Differences in treatment choices between prostate cancer patients using a decision aid and patients receiving care as usual: results from a randomized controlled trial.

OBJECTIVE: To determine whether or not decision aid (DA) use influences treatment decisions in patients with low and intermediate risk prostate cancer (PC). PATIENTS AND METHODS: In a cluster randomized controlled trial, patients were randomized to either DA use (DA group) or no DA use (control group). Between 2014 and 2016, newly diagnosed patients with low or intermediate risk PC were recruited in 18 hospitals in the Netherlands. DA users had access to a web-based DA that provided general PC information, PC-treatment information, and values clarification exercises to elicit personal preferences towards the treatment options. Control group patients received care as usual. Differences in treatment choice were analysed using multilevel logistic regressions. Differences in eligible treatment options between groups were compared using Pearson Chi-square tests. RESULTS: Informed consent was given by 382 patients (DA group N = 273, control group N = 109). Questionnaire response rate was 88% (N = 336). Active surveillance (AS) was an option for 38%, radical prostatectomy (RP) for 98%, external beam radiotherapy (EBRT) for 88%, and brachytherapy (BT) for 79% of patients. DA users received AS significantly more often than control group. Patients (29 vs 16%, p = 0.01), whereas the latter more often chose BT (29 vs 18%, p < 0.01). No differences were found between groups regarding RP and EBRT. DA users who were not eligible for AS, received surgery more often compared to the control group (53 vs 35%, p = 0.01). Patient and disease characteristics were evenly distributed between groups. CONCLUSION: DA-using PC patients chose the AS treatment option more often than non-DA-using patients did.

A clinician's guide for developing a prediction model: a case study using real-world data of patients with castration-resistant prostate cancer.

PURPOSE: With the increasing interest in treatment decision-making based on risk prediction models, it is essential for clinicians to understand the steps in developing and interpreting such models. METHODS: A retrospective registry of 20 Dutch hospitals with data on patients treated for castration-resistant prostate cancer was used to guide clinicians through the steps of developing a prediction model. The model of choice was the Cox proportional hazard model. RESULTS: Using the exemplary dataset several essential steps in prediction modelling are discussed including: coding of predictors, missing values, interaction, model specification and performance. An advanced method for appropriate selection of main effects, e.g. Least Absolute Shrinkage and Selection Operator (LASSO) regression, is described. Furthermore, the assumptions of Cox proportional hazard model are discussed, and how to handle violations of the proportional hazard assumption using time-varying coefficients. CONCLUSION: This study provides a comprehensive detailed guide to bridge the gap between the statistician and clinician, based on a large dataset of real-world patients treated for castration-resistant prostate cancer.

Treatment Preferences of Patients With Benign Prostatic Hyperplasia Before and After Using a Web-based Decision Aid.

OBJECTIVE: To evaluate treatment preferences of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) before and after using a web-based decision aid (DA). PATIENTS AND METHODS: Between July 2016 and January 2017 patients were invited to use a web-based LUTS/BPH DA. Treatment preferences (for lifestyle advices, medication or surgery) before and after DA use and responses on values clarification exercises were extracted from the DA. RESULTS: In total, 126 patients were included in the analysis. Thirty-four percent (43/126) had not received any previous treatment and were eligible for (continuation of) lifestyle advices or to start medication, as initial treatment. The other 66% (83/126) did use medication and were eligible, either for continuing medication or to undergo surgery. Before being exposed to the DA, 67 patients (53%) were undecided and 59 patients (47%) indicated an initial treatment preference. Half of the patients who were initially undecided were able to indicate a preference after DA use (34/67, 51%). Of those with an initial preference, 80% (47/59) confirmed their initial preference after DA use. Five out of 7 values clarification exercises used in the DA were discriminative between final treatment preferences. In 79%, the treatment preferred after DA use matched the received treatment. Overall, healthcare providers were positive about DA feasibility. CONCLUSION: Our findings suggest that a LUTS/BPH DA may help patients to confirm their initial treatment preference and support them in forming a treatment preference if they did not have an initial preference.

Changes in internet use and wishes of cancer survivors: A comparison between 2005 and 2017.

BACKGROUND: Given the major changes in internet use for health communication, the objective of the current study was to compare the internet use and wishes of cancer survivors between 2005 and 2017. METHODS: The authors drew a sample of 390 patients in 2005 and 539 patients in 2017 who were diagnosed with breast (128 patients in 2005 and 143 patients in 2017), prostate (96 patients in 2005 and 126 patients in 2017), or gynecologic (89 patients in 2005 and 188 patients in 2017) cancer or lymphoma (77 patients in 2005 and 82 patients in 2017) in 4 different hospitals for the periods 2002 through 2004 and 2014 through 2016. These patients were sent a paper-based questionnaire that contained 45 questions regarding demographics and 4 functions of internet use: content, communication, community, and e-health. RESULTS: The response in 2017 (53%) was lower than that in 2005 (75%). Survivors browsed the internet most frequently to search for information regarding cancer shortly after being diagnosed and while waiting for treatment. There was little change noted with regard to the relative importance attached to the various subjects. In 2017, significant increases were evident with regard to finances (+33%), health care insurance (+29%), and genetics and/or heritability (+27%). The wishes expressed in 2005 by patients were realized in part in 2017. CONCLUSIONS: A significant sample of cancer survivors in the Netherlands have indicated that the internet is an important source of information regarding their illness. However, little change was evident over the past 15 years with regard to patients' priorities regarding their wishes for internet use. The wishes of users in 2005 were found to accurately reflect the internet use of the majority of patients in 2017. The results of the current study support the belief that health care professionals should expand their online services and tailor them toward the needs and wishes of their patients.

Development and usability testing of a multi-criteria value clarification methods for patients with localized prostate cancer.

Current guidelines for the development of decision aids recommend that they have to include a process for helping patients clarify their personal values, for example, by using values clarification methods. In this article, we extensively described the development process of the web-based values clarification method for patients with localized low- to intermediate-risk prostate cancer based on the analytic hierarchy process. With analytic hierarchy process, the relative importance of different attributes of available treatments can be determined through series of pairwise comparisons of potential outcomes. Furthermore, analytic hierarchy process is able to use this information to present respondents with a quantitative overall treatment score and can therefore give actual treatment advice upon patients' request. The addition of this values clarification method to an existing web-based treatment decision aid for patients with localized prostate cancer is thought to improve the support offered to patients in their decision-making process and their decision quality.

Phytotherapy Adds to the Therapeutic Armamentarium for the Treatment of Mild-To-Moderate Lower Urinary Tract Symptoms in Men.

BACKGROUND: Practice guidelines hardly recommend herbal extracts for male lower urinary tract symptoms (LUTS). However, many patients are unsatisfied with first-line synthetic drugs and often prefer herbal medicines because of good tolerability. To improve the decision-making process, which should consider the patients' expectations, it is crucial to reflect on the role of phytotherapy in the treatment of LUTS. We (panel experts) reflected on current guideline recommendations and real practice across various European countries and debated the potential role of plant extracts with a focus on pumpkin seed soft extract investigated over 12 months in two randomised placebo-controlled trials. SUMMARY: Most guidelines give no clear recommendations on phytotherapy due to the heterogeneity of clinically investigated extracts. Nevertheless, plant extracts are prescribed to patients with mild-to-moderate LUTS. Also, self-medicating patients often handle their complaints with herbal products. Many patients aim to avoid synthetic drugs for fear of sexual functional side effects and a negative impact on their quality of life. For the elderly, vasoactive comedications might become an issue. When taking plant extracts, patients experience an acceptable symptomatic relief similar to that achieved with synthetics but without side effects. Key Messages: In shared decision-making for purely symptomatic treatment, a low risk of side effects takes priority. We propose to consider patient preferences in the treatment of mild-to-moderate LUTS in men with a low risk of disease progression. We found a consensus that pumpkin seed soft extract adds to the therapeutic armamentarium for patients who cannot or do not want to apply synthetic drugs.

Should we involve patients more actively? Perspectives of the multidisciplinary team on shared decision-making for older patients with metastatic castration-resistant prostate cancer.

OBJECTIVE: To evaluate perspectives of the multidisciplinary team concerning shared decision-making (SDM) in treatment decisions for older patients with metastatic castration-resistant prostate cancer (mCRPC). MATERIALS AND METHODS: A survey among Dutch healthcare providers was conducted to assess healthcare providers' perspectives on patient involvement in decision-making and the value of a decision aid (DA) in the decision-making process. Treatment recommendations were assessed using hypothetical cases in which providers were asked to evaluate their likelihood of pursuing listed treatment options. RESULTS: In total, 170 Dutch healthcare providers, including 82 urologists, 31 oncologists, and 57 oncology nurses completed the survey. Sixty-two percent of urologists, 65% of oncologists, and 51% of oncology nurses found that mCRPC patients take a passive role in decision-making and delegate treatment decisions to doctors due to advanced age (p = .45). Yet, 70% of urologists, 71% of oncologists, and 63% of oncology nurses agreed that mCRPC patients should be always involved in decision-making (p = .91). Fifty-two percent of urologists and 55% of oncologists stated that they are inadequately trained to apply SDM in clinical practice. Conversely, only 20% of oncology nurses believed that oncology nurses are inadequately trained. Fifty-four percent of all providers considered a DA suitable to support these patients and their healthcare providers in the decision-making process. All hypothetical cases showed variation in treatment recommendations among providers, with each of the five treatments ranging from extremely likely to extremely unlikely. CONCLUSIONS: The wide variation of treatment recommendations observed among the multidisciplinary team suggests that mCRPC patients and their healthcare providers may benefit from implementation of informed SDM. Given the perceived passive role of older patients with mCRPC in decision-making, interventions to engage them are needed. With slightly more than half of respondents finding DAs useful to facilitate the decision-making process, development and implementation of a DA would be an interesting field of research.

A global, incremental development method for a web-based prostate cancer treatment decision aid and usability testing in a Dutch clinical setting.

Many new decision aids are developed while aspects of existing decision aids could also be useful, leading to a sub-optimal use of resources. To support treatment decision-making in prostate cancer patients, a pre-existing evidence-based Canadian decision aid was adjusted to Dutch clinical setting. After analyses of the original decision aid and routines in Dutch prostate cancer care, adjustments to the decision aid structure and content were made. Subsequent usability testing (N = 11) resulted in 212 comments. Care providers mainly provided feedback on medical content, and patients commented most on usability and summary layout. All participants reported that the decision aid was comprehensible and well-structured and would recommend decision aid use. After usability testing, final adjustments to the decision aid were made. The presented methods could be useful for cultural adaptation of pre-existing tools into other languages and settings, ensuring optimal usage of previous scientific and practical efforts and allowing for a global, incremental decision aid development process.

Uptake and usage of an online prostate cancer treatment decision aid in Dutch clinical practice: A quantitative analysis from the Prostate Cancer Patient Centered Care trial.

Implementation of patient's decision aids in routine clinical care is generally low. This study evaluated uptake and usage of a novel Dutch web-based prostate cancer treatment decision aid within the Prostate Cancer Patient Centered Care trial. From an estimated total patient sample of 1006 patients, 351 received a decision aid (35% implementation rate; hospital ranges 16%-84%). After receipt of the decision aid, most patients accessed the decision aid, utilized most functions, although not completely, and discussed the decision aid summary in a subsequent consultation with their care provider. Including nurses for dissemination of decision aids seemed to positively affect decision aid uptake. Once received, patients seemed able to use the decision aid and engage in shared decision-making as intended; however, decision aid uptake and complete usage of all decision aid components should be further improved. Prior to the diagnosis consultation, handing out of the decision aid should be prepared.

Longitudinal regret and information satisfaction after deciding on treatment for localized prostate cancer with or without a decision aid. Results at one-year follow-up in the PCPCC trial.

OBJECTIVE: To investigate the effect of including an online decision aid (DA) during prostate cancer treatment counseling on decisional regret and information satisfaction in a one-year follow-up. METHODS: Within a cluster RCT, 18 Dutch hospitals were randomized to DA counseling or care-as-usual, patients (n = 382) initially completed questionnaires directly after treatment decision making. Six and twelve months later regret (Decisional Regret Scale) and information satisfaction (SCIP-B) were assessed. Anxious and depressive symptoms (HADS) was included as possible covariate. RESULTS: After 12 months, 43 participants (15%) regretted their treatment choice and 105 participants (36%) were dissatisfied with the information that was received at the time of decision-making, regardless of being exposed to the DA. Anxious and depressive symptoms at follow-up were associated with regret and information dissatisfaction. CONCLUSION: No long-term benefical effects emerged from DA usage compared to patients who underwent standard counseling. PRACTICE IMPLICATIONS: During PCa treatment counseling, healthcare providers should be aware of anxious and depressive symptoms.

Effectiveness of a web-based treatment decision aid for men with lower urinary tract symptoms due to benign prostatic hyperplasia.

OBJECTIVES: To evaluate the effectiveness of a web-based decision aid (DA), with values clarification exercises compared with usual care, for men with lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH). PATIENTS AND METHODS: Between July 2016 and January 2017, all new patients with LUTS/BPH who consulted the urologist were invited to use the DA and participate in this prospective questionnaire study. Patients who consulted the urologist between December 2015 and February 2016 served as controls. The DA was designed to support patients in making a well-informed treatment decision, corresponding with their personal preferences and values. Well-informed decision was measured by using a knowledge questionnaire. Value congruent decision was measured by the correspondence between responses on nine value statements and chosen treatment. The primary outcome, decision quality, was defined as the combination of well-informed decision and value congruent decision. Secondary outcomes were decisional conflict, involvement and received role in shared decision-making, decisional regret, and treatment choice. RESULTS: A total of 109 DA-users and 108 controls were included. DA-users were younger (68.4 vs 71.5 years; P = 0.003) and their education level was higher (P = 0.047) compared with the controls. Patients who used the DA made a well-informed and value congruent decision more often than the control group (43% vs 21%; P = 0.028). DA-users had less decisional conflict (score 33.2 vs 46.6; P = 0.003), experienced a less passive role in decision-making (22% vs 41%; P = 0.038), and reported less process regret (score 2.4 vs 2.8; P = 0.034). Furthermore, DA-users who had not used prior medication chose lifestyle advices more often than the control group (43% vs 11%; P = 0.002). Outcomes were adjusted for significantly different baseline characteristics. CONCLUSION: The LUTS/BPH DA seems to improve the decision quality by supporting patients in making more well-informed and value congruent treatment decisions. Therefore, further implementation of this DA into routine care is suggested.

Impact of a web-based prostate cancer treatment decision aid on patient-reported decision process parameters: results from the Prostate Cancer Patient Centered Care trial.

PURPOSE: To compare patients' evaluation of the treatment decision-making process in localized prostate cancer between counseling that included an online decision aid (DA) and standard counseling. METHODS: Eighteen Dutch hospitals were randomized to DA counseling (n = 235) or the control group with standard counseling (n = 101) in a pragmatic, cluster randomized controlled trial. The DA was provided to patients at, or soon after diagnosis. Decisional conflict, involvement, knowledge, and satisfaction with information were assessed with a questionnaire after treatment decision-making. Anxiety and depression served as covariates. RESULTS: The levels of decision involvement and conflict were comparable between patients in both groups. Patients with a DA felt more knowledgeable but scored equally well on a knowledge test as patients without a DA. Small significant negative effects were found on satisfaction with information and preparation for decision-making. A preference for print over online and depression and anxiety symptoms was negatively associated with satisfaction and conflict scores in the DA group. DISCUSSION: The DA aimed to support shared decision-making, while outcomes for a majority of DA users were comparable to patients who received standard counseling. Patients, who are less comfortable with the online DA format or experience anxiety or depression symptoms, could require more guidance toward shared decision-making. To evaluate long-term DA effects, follow-up evaluation on treatment satisfaction and decisional regret will be done.

The impact of prostate cancer diagnosis and treatment decision-making on health-related quality of life before treatment onset.

OBJECTIVE: The objective of this study is to test if patients' health-related quality of life (HRQoL) declines after prostate biopsy to detect Pca, and after subsequent treatment decision-making in case Pca is confirmed, and to test whether personality state and traits are associated with these potential changes in HRQoL. METHODS: Patients who were scheduled for prostate biopsy to detect Pca (N = 377) filled out a baseline questionnaire about HRQoL (EORTC QLQ-C30 and PR25), "big five" personality traits (BFI-10), optimism (LOT-r), and self-efficacy (Decision Self-efficacy Scale) (t0). Patients with confirmed Pca (N = 126) filled out a follow-up questionnaire on HRQoL within 2 weeks after treatment was chosen but had not yet started (t1). RESULTS: HRQoL declined between t0 and t1, reflected in impaired role and cognitive functioning, and elevated fatigue, constipation, and prostate-specific symptoms. Sexual activity and functioning improved. Baseline HRQoL scores were unrelated to the selection of a particular treatment, but for patients who chose a curative treatment, post-decision HRQoL showed a greater decline compared to patients who chose active surveillance. Optimism was associated with HRQoL at baseline; decisional self-efficacy was positively associated with HRQoL at follow-up. No associations between HRQoL and the "big five" personality traits were found. CONCLUSION: Patients who have undergone prostate biopsy and treatment decision-making for Pca experience a decline in HRQoL. Choosing treatment with a curative intent was associated with greater decline in HRQoL. Interventions aimed at optimism and decision self-efficacy could be helpful to reduce HRQoL impairment around the time of prostate biopsy and treatment decision-making.

How do patients choose between active surveillance, radical prostatectomy, and radiotherapy? The effect of a preference-sensitive decision aid on treatment decision making for localized prostate cancer.

PURPOSE: To determine the effect of a decision aid (DA) on treatment preferences and to investigate which patient preferences are important for final treatment preferences. We also determined if the patient׳s treatment decision was influenced by the urologist׳s treatment preference. PATIENTS AND METHODS: Between August 2014 and July 2015, newly diagnosed patients with low-/intermediate-risk prostate cancer were offered to use a web-based DA after diagnosis. Treatment preferences and patient׳s values were extracted from the DA. Urologists׳ treatment preferences were indicated at the time of inclusion. RESULTS: We included 181 patients, of whom 21% preferred active surveillance, 33% radical prostatectomy, 10% brachytherapy, 3% external beam radiotherapy, and 34% did not indicate a specific preferred treatment option after DA use (missing N = 6). Among 67%, treatment preference before DA use did not change after DA use. In men who chose active surveillance after DA use, 97% (37/38) preferred to postpone unnecessary treatment. For radical prostatectomy, 91% (52/57) of the patients valued tumor removal, and for brachytherapy, 88% (15/17) valued incontinence worse than bowel complaints. For 64% (missing N = 21) of the patients, urologists indicated one specific preferred treatment option as most suitable for the patient concerned. Agreement between final treatment decision and urologist׳s preference was lower (κ = 0.68) than between final treatment decision and preferred treatment after DA use (κ = 0.82). CONCLUSION: Most patients with prostate cancer chose the treatment in accordance with the post-DA preference and to a lesser extent the urologists preference; implications of this are prospectively investigated in an ongoing study.

Cancer survivors' preference for follow-up care providers: a cross-sectional study from the population-based PROFILES-registry.

BACKGROUND: The best practice for the organization of follow-up care in oncology is under debate, due to growing numbers of cancer survivors. Understanding survivors' preferences for follow-up care is elementary for designing patient-centred care. Based on data from prostate cancer and melanoma survivors, this study aims to identify: 1) preferences for follow-up care providers, for instance the medical specialist, the oncology nurse or the general practitioner; 2) characteristics associated with these preferences and 3) the preferred care provider to discuss cancer-related problems. MATERIAL AND METHODS: Survivors diagnosed with prostate cancer (N = 535) and melanoma (N = 232) between 2007 and 2013 as registered in The Netherlands Cancer Registry returned a questionnaire (response rate was 71% and 69%, respectively). A latent class cluster model analysis was used to define preferences and a multinomial logistic regression analysis was used to identify survivor-related characteristics associated with these preferences. RESULTS: Of all survivors, 29% reported no preference, 40% reported a preference for the medical specialist, 20% reported a preference for both the medical specialist and the general practitioner and 11% reported a preference for both the medical specialist and the oncology nurse. Survivors who were older, lower/intermediate educated and women were more likely to have a preference for the medical specialist. Lower educated survivors were less likely to have a preference for both the medical specialist and the general practitioner. Overall, survivors prefer to discuss diet, physical fitness and fatigue with the general practitioner, and hereditary and recurrence with the medical specialist. Only a small minority favored to discuss cancer-related problems with the oncology nurse. CONCLUSION: Survivors reported different preferences for follow-up care providers based on age, education level, gender and satisfaction with the general practitioner, showing a need for tailored follow-up care in oncology. The results indicate an urgency to educate patients about transitions in follow-up care.

Prostate cancer survivors with a passive role preference in treatment decision-making are less satisfied with information received: Results from the PROFILES registry.

OBJECTIVE: To investigate decision-making role preferences and their association with the evaluation of information received in a sample of low-risk and intermediate-risk prostate cancer (Pca) survivors. METHODS: Cross-sectional study involved 562 men diagnosed with low-risk or intermediate-risk Pca (median time since diagnosis, 48mo), measuring preferred decision-making role (Control Preference Scale) and the evaluation of information received (EORTC QLQ-INFO25). Analyses were performed using analysis of variance, chi-square tests, and multivariable linear regression models. RESULTS: Men who preferred a passive role were older and less educated than other preference groups and more often selected a noninvasive treatment option (all with P<0.001). The passive role preference group reported having received less information, judged the received information as less helpful, and indicated lower overall satisfaction with information received (all with P<0.05). Role preference groups did not differ in their desire to receive more information. CONCLUSION: Compared with nonpassive preference groups, the preference for a passive role in Pca treatment decision-making is associated with less satisfaction with the information received. PRACTICE IMPLICATIONS: Assessment of role preferences and tailored information provision could improve satisfaction with information received and perhaps may ultimately lead to improved patient participation in treatment decision-making.

Detection of High-grade Prostate Cancer Using a Urinary Molecular Biomarker-Based Risk Score.

BACKGROUND: To reduce overdiagnosis and overtreatment, a test is urgently needed to detect clinically significant prostate cancer (PCa). OBJECTIVE: To develop a multimodal model, incorporating previously identified messenger RNA (mRNA) biomarkers and traditional risk factors that could be used to identify patients with high-grade PCa (Gleason score ≥7) on prostate biopsy. DESIGN, SETTING, AND PARTICIPANTS: In two prospective multicenter studies, urine was collected for mRNA profiling after digital rectal examination (DRE) and prior to prostate biopsy. The multimodal risk score was developed on a first cohort (n=519) and subsequently validated clinically in an independent cohort (n=386). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The mRNA levels were measured using reverse transcription quantitative polymerase chain reaction. Logistic regression was used to model patient risk and combine risk factors. Models were compared using the area under the curve (AUC) of the receiver operating characteristic, and clinical utility was evaluated with a decision curve analysis (DCA). RESULTS AND LIMITATIONS: HOXC6 and DLX1 mRNA levels were shown to be good predictors for the detection of high-grade PCa. The multimodal approach reached an overall AUC of 0.90 (95% confidence interval [CI], 0.85-0.95) in the validation cohort (AUC 0.86 in the training cohort), with the mRNA signature, prostate-specific antigen (PSA) density, and previous cancer-negative prostate biopsies as the strongest, most significant components, in addition to nonsignificant model contributions of PSA, age, and family history. For another model, which included DRE as an additional risk factor, an AUC of 0.86 (95% CI, 0.80-0.92) was obtained (AUC 0.90 in the training cohort). Both models were successfully validated, with no significant change in AUC in the validation cohort, and DCA indicated a strong net benefit and the best reduction in unnecessary biopsies compared with other clinical decision-making tools, such as the Prostate Cancer Prevention Trial risk calculator and the PCA3 assay. CONCLUSIONS: The risk score based on the mRNA liquid biopsy assay combined with traditional clinical risk factors identified men at risk of harboring high-grade PCa and resulted in a better patient risk stratification compared with current methods in clinical practice. Therefore, the risk score could reduce the number of unnecessary prostate biopsies. PATIENT SUMMARY: This study evaluated a novel urine-based assay that could be used as a noninvasive diagnostic aid for high-grade prostate cancer (PCa). When results of this assay are combined with traditional clinical risk factors, risk stratification for high-grade PCa and biopsy decision making are improved.

Development of a decision aid for the treatment of benign prostatic hyperplasia: A four stage method using a Delphi consensus study.

OBJECTIVE: To develop a web-based decision aid (DA) for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH). METHODS: From February-September 2014 we performed a four-stage development method: 1: Two-round Delphi consensus method among urologists, 2: Identifying patients' needs and expectations, 3: Development of DA content and structure, 4: Usability testing with LUTS/BPH patients. RESULTS: 1 (N=15): Dutch urologists reached consensus on 61% of the statements concerning users' criteria, decision options, structure, and medical content. 2 (N=24): Consensus was reached in 69% on statements concerning the need for improvement of information provision, the need for DA development and that the DA should clarify patients' preferences. 3: DA development based on results from stage 1 and stage 2. 4 (N=10): Pros of the DA were clear information provision, systematic design and easy to read and re-read. CONCLUSION: A LUTS/BPH DA containing VCEs(**) was developed in cooperation with urologists and patients following a structured 4 stage method and was stated to be well accepted. PRACTICE IMPLICATIONS: This method can be adopted for the development of DAs to support other medical decision issues.

Patients are dissatisfied with information provision: perceived information provision and quality of life in prostate cancer patients.

OBJECTIVE: To determine the satisfaction with information received by prostate cancer survivors and associations with health-related quality of life (HRQoL) and illness perception. METHODS: A cross-sectional study was performed among 999 patients diagnosed between 2006 and 2009. All patients received a questionnaire on HRQoL (EORTC QLQ-C30), illness perception (B-IPQ) and satisfaction with information provision (EORTC QLQ-INFO-25). Multivariate regression analyses were performed to assess the association between satisfaction with information provision and HRQoL as well as illness perception. RESULTS: Response rate was 70% (N = 697), 34% (N = 222) indicated to be dissatisfied with the information received. Multivariate linear regression analyses showed a significant positive association between satisfaction with information provision and global health (P = <0.001), emotional functioning (P = 0.004), social functioning (P = 0.027), physical functioning (P = 0.002) and role functioning (P = 0.001). Satisfaction was negatively associated with illness perception subscales on consequences (P = 0.020), timeline (P = 0.031), personal control (P = 0.013), treatment control (P < 0.001), illness concern (P < 0.001), coherence (P = 0.001) and emotional representation (P = 0.004). Hence, more satisfied patients reported fewer consequences of disease, illness concern and emotional representation, but higher personal and treatment control and coherence. CONCLUSIONS: A third of all prostate cancer survivors reported to be dissatisfied with the information received and scored worse on HRQoL and illness perception. A prospective randomized study is needed to study the effect of an intervention that improves information provision on HRQoL and illness perception outcomes. Copyright © 2015 John Wiley & Sons, Ltd.

Presence and Number of Positive Surgical Margins after Radical Prostatectomy for Prostate Cancer: Effect on Oncological Outcome in a Population-Based Cohort.

INTRODUCTION: Additional insight in the occurrence and number of positive surgical margins (PSM) and the potential consequences is needed, since earlier studies show divergent results. This study aims at investigating the effect of the presence and number of PSM on oncological outcomes. METHODS: Retrospective population-based cohort study including 648 consecutive prostate cancer patients who underwent RP in the Southern Netherlands in 2006-2008. The effect of PSM on risk of treatment failure, defined by either biochemical recurrence or necessity of any additional therapy (Cox regression), was evaluated. RESULTS: PSM were observed in 39%; 11% had multiple PSM. Treatment failure was observed in 26% of all patients. Multivariably, the presence (hazard ratio 2.5) and number of PSM (hazard ratios: single 2.3; multiple 3.1) were independently associated with higher treatment failure rates, unlike location of PSM. CONCLUSIONS: Treatment failure rates are high among patients with PSM, especially in those with multiple PSM. This needs to be taken into account when decisions are made on the applicability of the adjuvant and salvage therapy.