The ACTIV-6 Stakeholder Advisory Committee: a model for virtual engagement in decentralized clinical trials.

Introduction: Engaging patients, caregivers, and other stakeholders to help guide the research process is a cornerstone of patient-centered research. Lived expertise may help ensure the relevance of research questions, promote practices that are satisfactory to research participants, improve transparency, and assist with disseminating findings. Methods: Traditionally engagement has been conducted face-to-face in the local communities in which research operates. Decentralized platform trials pose new challenges for the practice of engagement. We used a remote model for stakeholder engagement, relying on Zoom meetings and blog communications. Results: Here we describe the approach used for research partnership with patients, caregivers, and clinicians in the planning and oversight of the ACTIV-6 trial and the impact of this work. We also present suggestions for future remote engagement. Conclusions: The ACTIV-6 experience may inform proposed strategies for future engagement in decentralized trials.

AMIA Board White Paper: AMIA 2017 core competencies for applied health informatics education at the master's degree level.

This White Paper presents the foundational domains with examples of key aspects of competencies (knowledge, skills, and attitudes) that are intended for curriculum development and accreditation quality assessment for graduate (master's level) education in applied health informatics. Through a deliberative process, the AMIA Accreditation Committee refined the work of a task force of the Health Informatics Accreditation Council, establishing 10 foundational domains with accompanying example statements of knowledge, skills, and attitudes that are components of competencies by which graduates from applied health informatics programs can be assessed for competence at the time of graduation. The AMIA Accreditation Committee developed the domains for application across all the subdisciplines represented by AMIA, ranging from translational bioinformatics to clinical and public health informatics, spanning the spectrum from molecular to population levels of health and biomedicine. This document will be periodically updated, as part of the responsibility of the AMIA Accreditation Committee, through continued study, education, and surveys of market trends.

Locoregional Therapy With Curative Intent Versus Primary Liver Transplant for Hepatocellular Carcinoma: Systematic Review and Meta-Analysis.

BACKGROUND: Locoregional therapy with curative intent (CLRT) followed by salvage liver transplantation (SLT) in case of hepatocellular carcinoma (HCC) recurrence is an alternative to primary liver transplantation (LT) in selected patients with HCC. METHODS: We performed a systematic review and meta-analysis of studies comparing the survival of patients treated with CLRT versus LT, stratified by the stage of liver disease, extent of cancer, and whether SLT was offered or not. RESULTS: We included 48 studies involving 9835 patients (5736 patients with CLRT and 4119 patients with primary LT). Five-year overall survival (OS) and disease-free survival (DFS) was worse for all categories of CLRT combined, than for primary LT (odds ratio [OR] for OS, 0.59; 95% confidence interval [CI], 0.48-0.71; P < 0.01). However, 5-year OS for CLRT and primary LT was not significantly different among patients with (i) Child-A cirrhosis and (ii) single HCC lesion, although DFS was worse. When SLT was offered after CLRT, intention-to-treat analysis showed no significant difference in 5-year OS (OR, 1.0; 95% CI, 0.6-1.7) between CLRT-SLT and primary LT, though noninferiority could not be shown. Only 32.5% patients with HCC recurrence after CLRT actually received SLT, as the rest were not medically eligible. Thus, the DFS was worse with CLRT-SLT (OR, 0.31; 95% CI, 0.2-0.6) compared with LT. CONCLUSIONS: CLRT-SLT may be offered as first-line therapy to patients with HCC and well-compensated cirrhosis instead of primary LT because it may lead to better utilization of donor liver. However, a large proportion of patients with HCC recurrence after CLRT may not be candidates for SLT.

A Retrospective Evaluation of Response to Vitamin D Supplementation in Obese Versus Nonobese Patients.

OBJECTIVE: To evaluate the impact of body mass index (BMI) on vitamin D status following ergocalciferol therapy. METHODS: A retrospective evaluation of patients aged 18 years and older with a baseline serum 25(OH)D < 30 ng/mL who received prescription ergocalciferol 50 000 IU at any dose between July 2009 and November 2011 was conducted. Patients were included if pre- and posttreatment 25(OH)D levels were available within 3 months of therapy. RESULTS: Two hundred and thirteen patients were included in the study with 52% having a BMI ≥30 kg/m(2). Thirty-eight different ergocalciferol regimens were prescribed, and the majority of patients (66.2%) received a regimen consisting of 50 000 IU once weekly for variable durations. Mean 25(OH)D levels increased from 18.8 ± 6.6 ng/mL at baseline to 35.0 ± 13.8 ng/mL with 61.0% (n = 130) of patients having attained vitamin D sufficiency, 25(OH)D ≥ 30 ng/mL, with their prescribed ergocalciferol regimen. Obese patients with a BMI ≥30 were less likely to attain vitamin D sufficiency following replacement than patients with a BMI <30 kg/m(2) (52% vs 71%; P = .0161). CONCLUSION: Our study demonstrated an overall moderate response rate to replacement therapy with ergocalciferol and considerable variability in vitamin D replacement strategies initiated by primary care providers. Based on our findings, elevated BMI ≥30 kg/m(2) may impact the likelihood of attaining vitamin D sufficiency with ergocalciferol.

Development of an evidence-based clinical practice guideline on linear growth measurement of children.

Growth is an important indicator of child health; however, measurements are frequently inaccurate and unreliable. This article reviews the literature on linear growth measurement error and describes methods used to develop and evaluate an evidence-based clinical practice guideline on the measurement of recumbent length and stature of infants, children, and adolescents. Systematic methods were used to identify evidence to answer clinical questions about growth measurement. A multidisciplinary team critically appraised and synthesized the evidence to develop clinical practice recommendations using an evidence-based practice rating scheme. The guideline was prospectively evaluated through internal and external reviews and a pilot study to ensure its validity and reliability. Adoption of the clinical practice guideline can improve the accuracy and reliability of growth measurement data.

Predicting outcomes of hospitalization for heart failure using logistic regression and knowledge discovery methods.

The purpose of this study is to determine the best prediction of heart failure outcomes, resulting from two methods -- standard epidemiologic analysis with logistic regression and knowledge discovery with supervised learning/data mining. Heart failure was chosen for this study as it exhibits higher prevalence and cost of treatment than most other hospitalized diseases. The prevalence of heart failure has exceeded 4 million cases in the U.S.. Findings of this study should be useful for the design of quality improvement initiatives, as particular aspects of patient comorbidity and treatment are found to be associated with mortality. This is also a proof of concept study, considering the feasibility of emerging health informatics methods of data mining in conjunction with or in lieu of traditional logistic regression methods of prediction. Findings may also support the design of decision support systems and quality improvement programming for other diseases.

Albumin versus crystalloid therapy in the management of hepatorenal syndrome: a model for using meta analysis in cost effectiveness studies and the design of clinical trials.

We applied traditional methods of gathering, integrating and summarizing findings of current literature, with new approaches for assessing the cost effectiveness of two treatments for hepatorenal syndrome (HRS). Findings of this cost effectiveness study are used to form a proposal for a multi-center prospective clinical trial, to assess the economic and clinical benefits of albumen versus crystalloid therapy in the care of these patients. Our initial findings suggest that albumin therapy is superior to standard crystalloid therapy, in the treatment of HRS patients. The number of survival days appears to increase with this form of therapy per dollar cost, while patients await liver transplantation.