Branda, Megan E.

Background: Ovarian cancer has the highest mortality of all gynecologic malignancies, howeverthere is no proven effective screening for ovarian cancer. Evidence suggests that epithelial ovarian cancer begins in the fallopian tubes. Prophylactic bilateral total salpingectomy has been shown to reduce the risk of epithelial ovarian cancer and is now recommended to be considered at the time of sterilization procedures. There are limited well designed clinical trials that compare the safety and feasibility of total salpingectomy to that of traditional partial salpingectomy for tubal sterilization in obstetrics. We thus conducted a randomized controlled trial to assess the safety of bilateral total salpingectomy at the time of cesarean delivery. Methods: We conducted a non-inferiority randomized controlled trial at the Mayo Clinic, Rochester, Minnesota. Women age 21 years and older who were undergoing cesarean delivery and desired concomitant sterilization were enrolled between May 17, 2017 and July 16, 2018. Stratified randomization was performed based on number of previous cesarean deliveries and their Basal Metabolic Index, into a bilateral total salpingectomy (BTS) group and bilateral partial salpingectomy (BPS) group. All salpingectomies were performed using clamps and suture. The primary outcome was to compare the mean peri-operative hemoglobin change for both groups. Secondary objectives included sterilization completion time, postoperative length of stay, estimated blood loss, postoperative pain and adverse events. Results: Of the 111 women screened, 40 were enrolled and randomized. Of these, 38 underwent the assigned procedure (18 BTS, 20 BPS). No difference in Mean ± SD hemoglobin drop between groups (1.4 ± 0.7 g/dL for the BPS group and 1.8 ± 1.0 g/dL for the BTS group, p = 0.08), however the point estimate of –0.4 is very close to the non-inferiority margin of –0.5, and the CI widely exceeds the non-inferiority margin (95% CI –0.99, 0.17). Therefore non-inferiority was not shown. Mean time to completion of sterilization procedure was significantly longer in the BTS group (16.3 ± 5.6 minutes for the BTS group vs 5.1 ± 1.6 minutes for the BPS group, p < 0.01). No significant differences for other outcome measures. Conclusions: Bilateral total salpingectomy is not non-inferior to tradiational bilateral partial salpingectomy with regards to postoperative hemoglobin drop, and is associated with a small increase in operative time. There, however, was no difference in adverse events, postoperative length of stay and postoperative pain between the two groups. This information may be helpful when counseling patients.

Background: Although percutaneous coronary intervention (PCI) has not been shown to reduce the risk of death and myocardial infarction (MI) for stable coronary artery disease (CAD), many patients believe that PCI is a life-saving procedure. PCI for stable CAD is known to improve patients’ quality of life more rapidly than medications alone. We conducted a randomized trial to assess the impact of a decision aid (DA) compared to usual care (UC) for the treatment of stable CAD when there is a choice between PCI and optimal medical therapy (OMT). Methods: The PCI Choice trial was a prospective, randomized trial comparing the effects of DA versus UC. The DA was designed with a user-centered approach for an in-visit consultation, involving patients and clinicians throughout the development process. The final DA included information on myocardial infarction (MI), death and quality of life outcomes for PCI with OMT vs. OMT alone in the treatment of stable angina, stratified by angina type. Risks of procedure, bleeding, stent thrombosis, and need for future procedures were also depicted. The primary outcome was patient knowledge, measured by pre- and post-visit surveys. Additional outcomes included decisional conflict, patient satisfaction, preferred decision making style, and treatment decision. Results: A total of 110 patients were enrolled; mean age was 68.3 years and 26% of patients were women. At baseline, most patients had CCS Class I/II angina and were on a mean of two anti-anginal medications (2.3, SD 1.2). Knowledge increased among patients receiving DA compared to UC (63% vs. 44% p=0.0003). Specific knowledge about the impact of PCI for stable angina on death and MI was higher in both groups compared to prior studies (54% DA, 46% UC, p=0.45; 12% prior). Patient satisfaction was significantly higher in the DA group vs. UC (72% vs 40%, p=0.004). Decisional conflict was greater than in non-procedural DA trials, and was not different between the two arms (p=.43). Following exposure to DA, patients’ preference for sharing decision making tended to change more with DA (55% to 65%) than with UC (56% to 59%). While the proportion of patients choosing PCI over OMT was nearly half in both groups, there were fewer patients that remained undecided with DA (18% vs. 4%; p=0.14 overall difference). Conclusions: Exposure to a DA for the choice of PCI vs. optimal medical therapy in stable CAD improved patient knowledge and satisfaction and decreased uncertainty, without reducing the rate of PCI. Use of the DA in a larger patient population may further delineate impact on outcomes such as treatment choice, geographic variation and cost.

Abstract Background: Trial recruitment of Black, indigenous, and people of color (BIPOC) is key for interventions that interact with socioeconomic factors and cultural norms, preferences, and values. We report on our experience enrolling BIPOC participants into a multicenter trial of a shared decision-making intervention about anticoagulation to prevent strokes, in patients with atrial fibrillation (AF). Methods: We enrolled patients with AF and their clinicians in 5 healthcare systems (three academic medical centers, an urban/suburban community medical center, and a safety-net inner-city medical center) located in three states (Minnesota, Alabama, and Mississippi) in the United States. Clinical encounters were randomized to usual care with or without a shared decision-making tool about anticoagulation. Analysis: We analyzed BIPOC patient enrollment by site, categorized reasons for non-enrollment, and examined how enrollment of BIPOC patients was promoted across sites.Results: Of 2247 patients assessed, 922 were enrolled of which 147 (16%) were BIPOC patients. In comparison to trial-eligible White participants, eligible Black participants more frequently did not enroll (102 (11%) vs. 185 (15%); p <.001). The rate of BIPOC patients enrollment varied substantially by site and was generally reflective of the population served at each participating site. Enrollment of BIPOC patients benefited most from including and prioritizing practices most likely to care for BIPOC patients, with lower yield from specific efforts to reach BIPOC clinic attendees and enrolling BIPOC patients first when possible. Conclusions: Enrollment from practices that have implemented policies that favor the care of BIPOC patients can contribute to generate trustworthy estimates of the effect of these interventions in clinical practice that are applicable to BIPOC populations. Best practices to optimize the enrollment of BIPOC participants into trials that examined complex and culturally sensitive interventions remain to be developed.Clinical trial registration: ClinicalTrials.gov (NCT02905032)

Background Guidelines promote shared decision‐making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within‐encounter SDM tool to usual care (UC) increases patient involvement in decision‐making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results We conducted a multicenter, encounter‐level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow‐up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: clinicaltrials.gov. Identifier: NCT02905032.

Shared decision making (SDM) has been advocated to improve patient care, patient decision acceptance, patient-provider communication, patient motivation, adherence, and patient reported outcomes. Documentation of SDM is endorsed in several society guidelines and is a condition of reimbursement for selected cardiovascular and cardiac arrhythmia procedures. However, many clinicians argue that SDM already occurs with clinical encounter discussions or the process of obtaining informed consent and note the additional imposed workload of using and documenting decision aids without validated tools or evidence that they improve clinical outcomes. In reality, SDM is a process and can be done without decision tools, although the process may be variable. Also, SDM advocates counter that the low-risk process of SDM need not be held to the high bar of demonstrating clinical benefit and that increasing the quality of decision making should be sufficient. Our review leverages a multidisciplinary group of experts in cardiology, cardiac electrophysiology, epidemiology, and SDM, as well as a patient advocate. Our goal is to examine and assess SDM methodology, tools, and available evidence on outcomes in patients with heart rhythm disorders to help determine the value of SDM, assess its possible impact on electrophysiological procedures and cardiac arrhythmia management, better inform regulatory requirements, and identify gaps in knowledge and future needs.

Abstract Background Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation (AF). We recently showed that adding a within-encounter SDM tool to usual care (UC) increases patient involvement in decision making and clinician satisfaction, without affecting encounter length. Purpose We aimed to estimate the extent to which use of an SDM tool affected patient adherence to the decided care plan and clinical safety endpoints. Methods We conducted a multi-center, encounter-level randomized trial assessing the efficacy of UC with vs. without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice, AC) in patients with non-valvular AF considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months post-enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled [PDC] for DOAC, and as time in therapeutic range (TTR) for warfarin). We also followed for any safety outcomes (stroke [stroke or transient ischemic attack], major bleeding, or death). Results We enrolled 922 evaluable patient encounters (AC=463, UC=459), of which 814 (88%) had pharmacy and clinical follow-up. We found no differences between arms in either primary (78% of patients in AC filled their first prescription vs. 81% in UC) or secondary adherence to anticoagulation (see Figure, PDCDOAC was 74.1% in AC vs. 71.6% in UC; TTRwarfarin was 66.6% in AC vs. 64.4% in UC). PDCDOAC was better (65%) in AC than in UC (55%) (OR 1.49, CIs 1.00, 2.22). Safety outcomes, mostly bleeds, occurred in 13% (AC) of and 14% (UC) of participants. Conclusions This is the largest reported randomized trial in AF comparing usual care with and without an SDM tool to promote SDM. Although patients were more actively involved in SDM, we found no significant differences between arms in primary or secondary adherence to anticoagulation or clinical safety outcomes. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): The trial was funded by and conducted independently of the National Heart, Lung, and Blood Institute (NHLBI) of the U.S. National Institutes of Health (RO1 HL131535-01). The funding body had no influence on the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Figure 1

Objectives: Patient involvement in the choice of whether to undergo emergency department observation unit (EDOU) admission and cardiac stress testing or follow-up with a physician could increase knowledge, increase satisfaction, and safely decrease resource use. We test this hypothesis in a randomized trial. Methods: We developed and tested Chest Pain Choice, a decision aid that communicates the pre-test probability of an acute coronary syndrome (ACS) within 45 days and makes management options (EDOU admission and stress testing or 24-72 hr follow-up with a physician) explicit to the patient. Patients with a primary complaint of chest pain and no known coronary artery disease who were being considered for EDOU admission were eligible. Patient-clinician pairs were randomized to intervention (decision aid plus risk estimate) or usual care (no decision aid, no risk estimate). We used patient surveys and 30-day phone follow-up to assess the primary outcome (patient knowledge regarding their short-term risk for ACS), patient satisfaction, safety (delayed or missed ACS defined as acute myocardial infarction, ventricular arrhythmia, cardiogenic shock, or cardiac/unknown death), and resource use. Analysis was by intention to treat. Results: The 205 patients had the following characteristics: mean age (SD) 54.7 (11.8), 59% female, 36% history of HTN and 10% history of diabetes. Compared with usual care patients (n=104), patients receiving the decision aid (n=101) less frequently decided to be admitted to the EDOU for cardiac stress testing (58% vs 77%, absolute difference = 19%, 95% CI 6, 31), had a lower rate of stress testing (74% vs 90%, absolute difference = 16%, 95% CI 6, 26), greater knowledge of their exact pre-test probability of ACS (25% vs 1%, absolute difference = 24%, 95% CI 15, 33) and reported greater satisfaction with the decision-making process (strongly agree: 61% vs 40%, absolute difference = 21%, 95% CI 7, 33). There were no cases of delayed or missed ACS in either arm. Conclusion: Use of a decision aid in ED chest pain patients increased knowledge, increased satisfaction, and safely decreased resource use. In an era of health care reform, shared decision-making is a promising approach that may both increase patient engagement and decrease resource use.Funding(This research has received full or partial funding support from the American Heart Association, National Center)

Background: Shared decision-making with decision aids (DA) improves patient knowledge and reduces decisional conflict. The extent to which they do so across sociodemographic subgroups remains unknown. Methods: An encounter-level meta-analysis of five DA randomized trials examined the impact of sociodemographic variables on knowledge transfer and decisional conflict using a generalized linear model stratified by study and adjusted by treatment arm. Results: We analyzed 595 patient-clinician encounters. Significantly higher knowledge transfer with DA occurred in nearly all patient subgroups when compared to usual care (UC). Patients with more formal education tended to have greater knowledge transfer with UC; this was diminished with DA. There was a trend towards improved decisional conflict in all subgroups with the use of DA; overall decisional conflict was low. (see Table) Conclusion: The use of DA compared to UC significantly increases knowledge transfer across diverse subgroups and there is a tendency towards reduced decisional conflict. Differences at baseline, such as knowledge transfer across educational strata, may be mitigated with use of DA. In conclusion, DA are found to be effective across patient subgroups and may represent a novel strategy to lessen disparities.