Synthesis and cytotoxic evaluation of benzoxazole/benzothiazole-2-imino-coumarin hybrids and their coumarin analogues as potential anticancer agents.

Two series of 2-imino-coumarin based hybrids: 3-(benzoxazol-2-yl)-2H-chromen-2-imines 3-9 (series A-I) and 3-(benzothiazol-2-yl)-2H-chromen-2-imines 10-16 (series A-II), as well as their coumarin analogues: 3-(benzoxazol-2-yl)-2H-chromen-2-ones 17-21 (series B-I) and 3-(benzothiazol-2-yl)-2H-chromen-2-ones 22-28 (series B-II) were prepared as potential antitumor agents. The in vitro cytotoxic potency of the synthesized compounds was evaluated against five human cancer cell lines: DAN-G, A-427, LCLC-103H, RT-4 and SISO, and relationships between structure and anticancer activity are discussed. Among the compounds tested, 3-(benzo[d] oxazol-2-yl)-N,N-diethyl-2-imino-2H-chromen-7-amine (6, series A-I) and 3-(benzo[d]thiazol-2-yl)-6-fluoro-2H-chromen-2-one (26, series B-II) exhibited the most potent cytotoxic activity with IC50 values ranging from <0.01 µM to 1.1 µM. In particular, compound 6 demonstrated remarkable cytotoxicity against the A-427 ovarian cancer, the lung cancer LCLC-103H, urinary bladder cancer RT-4 and cervical cancer SISO cell lines with IC50 <0.01-0.30µM, inducing apoptosis in two representative cell lines.

[Preclinical safety evaluation of chloral hydrate after topical application using the example of psoriatic itch]. / Präklinische Validierung der Sicherheit von Chloralhydrat zur topischen Applikation am Beispiel des psoriatischen Pruritus.

BACKGROUND: Psoriasis is known today as a T­cell-mediated autoimmunological systemic disease. The chronic inflammatory processes involve neuroimmunological factors that are held responsible not only for various aspects of psychiatric-neurological comorbidities but also for neurosensory problems, primarily itching. Amongst other things, the significance of GABAA receptors are often discussed in this context. The topical use of chloral hydrate in semisolid preparations for antipruritic therapy goes back to Neisser and is currently experiencing a revival in individually manufactured formulations. However, it is currently unknown whether the unwanted side effects that are described for systemic use of chloral hydrate are also relevant for topical application. OBJECTIVES: For lack of clinical safety data, preclinical tests for cutaneous cytotoxicity and calculations for systemic bioavailability after topical application have been performed. CONCLUSION: The present data cannot fully remove safety concerns for topical application of chloral hydrate in the formulation favoured by the NRF (Neues Rezepturformularium)-the so-called 1­2-3-cream. A twice daily use of the 1­2-3-cream on a maximum of 10% of the body surface can be regarded as safe. For a better assessment of harmlessness, tests for cutaneous bioavailability (concentration-time profile) on human skin and clinical studies would be necessary.

Management practices on organic and conventional dairy herds in Minnesota.

The objective of this study was to describe and compare husbandry practices on organic and conventional dairy farms of similar sizes in Minnesota. Organic (ORG, n=35), same-sized conventional (SC, n=15, <200 cows) and medium-sized conventional (MC, n=13, ≥200 cows) dairy herds were visited in 2012, and farmers were interviewed once about their farm, herd demographics, and herd management practices concerning nutrition, housing, and reproductive programs. Organic farms had been established as long as conventional farms, and ORG producers had most commonly selected ORG farming because of a negative perception of pesticides for human health. The distribution of cattle breeds and ages differed across farm types. Organic farms had more crossbred cows and a greater number of older cows than conventional farms, who had mainly Holstein cattle. Organic farms did not dock tails, were more likely to use breeding bulls, and were less likely to conduct pregnancy diagnoses in cattle. All conventional farmers fed corn, corn silage, and hay, but no forage or feed supplement was fed by all ORG farms with the exception of pasture. Kelp was supplemented on most ORG farms but on none of the conventional farms. In summary, although there were differences across farm types regarding the use of pasture, feeds, and feed additives, breed and age distribution, reproductive management, and the use of tail docking, observations in other management areas showed large overlap across herd types.

[Epidermal aging and anti-aging strategies]. / Epidermale Alternsprozesse und Anti-Aging-Strategien.

Epithelial senescence is a complex process depending on intrinsic as well as extrinsic factors (e.g., UV or IR light, tobacco smoke) and must be seen in the context of the aging process especially of the corium and the subcutis. Morphological alterations become apparent in the form of epithelial atrophy, structural changes within the basal membrane, and a decrease in cell count of melanocytes and Langerhans cells. Signs of cellular senescence are reduced proliferation of keratinocytes, cumulation of dysplastic keratinocytes, various mutations (e.g., c-Fos/c-Jun, STAT3, FoxO1), as well as multiple lipid or amino acid metabolic aberrations (e.g., production of advanced glycation endproducts). This causes functional changes within the physical (lipid deficiency, water distribution dysfunction, lack of hygroscopic substances), chemical (pH conditions, oxygen radicals), and immunological barrier. Prophylactically, barrier-protective care products, antioxidant substances (e.g., vitamin C, B3, E, polyphenols, flavonoids), sunscreen products/measurements, and retinoids are used. For correcting alterations in aged epidermis, chemical peelings (fruit acids, ß-hydroxy acid, trichloroacetic acid, phenolic compounds), non-ablative (IPL, PDL, Nd:YAG) as well as ablative (CO2, Erbium-YAG) light-assisted methods are used.

Parasites and parasite management practices of organic and conventional dairy herds in Minnesota.

The objective of this study was to describe the prevalence and practices used to manage internal helminth parasites and external arthropod parasites on organic and conventional dairy herds in Minnesota. All organic (ORG) dairy herds in Minnesota (n=114) and a convenience sample of conventional herds were invited to participate in the study. Thirty-five ORG herds and 28 conventional herds were visited once in summer and fall of 2012. Conventional dairy herds were split into small conventional (SC,<200 cows) and medium-sized conventional herds (MC, ≥200 cows) so that SC herds were comparable in size to the ORG herds. Dairy managers were surveyed to assess their farm management practices and perceptions about parasites, hygiene scores were recorded for adult stock, and fecal samples were collected from a nominal 20 breeding-age heifers to characterize abundance of internal parasites. Nonparametric tests were used to compare fecal egg counts per gram (FEC) among farms grouped by management systems and practices. Organic farms had more designated pasture and were more likely to use rotational grazing compared with conventional farms, but the stocking densities of animals on pasture were similar among farm types. The overall FEC were very low, and only a few individual ORG heifers had FEC >500 eggs/gram. Samples from heifers on ORG farms had significantly more strongyle-type eggs than those on SC and MC farms (ORG: 6.6±2.1; SC: 0.5±0.3; MC: 0.8±0.7), but egg counts of other types of gastrointestinal parasites did not differ significantly among the 3 herd groups. Fly control measures were applied mainly to milking cows and preweaned calves and were used on 88.6% of ORG herds, 60.0% of SC herds, and 91.7% of MC herds. Approximately half of the producers reported having seen skin conditions suggestive of lice or tail mange in their cattle during the previous winter (ORG: 48.6%, SC: 57.1%, MC: 53.9%). Although most conventional producers reported treating these skin conditions, most organic producers stated they had not treated them. In conclusion, gastrointestinal parasite egg counts were low overall at the time of the survey, and most surveyed producers did not perceive gastrointestinal parasites to be a problem for their animals' health. Independent of the herd type, fly control was mostly targeted at the lactating herd and preweaned calves.

Open retropubic radical prostatectomy: Still a well-established surgical technique for prostate cancer management.

INTRODUCTION: The surgical treatment options for prostate cancer have changed rapidly, given the expansion of robotics. However, open retropubic radical prostatectomy (ORP) will continue to be performed in areas with financial limitations or with limited access to robotics. The purpose of this study was to determine the long-term oncological outcomes, to categorize complication rates and to examine the early continence rates in patients treated with ORP. METHODS: We identified all patients who underwent ORP at our institution between 2000 and 2020. A standardized pad test was used to determine the early continence rates upon catheter removal, the late continence around a year after surgery was determined by the number of pads per day. The Clavien-Dindo classification was used to report the complication rates. The biochemical recurrence (BCR)-free survival and overall survival (OS) rates were defined using the Kaplan-Meier method and log-rank analysis. Multivariable Cox-regression models were used to test the effect of different factors on biochemical recurrence. RESULTS: We analyzed 1095 patients. The median follow-up was 93.4 months. An overall 10-year BCR-free survival and OS of 73% and 82% respectively was found. A complication rate for Clavien Dindo≥3 was seen in 4.8% of patients. The early continence rate was 81.4% and the late continence 89,1%. Preoperative PSA level, Gleason score sum, pT stage, lymph node status, and surgical margin status were independent predictors of BCR (p<0.001, 95% CI). Limitations include retrospective and single center study design. CONCLUSIONS: ORP is a surgical procedure that provides excellent oncological- and early continence-rates.

Experimental verification of principal losses in a regulatory particulate matter emissions sampling system for aircraft turbine engines.

A sampling system for measuring emissions of nonvolatile particulate matter (nvPM) from aircraft gas turbine engines has been developed to replace the use of smoke number and is used for international regulatory purposes. This sampling system can be up to 35 m in length. The sampling system length in addition to the volatile particle remover (VPR) and other sampling system components lead to substantial particle losses, which are a function of the particle size distribution, ranging from 50 to 90% for particle number concentrations and 10-50% for particle mass concentrations. The particle size distribution is dependent on engine technology, operating point, and fuel composition. Any nvPM emissions measurement bias caused by the sampling system will lead to unrepresentative emissions measurements which limit the method as a universal metric. Hence, a method to estimate size dependent sampling system losses using the system parameters and the measured mass and number concentrations was also developed (SAE 2017; SAE 2019). An assessment of the particle losses in two principal components used in ARP6481 (SAE 2019) was conducted during the VAriable Response In Aircraft nvPM Testing (VARIAnT) 2 campaign. Measurements were made on the 25-meter sample line portion of the system using multiple, well characterized particle sizing instruments to obtain the penetration efficiencies. An agreement of ± 15% was obtained between the measured and the ARP6481 method penetrations for the 25-meter sample line portion of the system. Measurements of VPR penetration efficiency were also made to verify its performance for aviation nvPM number. The research also demonstrated the difficulty of making system loss measurements and substantiates the E-31 decision to predict rather than measure system losses.

Evaluation of the pathologic response to neoadjuvant treatment in rectal cancer. Experience at the Instituto de Cancerología de Medellín (Colombia, 2011-2017). / Evaluación de la respuesta patológica al tratamiento neoadyuvante en cáncer de recto. Experiencia del Instituto de Cancerología de Medellín (Colombia, 2011-2017).

INTRODUCTION AND AIMS: Neoadjuvant therapy in rectal cancer is associated with a decrease in tumor size and is the therapeutic indication for patients with T3 or T4 tumors or lymph node involvement. Our aim was to describe the frequency of pathologic response and the survival rate in patients that underwent neoadjuvant therapy for rectal cancer. MATERIALS AND METHODS: A retrospective follow-up study with a survival analysis was conducted. Patients with locally advanced rectal cancer that received neoadjuvant treatment and were operated on at the Instituto de Cancerología Las Américas (Medellín, Colombia) were analyzed. Survival was calculated using the Kaplan-Meier method. RESULTS: A total of 152 patients were included. Mean patient age was 59 years (12.8 SD), 53.9% were men, and 58.6% of the patients were diagnosed with stage IIIB disease. The pathologic complete response (pCR) was achieved in 17% of the patients. A total of 146 (96.1%) patients received the chemoradiotherapy protocol. Fifty-two (34.2%) patients developed metastasis and/or relapse, and one (3.8%) of those patients had presented with pCR. The median follow-up period was 33 months (Q1-Q3: 20-45), with an overall survival rate of 79.5% (95% CI 70.9-85.8). The 5-year survival rate for the patients that had pCR was 80% (95% CI 20.3-96.9). CONCLUSIONS: The frequency of pCR was similar to that in other published studies and disease recurrence was lower, compared with patients with no response. The 5-year survival rate in patients with pCR was high, albeit lower than that reported in other studies.

Efficacy and tolerability of pale sulfonated shale oil cream 4% in the treatment of mild to moderate atopic eczema in children: a multicentre, randomized vehicle-controlled trial.

BACKGROUND: Reports on controlled trials on the efficacy and tolerability of sulfonated shale oils in atopic eczema are not available so far. The aim of this study was to investigate whether topically applied, specially prepared pale sulfonated shale oil (PSSO) cream is capable of improving symptoms/signs of mild to moderate atopic eczema in children more efficaciously than a corresponding vehicle cream. PATIENTS AND METHODS: A total of 99 children suffering from mild to moderate atopic eczema were enrolled in this multicentre, randomized, vehicle-controlled study. Verum or vehicle cream was applied to the affected skin area three times a day over 4 weeks. As the primary outcome parameter served the reduction of the total score after 4 weeks of treatment, compared with the initial examination. Secondary outcome parameters were addressed as well. Tolerability was judged by investigators and patients/parents, and adverse events were documented. RESULTS: After 4 weeks of treatment, the total score declined from 13.4 ± 3.7 to 4.5 ± 7.4 score points in the verum group and from 13.0 ± 3.1 to 11.7 ± 8.6 score points in the vehicle group (P < 0.0001). The superiority of verum regarding total score was already apparent after a treatment period of 1 week (reduction by 5.6 ± 4.3 vs. 1.3 ± 5.9 score points; P < 0.0001). Tolerability was found superior at the end of the treatment in the verum when compared with the control group--both by investigators (P < 0.0001) and patients/parents (P = 0.0051). CONCLUSION: Pale sulfonated shale oil cream 4% is capable to treat mild to moderate atopic eczema in children more efficaciously than vehicle and is well tolerated. PSSO thus represents a valuable addition to our therapeutic armamentarium. PSSO should be considered in particular when valid alternatives for topical glucocorticoids are sought for.

[Depression in HIV infection: prevalence, risk factors and management]. / Prevalencia, factores de riesgo y manejo de la depresión en pacientes con infección por VIH: Revisión de la literatura.

Depression is one of the main psychiatric co-morbidities in HIV infection, presenting with a significantly higher prevalence than in the general population (around 35%). Its presence has been associated with poor quality of life, HIV disease progression and poor adherence to antiretroviral therapy. Although antidepressive treatment has demonstrated effectiveness on the management of depressive symptoms, improvement of clinical and laboratory parameters, and enhancement of antiretroviral adherence, depression is frequently under diagnosed and under treated in these patients. We analyzed the main international findings on depression prevalence, risk factors, con-sequences and management in people with HIV disease.

Renal insufficiency due to an orthohantavirus infection in the north of the Netherlands.

We describe a patient with an orthohantavirus infection in the north of the Netherlands. Orthohantavirus cases in the Netherlands are rare and most cases occur in the east of the Netherlands. Orthohantavirus infections should be included in the differential diagnosis in travellers and non-travellers, and patients from areas other than the east of the Netherlands if flu-like symptoms and acute renal insufficiency are present.

Malignant transformation of erythroid cells in vivo by introduction of a nonreplicating retrovirus vector.

DNA from a replication-defective spleen focus-forming virus (SFFV) was reconstructed and transfected into psi-2 cells containing a packaging-defective mutant of Moloney murine leukemia virus. Replication-incompetent retrovirus particles (helper virus-free containing genomes that express the transforming envelope gene of SFFV (gp52) transformed bone marrow cells in vitro and, after direct intravenous introduction of the vector, induced malignant erythroid disease in vivo. Disease induction was dependent on prior treatment of mice with phenylhydrazine, which probably increased the availability of erythroid target cells. Since there was no evidence of virus particle expression in mice with malignant disease, this study demonstrates the acute oncogenic potential of a limited number of erythroid cells expressing SFFV gp52. Direct inoculation of animals with nonreplicating retroviral vectors containing transforming genes may be useful in study the oncogenic effects of such genes.

Record media used by primary care providers in medically underserved regions of upstate New York was not pivotal to clinical result in the Informatics for Diabetes Education and Telemedicine (IDEATel) project.

PURPOSE: To examine integration of electronic medical records (EMRs) by primary care providers (PCPs) in a diabetes telemedicine project (IDEATel) in medically underserved rural areas and assess if access to digital records is associated with diabetes intermediate outcomes. METHOD: PCPs (n=61) with patients in IDEATel participated in structured interviews to determine current (2006 to 2007) and projected (2007 to 2008) use of paper and/or electronic medical data. T-tests examined group differences. RESULTS: 28% (17/61) of PCPs had comprehensive EMRs, but most electronic data were non-interoperative between offices; 6% of PCPs solely used paper; 92% of PCPs used mixed paper/electronic records. Half of 61 PCPs anticipated no migration within one year to an electronic record for common patient data, while one third anticipated that function would become greatly more electronic. Among 31 PCPs interviewed in depth in person, 70% (7/10) in private practice and 69% (9/13) in networks anticipated greater electronic media migration through system change, whereas 100% of responding academic PCPs (n=6) expected only system modifications. PCPs were most interested in data exchange for chronic disease management (94%), regional benchmarking (84%) and quality improvement (87%). Patient personal electronic health records were rarely mentioned. IDEATel patients of PCPs with or without access to comprehensive EMRs achieved similar haemoglobin A1c, blood pressure, LDL-cholesterol, and body mass index, but the small number invokes cautious interpretation. CONCLUSIONS: Our findings suggest an effective and complementary element of national health information technology (HIT) strategy, telemedicine, can be implemented by PCPs with success despite the lack of a concurrent EMR for efficient data exchange.

Colorectal cancer survival at an oncologic center in Colombia. A historic cohort study. / Supervivencia de cáncer colorrectal en un centro oncológico de Colombia. Estudio de cohorte histórica.

INTRODUCTION AND AIMS: In Colombia, cancer of the colon is the third most frequent cancer in relation to incidence and mortality. Five-year survival depends on stage at diagnosis, albeit that rate is not known for the country. The aim of the present study was to characterize the overall survival and disease-free survival rates in an adult population with colorectal cancer treated at an oncology center in Medellín, Colombia. MATERIALS AND METHODS: A retrospective cohort study was conducted. The case records of patients with a histologic diagnosis of colorectal cancer, seen within the time frame of 2011 and 2015, were reviewed. The overall survival and disease-free survival curves were calculated using the Kaplan-Meier method. RESULTS: A total of 824 (54.9%) patients with cancer of the colon and 676 (45.1%) with cancer of the rectum were treated. Mean patient age was 63.3 years, female sex predominated (56.3%), and 98.1% of the tumors were adenocarcinomas. The majority of the lesions were stage iii (31.9% in the colon and 35.5% in the rectum) at the time of diagnosis. Surgery was the most frequent treatment in the colon (85.2%) and radiotherapy was the most frequent in the rectum (75.4%). Overall survival at the median follow-up (27.3 months) was 66.7% for cancer of the colon and 63.9% for cancer of the rectum. Disease-free survival at the median follow-up (18.6 months in colon and 14.9 in rectum) was 72.5 and 68.9%, respectively. CONCLUSIONS: The clinical characteristics and treatment of patients were similar to those found in other studies. Two-year survival was higher than in other Colombian reports and 5-year survival was lower than that observed in developed countries.

Effect of zileuton on osteoporotic bone and its healing, expression of bone, and brain genes in rats.

Estrogen deficiency and aging are associated with osteoporosis, impaired bone healing, and lower cognitive performance. Close functional and physical connections occur between bone and the central nervous system. An anti-inflammatory drug, zileuton (which is an inhibitor of arachidonate 5-lipoxygenase), is known to have a positive effect on bone tissue repair and brain ischemia. We studied the effect of zileuton on osteopenic bone and its healing and on the genes considered to be crucial for the cross talks between bone and brain. Three-month-old Sprague-Dawley rats were ovariectomized or left untreated. After 8 wk, bilateral metaphyseal tibia osteotomy with plate osteosynthesis was performed in all rats. Ovariectomized rats were fed with food containing zileuton (1, 10, or 100 mg/kg body wt) for 5 wk. In tibiae, bone volume, callus and cortical volume, and gene expression of osteocalcin and alkaline phosphatase were enhanced by zileuton (10 or 100 mg); biomechanical properties and bone density were not changed. In femur, zileuton enlarged cortical volume distal and trabecular volume proximal, decreasing their density. The expression level of brain Sema3a, known to regulate bone mass positively, was downregulated after ovariectomy. In contrast, bone Sema4d, a negative regulator of bone mass, was upregulated in the tibia callus after ovariectomy, whereas zileuton treatment (10 or 100 mg) resulted in reverse effects. Here, we describe for the first time the expression of Rbbp4 mRNA and its increase in tibia after ovariectomy. Zileuton caused downregulation of Rbbp4 in the hippocampus and had an effect on bone healing, changed the expression of genes involved in cross talk between bones and brain, and may be a potent drug for further examination in estrogen deficiency-related dysfunction(s). NEW & NOTEWORTHY Zileuton, a 5-lipoxygenase inhibitor, increased bone volume, callus and cortical volume in osteotomized tibia, and trabecular and cortical volume in femur. Although the expression of Sema3a (positively regulating bone mass) in brain was downregulated and Sema4d (negatively regulating bone mass) was upregulated in tibia callus after ovariectomy, zileuton could counteract these effects. Rbbp4 (involved in age-related memory loss) was increased in tibia callus after ovariectomy.

In vitro suppression of programmed cell death of B cells by tissue inhibitor of metalloproteinases-1.

Cellular pathways for induction of programmed cell death (PCD) have been identified, but little is known about specific extracellular matrix processes that may affect apoptosis along those pathways. In this study, a series of Burkitt's lymphoma (BL) cell lines were assayed for their expression of tissue inhibitor of metalloproteinases (TIMP)-1. Results indicate that TIMP-1-positive BL lines show resistance to cold-shock-induced apoptosis. Furthermore, recombinant TIMP-1, but not TIMP-2 or a synthetic metalloproteinase inhibitor (BB-94), confers resistance to apoptosis induced by both CD95-dependent and -independent (cold shock, serum deprivation, and gamma-radiation) pathways in TIMP-1-negative BL lines. TIMP-1 suppression of PCD is not due to metalloproteinase inhibition, as reduction and alkylation of the TIMP-1 did not abolish this activity. Retroviral induction of TIMP-1 not only resulted in cell survival but also in continued DNA synthesis for up to 5 d in the absence of serum, while controls underwent apoptosis. This resistance to apoptosis is reversed by anti-TIMP-1 antibodies, demonstrating that secreted TIMP-1 is active in blocking apoptosis. Furthermore, TIMP-1 upregulation induced expression of Bcl-XL but not Bcl-2 as well as decreased NF-kappaB activity as compared with controls. These results demonstrate that TIMP-1 suppresses apoptosis in B cells and suggests a novel activity for TIMP-1 in tissue homeostasis.

Regulation of the resident chromosomal copy of c-myc by c-Myb is involved in myeloid leukemogenesis.

c-myb is a frequent target of retroviral insertional mutagenesis in murine leukemia virus-induced myeloid leukemia. Induction of the leukemogenic phenotype is generally associated with inappropriate expression of this transcriptional regulator. Despite intensive investigations, the target genes of c-myb that are specifically involved in development of these myeloid lineage neoplasms are still unknown. In vitro assays have indicated that c-myc may be a target gene of c-Myb; however, regulation of the resident chromosomal gene has not yet been demonstrated. To address this question further, we analyzed the expression of c-myc in a myeloblastic cell line, M1, expressing a conditionally active c-Myb-estrogen receptor fusion protein (MybER). Activation of MybER both prevented the growth arrest induced by interleukin-6 (IL-6) and rapidly restored c-myc expression in nearly terminal differentiated cells that had been exposed to IL-6 for 3 days. Restoration occurred in the presence of a protein synthesis inhibitor but not after a transcriptional block, indicating that c-myc is a direct, transcriptionally regulated target of c-Myb. c-myc is a major target that transduces Myb's proliferative signal, as shown by the ability of a c-Myc-estrogen receptor fusion protein alone to also reverse growth arrest in this system. To investigate the possibility that this regulatory connection contributes to Myb's oncogenicity, we expressed a dominant negative Myb in the myeloid leukemic cell line RI-4-11. In this cell line, c-myb is activated by insertional mutagenesis and cannot be effectively down regulated by cytokine. Myb's ability to regulate c-myc's expression was also demonstrated in these cells, showing a mechanism through which the proto-oncogene c-myb can exert its oncogenic potential in myeloid lineage hematopoietic cells.

Primary care providers' perceptions of home diabetes telemedicine care in the IDEATel project.

CONTEXT: Few telemedicine projects have systematically examined provider satisfaction and attitudes. PURPOSE: To determine the acceptability and perceived impact on primary care providers' (PCP) practices of a randomized clinical trial of the use of telemedicine to electronically deliver health care services to Medicare patients with diabetes in federally designated medically underserved areas of upstate New York, primarily those in rural areas and small towns with limited access to primary care. METHODS: A longitudinal phone survey was completed by 116 PCPs with patients with diabetes in the treatment arm of the trial, and conducted 12 and 24 months after a PCP's first patient was randomized to the home telemedicine arm of the trial. The 36-item survey included measures of acceptability (to PCPs, time required), impact (on patient knowledge, confidence, perceived health outcomes), and communication. Six open-ended questions were analyzed qualitatively. RESULTS: The quantitative data indicated positive responses in terms of acceptability of the telemedicine intervention to the PCPs and of the impact on the PCPs' patients. This was most evident in issues critical to good control of diabetes: patient knowledge, ability to manage diabetes, confidence, and compliance in managing diabetes. Key qualitative themes, on the positive end, were more patient control and motivation, helpfulness of having extra patient data, and involvement of nurses and dieticians. Negative themes were excessive paperwork and duplication taking more PCP time, and conflicting advice and management decisions from the telemedicine team, some without informing the PCP but none involving medications. CONCLUSIONS: Telemedicine was reported to be a positive experience for predominantly rural PCPs and their Medicare-eligible patients from medically underserved areas; several inefficiencies need to be refined.

A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus.

BACKGROUND: Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions who experience barriers to access to care or a high burden of illness. METHODS: The authors conducted a randomized, controlled trial comparing telemedicine case management to usual care, with blinding of those obtaining outcome data, in 1,665 Medicare recipients with diabetes, aged 55 years or greater, and living in federally designated medically underserved areas of New York State. The primary endpoints were HgbA1c, blood pressure, and low-density lipoprotein (LDL) cholesterol levels. RESULTS: In the intervention group (n = 844), mean HgbA1c improved over one year from 7.35% to 6.97% and from 8.35% to 7.42% in the subgroup with baseline HgbA1c > or =7% (n = 353). In the usual care group (n = 821) mean HgbA1c improved over one year from 7.42% to 7.17%. Adjusted net reductions (one-year minus baseline mean values in each group, compared between groups) favoring the intervention were as follows: HgbA1c, 0.18% (p = 0.006), systolic and diastolic blood pressure, 3.4 (p = 0.001) and 1.9 mm Hg (p < 0.001), and LDL cholesterol, 9.5 mg/dL (p < 0.001). In the subgroup with baseline HgbA1c > or =7%, net adjusted reduction in HgbA1c favoring the intervention group was 0.32% (p = 0.002). Mean LDL cholesterol level in the intervention group at one year was 95.7 mg/dL. The intervention effects were similar in magnitude in the subgroups living in New York City and upstate New York. CONCLUSION: Telemedicine case management improved glycemic control, blood pressure levels, and total and LDL cholesterol levels at one year of follow-up.