Biopsychosocial Factors Associated With Satisfaction and Sustained Use of Artificial Pancreas Technology and Its Components: a Call to the Technology Field

Purpose of Review

Summarize biopsychosocial factors associated with using continuous glucose monitors (CGMs), insulin pumps, and artificial pancreas (AP) systems and provide a “call to the field” about their importance to technology uptake and maintained use.

Recent Findings

Insulin pumps and CGMs are becoming standard of care for individuals with type 1 diabetes (T1D). AP systems combining a CGM, insulin pump, and automated dosing algorithm are available for commercial use. Despite improved glycemic control with AP system use, numerous barriers exist which may limit their benefit. Studies on components of AP systems (pumps, CGMs) are limited and demonstrate mixed results of their impact on fear of hypoglycemia, adherence, quality of life, depression and anxiety, and diabetes distress. Studies examining biopsychological factors associated specifically with sustained use of AP systems are also sparse.

Summary

Biological, psychological and social impacts of AP systems have been understudied and the information they provide has not been capitalized upon.

     

Do-it-yourself Artificial Pancreas – Technologiehype oder realer Nutzen?

Background

Most type 1 diabetes mellitus patients are not capable of achieving close to normal glucose levels and thus face a constant risk of severe hypoglycemia and diabetic ketoacidosis.

Objectives

Patients develop their own personal non-approved medical devices to compensate for gaps in the existing medical technology.

Materials and methods

Current studies are assessed and basic work and challenges are discussed.

Results

The authorization of such systems from patients themselves results in the development of medical devices suitable for use but approved only based on freely available algorithms. Legal framework conditions, lack of standards on the interoperability of medical devices and uncertainties about future technology trends are giving rise to ongoing controversies.

Conclusions

There is a need to validate these new approaches, agree upon success criteria and provide solid evidence of their effectiveness.

     

Defining Appropriate Use of Proton-Pump Inhibitors Among Medical Inpatients

BACKGROUND

Proton-pump inhibitors (PPIs) are commonly used among medical inpatients, both for prophylaxis against upper gastrointestinal bleeding (UGIB) and continuation of outpatient use. While PPIs reduce the risk of UGIB, they also appear to increase the risk of hospital-acquired pneumonia (HAP) and Clostridium difficile infection (CDI). Depending upon the underlying risks of these conditions and the changes in those risks with PPIs, use of proton-pump inhibitors may lead to a net benefit or net harm among medical inpatients.

OBJECTIVE

We aimed to determine the net impact of PPIs on hospital mortality among medical inpatients.

DESIGN

A microsimulation model, using literature-derived estimates of the risks of UGIB, HAP, and CDI among medical inpatients, along with the changes in risk associated with PPI use for each of these outcomes. The primary outcome was change in inpatient mortality.

PARTICIPANTS

Simulated general medical inpatients outside the intensive care unit (ICU).

MAIN MEASURE

Change in overall mortality during hospitalization.

KEY RESULTS

New initiation of PPI therapy led to an increase in hospital mortality in about 90 % of simulated patients. Continuation of outpatient PPI therapy on admission led to net increase in hospital mortality in 79 % of simulated patients. Results were robust to both one-way and multivariate sensitivity analyses, with net harm occurring in at least two-thirds of patients in all scenarios.

CONCLUSIONS

For the majority of medical inpatients outside the ICU, use of PPIs likely leads to a net increase in hospital mortality. Even in patients at particularly high risk of UGIB, only those at the very lowest risk of HCAP and CDI should be considered for prophylactic PPI use. Continuation of outpatient PPIs may also increase expected hospital mortality. Apart from patients with active UGIB, use of PPIs in hospitalized patients should be discouraged.

     

The Impact of an Enhanced Interpreter Service Intervention on Hospital Costs and Patient Satisfaction

BACKGROUND

Many health care providers do not provide adequate language access services for their patients who are limited English-speaking because they view the costs of these services as prohibitive. However, little is known about the costs they might bear because of unaddressed language barriers or the costs of providing language access services.

OBJECTIVE

To investigate how language barriers and the provision of enhanced interpreter services impact the costs of a hospital stay.

DESIGN

Prospective intervention study.

SETTING

Public hospital inpatient medicine service.

PARTICIPANTS

Three hundred twenty-three adult inpatients: 124 Spanish-speakers whose physicians had access to the enhanced interpreter intervention, 99 Spanish-speakers whose physicians only had access to usual interpreter services, and 100 English-speakers matched to Spanish-speaking participants on age, gender, and admission firm.

MEASUREMENTS

Patient satisfaction, hospital length of stay, number of inpatient consultations and radiology tests conducted in the hospital, adherence with follow-up appointments, use of emergency department (ED) services and hospitalizations in the 3 months after discharge, and the costs associated with provision of the intervention and any resulting change in health care utilization.

RESULTS

The enhanced interpreter service intervention did not significantly impact any of the measured outcomes or their associated costs. The cost of the enhanced interpreter service was $234 per Spanish-speaking intervention patient and represented 1.5% of the average hospital cost. Having a Spanish-speaking attending physician significantly increased Spanish-speaking patient satisfaction with physician, overall hospital experience, and reduced ED visits, thereby reducing costs by $92 per Spanish-speaking patient over the study period.

CONCLUSION

The enhanced interpreter service intervention did not significantly increase or decrease hospital costs. Physician–patient language concordance reduced return ED visit and costs. Health care providers need to examine all the cost implications of different language access services before they deem them too costly.

     

Cancer Center Volume and Type Impact Stage-Specific Utilization of Neoadjuvant Therapy in Rectal Cancer

Background

Neoadjuvant chemoradiation reduces local recurrence in locally advanced rectal cancer, and adherence to national and societal recommendations remains unknown.

Objective

To determine variability in guideline adherence in rectal cancer treatment and investigate whether hospital volume correlated with variability seen.

Design

We performed a retrospective analysis using the National Cancer Database rectal cancer participant user files from 2005 to 2010. Stage-specific predictors of neoadjuvant chemotherapy and radiation use were determined, and variation in use across hospitals analyzed. Hospitals were ranked based on likelihood of preoperative therapy use by stage, and observed-to-expected ratios for neoadjuvant therapy use calculated. Hospital outliers were identified, and their center characteristics compared.

Results

A total of 23,488 patients were identified at 1183 hospitals. There was substantial variability in the use of neoadjuvant chemoradiation across hospitals. Patients managed outside clinical guidelines for both stage 1 and stage 3 disease tended to receive treatment at lower-volume, community cancer centers.

Conclusions

There is substantial variability in adherence to national guidelines in the use of neoadjuvant chemoradiation for rectal cancer across all stages. Both hospital volume and center type are associated with over-treatment of early-stage tumors and under-treatment of more invasive tumors. These findings identify a clear need for national quality improvement efforts in the treatment of rectal cancer.

     

Establishing a General Medical Outpatient Clinic for Cancer Survivors in a Public City Hospital Setting

INTRODUCTION

Many cancer centers and community hospitals are developing novel models of survivorship care. However, few are specifically focused on services for socio-economically disadvantaged cancer survivors.

AIMS

To describe a new model of survivorship care serving culturally diverse, urban adult cancer patients and to present findings from a feasibility evaluation.

SETTING

Adult cancer patients treated at a public city hospital cancer center.

PROGRAM DESCRIPTION

The clinic provides comprehensive medical and psychosocial services for patients within a public hospital cancer center where they receive their oncology care.

PROGRAM EVALUATION

Longitudinal data collected over a 3-year period were used to describe patient demographics, patient needs, and services delivered. Since inception, 410 cancer patients have been served. Demand for services has grown steadily. Hypertension was the most frequent comorbid condition treated. Pain, depression, cardiovascular disease, hyperlipidemia, and bowel dysfunction were the most common post-treatment problems experienced by the patients. Financial counseling was an important patient resource.

DISCUSSION

This new clinical service has been well-integrated into its public urban hospital setting and constitutes an innovative model of health-care delivery for socio-economically challenged, culturally diverse adult cancer survivors.

     

Do Changes in Post-acute Care Use at Hospitals Participating in an Accountable Care Organization Spillover to All Medicare Beneficiaries?

Background

While early evidence suggests that Medicare accountable care organizations (ACOs) may reduce post-acute care (PAC) utilization for attributed beneficiaries, whether these effects spill over to all beneficiaries admitted to hospitals participating in ACOs stray is unknown.

Objective

The objective of this study was to evaluate whether changes in PAC use and Medicare spending spill over to all beneficiaries admitted to hospitals participating in the Medicare Shared Savings Program (MSSP).

Design

Observational study using a difference-in-differences design comparing changes in PAC utilization and spending among beneficiaries admitted to ACO-participating hospitals before and after the start of the ACO contracts, compared to those admitted to non-ACO hospitals.

Setting

A total of 233 hospitals participate in MSSP ACOs and 3103 non-ACO hospitals.

Participants

A national sample of 11,683,573 Medicare beneficiaries experiencing 26,503,086 hospital admissions from 2010 to 2013.

Exposure

Admission to a hospital participating in an MSSP ACO.

Main Measures

The probability of discharge and Medicare payments to inpatient rehabilitation facilities (IRF), skilled nursing facilities (SNF), and home health agencies (HHA).

Key Results

For beneficiaries admitted to hospitals that joined an ACO, the likelihood of being discharged to PAC did not change after the hospital joined the ACO compared with non-ACO hospitals over the same period (differential change in probability of discharge to any PAC was 0.000 (P?=?0.89), SNF was 0.000 (P?=?0.73), IRF was 0.000 (P?=?0.96), and HHA was 0.001 (P?=?0.57)). Payments reduced significantly for PAC overall (??$130.41, P?=?0.03), but not for any individual PAC type alone. These results were consistent in samples that were conditional on discharge to any PAC, across conditions with high PAC use nationally, and among ACO-participating hospitals that also had a PAC participant.

Conclusions

Hospital participation in an ACO did not result in spillovers in PAC utilization or payments to all beneficiaries, even when considering high PAC-use conditions and ACO hospitals that also have an ACO-participating PAC.

     

Transplantation of Macroencapsulated Insulin-Producing Cells

Purpose of Review

There is considerable interest in using macroencapsulation devices as a delivery strategy for transplanting insulin-producing cells. This review aims to summarize recent advances, to highlight remaining challenges, and to provide recommendations for the field.

Recent Findings

A variety of new device designs have been reported to improve biocompatibility and to provide protection for islet/beta cells from immune destruction while allowing continuous secretion of insulin. Some of these new approaches are in clinical trials, but more research is needed to determine how sufficient beta-cell mass can be transplanted in a clinically applicable device size, and that insulin is secreted with kinetics that will safely provide adequate controls of glucose levels.

Summary

Macroencapsulation is a potential solution to transplant beta cells without immunosuppression in diabetes patients, but new strategies must be developed to show that this approach is feasible.

     

Application of the qSOFA score to predict mortality in patients with suspected infection in a resource-limited setting in Malawi

Purpose

To determine the predictive value of qSOFA (quick Sequential Organ Failure Assessment) in Malawian patients with suspected infection.

Methods

Prospective observational study in a tertiary referral hospital in Malawi.

Results

Predictive ability of qSOFA was reasonable [AUROC 0.73 (95% CI 0.68–0.78)], increasing to 0.77 (95% CI 0.72–0.82) when classifying all patients with altered mental status as high risk. Adding HIV status as a variable to the qSOFA score did not improve predictive value.

Conclusion

qSOFA is a simple tool that can aid risk stratification in resource-limited settings.

     

Predictors of Insulin Initiation in Patients with Type 2 Diabetes: An Analysis of the Look AHEAD Randomized Trial

Background

The decision to initiate insulin in patients with type 2 diabetes is a challenging escalation of care that requires an individualized approach. However, the sociodemographic and clinical factors affecting insulin initiation are not well understood.

Objective

We sought to identify patient factors that were independent predictors of insulin initiation among participants in the Look AHEAD (Action for Health in Diabetes) clinical trial.

Design

Retrospective analysis of a randomized clinical trial.

Participants

Beginning in 2001, Look AHEAD enrolled ambulatory U.S. adults with type 2 diabetes who were overweight or obese and had a primary healthcare provider. Participants were randomized (1:1) to an intensive lifestyle intervention, or diabetes support and education. This study examined 3913 participants across the two trial arms who were not using insulin at baseline.

Main Measures

We used Cox proportional hazards models to estimate the association between participant characteristics and time to insulin initiation. We performed time-varying adjustment for HbA1c measured eight times over the 10-year study period, as well as for multiple clinical and socioeconomic factors.

Key Results

A total of 1087 participants (27.8%) initiated insulin during a median follow-up of 8.0 years. Age was inversely associated with insulin initiation (adjusted hazard ratio [aHR] 0.88 per 10 years, P?=?0.025). The risk of insulin initiation was greater with a higher number of diabetes complications (P?<?0.001 for trend); chronic kidney disease and cardiovascular disease were independently associated with insulin initiation. There was a lower risk of insulin initiation in black (aHR 0.77, P?=?0.008) and Hispanic participants (aHR 0.66, P?<?0.001) relative to white participants. Socioeconomic factors were not associated with insulin initiation.

Conclusions

Patient age, race/ethnicity, and diabetes complications may influence insulin initiation in type 2 diabetes, independent of glycemic control. Future work is needed to understand the drivers of racial differences in antihyperglycemic treatment, and to identify patients who benefit most from insulin.

     

Assessing Psychological Insulin Resistance in Type 2 Diabetes: a Critical Comparison of Measures

Purpose of Review

This study aims to examine the operationalisation of ‘psychological insulin resistance’ (PIR) among people with type 2 diabetes and to identify and critique relevant measures.

Recent Findings

PIR has been operationalised as (1) the assessment of attitudes or beliefs about insulin therapy and (2) hypothetical or actual resistance, or unwillingness, to use to insulin. Five validated PIR questionnaires were identified. None was fully comprehensive of all aspects of PIR, and the rigour and reporting of questionnaire development and psychometric validation varied considerably between measures.

Summary

Assessment of PIR should focus on the identification of negative and positive attitudes towards insulin use. Actual or hypothetical insulin refusal may be better conceptualised as a potential consequence of PIR, as its assessment overlooks the attitudes that may prevent insulin use. This paper provides guidance on the selection of questionnaires for clinical or research purpose and the development of new, or improvement of existing, questionnaires.

     

Circulatory Mechanotherapeutics: Moving with the Force

Purpose of Review

This review describes the current state of advancements in mechanical circulatory support (MCS) devices with significantly improved hemodynamic performance and decreased adverse events. Novel considerations for future MCS designs that impart spiral flow regimes will be detailed.

Recent Findings

Significant challenges in MCS device use have included size reduction, premature pump mechanical bearing failure, acquired bleeding disorders, and vascular complications related to high shear forces and jetting. Some of these problems have been improved upon, such as the use of magnetically levitated impellers and hydrodynamic bearings. The relative simplicity of continuous flow pumps has also enabled their miniaturization, portability, and reduced energy consumption. Recent studies by our group demonstrated that spiral forms of flow possess hemodynamically beneficial attributes at the MCS outflow cannula and aorta interface, reducing jet impact, organizing streamlines, and thereby improving endothelial function through wall shear stress modulation.

Summary

Despite MCS design improvements, they are far from perfect. Induced spiral fluid modulation may help address the known flow-mediated disturbances in vascular mechanobiology.

     

Comparative Effectiveness of Insulin versus Combination Sulfonylurea and Insulin: a Cohort Study of Veterans with Type 2 Diabetes

BACKGROUND

Type 2 diabetes patients often initiate treatment with a sulfonylurea and subsequently intensify their therapy with insulin. However, information on optimal treatment regimens for these patients is limited.

OBJECTIVE

To compare risk of cardiovascular disease (CVD) and hypoglycemia between sulfonylurea initiators who switch to or add insulin.

DESIGN

This was a retrospective cohort assembled using national Veterans Health Administration (VHA), Medicare, and National Death Index databases.

PARTICIPANTS

Veterans who initiated diabetes treatment with a sulfonylurea between 2001 and 2008 and intensified their regimen with insulin were followed through 2011.

MAIN MEASURES

The association between insulin versus sulfonylurea?+?insulin and time to CVD or hypoglycemia were evaluated using Cox proportional hazard models in a 1:1 propensity score-matched cohort. CVD included hospitalization for acute myocardial infarction or stroke, or cardiovascular mortality. Hypoglycemia included hospitalizations or emergency visits for hypoglycemia, or outpatient blood glucose measurements <60 mg/dL. Subgroups included age < 65 and ≥ 65 years and estimated glomerular filtration rate ≥ 60 and < 60 ml/min.

KEY FINDINGS

There were 1646 and 3728 sulfonylurea monotherapy initiators who switched to insulin monotherapy or added insulin, respectively. The 1596 propensity score-matched patients in each group had similar baseline characteristics at insulin initiation. The rate of CVD per 1000 person-years among insulin versus sulfonylurea?+?insulin users were 49.3 and 56.0, respectively [hazard ratio (HR) 0.85, 95 % confidence interval (CI) 0.64, 1.12]. Rates of first and recurrent hypoglycemia events per 1000 person-years were 74.0 and 100.0 among insulin users compared to 78.9 and 116.8 among sulfonylurea plus insulin users, yielding HR (95 % CI) of 0.94 (0.76, 1.16) and 0.87 (0.69, 1.10), respectively. Subgroup analysis results were consistent with the main findings.

CONCLUSIONS

Compared to sulfonylurea users who added insulin, those who switched to insulin alone had numerically lower CVD and hypoglycemia events, but these differences in risk were not statistically significant.

     

A retrospective study of viral central nervous system infections: relationship amongst aetiology,clinical course and outcome

Purpose

To describe the clinical pattern of viral central nervous system (CNS) infections and compare meningitis and encephalitis.

Methods

This is a retrospective study reporting the clinical characteristics and outcome of 138 cases of viral meningitis and meningoencephalitis in a real life experience at a referral centre in Turin, Northern Italy.

Results

Enteroviruses were predominant in younger patients who were mainly presenting with signs of meningitis, had shorter hospital admission and absence of complications, whereas herpesviruses had more often signs of encephalitis, were more frequent in elderly patients, had longer hospital admission and frequent complications and sequelae.

Conclusions

Two main clinical entities with different epidemiology, clinical aspects and prognosis may be identified within the group of viral CNS inefctions.

     

Gut Microbiome in Obesity,Metabolic Syndrome,and Diabetes

Purpose of Review

Obesity and diabetes are worldwide epidemics. There is also a growing body of evidence relating the gut microbiome composition to insulin resistance. The purpose of this review is to delineate the studies linking gut microbiota to obesity, metabolic syndrome, and diabetes.

Recent findings

Animal studies as well as proof of concept studies using fecal transplantation demonstrate the pivotal role of the gut microbiota in regulating insulin resistance states and inflammation.

Summary

While we still need to standardize methodologies to study the microbiome, there is an abundance of evidence pointing to the link between gut microbiome, inflammation, and insulin resistance, and future studies should be aimed at identifying unifying mechanisms.

     

Treatment of acute hepatitis C: recommendations from an expert panel of the Italian Society of Infectious and Tropical Diseases

Aim

This paper is aimed at providing practical recommendations for the management of acute hepatitis C (AHC).

Methods

This is an expert position paper based on the literature revision. Final recommendations were graded by level of evidence and strength of the recommendations.

Results

Treatment of AHC with direct-acting antivirals (DAA) is safe and effective; it overcomes the limitations of INF-based treatments.

Conclusions

Early treatment with DAA should be offered when available.

     

Artificial Pancreas or Novel Beta-Cell Replacement Therapies: a Race for Optimal Glycemic Control?

Purpose of Review

New treatment strategies are needed for patients with type 1 diabetes (T1D). Closed loop insulin delivery and beta-cell replacement therapy are promising new strategies. This review aims to give an insight in the most relevant literature on this topic and to compare the two radically different treatment modalities.

Recent Findings

Multiple clinical studies have been performed with closed loop insulin delivery devices and have shown an improvement in overall glycemic control and time spent in hypoglycemia. Beta-cell transplantation has been shown to normalize or greatly improve glycemic control in T1D, but the donor organ shortage and the necessity to use immunosuppressive agents are major drawbacks. Donor organ shortage may be solved by the utilization of stem cell-derived beta cells, which has shown great promise in animal models and are now tested in clinical studies. Immunosuppression may be avoided by encapsulation.

Summary

Closed loop insulin delivery devices are promising treatment strategies and are likely to be used in clinical practice in the short term. But this approach will always suffer from delays in glucose measurement and insulin action preventing it from normalizing glycemic control. In the long term, stem cell-derived beta cell transplantation may be able to achieve this, but wide implementation in clinical practice is still far away.

     

Sleep quality of mother-caregivers of Duchenne muscular dystrophy patients

Background

Sleep disturbance is a common problem for caregivers. In general, patients with Duchenne muscular dystrophy (DMD) use noninvasive ventilation to maintain quality of life and improve survival.

Objective

The aim of this study was to evaluate the sleep quality of caregiver-mothers of sons with DMD and factors that are associated with their sleep quality.

Methods

We evaluated 32 caregiver-mothers of sons with DMD and 32 mothers of sons without any neuromuscular or chronic disease (control—CTRL group). The evaluation of quality of sleep was made using the Pittsburgh Sleep Quality Index (PSQI).

Results

Caregiver-mothers had poor sleep quality, specifically longer sleep latency and reduced sleep efficiency. The impaired sleep quality of the caregiver-mothers was associated with the length of time of noninvasive ventilation used by their sons.

Conclusions

Our results suggest that caregiver-mothers of sons with DMD have poor quality of sleep, and the length of use of noninvasive ventilation of their sons is associated with better sleep of caregiver-mothers.

     

Effect of Pharmacist Counseling Intervention on Health Care Utilization Following Hospital Discharge: A Randomized Control Trial

Background

Reduction in 30-day readmission rates following hospitalization for acute coronary syndrome (ACS) and acute decompensated heart failure (ADHF) is a national goal.

Objective

The aim of this study was to determine the effect of a tailored, pharmacist-delivered, health literacy intervention on unplanned health care utilization, including hospital readmission or emergency room (ER) visit, following discharge.

Design

Randomized, controlled trial with concealed allocation and blinded outcome assessors

Setting

Two tertiary care academic medical centers

Participants

Adults hospitalized with a diagnosis of ACS and/or ADHF

Intervention

Pharmacist-assisted medication reconciliation, inpatient pharmacist counseling, low-literacy adherence aids, and individualized telephone follow-up after discharge

Main Measures

The primary outcome was time to first unplanned health care event, defined as hospital readmission or an ER visit within 30 days of discharge. Pre-specified analyses were conducted to evaluate the effects of the intervention by academic site, health literacy status (inadequate versus adequate), and cognition (impaired versus not impaired). Adjusted hazard ratios (aHR) and 95 % confidence intervals (CI) are reported.

Key Results

A total of 851 participants enrolled in the study at Vanderbilt University Hospital (VUH) and Brigham and Women’s Hospital (BWH). The primary analysis showed no statistically significant effect on time to first unplanned hospital readmission or ER visit among patients who received interventions compared to controls (aHR?=?1.04, 95 % CI 0.78-1.39). There was an interaction of treatment effect by site (p?=?0.04 for interaction); VUH aHR?=?0.77, 95 % CI 0.51-1.15; BWH aHR?=?1.44 (95 % CI 0.95-2.12). The intervention reduced early unplanned health care utilization among patients with inadequate health literacy (aHR 0.41, 95 % CI 0.17-1.00). There was no difference in treatment effect by patient cognition.

Conclusion

A tailored, pharmacist-delivered health literacy-sensitive intervention did not reduce post-discharge unplanned health care utilization overall. The intervention was effective among patients with inadequate health literacy, suggesting that targeted practice of pharmacist intervention in this population may be advantageous.