Lower Extremity Amputation in Fracture-Related Infection.

OBJECTIVES: To analyze demographics, comorbidities, fracture characteristics, presenting characteristics, microbiology, and treatment course of patients with fracture-related infections (FRIs) to determine risk factors leading to amputation. DESIGN: Retrospective cohort. SETTING: Single Level I Trauma Center (2013-2020). PATIENT SELECTION CRITERIA: Adults with lower extremity (femur and tibia) FRIs were identified through a review of an institutional database. Inclusion criteria were operatively managed fracture of the femur or tibia with an FRI and adequate documentation present in the electronic medical record. This included patients whose primary injury was managed at this institution and who were referred to this institution after the onset of FRI as long as all characteristics and risk factors assessed in the analysis were documented. Exclusion criteria were infected chronic osteomyelitis from a non-fracture-related pathology and a follow-up of less than 6 months. OUTCOME MEASURES AND COMPARISONS: Risk factors (demographics, comorbidities, and surgical, injury, and perioperative characteristics) leading to amputation in patients with FRIs were evaluated. RESULTS: A total of 196 patients were included in this study. The average age of the study group was 44±16 years. Most patients were men (63%) and White (71%). The overall amputation rate was 9.2%. There were significantly higher rates of chronic kidney disease (CKD; P = 0.039), open fractures (P = 0.034), transfusion required during open reduction internal fixation (P = 0.033), Gram-negative infections (P = 0.048), and FRI-related operations (P = 0.001) in the amputation cohort. On multivariate, patients with CKD were 28.8 times more likely to undergo amputation (aOR = 28.8 [2.27 to 366, P = 0.010). A subanalysis of 79 patients with either a methicillin-sensitive Staphylococcus aureus or methicillin-resistant S. aureus (MRSA) infection showed that patients with MRSA were significantly more likely to undergo amputation compared with patients with methicillin-sensitive Staphylococcus aureus (P = 0.031). MRSA was present in all cases of amputation in the Staphylococcal subanalysis. CONCLUSIONS: Findings from this study highlight CKD as a risk factor of amputation in the tibia and femur with fracture-related infection. In addition, MRSA was present in all cases of Staphylococcal amputation. Identifying patients and infection patterns that carry a higher risk of amputation can assist surgeons in minimizing the burden on these individuals. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

A Practical Framework for Novel Electronic Nicotine Delivery System Evaluation: Chemical and Toxicological Characterization of JUUL2 Aerosol and Comparison with Reference Cigarettes.

Electronic nicotine delivery systems (ENDSs) are designed as a non-combustible alternative to cigarettes, aiming to deliver nicotine without the harmful byproducts of tobacco combustion. As the category evolves and new ENDS products emerge, it is important to continually assess the levels of toxicologically relevant chemicals in the aerosols and characterize any related toxicology. Herein, we present a proposed framework for characterizing novel ENDS products (i.e., devices and formulations) and determining the reduced risk potential utilizing analytical chemistry and in vitro toxicological studies with a qualitative risk assessment. To demonstrate this proposed framework, long-term stability studies (12 months) analyzing relevant toxicant emissions from six formulations of a next-generation product, JUUL2, were conducted and compared to reference combustible cigarette (CC) smoke under both non-intense and intense puffing regimes. In addition, in vitro cytotoxicity, mutagenicity, and genotoxicity assays were conducted on aerosol and smoke condensates. In all samples, relevant toxicants under both non-intense and intense puffing regimes were substantially lower than those observed in reference CC smoke. Furthermore, neither cytotoxicity, mutagenicity, nor genotoxicity was observed in aerosol condensates generated under both intense and non-intense puffing regimes, in contrast to results observed for reference cigarettes. Following the proposed framework, the results demonstrate that the ENDS products studied in this work generate significantly lower levels of toxicants relative to reference cigarettes and were not cytotoxic, mutagenic, or genotoxic under these in vitro assay conditions.

The Impact of Smoking on Hospital Course and Postoperative Outcomes in Patients With Fracture-Related Infections.

OBJECTIVES: To assess the relationship between patient smoking status and fracture-related infection (FRI) characteristics including patient symptoms at FRI presentation, bacterial species of FRI, and rates of fracture union. DESIGN: Retrospective cohort study. SETTING: Urban level 1 trauma center. PATIENT SELECTION CRITERIA: All patients undergoing reoperation for FRI from January 2013 to April 2021 were identified through manual review of an institutional database. OUTCOME MEASURES AND COMPARISONS: Data including patient demographics, fracture characteristics, infection presentation, and hospital course were collected through review of the electronic medical record. Patients were grouped based on current smoker versus nonsmoker status. Hospital course and postoperative outcomes of these groups were then compared. Risk factors of methicillin-resistant Staphylococcus aureus (MRSA) infection, Staphylococcus epidermidis infection, and sinus tract development were evaluated using multivariable logistic regression. RESULTS: A total of 301 patients, comprising 155 smokers (51%) and 146 nonsmokers (49%), undergoing FRI reoperation were included. Compared with nonsmokers, smokers were more likely male (69% vs. 56%, P = 0.024), were younger at the time of FRI reoperation (41.7 vs. 49.5 years, P < 0.001), and had lower mean body mass index (27.2 vs. 32.0, P < 0.001). Smokers also had lower prevalence of diabetes mellitus (13% vs. 25%, P = 0.008) and had higher Charlson Comorbidity Index 10-year estimated survival (93% vs. 81%, P < 0.001). Smokers had a lower proportion of S. epidermidis infections (11% vs. 20%, P = 0.037), higher risk of nonunion after index fracture surgery (74% vs. 61%, P = 0.018), and higher risk of sinus tracts at FRI presentation (38% vs. 23%, P = 0.004). On multivariable analysis, smoking was not found to be associated with increased odds of MRSA infection. CONCLUSIONS: Among patients who develop a FRI, smokers seemed to have better baseline health regarding age, body mass index, diabetes mellitus, and Charlson Comorbidity Index 10-year estimated survival compared with nonsmokers. Smoking status was not significantly associated with odds of MRSA infection. However, smoking status was associated with increased risk of sinus tract development and nonunion and lower rates of S. epidermidis infection at the time of FRI reoperation. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Corrigendum: Analytical approaches for the evaluation of data deficient simulated leachable compounds in ENDS products: a case study.

[This corrects the article DOI: 10.3389/fchem.2023.1212744.].

Analytical approaches for the evaluation of data deficient simulated leachable compounds in ENDS products: a case study.

Leachable investigations are routinely undertaken across a range of sectors (e.g., pharmaceuticals, medical devices, etc.) to determine whether chemicals from a container closure system transfer into a product under normal conditions of use. For Electronic Nicotine Delivery Systems (ENDS) the container closure system includes all materials in contact with the e-liquid that is aerosolized and subsequently inhaled by the user. Currently, there is no guidance for conducting leachable studies for ENDS products, however, there are relevant guidance documents for orally inhaled drug products that can be applied to an ENDS container closure system. We present a case study of the analytical investigation of two leachable compounds identified in simulated leachable studies using aged JUULpods filled with unflavored e-liquid (PG/VG/nicotine/benzoic acid). Both compounds had limited toxicological information and were considered data deficient. A qualitative analysis of the aerosol collected from aged commercial JUULpods (Virginia Tobacco and Menthol), using a similar analytical method (LC-MS/MS) used in the simulated leachable studies, showed no trace or detectable levels of either leachable compound. Therefore, this qualitative analysis did not provide semi-quantitative values for the data-deficient leachable compounds necessary to support toxicological risk assessment. Further, no commercial authentic standards or reasonable synthetic route were available due to the molecular size and structural complexity of the compounds. Instead, method limits were established using an alternative approach to standard ICH guidelines. The experimentally determined method limit of quantitation, using spiked samples of simulated leachable e-liquid, provided conservative semi-quantitative values for each data deficient leachable compound in the aerosol that enabled a transfer efficiency from e-liquid to aerosol to be estimated. The transfer efficiency of each leachable compound was experimentally determined to be less than 2% based on the limit of quantitation, which then could be used to define a relevant exposure limit for the toxicological risk assessment. This work details a novel analytical approach for determining the transfer efficiency of data deficient leachable compounds from ENDS container closure systems into the ENDS aerosol to support toxicological health risk assessments.

The incidence of shoulder arthroplasty infection presents a substantial economic burden in the United States: a predictive model.

Background: Periprosthetic joint infections (PJIs) are a major cause of morbidity after shoulder arthroplasty. Prior national database studies have estimated the trends of shoulder PJI up to 2012.21 Since 2012, the landscape of shoulder arthroplasty has changed drastically with the expanding popularity of reverse total shoulder arthroplasty. The dramatic growth in primary shoulder arthroplasties is likely paralleled with an increase of PJI case volume. The purpose of this study is to quantify the rise in shoulder PJIs and the economic stress they currently place on the American healthcare system as well as the toll they will incur over the coming decade. Methods: The Nationwide Inpatient Sample database was queried for primary and revision anatomic total shoulder arthroplasty, reverse total shoulder arthroplasty, and hemiarthroplasty from 2011-2018. Multivariate regression was used to predict cases and charges through the year 2030 adjusted to 2021 purchasing power parity. Results: From 2011 to 2018, PJI was found to be 1.1% shoulder arthroplasties, from 0.8% (2011) to 1.4% (2018). Anatomic total shoulder arthroplasty experienced the greatest proportion of infections at 2.0%, followed by hemiarthroplasty at 1.0% and reverse total shoulder arthroplasty at 0.3%. Total hospital charges grew 324%, from $44.8 million (2011) to $190.3 million (2018). Our regression model projects 176% growth in cases and 141% growth in annual charges by 2030. Conclusion: This study demonstrates the large economic burden that shoulder PJIs pose on the American healthcare system, which is predicted to reach nearly $500 million in charges annually by 2030. Understanding trends in procedure volume and hospital charges will be critical in evaluating strategies to reduce shoulder PJIs.

Issues for recruitment and retention of clinical research professionals at academic medical centers: Part 1 - collaborative conversations Un-Meeting findings.

Background: Identification of evidence-based factors related to status of the clinical research professional (CRP) workforce at academic medical centers (AMCs) will provide context for National Center for Advancing Translational Science (NCATS) policy considerations and guidance. The objective of this study is to explore barriers and opportunities related to the recruitment and retention of the CRP workforce. Materials and Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore barriers and recommendations for improving AMC CRP recruitment, retention and diversity. Results: While certain institutions have established competency-based frameworks for job descriptions, standardization remains generally lacking across CTSAs. AMCs report substantial increases in unfilled CRP positions leading to operational instability. Data confirmed an urgent need for closing gaps in CRP workforce at AMCs, especially for attracting, training, retaining, and diversifying qualified personnel. Improved collaboration with human resource departments, engagement with principal investigators, and overcoming both organizational and resource challenges were suggested strategies, as well as development of outreach to universities, community colleges, and high schools raising awareness of CRP career pathways. Discussion: Based on input from 130 CRP leaders at 35 CTSAs, four National Institute of General Medical Sciences' Institutional Development Award (IDeA) program sites, along with industry and government representatives, we identified several barriers to successful recruitment and retention of a highly trained and diverse CRP workforce. Results, including securing institutional support, champions, standardizing and adopting proven national models, improving local institutional policies to facilitate CRP hiring and job progression point to potential solutions.

The Un-meeting approach to stimulate collaborative adult learning: an application for clinical research professionals.

We used a Zoom Un-meeting as an educational approach to provide experienced clinical research professional (CRP) adult learners a collaborative learning space to learn more about current issues for academic medical center (AMC) clinical research workforce development and collaborate on solution finding. CRPs operationalize the conduct of clinical trials and represent a significant brain trust for the Clinical and Translational Science (CTSA) consortium hubs with their vast knowledge base, extensive experience, understanding of relevant institutional policy, organizational culture, and clinical research operations. Un-meetings are an intentionally organized and coordinated group activity that encourages participants to focus on a topic and incorporate an open flow of ideas through brainstorming and an open discussion format, setting the stage for future collaborative action. We divided topics into a series of six consecutive monthly Un-meeting Zoom workshops. Ultimately, one resulting output from the meeting was the Center for Leading Innovation and Collaborations (CLIC) synergy paper award to support continued collaborative work. Currently, work teams have emerged to analyze qualitative data from brainstorming and breakout session recordings and to identify small-group activities. We describe this adult learning tool as valuable for exploring issues of AMC CRP professional development. This approach encouraged creative/critical thinking and opportunities for leadership, team science, and problem-solving among participants.

Branched chain amino acids selectively promote cardiac growth at the end of the awake period.

Essentially all biological processes fluctuate over the course of the day, manifesting as time-of-day-dependent variations with regards to the way in which organ systems respond to normal behaviors. For example, basic, translational, and epidemiologic studies indicate that temporal partitioning of metabolic processes governs the fate of dietary nutrients, in a manner in which concentrating caloric intake towards the end of the day is detrimental to both cardiometabolic and cardiovascular parameters. Despite appreciation that branched chain amino acids impact risk for obesity, diabetes mellitus, and heart failure, it is currently unknown whether the time-of-day at which dietary BCAAs are consumed influence cardiometabolic/cardiovascular outcomes. Here, we report that feeding mice a BCAA-enriched meal at the end of the active period (i.e., last 4 h of the dark phase) rapidly increases cardiac protein synthesis and mass, as well as cardiomyocyte size; consumption of the same meal at the beginning of the active period (i.e., first 4 h of the dark phase) is without effect. This was associated with a greater BCAA-induced activation of mTOR signaling in the heart at the end of the active period; pharmacological inhibition of mTOR (through rapamycin) blocked BCAA-induced augmentation of cardiac mass and cardiomyocyte size. Moreover, genetic disruption of the cardiomyocyte circadian clock abolished time-of-day-dependent fluctuations in BCAA-responsiveness. Finally, we report that repetitive consumption of BCAA-enriched meals at the end of the active period accelerated adverse cardiac remodeling and contractile dysfunction in mice subjected to transverse aortic constriction. Thus, our data demonstrate that the timing of BCAA consumption has significant implications for cardiac health and disease.

Implementation of the Navajo fruit and vegetable prescription programme to improve access to healthy foods in a rural food desert.

OBJECTIVE: To utilise a community-based participatory approach in the design and implementation of an intervention targeting diet-related health problems on Navajo Nation. DESIGN: A dual strategy approach of community needs/assets assessment and engagement of cross-sectorial partners in programme design with systematic cyclical feedback for programme modifications. SETTING: Navajo Nation, USA. PARTICIPANTS: Navajo families with individuals meeting criteria for programme enrolment. Participant enrolment increased with iterative cycles. RESULTS: The Navajo Fruit and Vegetable Prescription (FVRx) Programme. CONCLUSIONS: A broad, community-driven and culturally relevant programme design has resulted in a programme able to maintain core programmatic principles, while also allowing for flexible adaptation to changing needs.

Correction to: Glycemic control and healthcare utilization following pregnancy among women with pre-existing diabetes in Navajo Nation.

In the original publication of this article [1] an author's name needs to be revised from Katrina Nelson to Adrianne Katrina Nelson.

Glycemic control and healthcare utilization following pregnancy among women with pre-existing diabetes in Navajo Nation.

BACKGROUND: Native American communities experience greater burden of diabetes than the general population, including high rates of Type 2 diabetes among women of childbearing age. Diabetes in pregnancy is associated with risks to both the mother and offspring, and glycemic control surrounding the pregnancy period is of vital importance. METHODS: A retrospective chart review was conducted at a major Navajo Area Indian Health Service (IHS) hospital, tracking women with pre-existing diabetes who became pregnant between 2010 and 2012. Logistic regression was performed to find patient-level predictors of our desired primary outcome-having hemoglobin A1c (HbA1c) consistently < 8% within 2 years after pregnancy. Descriptive statistics were generated for other outcomes, including glycemic control and seeking timely IHS care. RESULTS: One hundred twenty-two pregnancies and 114 individuals were identified in the dataset. Baseline HbA1c was the only covariate which predicted our primary outcome (OR = 1.821, 95% CI = 1.184-2.801). Examining glycemic control among pregnancies with complete HbA1c data (n = 59), 59% were controlled before, 85% during, and 34% after pregnancy. While nearly all women received care in the immediate postpartum period, only 49% of women visited a primary care provider and 71% had HbA1c testing in the 2 years after pregnancy. CONCLUSIONS: This is the first analysis of outcomes among women with diabetes in pregnancy in Navajo Nation, the largest reservation and tribal health system in the United States. Our findings demonstrate the positive impact of specialized prenatal care in achieving glycemic control during pregnancy, while highlighting the challenges in maintaining glycemic control and continuity of healthcare after pregnancy.

Evaluation of a Free Milk in Schools Program in New Zealand: Effects on Children's Milk Consumption and Anthropometrics.

BACKGROUND: While dietary sources of calcium are important for bone health, the intake of milk and milk products decreases as children get older. A free milk in schools program may mitigate this decrease in milk consumption. We evaluated the Fonterra Milk for schools program (a free milk initiative) by determining changes in children's milk consumption and anthropometric measures over a 2-year period. METHODS: The evaluation was conducted in children aged 7-9 years in a representative sample of primary schools participating in the free milk program, in Auckland, New Zealand. The primary outcome was the proportion of children meeting the New Zealand guidelines for dairy and milk product consumption over 7 days (≥2 servings per day). Changes in anthropometric measures were also assessed as secondary outcomes. RESULTS: Nine schools (N = 511 children) participated in the evaluation. The proportion of children meeting the New Zealand guidelines for milk and milk product consumption over 7 days increased significantly from baseline to 2 years' follow-up (72% vs 94%; p < .001). Body mass index z scores did not change significantly between baseline and 2 years' follow-up. CONCLUSIONS: The Fonterra Milk for Schools initiative appears to be an effective way of increasing milk/milk product consumption behaviors in school-aged children.

Premature Mortality From Noncommunicable Diseases in the Federated States of Micronesia, 2003-2012.

This study was conducted to assess status, and understand burden, of premature and leading causes of deaths from noncommunicable diseases (NCDs) in the Federated States of Micronesia (FSM). From 2003 to 2012, ICD-10 coded mortality data from the national Health Information System were analyzed. Proportional mortality was calculated and a ranking list of the leading causes of premature death was produced. Of the 2349 premature deaths reported, 1970 (83.9%) were due to NCDs, and 1680 (71.5%) were from 4 main NCD groups-cardiovascular diseases, cancer, diabetes, and chronic respiratory diseases. Diabetes (19.5%), ischemic heart diseases (13.2%), and cerebrovascular diseases (7.1%) were the leading causes of premature deaths. The findings indicate that the burden of premature NCD deaths in FSM is higher than global levels, and existing efforts need to be strengthened to alter their course.

Text message-based diabetes self-management support (SMS4BG): study protocol for a randomised controlled trial.

BACKGROUND: Addressing the increasing prevalence, and associated disease burden, of diabetes is a priority of health services internationally. Interventions to support patients to effectively self-manage their condition have the potential to reduce the risk of costly and debilitating complications. The utilisation of mobile phones to deliver self-management support allows for patient-centred care at the frequency and intensity that patients desire from outside the clinic environment. Self-Management Support for Blood Glucose (SMS4BG) is a novel text message-based intervention for supporting people with diabetes to improve self-management behaviours and achieve better glycaemic control and is tailored to individual patient preferences, demographics, clinical characteristics, and culture. This study aims to assess whether SMS4BG can improve glycaemic control in adults with poorly controlled diabetes. This paper outlines the rationale and methods of the trial. METHODS/DESIGN: A two-arm, parallel, randomised controlled trial will be conducted across New Zealand health districts. One thousand participants will be randomised at a 1:1 ratio to receive SMS4BG, a theoretically based and individually tailored automated text message-based diabetes self-management support programme (intervention) in addition to usual care, or usual care alone (control). The primary outcome is change in glycaemic control (HbA1c) at 9 months. Secondary outcomes include glycaemic control at 3 and 6 months, self-efficacy, self-care behaviours, diabetes distress, health-related quality of life, perceived social support, and illness perceptions. Cost information and healthcare utilisation will also be collected as well as intervention satisfaction and interaction. DISCUSSION: This study will provide information on the effectiveness of a text message-based self-management support tool for people with diabetes. If found to be effective it has the potential to provide individualised support to people with diabetes across New Zealand (and internationally), thus extending care outside the clinic environment. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12614001232628 .

Mortality and life expectancy in Kiribati based on analysis of reported deaths.

BACKGROUND: Kiribati is an atoll country of 103,058 (2010 Census) situated in the central Pacific. Previous mortality estimates have been derived from demographic analyses of census data. This is the first mortality analysis based on reported deaths. METHODS: Recorded deaths were from the Ministry of Health and the Civil Registration Office for 2000-2009; populations were from the 2000, 2005, and 2010 censuses. Duplicate death records were removed by matching deaths within and between data sources using a combination of names, date of death, age, sex, island of residence, and cause of death. Probability of dying <5 years (5q0) and 15-59 years (45q15), and life expectancy (LE) at birth, were computed with 95 % confidence intervals. These data were compared with previous census analyses. RESULTS: There were 8,681 unique deaths reported over the decade 2000-2009 in Kiribati. The reconciled mortality data indicate 5q0 for both sexes of 64 per 1,000 live births in 2000-2004, and 51 for 2005-2009 (assuming no under-enumeration), compared with 69 and 59 for comparable periods from the 2005 and 2010 census analyses (children ever-born/children surviving method). Based on reconciled deaths, LE at birth (e0) for males was 54 years for 2000-2004 and 55 years in 2005-2009, five years lower than the 2005 and 2010 census estimates for comparable periods of 59 and 58 years. Female LE was 62 years for 2000-2004 and 63 years for 2005-2009, two-three years less than estimates for comparable periods of 63 and 66 years from the 2005 and 2010 census analyses. Adult mortality (45q15) was 47-48 % in males and 27-28 % in females from reconciled mortality over 2000-2009, higher than census estimates of 34-38 % in males and 21-26 % in females for the same periods. The reconciled data are very likely to be incomplete and actual mortality higher and life expectancy lower than reported here. CONCLUSION: This analysis indicates higher mortality than indirect demographic methods from the 2005 and 2010 Censuses. Reported deaths are most likely under-reported; especially 5q0, as many early neonatal deaths are probably classified as stillbirths. These analyses suggest that the health situation in Kiribati is more serious and urgent than previously appreciated.

Causes of death in Vanuatu.

BACKGROUND: The population of the Pacific Melanesian country of Vanuatu was 234,000 at the 2009 census. Apart from subsistence activities, economic activity includes tourism and agriculture. Current completeness of vital registration is considered too low to be usable for national statistics; mortality and life expectancy (LE) are derived from indirect demographic estimates from censuses/surveys. Some cause of death (CoD) data are available to provide information on major causes of premature death. METHODS: Deaths 2001-2007 were coded for cause (ICDv10) for ages 0-59 years from: hospital separations (HS) (n = 636), hospital medical certificates (MC) of death (n = 1,169), and monthly reports from community health facilities (CHF) (n = 1,212). Ill-defined causes were 3 % for hospital deaths and 20 % from CHF. Proportional mortality was calculated by cause (excluding ill-defined) and age group (0-4, 5-14 years), and also by sex for 15-59 years. From total deaths by broad age group and sex from 1999 and 2009 census analyses, community deaths were estimated by deduction of hospital deaths MC. National proportional mortality by cause was estimated by a weighted average of MC and CHF deaths. RESULTS: National estimates indicate main causes of deaths <5 years were: perinatal disorders (45 %) and malaria, diarrhea, and pneumonia (27 %). For 15-59 years, main causes of male deaths were: circulatory disease 27 %, neoplasms 13 %, injury 13 %, liver disease 10 %, infection 10 %, diabetes 7 %, and chronic respiratory disease 7 %; and for females: neoplasms 29 %, circulatory disease 15 %, diabetes 10 %, infection 9 %, and maternal deaths 8 %. Infection included tuberculosis, malaria, and viral hepatitis. Liver disease (including hepatitis and cancer) accounted for 18 % of deaths in adult males and 9 % in females. Non-communicable disease (NCD), including circulatory disease, diabetes, neoplasm, and chronic respiratory disease, accounted for 52 % of premature deaths in adult males and 60 % in females. Injuries accounted for 13 % in adult males and 6 % in females. Maternal deaths translate into an annual maternal mortality ratio of 130/100,000 for the period. CONCLUSION: Vanuatu manifests a double burden of disease with significant proportional mortality from perinatal disorders and infection/pneumonia <5 years and maternal mortality, coupled with significant proportional mortality in adults (15-59 years) from cardiovascular disease (CVD), neoplasms, and diabetes.

Reduction of inflammation and preservation of neurological function by anti-CD52 therapy in murine experimental autoimmune encephalomyelitis.

Alemtuzumab, a monoclonal antibody directed against human CD52, is used in the treatment of MS. To characterize the impact of anti-CD52 administration, a monoclonal antibody to mouse CD52 (anti-muCD52) was generated and evaluated in EAE mouse models of MS. A single course of anti-muCD52 provided a therapeutic benefit accompanied by a reduction in the frequency of autoreactive T lymphocytes and production of pro-inflammatory cytokines. Examination of the CNS revealed a decrease in infiltrating lymphocytes, demyelination and axonal loss. Electrophysiological assessment showed preservation of axonal conductance in the spinal cord. These findings suggest that anti-CD52 therapy may help preserve CNS integrity.

Acceptability of a mobile health exercise-based cardiac rehabilitation intervention: a randomized trial.

BACKGROUND: Mobile technologies (mHealth) have recently been used to deliver behavior change interventions; however, few have investigated the application of mHealth for treatment of ischemic heart disease (IHD). The Heart Exercise And Remote Technologies trial examined the effectiveness of an mHealth intervention to increase exercise behavior in adults with IHD. As a part of this trial, a process evaluation was conducted. METHODS: One hundred seventy-one adults with IHD were randomized to receive a 6-month mHealth intervention (n = 85) plus usual care or usual care alone (n = 86). The intervention delivered a theory-based, automated package of exercise prescription and behavior change text messages and a supporting Web site. Three sources of data were triangulated to assess intervention participant perceptions: (1) Web site usage statistics; (2) feedback surveys; and (3) semistructured exit interviews. Descriptive information from survey and Web data were merged with qualitative data and analyzed using a semantic thematic approach. RESULTS: At 24 weeks, all intervention participants provided Web usage statistics, 75 completed the feedback survey, and 17 were interviewed. Participants reported reading the text messages (70/75; 93%) and liked the content (55/75; 73%). The program motivated participants to exercise. Several suggestions to improve the program included further tailoring of the content (7/75; 7%) and increased personal contact (10/75; 13%). CONCLUSIONS: Adults with IHD were able to use an mHealth program and reported that text messaging is a good way to deliver exercise information. While mHealth is designed to be automated, programs might be improved if content and delivery were tailored to individual needs.

Diabetes Text-Message Self-Management Support Program (SMS4BG): A Pilot Study.

BACKGROUND: The increasing prevalence of diabetes and costly long-term complications associated with poor glycemic control are issues facing health services worldwide. Diabetes self-management, with the support of health care providers, is critical for successful outcomes, however, frequent clinical contact is costly. Text messages via short message service (SMS) have the advantage of instant transmission at low cost and, given the ubiquity of mobile phones, may be the ideal platform for the delivery of diabetes self-management support. A tailored text message-based diabetes support intervention called Self-Management Support for Blood Glucose (SMS4BG) was developed. The intervention incorporates prompts around diabetes education, management, and lifestyle factors (healthy eating, exercise, and stress management), as well as blood glucose monitoring reminders, and is tailored to patient preferences and clinical characteristics. OBJECTIVE: To determine the usability and acceptability of SMS4BG among adults with poorly controlled diabetes. METHODS: Adults (aged 17 to 69 years) with type 1 (n=12) or type 2 diabetes (n=30), a hemoglobin A1c (HbA1c) over 70 mmol/mol (8.6%), and who owned a mobile phone (n=42) were recruited to take part in a 3-month pilot study of SMS4BG. At registration, participants selected the modules they would like to receive and, where appropriate, the frequency and timing of blood glucose monitoring reminders. Patient satisfaction and perceptions of the usability of the program were obtained via semistructured phone interviews conducted at completion of the pilot study. HbA1c was obtained from patient records at baseline and completion of the pilot study. RESULTS: Participants received on average 109 messages during the 3-month program with 2 participants withdrawing early from the study. Follow-up interviews were completed with 93% of participants with all reporting SMS4BG to be useful and appropriate to their age and culture. Participants reported a range of perceived positive impacts of SMS4BG on their diabetes and health behaviors. HbA1c results indicated a positive impact of the program on glycemic control with a significant decrease in HbA1c from baseline to follow-up. CONCLUSIONS: A tailored text message-based intervention is both acceptable and useful in supporting self-management in people with poorly controlled diabetes. A randomized controlled trial of longer duration is needed to assess the efficacy and sustainability of SMS4BG.