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BACKGROUND:Treatment of chronic myeloid leukemia with a tyrosine kinase inhibitor (TKI) offers significant improvements over previous treatments in terms of survival and toxicity yet nevertheless is associated with reduced health-related quality of life and very high cost. Several small studies from Europe and Australia suggested that discontinuing TKIs with regular monitoring was safe. METHODS:The Life After Stopping TKIs (LAST) study is a large, U.S.-based study that aims to improve the evidence for clinical decision making regarding TKI discontinuation with monitoring in patients with chronic myeloid leukemia who have a deep molecular response to TKI therapy. The LAST study is a non-randomized, prospective, single-group longitudinal study of 173 patients. The co-primary objectives are to determine the proportion of patients who develop molecular recurrence (> 0.1% BCR-ABLIS) after discontinuing one of four TKIs (imatinib, dasatinib, nilotinib, or bosutinib) and to compare the patient-reported health status of patients before and after stopping TKIs. Outcomes are assessed at baseline and throughout the 36-month study follow-up period with a central laboratory used for blood samples. All samples with undetectable BCR-ABL are also examined using digital polymerase chain reaction, which is a more sensitive nanofluidic polymerase chain reaction system. DISCUSSION:Because of their high cost and side effects, discontinuation of TKIs for patients with chronic myeloid leukemia who have a deep molecular response to TKI therapy is a promising approach to treatment. The LAST study is the largest U.S.-based TKI discontinuation study. It is the first to allow participation from patients on any of 4 first- and second-generation TKIs, includes a robust approach to measurement of clinical and patient-reported outcomes, and is using digital polymerase chain reaction to explore better prediction of safe discontinuation. TRIAL REGISTRATION:This study was registered prospectively on October 21, 2014 and assigned trial number NCT02269267 .

Background While nearly 50% of adult women report at least one episode of urinary incontinence (UI), most never receive treatment. Objective To better integrate primary and specialty UI care, we conducted (i) an environmental scan to assess the availability of key pathway resources in primary care, (ii) interviews with primary care providers to understand barriers to care, and (iii) a pilot UI care pathway intervention. Methods Environmental scan: Clinic managers from all primary care clinics within a Midwestern healthcare system were invited to participate in an interview covering the availability of clinic resources. Provider interviews: Primary care providers were invited to participate in an interview covering current practices and perceived barriers to UI care. Pilot UI care pathway : Patients who screened positive for UI were provided resources for first-line behavioral management. Pilot patients completed questionnaires at baseline, 8 weeks, and 6 months. Results While many clinics had point-of-care urinalysis (17/21, 81%), most did not have a working bladder ultrasound (14/21, 67%) or on-site pelvic floor physical therapy (18/21, 86%). Providers (n  = 5) described barriers to completing almost every step of diagnosis and treatment for UI. The most persistent barrier was lack of time. Patients (n  = 15) reported several self-treatment strategies including avoiding bladder irritants (7/15, 47%) and performing Kegel exercises (4/15, 27%). Five patients (33%) requested follow-up care. At 6 months, patients reported small improvements in UI symptoms. Conclusion Promising results from a novel UI care pathway pilot indicate that streamlining UI care may assist primary care providers in the first-line treatment of UI. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the psychometric properties of the AL‐PROfile, a patient‐reported outcome measure combining the Patient‐Reported Outcomes Measurement Information System (PROMIS)‐29, two items from PROMIS Cognitive Function, and select Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO‐CTCAE) items. Methods: Content validity was assessed through cognitive debriefing interviews of 20 patients who completed the AL‐PROfile (Study 1). Study 2 involved 297 participants who completed the AL‐PROfile and Medical Outcomes Study 36‐item Short‐Form Health Survey (SF‐36). Reliability (internal consistency and test–retest reliability) and validity (convergent and discriminant validity, known groups validity by stage/organ involvement) were calculated. Results: Study 1 participants found the AL‐PROfile straightforward confirming the relevance of the included content. Some felt that certain questions were not related to their amyloidosis experience. Study 2 demonstrated acceptable internal consistency for all domains/items except PROMIS Cognitive Function and acceptable test–retest reliability for all except PROMIS Cognitive Function and PRO‐CTCAE nausea. Large correlations were seen for the same domain across measures while correlations for divergent domains within a measure and different domains across different measures were small. The PRO‐CTCAE items showed small to medium correlations with each other and with PROMIS and SF‐36 domains. Stage was associated with physical function, fatigue, social roles, swelling, and shortness of breath scores. Conclusion: The AL‐PROfile has acceptable reliability and validity for use in systemic light chain amyloidosis patients. [ABSTRACT FROM AUTHOR]

A study was conducted to assess patient satisfaction with telemedicine in the management of light chain (AL) amyloidosis, a rare disease with multiple organ involvement. The study surveyed members of the Amyloidosis Support Groups, Inc. and found that 71% of participants who had telemedicine visits for AL amyloidosis care reported being satisfied with their experience. The study did not find any associations between satisfaction and disease characteristics, such as stage, type of organ involvement, or number of telemedicine visits. However, the study acknowledged limitations, including the potential for selection bias and the need for further research to explore other factors that may influence patient satisfaction with telemedicine. [Extracted from the article]

PurposeTo evaluate the reliability and construct validity of measures from the Patient-Reported Outcomes Measurement Information System(®) (PROMIS(®)) for patients with heart failure before and after heart transplantation.MethodsWe assessed reliability of the PROMIS short forms using Cronbach's alpha and the average marginal reliability. To assess the construct validity of PROMIS computerized adaptive tests and short-form measures, we calculated Pearson product moment correlations between PROMIS measures of physical function, fatigue, depression, and social function and existing PRO measures of similar domains (i.e., convergent validity) as well as different domains (i.e., discriminate validity) in patients with heart failure awaiting heart transplant. We evaluated the responsiveness of these measures to change after heart transplant using effect sizes.ResultsForty-eight patients were included in the analyses. Across the many domains examined, correlations between conceptually similar domains were larger than correlations between different domains of health, demonstrating construct validity. Health status improved substantially after heart transplant (standardized effect sizes, 0.63-1.24), demonstrating the responsiveness of the PROMIS measures. Scores from the computerized adaptive tests and the short forms were similar.ConclusionsThis study provides evidence for the reliability and construct validity (including responsiveness to change) of four PROMIS domains in patients with heart failure before and after heart transplant. PROMIS measures are a reasonable choice in this context and will facilitate comparisons across studies and health conditions.

BackgroundPatient-centered care is respectful of and responsive to individual patient preferences, needs, and values. To provide patient-centered care, clinicians need to know and incorporate patients’ context into their communication and care with patients. Patient contextual data (PCD) encompass social determinants of health and patients’ needs, values, goals, and preferences relevant to their care. PCD can be challenging to collect as a routine component of the time-limited primary care visit. ObjectiveThis study aims to determine if patient-provider communication and patient activation are different for patient users and patient nonusers of an electronic health record (EHR)–integrated PCD tool and assess if the impact of using PCD on patient-provider communication and patient activation differs for Black and White patients. MethodsWe describe a randomized controlled trial of a prospective cohort of non-Hispanic White and Black patients who receive primary care services at a midwestern academic health care system in the United States. We will evaluate whether providing PCD through a consumer informatics tool enhances patient-provider communication, as measured by the Communication Assessment Tool, and we will evaluate patient activation, as measured by the Patient Activation Measure for PCD tool users and nonusers. Furthermore, owing to racial disparities in care and communication, we seek to determine if the adoption and use of the tool might narrow the differences between patient groups. ResultsThe trial was funded in November 2017 and received local ethics review approval in February 2019. The study began recruitment in April 2019 and enrollment concluded in October 2019 with 301 participants. The analysis was completed in May 2020, and trial results are expected to be published in winter 2020. ConclusionsRecently, there has been increased attention to the role of health information technology tools to enable patients to collaborate with providers through the sharing of PCD. The adoption of such tools may overcome the barriers of current EHRs by directly engaging patients to submit their contextual data. Effectively, these tools would support the EHR in providing a more holistic understanding of the patient. Research further supports that individuals who have robust digital engagement using consumer informatics tools have higher participation in treatment follow-up and self-care across populations. Therefore, it is critical to investigate interventions that elicit and share patients’ social risks and care preferences with the health care team as a mechanism to improve individualized care and reduce the gap in health outcomes. Trial RegistrationClinicalTrials.gov NCT03766841; https://clinicaltrials.gov/ct2/show/NCT03766841 International Registered Report Identifier (IRRID)RR1-10.2196/20309