Branda, Megan E.

AbstractIntroductionShared decision‐making (SDM) is a method of care by which patients and clinicians work together to co‐create a plan of care. Electronic health record (EHR) integration of SDM tools may increase adoption of SDM. We conducted a “lightweight” integration of a freely available electronic SDM tool, CV Prevention Choice, within the EHRs of three healthcare systems. Here, we report how the healthcare systems collaborated to achieve integration.MethodsThis work was conducted as part of a stepped wedge randomized pragmatic trial. CV Prevention Choice was developed using guidelines for HTML5‐based web applications. Healthcare systems integrated the tool in their EHR using documentation the study team developed and refined with lessons learned after each system integrated the electronic SDM tool into their EHR. CV Prevention Choice integration populates the tool with individual patient data locally without sending protected health information between the EHR and the web. Data abstraction and secure transfer systems were developed to manage data collection to assess tool implementation and effectiveness outcomes.ResultsTime to integrate CV Prevention Choice in the EHR was 12.1 weeks for the first system, 10.4 weeks for the second, and 9.7 weeks for the third. One system required two 1‐hour meetings with study team members and two healthcare systems required a single 1‐hour meeting. Healthcare system information technology teams collaborated by sharing information and offering improvements to documentation. Challenges included tracking CV Prevention Choice use for reporting and capture of combination medications. Data abstraction required refinements to address differences in how each healthcare system captured data elements.ConclusionTargeted documentation on tool features and resource mapping supported collaboration of IT teams across healthcare systems, enabling them to integrate a web‐based SDM tool with little additional research team effort or oversight. Their collaboration helped overcome difficulties integrating the web application and address challenges to data harmonization for trial outcome analyses.

Background The occurrence of shared decision making (SDM) in daily practice remains limited. Various patient characteristics have been suggested to potentially influence the extent to which clinicians involve patients in SDM. Objective To assess associations between patient characteristics and the extent to which clinicians involve patients in SDM. Methods We conducted a secondary analysis of data pooled from 10 studies comparing the care of adult patients with (intervention) or without (control) a within-encounter SDM conversation tool. We included studies with audio(-visual) recordings of clinical encounters in which decisions about starting or reconsidering treatment were discussed. Main Measures In the original studies, the Observing Patient Involvement in Decision Making 12-items (OPTION 12 item ) scale was used to code the extent to which clinicians involved patients in SDM in clinical encounters. We conducted multivariable analyses with patient characteristics (age, gender, race, education, marital status, number of daily medications, general health status, health literacy) as independent variables and OPTION 12 as a dependent variable. Results We included data from 1,614 patients. The between-arm difference in OPTION 12 scores was 7.7 of 100 points ( P < 0.001). We found no association between any patient characteristics and the OPTION 12 score except for education level ( p = 0.030), an association that was very small (2.8 points between the least and most educated), contributed mostly by, and only significant in, control arms (6.5 points). Subanalyses of a stroke prevention trial showed a positive association between age and OPTION 12 score ( P = 0.033). Conclusions Most characteristics showed no association with the extent to which clinicians involved patients in SDM. Without an SDM conversation tool, clinicians devoted more efforts to involve patients with higher education, a difference not observed when the tool was used. Highlights Most sociodemographic patient characteristics show no association with the extent to which clinicians involve patients in shared decision making. Clinicians devoted less effort to involve patients with lower education, a difference that was not observed when a shared decision-making conversation tool was used. SDM conversation tools can be useful for clinicians to better involve patients and ensure patients get involved equally regardless of educational background.

Objective To evaluate maternal risk factors associated with chronic villitis of unknown etiology (VUE) and to describe cooccurring placental pathologies. Study Design A retrospective case–control study was conducted using placental pathology records from deliveries ≥ 20 weeks between 2010 and 2018. Cases were placentas with documented chronic villitis without infectious cause, hereafter called VUE. Controls were placentas without this diagnosis, matched to the cases 2:1. Maternal and neonatal demographic and clinical data were collected. Descriptive statistics are reported with Fisher's exact test or a chi-squared test, as appropriate, and multivariable conditional logistic regression was conducted. Results Our study included 352 cases with VUE and 657 controls. A diagnosis of gestational diabetes (p = 0.03) and gestational hypertension (p = 0.06) was 1.5 times more likely to occur in those with a VUE diagnosis. A trend was also seen for chronic hypertension (odds ratio [OR] = 1.7, p = 0.07) and preeclampsia (OR = 1.5, p = 0.09) compared with controls. Placentas with VUE, specifically high-grade VUE, were more likely to be small for gestational age (p = 0.01), and to be diagnosed with other placental findings including lymphoplasmacytic or chronic deciduitis (p < 0.01), maternal (p < 0.01) and fetal vascular malperfusion (p = 0.02), and chorionitis (acute or chronic; p < 0.01). Conclusion Gestational diabetes and hypertension were associated with a diagnosis of VUE, and overall, VUE placentas have more abnormal placental findings compared with control. Understanding VUE risk factors may facilitate prenatal care strategies and counseling to achieve the best outcomes for pregnant patients and their neonates. Key Points

Congenital rubella syndrome is a constellation of birth defects that can have devastating consequences, impacting approximately 100,000 births worldwide each year. The incidence is much lower in countries that routinely vaccinate their population. In the US, postnatal immunization of susceptible women is an important epidemiological strategy for the prevention of rubella as the Center for Disease Control (CDC) does not recommend administering this vaccine during pregnancy due to its nature as a live attenuated virus vaccine. However, concerns that the co-administration of rubella vaccine with other immunoglobins (i.e., Rhogam) could compromise vaccine efficacy has produced warnings that can delay the administration of rubella vaccination postpartum, leaving women susceptible to the disease in subsequent pregnancies. We aimed to address whether the co-administration of the measles, mumps, and rubella (MMR) vaccine and Rhogam decreased antibody responses compared to those receiving only MMR vaccination. This retrospective cohort study utilized clinical data from 78 subjects who received the MMR vaccine and Rhogam after delivery and 45 subjects who received the MMR vaccine alone. Maternal demographics, pregnancy complications and rubella status at the start of a subsequent pregnancy were recorded for analysis. Overall, the two cohorts had similar baseline characteristics; however, lower parity was noted in the participants that received both MMR vaccination and Rhogam. Making assessments based on maternal antibody IgG index for rubella during the next pregnancy, we observed that 88% of the Rhogam + MMR vaccine group had positive serology scores, which was not significantly different from the 80% rate in the MMR-vaccine-only cohort (p = 0.2). In conclusion, no differences were observed in rubella immunity status in subsequent pregnancies in those mothers given both the MMR vaccine and Rhogam concurrently. Given these findings, warnings against co-administration of vaccines in combination with Rhogam appear unwarranted.

Background Previous studies have established that higher baseline quality of life (QOL) scores are associated with improved survival in patients with metastatic colorectal cancer (mCRC). We examined the relationship between overall survival (OS) and baseline QOL. Patients and Methods A total of 1 247 patients with mCRC participating in N9741 (comparing bolus 5-FU/LV, irinotecan [IFL] vs infusional 5-FU/leucovorin [LV]/oxaliplatin [FOLFOX] vs. irinotecan/oxaliplatin [IROX]) provided data at baseline on overall QOL using a single-item linear analogue self-assessment (LASA) 0–100 point scale. The association of OS according to clinically deficient (defined as CD-QOL, score 0–50) vs not clinically deficient (nCD-QOL, score 51–100) baseline QOL scores was tested. A multivariable analysis using Cox proportional hazards modeling was performed to adjust for the effects of multiple baseline factors. An exploratory analysis was performed evaluating OS according to baseline QOL status among patients who did or did not receive second-line therapy. Results Baseline QOL was a strong predictor of OS for the whole cohort (CD-QOL vs nCD-QOL: 11.2 months vs 18.4 months, P < .0001), and in each arm IFL 12.4 vs 15.1 months, FOLFOX 11.1 months vs 20.6 months, and IROX 8.9 months vs 18.1 months. Baseline QOL was associated with baseline performance status (PS) ( P < .0001). After adjusting for PS and treatment arm, baseline QOL was still associated with OS ( P = .017). Conclusions Baseline QOL is an independent prognostic factor for OS in patients with mCRC. The demonstration that patient-assessed QOL and PS are independent prognostic indicators suggests that these assessments provide important complementary prognostic information.

Introduction: Shared decision-making (SDM) about anticoagulant treatment in patients with atrial fibrillation (AF) is widely recommended but its effectiveness is unclear. We assessed the extent to which using an SDM tool promotes high-quality SDM. Hypothesis: SDM will improve communication quality, knowledge, and decisional conflict and will translate to improved medication adherence and outcomes. Methods: In this multicentre encounter-randomized trial, we included patients with nonvalvular AF considering starting/reviewing anticoagulation, and their clinicians. We compared usual care with or without ANTICOAGULATION CHOICE, an SDM conversation tool for use during the clinical encounter that presents individualized risk estimates and compares anticoagulation options across patient important issues. Results: We enrolled and video-recorded 922 patient-clinician encounters. So far, our data have shown that participants in both arms reported near-optimal communication quality, knowledge, and decisional conflict (JAMA IM-2020). Patients in intervention-arm estimated their stroke risks more accurately and were more involved in decision-making (JAMA IM-2020), clinicians were more satisfied (JAMA IM-2020), and cost conversation were more common (JAMA NO-2021). Use of the intervention had no effect on treatment decisions, encounter duration (JAMA IM-2020), treatment adherence, clinical outcomes (JAHA-epub) or patient-perceived sense of the care plan (PEC-epub). New analyses have shown that compared to eligible white participants, black participants more frequently did not enrol to the study. Enrolment of Black, indigenous, and people of colour benefited most form including and prioritizing practices most likely to care for them. We found no evidence of contamination (tool use, functional, or learned) between study arms. Conclusions: Use of an SDM tool improved some measures of SDM quality, without affecting treatment decisions and their sensibility, encounter duration, patient adherence, or clinical outcomes. Our results should calibrate expectations as to what could be accomplished by implementing SDM tools about anticoagulation in the care of patients with AF

AbstractObjectiveFetal surgery has improved neonatal outcomes; however, it is unknown if the intervention contributes to the developmental of inflammatory pathologies in the placenta. Here, an association between fetal surgery and placental pathology was examined.MethodThis case‐control study compared pregnancies with fetal surgery (n = 22), pregnancies with an indication for fetal surgery but without an intervention being done (n = 13), and gestational‐age and fetus‐number matched controls (n = 36). Data on maternal, infant, and placental outcomes were abstracted. Additionally, immunohistochemistry identified expression of lymphoid and myeloid cells in the placenta on a subset of cases. Comparisons were performed using Kruskal‐Wallis or Pearson's chi‐squared tests.ResultsMaternal characteristics were comparable between groups. Most fetal interventions were for diaphragmatic hernia, spina bifida, or twin‐to‐twin transfusion syndrome. Fetuses who were operated on before birth were more likely to be born preterm (p = 0.02). There was no increase in the rate of observed placental pathologies or immune cell infiltration in fetal surgery cases compared to controls.ConclusionThe data suggest that fetal surgery is not associated with increased inflammatory or morphologic pathology in the placenta. This observation supports the growing field of fetal surgery.

Objectives This study aimed to evaluate the prevalence of obstetric and gynecologic (Ob/Gyn) hospitalists and determine if an association exists between the presence of Ob/Gyn hospitalists and severe maternal morbidity (SMM). Methods This observational study included data from hospitals listed in the USA TODAY’s 2019 article titled, “Deadly deliveries: Childbirth complication rates at maternity hospitals.” Telephone and email surveys of staff in these hospitals identified the presence or absence of continuous providers in the hospital 24 hours, 7 days a week (24/7 coverage) and the types of providers who are employed, then compared these responses with the SMM cited by USA TODAY. Results Eight hundred ten hospitals were contacted, with participation from 614 labor and delivery units for a response rate of 75.8%. Fifty-seven percent of units were staffed with 24/7 coverage, with 46% of hospitals’ coverage primarily provided by an Ob/Gyn hospitalist and 54% primarily by a nonhospitalist OB/Gyn provider. The SMM and presence of 24/7 coverage increased with the level of neonatal care and delivery volume. Of hospitals with 24/7 coverage, those that primarily used Ob/Gyn hospitalists had a lower SMM for all mothers (1.7 versus 2.0, P = 0.014) and for low-income mothers (1.9 versus 2.30, P = 0.007) than those who primarily used nonhospitalist OB/Gyn providers. Conclusions Severe maternal morbidity increases with delivery volume, level of neonatal care, and 24/7 coverage. Of hospitals with 24/7 coverage, units that staff with Ob/Gyn hospitalists have lower levels of SMM than those that use nonhospitalist Ob/Gyn providers.

AbstractObjectiveTo evaluate the extent to which the canonical steps of shared decision making (SDM) take place in clinical encounters in practice and across SDM forms.MethodsWe assessed 100 randomly selected video‐recorded primary care encounters, obtained as part of a randomized trial of an SDM intervention in patients with type 2 diabetes. Two coders, working independently, noted each instance of SDM, classified it as one of four problem‐based forms to SDM (weighing alternatives, negotiating conflicting issues, solving problems, or developing existential insight), and noted the occurrence and timing of each of the four canonical SDM steps: fostering choice awareness, providing information, stating preferences, and deciding. Descriptive analyses sought to determine the relative frequency of these steps across each of the four SDM forms within each encounter.ResultsThere were 485 SDM steps noted (mean 4.85 steps per encounter), of which providing information and stating preferences were the most common. There were 2.7 (38 steps in 14 encounters) steps per encounter observed in encounters with no discernible SDM form, 3.4 (105 steps in 31 encounters) with one SDM form, 5.2 (129 steps in 25 encounters) with two SDM forms, and 7.1 (213 steps in 30 encounters) when ≥3 SDM forms were observed within the encounter. The prescribed order of the four SDM steps was observed in, at best, 16 of the 100 encounters. Stating preferences was a common step when weighing alternatives (38%) or negotiating conflicts (59.3%) but less common when solving problems (29.2%). The distribution of SDM steps was similar to usual care with or without the SDM intervention.ConclusionThe normative steps of SDM are infrequently observed in their prescribed order regardless of whether an SDM intervention was used. Some steps are more likely in some SDM forms but no pattern of steps appears to distinguish among SDM forms.Clinical Trial RegistrationClinicalTrial.gov: NCT01293578.

INTRODUCTION: While focal-occult placenta accreta spectrum (PAS) is known to lead to adverse outcomes, little is known of the morbidity in comparison to previa-associated PAS. METHODS: After IRB approval, retrospective review was conducted of pathologically confirmed (decidual layer absence or basal-plate myometrial fibers) PAS from 2018 to 2021 at a tertiary care center. Baseline characteristics and surgical, obstetric, and subsequent pregnancy outcomes were recorded. Focal-occult PAS was compared with previa-associated PAS using Kruskal-Wallis/Chi-square tests; P<.05 was considered significant. RESULTS: A total of 56 cases were identified: 22 previa-associated and 34 focal-occult PAS. All patients with previa-associated and 26.5% of those with focal-occult PAS underwent hysterectomy. Of the previa-associated PAS patients, 20 of 22 were diagnosed antenatally, as was 1 of 34 focal-occult PAS patients. Mean maternal age (32.5 vs. 33.1 year), number of previous dilation and curettage procedures (0.4 vs. 0.3), and in vitro fertilization rates (4.5% vs. 23.5%) were not significantly different between groups. Mean parity (3.7 vs. 1.4), gestational age at delivery (34.3 vs. 35.7 weeks), any previous cesarean delivery (95.5% vs. 29.4%), mean number of previous cesareans (2.5 vs. 0.5), and placental locations were significantly different between groups. All measures of morbidity, including postpartum hemorrhage rates (81.0% vs. 75.8%), median qualitative blood loss (1,500cc, range: 500–9,516cc vs. 1,660cc, range: 350–12,220cc), mean units of red blood cells transfused (1.8 vs. 1.9), massive transfusion (9.1% vs. 20.6%), ICU admission (9.1% vs. 14.7%), and reoperation rates (9.1% vs. 32.4%) were similar between groups. Six focal-occult PAS patients had a subsequent pregnancy, and two had recurrent PAS. CONCLUSION: Despite representing lower grade PAS, focal-occult PAS has similar measures of morbidity when compared to previa-associated PAS, potentially attributable to lack of antenatal detection.