Temporal trends and outcomes of peripheral artery disease revascularization and amputation among the HIV population.

OBJECTIVE: With antiretroviral therapy, people with HIV (PWH) are developing age-related diseases, including peripheral arterial disease (PAD). This study examined frequency and outcomes of peripheral vascular intervention (PVI) and primary amputation in PWH. DESIGN: We used the National Inpatient Sample (NIS) database to examine demographics, comorbidities, and temporal trends among PVI and primary amputation admissions by HIV status from 2012 to 2018. METHODS: Inverse probability of treatment weighting was used to calculate adjusted odds of in-hospital death and amputation. Cost of hospitalization and length of stay were compared by HIV status and revascularization approach. RESULTS: Of the 347 824 hospitalizations for PVI/amputation, 0.6% were PWH, which was stable over time. PWH had more renal and hepatic disease, whereas uninfected individuals had more traditional PAD risk factors. 55.2% of HIV+ admissions were endovascular compared with 49.3% in HIV- admissions, and 28.9% of the HIV+ admissions were elective compared with 42.1% among HIV-. HIV status did not impact amputation following PVI. In-hospital death was similar between groups following PVI or primary amputation. PWH had lower costs of hospitalization and a trend towards shorter hospital stays. CONCLUSION: Although PWH are developing more age-related chronic illnesses, the number of PAD-associated procedures has remained flat. Despite being younger with fewer traditional PAD risk factors, PWH had higher rates of unplanned PVI admissions and endovascular revascularization but similar in-hospital outcomes. These findings suggest PWH have different risk factors for PAD and are likely underdiagnosed and undertreated, whereas those who are treated have similar outcomes to the general population.

Chemotherapy and Radiation-Associated Cardiac Autonomic Dysfunction.

PURPOSE OF REVIEW: Cardiovascular autonomic dysfunction (AD) among cancer survivors is increasingly being recognized. However, the mechanisms and incidence are poorly understood. In this review, the clinical features, diagnostic modalities, proposed mechanisms, and currently available treatments of cardiovascular AD in cancer survivors are described. RECENT FINDINGS: Much of our current understanding of cardiovascular AD is based on disease states such as diabetes, multisystem atrophy, and Parkinson's disease. Several non-invasive tests, measurements, and scoring systems have been developed as surrogates for autonomic function, with some even demonstrating associations with all-cause mortality. The mechanism of cardiovascular AD specifically in the cancer population, however, has not been directly studied. The etiology of cardiovascular AD in cancer survivors is likely multifactorial, and proposed mechanisms include direct nerve damage by chemoradiation, the pro-inflammatory state associated with malignancy, and paraneoplastic syndromes. It may also be that cardiovascular AD is an early marker of global cardiomyopathy rather than its own condition. Current pharmacologic options for cardiovascular AD are extrapolated from how it has been treated in other disease processes, and these agents have not been studied in the cancer population or compared head-to-head. Cardiovascular AD in cancer survivors can cause significant debilitation and may be associated with all-cause mortality. Current diagnostic modalities have several limitations, such as standardization and validity. However, given the nonspecific nature of cardiovascular AD, these tools provide an objective marker for diagnosis and tracking treatment response. While the mechanism of cardiovascular AD in cancer survivors has not been directly studied, it may be useful to evoke mechanisms of cardiovascular AD in other disease states such as diabetes, Parkinson's disease, and multisystem atrophy in addition to identifying unique conditions associated with malignancy like a pro-inflammatory state. Until further studies are performed, management of cardiovascular AD as seen in other disease states may serve as a guide for symptom management in cancer survivors.

Physiological mechanisms of QRS narrowing in bundle branch block patients undergoing permanent His bundle pacing.

His bundle pacing is increasingly used to avoid chronic right ventricular pacing, and electrically resynchronize ventricular activation by narrowing or normalizing the QRS interval in left and right bundle branch block. The mechanisms by which this occurs remain poorly understood. In this review, the proposed mechanisms and evidence supporting them are discussed. Also discussed are aspects of mechanisms that are not completely supported by the evidence. We also review the differences and physiological bases for direct vs. indirect His bundle capture, and the physiological mechanisms for QRS narrowing vs. normalization following His bundle pacing.

Usefulness of His Bundle Pacing to Achieve Electrical Resynchronization in Patients With Complete Left Bundle Branch Block and the Relation Between Native QRS Axis, Duration, and Normalization.

His Bundle pacing (HBP) restores electrical synchronization in left bundle branch block (LBBB); however, the underlying mechanisms are poorly understood. We examined the relation between native QRS axis in LBBB, a potential indicator of the site of block, and QRS normalization in patients with LBBB. Data from patients (n = 41) undergoing HBP at 3 sites were studied (68 ± 13 years, 13 women). Study criteria included strictly defined complete LBBB and successful implantation of a permanent HBP lead. Preprocedure and postprocedure electrocardiograms were reviewed independently by 2 blinded readers. QRS axis and duration were measured to the nearest 10° and 10 ms, respectively. QRS narrowing or normalization was the primary end point. Of 29 patients meeting study criteria, 9 had frontal plane QRS axes between -60° and -80°, 10 from -40° to 0°, and 10 from +1° to +90°. QRS narrowing occurred in 24 patients (83%, 44 ± 34 ms, p <0.05). Percent QRS narrowing by axis were 26 ± 19%, 29 ± 25%, and 28 ± 23%, respectively. No correlation between prepacing QRS axis and postpacing narrowing was identified (r(2) = 0.001, p = 0.9). In patients with or without QRS normalization after HBP, mean QRS duration was 155 ± 21 vs 171 ± 8 ms, respectively, p = 0.014. HBP induces significant QRS narrowing in most patients and normalization in patients with shorter baseline QRS duration. In conclusion, the lack of correlation between native QRS axis and narrowing suggests that proximal His-Purkinje block causes most cases of LBBB, or that additional mechanisms underlie HBP efficacy. Further studies are needed to better understand how to predict those patients in whom HBP will normalize LBBB.

Coaching patients in the use of decision and communication aids: RE-AIM evaluation of a patient support program.

BACKGROUND: Decision aids educate patients about treatment options and outcomes. Communication aids include question lists, consultation summaries, and audio-recordings. In efficacy studies, decision aids increased patient knowledge, while communication aids increased patient question-asking and information recall. Starting in 2004, we trained successive cohorts of post-baccalaureate, pre-medical interns to coach patients in the use of decision and communication aids at our university-based breast cancer clinic. METHODS: From July 2005 through June 2012, we used the RE-AIM framework to measure Reach, Effectiveness, Adoption, Implementation and Maintenance of our interventions. RESULTS: 1. Reach: Over the study period, our program sent a total of 5,153 decision aids and directly administered 2,004 communication aids. In the most recent program year (2012), out of 1,524 eligible patient appointments, we successfully contacted 1,212 (80%); coached 1,110 (73%) in the self-administered use of decision and communication aids; sent 958 (63%) decision aids; and directly administered communication aids for 419 (27%) patients. In a 2010 survey, coached patients reported self-administering one or more communication aids in 81% of visits 2. Effectiveness: In our pre-post comparisons, decision aids were associated with increased patient knowledge and decreased decisional conflict. Communication aids were associated with increased self-efficacy and number of questions; and with high ratings of patient preparedness and satisfaction 3. Adoption: Among visitors sent decision aids, 82% of survey respondents reviewed some or all; among those administered communication aids, 86% reviewed one or more after the visit 4. IMPLEMENTATION: Through continuous quality adaptations, we increased the proportion of available staff time used for patient support (i.e. exploitation of workforce capacity) from 29% in 2005 to 84% in 2012 5. Maintenance: The main barrier to sustainability was the cost of paid intern labor. We addressed this by testing a service learning model in which student interns work as program coaches in exchange for academic credit rather than salary. The feasibility test succeeded, and we are now expanding the use of unpaid interns. CONCLUSION: We have sustained a clinic-wide implementation of decision and communication aids through a novel staffing model that uses paid and unpaid student interns as coaches.

Parasites and vectors carry no passport: how to fund cross-border and regional efforts to achieve malaria elimination.

BACKGROUND: Tremendous progress has been made in the last ten years in reducing morbidity and mortality caused by malaria, in part because of increases in global funding for malaria control and elimination. Today, many countries are striving for malaria elimination. However, a major challenge is the neglect of cross-border and regional initiatives in malaria control and elimination. This paper seeks to better understand Global Fund support for multi-country initiatives. METHODS: Documents and proposals were extracted and reviewed from two main sources, the Global Fund website and Aidspan.org. Documents and reports from the Global Fund Technical Review Panel, Board, and Secretariat documents such as guidelines and proposal templates were reviewed to establish the type of policies enacted and guidance provided from the Global Fund on multi-country initiatives and applications. From reviewing this information, the researchers created 29 variables according to eight dimensions to use in a review of Round 10 applications. All Round 10 multi-country applications (for HIV, malaria and tuberculosis) and all malaria multi-country applications (6) from Rounds 1 - 10 were extracted from the Global Fund website. A blind review was conducted of Round 10 applications using the 29 variables as a framework, followed by a review of four of the six successful malaria multi-country grant applications from Rounds 1 - 10. FINDINGS: During Rounds 3 - 10 of the Global Fund, only 5.8% of grants submitted were for multi-country initiatives. Out of 83 multi-country proposals submitted, 25.3% were approved by the Technical Review Panel (TRP) for funding, compared to 44.9% of single-country applications. The majority of approved multi-country applications were for HIV (76.2%), followed by malaria (19.0%), then tuberculosis (4.8%). TRP recommendations resulted in improvements to application forms, although guidance was generally vague. The in-depth review of Round 10 multi-country proposals showed that applicants described their projects in one of two ways: a regional 'network approach' by which benefits are derived from economies of scale or from enhanced opportunities for mutual support and learning or the development of common policies and approaches; or a 'cross-border' approach for enabling activities to be more effectively delivered towards border-crossing populations or vectors. In Round 10, only those with a 'network approach' were recommended for funding. The Global Fund has only ever approved six malaria multi-country applications. Four approved applications stated strong arguments for a multi-country initiative, combining both 'cross-border' and 'network' approaches. CONCLUSION: With the cancellation of Round 11 and the proposal that the Global Fund adopt a more targeted and strategic approach to funding, the time is opportune for the Global Fund to develop a clear consensus about the key factors and criteria for funding malaria specific multi-country initiatives. This study found that currently there was a lack of guidance on the key features that a successful multi-country proposal needs to be approved and that applications directed towards the 'network' approach were most successful in Round 10. This type of multi-country proposal may favour other diseases such as HIV, whereas the need for malaria control and elimination is different, focusing on cross-border coordination and delivery of interventions to specific groups. The Global Fund should seek to address these issues and give better guidance to countries and regions and investigate disease-specific calls for multi-country and regional applications.

Adoption, acceptability, and accuracy of an online clinical trial matching website for breast cancer.

BACKGROUND: Less than 5% of breast cancer patients participate in clinical trials. To increase patients' awareness and access to trials, we created BreastCancerTrials.org, a clinical trial matching website. BreastCancerTrials.org matched patients to trials based on their self-reported breast cancer history. It also provided a messaging platform through which patients could self-refer themselves to participating research sites. OBJECTIVE: To assess adoption by research sites, acceptability to patients, and patients' accuracy in providing information to BreastCancerTrials.org. METHODS: We approached 13 research sites in Northern California to list their trials on BreastCancerTrials.org. For adoption, we examined the willingness of contacted research sites to collaborate with BreastCancerTrials.org. For acceptability, we analyzed usage statistics of visitors who completed the BreastCancerTrials.org health history questionnaire in the first 14 months after launch and surveyed users who visited the website during its first year about their experience. For accuracy, we compared the self-reported health history of 20 patients against their medical records. The health history questionnaire was divided into four sections: About Me, personal information including date of birth and sex; My Health as of Today, current status including cancer stage, menopausal status, and sites with evidence of disease; My Cancer, diagnostic information such as hormone and human epidermal growth factor receptor 2 status; and My Treatment, an itemized record of past treatment including responses to therapy. RESULTS: A total of 12 sites contributed 55 trials. Regarding acceptability, 733 visitors registered on the website; 428 reported their health history; and 407 matched to at least one trial. Of 375 patients who were sent a survey, 75 responded (20%); 23 of the 75 (31%) contacted a research site, 12 of the 23 (52%) were eligible for a trial, and 5 of the 12 (42%) reported enrolling. As for accuracy, 20 clinic visitors reported 1456 health history items, 1324 of which matched their clinic record (90.93%). CONCLUSIONS: BreastCancerTrials.org was adopted by research sites. Patients found it acceptable and were able to provide accurate information for trial matching. Based on our findings, we launched an upgraded version of BreastCancerTrials.org as a national service in October 2008.

Impact of decision aids in a sustained implementation at a breast care center.

OBJECTIVE: We examined the reach and impact of five decision aids (DAs) routinely distributed to breast cancer patients as part of a shared decision making demonstration project. METHODS: From 2005 to 2008, we surveyed patients' change in knowledge and decisional conflict (DC) before and after their review of DAs. Using bivariate tests, we identified significant predictors of change in knowledge or decisional conflict and entered significant predictors into a multivariate regression model. RESULTS: We distributed 1553 DAs to 1098 patients and received 549 completed surveys. The DAs were associated with increased knowledge and decreased DC. For knowledge, significant predictors of above-average change included: lower baseline knowledge and viewing the surgery decision aid. For decisional conflict, significant predictors of above-average change included: higher decisional conflict; viewing any of the early-stage cancer DAs; and Hispanic ethnicity. CONCLUSIONS: DAs used in routine care were associated with significant knowledge gains and reductions in decisional conflict. Some subsets of patients (those reporting low baseline knowledge, high DC, or Hispanic ethnicity) may benefit more than others. PRACTICE IMPLICATIONS: Breast cancer patients benefit overall from routine distribution of DAs. Our exploratory findings may be useful in generating hypotheses to identify target populations who would most benefit from reviewing DAs.

Expanding the reach of decision and communication aids in a breast care center: a quality improvement study.

OBJECTIVE: One academically based breast cancer clinic implements decision and communication aids as part of routine clinical care. This quality improvement study aimed to expand reach of these supportive materials and services with budget-neutral program changes. METHODS: We used program theory and continuous quality improvement to design changes to our program. We calculated reach as the number of new patient visits for which we administered decision and communication aids. We compared reach before and after the program changes. RESULTS: Program changes included: reassigning program outreach tasks from over-committed to under-utilized personnel; deploying personnel in floating rather than fixed schedules; and creating a waitlist so service delivery was dynamically reallocated from overbooked to underbooked personnel. Before these changes, we reached 208 visitors with decision aids, and 142 visitors with communication aids. Changes were associated with expanded reach, culminating in program year 2008 with the delivery of 936 decision aids and 285 communication aids. CONCLUSIONS: We observed over a fourfold increase in decision aid reach and a twofold increase in communication aid reach. We attribute increases to recent program changes. PRACTICE IMPLICATIONS: This study illustrates how program theory and quality improvement methods can contribute to expanded reach of decision and communication aids.