at high ROB, predominantly due to lack of blinding and selective reporting. CONCLUSIONS: No overall change in the risk of death from any cause or cardiovascular mortality was identified but 95% CIs were often wide, indicating uncertainty. TAVI may reduce the risk of certain side effects while SAVR may reduce the risk of others. Most long-term (5-year) results are limited to older patients at high surgical risk (ie, early trials), therefore more data are required for low risk populations. Ultimately, neither surgical technique was considered dominant, and these results suggest that every patient with SAS should be individually engaged in SDM to make evidence-based, personalised decisions around their care based on the various benefits and risks associated with each treatment. PROSPERO REGISTRATION NUMBER: CRD42019138171.

Confirmatory factor analysis and recommendations for improvement of the Autonomy-Preference-Index (API).

OBJECTIVE: Validation of the German version of the Autonomy-Preference-Index (API), a measure of patients' preferences for decision making and information seeking. METHODS: Stepwise confirmatory factor analysis was conducted on a sample of patients (n = 1592) treated in primary care for depression (n = 186), surgical and internal medicine inpatients (n = 811) and patients with minor trauma treated in an emergency department (n = 595). An initial test of the model was done on calculation and validation halves of the sample. Both local and global indexes-of-fit suggested modifications to the scale. The scale was modified and re-tested in the calculation sample and confirmed in the validation sample. Subgroup analyses for age, gender and type of treatment setting were also performed. RESULTS: The confirmatory analysis led to a modified version of the API with better local and global indexes-of-fit for samples of German-speaking patients. Two items of the sub-scale, 'preference for decision-making', and one item of the sub-scale, 'preference for information seeking', showed very low reliability scores and were deleted. Thus, several global indexes-of-fit clearly improved significantly. The modified scale was confirmed on the validation sample with acceptable to good indices of fit. Results of subgroup analyses indicated that no adaptations were necessary. DISCUSSION AND CONCLUSIONS: This first confirmatory analysis for a German-speaking population showed that the API was improved by the removal of several items. There were theoretically plausible explanations for this improvement suggesting that the modifications might also be appropriate in English and other language versions.

Configural frequency analysis as a method of determining patients' preferred decision-making roles in dialysis.

BACKGROUND: Numerous studies examined factors in promoting a patient preference for active participation in treatment decision making with only modest success. The purpose of this study was to identify types of patients wishing to participate in treatment decisions as well as those wishing to play a completely active or passive role based on a Germany-wide survey of dialysis patients; using a prediction typal analysis method that defines types as configurations of categories belonging to different attributes and takes particularly higher order interactions between variables into account. METHODS: After randomly splitting the original patient sample into two halves, an exploratory prediction configural frequency analysis (CFA) was performed on one-half of the sample (n = 1969) and the identified types were considered as hypotheses for an inferential prediction CFA for the second half (n = 1914). 144 possible prediction types were tested by using five predictor variables and control preferences as criterion. An α-adjustment (0.05) for multiple testing was performed by the Holm procedure. RESULTS: 21 possible prediction types were identified as hypotheses in the exploratory prediction CFA; four patient types were confirmed in the confirmatory prediction CFA: patients preferring a passive role show low information seeking preference, above average trust in their physician, perceive their physician's participatory decision-making (PDM)-style positive, have a lower educational level, and are 56-75 years old (Type 1; p < 0.001) or > 76 years old (Type 2; p < 0.001). Patients preferring an active role show high information seeking preference, a higher educational level, and are < 55 years old. They have either below average trust, perceive the PDM-style negative (Type 3; p < 0.001) or above average trust and perceive the PDM-style positive (Type 4; p < 0.001). CONCLUSIONS: The method prediction configural frequency analysis was newly introduced to the research field of patient participation and could demonstrate how a particular control preference role is determined by an association of five variables.

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.

Importance of hemodialysis-related outcomes: comparison of ratings by a self-help group, clinicians, and health technology assessment authors with those by a large reference group of patients.

BACKGROUND: The selection of important outcomes is a crucial decision for clinical research and health technology assessment (HTA), and there is ongoing debate about which stakeholders should be involved. Hemodialysis is a complex treatment for chronic kidney disease (CKD) and affects many outcomes. Apart from obvious outcomes, such as mortality, morbidity and health-related quality of life (HRQoL), others such as, concerning daily living or health care provision, may also be important. The aim of our study was to analyze to what extent the preferences for patient-relevant outcomes differed between various stakeholders. We compared preferences of stakeholders normally or occasionally involved in outcome prioritization (patients from a self-help group, clinicians and HTA authors) with those of a large reference group of patients. PARTICIPANTS AND METHODS: The reference group consisted of 4,518 CKD patients investigated previously. We additionally recruited CKD patients via a regional self-help group, nephrologists via an online search and HTA authors via an expert database or personal contacts. All groups assessed the relative importance of the 23 outcomes by means of a discrete visual analog scale. We used descriptive statistics to rank outcomes and compare the results between groups. RESULTS: We received completed questionnaires from 49 self-help group patients, 19 nephrologists and 18 HTA authors. Only the following 3 outcomes were ranked within the top 7 outcomes by all 4 groups: safety, HRQoL and emotional state. The ratings by the self-help group were generally more concordant with the reference group ratings than those by nephrologists, while HTA authors showed the least concordance. CONCLUSION: Preferences of CKD patients from a self-help group, nephrologists and HTA authors differ to a varying extent from those of a large reference group of patients with CKD. The preferences of all stakeholders should form the basis of a transparent approach so as to generate a valid list of important outcomes.

Preferences of patients undergoing hemodialysis - results from a questionnaire-based study with 4,518 patients.

BACKGROUND: Chronic kidney disease is an increasing health problem worldwide and in its final stage (stage V) can only be treated by renal replacement therapy, mostly hemodialysis. Hemodialysis has a major influence on the everyday life of patients and many patients report dissatisfaction with treatment. Little is known about which aspects of treatment are considered important by hemodialysis patients. The objective of this study was to rate the relative importance of different outcomes for hemodialysis patients and to analyze whether the relative importance differed among subgroups of patients. PATIENTS AND METHODS: Within the framework of a yearly questionnaire which is distributed among patients receiving hemodialysis by the largest hemodialysis provider in Germany, we assessed the relative importance of 23 outcomes as rated on a discrete visual analog scale. Descriptive statistics were used to rank the outcomes. Subgroup analyses were performed using Mann-Whitney U or Kruskal-Wallis tests. RESULTS: Questionnaires of 4,518 hemodialysis patients were included in the analysis. The three most important outcomes were safety of treatment, health-related quality of life, and satisfaction with care. Further important outcomes were hospital stays, accompanying symptoms, hemodialysis duration, and the improvement or preservation of a good emotional state. Age, profession, and education had the strongest influence on relevant differences of preferences for outcomes; no relevant influence of sex or comorbidity was observed. CONCLUSION: Outcomes concerning the delivery or provision of care and aspects influencing quality of life are rated by patients to be at least as important as clinical outcomes. Many of the outcomes judged to be important by the patients are not regularly considered in research, evaluation studies, or quality programs.

All nations depend on the global knowledge pool--analysis of country of origin of studies used for health technology assessments in Germany.

BACKGROUND: Health Technology Assessments (HTAs) are used to inform decision-making and their usefulness depends on the quality and relevance of research and specific studies for health-policy decisions. Little is known about the country of origin of studies used for HTAs. OBJECTIVE: To investigate which countries have made the largest contributions to inform health policy decisions through studies included in HTAs in Germany. METHODS: The country of origin was extracted from all studies included in HTAs of the German Institute for Quality and Efficiency in Health Care, (IQWiG), published from 2/2006 to 9/2010. Studies were ranked according to the total number of studies per country, adjusted for population size, gross domestic product (GDP), and total health expenditure. RESULTS: 1087 studies were included in 54 HTA reports. Studies were assigned to 45 countries. Most of the studies (27%) originated from the United States (USA), 18% were multinational, followed by 7% from the United Kingdom (UK) and 5% from Germany. Nordic countries led the ranking when adjusting for population size/million (ranks 1-3,6,9/45 countries), GDP/billion US$ (1,2,5,9,14/45), or health expenditure/billion US$ (1,3,5,12,13/45). The relative contribution of the UK was stable in the analyses when adjusted for population size (7/45), GDP (7/45), and health expenditure (9/45), whereas the USA (13, 18, and 30/45) and Germany (17, 19, and 21/45) dropped in the ranking. CONCLUSIONS: More than half of the studies relevant for evidence-informed decision-making in Germany originated from the USA, followed by multinational research and the UK. Only 5% of the studies originated from Germany. According to our findings, there appears to be some discrepancy between the use of globally generated evidence and the contribution to the knowledge pool by individual countries.

Breast cancer patients' trust in physicians: the impact of patients' perception of physicians' communication behaviors and hospital organizational climate.

OBJECTIVE: To examine whether patients' perception of a hospital's organizational climate has an impact on their trust in physicians after accounting for physicians' communication behaviors as perceived by the patients and patient characteristics. METHODS: Patients undergoing treatment in breast centers in the German state of North Rhein-Westphalia in 2006 were asked to complete a standardized postal questionnaire. Disease characteristics were then added by the medical personnel. Multiple linear regressions were performed. RESULTS: 80.5% of the patients responded to the survey. 37% of the variance in patients' trust in physicians can be explained by the variables included in our final model (N=2226; R(2) adj.=0.372; p<0.001). Breast cancer patients' trust in their physicians is strongly associated with their perception of a hospital's organizational climate. The impact of their perception of physicians' communication behaviors persists after introducing hospital organizational characteristics. Perceived physician accessibility shows the strongest association with trust. CONCLUSIONS: A trusting physician-patient relationship among breast cancer patients is associated with both the perceived quality of the hospital organizational climate and perceived physicians' communication behaviors. PRACTICE IMPLICATIONS: With regard to clinical organization, efforts should be put into improving the organizational climate and making physicians more accessible to patients.