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BackgroundEliciting patient concerns and listening carefully to them contributes to patient-centered care. Yet, clinicians often fail to elicit the patient’s agenda and, when they do, they interrupt the patient’s discourse.ObjectiveWe aimed to describe the extent to which patients’ concerns are elicited across different clinical settings and how shared decision-making tools impact agenda elicitation.Design and ParticipantsWe performed a secondary analysis of a random sample of 112 clinical encounters recorded during trials testing the efficacy of shared decision-making tools.Main MeasuresTwo reviewers, working independently, characterized the elicitation of the patient agenda and the time to interruption or to complete statement; we analyzed the distribution of agenda elicitation according to setting and use of shared decision-making tools.Key ResultsClinicians elicited the patient’s agenda in 40 of 112 (36%) encounters. Agendas were elicited more often in primary care (30/61 encounters, 49%) than in specialty care (10/51 encounters, 20%); p = .058. Shared decision-making tools did not affect the likelihood of eliciting the patient’s agenda (34 vs. 37% in encounters with and without these tools; p = .09). In 27 of the 40 (67%) encounters in which clinicians elicited patient concerns, the clinician interrupted the patient after a median of 11 seconds (interquartile range 7–22; range 3 to 234 s). Uninterrupted patients took a median of 6 s (interquartile range 3–19; range 2 to 108 s) to state their concern.ConclusionsClinicians seldom elicit the patient’s agenda; when they do, they interrupt patients sooner than previously reported. Physicians in specialty care elicited the patient’s agenda less often compared to physicians in primary care. Failure to elicit the patient’s agenda reduces the chance that clinicians will orient the priorities of a clinical encounter toward specific aspects that matter to each patient.

Osteoporosis Choice, an encounter decision aid, can engage patients and clinicians in shared decision making about osteoporosis treatment. Its effectiveness compared to the routine provision to clinicians of the patient's estimated risk of fracture using the FRAX calculator is unknown. Patient-level, randomized, three-arm trial enrolling women over 50 with osteopenia or osteoporosis eligible for treatment with bisphosphonates, where the use of Osteoporosis Choice was compared to FRAX only and to usual care to determine impact on patient knowledge, decisional conflict, involvement in the decision-making process, decision to start and adherence to bisphosphonates. We enrolled 79 women in the three arms. Because FRAX estimation alone and usual care produced similar results, we grouped them for analysis. Compared to these, use of Osteoporosis Choice increased patient knowledge (median score 6 vs. 4, p = .01), improved understanding of fracture risk and risk reduction with bisphosphonates (p = .01 and p<.0001, respectively), had no effect on decision conflict, and increased patient engagement in the decision making process (OPTION scores 57% vs. 43%, p = .001). Encounters with the decision aid were 0.8 minutes longer (range: 33 minutes shorter to 3.0 minutes longer). There were twice as many patients receiving and filling prescriptions in the decision aid arm (83% vs. 40%, p = .07); medication adherence at 6 months was no different across arms. Supporting both patients and clinicians during the clinical encounter with the Osteoporosis Choice decision aid efficiently improves treatment decision making when compared to usual care with or without clinical decision support with FRAX results. clinical trials.gov NCT00949611.

Abstract BACKGROUND Late adverse radiation effects (ARE) typically occur many years after stereotactic radiosurgery (SRS) of intracranial arteriovenous malformations (AVM). They are characterized by perilesional edema or cyst formation and are distinct from radiation-induced changes (RIC) noted in the first 1 to 2 years after AVM SRS and radiation necrosis. OBJECTIVE To determine the incidence of late ARE after AVM SRS. METHODS Retrospective review of 233 AVM patients having SRS from 1990 to 2009. Patients had sporadic AVM, no prior radiation, and a minimum of 5 years of magnetic resonance imaging (MRI) follow-up. The median MRI follow-up after SRS was 9.8 years (range, 5-24.2). RESULTS Late ARE were observed in 16 patients (6.9%) at a median of 8.7 years after SRS (range, 2.0-16.1). The 5-, 10-, and 15-year incidence of late ARE was 0.4%, 7.7%, and 12.5%, respectively. Eight patients (3.4%) were symptomatic at the time of ARE detection. Three of 8 patients who were initially asymptomatic had documented cyst progression (at 11, 40, and 42 months), for an overall symptomatic rate of 4.7%. Five patients with asymptomatic ARE have been observed for a median of 9.3 years (range, 2.0-14.1) without progression. Patients having early RIC (hazard ratio [HR] = 2.11, P < .001), patients having obliteration (HR = 1.24, P = .02), and patients having SRS before April 1997 (HR = 1.12, P = .02) were more likely to develop late ARE. CONCLUSION Late ARE are common in AVM patients who develop early RIC after SRS. Resection of the thrombosed AVM and the adjacent damaged tissue is effective at eliminating the mass effect and improving patients’ neurological condition.

Background Patients living with diabetes and chronic conditions may face a significant burden managing their health. Many of these patients use digital medicine tools such as continuous glucose monitoring systems. Although measures exist to assess treatment burden from tasks such as managing medications and attending healthcare visits, there is no patient-reported measure that captures the burden of digital care. Therefore, the purpose of this study is to validate the Treatment Burden Questionnaire Plus Digital (TBQ + D), a patient-reported measure of treatment burden that includes using digital tools for adults with diabetes. Methods Adult patients with type 1 or type 2 diabetes mellitus completed the 25-item TBQ + D (scored 0 [none] to 10 [maximum] per item, total score range 0–250). We evaluated ease of administration, internal consistency, and tested hypotheses about the relationship between TBQ + D scores and treatment complexity, digital tool use intensity, social risk factors, and digital comfort to assess TBQ + D’s validity. Results Of 324 patients approached, 300 (93%) consented and completed the TBQ + D (mean age 57 [ SD 17], 50% female, 50% with type 2). The mean TBQ + D score was 53.7 ( SD 41.6). Internal consistency was excellent (Cronbach’s α  = 0.94). As hypothesized, higher TBQ + D scores were reported by patients with type 1 vs. type 2 diabetes mellitus (61.7 vs. 45.7, p  = .0008), maximal/moderate vs. minimal to no digital tool use (56.5/60.7 vs. 41.3, p  = .001), those on intensive insulin therapy vs. other treatments (61.4 vs. 38.0, p  < .0001), and those with greater social vulnerability ( p  < .0106). TBQ + D scores were not significantly higher in patients with HbA1c ≥ 8% ( p  = .055) or less comfortable with digital technology ( p  = .08). Conclusions TBQ + D is a novel and valid measure of treatment burden in patients living with diabetes, inclusive of digital burden, which can play a role in fostering minimally disruptive care for patients with diabetes.

Background The aim of this study was to assess the correlation between obstetric co-morbidity index (OBCMI) and severe maternal morbidity (SMM) in antepartum obstetrics transfers. By utilizing a population of transfers to a level IV maternal care facility, we hope to demonstrate validity for the use of OBCMI in the triage of transfer to provide risk-appropriate maternal care. Methods Antepartum obstetrics transfers to a single level IV maternal care facility from 1/1/2016 to 12/31/2020 that resulted in delivery during the same encounter were included in this retrospective study. The components of the OBCMI score were retrospectively collected by manual chart review of transfer and admission notes in the electronic medical record (EMR). SMM was determined via ICD-10 and CPT code extraction from time of transfer through six weeks postpartum and confirmed by the same reviewer. Mode of delivery, length of stay, ICU admission, readmission and reoperation were obtained via institutional databases and manual EMR review. Results Among 561 transfers meeting the inclusion criteria, the median OBCMI was significantly higher for transfers with a maternal-only indication ( n  = 232) compared to fetal-only( n  = 282) (median [IQR], 6 [4–8], 5 [4–6], and 1 [0–2] for maternal-only, maternal–fetal combined ( n  = 47), and fetal-only; p  < 0.001). The prevalence of SMM was 16.8% (39/232), 27.7% (13/47), 2.1% (6/282), p  < 0.0001 for those transferred for maternal, fetal and maternal, and fetal only indications respectively. The median (IQR) OBCMI score was 5 (4–8) and 3 (1–5) for those with versus without SMM. A cut-off OBCMI score of ≥ 4 was identified with 81% sensitivity (95% CI 68.6–90.1%) in predicting SMM ( P  = < .0001) and was noted to be significantly associated with operative delivery, blood transfusion, ICU admission, prolonged hospitalization, and reoperation. Using a cut-off OBCMI score of ≥ 4 on the population transferred for maternal and maternal–fetal combined indications only (279) yielded a specificity of 90.4% and sensitivity of 23.8% ( p  = 0.024). Conclusion OBCMI was demonstrated to discriminate for SMM in a population of obstetrics transfers to a Level IV maternal care facility. When stratifying for maternal indicated transfers, the ability of OBCMI as a predictive tool decreased. The obtained cutoff OBCMI value of ≥ 4 had high specificity but may miss a significant population that would benefit from transfer. Use of the OBCMI may be too crude of a measure to provide a comprehensive risk assessment to predict SMM and adverse obstetrics outcomes. Further studies that may include newer tools such as machine learning may be necessary to develop a more clinically useful tool.

To estimate the level of contamination in an encounter-randomized trial evaluating a shared decision-making (SDM) tool. We assessed contamination at three levels: (1) tool contamination (whether the tool was physically present in the usual care encounter), (2) functional contamination (whether components of the SDM tool were recreated in the usual care encounters without directly accessing the tool), and (3) learned contamination (whether clinicians “got better at SDM” in the usual care encounters as assessed by the OPTION-12 score). For functional and learned contamination, the interaction with the number of exposures to the tool was assessed. We recorded and analyzed 830 of 922 randomized encounters. Of the 411 recorded encounters randomized to usual care, the SDM tool was used in nine (2.2%) encounters. Clinicians discussed at least one patient-important issue in 377 usual care encounters (92%) and the risk of stroke in 214 encounters (52%). We found no significant interaction between number of times the SDM tool was used and subsequent functional or learned contamination. Despite randomly assigning clinicians to use an SDM tool in some and not other encounters, we found no evidence of contamination in usual care encounters.

Objective To evaluate the extent to which the canonical steps of shared decision making (SDM) take place in clinical encounters in practice and across SDM forms. Methods We 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. Results There 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. Conclusion The 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 Registration ClinicalTrial.gov: NCT01293578.

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.

Background Nonvalvular atrial fibrillation (AF) is a common ongoing health problem that places patients at risk of stroke. Whether and how a patient addresses this risk depends on each patient’s goals, context, and values. Consequently, leading cardiovascular societies recommend using shared decision making (SDM) to individualize antithrombotic treatment in patients with AF. The aim of this study is to assess the extent to which the Anticoagulation Choice conversation tool promotes high-quality SDM and influences anticoagulation uptake and adherence in patients with AF at risk of strokes. Methods This study protocol describes a multicenter, encounter-level, randomized trial to assess the effect of using the Anticoagulation Choice conversation tool in the clinical encounter, compared to usual care. The participating centers include an academic hospital system, a suburban community group practice, and an urban safety net hospital, all in Minnesota, USA. Patients with ongoing nonvalvular AF at risk of strokes (CHA 2 DS 2 -VASc score ≥ 1 in men, or ≥ 2 in women) will be eligible for participation. We aim to include 999 patients and their clinicians. The primary outcome is the quality of SDM as perceived by participants, and as assessed by a post-encounter survey that ascertains (a) knowledge transfer, (b) concordance of the decision made, (c) quality of communication, and (d) satisfaction with the decision-making process. Recordings of encounters will be reviewed to assess the extent of patient involvement and how participants use the tool (fidelity). Anticoagulant use, choice of agent, and adherence will be drawn from patients’ medical and pharmacy records. Strokes and bleeding events will be drawn from patient records. Discussion This study will provide a valid and precise measure of the effect of the Anticoagulation Choice conversation tool on SDM quality and processes, and on the treatment choices and adherence to therapy among AF patients at risk of stroke. Trial registration ClinicalTrials.gov, NCT02905032 . Registered on 9 September 2016.