Evidence-based Shared Decision-making Research Articles

Biomarker-Directed Radiotherapy in Breast Cancer

ImportanceIntegration of molecular biomarker information into systemic therapy has become standard practice in breast cancer care. However, its implementation in guiding radiotherapy (RT) is slower. Although postoperative RT is recommended for most patients after breast-conserving surgery and, depending on risk factors, following mastectomy, emerging evidence has indicated that patients with low scores on gene expression signatures or selected clinical-pathological features may have very low local recurrence rates. This narrative review explored the potential of biomarker-directed personalized RT approaches, which may optimize treatment strategies and be associated with improved patient outcomes and experiences.ObservationsDistinctions between prognostic and predictive biomarkers were highlighted, emphasizing the importance of analytical and clinical validity in biomarker-based studies. Findings from studies investigating the prognostic and predictive value of various genomic signatures and immunohistochemical markers for guiding breast RT were presented. These included the Adjuvant Radiotherapy Intensification Classifier and the Profile for the Omission of Local Adjuvant Radiation, which have shown potential in predicting RT benefits. The genomic-adjusted radiation dose and role of tumor-infiltrating lymphocytes were also discussed. Ongoing clinical trials exploring the use of biomarkers in ductal carcinoma in situ and invasive breast cancer to refine RT decision-making were illustrated.Conclusions and RelevanceThe results of this narrative review suggest that evidence-based shared decision-making is crucial to optimize treatment according to the individual’s predicted benefits and risks along with their personal preferences. Incorporation of biomarker-directed approaches in RT for breast cancer may hold promise for personalized treatment, potentially facilitating omission of RT for patients at low risk of recurrence, while identifying those who may benefit from intensified therapy. This personalized RT approach may be associated with improved clinical outcomes and quality of life and facilitate decision-making for people with breast cancer. However, there remains a need for robust clinical and analytical validation of biomarkers to ensure reliability and clinical utility for RT optimization.

Peyronie's Disease: An Outcomes-Based Guide to Non-Surgical and Novel Treatment Modalities.

The clinical landscape of Peyronie's disease is everchanging. There has been growing interest in non-invasive therapeutic options that could assist patients with achieving a meaningful reduction in penile curvature without surgical intervention. These therapies are wide-ranging in terms of their mechanisms of action, efficacies, and short- and long-term safety profiles. Recently, an abundance of outcomes literature on longstanding and novel non-surgical treatment modalities has been published. For sexual medicine providers hoping to offer patients the most up-to-date and evidence-based treatments for the management of Peyronie's disease, it can be challenging to gain a thorough understanding of this body of literature. In this clinical management review, the workup and current theories on the pathophysiology of Peyronie's disease are reviewed, and the most recent outcomes data on the currently available non-surgical treatment modalities are presented. With an accurate understanding of the current landscape of Peyronie's disease treatment, sexual health providers will be able to better evaluate and engage in evidence-based shared decision-making with their patients.

Systematic review of shared decision-making in guidelines about colorectal cancer screening.

We aimed to systematically evaluate quality of shared decision-making (SDM) in colorectal cancer (CRC) screening clinical practice guidelines (CPGs) and consensus statements (CSs). Search for CRC screening guidances was from 2010 to November 2021 in EMBASE, Web of Science, MEDLINE, Scopus and CDSR, and the World Wide Web. Three independent reviewers and an arbitrator rated the quality of each guidance using a SDM quality assessment tool (maximum score: 31). Reviewer agreement was 0.88. SDM appeared in 41/83 (49.4%) CPGs and 9/19 (47.4%) CSs. None met all the quality criteria, and 51.0% (52/102) failed to meet any quality items. Overall compliance was low (mean 1.63, IQR 0-2). Quality was better in guidances published after 2015 (mean 1, IQR 0-3 vs. mean 0.5, IQR 0-1.5; p= 0.048) and when the term SDM was specifically reported (mean 4.5, IQR 2.5-4.5 vs. mean 0.5, IQR 0-1.5; p< 0.001). CPGs underpinned by systematic reviews showed better SDM quality than consensus (mean 1, IQR 0-3 vs. mean 0, IQR 0-2, p= 0.040). SDM quality was suboptimal and mentioned in less than half of the guidances, and recommendations were scarce. Guideline developers should incorporate evidence-based SDM recommendations in guidances to underpin the translation of evidence into practice.

Shared Decision Making and Peer Support: New Directions for Research and Practice.

Shared Decision Making and Peer Support: New Directions for Research and Practice.

Breastfeeding and HIV in the Era of Undetectable=Untransmittable: Research, Policy, and Lived Experiences [01A

INTRODUCTION: Evidence that maintaining undetectable HIV viral load eliminates risk of sexual transmission (Undetectable=Untransmittable or “U=U”) has shifted paradigms in HIV care, introducing the potential for safe and natural conception and decreasing stigma. In this setting, U.S. women living with HIV (WLHIV) are questioning the recommendation against breastfeeding, particularly given breastfeeding's known personal and health benefits for infants and women. METHODS: We perform scoping review of infant feeding for WLHIV, highlight available evidence on breastfeeding, provide international context, and present preliminary findings from healthcare provider and patient interviews and surveys. RESULTS: Research on breastfeeding with HIV predominantly occurs in low-resource settings, limiting applicability to U.S. populations. The World Health Organization guidelines recommend breastfeeding for WLHIV in low-resource settings due to improved infant outcomes. U.S. policy aims to minimize perinatal HIV transmission, without considering the potential health risks of avoiding breastfeeding for infants and women; however in 2018, US guidelines have incorporated harm reduction language to help clinicians support women who breastfeed despite current recommendations. WLHIV identify concerns of stigma, inequity, feelings of maternal inadequacy, and fears around HIV criminalization related to breastfeeding. Providers express need for more education and relevant research. Both groups indicate that evidence-based shared decision-making, rather than harm reduction, may be a more appropriate approach in the U=U era. CONCLUSION: Further medical research and ethical evaluation of the recommendation against breastfeeding for U.S. WLHIV is needed. Provider and patient education should be prioritized to promote informed decisions and observational research participation. We advocate for more nuanced policy and individualized recommendations.

Beyond pros and cons \u2013 developing a patient decision aid to cultivate dialog to build relationships: insights from a qualitative study and decision aid development

BackgroundAn individualized approach using shared decision-making (SDM) and goal setting is a person-centred strategy that may facilitate prioritization of treatment options. SDM has not been adopted extensively in clinical practice. An interprofessional approach to SDM with tools to facilitate patient participation may overcome barriers to SDM use. The aim was to explore decision-making experiences of health professionals and people with diabetes (PwD), then develop an intervention to facilitate interprofessional shared decision-making (IP-SDM) and goal-setting.MethodsThis was a multi-phased study. 1) Feasibility: Using a descriptive qualitative study, individual interviews with primary care physicians, nurses, dietitians, pharmacists, and PwD were conducted. The interviews explored their experiences with SDM and priority-setting, including facilitators and barriers, relevance of a decision aid for priority-setting, and integration of SDM and a decision aid into practice. 2) Development: An evidence-based SDM toolkit was developed, consisting of an online decision aid, MyDiabetesPlan, and implementation tools. MyDiabetesPlan was reviewed by content experts for accuracy and comprehensiveness. Usability assessment was done with 3) heuristic evaluation and 4) user testing, followed by 5) refinement.ResultsSeven PwD and 10 clinicians participated in the interviews. From interviews with PwD, we identified that: (1) approaches to decision-making were diverse and dynamic; (2) a trusting relationship with the clinician and dialog were critical precursors to SDM; and, (3) goal-setting was a dynamic process. From clinicians, we found: (1) complementary (holistic and disease specific) approaches to the complex patient were used; (2) patient-provider agendas for goal-setting were often conflicting; (3) a flexible approach to decision-making was needed; and, (4) conflict could be resolved through SDM. Following usability assessment, we redesigned MyDiabetesPlan to consist of data collection and recommendation stages. Findings were used to finalize a multi-component toolkit and implementation strategy, consisting of MyDiabetesPlan, instructional card and videos, and orientation meetings with participating patients and clinicians.ConclusionsA decision aid can provide information, facilitate clinician-patient dialog and strengthen the therapeutic relationship. Implementation of the decision aid can fit into a model of team care that respects and exemplifies professional identity, and can facilitate intra-team communication.Trial registrationClinicaltrials.gov Identifier: NCT02379078. Date of Registration: 11 February 2015.

Engaging Multidisciplinary Stakeholders to Drive Shared Decision-Making in Oncology.

Although recognized as best practice, regular integration of shared decision-making (SDM) approaches between patients and oncologists remains an elusive goal. It is clear that usable, feasible, and practical tools are needed to drive increased SDM in oncology. To address this goal, we convened a multidisciplinary collaborative inclusive of experts across the health-care delivery ecosystem to identify key principles in designing and testing processes to promote SDM in routine oncology practice. In this commentary, we describe 3 best practices for addressing challenges associated with implementing SDM that emerged from a multidisciplinary collaborative: (1) engagement of diverse stakeholders who have interest in SDM, (2) development and validation of an evidence-based SDM tool grounded within an established conceptual framework, and (3) development of the necessary roadmap and consideration of the infrastructure needed for engendering patient engagement in decision-making. We believe these 3 principles are critical to the success of creating SDM tools to be utilized both within and outside of clinical practice. We are optimistic that shared use across settings will support adoption of this tool and overcome barriers to implementing SDM within busy clinical workflows. Ultimately, we hope that this work will offer new perspectives on what is important to patients and provide an important impetus for leveraging patient preferences and values in decision-making.

Share Decision Making Aid for Juvenile Idiopathic Arthritis: Moving from Informative Patient Education to Interactive Critical Thinking

Background: Shared decision making (SDM) is an emerging trend in paediatrics. Currently available SDM interventions are mere information on the disease or medication and often fail to engage the children in the medical decision process. It has been suggested that future decision aids should endorse better children engagement. Objectives: To develop, and evaluate an illustrated and interactive evidence-based SDM aid for JIA children, 2. 2.Positive perceived involvement of JIA patients in their own management that would be reflected on treatment outcomes. Methods: A multidisciplinary team defined SDM criteria based on the international standards (IPDAS). Eight categories emerged as highly important for SDM. Each category was supported by simple illustrations in an interactive style. At the end of each category the child is asked to make a decision in view of the information given. 94 JIA children evaluated the tool, in a randomized controlled study, in comparison to control group of 95 JIA patients treated according to standard protocols. Results: The SDM aid was developed to offer information about the disease, risks and benefits of treatment.97.5% of the children included reported comprehensibility of > 90/100. The patients' adherence to therapy was significantly (p<0.01) higher in the SDM group, whereas stopping DMARDs for intolerability, was significantly higher in the control group at 12-months of treatment. There was significant improvement in the patient reported outcomes in the SDM group, whilst absence from school was significantly higher in the control group (p< 0.01) Conclusions: This Illustrated-interactive SDM aid for JIA children was found to be a simple, user-friendly tool which can be implemented in standard practice. The developed SDM offered the children evidence-based information about the pros and cons of treatment options, improved their understanding of the disease, communication with their treating clinician and their ability to make an informed decision. Funding Statement: Authors declare none. Declaration of Interests: Nothing to declare. Ethics Approval Statement: Local ethical and methodological protocols for approval of the study were followed. All patients or their parents/ caregivers who participated in the study signed an informed consent according to the declaration of Helsinki.

Patient and provider perspectives on uptake of a shared decision making intervention for asthma in primary care practices

ABSTRACTObjective: Poor outcomes and health disparities related to asthma result in part from difficulty disseminating new evidence such as shared decision making (SDM) into clinical practice. As part of a three-arm cluster randomized dissemination study, evaluation of the impact of different dissemination methods was studied. Here we evaluate themes from patient and provider focus groups to assess the impact of a facilitated, traditional dissemination approach, or no intervention, on patient and provider perspectives of asthma care. Methods: Using semi-structured questions, twenty-four pre- and post-intervention focus groups with patients and providers took place across primary care practices. Discussions were held in all three arms both before and after the time of intervention rollout. Audio recordings were transcribed and analyzed for themes. Results: Across all sites patients and providers discussed themes of communication, asthma self-management, barriers, education, and patient awareness. After the intervention, compared to traditional sites, facilitated practices were more likely to discuss themes related to SDM, such as patient-centered communication, patient-provider negotiation on treatment plan, planning, goal-setting, and solutions to barriers. Conclusions: Emergent themes allowed for further understanding of how the SDM implementation was perceived at the patient and provider level. The facilitated implementation was associated with higher adoption of the SDM intervention. These themes and supporting quotes add to knowledge of best practices associated with implementing an evidence-based SDM intervention for asthma into primary care and will inform researchers, practices, and providers as they work to improve adoption of evidence-based interventions into practice.

Trends in rates of modified radical mastectomies and bilateral mastectomies in unilateral breast cancer.

569 Background: Women with unilateral breast cancer (BC) without genetic predisposition have a low risk for local and contralateral recurrence with breast conservation surgery (BCS) and adjuvant treatment. We aimed to study the pattern of surgical care across centers in rural New Mexico and its correlation to clinical outcomes. Methods: We retrospectively evaluated 533 patients with Stage 1-3 BC diagnosed between January 1989 to October 2015. Clinical Outcomes with BCS, sentinel lymph node dissection (SLND), simple mastectomy (SM), modified radical mastectomy (MRM) and Bilateral Mastectomy (BM) were studied. Descriptive statistics were performed to describe the proportion of surgery types. Predictors of clinical outcomes were evaluated by multivariate logistic regression. Results: Out of 533 patients, 510 (82%) had early stage (0-3) resectable BC. Among these, 48% (246/510) had either MRM (209/510) or BM (37/510). MRM was performed in 3% of stage 0 (6/209), 23% (49/209) stage I, 46%(97/209) of stage II and 27% (57/209) of Stage III patients. Overall, the rate of SLND was 42% among Early stage Breast cancer. Of 41 patients treated with bilateral mastectomy, 10 were positive for BRCA mutation, 6 for family history and 3 for contralateral disease. Median age of BM was 53 +12 y. The local recurrence rate was 8.8% (45/510), and metastatic recurrence rate was 15.5% (79/510). Lymphedema rate was 9.2% (47/510). Using MRM as reference, the Odds Ratio (OR) for lymphedema after BM and BCT were 2.15 (95% CI, 0.84-5.50) and 0.58 (0.28-1.22), respectively. With 9.6 years of median follow up, the predictive probabilities of lymphedema after BCT, SM, MRM and BM were 1%, 4%, 9% and 18%. The OR for local recurrence in women with BCT were 1.46 (95th C/I: 0.72-2.95), SM 0.27 (0.03-2.13), BM 2.06 (95th C/I:0.70-6.06). Conclusions: Less BCT and more aggressive procedures are being performed, and the latter is associated with more lymphedema. No significant differences were noted in local recurrences. Presence of a genetic mutation was not the sole indicator of BM’s in our patient population. There is a need for evidence-based shared decision-making and surgical management of breast cancer, especially in a rural community setting.

Implementing Shared Decision Making In Clinical Practice: Outcomes of a New Shared Decision Making Aid for Chronic Inflammatory Arthritis Patients

Abstract Objective: To develop and evaluate an evidence-based shared decision making (SDM) aid for patients with chronic arthritic conditions to inform them about the pros and cons of their treatment options and to help them make an informed shared decision. Methods: A multidisciplinary team defined criteria for the SDM as to design, medical content and functionality, particularly for elderly users. Development was according to the international standard (IPDAS). 174 patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, who were either treated or not yet treated, evaluated the tool, in a randomized controlled study, in comparison to control group composed of 171 patients treated according to standard methods. Results: The SDM aid was developed to offer information about the disease, the risks and benefits of treatment. 98% of the patients included reported comprehensibility of >85/100. There was no significant difference between the online and paper format SDM aids. The patients’ adherence to anti-rheumatic therapy was significantly (p<0.1) higher in the SDM group, whereas stopping DMARDs for intolerability was significantly (p<0.01) higher in the control group at 12 months of treatment. Conclusion: This evidence-based SDM aid for inflammatory arthritis patients, developed according to IPDAS criteria, was found to be a simple, user-friendly tool which can be implemented in standard clinical practice. It offered the chronic arthritis patients evidence-based information about the pros and cons of treatment options, improved patients’ understanding of the disease, communication with their treating clinician as well as ability to make an informed decision.

Results from a pragmatic prospective cohort study: Shared decision making improves outcomes for children with asthma

ABSTRACTObjective: Patient/provider shared decision making (SDM) improves asthma control in a pragmatic clinical trial setting. This study evaluated the impact of an evidence-based SDM toolkit on outcomes for patients with asthma implemented by providers in a real world setting. We hypothesized that these patients with asthma would demonstrate improved outcomes such as reduced emergency department (ED) visits, hospitalizations, and oral steroid use in the 12 months following a SDM visit compared to those who did not receive the intervention. Methods: Patients with asthma were identified within six primary care practices that serve vulnerable populations in Charlotte, NC (746 children; 718 adult patients). Propensity scores were used to match 200 children and 206 adults for analysis. The primary outcome variable was asthma exacerbation defined as an ED visit or hospitalization for asthma or outpatient prescription of an oral steroid. Patients were monitored at 3, 6, and 12 months after the intervention date. The outcome variables of ED visits, hospitalizations, and oral steroids were compared between intervention and matched control patients. Results: The proportion of pediatric patients with one or more exacerbations was significantly lower in the SDM intervention group compared to controls during 12 months after exposure to the intervention (33% vs. 47%, p = 0.023). For adults, there was not a strong association between use of the SDM intervention and outcomes improvement. Conclusions: The evidence-based SDM intervention implemented in this study was associated with improved asthma outcomes for pediatric patients but not adult patients in a real world clinical setting.

Impact of an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes on decisional conflict--study protocol for a randomized controlled trial.

BackgroundCompeting health concerns present real obstacles to people living with diabetes and other chronic diseases as well as to their primary care providers. Guideline implementation interventions rarely acknowledge this, leaving both patients and providers feeling overwhelmed by the volume of recommended actions. Interprofessional (IP) shared decision-making (SDM) with the use of decision aids may help to set treatment priorities. We developed an evidence-based SDM intervention for patients with diabetes and other conditions that was framed by the IP-SDM model and followed a user-centered approach. Our objective in the present study is to pilot an IP-SDM and goal-setting toolkit following the Knowledge-to-Action Framework to assess (1) intervention fidelity and the feasibility of conducting a larger trial and (2) impact on decisional conflict, diabetes distress, health-related quality of life and patient assessment of chronic illness care.Methods/DesignA two-step, parallel-group, clustered randomized controlled trial (RCT) will be conducted, with the primary goal being to assess intervention fidelity and the feasibility of conducting a larger RCT. The first step is a provider-directed implementation only; the second (after a 6-month delay) involves both provider- and patient-directed implementation. Half of the clusters will be assigned to receive the IP-SDM toolkit, and the other will be assigned to be mailed a diabetes guidelines summary. Individual interviews with patients, their family members and health care providers will be conducted upon trial completion to explore toolkit use. A secondary purpose of this trial is to gather estimates of the toolkit’s impact on decisional conflict. Secondary outcomes include diabetes distress, quality of life and chronic illness care, which will be assessed on the basis of patient-completed questionnaires of validated scales at baseline and at 6 and 12 months. Multilevel hierarchical regression models will be used to account for the clustered nature of the data.DiscussionAn individualized approach to patients with multiple chronic conditions using SDM and goal setting is a desirable strategy for achieving guideline-concordant treatment in a patient-centered fashion. Our pilot trial will provide insights regarding strategies for the routine implementation of such interventions in clinical practice, and it will offer an assessment of the impact of this approach.Trial registrationClinicaltrials.gov Identifier: NCT02379078. Date of Registration: 11 February 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0797-8) contains supplementary material, which is available to authorized users.