Shared Decision-making Process Research Articles

Identifying Womens' Needs in Making a Treatment Decision for Stress Urinary Incontinence: A Qualitative Study.

Choosing a treatment option for female stress urinary incontinence (SUI) is a preference-sensitive decision. Nowadays, shared decision making (SDM) is the preferred way of decision making. SDM considers the needs patients have regarding the decision-making process. The aim of this study was to identify decisional needs of women who are making a treatment decision for SUI. Semistructured interviews were planned with women who had been seeking treatment for SUI. Patients were recruited in two teaching hospitals in the Netherlands. Interviewers used a topic list based on the Ottawa decision support framework. The interviews were transcribed and coded. Themes and subthemes of factors relating to the treatment decision-making process were identified and described. We interviewed a total of 16 women. Four major themes of SUI patients' needs were identified: information on disorder and treatment, SDM, personalized health care, and consideration for social context. Within these themes, specific needs varied between individuals. In addition to the provision of objective information, other important identified needs were subjective, such as acknowledgment of symptoms and feeling understood by a physician. It was important for patients that they had a sufficient amount of time to make their decision. To ensure a good quality treatment decision in female SUI, several topics need to be addressed in an SDM process. The themes of decisional needs identified in this study can help improve the decision-making process.

Recent updates in therapeutic approach using tolvaptan for autosomal dominant polycystic kidney disease.

As a genetic disease, there has been a long-standing effort to identify therapeutic options for autosomal dominant polycystic kidney disease (ADPKD). Following the development of tolvaptan, a vasopressin 2 receptor antagonist, the treatment strategy for ADPKD patients with rapid disease progression has been changed with a disease-targeted approach. Tolvaptan showed significant efficacy in preserving kidney function and reducing the total kidney volume (TKV) growth rate. These effects were especially pronounced in patients with more severe clinical phenotypes, such as higher TKV and rapidly declining kidney function. Despite the therapeutic effects of tolvaptan, aquaretic symptoms are unavoidable side effects related to the mechanism of the drug and are also directly related to the quality of life. A shared decision-making process could be a valuable strategy for reducing the incidence of side effects and improving medication adherence. Herein, we aimed to review overall clinical trials for applying tolvaptan and suggest important factors during the shared decision-making process.

E011 What information should we provide to inform and empower our patients to participate in shared decision making? The patient perspective

Abstract Background/Aims With an increasing number of biologic and targeted synthetic disease-modifying anti-rheumatic drugs and their biosimilar agents coming to the market, there is an increased choice of treatments available to patients. It is paramount to understand what information patients require to weigh up risks and benefits of each treatment to empower them to take part in shared decision making. This study aims to explore which factors (in addition to their clinical history) are deemed most important by patients when choosing a treatment and if they believe cost of treatment should be considered. Methods 74 randomly selected patients, who had been referred to the biologic or targeted synthetic treatment pathway, were invited to complete an anonymous online survey. Paper responses were also offered to patients who were unable to participate electronically, to avoid digital exclusivity. The survey consisted of 10 questions looking at patient perspectives questioning if they wanted to be involved in decisions about biologic and targeted synthetic treatment, which patient factors were important to them, if they considered cost as an important factor, if they would find a decision aid such as graphic/diagrams useful and if they would like a written record of how a shared decision was made. Results A total of 50 patients responded to the survey (40/50 online vs. 10/50 paper survey). 94% of patients stated that they would like to be involved in decisions about choice of biologic/ targeted synthetic medication. 58% said they think it is important to consider the cost of treatment. Based on the responses from the patients, the top patient factors (chosen by more than 60% of respondents) which were considered important are: how treatment is given, where treatment is given, how often it needs to be taken, how frequently monitoring is required, likelihood and severity of possible side effects. 66% of respondents said they would like to be shown a graphic/diagram to support their shared decision making and 80% of respondents said they would like a written record to explain how a shared decision was made about the best treatment for them. Conclusion The majority of patients included in our study would like to be actively involved in the shared decision-making process and would like to be given information such as route, frequency and location of administration, frequency of monitoring and severity and likelihood of side effects. The majority felt they would benefit from having a graphic/ diagram with all the relevant information summarised to help understand information easily. Providing a written record of the shared decision making will also make the process more transparent. Feedback from the survey has informed our service redesign, specifically our approach to shared decision making, to improve our patients’ experience. Disclosure N. Mathews: None. F. Ferris: None. A. Bayliss: None. E. McCormack: None. K. Summerhayes: None. H. De Vere: None. E. Rose-Parfitt: None.

P054 Utilising a pharmacist-designed best value biologic and targeted synthetic shared decision-making tool to empower patients, support clinicians and save NHS resources

Abstract Background/Aims The dynamic pipeline and complex pricing of b/tsDMARD therapies make it challenging for clinicians to compare cost of treatments when undertaking shared decision making with patients in the clinic setting. NHSE have funded development of a Rheumatology Pharmacist designed, web based, best value biologic and targeted synthetic shared decision-making tool (BVBTS-SDMT) using live pricing from the Commercial Medicines Unit. A clinical workbook and treatment pathways have been developed to support the tool. Clinical parameters are entered into the tool, creating a list of available therapies in order of increasing cost relative to the patient’s weight and indication. Treatment pathways are consulted and clinical parameters (e.g. disease phenotype, co-morbidities, response to previous treatment) and patient preferences (e.g. route and frequency of administration, frequency of drug monitoring, personal beliefs) are discussed with the patient and documented in the clinical workbook. Inappropriate therapies are eliminated, identifying the most cost-effective treatment option for the patient synchronously during the consultation. This study explores the potential patient, clinician and cost benefits of adopting the tool in practice. Methods A random sample of 51 patients referred to the rheumatology non-medical prescribing team for starting b/tsDMARDs between 2019 and 2022 were recruited. Electronic records including referral email, patient notes and b/tsDMARD database were evaluated and recorded factors influencing shared decision making were analysed. Two rheumatology specialist pharmacists independently reviewed the historical clinical decision making to determine if the most cost-effective treatment option was chosen once all clinical factors and patient parameters were considered, using a record of historic treatment prices from retrospective homecare invoices and commissioning reports. Differentials between most cost-effective treatment and chosen treatment were calculated. Secondary outcome of comprehensiveness of clinical record was also analysed. Results Between 2019-2022, use of the BVBTS-SDMT would have saved an average of £1,695 per patient in the n = 51 sample. For the 210, 173 and 258 patients newly started on b/tsDMARDs in the years 2019-2020, 2020-21 and 2021-22 respectively, a total of £1,086,495 would have been saved if the tool had been in use. Clinical parameters, patient preferences and cost consideration affecting shared decision making were documented in 49%, 12% and 0% (respectively) of the 51 recruited patients’ clinical records. Conclusion This baseline data collection demonstrates use of the BVBTS-SDMT, in collaboration with treatment pathways and a clinical workbook, has potential to facilitate robust, consistent and methodological shared decision making with patients, encourage accurate reporting in patient records and save NHS money. This is a transformative approach to shared decision making; deviating from the traditional method of giving patients a couple of options to consider and instead working collaboratively through a shared decision-making process to find the most appropriate and cost-effective treatment option for the patient. Disclosure N. Mathews: None. C. McKenzie: None. E. Rose-Parfitt: None.

Performance of the shared decision-making process scale for use in evaluation of hereditary cancer genetic testing decisions.

This study aimed to evaluate feasibility, acceptability, reliability, and validity of the existing four-item Shared Decision Making (SDM) Process Scale for use in evaluating genetic testing decisions. Patients from a large hereditary cancer genetics practice were invited to participate in a two-part survey after completing pre-test genetic counseling. The online survey included the SDM Process Scale and the SURE scale, a measure of decisional conflict. SDM Process scores were compared to SURE scores to test convergent validity, and respondents were sent a second survey 1 week later to assess retest reliability. The response rate was 65% (n = 259/398) and missing data was low (<1%). SDM scores ranged from zero to four with a mean of 2.3 (SD = 1.1). Retest reliability was good, with intraclass correlation of 0.84, 95% confidence interval (0.79, 0.88). No relationship was found between SDM Process scores and decisional conflict (p = 0.46), likely because 85% of participants reported no decisional conflict. The four-item SDM Process Scale demonstrated feasibility, acceptability, and retest reliability, but not convergent validity with decisional conflict. These findings provide initial evidence for use of this scale to measure patient perceptions of SDM in pre-test counseling for hereditary cancer genetic testing.

Society for Maternal-Fetal Medicine Statement: Response to the Food and Drug Administration’s withdrawal of 17-alpha hydroxyprogesterone caproate

On April 5, 2023, the US Food and Drug Administration withdrew the approval of 17-alpha hydroxyprogesterone caproate, effective immediately, because of the lack of evidence that it reduces the risk of recurrent spontaneous preterm birth. This decision withdraws approval for all formulations of 17-alpha hydroxyprogesterone caproate (both intramuscular and subcutaneous) and applies to both brand name (Makena) and generic versions of the medication. We agree with the Food and Drug Administration determination and discourage continued prescribing of 17-alpha hydroxyprogesterone caproate, including through compounding pharmacies. We do not recommend changing indications for cerclage, indications for vaginal progesterone in patients with a short cervix, or recommendations against activity restriction based on the Food and Drug Administration withdrawal of 17-alpha hydroxyprogesterone caproate from the market. We recommend that discussion of the use of vaginal progesterone for primary prevention of recurrent preterm birth without input of cervical length or in those with a cervical length of ≥25 mm includes a shared decision-making process, especially if a progesterone formulation for preterm birth prevention was received in a previous pregnancy. The Food and Drug Administration determined that it would be inappropriate to delay the effective date of the withdrawal to allow patients currently receiving 17-alpha hydroxyprogesterone caproate to finish treatment. We agree with the Food and Drug Administration that there is no evidence of benefit with continued treatment. Patients currently receiving 17-alpha hydroxyprogesterone caproate can be counseled that the Food and Drug Administration's Center for Drug Evaluation and Research has not identified evidence of harm from discontinuation before 37 weeks of gestation.

Women’s Voices: Exploring Context and Practical Strategies for Women’s Health Shared Decision-Making in Community Health Settings

Shared decision-making (SDM) represents an opportunity to increase patient involvement in their healthcare. Limited research exists on the factors impacting women’s reproductive decision-making and what practical needs may be. This study aimed to identify factors women perceived as influencing their reproductive health decisions (e.g., family planning, accessing routine gynecological care) and to understand how these factors impact SDM within the reproductive healthcare context. We completed six focus groups with women aged 18 to 45 years in the United States. Women’s SDM processes were explored using techniques from grounded theory. This study offered insight into factors influencing women’s reproductive healthcare decisions and how these factors can negatively impact SDM. Participants indicated a desire to be invited into the healthcare discussion in which providers listened, supported, and validated their choices and needs. Participants provided recommendations from positive experiences to identify their preferences during a woman’s healthcare appointment. Additionally, participants described quality time as more important than the quantity of time spent during consultations. Prior negative healthcare experiences attributed to interaction with healthcare providers affected their SDM perspectives and healthcare engagement, as did family/friends and race. Participants suggested that previous interactions with healthcare providers influenced their decision to seek healthcare, explicitly citing community-based reproductive healthcare. Findings provide recommendations on how clinicians can engage in SDM, practical opportunities to fulfill women’s patient–provider involvement needs, and new insights into continuing to develop the SDM model in reproductive healthcare.

A retrospective study of differences in patients’ anxiety and satisfaction between paper-based and computer-based tools for “Shared Decision-Making”

We aimed to investigate differences in patients’ anxiety and satisfaction between patients undergoing paper-based patient decision aid (PDA) for shared decision-making (SDM) and those receiving computer-based PDA. We retrospectively collected questionnaires before and after SDM. Basic demographic data as well as anxiety, satisfaction, knowledge acquisition, and participation in SDM were recorded. We divided our population into subgroups according to use of paper-based or computer-based PDA. In addition, Pearson correlation analysis was applied to assess the relationships among variables. In total, 304 patients who visited our Division of Nephrology were included in the final analysis. Overall, over half of the patients felt anxiety (n = 217, 71.4%). Near half of the patients felt a reduction in anxiety after SDM (n = 143, 47.0%) and 281 patients (92.4%) were satisfied with the whole process of SDM. When we divided all the patients based on use of paper-based or computer-based PDA, the reduction of anxiety level was greater in the patients who underwent paper-based PDA when compared with that of those who underwent computer-based PDA. However, there was no significant difference in satisfaction between the two groups. Paper-based PDA was as effective as computer-based PDA. Further studies comparing different types of PDA are warranted to fill the knowledge gaps in the literature.

Topical nonsteroidal anti-inflammatory drugs for management of osteoarthritis pain: A consensus recommendation.

Osteoarthritis (OA) contributes to significant medical and socioeconomic burden in many populations. Its prevalence is expected to rise continuously owing to the combined effects of aging and increase in risk factors, including obesity, physical inactivity, and joint injuries. Pain is a hallmark presentation of OA. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are recommended by many international guidelines as an early treatment option of the management of osteoarthritic pain. However, the use of topical NSAIDs remains low in Malaysia and appears not to be a preferred agent in managing OA pain by prescribers. There is also limited guidance from local medical bodies on the use of topical NSAIDs to manage OA pain. This consensus recommendation is intended to serve as a practical guide for healthcare practitioners on the use of topical NSAIDs in the management of OA pain. Eight statements and recommendations were finalized covering the areas of OA burden, topical NSAIDs formulations, safety and efficacy of topical NSAIDs, and patient education. Robust evidence is available to support the efficacy and safety of topical NSAIDs, with its benefits further strengthened by ease of use and access. Taking these into consideration, we recommend that healthcare practitioners advocate for the early use of topical NSAIDs over oral NSAIDs for mild-to-moderate OA pain, while engaging in a shared decision-making process with patients for optimal clinical outcomes.

Renal denervation in the management of hypertension in adults. A clinical consensus statement of the ESC Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Since the publication of the 2018 European Society of Cardiology/European Society of Hypertension (ESC/ESH) Guidelines for the Management of Arterial Hypertension, several high-quality studies, including randomised, sham-controlled trials on catheter-based renal denervation (RDN) were published, confirming both the blood pressure (BP)-lowering efficacy and safety of radiofrequency and ultrasound RDN in a broad range of patients with hypertension, including resistant hypertension. A clinical consensus document by the ESC Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on RDN in the management of hypertension was considered necessary to inform clinical practice. This expert group proposes that RDN is an adjunct treatment option in uncontrolled resistant hypertension, confirmed by ambulatory BP measurements, despite best efforts at lifestyle and pharmacological interventions. RDN may also be used in patients who are unable to tolerate antihypertensive medications in the long term. A shared decision-making process is a key feature and preferably includes a patient who is well informed on the benefits and limitations of the procedure. The decision-making process should take (i) the patient's global cardiovascular (CV) risk and/or (ii) the presence of hypertension-mediated organ damage or CV complications into account. Multidisciplinary hypertension teams involving hypertension experts and interventionalists evaluate the indication and facilitate the RDN procedure. Interventionalists require expertise in renal interventions and specific training in RDN procedures. Centres performing these procedures require the skills and resources to deal with potential complications. Future research is needed to address open questions and investigate the impact of BP-lowering with RDN on clinical outcomes and potential clinical indications beyond hypertension.

Ramadan fasting and pregnancy: an evidence-based guide for the obstetrician

Pregnant Muslim women may be religiously exempt from fasting during the Islamic month of Ramadan, especially if there is concern for undue hardship or harm to maternal or fetal health. However, several studies demonstrate that most women still choose to fast during pregnancy and avoid discussing fasting with their providers. A targeted literature review of published studies on fasting during Ramadan and pregnancy or maternal and fetal outcomes was performed. We generally found little to no clinically significant effect of fasting on neonatal birthweight or preterm delivery. Conflicting data exist on fasting and mode of delivery. Fasting during Ramadan has been mainly associated with signs and symptoms of maternal fatigue and dehydration, with a minimal decrease in weight gain. There is conflicting data regarding the association with gestational diabetes mellitus and insufficient data on maternal hypertension. Fasting may affect some antenatal fetal testing indices, including nonstress tests, lower amniotic fluid levels, and lower biophysical profile scores. Current literature on the long-term effects of fasting on offspring suggests possible adverse effects, but more data are required. The quality of evidence was negatively impacted by the variation in defining "fasting during Ramadan" in pregnancy, study size and design, and potential confounders. Therefore, in counseling patients, obstetricians should be prepared to discuss the nuances in the existing data while demonstrating cultural and religious awareness and sensitivity to foster a trusting relationship between patient and provider. We provide a framework for obstetricians and other prenatal care providers to aid in that effort and supplemental materials to encourage patients to seek clinical advice on fasting. Providers should engage patients in a shared decision-making process and offer them a nuanced review of the evidence (including limitations) and individualized recommendations based on clinical experience and patient history. Finally, should certain patients choose to fast while pregnant, providers should offer medical recommendations, closer observation, and support to reduce harm and hardship while fasting.

Impact of the number of previous lumbar operations on patient-reported outcomes after surgery for lumbar spinal stenosis or lumbar disc herniation.

Repeated lumbar spine surgery has been associated with inferior clinical outcomes. This study aimed to examine and quantify the impact of this association in a national clinical register cohort. This is a population-based study from the Norwegian Registry for Spine surgery (NORspine). We included 26,723 consecutive cases operated for lumbar spinal stenosis or lumbar disc herniation from January 2007 to December 2018. The primary outcome was the Oswestry Disability Index (ODI), presented as the proportions reaching a patient-acceptable symptom state (PASS; defined as an ODI raw score ≤ 22) and ODI raw and change scores at 12-month follow-up. Secondary outcomes were the Global Perceived Effect scale, the numerical rating scale for pain, the EuroQoL five-dimensions health questionnaire, occurrence of perioperative complications and wound infections, and working capability. Binary logistic regression analysis was conducted to examine how the number of previous operations influenced the odds of not reaching a PASS. The proportion reaching a PASS decreased from 66.0% (95% confidence interval (CI) 65.4 to 66.7) in cases with no previous operation to 22.0% (95% CI 15.2 to 30.3) in cases with four or more previous operations (p < 0.001). The odds of not reaching a PASS were 2.1 (95% CI 1.9 to 2.2) in cases with one previous operation, 2.6 (95% CI 2.3 to 3.0) in cases with two, 4.4 (95% CI 3.4 to 5.5) in cases with three, and 6.9 (95% CI 4.5 to 10.5) in cases with four or more previous operations. The ODI raw and change scores and the secondary outcomes showed similar trends. We found a dose-response relationship between increasing number of previous operations and inferior outcomes among patients operated for degenerative conditions in the lumbar spine. This information should be considered in the shared decision-making process prior to elective spine surgery.

Considerations for shared decision-making in treatment of chronic rhinosinusitis with nasal polyps.

Shared decision-making is an approach where physicians and patients work together to determine a personalized treatment course. Such an approach is integral to patient-centered care in chronic rhinosinusitis with nasal polyps (CRSwNP). CRSwNP is a chronic inflammatory condition of the sinonasal cavity that can severely impact physical health, smell, and quality of life (QOL). Traditional standard-of-care treatment options include topical (i.e. sprays) and oral corticosteroids and endoscopic sinus surgery, but more recently, novel corticosteroid delivery methods (i.e. high volume irrigations, recently-approved exhalation breath-powered delivering devices, and drug-eluting steroid implants) and 3 new FDA approved biologics directed against type II immunomodulators have become available. The availability of these therapeutics offers exciting new opportunities in CRSwNP management but requires personalized and shared-decision making as each modality has variable impacts on CRSwNP and related comorbid conditions. Studies have published treatment algorithms, but the practical use of these lean guidelines is heavily influenced by the lens of the treating physician, the most common being otolaryngologists and allergy immunologists. Clinical equipoise occurs when there is no basis for one intervention to be regarded as "better" than another. While most guidelines, in general, support the use of topical corticosteroids with or without oral corticosteroids followed by ESS for the majority of unoperated CRSwNP patients, there are situations of clinical equipoise that arise particularly in CRSwNP who have failed surgery or those with severe comorbid conditions. In the shared decision-making process, clinicians and patients must consider symptomatology, goals, comfort, compliance, treatment efficacy, and treatment cost when determining the initial choice of therapy and escalation of therapy with the potential use of multiple modalities for recalcitrant CRSwNP. A summary of salient considerations that might constitute shared decision-making is presented in this summary.

Clavien-Dindo, comprehensive complication index and classification of intraoperative adverse events: a uniform and holistic approach in adverse event registration for (deep) endometriosis surgery.

What is the additional value of the comprehensive complication index (CCI) and ClassIntra system (classification for intraoperative adverse events (ioAEs)) in adverse event (AE) reporting in (deep) endometriosis (DE) surgery compared to only using the Clavien-Dindo (CD) system? The CCI and ClassIntra are useful additional tools alongside the CD system for a complete and uniform overview of the total AE burden in patients with extensive surgery (such as DE), and with this uniform data registration, it is possible to provide greater insight into the quality of care. Uniform comparison of AEs reported in the literature is hampered by scattered registration. In endometriosis surgery, the usage of the CD complication system and the CCI is internationally recommended; however, the CCI is not routinely adapted in endometriosis care and research. Furthermore, a recommendation for ioAEs registration in endometriosis surgery is lacking, although this is vital information in surgical quality assessments. A prospective mono-center study was conducted with 870 surgical DE cases from a non-university DE expertise center between February 2019 and December 2021. Endometriosis cases were collected with the EQUSUM system, a publicly available web-based application for registration of surgical procedures for endometriosis. Postoperative adverse events (poAEs) were classified with the CD complication system and CCI. Differences in reporting and classifying AEs between the CCI and the CD were assessed. ioAEs were assessed with the ClassIntra. The primary outcome measure was to assess the additional value toward the CD classification with the introduction of the CCI and ClassIntra. In addition, we report a benchmark for the CCI in DE surgery. A total of 870 DE procedures were registered, of which 145 procedures with one or more poAEs, resulting in a poAE rate of 16.7% (145/870), of which in 36 cases (4.1%), the poAE was classified as severe (≥Grade 3b). The median CCI (interquartile range) of patients with poAEs was 20.9 (20.9-31.7) and 33.7 (33.7-39.7) in the group of patients with severe poAEs. In 20 patients (13.8%), the CCI was higher than the CD because of multiple poAEs. There were 11 ioAEs reported (11/870, 1.3%) in all procedures, mostly minor and directly repaired serosa injuries. This study was conducted at a single center; thus, trends in AE rates and type of AEs could differ from other centers. Furthermore, no conclusion could be drawn on ioAEs in relation to the postoperative course because the power of this database is not robust enough for that purpose. From our data, we would advise to use the Clavien-Dindo classification system together with the CCI and ClassIntra for a complete overview of AE registration. The CCI appeared to provide a more complete overview of the total burden of poAEs compared to only reporting the most severe poAEs (as with CD). If the use of the CD, CCI, and ClassIntra is widely adapted, uniform data comparison will be possible at (inter)national level, providing better insight into the quality of care. Our data could be used as a first benchmark for other DE centers to optimize information provision in the shared decision-making process. No funding was received for this study. The authors have no conflicts of interest to declare. N/A.

3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis

BackgroundRandomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low–surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process. ObjectivesThe authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial. MethodsLow-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years. ResultsThere were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: −1.8% at year 1; −2.0% at year 2; and −2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years. ConclusionsWithin the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283)

Abstract P6-05-15: Standard of Care for HR+/HER2- Breast Cancer: Integrating The “Yale Model Shared Decision-Making Multidisciplinary Team Solution” into the Practice Setting

Abstract Background: Breast cancer patients are faced with treatment choices that can involve complex preference-sensitive decisions. The National Quality Forum initiated a “Call to Action” to integrate shared decision-making (SDM) processes into practice where clinicians and patients work together to make healthcare decisions that align with what matters most to patients. Projects In Knowledge, @Point of Care, Dartmouth and Yale collaborated to develop a pilot educational initiative to address and improve patient-centered care and SDM processes in the institutional cancer care setting. Methods: Training materials co-developed for the Yale Breast Cancer multidisciplinary team (N=11: oncologists, nurses/NPs, pharmacist) address SDM, CDK4/6 Inhibitor treatment of metastatic HR+ HER2- breast cancer, and clinician-patient role play methods implementing SDM in treatment discussions/decisions with patients. Reinforcement training, based on interim interview and case role play assessments, was customized to meet specific needs of the team. Qualitative semi-structured interviews and simulation case role play observational methods, using a two-rater system, were used to assess improved SDM performance. Baseline pre-intervention interviews and case role play assessments were compared to interim post-intervention and end of pilot (EOP) post-reinforcement training intervention interviews and case role play assessments (using a Likert scale 0-4 rating score: 0=0%; 1=25%, 2=50%; 3=75%; 4=100%). Following the training and assessments, a focus group of team members provided insights into the performance of the group, assessed the acceptability, feasibility, and repeatability of the program, and informed future education. Results: Semi-structured interview findings revealed that clinicians learned about nuances of CDK 4/6 inhibitors, crystallized their understanding of SDM through reinforcement training (customized in real time), and felt they were better able to implement SDM as a result of their case role play assessments. Training empowered the Yale Breast Cancer team to show pre- to post-education improvement in SDM case role play scenarios, ranging from 16% to 39%. Areas of greatest improvement: 1) determining decision style preference (+36%); 2) determining patients’ risk/burden tolerance (+32%); 3) determining patients’ activation, engagement, and self-efficacy (+34%), 4) determining trade-off decisions with patients (+39%), and 5) determining patients’ readiness to make a decision (+32%). Future research should explore how best to integrate SDM into the real world time restricted clinical practice. Conclusions: Educational training improved SDM skills for the multidisciplinary Yale Breast Cancer team, which can lead to improved clinician-patient decision-making and patient-centric care. The training process also facilitated team building and encouraged ongoing participation in SDM. Overall Yale Breast Cancer SDM Pilot Case Study Role-Play Assessments (Data reflect findings for 11 participants who completed their case role play) Citation Format: Elaine Rudell, Tarjani Agrawal, Patty Peterson, Michele Fallon Ingram, Brant Oliver, Kerin Adelson. Standard of Care for HR+/HER2- Breast Cancer: Integrating The “Yale Model Shared Decision-Making Multidisciplinary Team Solution” into the Practice Setting [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-05-15.

A 28-Day, Randomized, Controlled, Single-Blind, Phase 2 Study in Treatment-Resistant Major Depressive Disorder (TRD) Patients Receiving Intranasal Esketamine Comparing Addition of Almond Therapy TM with Treatment-as-Usual (TAU)

IntroductionTreatment Resistant Depression (TRD) occurs in up to 30% of patients with Major Depressive Disorder (MDD). New treatments are clearly needed and there is a burgeoning interest in novel agents including ketamine. While ketamine in various formulations has been demonstrated to have a robust antidepressant effect there is a lack of evidence-based psychotherapies specifically designed for combination use.ObjectivesWe hypothesize that the combination of “Almond TherapyTM” with intranasal ketamine will result in a statistically significantly better outcome as demonstrated by a greater reduction in MADRS scores and/or response rates and/or remission rates in TRD patients compared with those who receive esketamine plus TAU. Secondary outcome measures include PHQ-9, GAD-7, PCL-5, Asssessment of Quality of Life - 8D (AQOL-8D), and Rosenberg Self-Esteem Scale.MethodsWe have developed a research protocol combining a unique and specifically-designed, multi-modal psychotherapy program, “Almond TherapyTM”, with intranasal esketamine in a randomized, controlled, single-blind 28-day study. The therapy utilizes an individualized, evidence-informed approach for each participant consisting of a number of modules selected using a shared decision-making process determined at the first study visit. This uniquely tailored approach ensures that the chosen modules are personally meaningful to the participant, and thus, promotes therapeutic adherence. The proprietary therapy combines elements of cognitive behavioral therapy (CBT), trauma focused-CBT, Dialectical Behavioral Therapy (DBT), and mindfulness, together with biofeedback. In addition to in-clinic sessions, participants also receive standardized remote therapy sessions by trained therapists.ResultsPatient recruitment and enrolment has begun. Interim results are anticipated.ConclusionsThis study is the first examination of the potential additional clinical benefit of adding a specific therapy program to existing intranasal esketamine treatment. If demonstrated to be of clinical benefit then further studies may potentially provide comparison to other therapy programs and in conjunction with other agents.Disclosure of InterestP. Chue Shareolder of: Zylorion, P. Silverstone Shareolder of: Zylorion, Employee of: Zylorion, T. Hillier Shareolder of: Zylorion, Employee of: Zylorion, S. Rizvi: None Declared, S. Phillips Shareolder of: Zylorion, Employee of: Zylorion, L.-A. Langkaas Employee of: Zylorion, K. Davidson Employee of: Zylorion, M. Brown: None Declared, J. Chue: None Declared

Surgical Informed Consent: A Scoping Review of Physician-facing Decision Support Tools.

Physician-facing decision support tools facilitate shared decision-making (SDM) during informed consent, but it is unclear whether they are comprehensive in the domains they measure. In this scoping review, we aimed to (1) identify the physician-facing tools used during SDM; (2) assess the patient-centered domains measured by these tools; (3) determine whether tools are available for older adults and for use in various settings (elective vs. emergent); and (4) characterize domains future tools should measure. Using the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews, Embase, Medline, and Web of Science were queried for articles published between January 2000 and September 2022. Articles meeting inclusion criteria underwent title and abstract review. Eligible studies underwent data abstraction by two reviewers. Of 4365 articles identified, 160 were eligible. Tools to aid in surgical SDM focus on elective procedures (79%) and the outpatient setting (71%). Few tools are designed for older adults (5%) or for nonelective procedures (9%). Risk calculators were most common, followed by risk indices, prognostic nomograms, and communication tools. Of the domains measured, prognosis was more commonly measured (85%), followed by alternatives (28%), patient goals (36%), and expectations (46%). Most tools represented only one domain (prognosis, 33.1%) and only 6.7% represented all four domains. Tools to aid in the surgical SDM process measure short-term prognosis more often than patient-centered domains such as long-term prognosis, patient goals, and expectations. Further research should focus on communication tools, the needs of older patients, and use in diverse settings.

Gender-Affirmative Surgery: A Collaborative Approach between the Surgeon and Mental Health Professional.

Gender incongruence describes a condition in which an individual's gender identity does not align with their sex assigned at birth based on anatomic characteristics. Individuals with gender incongruence may request surgical interventions, and gender-affirmation surgery plays an important role for these individuals. The basis of care derives from principles elucidated in the Standards of Care, international guidelines that help inform clinical decision-making. Historically, mental health care professionals (MHCPs) and surgeons have worked collaboratively to select "appropriate" surgical candidates. However, as understanding of gender identity evolves, so does the relationship between the MHCP and the surgeon. The role of the MHCP has shifted from a requirement to verify an individual's identity to that of supporting and participating in a shared decision-making process between the individual and the health care team. This article discusses the evolution of the relationship between the MHCP and the surgeon and provides insight into the history of this relationship.

A federated approach to identify women with early-stage cervical cancer at low risk of lymph node metastases

ObjectiveLymph node metastases (pN+) in presumed early-stage cervical cancer negatively impact prognosis. Using federated learning, we aimed to develop a tool to identify a group of women at low risk of pN+, to guide the shared decision-making process concerning the extent of lymph node dissection. MethodsWomen with cervical cancer between 2005 and 2020 were identified retrospectively from population-based registries: the Danish Gynaecological Cancer Database, Swedish Quality Registry for Gynaecologic Cancer and Netherlands Cancer Registry. Inclusion criteria were: squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma; The International Federation of Gynecology and Obstetrics 2009 IA2, IB1 and IIA1; treatment with radical hysterectomy and pelvic lymph node assessment. We applied privacy-preserving federated logistic regression to identify risk factors of pN+. Significant factors were used to stratify the risk of pN+. ResultsWe included 3606 women (pN+ 11%). The most important risk factors of pN+ were lymphovascular space invasion (LVSI) (odds ratio [OR] 5.16, 95% confidence interval [CI], 4.59–5.79), tumour size 21–40 mm (OR 2.14, 95% CI, 1.89–2.43) and depth of invasion>10 mm (OR 1.81, 95% CI, 1.59–2.08). A group of 1469 women (41%)—with tumours without LVSI, tumour size ≤20 mm, and depth of invasion ≤10 mm—had a very low risk of pN+ (2.4%, 95% CI, 1.7–3.3%). ConclusionEarly-stage cervical cancer without LVSI, a tumour size ≤20 mm and depth of invasion ≤10 mm, confers a low risk of pN+. Based on an international privacy-preserving analysis, we developed a useful tool to guide the shared decision-making process regarding lymph node dissection.