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.

Development and validation of a patient decision aid for prostate Cancer therapy: from paternalistic towards participative shared decision making.

BACKGROUND: Patient decision aids (PDAs) can support the treatment decision making process and empower patients to take a proactive role in their treatment pathway while using a shared decision-making (SDM) approach making participatory medicine possible. The aim of this study was to develop a PDA for prostate cancer that is accurate and user-friendly. METHODS: We followed a user-centered design process consisting of five rounds of semi-structured interviews and usability surveys with topics such as informational/decisional needs of users and requirements for PDAs. Our user-base consisted of 8 urologists, 4 radiation oncologists, 2 oncology nurses, 8 general practitioners, 19 former prostate cancer patients, 4 usability experts and 11 healthy volunteers. RESULTS: Informational needs for patients centered on three key factors: treatment experience, post-treatment quality of life, and the impact of side effects. Patients and clinicians valued a PDA that presents balanced information on these factors through simple understandable language and visual aids. Usability questionnaires revealed that patients were more satisfied overall with the PDA than clinicians; however, both groups had concerns that the PDA might lengthen consultation times (42 and 41%, respectively). The PDA is accessible on http://beslissamen.nl/ . CONCLUSIONS: User-centered design provided valuable insights into PDA requirements but challenges in integrating diverse perspectives as clinicians focus on clinical outcomes while patients also consider quality of life. Nevertheless, it is crucial to involve a broad base of clinical users in order to better understand the decision-making process and to develop a PDA that is accurate, usable, and acceptable.

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.

A biodegradable rectal balloon implant to protect the rectum during prostate cancer radiotherapy for a patient with active Crohn's disease.

BACKGROUND: Radiotherapy in patients with active inflammatory bowel disease (IBD) is usually considered an absolute exclusion criterion for prostate cancer radiotherapy treatment.There are no reports available on the use of a biodegradable rectal balloon implantation (RBI) in patients with active IBD for prostate cancer radiotherapy. CASE PRESENTATION: We report on a patient with high-risk prostate cancer with the comorbidity of an active IBD with pancolitis location. He was treated with neo-adjuvant hormonal therapy and high-dose external beam radiotherapy to the prostate and the seminal vesicles. Before radiotherapy treatment, a biodegradable RBI was implanted between the prostate and the anterior rectal wall to push the rectum outside of the high-dose area. This patient at high-risk for rectal toxicity was successfully irradiated to his prostate with only a grade I urinary toxicity, no acute rectal toxicity or toxicity flare of the IBD. CONCLUSIONS: This case describes the use of a RBI implantation in patients with active IBD for prostate cancer radiotherapy. The use of a biodegradable RBI proved to be a promised solution for such patients, and have to be further investigated.

Implantation of a biodegradable rectum balloon implant: tips, Tricks and Pitfalls.

INTRODUCTION: A rectum balloon implant (RBI) is a new device to spare rectal structures during prostate cancer radiotherapy. The theoretical advantages of a RBI are to reduce the high radiation dose to the anterior rectum wall, the possibility of a post-implant correction, and their predetermined shape with consequent predictable position. OBJECTIVE: To describe, step-by-step, our mini-invasive technique for hands-free transperineal implantation of a RBI before start of radiotherapy treatment. MATERIALS AND METHODS: We provide step-by-step instructions for optimization of the transperineal implantation procedure performed by urologists and/or radiation oncologists experienced with prostate brachytherapy and the use of the real-time bi-plane transrectal ultrasonography (TRUS) probe. A RBI was performed in 15 patients with localised prostate cancer. Perioperative side-effects were reported. RESULTS: We provide 'tips and tricks' for optimizing the procedure and proper positioning of the RBI. Please watch the animation, see video in https://vimeo.com/205852376/789df4fae4. The side-effects included mild discomfort to slight pain at the perineal region in 8 out of 15 patients. Seven patients (47%) had no complaints at all. Two patients developed redness of the skin, where prompt antibiotic regimen was started with no further sequelae. One patient revealed a temporary urine retention, which resolved in a few hours following conservative treatment. Further no perioperative complications occurred. CONCLUSION: This paper describes in detail the implantation procedure for an RBI. It is a feasible, safe and very well-tolerated procedure.

Spacers in radiotherapy treatment of prostate cancer: is reduction of toxicity cost-effective?

BACKGROUND AND PURPOSE: To compare the cost-effectiveness of treating prostate cancer patients with intensity-modulated radiation therapy and a spacer (IMRT+S) versus IMRT-only without a spacer (IMRT-O). MATERIALS AND METHODS: A decision-analytic Markov model was constructed to examine the effect of late rectal toxicity and compare the costs and quality-adjusted Life Years (QALYs) of IMRT-O and IMRT+S. The main assumption of this modeling study was that disease progression, genito-urinary toxicity and survival were equal for both comparators. RESULTS: For all patients, IMRT+S revealed a lower toxicity than IMRT-O. Treatment follow-up and toxicity costs for IMRT-O and IMRT+S amounted to €1604 and €1444, respectively, thus saving €160 on the complication costs at an extra charge of €1700 for the spacer in IMRT+S. The QALYs yielded for IMRT-O and IMRT+S were 3.542 and 3.570, respectively. This results in an incremental cost-effectiveness ratio (ICER) of €55,880 per QALY gained. For a ceiling ratio of €80,000, IMRT+S had a 77% probability of being cost-effective. CONCLUSION: IMRT+S is cost-effective compared to IMRT-O based on its potential to reduce radiotherapy-related toxicity.

The effectiveness of a treatment protocol for male lower urinary tract symptoms in general practice: a practical randomised controlled trial.

BACKGROUND: Randomised controlled trials have shown the efficacy of several treatment modalities for lower urinary tract symptoms (LUTS) in selected populations. The effectiveness in daily practice has hardly been investigated, especially in primary care and is dependent on choices between all possible treatment options and best investigated in a comprehensive study, including all treatment modalities (watchful waiting, alpha-blockers, 5-alpha-reductase inhibitors, and surgery). AIM: Assessment of the effectiveness of a comprehensive treatment protocol for LUTS in primary care. DESIGN OF STUDY: Randomised controlled trial. SETTING: Fourteen general practices in the Netherlands. INTERVENTION: treatment protocol based on a formalised expert opinion. Control condition: usual care. STUDY POPULATION: 208 subjects with moderate to severe LUTS (IPSS > or =8, median = 13). OUTCOME MEASURES: symptom severity (IPSS [International Prostate Symptom Score]), bother score (Dan-PSS [Danish Prostate Symptom Score]), and maximum urinary flow (Q(max)); incidence of acute urinary retention and urinary tract infections. RESULTS: In the intervention group markedly more subjects used an alpha-blocker at end of follow-up than in the usual care group (24% versus 6%). No significant differences were found between intervention and control group in IPSS, Q(max) or Dan-PSS. CONCLUSION: alpha-blockers and watchful waiting are the most frequent treatment modalities for LUTS in primary care. Our study showed no evidence that a protocol using well-defined indications for all possible treatment modalities based on a formalised expert opinion procedure has added value. Based on our results, we cannot recommend a broadening of the indication for alpha-blockers, which, however, seems to be the current trend.

A decision aid for GPs for the treatment of elderly male patients with lower urinary tract symptoms (LUTS).

BACKGROUND: GPs have four main treatment options for lower urinary tract symptoms (LUTS): watchful waiting, alpha-blockers, 5-alpha-reductase inhibitors or (referral for) surgery. Guidelines do not provide clear cut-off values for (combinations of) symptoms and physical examination results to decide which treatment is best. OBJECTIVE: (i) To develop a decision aid ('checklist') for GPs for the treatment of patients with LUTS. (ii) To assess its value for use in a primary care population. Materials and methods. Population-based cross-sectional study. Included were subjects with uncomplicated LUTS for whom treatment in primary care may be appropriate. [International Prostate Symptom Score (IPSS) > or = 8, no prior prostate surgery, prostate-specific antigen (PSA) value < 10 ng/ml]. For each subject the appropriateness of surgery and alpha-blocker treatment was determined using a previously validated formalized international expert panel judgement. Regression models using data available in primary care were constructed to predict the panel judgement. Subsequently these models were transformed into simple checklists. Finally, the efficiency of these checklists was calculated. RESULTS: The best checklists consisted of age, symptoms severity, type of symptoms, a quality of life score and PSA value. Assuming one would like to provide at least 95% of the subjects for whom a certain treatment is appropriate with this treatment (i.e. 'sensitivity' of the checklist > or = 95%), one can reach a positive predictive value of 50-60%. CONCLUSION: Simple checklists based on the judgement of experts regarding the most appropriate therapy can help GPs to advise their patients of a rational treatment strategy.

Bacillus Calmette-Guerin versus epirubicin for primary, secondary or concurrent carcinoma in situ of the bladder: results of a European Organization for the Research and Treatment of Cancer--Genito-Urinary Group Phase III Trial (30906).

PURPOSE: We compared the efficacy and side effects of intravesical instillations of bacillus Calmette-Guerin (BCG) and epirubicin in patients with carcinoma in situ (CIS) of the bladder. MATERIALS AND METHODS: Patients with primary, secondary or concurrent CIS of the bladder were randomized to 81 mg BCG-Connaught (6 weekly instillations) or 50 mg epirubicin (8 weekly instillations). When a complete response (CR), defined as no Ta/T1 or CIS on biopsy and negative cytology, was obtained, patients in the 2 groups received maintenance instillations at months 3, 6, 12, 18, 24, 30 and 36. When no complete response was observed, the original treatment was repeated, followed again by cystoscopy and biopsies plus cytology. RESULTS: A total of 168 patients were randomized between March 1993 and April 1999 to receive BCG (84) or epirubicin (84), while 4 on epirubicin and 3 on BCG were ineligible. The majority (52%) had concurrent CIS. Primary and secondary CIS was found in 23% and 24% of cases, respectively. The overall CR rate was 56% for epirubicin and 65% for BCG (p = 0.21, 90% CI 21.5 to -2.9). When tumor was found following 2 instillation courses, further treatment was left to the investigator (BCG in 29 cases and epirubicin in 37). Time to bladder tumor recurrence after CR was longer in patients treated with BCG vs epirubicin (median 5.1 vs 1.4 years). CIS recurrences were more frequently observed in complete responders to epirubicin (45% vs 16%). No differences in time to progression or duration of survival were observed. Side effects were more frequently seen in patients on BCG with 26 on BCG and 8 on epirubicin stopping treatment due to side effects. CONCLUSIONS: No significant difference in CR rates could be demonstrated with intravesical instillations of epirubicin or BCG. Time to recurrence was significantly longer in patients treated with BCG after having achieved a CR. More CIS recurrences were found in patients treated with epirubicin. For time to progression and survival longer followup is warranted. Side effects were more frequent in patients on BCG.