Barriers and facilitators of healthcare professionals in integrating shared decision-making in pancreatic cancer treatment: A network approach.

PURPOSE: Shared decision-making (SDM) is crucial in pancreatic cancer treatment due to its choice-sensitive nature and limited prognosis. Treatment of pancreatic cancer is organized in a network approach. Several obstacles exist on different levels-patient, healthcare professional, organizational, societal-that impede integration of SDM. This study aims to identify barriers and facilitators to SDM implementation within a comprehensive cancer network. METHODS: A qualitative research design was applied, involving interviews and focus groups on barriers and facilitators with healthcare professionals involved in the implementation of SDM. In one comprehensive cancer network in the Netherlands, including seven hospitals, a project was initiated with the goal of empowering patients and healthcare professionals in SDM throughout primary, secondary and tertiary healthcare settings. A total of 17 participants were assessed. Directed qualitative content analysis was performed by two researchers. RESULTS: Main findings revealed barriers such as time constraints, lack of priority of physicians, little involvement of general practitioners, and insufficient social context of patients in referrals, alongside facilitators including learning communities with practical SDM examples, metro mapping, involvement of case manager in implementation and patient empowerment strategies. CONCLUSION: Addressing cultural, systemic barriers and developing innovative strategies are of importance to enhance SDM in pancreatic cancer treatment in a network approach. This study provides understanding of SDM implementation in complex healthcare settings and offers valuable guidance for future interventions seeking to improve decision-making processes in pancreatic cancer treatment and beyond.

The role of the purposeful shared decision making model in vascularized composite allotransplantation.

For some patients who have lost the lower part of an arm, hand transplant offers the possibility of receiving a new limb with varying degrees of sensation and function. This procedure, Vascularized Composite Allotransplantation (VCA), is demanding for patients and their care community and comes with significant risks. As a high-stakes decision, patients interested in VCA are subject to extensive clinical evaluation and eligibility decision making. Patients and their care community must also decide if hand transplant (versus other approaches including rehabilitative therapies with or without prosthesis) is right for them. This decision making is often confusing and practically and emotionally fraught. It is complicated in four ways: by the numerous beneficial and harmful potential effects of hand transplant or other options, the number of people affected by VCA and the diverse or conflicting positions that they may hold, the practical demands and limitations of the patient's life situation, and the existential significance of limb loss and transplant for the patient's being. Patients need support in working through these treatment determining issues. Evaluation does not provide this support. Shared decision making (SDM) is a method of care that helps patients think, talk, and feel their way through to the right course of action for them. However, traditional models of SDM that focus on weighing possible beneficial and harmful effects of treatments are ill-equipped to tackle the heterogeneous issues of VCA. A recent model, Purposeful SDM extends the range of troubling issues that SDM can help support beyond opposing effects, to include conflicting positions, life situations, and existential being. In this paper we explore the pertinence of these issues in VCA, methods of SDM that each require of clinicians, the benefits of supporting patients with the breadth of issues in their unique problematic situations, implications for outcomes and practice, and extend the theory of the Purposeful SDM model itself based on the issues present in hand transplant decision making.

Medical Complexity of Children with Special Healthcare Needs and Healthcare Experiences.

The rising prevalence of CSHCN has led to significant challenges for caregivers, particularly mothers, who face difficulties from caregiving demands and managing complex healthcare interactions. The objective of this study was to examine the association between the medical complexity of CSHCN and the healthcare experiences of their mothers while exploring the influence of sociodemographic factors on these associations. The study utilized data from the 2016-2020 National Survey of Children's Health (NSCH), involving 17,434 mothers of CSHCN. Mothers provided information on the medical complexity of CSHCN, healthcare experiences (care coordination, family-centered care, and shared decision-making), and sociodemographic information (race, community, insurance, child sex, age, and federal poverty level). Results from multiple regressions revealed that greater medical complexity was associated with more negative healthcare experiences. Minoritized mothers, those in rural areas, and families with lower income reported lower levels of family-centered care, indicating significant disparities. Additionally, the negative association between medical complexity and healthcare experiences was pronounced for White families and those with private insurance compared to minoritized families and those with public insurance. This study highlights the necessity for targeted interventions to improve care coordination, family-centered care, and shared decision-making, emphasizing the need for a comprehensive, family-centered approach to address healthcare disparities and promote health equity for CSHCN and their families.

The 3-Level Approach to Facelift Planning: A Simple Paradigm for Surgical Rejuvenation of the Face.

Our role as aesthetic surgeons demands individualized surgical planning that maximizes patient input and understanding. The value of such shared decision-making (SDM) in aesthetic surgery is becoming increasingly appreciated. This is particularly true for potential patients seeking surgical rejuvenation of the face, where the volume of "educational" information available on the internet, and through various social medial channels, may be overwhelming and even misleading. Presented is a "3-Level approach to facelift planning" named for the facial subregions targeted. This novel paradigm maximizes SDM with its simplicity and reproducibility, serves as an invaluable educational tool for patients, novice and seasoned surgeons alike, and facilitates communication between senior surgeons through its descriptive standardization. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Sharing a medical decision.

During the last decades, shared decision making (SDM) has become a very popular model for the physician-patient relationship. SDM can refer to a process (making a decision in a shared way) and a product (making a shared decision). In the literature, by far most attention is devoted to the process. In this paper, I investigate the product, wondering what is involved by a medical decision being shared. I argue that the degree to which a decision to implement a medical alternative is shared should be determined by taking into account six considerations: (i) how the physician and the patient rank that alternative, (ii) the individual preference scores the physician and the patient (would) assign to that alternative, (iii) the similarity of the preference scores, (iv) the similarity of the rankings, (v) the total concession size, and (vi) the similarity of the concession sizes. I explain why shared medical decisions are valuable, and sketch implications of the analysis for the physician-patient relationship.

An opponent model for agent-based shared decision-making via a genetic algorithm.

Introduction: Shared decision-making (SDM) has received a great deal of attention as an effective way to achieve patient-centered medical care. SDM aims to bring doctors and patients together to develop treatment plans through negotiation. However, time pressure and subjective factors such as medical illiteracy and inadequate communication skills prevent doctors and patients from accurately expressing and obtaining their opponent's preferences. This problem leads to SDM being in an incomplete information environment, which significantly reduces the efficiency of the negotiation and even leads to failure. Methods: In this study, we integrated a negotiation strategy that predicts opponent preference using a genetic algorithm with an SDM auto-negotiation model constructed based on fuzzy constraints, thereby enhancing the effectiveness of SDM by addressing the problems posed by incomplete information environments and rapidly generating treatment plans with high mutual satisfaction. Results: A variety of negotiation scenarios are simulated in experiments and the proposed model is compared with other excellent negotiation models. The results indicated that the proposed model better adapts to multivariate scenarios and maintains higher mutual satisfaction. Discussion: The agent negotiation framework supports SDM participants in accessing treatment plans that fit individual preferences, thereby increasing treatment satisfaction. Adding GA opponent preference prediction to the SDM negotiation framework can effectively improve negotiation performance in incomplete information environments.

Surgery versus radiosurgery for vestibular schwannoma: Shared decision making in a multidisciplinary clinic.

Background: Our neurosurgical unit adopted a model of shared decision-making (SDM) based on multidisciplinary clinics for vestibular schwannoma (VS). A unique feature of this clinic is the interdisciplinary counseling process with a surgeon presenting the option of surgery, an oncologist radiosurgery or radiotherapy, and a specialist nurse advocating for the patient. Methods: This is a retrospective cohort study. All new patients seen in the combined VS clinic and referred from the skull base multidisciplinary team (MDT) from beginning of June 2013 to end of January 2019 were included. Descriptive statistics and frequency analysis were carried out for the full cohort. Results: Three hundred and fifty-four patients presenting with new or previously untreated VS were included in the analysis. In our cohort, roughly one-third of patients fall into each of the treatment strategies with slightly smaller numbers of patients undergoing surgery than watch, wait and rescan (WWR) ,and SRS (26.6% vs. 32.8% and 37.9%, respectively). Conclusion: In our experience, the combined surgery/oncology/specialist nurse clinic streamlines the patient experience for those with a VS suitable for either microsurgical or SRS/radiotherapy treatment. Decision-making in this population of patients is complex and when presented with all treatment options patients do not necessarily choose the least invasive option as a treatment. The unique feature of our clinic is the multidisciplinary counseling process with a specialist nurse advocating and guiding the patient. Treatment options are likely to become more rather than less complex in future years making combined clinics more valuable than ever in the SDM process.

Financial burden of men with localized prostate cancer: a process paper.

Background: Many individuals undergoing cancer treatment experience substantial financial hardship, often referred to as financial toxicity (FT). Those undergoing prostate cancer treatment may experience FT and its impact can exacerbate disparate health outcomes. Localized prostate cancer treatment options include: radiation, surgery, and/or active surveillance. Quality of life tradeoffs and costs differ between treatment options. In this project, our aim was to quantify direct healthcare costs to support patients and clinicians as they discuss prostate cancer treatment options. We provide the transparent steps to estimate healthcare costs associated with treatment for localized prostate cancer among the privately insured population using a large claims dataset. Methods: To quantify the costs associated with their prostate cancer treatment, we used data from the Truven Health Analytics MarketScan Commercial Claims and Encounters, including MarketScan Medicaid, and peer reviewed literature. Strategies to estimate costs included: (1) identifying the problem, (2) engaging a multidisciplinary team, (3) reviewing the literature and identifying the database, (4) identifying outcomes, (5) defining the cohort, and (6) designing the analytic plan. The costs consist of patient, clinician, and system/facility costs, at 1-year, 3-years, and 5-years following diagnosis. Results: We outline our specific strategies to estimate costs, including: defining complex research questions, defining the study population, defining initial prostate cancer treatment, linking facility and provider level related costs, and developing a shared understanding of definitions on our research team. Discussion and next steps: Analyses are underway. We plan to include these costs in a prostate cancer patient decision aid alongside other clinical tradeoffs.

Implementing shared decision making according to the choosing wisely programme: Perioperative medicine for older people undergoing surgery.

BACKGROUND: Shared decision making (SDM) is the process whereby patients and healthcare professionals work together to achieve a consensus management decision, based on best clinical evidence and patient's preferences. No formal approach to documentation of SDM conversations exists in setting of peri-operative medicine. OBJECTIVE: To assess and improve the quality and consistency of documentation regarding SDM conversations in an elective surgical outpatient population and appraise the satisfaction of patients and professionals in SDM. METHODS: The study was conducted in a geriatrician led perioperative medicine for older people undergoing surgery service, at an inner-city teaching hospital serving a tertiary surgical referral population. The quality improvement programme intervention comprised a Choosing Wisely, UK SDM tool, consisting of Benefits, Risks, Alternatives and Doing Nothing (BRAN mnemonic), clinic posters, patient leaflets, and an introductory SDM workshop and education sessions, and observation and standardised feedback of SDM. Clinic letters were reviewed to identify SDM documentation compliance. Participants included clinicians of all grades and disciplines, and consecutive patients attending the clinic. RESULTS: Clinician interviews revealed inconsistent documentation of SDM. We reviewed 203 clinic letters following the initial implementation of SDM documentation tool, only 59% (n = 120) had fully completement BRAN tool. Additional interventions improved clinic SDM documentation compliance to 98%. A prospective observation study conducted revealed patients and clinician satisfaction at 93% and 79%, respectively. CONCLUSION: The BRAN tool is adaptable to many health decision settings, including discussions related to treatment, investigations, and procedures, which expands its potential to improve patient safety.

Development of a standard set of PROs and generic PROMs for Dutch medical specialist care : Recommendations from the Outcome-Based Healthcare Program Working Group Generic PROMs.

PURPOSE: The added value of measuring patient-reported outcomes (PROs) for delivering patient-centered care and assessment of healthcare quality is increasingly evident. However, healthcare system wide data collection initiatives are hampered by the proliferation of patient-reported outcome measures (PROMs) and conflicting data collection standards. As part of a national initiative of the Dutch Ministry of Health, Welfare and Sport we developed a consensus-based standard set of generic PROs and PROMs to be implemented across Dutch medical specialist care. METHODS: A working group of mandated representatives of umbrella organizations involved in Dutch medical specialist care, together with PROM experts and patient organizations worked through a structured, consensus-driven co-creation process. This included literature reviews, online expert and working group meetings, and feedback from national patient- and umbrella organizations. The 'PROM-cycle' methodology was used to select feasible, valid, and reliable PROMs to obtain domain scores for each of the PROs included in the set. RESULTS: Eight PROs across different domains of health were ultimately endorsed: symptoms (pain & fatigue), functioning (physical, social/participation, mental [anxiety & depression]), and overarching (quality of life & perceived overall health). A limited number of generic PROMs was endorsed. PROMIS short forms were selected as the preferred instruments for all PROs. Several recommendations were formulated to facilitate healthcare system level adoption and implementation of the standard set. CONCLUSIONS: We developed a consensus-based standard set of Generic PROMs and a set of recommendations to facilitate healthcare system wide implementation across Dutch medical specialist care.

Decision-making by cancer patients and the role of a counselling facility for complementary and alternative medicine: a cohort study.

OBJECTIVE: The aim of this cohort study was to gain insight on influencing factors on the decision-making process in conventional medicine compared to complementary and alternative medicine (CAM). METHODS: A standardized questionnaire was distributed among cancer patients who attended the counselling facility for CAM of a German university hospital in 2020. RESULTS: Fifty patients (30.3%) returned the questionnaire. After counselling on CAM, most patients made a decision in CAM but also in conventional medicine. Thus, the focus on informed decision-making during counselling on CAM had a strong effect on the decision-making process in conventional medicine. Patients reporting good support also reported making decisions together with physicians and relatives. Moreover, after counselling on CAM, patients reported being more satisfied with their decision in both settings afterwards. CONCLUSION: Information on CAM which focuses on informed decision-making, supports patient's ability to understand and weigh risks and benefits of treatments, supports shared decision-making and enables patients to transfer these competences also to decisions on conventional medicine. So counselling on CAM may further decision-making competences in cancer patients. This encourages patients to engage in shared decision-making and increases patient's satisfaction with decisions.

Patient and Clinician Perspectives on Shared Decision Making in Vascular Access Selection: A Qualitative Study.

RATIONALE & OBJECTIVE: Collaborative approaches to vascular access selection are being increasingly encouraged to elicit patients' preferences and priorities where no unequivocally superior choice exists. We explored how patients, their caregivers, and clinicians integrate principles of shared decision making when engaging in vascular access discussions. STUDY DESIGN: Qualitative description. SETTING & PARTICIPANTS: Semistructured interviews with a purposive sample of patients, their caregivers, and clinicians from outpatient hemodialysis programs in Alberta, Canada. ANALYTICAL APPROACH: We used a thematic analysis approach to inductively code transcripts and generate themes to capture key concepts related to vascular access shared decision making across participant roles. RESULTS: 42 individuals (19 patients, 2 caregivers, 21 clinicians) participated in this study. Participants identified how access-related decisions follow a series of major decisions about kidney replacement therapy and care goals that influence vascular access preferences and choice. Vascular access shared decision making was strengthened through integration of vascular access selection with dialysis-related decisions and timely, tailored, and balanced exchange of information between patients and their care team. Participants described how opportunities to revisit the vascular access decision before and after dialysis initiation helped prepare patients for their access and encouraged ongoing alignment between patients' care priorities and treatment plans. Where shared decision making was undermined, hemodialysis via a catheter ensued as the most readily available vascular access option. LIMITATIONS: Our study was limited to patients and clinicians from hemodialysis care settings and included few caregiver participants. CONCLUSIONS: Findings suggest that earlier, or upstream, decisions about kidney replacement therapies influence how and when vascular access decisions are made. Repeated vascular access discussions that are integrated with other higher-level decisions are needed to promote vascular access shared decision making and preparedness.

Patient involvement in medical decisions: a survey of shared decision making during physical therapy consultations.

INTRODUCTION: Shared decision making (SDM) is widely affirmed as an ethical principle in healthcare; underpinned by both evidence of its positive outcomes among patients and strong inducements for its adoption by health professionals. This study investigated patients' involvement in SDM, determined its association with their personal characteristics and identified factors influencing their participation. METHOD: A cross-sectional survey was executed among 148 consenting patients, who were recruited using convenience sampling technique and invited to complete self-report questionnaires on SDM. Data were analyzed via descriptive and inferential statistics. RESULTS: Only 14 patients (9.5%) were involved in SDM whilst most patients (88.5%) had passive roles during consultation. SDM involvement had significant associations with age (p = .006) and educational status (p = .021). Most patients (67.6%) identified 'Doubt towards SDM,' as a factor that could hinder this collaborative process. Similarly, majority of the patients acknowledged the relevance of the influential factors: 'Physiotherapist's support' (83.7%) and 'Adequate health Information' (75%), toward promoting involvement in SDM. CONCLUSION: Patient involvement in SDM was low in this study. Older and less/uneducated patients exhibited an increased tendency of noninvolvement. Key influential factors that either facilitate or hinder patients' involvement in SDM were revealed. There is a need to curtail drawbacks to SDM and promote its execution in physical therapy as well as general clinical practice.

An integrated precision medicine approach in major depressive disorder: a study protocol to create a new algorithm for the prediction of treatment response.

Major depressive disorder (MDD) is the most common psychiatric disease worldwide with a huge socio-economic impact. Pharmacotherapy represents the most common option among the first-line treatment choice; however, only about one third of patients respond to the first trial and about 30% are classified as treatment-resistant depression (TRD). TRD is associated with specific clinical features and genetic/gene expression signatures. To date, single sets of markers have shown limited power in response prediction. Here we describe the methodology of the PROMPT project that aims at the development of a precision medicine algorithm that would help early detection of non-responder patients, who might be more prone to later develop TRD. To address this, the project will be organized in 2 phases. Phase 1 will involve 300 patients with MDD already recruited, comprising 150 TRD and 150 responders, considered as extremes phenotypes of response. A deep clinical stratification will be performed for all patients; moreover, a genomic, transcriptomic and miRNomic profiling will be conducted. The data generated will be exploited to develop an innovative algorithm integrating clinical, omics and sex-related data, in order to predict treatment response and TRD development. In phase 2, a new naturalistic cohort of 300 MDD patients will be recruited to assess, under real-world conditions, the capability of the algorithm to correctly predict the treatment outcomes. Moreover, in this phase we will investigate shared decision making (SDM) in the context of pharmacogenetic testing and evaluate various needs and perspectives of different stakeholders toward the use of predictive tools for MDD treatment to foster active participation and patients' empowerment. This project represents a proof-of-concept study. The obtained results will provide information about the feasibility and usefulness of the proposed approach, with the perspective of designing future clinical trials in which algorithms could be tested as a predictive tool to drive decision making by clinicians, enabling a better prevention and management of MDD resistance.

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.

Improving Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care: Pilot trial of a complex intervention.

Introduction: The Initial Medication Adherence (IMA) intervention is a multidisciplinary and shared decision-making intervention to improve initial medication adherence addressed to patients in need of new treatments for cardiovascular diseases and diabetes in primary care (PC). This pilot study aims to evaluate the feasibility and acceptability of the IMA intervention and the feasibility of a cluster-RCT to assess the effectiveness and cost-effectiveness of the intervention. Methods: A 3-month pilot trial with an embedded process evaluation was conducted in five PC centers in Catalonia (Spain). Electronic health data were descriptively analyzed to test the availability and quality of records of the trial outcomes (initiation, implementation, clinical parameters and use of services). Recruitment and retention rates of professionals were analyzed. Twenty-nine semi-structured interviews with professionals (general practitioners, nurses, and community pharmacists) and patients were conducted to assess the feasibility and acceptability of the intervention. Three discussion groups with a total of fifteen patients were performed to review and redesign the intervention decision aids. Qualitative data were thematically analyzed. Results: A total of 901 new treatments were prescribed to 604 patients. The proportion of missing data in the electronic health records was up to 30% for use of services and around 70% for clinical parameters 5 months before and after a new prescription. Primary and secondary outcomes were within plausible ranges and outliers were barely detected. The IMA intervention and its implementation strategy were considered feasible and acceptable by pilot-study participants. Low recruitment and retention rates, understanding of shared decision-making by professionals, and format and content of decision aids were the main barriers to the feasibility of the IMA intervention. Discussion: Involving patients in the decision-making process is crucial to achieving better clinical outcomes. The IMA intervention is feasible and showed good acceptability among professionals and patients. However, we identified barriers and facilitators to implementing the intervention and adapting it to a context affected by the COVID-19 pandemic that should be considered before launching a cluster-RCT. This pilot study identified opportunities for refining the intervention and improving the design of the definitive cluster-RCT to evaluate its effectiveness and cost-effectiveness. Clinical trial registration: ClinicalTrials.gov, identifier NCT05094986.

Hospitalization as an opportunity to engage underserved individuals in shared decision-making for lung cancer screening: results from two randomized pilot trials.

PURPOSE: Medicare requires tobacco dependence counseling and shared decision-making (SDM) for lung cancer screening (LCS) reimbursement. We hypothesized that initiating SDM during inpatient tobacco treatment visits would increase LCS among patients with barriers to proactively seeking outpatient preventive care. METHODS: We collected baseline assessments and performed two pilot randomized trials at our safety-net hospital. Pilot 1 tested feasibility, acceptability, and preliminary efficacy of a nurse practitioner initiating SDM for LCS during hospitalization (Inpatient SDM). We collected qualitative data on barriers encountered during Pilot 1. Pilot 2 added a community health worker (CHW) to address barriers to LCS completion (Inpatient SDM + CHW-navigation). For both studies, preliminary efficacy was an intention-to-treat analysis of LCS completion at 3 months between intervention and comparator (furnishing of LCS decision aid only) groups. RESULTS: Baseline assessments showed that patients preferred in-person LCS discussions versus self-reviewing materials; overall 20% had difficulty understanding written information. In Pilot 1, 4% (2/52) in Inpatient SDM versus 2% (1/48, comparator) completed LCS (p = 0.6), despite 89% (89/100) desiring LCS. Primary care providers noted that competing priorities and patient factors (e.g., social barriers to keeping appointments) prevented the intervention from working as intended. In Pilot 2, 50% (5/10) in Inpatient SDM + CHW-navigation versus 9% (1/11, comparator) completed LCS (p < 0.05). Many patients were ineligible due to recent diagnostic chest CT (Pilot 1: 255/659; Pilot 2: 239/527). CONCLUSIONS: Inpatient SDM + CHW-navigation shows promise to improve LCS rates among underserved patients who smoke, but feasibility is limited by recent diagnostic chest CT among inpatients. Implementing CHW-navigation in other clinical settings may facilitate LCS for underserved patients. TRAIL REGISTRATION: ClinicalTrials.gov Identifier: NCT03276806 (8 September 2017); NCT03793894 (4 January 2019).

PROSHADE Protocol: Designing and Evaluating a Decision Aid for Promoting Shared Decision Making in Opportunistic Screening for Prostate Cancer: A Mix-Method Study.

Background: Opportunistic prostate-specific antigen (PSA) screening may reduce prostate cancer mortality risk but is associated with false positive results, biopsy complications and overdiagnosis. Although different organisations have emphasised the importance of shared decision making (SDM) to assist men in deciding whether to undergo prostate cancer screening, recent evaluations show that the available decision aids fail to facilitate SDM, mainly because they do not consider the patients' perspective in their design. We aim to systematically develop and test a patient decision aid to promote SDM in prostate cancer screening, following the Knowledge to Action framework. Methods: (1) Feasibility study: a quantitative survey evaluating the population and clinician (urologists and general practitioners) knowledge of the benefits and risks derived from PSA determination and the awareness of the available recommendations. Focus groups to explore the challenges patients and clinicians face when discussing prostate cancer screening, the relevance of a decision aid and how best to integrate it into practice. (2) Patient decision aid development: Based on this data, an evidence-based multicomponent SDM patient decision aid will be developed. (3) User-testing: an assessment of the prototype of the initial patient decision aid through a user-testing design based on mix-methods (questionnaire and semi-structured review). The decision aid will be refined through several iterative cycles of feedback and redesign. (4) Validation: an evaluation of the patient decision aid through a cluster-randomised controlled trial. Discussion: The designed patient decision aid will provide balanced information on screening benefits and risks and should help patients to consider their personal preferences and to take a more active role in decision making. Conclusions: The well-designed patient decision aid (PDA) will provide balanced information on screening benefits and risks and help patients consider their personal preferences.