Introducing Decision Aids into Routine Prostate Cancer Care in The Netherlands: Implementation and Patient Evaluations from the Multi-regional JIPPA Initiative.

Uptake of decision aids (DAs) in daily routine is low, resulting in limited knowledge about successful DA implementation at a large scale. We assessed implementation rates after multi-regional implementation of three different prostate cancer (PCa) treatment DAs and patient-perceived barriers and facilitators to use a DA. Thirty-three hospitals implemented one out of the three DAs in routine care. Implementation rates for each DA were calculated per hospital. After deciding about PCa treatment, patients (n = 1033) completed a survey on pre-formulated barriers and facilitators to use a DA. Overall DA implementation was 40%. For each DA alike, implementation within hospitals varied from incidental (< 10% of eligible patients receiving a DA) to high rates of implementation (> 80%). All three DAs were evaluated positively by patients, although concise and paper DAs yielded higher satisfaction scores compared with an elaborate online DA. Patients were most satisfied when they received the DA within a week after diagnosis. Pre-formulated barriers to DA usage were experienced by less than 10% of the patients, and most patients confirmed the facilitators. Many patients received a DA during treatment counseling, although a wide variation in uptake across hospitals was observed for each DA. Most patients were satisfied with the DA they received. Sustained implementation of DAs in clinical routine requires further encouragement and attention.

Development of a Decision Aid for Genital Gender-Affirming Surgery in Transmen.

BACKGROUND: As genital gender-affirming surgery (GAS) is a demanding and life-changing intervention, transmen should be able to make choices about the surgical treatment based on outcomes that are most important to them, while taking into consideration the concomitant risks involved. AIM: Develop a decision aid (DA) for genital surgery in transmen (DA-GST) that can assist both transmen and health care professionals (HCPs) in making a well-informed decision about the surgical treatment. METHODS: A qualitative focus group study was performed. 5 Focus groups were organized with both HCPs and transmen. These were led by an independent professional moderator. Data collected during these focus groups were analyzed to provide content for the DA. OUTCOMES: To develop content for a DA-GST. RESULTS: Data collected during the focus groups related to the treatment options, information deemed relevant by transmen, and the arguments for or against each treatment option. Collected items were divided into the following themes: outcome, quality of life, environment, sexuality, and beliefs. CLINICAL IMPLICATIONS: The tool will be useful in assisting both transmen and HCPs in the shared decision-making process regarding genital GAS by exploring which domains are most relevant for each specific individual. STRENGTHS & LIMITATIONS: This DA was developed according to an iterative participatory design approach to fit the needs of both transmen and HCPs. Issues that transmen find important and relevant pertaining to genital GAS were translated into arguments that were incorporated in the DA-GST. The study is limited by the group that had participated. Not all arguments for or against specific surgical options may be covered by the DA-GST. CONCLUSION: An online DA was developed to support transmen with their decision-making process concerning all surgical options for removal of reproductive organs and genital GAS. Özer M, Pigot GL, Bouman M-B, et al. Development of a Decision Aid for Genital Gender-Affirming Surgery in Transmen. J Sex Med 2018;15:1041-1048.

Development of a patient decision aid for the treatment of localised prostate cancer: a participatory design approach.

AIMS AND OBJECTIVES: To develop a patient decision aid and to prepare an overview of requirements for implementation. BACKGROUND: We developed a decision aid that fits the preferences of patients and health care professionals to ensure adequate uptake in clinical practice. DESIGN: A participatory design approach was used to acquire insight into preferences regarding the content and design of a decision aid and into barriers and aspects of the decision aid that facilitate implementation in clinical practice. METHODS: Three focus group interviews with patients, their partners and health care professionals were conducted. A prototype of the decision aid was developed and presented to patients (n = 14) and health care professionals (n = 13) in semi-structured interviews. Patients (n = 5) participated in a usability study. Data were analysed by two independent coders. RESULTS: Health care professionals considered medical information on treatments and side effects as the most important aspect to be included in the decision aid. Patients also focused on nonmedical considerations, such as location. Both expected the decision aid to support patients in making a treatment choice. According to health care professionals, the oncology nurse was the most suitable to discuss the decision aid with patients, while some patients preferred to discuss the patient decision aid with the urologist. The main barrier to implementation of the decision aid was said to be the expectation that it is time and money consuming, while the incorporation of the decision aid into clinical guidelines and basing the content on these guidelines, would promote implementation. CONCLUSIONS: By using a participatory design approach a patient decision aid was designed to meet patients' and health care professionals' needs. Insight was also gained on requirements for implementation. RELEVANCE TO CLINICAL PRACTICE: Wide-scale implementation of decision aids is desirable. An overview is provided of requirements for implementation to successfully incorporate a decision aid into clinical practice.

Sexual Dysfunction and Bother Due to Erectile Dysfunction in the Healthy Elderly Male Population: Prevalence from a Systematic Review.

CONTEXT: Therapies initiated by urologists, medical as well as surgical, may cause adverse effects in different sexual domains. Sexual domains that are often affected are sexual interest, sexual activity, and erectile functioning. As many elderly men undergo these therapies, it is important to know the prevalence of sexual dysfunction (SD) in these domains and its impact in the healthy elderly male population. This may help healthcare providers counsel their patients properly on possible adverse effects. OBJECTIVE: To review the prevalence of sexual functioning and SD in the domains of sexual desire, sexual activity, and erectile dysfunction (ED) and its impact (bother and medical use), stratified by age. EVIDENCE ACQUISITION: This systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement. Studies investigating the prevalence of SD, stratified by age, were eligible. Studies investigating bother due to ED, and studies evaluating medical use or use of medical professional healthcare providers in association with SD were eligible. EVIDENCE SYNTHESIS: A total of 76 articles were eligible for a full systematic review. Lack of sexual desire was reported to vary between 12% and 51.6% for men aged ≥60 yr, 20% and 65.9% for men aged ≥70 yr, and 40% and 82.4% for men aged ≥80 yr. The percentages of men bothered by ED were as follows: 14.3-70% for men aged ≥60 yr, 6.7-48% for men aged ≥70 yr, and 38% for men aged ≥80 yr. A substantial number of men (50.3-92%) find a normal sex life important as they age and remain sexually active. Only a minority of elderly men seek help from healthcare professionals or use medication for SD. CONCLUSIONS: The prevalence of SD in the healthy male population, reflected by a loss of sexual desire and sexual activity, increases only slightly with age. Bother due to ED is relatively low and there is an association with age. Still, a large number of men in the middle-aged and elderly groups regard sexuality as an important aspect of life. While considering a surgical or medical therapy that could have an impact on sexual functioning, sexually related outcomes should be set against current sexual functioning and a probable decline of sexual functioning due to ageing. PATIENT SUMMARY: While counselling elderly patients for sexual dysfunction when starting a treatment that could have an influence on sexual functioning, one should consider current sexual functioning and its importance for the individual.

Effectiveness, cost-utility and implementation of a decision aid for patients with localised prostate cancer and their partners: study protocol of a stepped-wedge cluster randomised controlled trial.

INTRODUCTION: Patient decision aids (PDAs) have been developed to help patients make an informed choice for a treatment option. Despite proven benefits, structural implementation falls short of expectations. The present study aims to assess the effectiveness and cost-utility of the PDA among newly diagnosed patients with localised prostate cancer and their partners, alongside implementation of the PDA in routine care. METHODS/ANALYSIS: A stepped-wedge cluster randomised trial will be conducted. The PDA will be sequentially implemented in 18 hospitals in the Netherlands, over a period of 24 months. Every 3 or 6 months, a new cluster of hospitals will switch from usual care to care including a PDA.The primary outcome measure is decisional conflict experienced by the patient. Secondary outcomes comprise the patient's quality of life, treatment preferences, role in the decision making, expectations of treatment, knowledge, need for supportive care and decision regret. Furthermore, societal cost-utility will be valued. Other outcome measures considered are the partner's treatment preferences, experienced participation to decision making, quality of life, communication between patient, partner and health care professional, and the effect of prostate cancer on the relationship, social contacts and their role as caregiver. Patients and partners receiving the PDA will also be asked about their satisfaction with the PDA.Baseline assessment takes place after the treatment choice and before the start of a treatment, with follow-up assessments at 3, 6 and 12 months following the end of treatment or the day after deciding on active surveillance. Outcome measures on implementation include the implementation rate (defined as the proportion of all eligible patients who will receive a PDA) and a questionnaire for health care professionals on determinants of implementing an innovation. ETHICS AND DISSEMINATION: This study will be conducted in accordance with local laws and regulations of the Medical Ethics Committee of VU University Medical Center, Amsterdam, The Netherlands. The results from this stepped-wedge trial will be presented at scientific meetings and published in peer-reviewed journals. TRIAL REGISTRATION: Nederlands Trial Register NTR TC5177, registration date: May 28th 2015.Pre-results.

Risk of disease flare with LHRH agonist therapy in men with prostate cancer: myth or fact?

OBJECTIVES: The traditional assumption of a linear relationship between serum testosterone and prostate cancer growth has been seriously challenged, as overwhelming evidence contradicts its basic principles. Luteinizing hormone-releasing hormone (LHRH) agonists are known to cause a peak in serum testosterone level in the initial weeks of treatment, and prevention of the clinical sequelae of testosterone flare by concomitant use of antiandrogens is recommended. Along the present biological concept that there appears to be a limit to the ability of androgens to stimulate prostate cancer growth, termed the saturation model, the use of antiandrogens to prevent this disease flare is questioned. The purpose of this review is to gain historical and modern evidence to provide an objective and up-to-date basis for clinical decision making. METHODS AND MATERIALS: We performed a comprehensive research of the electronic databases PubMed and Embase until April 1, 2014. Studies with the subject of disease flare in men with prostate cancer on LHRH agonist therapy were included, as were studies that assessed the efficacy of antiandrogens to prevent this flare. Case reports were included as well. RESULTS: Overall, 25 studies considering disease flare were included: 9 randomized clinical trials with an LHRH agonist and an LHRH agonist/antiandrogen arm, 14 observational studies evaluating LHRH agonists only, and 2 case reports. The incidence of disease flare was reported between 0% and 83% owing to a wide set of clinical, biochemical, and radiological factors evaluated. In some of the randomized clinical trials, a statistically significant reduction of the incidence of disease flare by concomitant use of antiandrogens was reported. Most of these historical studies report on subjective worsening of disease symptoms as outcome measure. More objective outcome measures such as the prostate-specific antigen level did not seem to increase to higher than the baseline values. CONCLUSIONS: At present, there is a lack of compelling data showing definite disease progression during the short period of testosterone flare after initiation of LHRH agonist therapy. Based on the saturation model, presence of disease flare and the need to prevent this flare by concomitant use of antiandrogens might well be a misconception.