Outcomes of Warfarin Home INR Monitoring vs Office-Based Monitoring: a Retrospective Claims-Based Analysis.

BACKGROUND: Home INR testing (patient self-testing) is feasible and effective for warfarin patients but little is known about real-world differences in outcomes for patients using PST versus laboratory-based INR monitoring. OBJECTIVE: To compare the safety/efficacy of patient self-testing of real-world warfarin therapy versus office/lab-based monitoring of therapy. DESIGN/SETTING/PARTICIPANTS/EXPOSURE: A retrospective claims-based analysis of warfarin patients enrolled in the MarketScan® Commercial Claims and Encounters and Medicare databases between January 1, 2013, and March 30, 2020. Stratification was based on INR testing method: patient self-testing versus testing at physicians' offices/local laboratory. The probability of adverse events in each cohort was determined after adjusting for demographic and baseline clinical characteristics using a repeated measures analysis. MAIN MEASURES: Rates of all adverse events: deep venous thrombosis, pulmonary embolism, bleeding, and stroke. A secondary outcome of interest was emergency department visits. KEY RESULTS: A total of 37,837 patients were included in the analysis: 1592 patients in the patient self-testing group and 36,245 in the office-based therapy group. After adjusting for demographic and baseline clinical characteristics, patients in the office-based group had statistically significantly higher rates of all adverse events (incidence rate ratio [IRR]=2.07, 95% CI [1.82, 2.36]), and specific adverse events including thromboembolism (IRR=4.38, 95% CI [3.29, 5.84]), major bleed (IRR=1.45, 95% CI [1.28, 1.64]), and stroke (IRR=1.30, 95% CI [1.05, 1.61]) than patients in the patient self-testing group. Office-based patients also had a statistically significant higher rate of emergency department visits than patient self-testing patients (IRR = 1.65, 95% CI [1.47, 1.84]). CONCLUSIONS/RELEVANCE: This analysis of real-world claims data shows lower rates of stroke, thromboembolism, and major bleeding, as well as fewer emergency department visits, with patient self-testing compared to office-based/lab INR monitoring. Our finding that PST is safe and effective among current users suggests that more patients may benefit from its use.

Virtual Education for Patient Self-Testing for Warfarin Therapy Is Effective During the COVID-19 Pandemic.

BACKGROUND: Prior to the COVID-19 pandemic, warfarin users were required to complete in-person training in order to participate in approved international normalized ratio (INR) patient self-testing (PST) programs. To minimize in-person contact during the pandemic, a federal waiver of the in-person training requirement allowed new patients to begin PST after completing virtual training. However, it was uncertain whether such patients achieved comparable levels of INR control to patients receiving in-person training. METHODS: INR results for patients receiving virtual training upon PST commencement between April 1, 2020, and December 31, 2020, were compared to those of patients initiating PST with in-person training between April 1, 2019, and December 31, 2019. The primary outcome was the difference in warfarin time in therapeutic range (TTR) between the groups, with secondary outcomes including differences in the percentages of INR values within individually prescribed INR range and of critical INR values. RESULTS: The records of 33,683 patients were included in the analysis (13,568 in the "In-Person" sample; 20,115 in the "Virtual" sample). Patients in the Virtual sample achieved a TTR of 66.78%, compared to the In-Person sample (64.19%; absolute difference 2.59; 95% confidence interval [CI] = 2.50-2.68, p < 0.001). The TTR values were also statistically significantly higher in all subgroups evaluated across categories of patient age, gender, geography, and indication. Similarly favorable results were achieved for INR values in range and critical values. CONCLUSION: Virtual education for PST for warfarin therapy is effective and should continue to be an option for patients and providers throughout the pandemic, and possibly beyond.

Creatinine Versus Cystatin C: Differing Estimates of Renal Function in Hospitalized Veterans Receiving Anticoagulants.

BACKGROUND: Current practice in anticoagulation dosing relies on kidney function estimated by serum creatinine using the Cockcroft-Gault equation. However, creatinine can be unreliable in patients with low or high muscle mass. Cystatin C provides an alternative estimation of glomerular filtration rate (eGFR) that is independent of muscle. OBJECTIVE: We compared cystatin C-based eGFR (eGFRcys) with multiple creatinine-based estimates of kidney function in hospitalized patients receiving anticoagulants, to assess for discordant results that could impact medication dosing. DESIGN: Retrospective chart review of hospitalized patients over 1 year who received non-vitamin K antagonist anticoagulation, and who had same-day measurements of cystatin C and creatinine. PARTICIPANTS: Seventy-five inpatient veterans (median age 68) at the San Francisco VA Medical Center (SFVAMC). MAIN MEASURES: We compared the median difference between eGFR by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) study equation using cystatin C (eGFRcys) and eGFRs using three creatinine-based equations: CKD-EPI (eGFREPI), Modified Diet in Renal Disease (eGFRMDRD), and Cockcroft-Gault (eGFRCG). We categorized patients into standard KDIGO kidney stages and into drug-dosing categories based on each creatinine equation and calculated proportions of patients reclassified across these categories based on cystatin C. KEY RESULTS: Cystatin C predicted overall lower eGFR compared to creatinine-based equations, with a median difference of - 7.1 (IQR - 17.2, 2.6) mL/min/1.73 m2 versus eGFREPI, - 21.2 (IQR - 43.7, - 8.1) mL/min/1.73 m2 versus eGFRMDRD, and - 25.9 (IQR - 46.8, - 8.7) mL/min/1.73 m2 versus eGFRCG. Thirty-one to 52% of patients were reclassified into lower drug-dosing categories using cystatin C compared to creatinine-based estimates. CONCLUSIONS: We found substantial discordance in eGFR comparing cystatin C with creatinine in this group of anticoagulated inpatients. Our sample size was limited and included few women. Further investigation is needed to confirm these findings and evaluate implications for bleeding and other clinical outcomes. NIH TRIAL REGISTRY NUMBER: Not applicable.

Supporting teams to optimize function and independence in Veterans: a multi-study program and mixed methods protocol.

BACKGROUND: Successful implementation of new clinical programs depends on effectively establishing, reorganizing, or enhancing team structures and processes to coordinate the work of individuals who are interdependent in their tasks, manage relationships, and share responsibility for outcomes. However, a one-size-fits-all approach is rarely effective. In partnership with VA national clinical leaders and local clinical champions, the Optimizing Function and Independence VA Quality Enhancement Research Initiative program (Function QUERI) will evaluate efforts to implement team-based clinical programs for Veterans at risk for functional decline and disability. METHODS: Function QUERI will implement and evaluate three innovative, evidence-based clinical programs in VA medical centers: (1) a group physical therapy program for knee osteoarthritis (Group PT); (2) assisted early mobility for hospitalized older veterans (STRIDE), a supervised walking program for hospitalized older veterans; and (3) implementation of helping invested family members improve veteran experiences study (iHI-FIVES), a skills training program for caregivers of disabled Veterans. A common reason for clinical care gaps in these populations is poor communication and coordination among the many interdisciplinary providers involved in their care. To facilitate the implementation of the clinical programs, Function QUERI will evaluate the impact of complexity science-based implementation intervention to promote team readiness (CONNECT), an implementation intervention designed as a bundle of interaction-oriented activities to promote team function and readiness for change, on the implementation of clinical programs across multiple sites. The evaluation will use a mixed methods design. Group PT is a local, single-site quality improvement project where a modified CONNECT intervention will be tested to inform the remaining program implementation projects. For STRIDE and iHI-FIVES projects, we will randomize participating sites to implement the clinical program, with the CONNECT intervention or not, and will use a stepped-wedge cluster randomized trial design. DISCUSSION: Function QUERI will translate its findings across its projects to identify the contextual factors and components from CONNECT that improve team processes and function to optimize effective implementation for future rollout of VA clinical programs. Synthesizing findings within and across projects, we will specify dimensions of team characteristics and function that enhance capacity for clinical innovation and uptake of evidence-based programs. TRIAL REGISTRATION: NCT03300336 Registered September 28, 2017, NCT03474380 Registered March 15, 2018.

Minding the Gaps: Assessing Communication Outcomes of Electronic Preconsultation Exchange.

BACKGROUND: Effective communication between referring and specialty providers is key to optimizing patient safety. Communication was assessed in an electronic referral system by review of referrals to a public urban health care system's gastroenterology clinic that were not scheduled for appointments. METHODS: All electronic referrals to a publicly funded, urban health care system's adult gastroenterology clinic from November 1, 2009, to November 30, 2010, were reviewed that did not result in scheduling of appointments. An assessment was made of whether in-person visits were unnecessary by preconsultation exchange or whether the referrals remained unscheduled for other reasons. For the latter group, reasons why the referrals remained unscheduled were examined, and medical records were reviewed for actual patient harm when sufficient information was present in the chart or for potential harm when no further information about the referral complaint was available. RESULTS: Eighty-six (32%) of 266 not-scheduled referrals were resolved via preconsultation exchange. For another 96 (36%), patients were not ultimately considered to require appointments or were scheduled via other routes. Nine patients received unplanned care while awaiting scheduling decisions, 5 of whom had harm that was related to referral complaints, although scheduling of appointments may not have avoided this harm. Of 75 patients for whom further information was not available about the referral complaints, most were not seen back in primary care, and 55 (73%) had potential for major harm. CONCLUSION: Few adverse outcomes in electronic referrals not scheduled for in-person gastroenterology visits were found, and none were clearly due to communication lapses in the referral process. Contributors to the potential for harm in referrals that were unintentionally left unscheduled included discontinuity of care and lack of patient or provider follow-up.

Clinical developments in the treatment of relapsed or relapsed and refractory multiple myeloma: impact of panobinostat, the first-in-class histone deacetylase inhibitor.

BACKGROUND: Panobinostat is a new agent for the treatment of relapsed and refractory multiple myeloma (rrMM) as part of a combination regimen. This article presents an overview of the mechanism of action, pharmacokinetics, safety, efficacy, patient care strategies, and role of the agent in treating rrMM patients. RESULTS: Panobinostat belongs to the class of drugs known as histone deacetylase inhibitors, and has high activity against Class I, II, and IV nonhistone deacetylases and histone deacetylases. It represents the first of its class to receive approval for use in MM, and received priority review and orphan drug status in both US and Europe, when used in combination with bortezomib and dexamethasone in the treatment of rrMM. Approval of panobinostat was based on subgroup analysis of Phase III data obtained in the PANORAMA trial program for evaluation of the combination of panobinostat, bortezomib, and dexamethasone. Additional clinical trials have continued to explore optimal dosing regimens and novel combination regimens to further clarify the optimal role of panobinostat in the arsenal of drugs for rrMM. Panobinostat has shown a manageable safety profile characterized primarily by hematologic toxicities (thrombocytopenia, neutropenia, lymphopenia, and anemia), gastrointestinal toxicities, notably diarrhea and nausea, as well as fatigue/asthenia, electrolyte abnormalities, and less commonly cardiac toxicities. CONCLUSION: Panobinostat represents an important addition to the treatment armamentarium for patients with rrMM, and studies are underway evaluating its optimal dosing strategy and role in combination with other drugs used to treat this patient population.

Open-Minded Cognition.

The present research conceptualizes open-minded cognition as a cognitive style that influences how individuals select and process information. An open-minded cognitive style is marked by willingness to consider a variety of intellectual perspectives, values, opinions, or beliefs-even those that contradict the individual's opinion. An individual's level of cognitive openness is expected to vary across domains (such as politics and religion). Four studies develop and validate a novel measure of open-minded cognition, as well as two domain-specific measures of religious and political open-minded cognition. Exploratory and confirmatory factor analysis (controlling for acquiescence bias) are used to develop the scales in Studies 1 to 3. Study 4 demonstrates that these scales possess convergent and discriminant validity. Study 5 demonstrates the scale's unique predictive validity using the outcome of Empathic Concern (Davis, 1980). Study 6 demonstrates the scale's unique predictive validity using the outcomes of warmth toward racial, religious, and sexual minorities.

Hyperspectral imaging and characterization of live cells by broadband coherent anti-Stokes Raman scattering (CARS) microscopy with singular value decomposition (SVD) analysis.

Coherent anti-Stokes Raman scattering (CARS) microscopy can be used as a powerful imaging technique to identify chemical compositions of complex samples in biology, biophysics, medicine, and materials science. In this work we developed a CARS microscopic system capable of hyperspectral imaging. By employing an ultrafast laser source, a photonic crystal fiber, and a scanning laser microscope together with spectral detection by a highly sensitive back-illuminated cooled charge-coupled device (CCD) camera, we were able to rapidly acquire and process hyperspectral images of live cells with chemical selectivity. We discuss various aspects of hyperspectral CARS image analysis and demonstrate the use of singular value decomposition methods to characterize the cellular lipid content.

New elements for informed decision making: a qualitative study of older adults' views.

OBJECTIVE: To explore older adults' views of existing informed decision making (IDM) elements and investigate the need for additional elements. METHODS: We recruited persons 65 and older to participate in six focus groups. Participants completed questionnaires about IDM preferences, and discussed videotapes of idealized patient-physician interactions in light of seven IDM elements: (1) discussion of the patient's role in decision making; (2) discussion of the clinical issue; (3) discussion of alternatives; (4) discussion of benefits/risks; (5) discussion of uncertainties; (6) assessment of patient understanding; and (7) exploration of patient preference. We used a modified grounded theory approach to assess agreement with existing IDM elements and identify new elements. RESULTS: In questionnaires, 97-100% of 59 participants rated each IDM element as "somewhat" or "very" important. Qualitative analysis supported existing elements and suggested two more: opportunity for input from trusted others, and discussion of decisions' impacts on patients' daily lives. Elements overlapped with global communication themes. CONCLUSION: Focus groups affirmed existing IDM elements and suggested two more with particular relevance for older patients. PRACTICE IMPLICATIONS: Incorporation of additional IDM elements into clinical practice can enhance informed participation of older adults in decision making.

Interpreter perspectives of in-person, telephonic, and videoconferencing medical interpretation in clinical encounters.

OBJECTIVE: To examine professional medical interpreters' perspectives of in-person and remote interpreting modalities. METHODS: Survey of interpreters at three medical centers assessing satisfaction with aspects of communication using each modality, and adequacy of videoconferencing medical interpretation (VMI) and telephonic interpretation for 21 common clinical scenarios in the hospital and ambulatory care settings. RESULTS: 52 interpreters completed the survey (73% response). All modalities were equally satisfactory for conveying information. Respondents favored in-person to telephonic interpretation for establishing rapport (95% versus 71%, p=.002) and for facilitating clinician understanding of patients' social and cultural backgrounds (92% versus 69%, p=.002). Scenarios with substantial educational or psychosocial dimensions had no more than 70% of respondents rating telephonic interpretation as adequate (25-70%); for all of these scenarios, VMI represented an improvement (52-87%). CONCLUSION: From the interpreter perspective, telephonic interpretation is satisfactory for information exchange, but less so for interpersonal aspects of communication. In scenarios where telephonic interpretation does not suffice, particularly those with substantial educational or psychosocial components, VMI offers improved communication. PRACTICE IMPLICATIONS: Differences in interpreters' perspectives of modalities based on communication needs and clinical scenario suggest mixed use of multiple modalities may be the best language access strategy.

A computerized education module improves patient knowledge and attitudes about appropriate antibiotic use for acute respiratory tract infections.

BACKGROUND: Over-use of antibiotics for acute respiratory infections (ARIs) increases antimicrobial resistance, treatment costs, and side effects. Patient desire for antibiotics contributes to over-use. OBJECTIVE: To explore whether a point-of-care interactive computerized education module increases patient knowledge and decreases desire for antibiotics. METHODS: Bilingual (English/Spanish) interactive kiosks were available in 8 emergency departments as part of a multidimensional intervention to reduce antibiotic prescribing for ARIs. The symptom-tailored module included assessment of symptoms, knowledge about ARIs (3 items), and desire for antibiotics on a 10-point visual analog scale. Multivariable analysis assessed predictors of change in desire for antibiotics. RESULTS: Of 686 adults with ARI symptoms, 63% initially thought antibiotics might help. The proportion of patients with low (1-3 on the scale) desire for antibiotics increased from 22% pre-module to 49% post-module (p<.001). Self-report of "learning something new" was associated with decreased desire for antibiotics, after adjusting for baseline characteristics (p=.001). CONCLUSION: An interactive educational kiosk improved knowledge about antibiotics and ARIs. Learning correlated with changes in personal desire for antibiotics. PRACTICE IMPLICATIONS: By reducing desire for antibiotics, point-of-care interactive educational computer technology may help decrease inappropriate use for antibiotics for ARIs.