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Sample records for patients tacrolimus improved

  1. Tacrolimus

    Science.gov (United States)

    ... unusual bleeding or bruising seizures coma (loss of consciousness for a period of time) Tacrolimus may cause ... for more information if you do not have access to a take-back program.It is important ...

  2. Tacrolimus-induced thrombotic microangiopathy in orthotopic liver transplant patients: case series of four patients.

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    Nwaba, A; MacQuillan, G; Adams, L A; Garas, G; Delriviere, L; Augustson, B; DeBoer, B; Moody, H; Jeffrey, G P

    2013-03-01

    Thrombotic microangiopathy (TMA) is a potentially fatal complication in solid organ and bone marrow transplant patients, with reported incidence of 0.5-3% and mortality of about 75%. To emphasise the importance of early diagnosis and prompt commencement of therapy results in improved clinical outcomes. A retrospective study of all patients who underwent orthotopic liver transplantation (OLTX) at the Western Australian Liver Transplantation Service from May 1994 to December 2010 was conducted to identify patients who developed tacrolimus-induced TMA. We identified four patients with tacrolimus-induced TMA post-OLTX, derived from a cohort of 104 patients treated with tacrolimus in our institution. The mean age at diagnosis was 40 years, and the mean time of onset was 63 ± 7.5 weeks after OLTX. The indications for OLTX in the four patients were fulminant hepatic failure in three (Wilson disease, paracetamol overdose and post-partum thrombotic thrombocytopenic purpura) and hepatitis C virus-related cirrhosis. All patients had tacrolimus post-OLTX. At diagnosis, tacrolimus was discontinued in all patients, and three of the four patients underwent plasma exchange and all patients improved clinically. Mean duration of follow up was 15 ± 7.5 months. There was no mortality 6 months post-TMA. Early diagnosis with immediate discontinuation or conversion of calcineurin inhibitors and plasma exchange should be offered to OLTX patients with TMA as it results in good outcomes. © 2013 The Authors; Internal Medicine Journal © 2013 Royal Australasian College of Physicians.

  3. Cyclosporin versus tacrolimus for liver transplanted patients

    DEFF Research Database (Denmark)

    Haddad, E M; McAlister, V C; Renouf, E

    2006-01-01

    Most liver transplant recipients receive either cyclosporin or tacrolimus to prevent rejection. Both drugs inhibit calcineurin phosphatase which is thought to be the mechanism of their anti-rejection effect and principle toxicities. The drugs have different pharmacokinetic profiles and potencies....... Several randomised clinical trials have compared cyclosporin and tacrolimus in liver transplant recipients, but it remains unclear which is superior....

  4. Mechanisms of lower maintenance dose of tacrolimus in obese patients.

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    Sawamoto, Kazuki; Huong, Tran T; Sugimoto, Natsumi; Mizutani, Yuka; Sai, Yoshimichi; Miyamoto, Ken-ichi

    2014-01-01

    A retrospective analysis suggested that blood tacrolimus concentrations were consistent among patients with a body mass index (BMI) that was lean (maintenance dose of tacrolimus in patients with BMI ≥ 25 was significantly lower compared with that in patients with a BMI of less than 25. Lean and obese Zucker rats fed a normal diet were given tacrolimus intravenously or orally. The blood concentrations of tacrolimus in obese rats were significantly higher than those in lean rats after administration via both routes. The moment analysis has suggested that CLtot and Vdss of tacrolimus were not significantly different between lean and obese rats. The bioavailability was higher in obese rats, compared with that in lean rats. The protein expression of Cyp3a2 in the liver was significantly decreased in obese rats, compared with lean rats, while P-gp in the small intestine was also significantly decreased in obese rats. These results suggested that the steady-state trough concentration of tacrolimus in obese patients was well maintained by a relatively low dose compared with that in normal and lean patients, presumably due to increased bioavailability.

  5. Therapeutic equivalence and pharmacokinetics of generic tacrolimus formulation in de novo kidney transplant patients.

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    Min, Sang-Il; Ha, Jongwon; Kim, Yon Su; Ahn, Sang Hyun; Park, Taejin; Park, Dae Do; Kim, Suh Min; Min, Seung-Kee; Hong, Hyejin; Ahn, Curie; Kim, Sang Joon

    2013-12-01

    There is a growing concern about the therapeutic equivalence of the generic tacrolimus formulation (GEN Tacrolimus) to the reference tacrolimus (REF Tacrolimus) in solid organ transplantation. A prospective, randomized study of 126 de novo renal transplant patients was conducted to compare the efficacy, safety and pharmacokinetic (PK) profiles between GEN tacrolimus (n = 63) and REF tacrolimus (n = 63). The PK of tacrolimus was evaluated on Day 10 and 6 months under steady-state condition. Crossover study was carried out in 66 patients at 6 months. On Day 10, 117 patients completed PK profiles (54 GEN tacrolimus and 63 REF tacrolimus) and GEN tacrolimus showed comparable C(0) (9.8 ± 2.5 versus 9.7 ± 3.0 ng/mL, P = 0.80) but significantly higher dose-normalized C(max) (309.1 ± 191.9 versus 192.5 ± 95.2 ng/mL/mg/kg, P PK profiles evaluated at 9 months showed that generic substitution also resulted in an 'early and high C(max)'. Efficacy and safety data were comparable over the 9-month study period. Therapeutic equivalence and the PK of GEN tacrolimus should be evaluated in patients undergoing de novo renal transplantation.

  6. Tacrolimus Topical

    Science.gov (United States)

    ... or lymphoma (cancer in a part of the immune system). There is not enough information available to tell whether tacrolimus ointment caused these patients to develop cancer. Studies of transplant patients and laboratory animals and an understanding of the way tacrolimus works ...

  7. Efficacy and safety of tacrolimus treatment for rheumatoid arthritis patients undergoing hemodialysis.

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    Yamashita, Misuzu; Natsumeda, Masamitsu; Takasugi, Koji; Ueno, Akiko; Ezawa, Kayo; Ezawa, Kazuhiko

    2008-01-01

    Rheumatoid arthritis (RA) is an autoimmune disorder characterized by progressive joint destruction that requires aggressive treatment using appropriate disease-modifying antirheumatic drugs (DMARDs). RA patients with renal failure, however, are intolerant to most DMARDs due to the potential toxicity. In Japan, tacrolimus was approved for the treatment of RA in 2005. Based on its pharmacokinetics, tacrolimus may be administered to the patients undergoing hemodialysis. We report two cases of RA patients on hemodialysis treated effectively and safely with tacrolimus.

  8. Tacrolimus in preventing transplant rejection in Chinese patients – optimizing use

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    Li CJ

    2015-01-01

    Full Text Available Chuan-Jiang Li,1,* Liang Li2,* 1Department of Surgery, Nanfang Hospital, 2Department of Medical Genetics, School of Basic Medical Sciences, Southern Medical University, Guangzhou, People’s Republic of China *The authors contributed equally to this work Abstract: Tacrolimus is a product of fermentation of Streptomyces, and belongs to the family of calcineurin inhibitors. It is a widely used immunosuppressive drug for preventing solid-organ transplant rejection. Compared to cyclosporine, tacrolimus has greater immunosuppressive potency and a lower incidence of side effects. It has been accepted as first-line treatment after liver and kidney transplantation. Tacrolimus has specific features in Chinese transplant patients; its in vivo pharmacokinetics, treatment regimen, dose and administration, and adverse-effect profile are influenced by multiple factors, such as genetics and the spectrum of primary diseases in the Chinese population. We reviewed the clinical experience of tacrolimus use in Chinese liver- and kidney-transplant patients, including the pharmacology of tacrolimus, the immunosuppressive effects of tacrolimus versus cyclosporine, effects of different factors on tacrolimus metabolism on Chinese patients, personalized medicine, clinical safety profile, and patient satisfaction and adherence. This article provides guidance for the rational and efficient use of tacrolimus in Chinese organ-transplant patients. Keywords: tacrolimus, liver transplantation, kidney transplant, Chinese, personalized medicine

  9. Tacrolimus-related hypertrophic cardiomyopathy in an adult cardiac transplant patient

    Institute of Scientific and Technical Information of China (English)

    LIU Tong; DONG Jian-zeng; GAO Yun; GAO Yu-long; CHENG Yu-tong; WANG Su; LI Zhi-zhong; ZHANG Hai-bo; MENG Xu; MA Chang-sheng

    2012-01-01

    Left ventricular hypertrophy associated with the use of tacrolimus is a rare complication of solid organ transplantation in adult recipients.We present a cardiac transplant recipient who developed severe concentric left ventricular hypertrophy with congestive heart failure related to myocardial hypertrophy on tacrolimus.Hypertrophy improved when the drug was discontinued and replaced with sirolimus.

  10. Evaluation of Flexible Tacrolimus Drug Concentration Monitoring Approach in Patients Receiving Extended-Release Once-Daily Tacrolimus Tablets.

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    Philosophe, Benjamin; Leca, Nicolae; West-Thielke, Patricia M; Horwedel, Timothy; Culkin-Gemmell, Christine; Kistler, Kristin; Stevens, Daniel R

    2018-02-20

    The majority of United States kidney transplant patients are treated with tacrolimus, a drug effective in preventing graft rejection, but with a narrow therapeutic range, necessitating close monitoring to avoid increased risks of transplant rejection or toxicity if the tacrolimus concentration is too low or too high, respectively. The trough drug concentration tests are time sensitive; patients treated on a twice-daily basis have blood draws exactly 12 hours after their previous dose. The schedule's rigidity causes problems for both patients and health care providers. Novel once-daily tacrolimus formulations such as LCPT (an extended-release tablet by Veloxis Pharmaceuticals, Inc., Cary, North Carolina) have allowed for blood draws on a once-daily basis; however, even that schedule can be restrictive. Results from tests taken either before or after that 24-hour target time may be discarded, or worse, may lead to inappropriate dose changes. Data from ASTCOFF, a phase 3B pharmacokinetic clinical trial (NCT02339246), demonstrated that the unique pharmacokinetic curve of LCPT may allow for a therapeutic monitoring window that extends for 3 hours before or after the 24-hour monitoring target. Furthermore, important tools to help clinicians interpret these levels, such as formulas to estimate the 24-hour trough level if an alternative monitoring time is used, were constructed from these data. These study results give treating clinicians access to data that allow them to safely use and monitor LCPT in their patients and expand the body of evidence surrounding differentiation and practical application of the novel LCPT tacrolimus formulation. © 2018, The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals, Inc. on behalf of American College of Clinical Pharmacology.

  11. The calcineurin activity profiles of cyclosporin and tacrolimus are different in stable renal transplant patients

    DEFF Research Database (Denmark)

    Koefoed-Nielsen, PB; Karamperis, N; Hojskov, C

    2006-01-01

    Cyclosporin and tacrolimus remain the cornerstone immunosuppressive drugs in organ transplantation. Dosing and monitoring these drugs is based on pharmacokinetic protocols, but measuring a pharmacodynamic parameter, calcineurin phosphatase (CaN) activity, could be a valuable supplement...... in determining optimal doses. Forty stable renal transplant patients were investigated three times in a 6-month period. Blood samples were drawn at 0, 1, 2, 3 and 4 h after oral intake of tacrolimus (FK) or cyclosporin at days 1 and 180. At day 90, one blood sample at trough level (FK) or C2 level (cyclosporin A...... at days 1 and 180 were the same for both drugs. Furthermore, we found that patients treated with tacrolimus or cyclosporin displayed different calcineurin activity profiles. We found that cyclosporin displayed greater calcineurin inhibition than tacrolimus. We have demonstrated that the two drugs exert...

  12. [The therapeutic drug monitoring network server of tacrolimus for Chinese renal transplant patients].

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    Deng, Chen-Hui; Zhang, Guan-Min; Bi, Shan-Shan; Zhou, Tian-Yan; Lu, Wei

    2011-07-01

    This study is to develop a therapeutic drug monitoring (TDM) network server of tacrolimus for Chinese renal transplant patients, which can facilitate doctor to manage patients' information and provide three levels of predictions. Database management system MySQL was employed to build and manage the database of patients and doctors' information, and hypertext mark-up language (HTML) and Java server pages (JSP) technology were employed to construct network server for database management. Based on the population pharmacokinetic model of tacrolimus for Chinese renal transplant patients, above program languages were used to construct the population prediction and subpopulation prediction modules. Based on Bayesian principle and maximization of the posterior probability function, an objective function was established, and minimized by an optimization algorithm to estimate patient's individual pharmacokinetic parameters. It is proved that the network server has the basic functions for database management and three levels of prediction to aid doctor to optimize the regimen of tacrolimus for Chinese renal transplant patients.

  13. Development and Improvement of Simple Colonic Mucosal Ulcer during Treatment of Severe Ulcerative Colitis with Tacrolimus

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    Ayumi Ito

    2017-03-01

    Full Text Available Diarrhea, melena, and lower abdominal pain developed in a male in his 20s and colonoscopy showed pancolitis-type severe ulcerative colitis (UC. Treatment was initiated with 4,000 mg of 5-aminosalicylic acid and 60 mg/day of prednisolone, but the symptoms and inflammatory reaction worsened with prednisolone dose reduction. Tacrolimus was added to the treatment, which subsequently induced remission. Serial colonoscopies during the treatment showed improvement in ulcer and mucosal edema throughout the entire large intestine, but a new solitary round ulcer appeared at the end of the ileum. Since no signs of Behçet’s disease were noted, it was considered as a simple ulcer, a complication of UC. Tacrolimus treatment was continued based on continued improvement in clinical features and colonic mucosa, excluding the end of the ileum. Colonoscopy at 6 months after initiation of tacrolimus showed healing of the large intestinal mucosa, although mild congestion was still noted. The solitary round ulcer at the end of the ileum improved to a small erosion. We report the improvement of a simple ulcer that developed during tacrolimus treatment.

  14. The calcineurin activity profiles of cyclosporin and tacrolimus are different in stable renal transplant patients

    DEFF Research Database (Denmark)

    Koefoed-Nielsen, Pernille Bundgaard; Karamperis, Nikolaos; Jørgensen, Kaj Anker

    2006-01-01

    in determining optimal doses. Forty stable renal transplant patients were investigated three times in a 6-month period. Blood samples were drawn at 0, 1, 2, 3 and 4 h after oral intake of tacrolimus (FK) or cyclosporin at days 1 and 180. At day 90, one blood sample at trough level (FK) or C2 level (cyclosporin A...... significantly different effects on calcineurin activity in renal transplant patients with stable, well-functioning grafts and that tacrolimus-treated patients can maintain good, stable graft function with minimal CaN inhibition.......Cyclosporin and tacrolimus remain the cornerstone immunosuppressive drugs in organ transplantation. Dosing and monitoring these drugs is based on pharmacokinetic protocols, but measuring a pharmacodynamic parameter, calcineurin phosphatase (CaN) activity, could be a valuable supplement...

  15. Tacrolimus Therapy for Three Patients with Elderly-Onset Ulcerative Colitis: Report of Three Cases

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    Rumiko Kobayashi

    2016-07-01

    Full Text Available In recent years, cases of elderly-onset ulcerative colitis (UC have been increasing in number and are currently reported to account for 10–15% of all cases of UC. Although the treatment of UC is essentially similar between older and younger patients, evidence of the therapeutic efficacy of tacrolimus in elderly-onset UC patients is still limited. Herein, we report our attempt to induce remission using tacrolimus in three patients with elderly-onset UC. A 75-year-old Japanese woman, a 71-year-old Japanese man and a 76-year-old Japanese woman with severe elderly-onset UC of the pancolitis type were treated with tacrolimus. Although all three patients showed response to the drug, the eventual outcome was poor in the first patient, who developed toxic megacolon, underwent surgery, and suffered from recurrent infections and hemorrhage after the surgery. However, clinical remission was successfully achieved in the second and third patient. Tacrolimus shows some indication of effectiveness in the treatment of elderly-onset UC. However, in elderly-onset UC patients, it is necessary to keep in mind the higher risk of adverse effects of medical therapy and postoperative complications because of the high comorbidity rates. Moreover, in situations where surgery needs to be considered, it is important to ensure appropriate timing of the surgery.

  16. Tacrolimus Improves Symptoms of Children With Myasthenia Gravis Refractory to Prednisone.

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    Liu, Chanchan; Gui, Mengcui; Cao, Yayun; Lin, Jing; Li, Yue; Ji, Suqiong; Bu, Bitao

    2017-12-01

    Myasthenia gravis tends to affect children in China. Oral pyridostigmine and prednisone could effectively improve the symptoms, but multiple side effects become a major concern after long-term oral prednisone. To avoid the long-term complications of prednisone therapy and to obtain more satisfactory improvement, we tested the efficacy and safety of tacrolimus in children with myasthenia gravis. Children with myasthenia gravis who had not achieved satisfactory improvement or who experienced severe side effects after prednisone therapy were recruited between January 2015 and December 2016 at Tongji Hospital. All the children were treated with tacrolimus 1 mg to 2 mg daily and the dose was adjusted on the basis of the clinical response and the serum concentration. The dosage of prednisone, the severity of symptoms, blood samples, the serum concentration of tacrolimus, and titers of antiacetylcholine receptor antibodies were evaluated every four weeks. Fourteen children were enrolled. One child withdrew two weeks after the enrollment. Thirteen children have completed the therapy for one year. At the end point, the dosage of prednisone was significantly decreased (P myasthenia gravis score, and myasthenia gravis-specific manual muscle testing and myasthenia gravis-activities of daily living scores were significantly improved (P myasthenia gravis. Randomized clinical trials are needed to confirm the observation. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. The onset risk of carcinoma in patients continuing tacrolimus topical treatment for oral lichen planus: a case report.

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    Morita, Mayu; Asoda, Seiji; Tsunoda, Kazuyuki; Soma, Tomoya; Nakagawa, Taneaki; Shirakawa, Masayori; Shoji, Hirofumi; Yagishita, Hisao; Nishikawa, Takeji; Kawana, Hiromasa

    2017-04-01

    Oral lichen planus is a chronic inflammatory mucocutaneous disease. Topical use of steroids and other immuno-modulating therapies have been tried for this intractable condition. Nowadays, tacrolimus ointment is used more commonly as a choice for treatment. However, a number of discussions have taken place after tacrolimus was reported to be carcinogenic. This report describes a patient who applied tacrolimus ointment to the lower lip after being diagnosed with oral lichen planus in 2008, and whose lesion developed squamous cell carcinoma in 2010. Since the relationship between tacrolimus and cancer development has been reported in only a few cases, including this case report, the clinician must be careful selecting tacrolimus as a second-line treatment for oral lichen planus.

  18. High Intrapatient Variability of Tacrolimus Levels and Outpatient Clinic Nonattendance Are Associated With Inferior Outcomes in Renal Transplant Patients

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    Dawn L. Goodall, MSc

    2017-08-01

    Conclusions. This study shows that high tacrolimus IPV and clinic nonattendance are associated with inferior allograft survival. Interventions to minimize the causes of high variability, particularly nonadherence are essential to improve long-term allograft outcomes.

  19. Tacrolimus in the treatment of myasthenia gravis in patients with an inadequate response to glucocorticoid therapy: randomized, double-blind, placebo-controlled study conducted in China.

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    Zhou, Lei; Liu, Weibin; Li, Wei; Li, Haifeng; Zhang, Xu; Shang, Huifang; Zhang, Xu; Bu, Bitao; Deng, Hui; Fang, Qi; Li, Jimei; Zhang, Hua; Song, Zhi; Ou, Changyi; Yan, Chuanzhu; Liu, Tao; Zhou, Hongyu; Bao, Jianhong; Lu, Jiahong; Shi, Huawei; Zhao, Chongbo

    2017-09-01

    To determine the efficacy of low-dose, immediate-release tacrolimus in patients with myasthenia gravis (MG) with inadequate response to glucocorticoid therapy in a randomized, double-blind, placebo-controlled study. Eligible patients had inadequate response to glucocorticoids (GCs) after ⩾6 weeks of treatment with prednisone ⩾0.75 mg/kg/day or 60-100 mg/day. Patients were randomized to receive 3 mg tacrolimus or placebo daily (orally) for 24 weeks. Concomitant glucocorticoids and pyridostigmine were allowed. Patients continued GC therapy from weeks 1-4; from week 5, the dose was decreased at the discretion of the investigator. The primary efficacy outcome measure was a reduction, relative to baseline, in quantitative myasthenia gravis (QMG) score assessed using a generalized linear model; supportive analyses used alternative models. Of 138 patients screened, 83 [tacrolimus ( n = 45); placebo ( n = 38)] were enrolled and treated. The change in adjusted mean QMG score from baseline to week 24 was -4.9 for tacrolimus and -3.3 for placebo (least squares mean difference: -1.7, 95% confidence interval: -3.5, -0.1; p = 0.067). A post-hoc analysis demonstrated a statistically significant difference for QMG score reduction of ⩾4 points in the tacrolimus group (68.2%) versus the placebo group (44.7%; p = 0.044). Adverse event profiles were similar between treatment groups. Tacrolimus 3 mg treatment for patients with MG and inadequate response to GCs did not demonstrate a statistically significant improvement in the primary endpoint versus placebo over 24 weeks; however, a post-hoc analysis demonstrated a statistically significant difference for QMG score reduction of ⩾4 points in the tacrolimus group versus the placebo group. This study was limited by the low number of patients, the absence of testing for acetylcholine receptor antibody and the absence of stratification by disease duration (which led to a disparity between the two groups). Clinical

  20. Tacrolimus loaded biocompatible lecithin-based microemulsions with improved skin penetration: Structure characterization and in vitro/in vivo performances.

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    Savić, Vedrana; Todosijević, Marija; Ilić, Tanja; Lukić, Milica; Mitsou, Evgenia; Papadimitriou, Vassiliki; Avramiotis, Spyridon; Marković, Bojan; Cekić, Nebojša; Savić, Snežana

    2017-08-30

    In order to improve skin penetration of tacrolimus we aimed to develop potentially non-irritant, lecithin-based microemulsions containing ethanol, isopropanol and/or propylene glycol as cosurfactants, varying caprylic/capric triglycerides and propylene glycol monocaprylate as oil phase. The influence of excipients on the size of microemulsion region in pseudo-ternary phase diagrams and their ability to form different types of microemulsions was evaluated. The comprehensive physicochemical characterization of microemulsions and the evaluation of their structure was performed, while the localization of tacrolimus in microemulsions was further investigated using electron paramagnetic resonance spectroscopy. Moreover, stability studies proved no change in tacrolimus content during one year of storage at room temperature. In addition, in vivo skin performance indicated no skin irritation potential of blank microemulsions, whereas in vitro release testing using Franz diffusion cells showed superior release rate of tacrolimus from microemulsions (0.98±0.10 and 0.92±0.11μg/cm 2 /h for two bicontinuous and 1.00±0.24μg/cm 2 /h for oil-in-water microemulsion) compared to referent Protopic ointment (0.15±0.08μg/cm 2 /h). Furthermore, ex vivo penetration assessed through porcine ear skin using tape stripping, confirmed superiority of two microemulsions related to the reference, implying developed microemulsions as promising carriers for dermal delivery of tacrolimus. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. Sirolimus Associated with Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial.

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    Kojima, Cristiane Akemi; Nga, Hong Si; Takase, Henrique Mochida; Bravin, Ariane Moyses; Martinez Garcia, Márcia de Fátima Faraldo; Garcia, Paula Dalsoglio; Contti, Mariana Moraes; de Andrade, Luis Gustavo Modelli

    2018-06-01

    There is no consensus on the best immunosuppressive regimen for elderly renal transplant recipients. The objective of this study was to assess cytomegalovirus infection incidence and kidney transplant outcomes in elderly recipients treated with mammalian target of rapamycin inhibitors sirolimus/ tacrolimus at low doses compared with those receiving tacrolimus/mycophenolate sodium. In this single-center prospective randomized study (Trial Registration No. NCT02683291), kidney transplant recipients over 60 years of age were randomly allocated into 2 groups: tacrolimus-sirolimus (21 patients) and tacrolimus-mycophenolate (23 patients). Cytomegalovirus infection rate and patient survival, biopsy-proven acute rejection, and renal function at 12 months were assessed. Cytomegalovirus infection rate was higher in the mycophenolate group (60.9%) than in the sirolimus group (16.7%; P = .004). The rates of biopsy-proven acute rejection, patient survival, graft survival, and estimated glomerular filtration rate over 12 months did not significantly differ between groups. The incidence of cytomegalovirus infection was significantly lower in the sirolimus group. The use of tacrolimus combined with sirolimus in elderly kidney transplant recipients is safe.

  2. Impact of the CYP3A5*1 Allele on the Pharmacokinetics of Tacrolimus in Japanese Heart Transplant Patients.

    Science.gov (United States)

    Uno, Takaya; Wada, Kyoichi; Matsuda, Sachi; Terada, Yuka; Oita, Akira; Kawase, Atsushi; Takada, Mitsutaka

    2018-04-24

    Tacrolimus, a major immunosuppressant used after transplantation, is associated with large interindividual variation involving genetic polymorphisms in metabolic processes. A common variant of the cytochrome P450 (CYP) 3A5 gene, CYP3A5*3, affects blood concentrations of tacrolimus. However, tacrolimus pharmacokinetics at the early stage of transplantation have not been adequately studied in heart transplantation. We retrospectively examined the impact of the CYP3A5 genotype on tacrolimus pharmacokinetics at the early stage of heart transplantation. The tacrolimus pharmacokinetic profile was obtained from 65 patients during the first 5 weeks after heart transplantation. Differences in the patients' characteristics and tacrolimus pharmacokinetic parameters between the CYP3A5 expresser (*1/*1 or *1/*3 genotypes) and non-expresser (*3/*3 genotype) groups were assessed by the Chi-square test, Student's t test, or Mann-Whitney U test. The CYP3A5 *1/*1, *1/*3, and *3/*3 genotypes were detected in 5, 22, and 38 patients, respectively. All patients started clotrimazole therapy approximately 1 week after starting tacrolimus. Apparent clearance and dose/weight to reach the target trough concentration (C 0 ) were significantly higher in the expresser group than in the non-expresser group (0.32 vs. 0.19 L/h/kg, p = 0.0003; 0.052 vs. 0.034 mg/kg/day, p = 0.0002); there were no significant differences in the area under the concentration-time curve from 0 to 12 h (AUC 0-12 ) and concentrations at any sampling time point between the two groups. Similar concentration-time curves for tacrolimus were obtained in the expresser and non-expresser groups by dose adjustment based on therapeutic drug monitoring. These results demonstrate the importance of the CYP3A5 genotype in tacrolimus dose optimization based on therapeutic drug monitoring after heart transplantation.

  3. The relationship between tacrolimus concentration-dose ratio and genetic polymorphism in patients subjected to renal transplantation

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    Rančić Nemanja

    2018-01-01

    Full Text Available Background/Aim. Tacrolimus concentration-dose ratio as a potential therapeutic drug monitoring strategy was suggested to be used for the patients subjected to renal transplantation. The aim of this study was examining the relationship between tacrolimus concentration-dose ratio, suggested to be used as a therapeutic drug monitoring strategy and the polymorphisms of genes encoding the most important enzymes, such as CYP3A5 and CYP3A4, as well as the transporter P-glycoprotein, for its metabolism and elimination. Methods. The study was designed as a prospective case series study, in which the unit of monitoring was the outpatient examination of 54 patients subjected to renal transplantation. Genotyping was performed by 7500 Real- Time PCR System by assessing allelic discrimination based on TaqMan® methodology. Results. Patients (n = 13 who were treated with less than 2 mg of tacrolimus/day (0.024 ± 0.006 mg/kg/day had the tacrolimus concentration-dose ratio larger than 150 ng/mL/mg/kg. In this group, 84.62% patients had CYP3А5 *3*3 allele. All of these patients had CYP3А4 *1*1/*1*1B allele. Regarding ABCB1 C3435T gene, 30.77% of patients had the TT gene variant, while 69.23% of our patients had CC and CT gene variants. Conclusion. Tacrolimus concentration-dose ratio greater than 150 ng/mL/mg/kg is cut-off value in patients subjected to renal transplantation which might point to patients who are poor CYP3A5 metabolizers and/or with dysfunctional P-glycoprotein.

  4. Tacrolimus concentration to dose ratio in solid organ transplant patients treated with fecal microbiota transplantation for recurrent Clostridium difficile infection.

    Science.gov (United States)

    Woodworth, Michael H; Kraft, Colleen S; Meredith, Erika J; Mehta, Aneesh K; Wang, Tiffany; Mamo, Yafet T; Dhere, Tanvi; Sitchenko, Kaitlin L; Patzer, Rachel E; Friedman-Moraco, Rachel J

    2018-04-01

    Fecal microbiota transplantation (FMT) is increasingly being performed for Clostridium difficile infection in solid organ transplant (SOT) patients; however, little is known about the potential pharmacokinetic or pharmacomicrobial effects this may have on tacrolimus levels. We reviewed the medical records of 10 SOT patients from September 2012-December 2016 who were taking tacrolimus at time of FMT for recurrent C. difficile infection. We compared the differences in tacrolimus concentration/dose ratio (C/D ratio) 3 months prior to FMT vs 3 months after FMT. The mean of the differences in C/D ratio calculated as (ng/mL)/(mg/kg/d) was -17.65 (95% CI -1.25 to 0.58) (ng/mL)/(mg/kg/d), P-value .43 by Wilcoxon signed-rank test. The mean of the differences in C/D ratio calculated as (ng/mL)/(mg/d) was -0.33 (95% CI -1.25 to 0.58) (ng/mL)/(mg/d), P-value .28 by Wilcoxon signed-rank test. Of these patients, 2/10 underwent allograft biopsy for allograft dysfunction in the year after FMT, with no evidence of allograft rejection on pathology. These preliminary data suggest that FMT may not predictably alter tacrolimus levels and support its safety for SOT patients however further study in randomized trials is needed. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  5. TACROLIMUS OINTMENT FOR TREATMENT OF VKC

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    Navin Chandra

    2017-05-01

    Full Text Available BACKGROUND Vernal Keratoconjunctivitis (VKC is a bilateral recurrent chronic allergy inflammatory disorder of ocular surface, which is seasonally exacerbated mostly involving tarsal and bulbar conjunctiva in chronic and severe cases involves cornea as well. Affects mostly children and young adults with male predominance. Tacrolimus (FK-506 is a highly potent immune modulatory agent produced by the fungus Streptomyces tsukubaensis. MATERIALS AND METHODS This prospective, nonrandomised case series enrolled 20 patients (40 eyes with severe VKC who were treated with tacrolimus 0.1% ointment. The mean age of the patients was 18.25 ± 4.2 years (range, 9-31 years. Each patient completed a follow-up period of at least 12 months. The main outcome measure was the clinical response to treatment. RESULTS Significant improvements in clinical signs and symptoms were achieved in all patients 6 weeks after starting treatment with topical tacrolimus. Treatment was gradually reduced with increasing intervals between applications. VKC recurred in all patients who attempted to discontinue treatment. No additional medications were required and no significant changes in visual acuity or refraction were documented. Five patients discontinued treatment due to a severe burning sensation and were excluded from the study. CONCLUSION Tacrolimus 0.1% ointment is a safe and effective treatment for VKC refractory to standard treatment and maybe used as a substitute for steroid treatments used to controlled-disease activity. However, adverse effects could cause poor patient compliance.

  6. Systematic Review and Meta-Analysis of Tacrolimus versus Ciclosporin as Primary Immunosuppression After Liver Transplant.

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    Gorden Muduma

    Full Text Available Several meta-analyses comparing ciclosporin with tacrolimus have been conducted since the 1994 publication of the tacrolimus registration trials, but most captured data from randomized controlled trials (RCTs predating recent improvements in waiting list prioritization, induction protocols and concomitant medications. The present study comprised a systematic review and meta-analysis of ciclosporin and tacrolimus in liver transplant recipients using studies published since January 2000.Searches of PubMed, the Cochrane Library and EMBASE identified RCTs of tacrolimus and ciclosporin as the immunosuppressant in adult primary liver transplant recipients, published between January 2000 and August 6, 2014. A random effects meta-analysis was conducted to evaluate the relative risk of death, graft loss, acute rejection (AR, new-onset diabetes after transplantation (NODAT and hypertension with tacrolimus relative to ciclosporin at 12 months.The literature search identified 11 RCTs comparing ciclosporin with tacrolimus. Relative to ciclosporin, tacrolimus was associated with significantly improved outcomes in terms of patient mortality (risk ratio [RR] with ciclosporin of 1.26; 95% confidence interval [95%CI] 1.01-1.58. Tacrolimus was superior to ciclosporin in terms of hypertension (RR with ciclosporin 1.26; 95%CI 1.07-1.47, but inferior in terms of NODAT (RR with ciclosporin 0.60; 95%CI 0.47-0.77. There were no significant differences between ciclosporin and tacrolimus in terms of graft loss or AR.Meta-analysis of RCTs published since 2000 showed tacrolimus to be superior to ciclosporin in terms of patient mortality and hypertension, while ciclosporin was superior in terms of NODAT. No significant differences were identified in terms of graft loss or AR. These findings provide further evidence supporting the use of tacrolimus as the cornerstone of immunosuppressive therapy in liver transplant recipients.

  7. Characteristic features of tacrolimus-induced lung disease in rheumatoid arthritis patients.

    Science.gov (United States)

    Sasaki, Takanori; Nakamura, Wataru; Inokuma, Shigeko; Matsubara, Erika

    2016-02-01

    This paper aims to study the background and clinical characteristics of tacrolimus (TAC)-induced lung disease. A case of a rheumatoid arthritis (RA) patient who developed TAC-induced interstitial lung disease (TAC-ILD) is reported. The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) website was searched for cases of TAC-ILD and its prevalence among all cases of TAC-related adverse events. As for cases of TAC-ILD, its underlying disease, preexisting lung diseases, and fatal outcome were also searched. Literature review of TAC-ILD cases was added. A 65-year-old female RA patient with preexisting bronchiectasis developed near-fatal TAC-ILD. Amelioration of RA, ground-glass opacities in the upper, anterior, and central lung fields, and decrease in peripheral blood lymphocyte count were the major findings in this patient. A search of the PMDA website revealed the following: the prevalence of TAC-ILD was 3 % of all cases of TAC-related adverse events, 56 out of 85 RA cases (66 %), and one out of 15 other cases had a preexisting lung disease; the prevalences of fatal outcome in RA and other cases were 24 and 38 %, respectively. A few cases in the literature had preexisting ILD and developed diffuse alveolar damage. In our case, preexisting bronchiectasis, arthritis remission, newly developed ground-glass opacities (GGOs) in the upper, anterior, and central lung fields, and decrease in peripheral blood lymphocyte count were the major findings. From the search of the PMDA website, about one fourth of the cases with TAC-related lung injury had a fatal outcome, and among RA patients, two thirds had preexisting lung diseases.

  8. Open-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft Recipients

    Science.gov (United States)

    Tedesco-Silva, Helio; Peddi, V. Ram; Sánchez-Fructuoso, Ana; Marder, Brad A.; Russ, Graeme R.; Diekmann, Fritz; Flynn, Alison; Hahn, Carolyn M.; Li, Huihua; Tortorici, Michael A.; Schulman, Seth L.

    2016-01-01

    Background Calcineurin inhibitor–associated nephrotoxicity and other adverse events have prompted efforts to minimize/eliminate calcineurin inhibitor use in kidney transplant recipients. Methods This open-label, randomized, multinational study evaluated the effect of planned transition from tacrolimus to sirolimus on kidney function in renal allograft recipients. Patients received tacrolimus-based immunosuppression and then were randomized 3 to 5 months posttransplantation to transition to sirolimus or continue tacrolimus. The primary end point was percentage of patients with 5 mL/min per 1.73 m2 or greater improvement in estimated glomerular filtration rate from randomization to month 24. Results The on-therapy population included 195 patients (sirolimus, 86; tacrolimus, 109). No between-group difference was noted in percentage of patients with 5 mL/min per 1.73 m2 or greater estimated glomerular filtration rate improvement (sirolimus, 34%; tacrolimus, 42%; P = 0.239) at month 24. Sirolimus patients had higher rates of biopsy-confirmed acute rejection (8% vs 2%; P = 0.02), treatment discontinuation attributed to adverse events (21% vs 3%; P renal function improvement at 24 months is similar for patients with early conversion to sirolimus after kidney transplantation versus those remaining on tacrolimus. PMID:27500260

  9. Topical tacrolimus solution in autoimmune polyglandular syndrome-1-associated keratitis.

    Science.gov (United States)

    Shoughy, Samir S; Tabbara, Khalid F

    2017-09-01

    To evaluate the efficacy of topical tacrloimus eye drops in the treatment of keratitis associated with autoimmune polyglandular syndrome (APS)-1. This is a retrospective review of 10 patients with APS-1. The patients were treated with topical tacrolimus 0.01% solution at The Eye Center, between 1 March 2012 and 30 April 2016. The outcome measures included improvement in visual acuity, photophobia and keratitis following treatment. Clinical assessment was carried out before, during and on the last visit following initiation of therapy. A total of 10 patients were included. There were five male and five female patients. The mean age was 11 years with age range of 3-42 years. The mean duration of treatment with topical tacrolimus was 26 months (range 8-46 months). There was improvement of photophobia in 7 out of 10 patients following therapy with topical tacrolimus. In three patients, the photophobia was persistent. There was no clinically detectable improvement in the severity of keratitis in all patients. The mean best corrected visual acuity was 0.1 before and following therapy. Topical tacrolimus is effective in reducing the photophobia in patients with APS-1-associated keratitis, but showed no effects on the severity of keratitis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  10. Artificial neural network model for predicting the bioavailability of tacrolimus in patients with renal transplantation

    Science.gov (United States)

    Thishya, Kalluri; Vattam, Kiran Kumar; Naushad, Shaik Mohammad; Raju, Shree Bhushan

    2018-01-01

    The objective of the current study was to explore the role of ABCB1 and CYP3A5 genetic polymorphisms in predicting the bioavailability of tacrolimus and the risk for post-transplant diabetes. Artificial neural network (ANN) and logistic regression (LR) models were used to predict the bioavailability of tacrolimus and risk for post-transplant diabetes, respectively. The five-fold cross-validation of ANN model showed good correlation with the experimental data of bioavailability (r2 = 0.93–0.96). Younger age, male gender, optimal body mass index were shown to exhibit lower bioavailability of tacrolimus. ABCB1 1236 C>T and 2677G>T/A showed inverse association while CYP3A5*3 showed a positive association with the bioavailability of tacrolimus. Gender bias was observed in the association with ABCB1 3435 C>T polymorphism. CYP3A5*3 was shown to interact synergistically in increasing the bioavailability in combination with ABCB1 1236 TT or 2677GG genotypes. LR model showed an independent association of ABCB1 2677 G>T/A with post transplant diabetes (OR: 4.83, 95% CI: 1.22–19.03). Multifactor dimensionality reduction analysis (MDR) revealed that synergistic interactions between CYP3A5*3 and ABCB1 2677 G>T/A as the determinants of risk for post-transplant diabetes. To conclude, the ANN and MDR models explore both individual and synergistic effects of variables in modulating the bioavailability of tacrolimus and risk for post-transplant diabetes. PMID:29621269

  11. Low-dose tacrolimus combined with donor-derived mesenchymal stem cells after renal transplantation: a prospective, non-randomized study

    OpenAIRE

    Pan, Guang-hui; Chen, Zheng; Xu, Lu; Zhu, Jing-hui; Xiang, Peng; Ma, Jun-jie; Peng, Yan-wen; Li, Guang-hui; Chen, Xiao-yong; Fang, Jia-li; Guo, Yu-he; Zhang, Lei; Liu, Long-shan

    2016-01-01

    Calcineurin inhibitors, including tacrolimus, are largely responsible for advances in allotransplantation. However, the nephrotoxicity associated with these immunosuppressants impairs patients' long-term survival after renal allograft. Therefore, novel regimens that minimize or even eliminate calcineurin inhibitors could improve transplantation outcomes. In this pilot study, we investigated the use of low-dose tacrolimus in combination with mesenchymal stem cells (MSCs), which are immunosuppr...

  12. Comparison between the efficacy of microneedling combined with 5-fluorouracil vs microneedling with tacrolimus in the treatment of vitiligo.

    Science.gov (United States)

    Mina, Mary; Elgarhy, Lamia; Al-Saeid, Hanan; Ibrahim, Zeinab

    2018-03-12

    Several treatment modalities had been used for the treatment of vitiligo, but the optimal treatment has not yet been identified. To study the efficacy of microneedling with 5-flurouracil vs its efficacy with tacrolimus in the treatment of vitiligo. Twenty-five patients with vitiligo were subjected to microneedling of 2 patches of vitiligo with dermapen, then application of 5-fluorouracil to 1 patch and tacrolimus on the other patch. This procedure was repeated every 2 weeks for every patient for maximum 6 months (12 sessions). The patients were followed up for 3 months after the last session. The overall repigmentation was significantly higher in 5-fluorouracil-treated patches compared with tacrolimus. Excellent improvement occurred in 48% of 5- flurouracil-treated patches while only in 16% of tacrolimus-treated patches. In the acral parts, 40% of the patches treated with 5-fluorouracil achieved excellent improvement (repigmentation >75%), while no patch in the acral parts achieved excellent improvement with tacrolimus. However, there was significant difference between the 2 drugs,regarding inflammation, ulceration, and hyperpigmentation which occurred with 5-fluorouracil. Microneedling combined with 5-fluorouracil or tacrolimus is safe and effective treatment of vitiligo. However, 5-fluorouracil achieved a greater percentage of repigmentation than tacrolimus particularly in the acral parts. © 2018 Wiley Periodicals, Inc.

  13. New tablet formulation of tacrolimus with smaller interindividual variability may become a better treatment option than the conventional capsule formulation in organ transplant patients

    Directory of Open Access Journals (Sweden)

    Kim YK

    2017-09-01

    Full Text Available Yu Kyong Kim,1 Anhye Kim,1,2 Shin Jung Park,3 Howard Lee1,4 1Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, 2Clinical Trial Center, Ajou University Medical Center, Suwon, 3Research Institute, Chong Kun Dang Pharmaceutical Corp, Yongin, 4Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Suwon, Republic of Korea Abstract: To evaluate the pharmacokinetic (PK and tolerability profiles of a new tablet formulation of tacrolimus and its interindividual variability (IIV in the systemic exposure, and to compare them with those of the conventional capsule formulation, a randomized, open-label, two-treatment, two-period, two-sequence, crossover study was performed in 47 healthy males. The capsule or tablet formulation of tacrolimus was orally administered, and serial blood samples were collected up to 96 hours after dosing. Whole-blood tacrolimus concentration was determined using liquid chromatography–tandem mass spectrometry. The maximum whole-blood tacrolimus concentration (Cmax and the area under the whole-blood tacrolimus concentration–time curve from 0 hour to the last quantifiable concentration (AUClast were compared between the two formulations. The similarity factor (f2 of the in vitro dissolution profiles was calculated. The geometric mean ratio (90% confidence interval of tablet to capsule was 0.9680 (0.8873–1.0560 and 1.0322 (0.9359–1.1385 for Cmax and AUClast, respectively. The IIV of Cmax and AUClast of the tablet was smaller than the capsule. The f2 values were >50 in all media. Both formulations were well tolerated. Thus, the tablet formulation of tacrolimus has smaller IIV in the systemic exposure than capsule, while having comparable PK and tolerability profiles, which may render it as a better treatment option for organ transplant patients. Keywords: new formulation, incrementally

  14. Improved oral absorption of tacrolimus by a solid dispersion with hypromellose and sodium lauryl sulfate.

    Science.gov (United States)

    Jung, Hyuck Jun; Ahn, Hye In; Park, Ji Yeon; Ho, Myoung Jin; Lee, Dae Ro; Cho, Ha Ra; Park, Jun Seo; Choi, Yong Seok; Kang, Myung Joo

    2016-02-01

    A novel surfactant-incorporated hydroxypropyl methylcellulose (HPMC) solid dispersion (SD) system was constructed in order to facilitate the release rate and oral absorption of tacrolimus (FK506), a poorly water-soluble immunosuppressant. Several emulsifiers including sodium lauryl sulfate (SLS), as drug release promotors, were employed with HPMC to fabricate SD using the solvent wetting method. The solid state characteristics using differential scanning calorimetry and X-ray powder diffraction, revealed that FK506 was molecularly distributed within all dispersions in amorphous form. The dissolution rates of FK506 in SLS-incorporated SDs were much higher than those in SDs prepared with HPMC alone, and even with stearoyl polyoxyl-32 glycerides or tocopheryl polyethylene glycol 1000 succinate. In particular, the greatest dissolution enhancement was obtained from the SD consisting of the drug, HPMC, and SLS in a weight ratio of 1:1:3, providing a 50-fold higher drug concentration within 15 min, compared with HPMC SD. In vivo absorption study in rats demonstrates that the optimized formula remarkably increased the oral absorption of FK506, providing about 4.0-fold greater bioavailability (p<0.05) compared with the marketed product (Prograf®, Astellas Pharma). These data suggest that a novel SLS/HPMC SD may be an advantageous dosage form of FK506, boosting the dissolution and absorption in gastrointestinal tract. Copyright © 2015 Elsevier B.V. All rights reserved.

  15. Decreased calcineurin immunoreactivity in the postmortem brain of a patient with schizophrenia who had been prescribed the calcineurin inhibitor, tacrolimus, for leukemia

    Directory of Open Access Journals (Sweden)

    Wada A

    2016-07-01

    Full Text Available Akira Wada,1,2 Yasuto Kunii,1 Jyunya Matsumoto,1 Mizuki Hino,1 Atsuko Nagaoka,1 Shin-ichi Niwa,3 Hirooki Yabe1 1Department of Neuropsychiatry, Fukushima Medical University School of Medicine, Fukushima City, Fukushima, 2Department of Neuropsychiatry, The University of Tokyo Hospital, Bunkyo-ku, Tokyo, 3Department of Psychiatry, Aizu Medical Center, Fukushima Medical University, Aizuwakamatsu City, Fukushima, Japan Background: The calcineurin (CaN inhibitor, tacrolimus, is widely used in patients undergoing allogeneic organ transplantation and in those with certain allergic diseases. Recently, several reports have suggested that CaN is also associated with schizophrenia. However, little data are currently available on the direct effect of tacrolimus on the human brain.Case: A 23-year-old Japanese female experienced severe delusion of persecution, delusional mood, suspiciousness, aggression, and excitement. She visited our hospital and was diagnosed with schizophrenia. When she was 27 years old, she had severe general fatigue, persistent fever, systemic joint pain, gingival bleeding, and breathlessness and was diagnosed with acute myelomonocytic leukemia. Later she underwent bone marrow transplantation (BMT, she was administered methotrexate and cyclosporin A to prevent graft versus host disease (GVHD. Three weeks after BMT, she showed initial symptoms of GVHD and was prescribed tacrolimus instead of cyclosporin A. Seven months after BMT at the age of 31 years, she died of progression of GVHD. Pathological anatomy was examined after her death, including immunohistochemical analysis of her brain using anti-CaN antibodies. For comparison, we used our previous data from both a schizophrenia group and a healthy control group. No significant differences were observed in the percentage of CaN-immunoreactive neurons among the schizophrenia group, healthy control group, and the tacrolimus case (all P>0.5, analysis of covariance. Compared with the

  16. A multicenter experience with generic tacrolimus conversion.

    Science.gov (United States)

    McDevitt-Potter, Lisa M; Sadaka, Basma; Tichy, Eric M; Rogers, Christin C; Gabardi, Steven

    2011-09-27

    The first generic tacrolimus product gained Food and Drug Administration approval in August 2009. This prospective, observational trial sought to determine the need for dose titrations and measure drug cost savings on conversion to generic tacrolimus. Transplant recipients on stable tacrolimus doses were converted from brand to generic tacrolimus on a mg:mg basis. Data were collected at the time of generic conversion (study arm) and at a time point exactly 6 months before conversion (control arm) for all subjects. Seventy conversions from four centers are reported. Subjects were a mean of 70 months after kidney (n=37), liver (n=28), or multiorgan (n=5) transplant. In the study arm, mean tacrolimus doses were 4.4 and 4.5 mg/d and mean tacrolimus trough concentrations were 5.8 and 5.9 ng/mL before and after conversion, respectively. In the control arm, mean tacrolimus doses were 4.6 and 4.6 mg/d and mean tacrolimus trough concentrations were 6.1 and 5.9 ng/mL before and after the control time point, respectively. Dose titrations occurred in five patients (7%) in the control arm and 15 patients (21%) in the study arm (P=0.028). Mean monthly drug costs were $645 for brand, $593 for generic, and $595 for generic after dose titrations. Mean monthly patient copays were $38 for brand and $15 for generic. These cumulative data show that dose requirements and trough levels are similar between brand and generic tacrolimus and that generic substitution allows for savings. However, postconversion monitoring is prudent as patients may require dose titration.

  17. ATG-Fresenius treatment and low-dose tacrolimus: results of a randomized controlled trial in liver transplantation.

    Science.gov (United States)

    Benítez, C E; Puig-Pey, I; López, M; Martínez-Llordella, M; Lozano, J J; Bohne, F; Londoño, M C; García-Valdecasas, J C; Bruguera, M; Navasa, M; Rimola, A; Sánchez-Fueyo, A

    2010-10-01

    We report the results of a prospective randomized controlled trial in liver transplantation assessing the efficacy and safety of antithymocyte globulin (ATG-Fresenius) plus tacrolimus monotherapy at gradually decreasing doses. Patients were randomized to either: (a) standard-dose tacrolimus plus steroids;or (b) peritransplant ATG-Fresenius plus reduced-dose tacrolimus monotherapy followed by weaning of tacrolimus starting 3 months after transplantation. The primary end-point was the achievement of very low-dose tacrolimus (every-other-day or once daily dose with Fresenius group but no benefits in terms of improved renal function, lower metabolic complications or increased prevalence of tolerance-related biomarkers were observed. In conclusion, the use of ATG-Fresenius and tacrolimus at gradually decreasing doses was associated with a high rate of rejection, did not allow for the administration of very low doses of tacrolimus and failed to provide detectable clinical benefits. ClinicalTrials.gov identifier: NCT00436722. © 2010 The Authors Journal compilation © 2010 The American Society of Transplantation and the American Society of Transplant Surgeons.

  18. Pharmacokinetic interaction between corticosteroids and tacrolimus after renal transplantation.

    Science.gov (United States)

    Anglicheau, Dany; Flamant, Martin; Schlageter, Marie Hélène; Martinez, Frank; Cassinat, Bruno; Beaune, Philippe; Legendre, Christophe; Thervet, Eric

    2003-11-01

    Tacrolimus is an immunosuppressive drug that is a substrate of cytochrome P450 3A (CYP3A) enzymes and P-glycoprotein (P-gp). After transplantation, many pharmacological interactions have been described. Corticosteroids induce both CYP3A and P-gp activity. This study was designed to investigate the presence of a clinically significant interaction between steroids and tacrolimus after renal transplantation. We studied 83 renal transplant recipients receiving tacrolimus after transplantation. Patients were divided into three groups, according to steroid dose (low: 0-0.15 mg/kg/day; intermediate: 0.16-0.25 mg/kg/day; and high: >0.25 mg/kg/day). All other medications, including those known to interact with CYP3A and/or P-gp, were recorded. Steroid dosage, tacrolimus dosage, tacrolimus trough concentration (C0) and tacrolimus concentration/dose ratio [C0 divided by the 24 h dosage (mg/kg)] were assessed for each dosage group after 1 and 3 months of tacrolimus treatment. The three groups were not different as regards the use of non-immunosuppressive treatments or clinical events. At 1 and 3 months, the tacrolimus doses and concentration/dose ratios differed significantly in the three steroid dosage groups. With the higher doses, higher tacrolimus doses were needed to achieve the blood tacrolimus targeted trough level. We demonstrated that pharmacokinetic interaction occurs between steroids and tacrolimus in renal transplant patients. The higher the steroid dosage, the higher the dosage of tacrolimus needed to achieve target trough levels in these patients. The most likely interaction mechanism is specific enzymatic induction of CYP3A and/or P-gp. Interaction is present, even when the steroid dosage is low. The clinical events liable to occur during steroid sparing or tapering must be taken into account because it may be associated with episodes of tacrolimus-related nephrotoxicity.

  19. Erratic tacrolimus exposure, assessed using the standard deviation of trough blood levels, predicts chronic lung allograft dysfunction and survival.

    Science.gov (United States)

    Gallagher, Harry M; Sarwar, Ghulam; Tse, Tracy; Sladden, Timothy M; Hii, Esmond; Yerkovich, Stephanie T; Hopkins, Peter M; Chambers, Daniel C

    2015-11-01

    Erratic tacrolimus blood levels are associated with liver and kidney graft failure. We hypothesized that erratic tacrolimus exposure would similarly compromise lung transplant outcomes. This study assessed the effect of tacrolimus mean and standard deviation (SD) levels on the risk of chronic lung allograft dysfunction (CLAD) and death after lung transplantation. We retrospectively reviewed 110 lung transplant recipients who received tacrolimus-based immunosuppression. Cox proportional hazard modeling was used to investigate the effect of tacrolimus mean and SD levels on survival and CLAD. At census, 48 patients (44%) had developed CLAD and 37 (34%) had died. Tacrolimus SD was highest for the first 6 post-transplant months (median, 4.01; interquartile range [IQR], 3.04-4.98 months) before stabilizing at 2.84 μg/liter (IQR, 2.16-4.13 μg/liter) between 6 and 12 months. The SD then remained the same (median, 2.85; IQR, 2.00-3.77 μg/liter) between 12 and 24 months. A high mean tacrolimus level 6 to 12 months post-transplant independently reduced the risk of CLAD (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.63-0.86; p < 0.001) but not death (HR, 0.96; 95% CI, 0.83-1.12; p = 0.65). In contrast, a high tacrolimus SD between 6 and 12 months independently increased the risk of CLAD (HR, 1.46; 95% CI, 1.23-1.73; p < 0.001) and death (HR, 1.27; 95% CI, 1.08-1.51; p = 0.005). Erratic tacrolimus levels are a risk factor for poor lung transplant outcomes. Identifying and modifying factors that contribute to this variability may significantly improve outcomes. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

  20. Topical tacrolimus for atopic dermatitis.

    Science.gov (United States)

    Cury Martins, Jade; Martins, Ciro; Aoki, Valeria; Gois, Aecio F T; Ishii, Henrique A; da Silva, Edina M K

    2015-07-01

    Atopic dermatitis (AD) (or atopic eczema) is a chronic inflammatory skin condition that affects children and adults and has an important impact on quality of life. Topical corticosteroids (TCS) are the first-line therapy for this condition; however, they can be associated with significant adverse effects when used chronically. Tacrolimus ointment (in its 2 manufactured strengths of 0.1% and 0.03%) might be an alternative treatment. Tacrolimus, together with pimecrolimus, are drugs called topical calcineurin inhibitors (TCIs). To assess the efficacy and safety of topical tacrolimus for moderate and severe atopic dermatitis compared with other active treatments. We searched the following databases up to 3 June 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (Issue 5, 2015), MEDLINE (from 1946), EMBASE (from 1974), LILACS (from 1982), and the Global Resource of Eczema Trials (GREAT database). We searched six trials registers and checked the bibliographies of included studies for further references to relevant trials. We contacted specialists in the field for unpublished data.A separate search for adverse effects of topical tacrolimus was undertaken in MEDLINE and EMBASE on 30 July 2013. We also scrutinised the U.S. Food and Drug Administration (FDA) websites for adverse effects information. All randomised controlled trials (RCTs) of participants with moderate to severe atopic dermatitis (both children and adults) using topical tacrolimus at any dose, course duration, and follow-up time compared with other active treatments. Two authors independently screened and examined the full text of selected studies for compliance with eligibility criteria, risk of bias, and data extraction. Our three prespecified primary outcomes were physician's assessment, participant's self-assessment of improvement, and adverse effects. Our secondary outcomes included assessment of improvement of the disease by validated or objective measures, such as

  1. Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis.

    Science.gov (United States)

    Takeuchi, Tsutomu; Kawai, Shinichi; Yamamoto, Kazuhiko; Harigai, Masayoshi; Ishida, Kota; Miyasaka, Nobuyuki

    2014-01-01

    A post-marketing surveillance (PMS) program was implemented to assess the safety and effectiveness of tacrolimus (TAC) in Japanese rheumatoid arthritis (RA) patients and to identify risk factors related to adverse drug reactions (ADRs). Patients were registered centrally and monitored for all adverse events (AEs) for 24 weeks. Effectiveness was evaluated using the Disease Activity Score 28-CRP (DAS28-CRP). Data from 3,172 patients (mean age 62.2 years) were evaluated in the safety analysis. Of the safety population, 78.5 %were female and 25.9 % were in Steinbrocker's functional class 3 or 4. TAC was prescribed as monotherapy in 52.5 % and the most common concomitant disease modifying antirheumatic drug (DMARD) was methotrexate, used in 28.9 % of the patients. The incidence of AEs, serious AEs (SAEs), ADRs and serious ADRs were 41.2, 6.4, 36.0, and 4.9 %, respectively. The most frequent serious ADR category was infections and infestations. Age ≥ 65 years, concurrent renal dysfunction, and concurrent diabetes mellitus were identified as significant risk factors for ADR. Based on EULAR response criteria, 65.4 % of the patients showed moderate or good response. The results demonstrate that TAC is well tolerated by Japanese patients with active RA, including those receiving concomitant methotrexate, in the real world.

  2. A search for new CYP3A4 variants as determinants of tacrolimus dose requirements in renal-transplanted patients.

    Science.gov (United States)

    Tavira, Beatriz; Coto, Eliecer; Diaz-Corte, Carmen; Alvarez, Victoria; López-Larrea, Carlos; Ortega, Francisco

    2013-08-01

    The CYP3A5*3 and CYP3A4*1B alleles have been related with tacrolimus (Tac) dose requirements. The rare CYP3A4*22 variant has also been associated with a significantly lower Tac dose. We genotyped the three single-nucleotide polymorphisms in 206 kidney-transplanted patients who received Tac as the primary immunosuppressor. CYP3A5*1 and CYP3A4*1B allele carriers received a significantly higher Tac dose (PCYP3A4*22 genotypes, either nominally or according to the CYP3A5 genotype (expressers vs. nonexpressers). Sequencing of CYP3A4 coding exons in a total of 15 patients revealed only one nonreported missense change (p.P227>T) in one patient. We concluded that CYP3A5*3 and CYP3A4*1B were the main determinants of the Tac dose-adjusted blood concentration in our cohort of renal-transplanted patients.

  3. Tacrolimus treatment of atopic eczema/dermatitis syndrome.

    Science.gov (United States)

    Thestrup-Pedersen, Kristian

    2003-10-01

    Atopic dermatitis is today the most common chronic disease of children in Europe, the US and Japan. The 'golden standard' of therapy is topical glucocorticosteroids and emollients. The steroids have been on the market for four decades, are efficacious, but only advised for short-term treatment due to their risks of side effects. More than 16,000 persons suffering from atopic dermatitis have been enrolled in clinical studies of tacrolimus. One third of patients with moderate to severe atopic dermatitis experience over 90% improvement in their disease over a 12-week treatment period and up to 70% of patients have over 50% improvement. A 1-year treatment leads to more than 90% improvement in 75% of patients. The most pronounced side effect is a burning sensation occurring in up to 60% of patients. Atopic dermatitis is a chronic skin disease leading to a demand for long-term treatment control. Such treatment options have not previously been available--except for emollients which are not efficacious for controlling skin inflammation. Tacrolimus and pimecrolimus are new treatment options, free from the potential side effects of topical steroids, which are known for their efficacy in short-term treatment. The new treatment modalities prevent the eczema from relapsing and at the same time they control active eczema. The future will see a shift towards the long-term use of tacrolimus which is able to control the skin inflammation and, hopefully, shorten the course of the eczema.

  4. Late conversion from tacrolimus to a belatacept-based immuno-suppression regime in kidney transplant recipients improves renal function, acid-base derangement and mineral-bone metabolism.

    Science.gov (United States)

    Schulte, Kevin; Vollmer, Clara; Klasen, Vera; Bräsen, Jan Hinrich; Püchel, Jodok; Borzikowsky, Christoph; Kunzendorf, Ulrich; Feldkamp, Thorsten

    2017-08-01

    Calcineurin inhibitor (CNI)-induced nephrotoxicity and chronic graft dysfunction with deteriorating glomerular filtration rate (GFR) are common problems of kidney transplant recipients. The aim of this study was to analyze the role of belatacept as a rescue therapy in these patients. In this retrospective, observational study we investigated 20 patients (10 females, 10 males) who were switched from a CNI (tacrolimus) to a belatacept-based immunosuppression because of CNI intolerance or marginal transplant function. Patient follow-up was 12 months. Patients were converted to belatacept in mean 28.8 months after transplantation. Reasons for conversion were CNI intolerance (14 patients) or marginal transplant function (6 patients). Mean estimated GFR (eGFR) before conversion was 22.2 ± 9.4 ml/min at baseline and improved significantly to 28.3 ± 10.1 ml/min at 4 weeks and to 32.1 ± 12.6 ml/min at 12 months after conversion. Serum bicarbonate significantly increased from 24.4 ± 3.2 mmol/l at baseline to 28.7 ± 2.6 mmol/l after 12 months. Conversion to belatacept decreased parathyroid hormone and phosphate concentrations significantly, whereas albumin levels significantly increased. In 6 cases an acute rejection preceded clinically relevant CNI toxicity; only two patients suffered from an acute rejection after conversion. Belatacept was well tolerated and there was no increase in infectious or malignant side effects. A late conversion from a tacrolimus-based immunosuppression to belatacept is safe, effective and significantly improves renal function in kidney transplant recipients. Additionally, the conversion to belatacept has a beneficial impact on acid-base balance, mineral-bone and protein metabolism, independently of eGFR.

  5. Clinical Validation of Simultaneous Analysis of Tacrolimus, Cyclosporine A, and Creatinine in Dried Blood Spots in Kidney Transplant Patients.

    Science.gov (United States)

    Veenhof, Herman; Koster, Remco A; Alffenaar, Jan-Willem C; Berger, Stefan P; Bakker, Stephan J L; Touw, Daan J

    2017-07-01

    Monitoring of creatinine and immunosuppressive drug concentrations, such as tacrolimus (TaC) and cyclosporin A (CsA), is important in the outpatient follow-up of kidney transplant recipients. Monitoring by dried blood spot (DBS) provides patients the opportunity to sample a drop of blood from a fingerprick at home, which can be sent to the laboratory by mail. We performed a clinical validation in which we compared measurements from whole-blood samples obtained by venapuncture with measurements from DBS samples simultaneously obtained by fingerprick. After exclusion of 10 DBS for poor quality, and 2 for other reasons, 199, 104, and 58 samples from a total of 172 patients were available for validation of creatinine, TaC and CsA, respectively. Validation was performed by means of Passing & Bablok regression, and bias was assessed by Bland-Altman analysis. For creatinine, we found y = 0.73x - 1.55 (95% confidence interval [95% CI] slope, 0.71-0.76), giving the conversion formula: (creatinine plasma concentration in μmol/L) = (creatinine concentration in DBS in μmol/L)/0.73, with a nonclinically relevant bias of -2.1 μmol/L (95% CI, -3.7 to -0.5 μmol/L). For TaC, we found y = 1.00x - 0.23 (95% CI slope, 0.91-1.08), with a nonclinically relevant bias of -0.28 μg/L (95% CI, -0.45 to -0.12 μg/L). For CsA, we found y = 0.99x - 1.86 (95% CI slope, 0.91-1.08) and no significant bias. Therefore, for neither TaC nor CsA, a conversion formula is required. DBS sampling for the simultaneous analysis of immunosuppressants and creatinine can replace conventional venous sampling in daily routine.

  6. Evaluation of adherence and tolerability of prolonged-release tacrolimus (Advagraf™) in kidney transplant patients in Germany: A multicenter, noninterventional study.

    Science.gov (United States)

    Lehner, Lukas J; Reinke, Petra; Hörstrup, Jan H; Rath, Thomas; Suwelack, Barbara; Krämer, Bernhard K; Budde, Klemens; Banas, Bernhard

    2018-01-01

    This study assessed adherence to prolonged-release tacrolimus (PR-T)-based immunosuppression during routine maintenance of renal transplant recipients in Germany. Patients had received PR-T for ≥1 month at inclusion. Data were collected during four visits (V): baseline (V1), 6 (V2), 12 (V3), and 18 (V4) months. Composite primary endpoint: nonadherence at V4, defined as self-reported nonadherence on the Basel Assessment of Adherence with Immunosuppressive Medication Scale (BAASIS © ), investigator-rated nonadherence, and/or V4 tacrolimus trough level outside a predefined range. Secondary endpoints: individual BAASIS items, incidence of rejection, kidney function, and safety. Overall, 153 adult kidney recipients (mean [standard deviation] time post-transplant 5.8 [4.6] years) were included. Nonadherence was high at V4 (67.7% [95% confidence interval 58.9%, 75.6%]). Medication-taking adherence was 86.9% and 91.3% at V1 and V4, respectively; adherence to timing of medication intake was 58.2% and 58.3%, with little evidence of missed doses/drug holidays. Investigators rated adherence "good" in 85.6% of patients (V4). Two (1.3%) patients had acute rejection episodes. Kidney function remained stable (mean creatinine clearance, V1: 62.1 mL/min; V4: 65.3 mL/min). Investigators rated effectiveness of PR-T as "very good"/"good" in 91.5% of patients. Most patients (94.7%) found PR-T dosing more convenient than immediate-release tacrolimus. PR-T was well tolerated with high medication persistence. © 2017 The Authors. Clinical Transplantation Published by John Wiley & Sons Ltd.

  7. Generic tacrolimus in solid organ transplantation

    DEFF Research Database (Denmark)

    Taube, D; Jones, G; O'Beirne, J

    2014-01-01

    The availability of a wide range of immunosuppressive therapies has revolutionized the management of patients who have undergone solid organ transplantation (SOT). However, the cost of immunosuppressive drugs remains high. This situation has led to the development of generic equivalents, which...... innovator tacrolimus drug (Prograf) in both healthy volunteers and kidney transplant patients. Clinical experience with this generic tacrolimus formulation has also been established in both de novo and conversion patients who have undergone kidney and liver transplantation, as well as in conversion of other...

  8. Immunosuppression Adherence in Stable Kidney Transplant Patients Converted From Immediate- to Prolonged-Release Tacrolimus in Clinical Practice: A Norwegian Study.

    Science.gov (United States)

    Abedini, Sadollah; Gøransson, Lasse; Cockburn, Elinor; Kilany, Suzanne; Holdaas, Hallvard

    2018-02-01

    This study investigated medication adherence in kidney transplant patients (KTPs) converted from immediate-release tacrolimus (IR-T) to prolonged-release tacrolimus (PR-T)-based immunosuppression in routine practice. Noninterventional, observational, multicenter study in Norway. Included adult KTPs with stable graft function, converted from IR-T (baseline) to PR-T (1 mg:1 mg) in routine practice. Data were collected at baseline, and months 1, 3, 6, and 12 postconversion. Primary endpoint: adherence using the Basel Assessment of Adherence to Immunosuppressive Medication Scale. Secondary assessments: tacrolimus dose and trough levels (target, 3-7 ng/mL), clinical laboratory parameters (eg, estimated glomerular filtration rate [Modified Diet in Renal Disease]), and adverse events. Ninety-one KTPs (mean ± SD age 47.7 ± 14.3 years) were analyzed. Mean ± SD change in PR-T dose from baseline (4.4 ± 2.4 mg/d) to month 12 was -0.1 ± 0.9 mg/d; mean tacrolimus trough levels remained within target. Overall medication adherence increased from 45.6% at baseline to 58.1% at month 1, but was similar to baseline thereafter; taking and timing adherence followed a similar pattern. Odds ratio (OR) for adherence at month 1 (but not at other time points) was greater versus baseline for overall (OR, 1.71; P = 0.0205), taking (OR, 3.38; P = 0.0004), and timing (OR, 1.77, P = 0.0252) dimensions. Mean ± SD Basel Assessment of Adherence to Immunosuppressive Medication Scale visual analogue scale score at baseline was 96.4 ± 5.5%, and increased postconversion. Estimated glomerular filtration rate remained stable (month 12, 61.6 ± 17.7 mL/min per 1.73 m 2 ), as did other laboratory parameters. Two (2.2%) patients had adverse events considered probably/possibly treatment-related. There was disparity between high, patient-perceived and low, actual adherence. Converting stable KTPs from IR-T to PR-T in routine practice did not impact long-term adherence to immunosuppression; renal

  9. High-performance liquid chromatography-tandem mass spectrometry as a reference for analysis of tacrolimus to assess two immunoassays in patients with liver and renal transplants.

    Science.gov (United States)

    Salm, P; Taylor, P J; Clark, A; Balderson, G A; Grygotis, A; Norris, R L; Lynch, S V; Shaw, L M; Pond, S M

    1997-12-01

    The accuracy and imprecision of three assays used for therapeutic monitoring of tacrolimus were tested using blood-containing weighed-in amounts of the drug, an enzyme-linked immunosorbent assay (ELISA), a microparticle enzyme immunoassay (MEIA I), and a high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS2) assay. Accuracy was acceptable for the HPLC-MS2 assay at all concentrations tested (ELISA at 1.0 and 4.0 microg/l. Accuracy was not acceptable for the ELISA at 15.0 and 50.0 microg/l or for the MEIA I at all concentrations tested. Imprecision was acceptable for the HPLC-MS2 assay at all concentrations tested (coefficient of variation ELISA at 15.0 and 50.0 microg/l, and for the MEIA I at 15.0 and 50.0 microg/l. Imprecision was not acceptable for the ELISA at 1.0 and 4.0 microg/l or for the MEIA I at 1.0 and 4.0 microg/l. This assessment with weighed-in amounts of tacrolimus verified the HPLC-MS2 assay as a reference method. The performance of the two immunoassays with HPLC-MS2 was then compared in the clinical setting using blood from patients with liver (n = 30) and renal (n = 37) transplants. In the liver transplant group (127 samples), the range of tacrolimus concentrations measured by HPLC-MS2, ELISA, and MEIA I was 1.9 to 31.8, 2.1 to 35.0, and less than 0.1 to 36.5 mg/l, respectively. In the renal transplant group (129 samples), the ranges were 1.7 to 26.1, 1.9 to 24.4, and 0.9 to 28.5 microg/l, respectively. Compared with the HPLC-MS2, the ELISA had minimal bias (0.1 to 0.2 microg/l) but unacceptable variability in values (SD > 13%). The MEIA I had unacceptable bias (1.7-1.8 microg/l) and variability (SD > 23%). These data indicated that neither the ELISA nor MEIA I is interchangeable with HPLC-MS2. Moreover, in view of the current trend to reduce the therapeutic dose of tacrolimus, quantitative results using the MEIA I would not be obtainable during therapeutic drug monitoring in some patients in whom effective therapeutic

  10. A tacrolimus-related immunosuppressant with reduced toxicity.

    Science.gov (United States)

    Dumont, F J; Koprak, S; Staruch, M J; Talento, A; Koo, G; DaSilva, C; Sinclair, P J; Wong, F; Woods, J; Barker, J; Pivnichny, J; Singer, I; Sigal, N H; Williamson, A R; Parsons, W H; Wyvratt, M

    1998-01-15

    Tacrolimus (FK506) has potent immunosuppressive properties reflecting its ability to block the transcription of lymphokine genes in activated T cells through formation of a complex with FK506 binding protein-12, which inhibits the phosphatase activity of calcineurin. The clinical usefulness of tacrolimus is limited, however, by severe adverse effects, including neurotoxicity and nephrotoxicity. Although this toxicity, like immunosuppression, appears mechanistically related to the calcineurin inhibitory action of the drug, a large chemistry effort has been devoted to search for tacrolimus analogs with reduced toxicity but preserved immunosuppressive activity that might have enhanced therapeutic utility. Here, we report on the identification of such an analog, which was synthetically derived from ascomycin (ASC), the C21 ethyl analog of tacrolimus, by introducing an indole group at the C32 position. The profile of biological activity of indolyl-ASC was characterized in rodent models of immunosuppression and toxicity. Indolyl-ASC was found to exhibit an immunosuppressive potency equivalent to that of tacrolimus in T-cell activation in vitro and in murine transplant models, even though indolyl-ASC bound about 10 times less to intracellular FK506 binding protein-12 than tacrolimus or ASC. Further evaluation of indolyl-ASC revealed that it is threefold less potent than tacrolimus in inducing hypothermia, a response that may reflect neurotoxicity, and in causing gastrointestinal transit alterations in mice. Moreover, indolyl-ASC was at least twofold less nephrotoxic than tacrolimus upon 3-week oral treatment in rats. Altogether, these data indicate a modest but definite improvement in the therapeutic index for indolyl-ASC compared with tacrolimus in rodent models.

  11. Safety and effectiveness of tacrolimus add-on therapy for rheumatoid arthritis patients without an adequate response to biological disease-modifying anti-rheumatic drugs (DMARDs): Post-marketing surveillance in Japan.

    Science.gov (United States)

    Takeuchi, Tsutomu; Ishida, Kota; Shiraki, Katsuhisa; Yoshiyasu, Takashi

    2018-01-01

    Post-marketing surveillance (PMS) was conducted to assess the safety and effectiveness of tacrolimus (TAC) add-on therapy for patients with rheumatoid arthritis (RA) and an inadequate response to biological disease-modifying anti-rheumatic drugs (DMARDs). Patients with RA from 180 medical sites across Japan were registered centrally with an electronic investigation system. The observational period was 24 weeks from the first day of TAC administration concomitantly with biological DMARDs. Safety and effectiveness populations included 624 and 566 patients, respectively. Patients were predominantly female (81.1%), with a mean age of 61.9 years. Overall, 125 adverse drug reactions (ADRs) occurred in 94 patients (15.1%), and 15 serious ADRs occurred in 11 patients (1.8%). These incidences were lower compared with previously reported incidences after TAC treatment in PMS, and all of the observed ADRs were already known. A statistically significant improvement was observed in the primary effectiveness variable of Simplified Disease Activity Index after TAC treatment; 62.7% of patients achieved remission or low disease activity at week 24. TAC is well tolerated and effective when used as an add-on to biological DMARDs in Japanese patients with RA who do not achieve an adequate response to biological DMARDs in a real-world clinical setting.

  12. A possible simplification for the estimation of area under the curve (AUC₀₋₁₂) of enteric-coated mycophenolate sodium in renal transplant patients receiving tacrolimus.

    Science.gov (United States)

    Fleming, Denise H; Mathew, Binu S; Prasanna, Samuel; Annapandian, Vellaichamy M; John, George T

    2011-04-01

    Enteric-coated mycophenolate sodium (EC-MPS) is widely used in renal transplantation. With a delayed absorption profile, it has not been possible to develop limited sampling strategies to estimate area under the curve (mycophenolic acid [MPA] AUC₀₋₁₂), which have limited time points and are completed in 2 hours. We developed and validated simplified strategies to estimate MPA AUC₀₋₁₂ in an Indian renal transplant population prescribed EC-MPS together with prednisolone and tacrolimus. Intensive pharmacokinetic sampling (17 samples each) was performed in 18 patients to measure MPA AUC₀₋₁₂. The profiles at 1 month were used to develop the simplified strategies and those at 5.5 months used for validation. We followed two approaches. In one, the AUC was calculated using the trapezoidal rule with fewer time points followed by an extrapolation. In the second approach, by stepwise multiple regression analysis, models with different time points were identified and linear regression analysis performed. Using the trapezoidal rule, two equations were developed with six time points and sampling to 6 or 8 hours (8hrAUC[₀₋₁₂exp]) after the EC-MPS dose. On validation, the 8hrAUC(₀₋₁₂exp) compared with total measured AUC₀₋₁₂ had a coefficient of correlation (r²) of 0.872 with a bias and precision (95% confidence interval) of 0.54% (-6.07-7.15) and 9.73% (5.37-14.09), respectively. Second, limited sampling strategies were developed with four, five, six, seven, and eight time points and completion within 2 hours, 4 hours, 6 hours, and 8 hours after the EC-MPS dose. On validation, six, seven, and eight time point equations, all with sampling to 8 hours, had an acceptable r with the total measured MPA AUC₀₋₁₂ (0.817-0.927). In the six, seven, and eight time points, the bias (95% confidence interval) was 3.00% (-4.59 to 10.59), 0.29% (-5.4 to 5.97), and -0.72% (-5.34 to 3.89) and the precision (95% confidence interval) was 10

  13. Efficacy and safety of low-dose topical tacrolimus in vernal keratoconjunctivitis.

    Science.gov (United States)

    Shoughy, Samir S; Jaroudi, Mahmoud O; Tabbara, Khalid F

    2016-01-01

    The objective of this study was to evaluate the efficacy and safety of topical low-dose tacrolimus (0.01%) solution in patients with vernal keratoconjunctivitis (VKC). A total of 62 consecutive patients with VKC refractory to conventional treatment were included retrospectively. Tacrolimus 0.01% ophthalmic solution was administered to patients twice daily after discontinuation of all previous topical medications. The duration of treatment ranged from 1 month to 29 months. The clinical symptoms of itching, redness, foreign body sensation, and discharge and the clinical signs of conjunctival hyperemia, conjunctival papillary hypertrophy, limbal infiltration, Trantas dots, and superficial punctate keratopathy were graded as 0 (normal), 1+ (mild), 2+ (moderate), or 3+ (severe). Assessment was carried out before initiation of therapy and on the last visit after treatment. There were 62 patients with VKC comprising 49 male and 13 female patients. The median age was 12 years (range: 5-47 years). The mean visual acuity improved from 20/30 to 20/25 following treatment. There was statistically significant improvement in symptoms of itching (P<0.001), redness (P<0.001), foreign body sensation (P<0.001), and discharge (P<0.001). Statistically significant improvement was also observed in clinical signs of conjunctival hyperemia (P<0.001), limbal infiltration (P<0.001), Trantas dots (P<0.001), superficial punctate keratopathy (P<0.001), and conjunctival papillary hypertrophy (P<0.001). The solution form of tacrolimus was well tolerated. None of the patients developed elevation of intraocular pressure, cataract, or infectious keratitis. Low-dose topical tacrolimus 0.01% solution is effective and safe in the management of patients with refractory VKC.

  14. Pharmacokinetics of prolonged-release tacrolimus and implications for use in solid organ transplant recipients.

    Science.gov (United States)

    Tanzi, Maria G; Undre, Nasrullah; Keirns, James; Fitzsimmons, William E; Brown, Malcolm; First, M Roy

    2016-08-01

    Prolonged-release tacrolimus was developed as a once-daily formulation with ethylcellulose as the excipient, resulting in slower release and reduction in peak concentration (Cmax ) for a given dose compared with immediate-release tacrolimus, which is administered twice daily. This manuscript reviews pharmacokinetic information on prolonged-release tacrolimus in healthy subjects, in transplant recipients converted from immediate-release tacrolimus, and in de novo kidney and liver transplant recipients. As with the immediate-release formulation, prolonged-release tacrolimus shows a strong correlation between trough concentration (Cmin ) and area under the 24-hour time-concentration curve (AUC24 ), indicating that trough whole blood concentrations provide an accurate measure of drug exposure. We present the pharmacokinetic similarities and differences between the two formulations, so that prescribing physicians will have a better understanding of therapeutic drug monitoring in patients receiving prolonged-release tacrolimus. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. Clinical study of double dose of valsartan combined with tacrolimus in treatment of diabetic nephropathy.

    Science.gov (United States)

    Jin, H; Zhang, H-N; Hou, X-L; Zhang, B; Wu, J; Zhang, H-B

    2016-01-01

    To investigate the clinical effect of double dose of valsartan combined with tacrolimus in the treatment of diabetic nephropathy (DN). HA total of 86 cases diagnosed with DN were selected from October 2013 to October 2014 in Zaozhuang Municipal Hospital, China. The study was approved by our hospital Ethics Committee and written consent was obtained from patients and their family members. Patients were randomly divided into three groups according to the sequence of admission, group A (conventional dose of valsartan group, n = 28 cases), group B (double dose of valsartan group, n = 29 cases) and group C (double dose of valsartan combined with tacrolimus group, n = 29). Clinical effects were compared by analyzing the renal function tests after 8 weeks. 24h urine protein, serum creatinine level of patients in group B and group C were significantly lower than that of group A. Those in group C was much lower. The glomerular filtration rates were significantly higher for group B and C than that of group A, and those in group C were much higher. The difference is statistically significant (p valsartan combined with tacrolimus treatment of DN patients can improve clinical symptoms, reducing inflammation, inhibiting or even reversing the interstitial fibrosis, which will improve the curative effect and reduce the recurrence, as to provide a new theoretical basis for the clinical treatment of the disease.

  16. An analysis of tacrolimus-related complications in the first 30 days after liver transplantation

    Directory of Open Access Journals (Sweden)

    Lucas Souto Nacif

    2014-11-01

    Full Text Available OBJECTIVES: Orthotopic liver transplantation has improved survival in patients with end-stage liver disease; however, therapeutic strategies that achieve ideal immunosuppression and avoid early complications are lacking. To correlate the dose and level of Tacrolimus with early complications, e.g., rejection, infection and renal impairment, after liver transplantation. From November 2011 to May 2013, 44 adult liver transplant recipients were studied in this retrospective comparative study. RESULTS: The most frequent indication for liver transplantation was hepatitis C cirrhosis (47.7%, with a higher prevalence observed in male patients (68.18%. The ages of the subjects ranged from 19-71 and the median age was 55.5 years. The mean length of the hospital stay was 16.1±9.32 days and the mean Model for End-stage Liver Disease score was 26.18±4.28. There were five cases of acute cellular rejection (11.37% and 16 cases of infection (36.37%. The blood samples that were collected and analyzed over time showed a significant correlation between the Tacrolimus blood level and the deterioration of glomerular filtration rate and serum creatinine (p<0.05. Patients with infections had a higher serum level of Tacrolimus (p = 0.012. The dose and presence of rejection were significantly different (p = 0.048 and the mean glomerular filtration rate was impaired in patients who underwent rejection compared with patients who did not undergo rejection (p = 0.0084. CONCLUSION: Blood Tacrolimus levels greater than 10 ng/ml were correlated with impaired renal function. Doses greater than 0.15 mg/kg/day were associated with the prevention of acute cellular rejection but predisposed patients to infectious disease.

  17. C2 (2-h) levels are not superior to trough levels as estimates of the area under the curve in tacrolimus-treated renal-transplant patients

    DEFF Research Database (Denmark)

    Jørgensen, Kaj; Povlsen, Johan; Madsen, Søren

    2002-01-01

    and AUC by Pearson's correlation coefficient, and pairs of correlation coefficients were compared by an asymptotic Wald-type test. RESULTS: AUC varied five-fold despite near-equal dosing. Pearson's correlation coefficient for trough level, 1, 2, 3, 4, and 6 h were 0.84, 0.60, 0.81, 0.95, 0.95, and 0.......94 on day 3 and 0.94, 0.69, 0.92, 0.96, 0.94, 0.92 on day 14. Three-, 4- and 6-h levels had significantly higher correlation coefficients compared to trough, 1- and 2-h levels. One-hour samples had significantly lower correlation coefficients compared to all other sampling times on day 14. The patient...... with the highest AUC developed nephrotoxicity despite trough levels in the desired range. CONCLUSIONS: Two-hour levels are not superior to trough levels in tacrolimus-treated renal transplant patients. Despite good correlation between trough level and AUC, some patients may still receive nephrotoxic doses despite...

  18. Diabetic ketoacidosis associated with tacrolimus in solid organ transplant recipients

    International Nuclear Information System (INIS)

    Maqsood, M.Q.; Rabbani, M.; Habib, M.; Saleem, T.

    2011-01-01

    Diabetic ketoacidosis in patients receiving tacrolimus in the post-transplant setting is rare. We describe two such cases in solid-organ transplant recipients. The first patient, a 17-year-old male, presented with severe diabetic ketoacidosis and was managed with intravenous fluids and insulin infusion. He was a known case of Laurence-Moon-Bardet-Biedl syndrome and had received a renal transplant 2 years ago and was receiving tacrolimus since then. Although diabetic ketoacidosis resolved in 24 hours, large doses of subcutaneous insulin (unto 130 units per day) were needed to keep serum glucose within the normal range. Substitution of tacrolimus with cyclosporine obviated the need for insulin or oral hypoglycaemics. The second patient, a 55-year-old woman, presented with a history of polyuria for 3 days. She had received a hepatic transplant 2 years ago and tacrolimus was being used since then. Mild diabetic ketoacidosis was managed with fluid resuscitation and subcutaneous insulin. Her insulin requirement after an uneventful recovery has been 54 - 70 units per day. Clinicians should be cognizant of the possibility of hyperglycaemic crisis presenting as sudden onset of diabetic ketoacidosis in patients receiving tacrolimus. Use of an alternative calcineurin inhibitor may provide a safer solution to minimize future morbidity in such patients. (author)

  19. Efficacy and safety of low-dose topical tacrolimus in vernal keratoconjunctivitis

    Directory of Open Access Journals (Sweden)

    Shoughy SS

    2016-04-01

    Full Text Available Samir S Shoughy,1 Mahmoud O Jaroudi,1 Khalid F Tabbara1–3 1The Eye Center and The Eye Foundation for Research in Ophthalmology, 2Department of Ophthalmology, College of Medicine, King Saud University, Riyadh, Saudi Arabia; 3Wilmer Ophthalmological Institute of the Johns Hopkins University School of Medicine, Baltimore, MD, USA Objective: The objective of this study was to evaluate the efficacy and safety of topical low-dose tacrolimus (0.01% solution in patients with vernal keratoconjunctivitis (VKC. Patients and methods: A total of 62 consecutive patients with VKC refractory to conventional treatment were included retrospectively. Tacrolimus 0.01% ophthalmic solution was administered to patients twice daily after discontinuation of all previous topical medications. The duration of treatment ranged from 1 month to 29 months. The clinical symptoms of itching, redness, foreign body sensation, and discharge and the clinical signs of conjunctival hyperemia, conjunctival papillary hypertrophy, limbal infiltration, Trantas dots, and superficial punctate keratopathy were graded as 0 (normal, 1+ (mild, 2+ (moderate, or 3+ (severe. Assessment was carried out before initiation of therapy and on the last visit after treatment. Results: There were 62 patients with VKC comprising 49 male and 13 female patients. The median age was 12 years (range: 5–47 years. The mean visual acuity improved from 20/30 to 20/25 following treatment. There was statistically significant improvement in symptoms of itching (P<0.001, redness (P<0.001, foreign body sensation (P<0.001, and discharge (P<0.001. Statistically significant improvement was also observed in clinical signs of conjunctival hyperemia (P<0.001, limbal infiltration (P<0.001, Trantas dots (P<0.001, superficial punctate keratopathy (P<0.001, and conjunctival papillary hypertrophy (P<0.001. The solution form of tacrolimus was well tolerated. None of the patients developed elevation of intraocular pressure

  20. Progressive necrotic encephalopathy following tacrolimus therapy for liver transplantation.

    Science.gov (United States)

    Aridon, Paolo; Ragonese, Paolo; Di Benedetto, Norma; Grasso, Giovanni; Conaldi, Pier Giulio; D'Amelio, Marco; Savettieri, Giovanni

    2009-12-01

    Previously described neurologic damage induced by immunosuppressive treatments includes transient or reversible central nervous system involvement. We describe a 57-year-old man who underwent liver transplantation and was started on immunosuppressive therapy with tacrolimus (FK506). Six months later, he started complaining of a progressive motor and sensory impairment of the left side, together with cognitive impairment. Brain MRI showed an enlarging lesion of the white matter with peripheral contrast enhancement. PET study indicated severe hypometabolism in the right hemisphere and spectroscopic MRI showed a peak of choline and relative reduction of other metabolites. Findings of CSF examinations and cultures, serology, and molecular techniques were normal. Tacrolimus treatment was stopped. A cerebral biopsy of the lesion showed a sub acute necrotizing process. In the following months, cognitive status of the patient tended to improve although he remained hemiplegic, while serial MRI confirmed the tendency to the recovery of the lesion that was still present 1 year after. The present observation describes a progressive encephalopathy associated with immune suppression with an unusual feature and permanent brain damage.

  1. Effectiveness and safety of topical tacrolimus in treatment of vitiligo

    Directory of Open Access Journals (Sweden)

    Ghasem Rahmatpour Rokni

    2017-01-01

    Full Text Available Vitiligo is one of the most primitive well-known dermatoid disorders with different suggested therapies. Therefore, this study investigated the efficiency and safety of topical tacrolimus in treatment of patients with vitiligo. This study was a clinical randomized designed study pre- post-test method, has been conducted on thirty cases with vitiligo who have referred to polyclinic and dermatology clinic. Participant′s evaluated and demographic information recorded in designed checklist. In the next stage, the disease activity scored by vitiligo index disease activity system. Photography and depigmentation percent has recorded before treatment and further in 4 th , 8 th , 12 th , 16 th , 20 th , and 24 th weeks. Finally, gathered data compared through SPSS-20 software. The final sample comprised 30 persons including: 12 men (40% and 18 women (60%. The average of patient′s age in this study was 26/13 ΁ 18/20 (2-76-year-old. Eleven persons was ≤15 years old and rest was older than 15. Sixty-six lesions have funded in patients that maximum has accrued on face and neck (37/87% and trunk (21/21%. In addition, minimum of lesions is related to genitalia (9/09%. In the in 4 th , 8 th , 12 th , 16 th weeks, improvement in face and neck had increased significantly, into the past weeks. In the 20 th and 24 th weeks, the improvement has increased although it was not significant enhancement. Also about trunk, in the 4 th week the improvement does not have significant increasing in compare to the past week. In the eighth, 12 th , 16 th , 20 th , and 24 th weeks the improvement has been increased significantly in compare to the past weeks. Although in the case of limbs and genitalia, the improvement was lower. There was no significant difference between male and females and age. Although the improvement was, slow in older persons. Study results, has presented applying topical tacrolimus in vitiligo, particularly in face and neck, could be effective and

  2. Treatment of Acute Tacrolimus Toxicity with Phenytoin in Solid Organ Transplant Recipients

    Directory of Open Access Journals (Sweden)

    Arin S. Jantz

    2013-01-01

    Full Text Available The pharmacokinetics of tacrolimus are influenced by many factors, including genetic variability, acute infections, liver dysfunction, and interacting medications, which can result in elevated concentrations. The most appropriate management of acute tacrolimus toxicity has not been defined though case reports exist describing the therapeutic use of enzyme inducers to increase tacrolimus metabolism and decrease concentrations. We are reporting on the utilization of phenytoin to assist in decreasing tacrolimus concentrations in a case series of four solid organ transplant recipients with acute, symptomatic tacrolimus toxicity presenting with elevated serum creatinine, potassium, and tacrolimus trough concentrations greater than 30 ng/mL. All four patients had the potential causative agents stopped or temporarily held and were given 300 to 400 mg/day of phenytoin for two to three days. Within three days of beginning phenytoin, all four patients had a decrease in tacrolimus concentration to less than 15 ng/mL, a return to or near baseline creatinine concentration, and lack of phenytoin-related side effects. Therefore, phenytoin appears to be a safe and potentially beneficial treatment option in patients with symptomatic tacrolimus toxicity.

  3. Adherence to and Acceptance of Once-Daily Tacrolimus After Kidney and Liver Transplant: Results From OSIRIS, a French Observational Study.

    Science.gov (United States)

    Cassuto, Elisabeth; Pageaux, Georges P; Cantarovich, Diego; Rostaing, Lionel; Loupy, Alexandre; Roche, Bruno; Duvoux, Christophe; Moreau, Karine; Thervet, Eric; Mazouz, Hakim; Bourhis, Yann; Dharancy, Sébastien; Kessler, Michèle

    2016-10-01

    Adherence to immunosuppressive treatments is a major concern in transplanted patients. This 6-month French observational, longitudinal, prospective study aimed to assess patient adherence to and acceptance of once-daily tacrolimus (Advagraf) initiation in kidney and liver transplant recipients. Data from 1106 patients initiating once-daily tacrolimus during posttransplant follow-up were analyzed. Adherence and acceptance were assessed using self-administered questionnaires at inclusion and at 3 and 6 months. Mean age was 52.4 ± 13.2 years, 61.5% were men. For 94.9% of patients, once-daily tacrolimus was prescribed after switching from twice-daily tacrolimus. At inclusion, 20.9% of patients reported good treatment adherence, 72.0% minor nonadherence, and 7.1% were nonadherent. Mean general acceptance score (range, 0-100) was 77.7 (±24.7). At 3 months, adherence was improved in 21.1%, unchanged in 69.2%, and worsened in 9.7% of patients. Mean general acceptance score was 75.4 (±26.5). General acceptance score was improved in 28.0%, unchanged in 39.4%, and worsened in 32.7% of patients. At 6 months, similar changes in adherence and acceptance were observed. Higher general acceptance score at month 3 was significantly associated with better adherence at month 6. Conversion to once-daily tacrolimus led to an improved rate of adherence at month 3 in more than 20% of patients and a worsened rate of adherence in less than 10% of patients.

  4. Central pontine myelinolysis (CPM) associated with tacrolimus (FK506) after liver transplantation.

    Science.gov (United States)

    Fukazawa, Kyota; Nishida, Seigo; Aguina, Luz; Pretto, Ernesto

    2011-01-01

    Central pontine myelinolysis (CPM) is the most detrimental neurologic complication after liver transplantation. The incidence of CPM after liver transplantation ascends to 17%. Although the precise etiology and pathogenesis of CPM is largely unknown, a growing literature implicates a possible role of immunosuppressive agents, such as Cyclosporine (incidence 30%) on its development. Other immunosuppressive agents also can cause CPM but the frequency of these cases is less compared to Cyclosporine. There is only one case report for Tacrolimus (FK506)-associated speech disorder, which might be an atypical presentation of CPM, and no case reports for Rapamycin. We present a case of Tacrolimus induced CPM. A 62-year-old woman who underwent liver transplantation developed clinical symptoms with radiologic evidence consistent with CPM 7 days after liver transplant. Since the electrolytes in this patient remained normal from her admission, the hypothesis of inmunossupressor neurotoxicity was established and the therapy was switched, resulting in an evident clinical and radiological improvement of her condition in the following days. Five months later, the patient's only neurological deficit was slight dysarthria and a follow-up MRI showed no abnormalities. This case provides evidence of Tacrolimus-associated CPM after transplantation, which presented with a classic "lock-in syndrome" with radiographic confirmation.

  5. Different Influences on Tacrolimus Pharmacokinetics by Coadministrations of Zhi Ke and Zhi Shi in Rats

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    Shiuan-Pey Lin

    2011-01-01

    Full Text Available Tacrolimus, an immunosuppressant with narrow therapeutic window, has been used widely in transplant patients. Grapefruit juice and pomelo have been reported to increase the blood levels of tacrolimus. Zhi Ke and Zhi Shi, the ripe peels and unripe fruits of Citrus aurantium which is chemotaxonomically related to grapefruit and pomelo, are in wide use in clinical Chinese medicine. To investigate the possible interaction of these two Citrus herbs with tacrolimus, male Sprague-Dawley rats were orally given tacrolimus (1.5 mg/kg with and without Zhi Ke and Zhi Shi decoctions in a cross-over design. Blood samples were withdrawn via cardiopuncture at specific time and quantitated by a microparticle enzyme immunoassay. In addition, to explore the mechanism of interaction, LS 180 cell line was used for the transport study of rhodamine 123, a typical substrate of P-glycoprotein (P-gp. The results showed that Zhi Shi significantly decreased the Cmax⁡ and AUC0-t of tacrolimus by 72.4% and 72.0%, respectively, whereas Zhi Ke did not affect tacrolimus pharmacokinetics. LS 180 cell line study indicated that Zhi Shi increased the efflux activity of P-gp, enabling us to explain the decreased oral bioavailability of tacrolimus caused by Zhi Shi. Hence, we suggest that Zhi Shi be contraindicated for transplant patients treated with tacrolimus to reduce the risk of allograft rejection.

  6. Different Influences on Tacrolimus Pharmacokinetics by Coadministrations of Zhi Ke and Zhi Shi in Rats

    Science.gov (United States)

    Lin, Shiuan-Pey; Wu, Ping-Ping; Hou, Yu-Chi; Tsai, Shang-Yuan; Wang, Meng-Ju; Fang, Shih-Hua; Chao, Pei-Dawn Lee

    2011-01-01

    Tacrolimus, an immunosuppressant with narrow therapeutic window, has been used widely in transplant patients. Grapefruit juice and pomelo have been reported to increase the blood levels of tacrolimus. Zhi Ke and Zhi Shi, the ripe peels and unripe fruits of Citrus aurantium which is chemotaxonomically related to grapefruit and pomelo, are in wide use in clinical Chinese medicine. To investigate the possible interaction of these two Citrus herbs with tacrolimus, male Sprague-Dawley rats were orally given tacrolimus (1.5 mg/kg) with and without Zhi Ke and Zhi Shi decoctions in a cross-over design. Blood samples were withdrawn via cardiopuncture at specific time and quantitated by a microparticle enzyme immunoassay. In addition, to explore the mechanism of interaction, LS 180 cell line was used for the transport study of rhodamine 123, a typical substrate of P-glycoprotein (P-gp). The results showed that Zhi Shi significantly decreased the C max and AUC0−t of tacrolimus by 72.4% and 72.0%, respectively, whereas Zhi Ke did not affect tacrolimus pharmacokinetics. LS 180 cell line study indicated that Zhi Shi increased the efflux activity of P-gp, enabling us to explain the decreased oral bioavailability of tacrolimus caused by Zhi Shi. Hence, we suggest that Zhi Shi be contraindicated for transplant patients treated with tacrolimus to reduce the risk of allograft rejection. PMID:21318106

  7. Analyses of marketplace tacrolimus drug product quality: bioactivity, NMR and LC-MS.

    Science.gov (United States)

    Sommers, Cynthia D; Pang, Eric S; Ghasriani, Houman; Berendt, Robert T; Vilker, Vincent L; Keire, David A; Boyne, Michael T

    2013-11-01

    Tacrolimus (FK506) is a potent, narrow therapeutic index, immunosuppressive drug used to avoid organ rejection in patients that have undergone organ transplantation. Recent clinical reports suggested a significant reduction in the tacrolimus concentration/dose ratio in the plasma of liver and kidney recipients when the reference listed drug was substituted with a generic drug. In response to these concerns about switching between tacrolimus from different approved manufacturers during treatment, the FDA initiated purity, potency and quality studies of the innovator and generic tacrolimus products available in the US marketplace. A combination of analytical methods, including mass spectrometry (LC-MS), nuclear magnetic resonance (NMR) and bioactivity assay were developed and validated to assess the quality of tacrolimus. These tests measured the identity, impurities and activity of tacrolimus from active pharmaceutical ingredient (API) sources and with formulated drug product from five different approved manufactures. In addition, some testing was performed on tacrolimus capsules obtained from a non US approved Indian source. The data obtained showed no discernible difference in the impurity profiles and potency between the generic and innovator tacrolimus products. Copyright © 2013. Published by Elsevier B.V.

  8. Topical tacrolimus and periodontal therapy in the management of a case of oral chronic GVHD characterized by specific gingival localization.

    Science.gov (United States)

    Conrotto, Davide; Broccoletti, Roberto; Carcieri, Paola; Giaccone, Luisa; Arduino, Paolo G

    2014-01-01

    Background. Chronic graft versus host disease (cGVHD) is a complication following bone marrow transplantation. The oral lesions are difficult to control with a systemic pharmacological therapy. Case Description. A 63-year-old female patient, who underwent an allogeniec transplantation for acute myeloid leukemia, developed a chronic oral and cutaneous GVHD. The patient was treated with topical tacrolimus 0.1%, twice daily for two months, and underwent a protocol of oral hygiene characterized by 3 appointments of scaling, root planning, and daily oral hygiene instructions. The patient showed marked resolution of gingival lesions and a significant improvement of related pain and gingival inflammatory indexes. Clinical Implications. This case report suggests that treatment with topical tacrolimus and professional oral hygiene may be helpful in the management of chronic oral GVHD with severe gingival involvement.

  9. Topical Tacrolimus and Periodontal Therapy in the Management of a Case of Oral Chronic GVHD Characterized by Specific Gingival Localization

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    Davide Conrotto

    2014-01-01

    Full Text Available Background. Chronic graft versus host disease (cGVHD is a complication following bone marrow transplantation. The oral lesions are difficult to control with a systemic pharmacological therapy. Case Description. A 63-year-old female patient, who underwent an allogeniec transplantation for acute myeloid leukemia, developed a chronic oral and cutaneous GVHD. The patient was treated with topical tacrolimus 0.1%, twice daily for two months, and underwent a protocol of oral hygiene characterized by 3 appointments of scaling, root planning, and daily oral hygiene instructions. The patient showed marked resolution of gingival lesions and a significant improvement of related pain and gingival inflammatory indexes. Clinical Implications. This case report suggests that treatment with topical tacrolimus and professional oral hygiene may be helpful in the management of chronic oral GVHD with severe gingival involvement.

  10. Treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop: Prospective double-blind randomized study.

    Science.gov (United States)

    Moscovici, Bernardo Kaplan; Holzchuh, Ricardo; Sakassegawa-Naves, Fernando Eiji; Hoshino-Ruiz, Diego Ricardo; Albers, Marcos Bottene Villa; Santo, Ruth Miyuki; Hida, Richard Yudi

    2015-10-01

    To describe the clinical efficacy of the treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop. Prospective double-blind randomized study. Institutional outpatient clinic. Forty-eight eyes of twenty-four patients with dry eye related to Sjögren syndrome were enrolled in this study. The patients were randomized in 2 groups: tacrolimus (n=14) and vehicle (n=10) group. The tacrolimus group received a vial containing tacrolimus 0.03% (almond oil as vehicle) and the other group received the almond oil vehicle. All patients were instructed to use the eye drops every 12h in the lower conjunctival sac. Schirmer I test, break-up-time (BUT), corneal fluorescein and Rose Bengal staining scores were evaluated in all patients one day before the treatment (baseline), 7, 14, 28 and 90 days after treatment with the eye drops. The average fluorescein and Rose Bengal scores improved statistically after 7 days of treatment and even more after 90 days. The average Schirmer I and BUT values were unchanged after 7, 14 and 21 days but did show an improvement relative to baseline after 28 days of treatment. Schirmer I, BUT, fluorescein and Rose Bengal did not show any statistical significance in the vehicle group. Topical 0.03% tacrolimus eye drop improved tear stability and ocular surface status in cases of inflammatory or SS-related dry eye. ClinicalTrials.gov Identifier: NCT01850979. Copyright © 2015 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.

  11. The Comparison of Efficacy of Adcortyl Ointment and Topical Tacrolimus in Treatment of Erosive Oral Lichen Planus

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    Arash Azizi

    2007-12-01

    Full Text Available

    Background and aims. Oral lichen planus (OLP is a common chronic mucocutaneous disease. Patients with atrophic and erosive lichen planus often have symptoms of soreness and need proper treatment. The main therapy of OLP has been the administration of topical or systemic corticosteroids. Potent topical corticosteroids have been increasingly prescribed in the treatment of erosive lichen planus. The purpose of this study was to compare the efficacy of adcortyl ointment (triamcinolone in orabase with topical tacrolimus for the treatment of erosive oral lichen planus.

    Materials and methods. Sixty Patients with histopathologically confirmed oral lichen planus were enrolled in the study. The severity of lesions was scored from 0 to 5 according to the criteria described in a previous study. Patients were randomly given adcortyl (group A and topical tacrolimus ointment (group B and asked to apply the medication on dried lesions 4 times a day. The lesions were evaluated after 4 weeks of treatment. Visual analogue scale was used to assess the severity of pain before and after treatment. The severity scores were analyzed using the Kruskal-Wallis k-sample test.

    Results. The average score of lesions improved from 3.4 to 1.5 in patients who received adcortyl ointment and from 3.2 to 1.2 in patients who received topical tacrolimus ointment. The differences between the improvements in scores were not statistically significant in the two groups. The average pain severity in A and B groups was 8.2 and 7.8 at the beginning of treatment, and 3.5 and 3.2 at the end of treatment, respectively. There was a statistically significant reduction in pain severity in both groups.

    Conclusion. Topical tacrolimus is a safe and effective alternative therapy in the treatment of oral lichen planus.

  12. Tacrolimus inhibits the revascularization of isolated pancreatic islets.

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    Ryuichi Nishimura

    Full Text Available AIMS: Immunosuppressive drugs could be crucial factors for a poor outcome after islet allotransplantation. Unlike rapamycin, the effects of tacrolimus, the current standard immunosuppressant used in islet transplantation, on graft revascularization remain unclear. We examined the effects of tacrolimus on islet revascularization using a highly sensitive imaging system, and analyzed the gene expression in transplanted islets by introducing laser microdissection techniques. METHODS: Islets isolated from C57BL/6-Tg (CAG-EGFP mice were transplanted into the nonmetallic dorsal skinfold chamber on the recipients. Balb/c athymic mice were used as recipients and were divided into two groups: including a control group (n = 9 and tacrolimus-treated group (n = 7. The changes in the newly-formed vessels surrounding the islet grafts were imaged and semi-quantified using multi-photon laser-scanning microscopy and a Volocity system. Gene expression in transplanted islets was analyzed by the BioMark dynamic system. RESULTS: The revascularization process was completed within 14 days after pancreatic islet transplantation at subcutaneous sites. The newly-formed vascular volume surrounding the transplanted islets in the tacrolimus-treated group was significantly less than that in the control group (p<0.05. Although the expression of Vegfa (p<0.05 and Ccnd1 (p<0.05 was significantly upregulated in the tacrolimus-treated group compared with that of the control group, no differences were observed between the groups in terms of other types of gene expression. CONCLUSIONS: The present study demonstrates that tacrolimus inhibits the revascularization of isolated pancreatic islets without affecting the characteristics of the transplanted grafts. Further refinements of this immunosuppressive regimen, especially regarding the revascularization of islet grafts, could improve the outcome of islet allotransplantation.

  13. Sirolimus Versus Tacrolimus as Primary Immunosuppressant After Renal Transplantation: A Meta-Analysis and Economics Evaluation.

    Science.gov (United States)

    Liu, Jin-Yu; Song, Ming; Guo, Min; Huang, Feng; Ma, Bing-Jun; Zhu, Lan; Xu, Gang; Li, Juan; You, Ru-Xu

    Sirolimus and tacrolimus are the major immunosuppressants for renal transplantation. Several studies have compared these 2 drugs, but the outcomes were not consistent. The aim of this study was to evaluate the efficacy, safety, and pharmacoeconomics of sirolimus and tacrolimus in the treatment of renal transplantation and provide evidence for the selection of essential drugs. Trials were identified through a computerized literature search of PubMed, EMBASE, Cochrane controlled trials register, Cochrane Renal Group Specialized Register of randomized controlled trials, and Chinese Biomedical database. Two independent reviewers assessed trials for eligibility and quality and then extracted data. Data were extracted for patient and graft mortality, acute rejection (AR), and adverse events. Dichotomous outcomes were reported as relative risk with 95% confidence intervals. A decision tree model was populated with data from a literature review and used to estimate costs and QALYs gained and incremental cost-effectiveness. Altogether, 1189 patients from 8 randomized controlled trials were included. The results of our analysis were that tacrolimus reduced the risks after renal transplantation of AR and patient withdrawn. Nevertheless, tacrolimus increased the risk of infection. Pharmacoeconomic analysis showed that tacrolimus represented a more cost-effective treatment than does cyclosporine for the prevention of adverse events after renal transplant. Tacrolimus is an effective and safe immunosuppressive agent, and it may be more cost-effective than cyclosporine for the primary prevention of AR in renal transplant recipients. However, it should be noted that such superiority was reversal when the cost of sirolimus and tacrolimus changed.

  14. Successful treatment with tacrolimus in TAFRO syndrome: two case reports and literature review.

    Science.gov (United States)

    Shirai, Taiichiro; Onishi, Akira; Waki, Daisuke; Saegusa, Jun; Morinobu, Akio

    2018-06-01

    TAFRO syndrome is a systemic inflammatory disorder characterized by thrombocytopenia, anasarca, fever, reticulin fibrosis, renal dysfunction, and organomegaly. In contrast to that in multicentric Castleman disease, interleukin-6 targeting strategies seem ineffective in some TAFRO syndrome cases; however, the optimal treatment remains unclear. Here, we report 2 cases of TAFRO syndrome, where 1 with cardiomyopathy, successfully treated with tacrolimus. This is the first case report of successful treatment with tacrolimus in TAFRO syndrome. Both patients (cases 1 and 2) developed fever, anasarca, thrombocytopenia, renal dysfunction, and mild hepatosplenomegaly. In both patients, lymph node pathology revealed mixed type Castleman disease-like features, and bone marrow showed reticulin myelofibrosis. TAFRO syndrome was diagnosed based on the patients' laboratory, clinical, and pathologic findings. In case 2, we observed a rare complication of cardiomyopathy with no evidence of takotsubo cardiomyopathy or viral myocarditis. In case 1, tocilizumab combined with glucocorticoids was ineffective and caused septic shock; additionally, cyclosporine A was discontinued because of hepatotoxicity. However, tacrolimus was effective in resolving TAFRO syndrome without any adverse events. In case 2, tacrolimus completely reversed TAFRO syndrome and was also effective in cardiomyopathy. This report suggests that tacrolimus is potentially effective and safe as an initial treatment and a glucocorticoid-sparing agent. Our literature review shows that calcineurin inhibitors, including tacrolimus, may be effective in TAFRO syndrome. Since previous studies indicate a role of Th1 inflammation in TAFRO syndrome pathogenesis, tacrolimus may, therefore, be effective in treating TAFRO syndrome.

  15. A Low Concentration of Tacrolimus/Semifluorinated Alkane (SFA) Eyedrop Suppresses Intraocular Inflammation in Experimental Models of Uveitis.

    Science.gov (United States)

    De Majumdar, S; Subinya, M; Korward, J; Pettigrew, A; Scherer, D; Xu, H

    2017-01-01

    Corticosteroids remain the mainstay therapy for uveitis, a major cause of blindness in the working age population. However, a substantial number of patients cannot benefit from the therapy due to steroids resistance or intolerance. Tacrolimus has been used to treat refractory uveitis through systemic administration. The aim of this study was to evaluate the therapeutic potential of 0.03% tacrolimus eyedrop in mouse models of uveitis. 0.03% tacrolimus in perfluorobutylpentane (F4H5) (0.03% Tacrolimus/SFA) was formulated using a previously published protocol. Tacrolimus suspended in PBS (0.03% Tacrolimus/PBS) was used as a control. In addition, 0.1% dexamethasone (0.1% DXM) was used as a standard therapy control. Endotoxin-induced uveitis (EIU) and experimental autoimmune uveoretinitis (EAU) were induced in adult C57BL/6 mice using protocols described previously. Mice were treated with eyedrops three times/day immediately after EIU induction for 48 h or from day 14 to day 25 post-immunization (for EAU). Clinical and histological examinations were conducted at the end of the experiment. Pharmacokinetics study was conducted in mice with and without EIU. At different times after eyedrop treatment, ocular tissues were collected for tacrolimus measurement. The 0.03% Tacrolimus/SFA eyedrop treatment reduced the clinical scores and histological scores of intraocular inflammation in both EIU and EAU to the levels similar to 0.1% DXM eyedrop treatment. The 0.03% Tacrolimus/PBS did not show any suppressive effect in EIU and EAU. Pharmacokinetic studies showed that 15 min after topical administration of 0.03% Tacrolimus/SFA, low levels of tacrolimus were detected in the retina (48 ng/g tissue) and vitreous (2.5 ng/ml) in normal mouse eyes, and the levels were significantly higher in EIU eyes (102 ng/g tissue in the retina and 24 ng/ml in the vitreous). Tacrolimus remained detectable in intraocular tissues of EIU eyes 6 h after topical administration (68 ng/g retinal tissue, 10

  16. Differences in Peripheral Blood Lymphocytes between Brand-Name and Generic Tacrolimus Used in Stable Liver Transplant Recipients.

    Science.gov (United States)

    Kim, Jong Man; Kwon, Choon Hyuck David; Joh, Jae-Won; Sinn, Dong Hyun; Choi, Gyu-Seong; Park, Jae Berm; Kang, Eun-Suk; Lee, Suk-Koo

    2017-01-01

    In this study, peripheral blood lymphocytes were compared between a brand-name and a generic tacrolimus group in stable liver transplant recipients. Sixteen patients who underwent ABO-compatible living donor liver transplants between 2012 and 2013 and had stable graft function were included in this study. Ten patients received brand-name tacrolimus and 6 patients received generic tacrolimus. CD3, CD4, CD8, γδ, CD4+FoxP3+, and CD3-CD56+ T cells were analyzed in peripheral blood obtained preoperatively and 4, 8, 12, and 24 weeks after liver transplantation. Categorical variables were compared using a χ2 test or Fisher exact test, and continuous variables were compared using the Mann-Whitney U test. Regarding the baseline and perioperative characteristics, there were no statistically significant differences between the 2 groups. Immunosuppression also was not different. Subtype analysis of T-cell populations carried out in parallel showed similar levels of CD3, CD4, CD8, and γδT cells with brand-name tacrolimus and generic tacrolimus in stable liver transplant recipients. However, the levels of CD4+Foxp3+ and CD3-CD56+ T cells were higher in the brand-name tacrolimus group than in the generic tacrolimus group 8 weeks after transplantation (p brand-name tacrolimus group than in the generic tacrolimus group after transplantation. This finding showed that brand-name tacrolimus could have more potential immunosuppressive activity than generic tacrolimus regarding the contribution of CD4+Foxp3+ T cells to graft tolerance in liver transplant recipients. © 2017 S. Karger AG, Basel.

  17. Tacrolimus concentration/dose ratio as a therapeutic drug monitoring strategy: The influence of gender and comedication

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    Rančić Nemanja

    2015-01-01

    Full Text Available Background/Aim. A combination of tacrolimus and other drugs such as corticosteroids has been commonly used immunosuppresive regimens. On the other hand, there is a growing body of evidence that male and female may differ in their response to the equal drug treatment. The aim of the study was to estimated the use of tacrolimus concentration/dose (C/D ratio for the assessment of the influence of gender differences and comedication on tacrolimus exposure in renal transplant recipients. Methods. This prospective case series study included 54 patients, in which the unit of monitoring was outpatient examination (1,872 of the renal transplant patients. The patients were monitored in the period 2010-2014, starting one month after the transplantation. Tacrolimus trough concentrations (TTC were measured by chemiluminescence microparticles immunoassay. Results. TTC and the tacrolimus C/D ratio were significantly lower in the females comparing with the males. Contrary to the males, in the females a significant increase of the tacrolimus daily dose (TDD per body weight and TTC, along with the corticosteroid dose increase, was not accompanied by any significant changes in the tacrolimus C/D ratio; in different corticosteroid doses faster elimination of tacrolimus was found with the exception of the doses > 0.25 mg/kg. In the patients treated with proton pump inhibitors, mainly with pantoprazole TDD per body weight and TTC were significantly higher, while the tacrolimus C/D ratio was significantly lower compared to the patients without this treatment. In the patients treated with calcium channel blockers, TDD per body weight was significantly lower (particularly with amlodipine while the tacrolimus C/D ratio was higher compared to the patients who were not treated by them. Conclusion. A lower tacrolimus exposure was detected in females in comparison to males. When gender differences were considered in the context of different corticosteroid doses, faster

  18. Manic-Like Psychosis Associated with Elevated Trough Tacrolimus Blood Concentrations 17 Years after Kidney Transplant

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    Giuseppe Bersani

    2013-01-01

    Full Text Available Several neurological side effects induced by tacrolimus are described in the scientific literature, ranging from mild neurological symptoms to delirium and psychosis. We report the case of a 46-year-old man with no prior psychiatric history who suddenly manifested manic-like psychosis associated with elevated trough tacrolimus blood concentrations 17 years after kidney transplant. The use of antipsychotics may improve the severity of symptoms; but in order to obtain a complete remission, the reduction in the dose of tacrolimus, or its replacement with alternative immunosuppressant therapies, is recommended.

  19. Proximal Tubular Injury in Medullary Rays Is an Early Sign of Acute Tacrolimus Nephrotoxicity

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    Diane Cosner

    2015-01-01

    Full Text Available Tacrolimus (FK506 is one of the principal immunosuppressive agents used after solid organ transplantations to prevent allograft rejection. Chronic renal injury induced by tacrolimus is characterized by linear fibrosis in the medullary rays; however, the early morphologic findings of acute tacrolimus nephrotoxicity are not well characterized. Kidney injury molecule-1 (KIM-1 is a specific injury biomarker that has been proven to be useful in the diagnosis of mild to severe acute tubular injury on renal biopsies. This study was motivated by a patient with acute kidney injury associated with elevated serum tacrolimus levels in whom KIM-1 staining was present only in proximal tubules located in the medullary rays in the setting of otherwise normal light, immunofluorescent, and electron microscopy. We subsequently evaluated KIM-1 expression in 45 protocol and 39 indicated renal transplant biopsies to determine whether higher serum levels of tacrolimus were associated with acute segment specific injury to the proximal tubule, as reflected by KIM-1 staining in the proximal tubules of the cortical medullary rays. The data suggest that tacrolimus toxicity preferentially affects proximal tubules in medullary rays and that this targeted injury is a precursor lesion for the linear fibrosis seen in chronic tacrolimus toxicity.

  20. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis

    NARCIS (Netherlands)

    Reitamo, Sakari; van Leent, Edwin J. M.; Ho, Vincent; Harper, John; Ruzicka, Thomas; Kalimo, Kirsti; Cambazard, Frédéric; Rustin, Malcolm; Taïeb, Alain; Gratton, David; Sauder, Daniel; Sharpe, Graham; Smith, Catherine; Jünger, Michael; de Prost, Yves

    2002-01-01

    Vehicle-controlled studies have demonstrated the efficacy and safety of tacrolimus ointment in the treatment of patients with atopic dermatitis (AD). This study was undertaken to compare 0.03% and 0.1% tacrolimus ointment with 1% hydrocortisone acetate ointment in children 2 to 15 years of age with

  1. Conservation of small-airway function by tacrolimus/cyclosporine conversion in the management of bronchiolitis obliterans following lung transplantation.

    Science.gov (United States)

    Revell, M P; Lewis, M E; Llewellyn-Jones, C G; Wilson, I C; Bonser, R S

    2000-12-01

    We studied serial lung function in 11 patients with bronchiolitis obliterans syndrome who were treated with tacrolimus conversion following lung or heart-lung transplantation. Our results show that tacrolimus conversion slows the decline of lung function in bronchiolitis obliterans syndrome. The attenuation continues for at least 1 year following conversion.

  2. Efficacy and Safety of Mycophenolate Mofetil and Tacrolimus as Second-line Therapy for Patients With Autoimmune Hepatitis

    DEFF Research Database (Denmark)

    Efe, Cumali; Hagström, Hannes; Ytting, Henriette

    2017-01-01

    BACKGROUND & AIMS: Predniso(lo)ne, alone or in combination with azathioprine, is the standard-of-care (SOC) therapy for autoimmune hepatitis (AIH). However, the SOC therapy is poorly tolerated or does not control disease activity in up to 20% of patients. We assessed the efficacy of mycophenolate...

  3. The carcinogenic potential of tacrolimus ointment beyond immune suppression: a hypothesis creating case report.

    Science.gov (United States)

    Becker, Jürgen C; Houben, Roland; Vetter, Claudia S; Bröcker, Eva B

    2006-01-11

    Since tacrolimus ointment was approved by the U.S. Food and Drug Administration (FDA) as a promising treatment for atopic dermatitis, it has been approved in more than 30 additional countries, including numerous European Union member nations. Moreover, in the current clinical routine the use of this drug is no longer restricted to the approved indication, but has been extended to a wide variety of inflammatory skin diseases including some with the potential of malignant transformation. So far, the side-effects reported from the topical use of tacrolimus have been relatively minor (e.g. burning, pruritus, erythema). Recently, however, the FDA reviewed the safety of topical tacrolimus, which resulted in a warning that the use of calcineurin inhibitors may be associated with an increased risk of cancer. Oral lichen planus (OLP) was diagnosed in a 56-year-old women in February 1999. After several ineffective local and systemic therapeutic measures an off-label treatment of this recalcitrant condition using Tacrolimus 0.1% ointment was initiated in May 2002. After a few weeks of treatment most of the lesions ameliorated, with the exception of the plaques on the sides of the tongue. Nevertheless, the patient became free of symptoms which, however, reoccurred once tacrolimus was weaned, as a consequence treatment was maintained. In April 2005, the plaques on the left side of the tongue appeared increasingly compact and a biopsy specimen confirmed the suspected diagnosis of an oral squamous cell carcinoma. The suspected causal relationship between topical use of tacrolimus and the development of a squamous cell carcinoma prompted us to test the notion that the carcinogenicity of tacrolimus may go beyond mere immune suppression. To this end, tacrolimus has been shown to have an impact on cancer signalling pathways such as the MAPK and the p53 pathway. In the given case, we were able to demonstrate that these pathways had also been altered subsequent to tacrolimus therapy.

  4. The carcinogenic potential of tacrolimus ointment beyond immune suppression: a hypothesis creating case report

    Directory of Open Access Journals (Sweden)

    Vetter Claudia S

    2006-01-01

    Full Text Available Abstract Background Since tacrolimus ointment was approved by the U.S. Food and Drug Administration (FDA as a promising treatment for atopic dermatitis, it has been approved in more than 30 additional countries, including numerous European Union member nations. Moreover, in the current clinical routine the use of this drug is no longer restricted to the approved indication, but has been extended to a wide variety of inflammatory skin diseases including some with the potential of malignant transformation. So far, the side-effects reported from the topical use of tacrolimus have been relatively minor (e.g. burning, pruritus, erythema. Recently, however, the FDA reviewed the safety of topical tacrolimus, which resulted in a warning that the use of calcineurin inhibitors may be associated with an increased risk of cancer. Case presentation Oral lichen planus (OLP was diagnosed in a 56-year-old women in February 1999. After several ineffective local and systemic therapeutic measures an off-label treatment of this recalcitrant condition using Tacrolimus 0.1% ointment was initiated in May 2002. After a few weeks of treatment most of the lesions ameliorated, with the exception of the plaques on the sides of the tongue. Nevertheless, the patient became free of symptoms which, however, reoccurred once tacrolimus was weaned, as a consequence treatment was maintained. In April 2005, the plaques on the left side of the tongue appeared increasingly compact and a biopsy specimen confirmed the suspected diagnosis of an oral squamous cell carcinoma. Conclusion The suspected causal relationship between topical use of tacrolimus and the development of a squamous cell carcinoma prompted us to test the notion that the carcinogenicity of tacrolimus may go beyond mere immune suppression. To this end, tacrolimus has been shown to have an impact on cancer signalling pathways such as the MAPK and the p53 pathway. In the given case, we were able to demonstrate that these

  5. The carcinogenic potential of tacrolimus ointment beyond immune suppression: a hypothesis creating case report

    International Nuclear Information System (INIS)

    Becker, Jürgen C; Houben, Roland; Vetter, Claudia S; Bröcker, Eva B

    2006-01-01

    Since tacrolimus ointment was approved by the U.S. Food and Drug Administration (FDA) as a promising treatment for atopic dermatitis, it has been approved in more than 30 additional countries, including numerous European Union member nations. Moreover, in the current clinical routine the use of this drug is no longer restricted to the approved indication, but has been extended to a wide variety of inflammatory skin diseases including some with the potential of malignant transformation. So far, the side-effects reported from the topical use of tacrolimus have been relatively minor (e.g. burning, pruritus, erythema). Recently, however, the FDA reviewed the safety of topical tacrolimus, which resulted in a warning that the use of calcineurin inhibitors may be associated with an increased risk of cancer. Oral lichen planus (OLP) was diagnosed in a 56-year-old women in February 1999. After several ineffective local and systemic therapeutic measures an off-label treatment of this recalcitrant condition using Tacrolimus 0.1% ointment was initiated in May 2002. After a few weeks of treatment most of the lesions ameliorated, with the exception of the plaques on the sides of the tongue. Nevertheless, the patient became free of symptoms which, however, reoccurred once tacrolimus was weaned, as a consequence treatment was maintained. In April 2005, the plaques on the left side of the tongue appeared increasingly compact and a biopsy specimen confirmed the suspected diagnosis of an oral squamous cell carcinoma. The suspected causal relationship between topical use of tacrolimus and the development of a squamous cell carcinoma prompted us to test the notion that the carcinogenicity of tacrolimus may go beyond mere immune suppression. To this end, tacrolimus has been shown to have an impact on cancer signalling pathways such as the MAPK and the p53 pathway. In the given case, we were able to demonstrate that these pathways had also been altered subsequent to tacrolimus therapy

  6. Tacrolimus drug level and response to treatment in idiopathic childhood steroid resistant nephrotic syndrome

    International Nuclear Information System (INIS)

    Shah, S.S.; Hafeez, F.; Akhtar, N.

    2015-01-01

    The management of Steroid Resistant Nephrotic Syndrome (SRNS) is an uphill task for paediatric nephrologists as immunosuppressive agents are the mainstay of treatment in these patients. Tacrolimus is used along with steroids. This study is conducted to see the relationship between the tacrolimus dose, drug level and response in the management of SRNS. Methods: This quasi experimental study was conducted at The Childrens Hospital Lahore over a period of one year. Patients with SRNS of either sex and 1-10 years of age were included and those with secondary nephrotic syndrome were excluded. Tacrolimus was given at a dose of 0.05-0.1 mg/kg/day in 2 divided doses along with steroids. The follow-up was done for six months with proteinuria monitoring and tacrolimus drug levels done two weeks after initiation of treatment. Results: Out of 42 patients, 27 (64.3%) were males and 15 (35.7%) were females. The most common histological diagnosis observed was mesangio-proliferative glomerulonephritis in 30 (71.4%) patients. The tacrolimus trough level range was 0.5-15.20 ng/ml with a mean value of 4.68 ng/ml±2.85. Forty-one (97.6%) children showed complete response to treatment while one patient showed partial response. Conclusion: This study suggests that tacrolimus is an effective drug for treatment of SRNS in paediatric patients and there is no linear relationship between the drug dose, response and drug level. (author)

  7. CYP3A5 polymorphisms in renal transplant recipients: influence on tacrolimus treatment

    Directory of Open Access Journals (Sweden)

    Chen L

    2018-03-01

    Full Text Available Lucy Chen,1 G V Ramesh Prasad2 1Kidney Transplant Program, St Michael’s Hospital, Toronto, ON, Canada; 2Division of Nephrology, St Michael’s Hospital, Toronto, ON, Canada Abstract: Tacrolimus is a commonly used immunosuppressant after kidney transplantation. It has a narrow therapeutic range and demonstrates wide interindividual variability in pharmacokinetics, leading to potential underimmunosuppression or toxicity. Genetic polymorphism in CYP3A5 enzyme expression contributes to differences in tacrolimus bioavailability between individuals. Individuals carrying one or more copies of the wild-type allele *1 express CYP3A5, which increases tacrolimus clearance. CYP3A5 expressers require 1.5 to 2-fold higher tacrolimus doses compared to usual dosing to achieve therapeutic blood concentrations. Individuals with homozygous *3/*3 genotype are CYP3A5 nonexpressers. CYP3A5 nonexpression is the most frequent phenotype in most ethnic populations, except blacks. Differences between CYP3A5 genotypes in tacrolimus disposition have not translated into differences in clinical outcomes, such as acute rejection and graft survival. Therefore, although genotype-based dosing may improve achievement of therapeutic drug concentrations with empiric dosing, its role in clinical practice is unclear. CYP3A5 genotype may predict differences in absorption of extended-release and immediate-release oral formulations of tacrolimus. Two studies found that CYP3A5 expressers require higher doses of tacrolimus in the extended-release formulation compared to immediate release. CYP3A5 genotype plays a role in determining the impact of interacting drugs, such as fluconazole, on tacrolimus pharmacokinetics. Evidence conflicts regarding the impact of CYP3A5 genotype on risk of nephrotoxicity associated with tacrolimus. Further study is required. Keywords: calcineurin inhibitor, graft, pharmacogenomics, kidney, genotype

  8. Improving Patient Safety: Improving Communication.

    Science.gov (United States)

    Bittner-Fagan, Heather; Davis, Joshua; Savoy, Margot

    2017-12-01

    Communication among physicians, staff, and patients is a critical element in patient safety. Effective communication skills can be taught and improved through training and awareness. The practice of family medicine allows for long-term relationships with patients, which affords opportunities for ongoing, high-quality communication. There are many barriers to effective communication, including patient factors, clinician factors, and system factors, but tools and strategies exist to address these barriers, improve communication, and engage patients in their care. Use of universal precautions for health literacy, appropriate medical interpreters, and shared decision-making are evidence-based tools that improve communication and increase patient safety. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.

  9. Association of the multidrug resistance-1 gene single-nucleotide polymorphisms with the tacrolimus dose requirements in renal transplant recipients.

    Science.gov (United States)

    Anglicheau, Dany; Verstuyft, Céline; Laurent-Puig, Pierre; Becquemont, Laurent; Schlageter, Marie-Hélène; Cassinat, Bruno; Beaune, Philippe; Legendre, Christophe; Thervet, Eric

    2003-07-01

    The immunosuppressive drug tacrolimus, whose pharmacokinetic characteristics display large interindividual variations, is a substrate for P-glycoprotein (P-gp), the product of the multidrug resistance-1 (MDR1) gene. Some of the single nucleotide polymorphisms (SNP) of MDR1 reported correlated with the in vivo activity of P-gp. Because P-gp is known to control tacrolimus intestinal absorption, it was postulated that these polymorphisms are associated with tacrolimus pharmacokinetic variations in renal transplant recipients. The objective of this study was to evaluate in a retrospective study of 81 renal transplant recipients the effect on tacrolimus dosages and concentration/dose ratio of four frequent MDR1 SNP possibly associated with P-gp function (T-129C in exon 1b, 1236C>T in exon 12, 2677G>T,A in exon 21, and 3435C>T in exon 26). As in the general population, the SNP in exons 12, 21, and 26 were frequent (16, 17.3, and 22.2% for the variant homozygous genotype, respectively) and exhibited incomplete linkage disequilibrium. One month after tacrolimus introduction, exon 21 SNP correlated significantly with the daily tacrolimus dose (P < or = 0.05) and the concentration/dose ratio (P < or = 0.02). Tacrolimus dose requirements were 40% higher in homozygous than wild-type patients for this SNP. The concentration/dose ratio was 36% lower in the wild-type patients, suggesting that, for a given dose, their tacrolimus blood concentration is lower. Haplotype analysis substantiated these results and suggested that exons 26 and 21 SNP may be associated with tacrolimus dose requirements. Genotype monitoring of the MDR1 gene reliably predicts the optimal dose of tacrolimus in renal transplant recipients and may predict the initial daily dose needed by individual patients to obtain adequate immunosuppression.

  10. Prevention of organ rejection in renal and liver transplantation with extended release tacrolimus

    Directory of Open Access Journals (Sweden)

    Reschen ME

    2014-09-01

    Full Text Available Michael E Reschen, Christopher A O’Callaghan Henry Wellcome Building, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom Abstract: Tacrolimus is the key immunosuppressant used to prevent allograft rejection in kidney and liver transplant recipients. Despite the efficacy of tacrolimus and adjunctive immunosuppressants, a substantial number of patients experience episodes of acute rejection and late graft loss. Nonadherence is an etiological factor in both acute rejection and graft loss. In 2007, a prolonged release version of tacrolimus became available that allows once daily administration, thus halving the pill burden compared to the standard twice-daily tacrolimus. An increasing number of studies in de novo transplantation and in treatment conversion have evaluated the pharmacokinetic profile, efficacy, and safety of prolonged-release tacrolimus. We have reviewed the literature on the use of prolonged-release tacrolimus and hope that this will be of value in the design of protocols for transplant immunosuppression.Keywords: immunosuppression, kidney, hepatic, allograft, adherence

  11. A case of tacrolimus-induced encephalopathy after kidney transplantation

    Directory of Open Access Journals (Sweden)

    Myoung Uk Kim

    2011-01-01

    Full Text Available We present a case of tacrolimus-induced encephalopathy after successful kidney transplantation. An 11-year-old girl presented with sudden onset of neurologic symptoms, hypertension, and psychiatric symptoms, with normal kidney function, after kidney transplantation. The symptoms improved after cessation of tacrolimus. Magnetic resonance imaging (MRI showed acute infarction of the middle cerebral artery (MCA territory in the right frontal lobe. Three days later, she had normal mental function and maintained normal blood pressure with left hemiparesis. Follow-up MRI was performed on D19, showing new infarct lesions at both cerebral hemispheres. Ten days later, MRI showed further improvement, but brain single photon emission computed tomography (SPECT showed mild reduction of uptake in both the anterior cingulate gyrus and the left thalamus. One month after onset of symptoms, angiography showed complete resolution of stenosis. However, presenting as a mild fine motor disability of both hands and mild dysarthria, what had been atrophy at both centrum semiovale at 4 months now showed progression to encephalomalacia. There are two points of interest in this case. First, encephalopathy occurred after administration of tacrolimus and improved after discontinuation of the drug. Second, the development of right-side hemiplegia could not be explained by conventional MRI; but through diffusion tensor imaging (DTI and diffusion tensor tractography (DTT of white matter tract, visualization was possible.

  12. Sirolimus for rescue and primary immunosuppression in transplanted children receiving tacrolimus.

    Science.gov (United States)

    Sindhi, R; Webber, S; Venkataramanan, R; McGhee, W; Phillips, S; Smith, A; Baird, C; Iurlano, K; Mazariegos, G; Cooperstone, B; Holt, D W; Zeevi, A; Fung, J J; Reyes, J

    2001-09-15

    The role of sirolimus (SRL) as a rescue agent (n=42) and as a component of primary immunosuppression (n=8) was evaluated in a mixed population of 50 transplanted children receiving tacrolimus (liver: 26, heart: 5, intestinal: 5, liver-intestine: 9, lung: 1, bone marrow: 1, liver-kidney: 1, multivisceral: 1). Rescue indications for tacrolimus (TAC) failure were recurrent acute rejection and acute rejection complicating withdrawal of immunosuppression in posttransplant lymphoproliferative disorder (PTLD). Rescue indications for TAC toxicity were nephrotoxicity, pancreatitis, seizures, hypertrophic cardiomyopathy, and graft-versus-host disease. Mean age at rescue was 11.5 years and mean follow-up was 204 (range 18-800) days. As primary immunosuppression, SRL+TAC prevented early acute rejection in 7/8 children. The indication for rescue resolved in 33/42 children. In children with TAC toxicity, this was associated with decrease in TAC doses by 50%, significant improvements in renal function, and continuing decline in Epstein-Barr virus (EBV) viral load in PTLD patients. Serious adverse events led to discontinuation of SRL in 9/42 rescue patients, 3 of them also experienced acute rejection. Three additional children also experienced acute rejection on SRL therapy (overall incidence 6/50, 12%). Pharmacokinetic analysis in the first week of SRL administration suggested a short half-life (11.8+/-5.5 hr, n=21). SRL and reduced-dose TAC may achieve adequate immunosuppression without compromising renal function or enhancing EBV viremia significantly.

  13. Comparison of Semen Analysis Parametes Changes after Priscription of Two Immunosuppresive Drugs, Tacrolimus and Cyclosporine in Men Undergoing Renal Transplantation

    Directory of Open Access Journals (Sweden)

    Ali Ramouz

    2017-02-01

    Full Text Available Background & Objective: The research objective was to investigate the prevalence of infertility in renal transplant patients receiving immunosuppressive agents and compare the impact of tacrolimus (target of Rapamycin inhibitors (TOR-I and Cyclosporine on spermogram parameters after the transplantation. Material & Methods: In this prospective study, from March 2013 to March 2014, all male patient who underwent renal transplantation and were treated with Tacrolimus or Cyclosporine, were included. Patients’ spermogram was analyzed in terms of sperm count and motility. Results: Average sperm count in patients receiving cyclosporine and tacrolimus before the transplantation was 1.73 × 106 and 2.08 × 106 and after the transplantation was 1.2 × 106 and 1.22 × 106, respectively (P=0.008(P=0.002. Average percentage of the motile sperms of patients treated with Cyclosporine, before the transplantation and start of immunosuppressive course was 45.10%, which decreased to 40.50% at the end of the course. The analysis indicated a significant reduction in sperm motility (P=0.001. Average percentage of the motile sperms of patients receiving Tacrolimus, before the transplantation and start of treatment was 46% that decreased to 38% after the transplantation. This finding presents the significantly reduced sperm motility (P=0.002. Finally, the effective sperm motility in patients treated with Cyclosporine was significantly higher than patients treated with Tacrolimus. Conclusion: Tacrolimus reduces sperms’ motility in renal transplant patients significantly higher than Cyclosporine.

  14. Effect of Topical Tacrolimus on Vitiligo in Children

    Directory of Open Access Journals (Sweden)

    Mohammed Ziaur Rahman Bhuiyan

    2016-01-01

    Full Text Available Background: Considering safe treatment modalities for children with vitiligo, search for newer therapeutic agents continues. Hence, new immunomodulatory agents such as calcineurinantagonists, frequently referred to as topical immunomodulators (TIMs have recently been introduced as new promising tools to treat acquired hypopigmentary disorders. Tacrolimus is safe in treating children due to lack of skin atrophy and less data are available on effect of topical tacrolimus on vitiligo. Objective: To see the effect of topical tacrolimus on vitiligo in children. Materials and Methods: This prospective study was done in outpatient department of Dermatology and Venereology, Chittagong Medical College Hospital (CMCH, Bangladesh. Clinically diagnosed vitiligo patients of up to 12 years age visiting Skin & VD OPD, CMCH during study period were the study population (total 30. The study was carried out from November 2007 to April 2008. Results: A total of 30 patients, 13 (43.33% males and 17 (56.66% females with focal, segmental or generalized vitiligo were studied. Seventy percent of study subjects were from 7–12 years of age. Topical tacrolimus 0.03% ointment was administered twice daily for 12 weeks to each patient. Repigmentation was complete (>75% in 43.33% cases (13/30, was moderate (50–75% in 33.33% (10/30, mild (<50% in 13.33% (4/30. Clinical adverse effects were noted in 6.67% (2/30 of cases where pruritus was in 3.33% (1/30 and burning in 3.33% (1/30. None of the reactions was severe, all were mild and well-tolerated and most occurred within the first month of initiation of treatment and resolved with continued use of drug and completely cured after the treatment completed. Nobody had to discontinue the therapy for side effects. Conclusion: In conclusion, tacrolimus ointment may be a rapidly efficacious and safe option for the treatment of vitiligo in children. The ease of topical self-administration with minimal side effects makes this novel

  15. HEMOFILTRATION AND COUPLED PLASMA FILTRATION ADSORPTION IMPACT ON TACROLIMUS BLOOD CONCENTRATION IN RENAL TRANSPLANT RECIPIENTS

    Directory of Open Access Journals (Sweden)

    A.V. Vatazin

    2014-01-01

    Full Text Available Aim. To study the effect of hemofi ltration and coupled plasma fi ltration adsorption on tacrolimus blood concentration in renal transplant recipients.Methods and results. The study included 8 renal transplant recipients. In these patients immediately after the operation was performed the coupled plasma fi ltration adsorption with hemofiltration using a cartridge Mediasorb to reduce the severity of reperfusion injury. We have found that during this extracorporeal blood correction procedure there was statistically not signifi cant decrease of tacrolimus blood concentration. However, concentration of tacrolimus remained in the therapeutic range even after the procedure and it was not signifi cantly different from the control point С0.Conclusion. Coupled plasma fi ltration adsorption is safe in renal transplant recipients and has no signifi cant impact on tacrolimus blood concentration. However, the downward trend in the concentration of tacrolimus in the course of these procedures, especially in continuous or semicontinuous mode, as well as in patients with low hematocrit and hypoalbuminemia, requires individual monitoring.

  16. False Elevation of the Blood Tacrolimus Concentration, as Assessed by an Affinity Column-mediated Immunoassay (ACMIA), Led to Acute T Cell-mediated Rejection after Kidney Transplantation.

    Science.gov (United States)

    Kono, Momoko; Hasegawa, Jumpei; Ogawa, Hina; Yoshikawa, Kanae; Ishiwatari, Ayumi; Wakai, Sachiko; Tanabe, Kazunari; Shirakawa, Hiroki

    2018-05-01

    Tacrolimus is the most commonly used immunosuppressant. Because of its narrow therapeutic range, it is necessary to frequently monitor its concentration. We report the case of a 25-year-old man who underwent kidney transplantation whose tacrolimus concentrations, as measured by an affinity column-mediated immunoassay, were falsely elevated. As we reduced the dose of tacrolimus, the recipient developed T cell-mediated rejection. Using the same blood samples, an enzyme-multiplied immunoassay technique showed that the patient's levels of tacrolimus were extremely low. A further examination indicated that the false increase in the tacrolimus concentration was likely due to an unknown interfering substance. We administered methylprednisolone and antithymocyte-globulin. The patient's serum creatinine level decreased and remained stable after these treatments.

  17. A short-term trial of tacrolimus ointment for atopic dermatitis. European Tacrolimus Multicenter Atopic Dermatitis Study Group

    NARCIS (Netherlands)

    Ruzicka, T.; Bieber, T.; Schöpf, E.; Rubins, A.; Dobozy, A.; Bos, J. D.; Jablonska, S.; Ahmed, I.; Thestrup-Pedersen, K.; Daniel, F.; Finzi, A.; Reitamo, S.

    1997-01-01

    Tacrolimus (FK 506) is an effective immunosuppressant drug for the prevention of rejection after organ transplantation, and preliminary studies suggest that topical application of tacrolimus is effective in the treatment of atopic dermatitis. We conducted a randomized, doubleblind, multicenter study

  18. Dyslipidaemia among renal transplant recipients: cyclosporine versus tacrolimus.

    Science.gov (United States)

    Fazal, Muhammad Asim; Idrees, Muhammad Khalid; Akhtar, Syed Fazal

    2014-05-01

    To compare new onset dyslipidaemia in live-related renal transplant recipients taking cyclosporine versus tacrolimus after 3 months of therapy. The randomised controlled trial was conducted at the Sindh Institute of Urology and Transplantation (SIUT) Karachi, from September 2010 to April 2011, and included 182 End Stage Renal Disease patients on maintenance haemodialysis with pre-transplant normal lipid profile. The patients, who had live-related renal transplant, were randomly allocated to two equal groups using lottery. Group A received cyclosporine (3 mg/kg) and group B was treated with tacrolimus (0.1 mg/kg). All patients had pre-transplant fasting lipid profile checked when they were on maintenance haemodialysis and 3 months after renal transplantation. Serum fasting lipid profile was collected by taking 5 ml blood by venipuncture after an overnight fast of 9-12 hours. SPSS 10 was used for statistical analyses. Of the 182 patients, 144 (79.1%) were males and 38 (20.9%) were females. The overall mean age was 30.18 +/- 9.57 years, and the mean weight was 54.41 +/- 11.144 kg. Significant difference was not observed between the two groups regarding age and weight of the patients. Dyslipidaemia was found in 115(63.2%) subjects; 61(67%) in group A and 54 (59.3%) in group B. There was no statistical difference (p=0.28) when comparison was done after 3 months of therapy. The occurrence of new onset hyperlipidaemia is similar in renal transplant recipients receiving either cyclosporine or tacrolimus in first 3 months post-transplant, but there is room for more research in this field as dyslipidaemia following successful renal transplantation is a frequent and persistent complication.

  19. Dyslipidaemia among renal transplant recipients: cyclosporine versus tacrolimus

    International Nuclear Information System (INIS)

    Fazal, M. A.; Idrees, M. K.; Akhtar, S. F.

    2014-01-01

    Objectives: To compare new onset dyslipidaemia in live-related renal transplant recipients taking cyclosporine versus tacrolimus after 3 months of therapy. Methods: The randomised controlled trial was conducted at the Sindh Institute of Urology and Transplantation (SIUT) Karachi, from September 2010 to April 2011, and included 182 End Stage Renal Disease patients on maintenance haemodialysis with pre-transplant normal lipid profile. The patients, who had live-related renal transplant, were randomly allocated to two equal groups using lottery. Group A received cyclosporine (3mg/kg) and group B was treated with tacrolimus (0.1mg/kg). All patients had pre-transplant fasting lipid profile checked when they were on maintenance haemodialysis and 3 months after renal transplantation. Serum fasting lipid profile was collected by taking 5ml blood by venipuncture after an overnight fast of 9-12 hours. SPSS 10 was used for statistical analyses. Results: Of the 182 patients, 144(79.1%) were males and 38(20.9%) were females. The overall mean age was 30.18+-9.57 years, and the mean weight was 54.41+- 11.144kg. Significant difference was not observed between the two groups regarding age and weight of the patients. Dyslipidaemia was found in 115(63.2%) subjects; 61(67%) in group A and 54(59.3%) in group B. There was no statistical difference (p=0.28) when comparison was done after 3 months of therapy. Conclusions: The occurrence of new onset hyperlipidaemia is similar in renal transplant recipients receiving either cyclosporine or tacrolimus in first 3 months post-transplant, but there is room for more research in this field as dyslipidaemia following successful renal transplantation is a frequent and persistent complication. (author)

  20. An observational study evaluating tacrolimus dose, exposure, and medication adherence after conversion from twice- to once-daily tacrolimus in liver and kidney transplant recipients.

    Science.gov (United States)

    Bäckman, Lars; Persson, Carl-Axel

    2014-03-17

    Immunosuppression regimens in transplantation medicine are complex. Drugs with extended release action have simplified medication dosing without affecting efficacy. This prospective, observational, multicenter study, conducted in a routine medical practice setting, evaluated changes in tacrolimus daily dose and trough levels and patient-reported medication adherence at day 90 after 1:1 (mg: mg) conversion to once-daily tacrolimus in adult liver and kidney transplant recipients. Data from 224 recipients of a liver (n=19) or kidney (n=205) transplant, average age 51±14.5 years, were evaluated. The mean change in tacrolimus daily dose was +0.04 mg/day. Dose remained stable after conversion in 62.5%, was lower in 15.6%, and higher in 22% of patients. Trough level after conversion was lower in 62.6% and higher in 36.5%; generally, levels were 12.8% lower than pre-conversion levels. No acute rejection, graft loss, or serious safety events were observed. Two deaths occurred due to myocardial infarction. Conversion helped 19% to less frequently forget medications and 55% reported no difference in remembering to take the once-daily dose after conversion. The change in dosing frequency was identified as "better" for 55%. Tacrolimus daily dose remained stable while trough levels were significantly lower after conversion to once-daily dosing. Safety and efficacy were maintained; reduced dosing frequency had no apparent influence on patient-reported medication adherence.

  1. Tacrolimus Versus Cyclosporine as Primary Immunosuppressant After Renal Transplantation: A Meta-Analysis and Economics Evaluation.

    Science.gov (United States)

    Liu, Jin-Yu; You, Ru-Xu; Guo, Min; Zeng, Lu; Zhou, Pu; Zhu, Lan; Xu, Gang; Li, Juan; Liu, Dong

    2016-01-01

    Tacrolimus and cyclosporine are the major immunosuppressants for renal transplantation. Several studies have compared these 2 drugs, but the outcomes were not consistent. The aim of this study was to evaluate the efficacy, safety, and pharmacoeconomics of cyclosporine and tacrolimus in the treatment of renal transplantation and provide evidence for the selection of essential drugs. Trials were identified through a computerized literature search of PubMed, EMBASE, Cochrane Controlled Trials Register, Cochrane Renal Group Specialized Register of randomized controlled trials, and Chinese Biomedical database. Two independent reviewers assessed trials for eligibility and quality and then extracted data. Data were extracted for patient and graft mortality, acute rejection, and adverse events. Dichotomous outcomes were reported as relative risk with 95% confidence intervals. A decision tree model was populated with data from a literature review and used to estimate costs and quality-adjusted life years gained and incremental cost-effectiveness. Altogether, 6137 patients from 27 randomized controlled trials were included. The results of our analysis were that tacrolimus reduced the risks after renal transplantation of patient mortality, graft loss, acute rejection, and hypercholesterolemia. Nevertheless, tacrolimus increased the risk of new-onset diabetes. Pharmacoeconomic analysis showed that tacrolimus represented a more cost-effective treatment than does cyclosporine for the prevention of adverse events following renal transplant. Tacrolimus is an effective and safe immunosuppressive agent and it may be more cost-effective than cyclosporine for the primary prevention of graft rejection in renal transplant recipients. However, new-onset diabetes should be closely monitored during the medication period.

  2. IMPROVING PATIENT SAFETY:

    DEFF Research Database (Denmark)

    Bagger, Bettan; Taylor Kelly, Hélène; Hørdam, Britta

    Improving patient safety is both a national and international priority as millions of patients Worldwide suffer injury or death every year due to unsafe care. University College Zealand employs innovative pedagogical approaches in educational design. Regional challenges related to geographic......, social and cultural factors have resulted in a greater emphasis upon digital technology. Attempts to improve patient safety by optimizing students’ competencies in relation to the reporting of clinical errors, has resulted in the development of an interdisciplinary e-learning concept. The program makes...

  3. Conversion From Twice-Daily Tacrolimus Capsules to Once-Daily Extended-Release Tacrolimus (LCPT): A Phase 2 Trial of Stable Renal Transplant Recipients

    Science.gov (United States)

    Gaber, A. Osama; Alloway, Rita R.; Bodziak, Kenneth; Kaplan, Bruce; Bunnapradist, Suphamai

    2013-01-01

    Background LCP-Tacro is an extended-release formulation of tacrolimus designed for once-daily dosing. Phase 1 studies demonstrated greater bioavailability to twice-daily tacrolimus capsules and no new safety concerns. Methods In this phase 2 study, adult stable kidney transplant patients on tacrolimus capsules (Prograf) twice-daily were converted to tacrolimus tablets (LCP-Tacro) once-daily; patients continued on LCP-Tacro once-daily for days 8 to 21; trough levels were to be maintained between 5 and 15 ng/mL; 24-hr pharmacokinetic assessments were done on days 7 (baseline pre-switch), 14, and 21. Results Forty-seven patients completed LCP-Tacro dosing per protocol. The mean conversion ratio was 0.71. Pharmacokinetic data demonstrated consistent exposure (AUC) at the lower conversion dose. Cmax (P=0.0001), Cmax/Cmin ratio (P<0.001), percent fluctuation (P<0.0001), and swing (P=0.0004) were significantly lower and Tmax significantly (P<0.001) longer for LCP-Tacro versus Prograf. AUC24 and Cmin correlation coefficients after 7 and 14 days of therapy were 0.86 or more, demonstrating a robust correlation between LCP-Tacro tacrolimus exposure and trough levels. There were three serious adverse events; none were related to study drug and all were resolved. Conclusions Stable kidney transplant patients can be safely converted from Prograf twice-daily to LCP-Tacro. The greater bioavailability of LCP-Tacro allows for once-daily dosing and similar (AUC) exposure at a dose approximately 30% less than the total daily dose of Prograf. LCP-Tacro displays flatter kinetics characterized by significantly lower peak-trough fluctuations. PMID:23715050

  4. Stability of tacrolimus solutions in polyolefin containers.

    Science.gov (United States)

    Lee, Jun H; Goldspiel, Barry R; Ryu, Sujung; Potti, Gopal K

    2016-02-01

    Results of a study to determine the stability of tacrolimus solutions stored in polyolefin containers under various temperature conditions are reported. Triplicate solutions of tacrolimus (0.001, 0.01, and 0.1 mg/mL) in 0.9% sodium chloride injection or 5% dextrose injection were prepared in polyolefin containers. Some samples were stored at room temperature (20-25 °C); others were refrigerated (2-8 °C) for 20 hours and then stored at room temperature for up to 28 hours. The solutions were analyzed by stability-indicating high-performance liquid chromatography (HPLC) assay at specified time points over 48 hours. Solution pH was measured and containers were visually inspected at each time point. Stability was defined as retention of at least 90% of the initial tacrolimus concentration. All tested solutions retained over 90% of the initial tacrolimus concentration at all time points, with the exception of the 0.001-mg/mL solution prepared in 0.9% sodium chloride injection, which was deemed unstable beyond 24 hours. At all evaluated concentrations, mean solution pH values did not change significantly over 48 hours; no particle formation was detected. During storage in polyolefin bags at room temperature, a 0.001-mg/mL solution of tacrolimus was stable for 24 hours when prepared in 0.9% sodium chloride injection and for at least 48 hours when prepared in 5% dextrose injection. Solutions of 0.01 and 0.1 mg/mL prepared in either diluent were stable for at least 48 hours, and the 0.01-mg/mL tacrolimus solution was also found to be stable throughout a sequential temperature protocol. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  5. Teleophthalmology: improving patient outcomes?

    Directory of Open Access Journals (Sweden)

    Sreelatha OK

    2016-02-01

    Full Text Available Omana Kesary Sreelatha,1 Sathyamangalam VenkataSubbu Ramesh2 1Ophthalmology Department, Sultan Qaboos University Hospital, Muscat, Oman; 2Department of Optometry, School of Allied Health Sciences, Manipal University, Manipal, India Abstract: Teleophthalmology is gaining importance as an effective eye care delivery modality worldwide. In many developing countries, teleophthalmology is being utilized to provide quality eye care to the underserved urban population and the unserved remote rural population. Over the years, technological innovations have led to improvement in evidence and teleophthalmology has evolved from a research tool to a clinical tool. The majority of the current teleophthalmology services concentrate on patient screening and appropriate referral to experts. Specialty care using teleophthalmology services for the pediatric group includes screening as well as providing timely care for retinopathy of prematurity (ROP. Among geriatric eye diseases, specialty teleophthalmology care is focused toward screening and referral for diabetic retinopathy (DR, glaucoma, age-related macular degeneration (ARMD, and other sight-threatening conditions. Comprehensive vision screening and refractive error services are generally covered as part of most of the teleophthalmology methods. Over the past decades, outcome assessment of health care system includes patients’ assessments on their health, care, and services they receive. Outcomes, by and large, remain the ultimate validators of the effectiveness and quality of medical care. Teleophthalmology produces the same desired clinical outcome as the traditional system. Remote portals allow specialists to provide care over a larger region, thereby improving health outcomes and increasing accessibility of specialty care to a larger population. A high satisfaction level and acceptance is reported in the majority of the studies because of increased accessibility and reduced traveling cost and time

  6. Metabolic differences of tacrolimus between patients with combined liver and kidney transplantation and patients with single liver or single kidney transplantation%他克莫司在肝肾联合移植患者与单纯肝移植及单纯肾移植患者之间代谢的差异

    Institute of Scientific and Technical Information of China (English)

    鲁燕侠; 邹德勇; 王新; 严莲珍

    2017-01-01

    目的 探讨他克莫司在不同器官移植受者间的代谢差异.方法 采用回顾性研究方法,选择武警总医院器官移植中心2002年1月至2012年8月收治的器官移植患者30例,分为肝肾联合移植(SLK)组、单纯肝移植组和单纯肾移植组,每组10例.SLK组与单纯肝移植组两组给药方案相同,术中均给予甲泼尼龙注射液,术后采用他克莫司+吗替麦考酚酯+泼尼松三联免疫抑制治疗方案.术后第1天给予他克莫司,初始剂量0.06 mg·kg-1·d-1,分2次服用,术后第3天开始检测他克莫司全血谷浓度;单纯肾移植组术后2~4 d给予他克莫司,初始剂量为0.15 mg·kg-1·d-1,分2次服用,服药3 d后开始监测他克莫司全血谷浓度.比较3组移植术后1个月内他克莫司的服药剂量和全血谷浓度.结果 术后1个月SLK组口服他克莫司剂量(μg·kg-1·d-1:74.78±32.65比80.62±24.02、85.58±16.78)及血药浓度监测值(μg/L:6.64±2.73比7.50±3.08、7.46±3.20)均低于单纯肝移植组和单纯肾移植组,但组间比较差异无统计学意义(均P>0.05).结论 SLK中移植肝对于移植肾的保护作用可能与术后时间有关.术后1个月内移植肝对于移植肾未显示出保护作用.%Objective To investigate the metabolic differences of Tacrolimus in different transplant recipients. Methods A retrospective study was conducted, 30 patients of the organ transplant admitted to organ transplantation center of General Hospital of Chinese People's Armed Police Forces from January 2002 to August 2012 were enrolled, and they were divided into combined liver and kidney transplant (SLK) group, single liver transplant group and single renal transplant group, 10 cases in each group. The SLK group and the simple liver transplantation group were given the same drug regimen, methylprednisolone injection was given during operation, and tacrolimus+ mycophenolate mofetil+ prednisone triple immunosuppressive therapy was taken after operation, on

  7. Tacrolimus interaction with nafcillin resulting in significant decreases in tacrolimus concentrations: A case report.

    Science.gov (United States)

    Wungwattana, Minkey; Savic, Marizela

    2017-04-01

    Tacrolimus (TAC) is subject to many drug interactions as a result of its metabolism primarily via CYP450 isoenzyme 3A4. Numerous case reports of TAC and CYP3A4 inducers and inhibitors have been described including antimicrobials, calcium channel antagonists, and antiepileptic drugs. We present the case of a 13-year-old patient with cystic fibrosis and a history of liver transplantation, where subtherapeutic TAC concentrations were suspected to be a result of concomitant TAC and nafcillin (NAF) therapy. The observed drug interaction occurred on two separate hospital admissions, during both of which the patient exhibited therapeutic TAC concentrations prior to exposure to NAF, a CYP3A4 inducer. Upon discontinuation of NAF, TAC concentrations recovered in both instances. This case represents a drug-drug interaction between TAC and NAF that has not previously been reported to our knowledge. Despite the lack of existing reports of interaction between these two agents, this case highlights the importance of therapeutic drug monitoring and assessing for any potential drug-drug or drug-food interactions in patients receiving TAC therapy. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  8. Cyclosporine versus tacrolimus: cost-effectiveness analysis for renal transplantation in Brazil

    Science.gov (United States)

    Guerra, Augusto Afonso; Silva, Grazielle Dias; Andrade, Eli Iola Gurgel; Cherchiglia, Mariângela Leal; Costa, Juliana de Oliveira; Almeida, Alessandra Maciel; Acurcio, Francisco de Assis

    2015-01-01

    OBJECTIVE To analyze the cost-effectiveness of treatment regimens with cyclosporine or tacrolimus, five years after renal transplantation. METHODS This cost-effectiveness analysis was based on historical cohort data obtained between 2000 and 2004 and involved 2,022 patients treated with cyclosporine or tacrolimus, matched 1:1 for gender, age, and type and year of transplantation. Graft survival and the direct costs of medical care obtained from the National Health System (SUS) databases were used as outcome results. RESULTS Most of the patients were women, with a mean age of 36.6 years. The most frequent diagnosis of chronic renal failure was glomerulonephritis/nephritis (27.7%). In five years, the tacrolimus group had an average life expectancy gain of 3.96 years at an annual cost of R$78,360.57 compared with the cyclosporine group with a gain of 4.05 years and an annual cost of R$61,350.44. CONCLUSIONS After matching, the study indicated better survival of patients treated with regimens using tacrolimus. However, regimens containing cyclosporine were more cost-effective. PMID:25741648

  9. Probable tacrolimus toxicity from tibolone co-administration in a woman: a case report

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    Clark Carolyn J

    2010-08-01

    Full Text Available Abstract Introduction Tibolone is a synthetic steroid, used with increasing frequency to treat symptoms of menopause, including patients with solid-organ transplants who are taking concurrent immune suppression. To the best of our knowledge, there are no reported drug interactions between tibolone and tacrolimus, one of the principal immune suppressants used in kidney transplantation. Case presentation We report the case of a 49-year-old Caucasian woman who had received a kidney transplant and who developed acute kidney injury secondary to tacrolimus toxicity 10 days after starting tibolone therapy. No alternative causes were found. Tibolone is known to be a weak competitive inhibitor of CYP3A4, which is involved in tacrolimus metabolism. Conclusions Despite a careful evaluation, no alternative reason was found for the acute kidney injury, and her kidney function returned to the previous baseline within several days of cessation of the medication, and with no other specific treatment. Using the Drug Interaction Probability Scale we conclude that she experienced a probable drug interaction. We believe that transplant clinicians should utilise frequent therapeutic drug monitoring of tacrolimus in patients starting or stopping tibolone therapy.

  10. Once-Daily Tacrolimus Extended-Release Formulation: 1 Year after Conversion in Stable Pediatric Kidney Transplant Recipients

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    Lars Pape

    2011-01-01

    Full Text Available It is speculated that a once-daily dosage of immunosuppression can increase adherence and thereby graft survival. Until now, there have been no studies on once-daily use of Tacrolimus extended-release formulation (TAC-ER in children following pediatric kidney transplantation. In 11 stable pediatric kidney recipients >10 years, efficacy, safety, and tolerability of a switch to TAC-ER were observed over one year. Adherence was determined by use of the BAASIS-Scale Interview and comparison of individual variability of Tacrolimus trough levels. Over the observation period, two acute rejections were observed in one girl with nonadherence and repeated Tacrolimus trough levels of 0 ng/m. Beside this, there were no acute rejections in this trial. TAC dose was increased in 3/11 patients and decreased in 2/11 patients within the course of the study. Six patients did not require a dose adjustment. All but one patient had a maximum of 1 dose change during therapy. Mean Tacrolimus dose, trough levels, and Glomerular filtration rates were also stable. Adherence, as measured by BAASIS-Scale Interview and coefficient of variation of Tacrolimus trough levels, was good at all times. It is concluded that conversion to Tac-ER is safe in low-risk children following pediatric kidney transplantation.

  11. STUDY OF THERAPEUTIC COMPARISON OF TACROLIMUS 0.1% AND MINOXIDIL 2% IN ALOPECIA AREATA

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    Kallappa C. Herkal

    2013-07-01

    Full Text Available Introduction: Alopecia areata is a unique, idiopathic disease in which there is patchy hair loss. The variable and uncertain natural history of alopecia areata is accounting for the multiplicity of uncritical claims for a large variety of therapeutic procedures. Aim: to find the therapeutic comparison between tacrolimus 0.1% ointment and minoxidil 2% solution. Material and Methods: Patients attending skin out patient department in Navodaya medical college hospital and research centre, Raichur were screened and the consenting consecutive cases of Aopecia Areata (AA from December 2010 to November 2011 were chosen for study. There were 75 patients in the study. It is a randomized, single blind, intension to treat study. The eligible patients for the study were randomly allocated into two groups-Group A and Group B (38 in Group A and 37 in Group B. Patients in Group A were treated with 2% Minoxidi solution to be applied twice daily over the alopecia patch, where as Patients in Group B were treated with Tacrolimus 0.1% ointment applied twice daily. Patients were followed up at 2, 4, 6, 8, 10 and 12 weeks. Alopecia Grading Score (AGS was calculated at baseline and 12 weeks. Regrowth Score (RGS was calculated at 12 weeks. Results: Total 69 patients completed the study (35 in Group A and 34 in Group B. In our study RGS ≥ 3 was observed in 65.71% of patients treated with Tinoxidil 2% solution and 44.12% of patients treated with Tacrolimus 0.1% ointment. Conclusion: In our study Minoxidil 2% solution had better stimulatory effect on hair growth compared to Tacrolimus 0.1% ointment in the treatment of mild to moderate patchy alopecia areata. The combination treatment may yield a better clinical response than either of the agents used singly.

  12. The calcineurin inhibitor tacrolimus reduces proteinuria in membranous nephropathy accompanied by a decrease in angiopoietin-like-4.

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    Lei Peng

    Full Text Available Tacrolimus is an anticalcineurinic agent with potent immunosuppressive activity that has recently been shown to have the added benefit of reducing proteinuria in membranous nephropathy (MN patients. However, its potential mechanisms remain unknown. To reveal the mechanism, rat cohorts were administered tacrolimus or vehicle from days 7 to 28 after the induction of passive Heymann nephritis (PHN. PHN induction resulted in heavy proteinuria and increased expression of desmin, a marker of injured podocytes. We also showed that the glomerular expression of angiopoietin-like-4 (Angptl4 was markedly upregulated in PHN rats and human MN followed by an increase in urine Angptl4 excretion. In addition, increased Angptl4 expression may be related to podocyte injury and proteinuria. Furthermore, upregulated Angptl4 expression primarily colocalized with podocytes rather than endothelial or mesangial cells, indicating that podocytes may be the source of Angptl4, which then gradually migrated to the glomerular basement membrane over time. However, tacrolimus treatment markedly reduced glomerular and urinary Angptl4, accompanied by a reduction in the established proteinuria and the promotion of podocyte repair. Additionally, glomerular immune deposits and circulating IgG levels induced by PHN clearly decreased following tacrolimus treatment. In conclusion, this is the first demonstration that the calcineurin inhibitor tacrolimus can reduce Angptl4 in podocytes accompanied by a decrease in established proteinuria and promotion of podocyte repair in MN.

  13. Immunosuppression Adherence in Stable Kidney Transplant Patients Converted From Immediate- to Prolonged-Release Tacrolimus in Clinical Practice: A Norwegian Study

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    Sadollah Abedini, MD, PhD

    2018-02-01

    Conclusions. There was disparity between high, patient-perceived and low, actual adherence. Converting stable KTPs from IR-T to PR-T in routine practice did not impact long-term adherence to immunosuppression; renal function remained stable.

  14. A Markov chain model to evaluate the effect of CYP3A5 and ABCB1 polymorphisms on adverse events associated with tacrolimus in pediatric renal transplantation.

    Science.gov (United States)

    Sy, Sherwin K B; Heuberger, Jules; Shilbayeh, Sireen; Conrado, Daniela J; Derendorf, Hartmut

    2013-10-01

    The SNP A6986G of the CYP3A5 gene (*3) results in a non-functional protein due to a splicing defect whereas the C3435T was associated with variable expression of the ABCB1 gene, due to protein instability. Part of the large interindividual variability in tacrolimus efficacy and toxicity can be accounted for by these genetic factors. Seventy-two individuals were examined for A6986G and C3435T polymorphism using a PCR-RFLP-based technique to estimate genotype and allele frequencies in the Jordanian population. The association of age, hematocrit, platelet count, CYP3A5, and ABCB1 polymorphisms with tacrolimus dose- and body-weight-normalized levels in the subset of 38 pediatric renal transplant patients was evaluated. A Markov model was used to evaluate the time-dependent probability of an adverse event occurrence by CYP3A5 phenotypes and ABCB1 genotypes. The time-dependent probability of adverse event was about double in CYP3A5 non-expressors compared to the expressors for the first 12 months of therapy. The CYP3A5 non-expressors had higher corresponding normalized tacrolimus levels compared to the expressors in the first 3 months. The correlation trend between probability of adverse events and normalized tacrolimus concentrations for the two CYP3A5 phenotypes persisted for the first 9 months of therapy. The differences among ABCB1 genotypes in terms of adverse events and normalized tacrolimus levels were only observed in the first 3 months of therapy. The information on CYP3A5 genotypes and tacrolimus dose requirement is important in designing effective programs toward management of tacrolimus side effects particularly for the initial dose when tacrolimus blood levels are not available for therapeutic drug monitoring.

  15. Probable tacrolimus toxicity from tibolone co-administration in a woman: a case report

    OpenAIRE

    Clark Carolyn J; Hawley Carmel M; Mudge David W

    2010-01-01

    Abstract Introduction Tibolone is a synthetic steroid, used with increasing frequency to treat symptoms of menopause, including patients with solid-organ transplants who are taking concurrent immune suppression. To the best of our knowledge, there are no reported drug interactions between tibolone and tacrolimus, one of the principal immune suppressants used in kidney transplantation. Case presentation We report the case of a 49-year-old Caucasian woman who had received a kidney transplant an...

  16. Investigation on biological properties of tacrolimus-loaded poly(1,3-trimethylene carbonate) in vitro

    Science.gov (United States)

    Hou, Ruixia; Wu, Leigang; Wang, Jin; Huang, Nan

    2010-06-01

    The drug-eluting stents have been regarded as a milestone in inhibiting the restenosis of coronary arteries. However, adverse reactions caused by bare-metal stents and non-biodegradable polymer coatings may result in some clinical problems. In this study, a new tacrolimus-eluting stent coated with biodegradable poly(1,3-trimethylene carbonate) (PTMC) is developed. The structures are characterized by Fourier transform infrared (FTIR) analysis, and the wettability is measured by contact angle assay. The biological behaviors are evaluated by the in vitro platelets adhesion test, APTT test, the human umbilical cord artery smooth muscle cells (HUCASMCs), 4',6-diamidine-2-phenylindole (DAPI) and actin immunofluorescence staining, MTT colorimetric assay. These results show that after blending tacrolimus into PTMC, the anticoagulant behavior is improved, and the adhesion and proliferation of HUCASMCs on samples are inhibited. This work aims to find one kind of surface erosion biodegradable polymers that can be applied as drug-eluting stent coatings.

  17. Physicochemical characterization of tacrolimus-loaded solid dispersion with sodium carboxylmethyl cellulose and sodium lauryl sulfate.

    Science.gov (United States)

    Park, Young-Joon; Ryu, Dong-Sung; Li, Dong Xun; Quan, Qi Zhe; Oh, Dong Hoon; Kim, Jong Oh; Seo, Youn Gee; Lee, Young-Im; Yong, Chul Soon; Woo, Jong Soo; Choi, Han-Gon

    2009-06-01

    To develop a novel tacrolimus-loaded solid dispersion with improved solubility, various solid dispersions were prepared with various ratios of water, sodium lauryl sulfate, citric acid and carboxylmethylcellulose-Na using spray drying technique. The physicochemical properties of solid dispersions were investigated using scanning electron microscopy, differential scanning calorimetery and powder X-ray diffraction. Furthermore, their solubility and dissolution were evaluated compared to drug powder. The solid dispersion at the tacrolimus/CMC-Na/sodium lauryl sulfate/citric acid ratio of 3/24/3/0.2 significantly improved the drug solubility and dissolution compared to powder. The scanning electron microscopy result suggested that carriers might be attached to the surface of drug in this solid dispersion. Unlike traditional solid dispersion systems, the crystal form of drug in this solid dispersion could not be converted to amorphous form, which was confirmed by the analysis of DSC and powder X-ray diffraction. Thus, the solid dispersion system with water, sodium lauryl sulfate, citric acid and CMC-Na should be a potential candidate for delivering a poorly water-soluble tacrolimus with enhanced solubility and no convertible crystalline.

  18. 15 year experience of tacrolimus application in medical practice

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    Y. S. Kondratyeva

    2016-01-01

    Full Text Available The review presents modern literature data on the use of tacrolimus in medical practice. The results of national and international research on the effectiveness and safety of the drug at various dermatoses are presented.

  19. Different top-down approaches to estimate measurement uncertainty of whole blood tacrolimus mass concentration values.

    Science.gov (United States)

    Rigo-Bonnin, Raül; Blanco-Font, Aurora; Canalias, Francesca

    2018-05-08

    Values of mass concentration of tacrolimus in whole blood are commonly used by the clinicians for monitoring the status of a transplant patient and for checking whether the administered dose of tacrolimus is effective. So, clinical laboratories must provide results as accurately as possible. Measurement uncertainty can allow ensuring reliability of these results. The aim of this study was to estimate measurement uncertainty of whole blood mass concentration tacrolimus values obtained by UHPLC-MS/MS using two top-down approaches: the single laboratory validation approach and the proficiency testing approach. For the single laboratory validation approach, we estimated the uncertainties associated to the intermediate imprecision (using long-term internal quality control data) and the bias (utilizing a certified reference material). Next, we combined them together with the uncertainties related to the calibrators-assigned values to obtain a combined uncertainty for, finally, to calculate the expanded uncertainty. For the proficiency testing approach, the uncertainty was estimated in a similar way that the single laboratory validation approach but considering data from internal and external quality control schemes to estimate the uncertainty related to the bias. The estimated expanded uncertainty for single laboratory validation, proficiency testing using internal and external quality control schemes were 11.8%, 13.2%, and 13.0%, respectively. After performing the two top-down approaches, we observed that their uncertainty results were quite similar. This fact would confirm that either two approaches could be used to estimate the measurement uncertainty of whole blood mass concentration tacrolimus values in clinical laboratories. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  20. Pharmacokinetics of a self-microemulsifying drug delivery system of tacrolimus.

    Science.gov (United States)

    von Suesskind-Schwendi, Marietta; Gruber, Michael; Touraud, Didier; Kunz, Werner; Schmid, Christof; Hirt, Stephan W; Lehle, Karla

    2013-07-01

    This study evaluated the pharmacokinetics of tacrolimus (Tac) in a novel self-microemulsifying drug delivery system (SMEDDS) for improved oral administration. SMEDDS Tac consisted of ethyl oleate as the oily phase, Solutol HS 15 as the surfactant and glycofurol as the co-surfactant and contained 0.5mg/mL tacrolimus. Blood and tissue concentrations of tacrolimus from two study groups (oral application of SMEDDS Tac and Prograf®) were determined using ELISA technique following tacrolimus administration in rats. There was no difference between area under the whole blood concentration-time curve in the SEDDM Tac group and the Prograf® group. Maximum concentrations of the drug were three times higher (P<0.05) in the SEDDM Tac group accompanied by a 3-fold earlier peak time. Elimination half-life was significantly lower in the SEDDM Tac group. Application of SMEDDS Tac increased tissue accumulation. Already after 15 min, Tac levels of small intestine, liver, kidney, spleen, heart and bone marrow were significantly higher in the SMEDDS Tac group than in the Prograf® group (P<0.05). However, the Tac concentration in the kidney was significantly lower in the SMEDDS Tac group. Formulation of SMEDDS did not affect blood-brain barrier function. The SMEDDS is a potentially useful method for a local delivery of Tac to target organs. The selection of the optimum SMEDDS Tac composition might have advantage as an alternative oral dosage form for Tac. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  1. Application of Machine-Learning Models to Predict Tacrolimus Stable Dose in Renal Transplant Recipients

    Science.gov (United States)

    Tang, Jie; Liu, Rong; Zhang, Yue-Li; Liu, Mou-Ze; Hu, Yong-Fang; Shao, Ming-Jie; Zhu, Li-Jun; Xin, Hua-Wen; Feng, Gui-Wen; Shang, Wen-Jun; Meng, Xiang-Guang; Zhang, Li-Rong; Ming, Ying-Zi; Zhang, Wei

    2017-02-01

    Tacrolimus has a narrow therapeutic window and considerable variability in clinical use. Our goal was to compare the performance of multiple linear regression (MLR) and eight machine learning techniques in pharmacogenetic algorithm-based prediction of tacrolimus stable dose (TSD) in a large Chinese cohort. A total of 1,045 renal transplant patients were recruited, 80% of which were randomly selected as the “derivation cohort” to develop dose-prediction algorithm, while the remaining 20% constituted the “validation cohort” to test the final selected algorithm. MLR, artificial neural network (ANN), regression tree (RT), multivariate adaptive regression splines (MARS), boosted regression tree (BRT), support vector regression (SVR), random forest regression (RFR), lasso regression (LAR) and Bayesian additive regression trees (BART) were applied and their performances were compared in this work. Among all the machine learning models, RT performed best in both derivation [0.71 (0.67-0.76)] and validation cohorts [0.73 (0.63-0.82)]. In addition, the ideal rate of RT was 4% higher than that of MLR. To our knowledge, this is the first study to use machine learning models to predict TSD, which will further facilitate personalized medicine in tacrolimus administration in the future.

  2. Olmesartan Attenuates Tacrolimus-Induced Biochemical and Ultrastructural Changes in Rat Kidney Tissue

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    Naif O. Al-Harbi

    2014-01-01

    Full Text Available Tacrolimus, a calcineurin inhibitor, is clinically used as an immunosuppressive agent in organ transplantation, but its use is limited due to its marked nephrotoxicity. The present study investigated the effect of olmesartan (angiotensin receptor blocker on tacrolimus-induced nephrotoxicity in rats. A total of 24 rats were divided into four groups, which included control, tacrolimus, tacrolimus + olmesartan, and olmesartan groups. Tacrolimus-induced nephrotoxicity was assessed biochemically and histopathologically. Tacrolimus significantly increased BUN and creatinine level. Treatment with olmesartan reversed tacrolimus-induced changes in the biochemical markers (BUN and creatinine of nephrotoxicity. Tacrolimus significantly decreased GSH level and catalase activity while increasing MDA level. Olmesartan also attenuated the effects of tacrolimus on MDA, GSH, and catalase. In tacrolimus group histological examination showed marked changes in renal tubule, mitochondria, and podocyte processes. Histopathological and ultrastructural studies showed that treatment with olmesartan prevented tacrolimus-induced renal damage. These results suggest that olmesartan has protective effects on tacrolimus-induced nephrotoxicity, implying that RAS might be playing role in tacrolimus-induced nephrotoxicity.

  3. Comparable Renal Function at 6 Months with Tacrolimus Combined with Fixed-Dose Sirolimus or MMF: Results of a Randomized Multicenter Trial in Renal Transplantation

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    Eveline Van Gurp

    2010-01-01

    Full Text Available In a multicenter trial, renal transplant recipients were randomized to tacrolimus with fixed-dose sirolimus (Tac/SRL, N = 318 or tacrolimus with MMF (Tac/MMF, N = 316. Targeted tacrolimus trough levels were lower in the Tac/SRL group after day 14. The primary endpoint was renal function at 6 months using creatinine clearance (Cockcroft-Gault and was comparable at 66.4 mL/min (SE 1.4 with Tac/SRL and at 65.2mL/min (SE 1.3 with Tac/MMF (completers. Biopsy-confirmed acute rejection was 15.1% (Tac/SRL and 12.3% (Tac/MMF. In both groups, graft survival was 93% and patient survival was 99.0%. Premature withdrawal due to an adverse event was twice as high in the Tac/SRL group, 15.1% versus 6.3%. Hypercholesterolemia incidence was higher with Tac/SRL (P30 consecutive days in previously nondiabetic patients was 17.8%, Tac/SRL, and 24.8%, Tac/MMF. Evaluation at 6 months showed comparable renal function using tacrolimus/sirolimus and tacrolimus/MMF regimens.

  4. Effects of Storage Temperature and Time on Stability of Serum Tacrolimus and Cyclosporine A Levels in Whole Blood by LC-MS/MS

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    İbrahim Kaplan

    2015-01-01

    Full Text Available Tacrolimus and cyclosporine A are immunosuppressant drugs with narrow therapeutic windows. The aim of this study was to investigate the stability of tacrolimus and cyclosporin A levels in whole blood samples under different storage conditions. Whole blood samples were obtained from 15 patients receiving tacrolimus and 15 patients receiving cyclosporine A. Samples were immediately analyzed and then stored at different conditions (room temperature (24°C−26°C for 24 hours, +4°C for 24 and 48 hours, and −20°C for one month and then analyzed again. For tacrolimus, there was a significant difference between samples analyzed immediately and those kept 24 hours at room temperature (P=0.005 (percent change 32.89%. However, there were no significant differences between the other groups. For cyclosporine A, there was a significant difference between samples analyzed immediately and those kept 24 hours (P=0.003 (percent change 19.47% and 48 hours (P=0.002 (percent change 15.38% at +4°C and those kept 24 hours at room temperature (P=0.011 (percent change 9.71%. Samples of tacrolimus should be analyzed immediately or stored at either +4°C or −20°C, while samples of cyclosporine A should be analyzed immediately or stored at −20°C.

  5. Impact of cytochrome p450 3A5 genetic polymorphism on tacrolimus doses and concentration-to-dose ratio in renal transplant recipients.

    Science.gov (United States)

    Thervet, Eric; Anglicheau, Dany; King, Barry; Schlageter, Marie-Hélène; Cassinat, Bruno; Beaune, Philippe; Legendre, Christophe; Daly, Ann K

    2003-10-27

    Tacrolimus pharmacokinetic characteristics vary greatly among individuals. Tacrolimus is a substrate of cytochrome p450 (CYP), of subfamily CYP3A. CYP3A activity is the sum of the activities of the family of CYP3A genes, including CYP3A5. Subjects with the CYP3A5*1/*1 genotype express large amounts of CYP3A5. Heterozygotes (genotype CYP3A5*1/*3) also express the enzyme. We postulated that CYP3A5 polymorphism is associated with tacrolimus pharmacokinetic variations. CYP3A5 genotype was evaluated in 80 renal transplant recipients and correlated with the daily tacrolimus dose and concentration-to-dose ratio. The frequency of the homozygous CYP3A5*1 genotype (CYP3A5*1/*1) was 5%, and 11% of subjects were heterozygous (CYP3A5*1/*3). The mean doses required to obtain the targeted concentration-to-dose ratio were significantly lower in patients with the CYP3A5*1/*1 genotype. Determination of CYP3A5 genotype is predictive of the dose of tacrolimus in renal transplant recipients and may help to determine the initial daily dose needed by individual patients for adequate immunosuppression without excess nephrotoxicity.

  6. Strangers headed to a strange land? A pilot study of using a transition coordinator to improve transfer from pediatric to adult services.

    Science.gov (United States)

    Annunziato, Rachel A; Baisley, Margaret C; Arrato, Nicole; Barton, Codette; Henderling, Fiona; Arnon, Ronen; Kerkar, Nanda

    2013-12-01

    To compare the impact of a transition coordinator on outcomes for pediatric liver transplant recipients vs a historical comparison group. To examine the utility of a transition coordinator, medication adherence, as measured by SDs of tacrolimus blood levels (Tacrolimus SD), was compared between the "transition coordinator group" (20 transplant recipients transferred between 2007 and 2012) and comparison group for 1 year before and after transfer. Measures of health care management, quality of life, and acceptability were administered to the transition coordinator group as well. A repeated measures ANOVA was used to compare adherence values between the transition coordinator group and the comparison group. During the year before transfer, for the transition coordinator group, Tacrolimus SD was 1.98 (SD = 1.05) vs 3.25 (SD = 1.19) for comparison patients, F(1,25) = 4.77, P = .04. After transfer, levels remained stable for the transition coordinator group, Tacrolimus SD = 1.88 (SD = 1.57), but increased for comparison patients, Tacrolimus SD = 4.36 (SD = 0.99), F(1,25) = 6.99, P = .01. Psychosocial outcomes remained stable during the transfer period and acceptability was high. Our findings, although limited by a small sample size, suggest that a transition coordinator is a promising method to improve this process. Copyright © 2013 Mosby, Inc. All rights reserved.

  7. Topical tacrolimus for the treatment of severe allergic keratoconjunctivitis in children

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    Vera Lucia Liendo

    Full Text Available ABSTRACT Purpose: Administration of eye drops containing antihistamines or sodium cromoglycate and its derivatives for the treatment of allergic keratoconjunctivitis is often insufficient and usually requires the addition of corticosteroids. However, the risk of complications, such as glaucoma and cataract, limits the use of corticosteroids to short courses, resulting in inadequate long-term treatment response. Immunosuppressive drugs have been considered as a valid alternative to steroids for atopic keratoconjunctivitis and vernal keratoconjunctivitis. This study aimed to evaluate the use of topical tacrolimus (TCL in improving the clinical signs of severe allergic keratoconjuctivitis in children. Methods: Patients with severe allergic keratoconjunctivitis associated with corneal epitheliopathy, gelatinous limbal infiltrates, and/or papillary reaction, along with a history of recurrences and resistance to conventional topical anti-allergy agents, were included in this open clinical trial. Patients were treated with 0.03% TCL ointment for ocular use. A severity score ranging from 0 to 9, with 9 being the highest and 0 being the lowest, was assigned based on signs observed on biomicroscopy prior to and following TCL treatment. Results: Analyses included 66 eyes of 33 patients. After a mean follow-up period of 13 months (range, 12-29 months, TCL treatment significantly decreased the mean symptom score severity for the right (from 5.56 ± 1.18 to 2.76 ± 1.5; p<0.001 and left (from 5.94 ± 1.16 to 2.86 ± 1.64; p<0.001. Conclusion: Topical TCL was effective and significantly improved the clinical signs of allergic keratoconjuctivitis in children. Thus, it is a potential new option for severe and challenging cases of ocular allergy.

  8. Budget impact of switching from an immediate-release to a prolonged-release formulation of tacrolimus in renal transplant recipients in the UK based on differences in adherence

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    Muduma G

    2014-03-01

    Full Text Available Gorden Muduma,1 Isaac Odeyemi,1 Jayne Smith-Palmer,2 Richard F Pollock21Astellas Pharma Europe, Chertsey, UK; 2Ossian Health Economics and Communications, Basel, SwitzerlandBackground and aims: Advagraf is a once-daily prolonged-release formulation of tacrolimus with proven noninferiority to Prograf, a twice-daily immediate-release formulation of tacrolimus, in biopsy-proven acute rejection, graft survival and patient survival in renal transplant recipients. Advagraf is associated with improved adherence compared with Prograf, which may ultimately improve long-term outcomes. The present study assessed the budget impact of switching patients from Prograf to Advagraf in the UK.Materials and methods: A budget-impact model was constructed based on published data on acute rejection, graft failure, and mortality in the UK setting. Patients were assumed to convert from Prograf to Advagraf on a 1:1 milligram:milligram basis. In a study comparing the adherence rates between once-daily versus twice-daily formulations of tacrolimus, the proportion of patients taking the prescribed number of daily doses was 88.2% in Advagraf patients and 78.8% in Prograf patients. The model applied a relative risk of graft failure of 3.47 to nonadherent patients based on data from a 2004 meta-analysis (based on graft-failure rates of 1.3%–40.0% in adherent patients, compared with 6.1%–100% in nonadherent patients. Cost data were taken from the March 2013 British National Formulary and 2012–2013 National Health Service tariff information. The analysis was performed over a 5-year time horizon and future costs were not discounted, in line with International Society for Pharmacoeconomics and Outcomes Research guidelines.Results: Over a 5-year time horizon, the mean cost per patient (including tacrolimus, concomitant immunosuppressive medications, dialysis after graft failure, and treatment for acute rejection was £29,328 (standard deviation [SD] £2,844 for Advagraf

  9. Patients Provide Recommendations for Improving Patient Satisfaction.

    Science.gov (United States)

    Moore, Angelo D; Hamilton, Jill B; Krusel, Jessica L; Moore, LeeAntoinette G; Pierre-Louis, Bosny J

    2016-04-01

    National Committee for Quality Assurance recommends patient-centered medical homes incorporate input from patient populations; however, many health care organizations do not. This qualitative study used two open-ended questions from 148 active duty Army Soldiers and their family members to illicit recommendations for primary care providers and clinic leadership that would improve their health care experiences. Content analysis and descriptive statistics were used to analyze responses. Participant responses were related to four major themes: Access to Care, Interpersonal Interaction, Satisfaction of Care, and Quality of Care. Participants were overall satisfied with their care; however, spending less time waiting for appointments and to see the provider or specialist were the most frequently requested improvements related to Access to Care. For Interpersonal Interaction, 82% of the responses recommended that providers be more attentive listeners, courteous, patient, caring, and respectful. Decreasing wait times and improving interpersonal skills would improve health care experiences and patient satisfaction. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

  10. Effect of concomitant administration of nifedipine and tacrolimus on the development of gingival overgrowth in rats

    Directory of Open Access Journals (Sweden)

    Sheng-Yi Chen

    2015-03-01

    Conclusion: Gingival overgrowth could be induced either by nifedipine or by tacrolimus, although the extent of gingival overgrowth induced by tacrolimus would be less than that by nifedipine. However, a concomitant administration of nifedipine and tacrolimus did not aggravate the induced gingival overgrowth.

  11. Post-Transplant Cyclophosphamide and Tacrolimus-Mycophenolate Mofetil Combination Prevents Graft-versus-Host Disease in Allogeneic Peripheral Blood Hematopoietic Cell Transplantation from HLA-Matched Donors.

    Science.gov (United States)

    Carnevale-Schianca, Fabrizio; Caravelli, Daniela; Gallo, Susanna; Coha, Valentina; D'Ambrosio, Lorenzo; Vassallo, Elena; Fizzotti, Marco; Nesi, Francesca; Gioeni, Luisa; Berger, Massimo; Polo, Alessandra; Gammaitoni, Loretta; Becco, Paolo; Giraudo, Lidia; Mangioni, Monica; Sangiolo, Dario; Grignani, Giovanni; Rota-Scalabrini, Delia; Sottile, Antonino; Fagioli, Franca; Aglietta, Massimo

    2017-03-01

    Allogeneic hematopoietic cell transplant (HCT) remains the only curative therapy for many hematologic malignancies but it is limited by high nonrelapse mortality (NRM), primarily from unpredictable control of graft-versus-host disease (GVHD). Recently, post-transplant cyclophosphamide demonstrated improved GVHD control in allogeneic bone marrow HCT. Here we explore cyclophosphamide in allogeneic peripheral blood stem cell transplantation (alloPBSCT). Patients with high-risk hematologic malignancies received alloPBSCT from HLA-matched unrelated/related donors. GVHD prophylaxis included combination post-HCT cyclophosphamide 50 mg/kg (days +3 and +4) and tacrolimus/mofetil mycophenolate (T/MMF) (day +5 forward). The primary objective was the cumulative incidence of acute and chronic GVHD. Between March 2011 and May 2015, 35 consecutive patients received the proposed regimen. MMF was stopped in all patients at day +28; the median discontinuation of tacrolimus was day +113. Acute and chronic GVHD cumulative incidences were 17% and 7%, respectively, with no grade IV GVHD events, only 2 patients requiring chronic GVHD immunosuppression control, and no deaths from GVHD. Two-year NRM, overall survival, event-free survival, and chronic GVHD event-free survival rates were 3%, 77%, 54%, and 49%, respectively. The graft-versus-tumor effect was maintained as 5 of 15 patients (33%) who received HCT with evidence of disease experienced further disease response. A post-transplant cyclophosphamide + T/MMF combination strategy effectively prevented acute and chronic GVHD after alloPBSCT from HLA-matched donors and achieved an unprecedented low NRM without losing efficacy in disease control or impaired development of the graft-versus-tumor effect. This trial is registered at clinicaltrials.gov as NCT02300571. Copyright © 2017 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  12. COMPARATIVE STUDY OF TOPICAL MOMETASONE FUROATE 0.1%, TOPICAL 0.03% TACROLIMUS, TOPICAL BASIC FIBROBLAST GROWTH FACTOR (bFGF IN CHILDHOOD VITILIGO

    Directory of Open Access Journals (Sweden)

    Kavitha S. B

    2017-08-01

    Full Text Available BACKGROUND Vitiligo, the commonest of all pigmentary disorders, is an idiopathic, acquired cutaneous achromia, characterised by circumscribed, chalky white macules. It may also involve the pigment epithelium of the eyes, the inner ear and the leptomeninges. Although, vitiligo can begin at any age, it develops before the age of 20 years in 50% of the patients and before the age of 10 years in 25% of patients. MATERIALS AND METHODS The study was conducted for a period of one year with 6 months active intervention. A group of 60 consecutive children attending the outpatient Department of Dermatology were included in this study. The same patients were acting as controls. RESULTS Grade 4 response was seen in 12 cases (60% who were on mometasone (VV-20%, focal-30%, segmental-10%, in 10 cases (50% on tacrolimus (VV-20%, focal-30% and in 4 cases (20% on bFGF (focal. Lesions on the face and neck showed grade 4 response in 16 cases (mometasone-8, tacrolimus-6 and bFGF-2, extremities in 6 cases. On the whole grade, 4 response was observed more with mometasone (60% followed by tacrolimus (50%. Grade 3 response was observed with bFGF (30%. CONCLUSION Topical mometasone was very effective among the 3 drugs used in childhood vitiligo showing grade 4 repigmentation in all types of vitiligo except mucosal vitiligo. Tacrolimus proved almost as effective as mometasone to restore skin colour in lesions of vitiligo in children. Because it does not produce atrophy or other adverse effects, tacrolimus may be very useful for younger patients, and for sensitive areas of the skin such as eyelids, it should be considered in other skin disorders currently treated with topical steroids for prolonged periods. Topical basic fibroblast growth factor though less effective than mometasone and tacrolimus, but can be tried as initial therapy in resistant cases such as segmental vitiligo as initial therapy of small vitiligo patches when physicians may not like to initiate high risk

  13. Update on the clinical utility of once-daily tacrolimus in the management of transplantation

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    Revollo J

    2015-05-01

    Full Text Available Jane Revollo Department of Pharmacy, Jackson Memorial Hospital, University of Miami Leonard M Miller School of Medicine Miami, FL, USAThe review by Posadas Salas and Srinivas of the clinical utility of once-daily tacrolimus formulations in the management of transplant patients1 was timely and relevant. It is worth noting, however, the data were presented in a way that overlooked several key differences between two distinct once-daily tacrolimus formulations. These formulations differ in bioavailability, Cmax, Tmax, dose required to achieve target trough levels, and time to reach target trough. The specific formulation and dosing information of one product was detailed in this review (described as modified release 4 [MR-4]; Astagraf®, Astellas Pharma Inc., Tokyo, Japan, but no formulation or dosing details were provided for a very different once-daily tacrolimus formulation (LCP-Tacro™; Veloxis Pharmaceuticals A/S, Hørsholm, Denmark for which a thorough review was recently published.2 The latter product is currently approved in Europe and under review by the US Food and Drug Administration in the US. In presenting data in this review, the authors did not identify which product was investigated in each of the studies discussed. This could easily lead to misinterpretation of results or erroneous conclusions, ie, that both once-daily formulations are the same. In fact, a careful parsing of the data clearly demonstrates that they are not equivalent. Misunderstanding of this point could have a potentially serious impact on appropriate dosing, safety, and patient management in the post-transplant setting. Differentiation between the two products is needed to clarify what appear to be conflicting results of the studies presented in this review.View original paper by Posadas Salas and Srinivas

  14. Orthogeriatric care: improving patient outcomes

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    Tarazona-Santabalbina FJ

    2016-06-01

    Full Text Available Francisco José Tarazona-Santabalbina,1,2 Ángel Belenguer-Varea,1,2 Eduardo Rovira,1,2 David Cuesta-Peredó1,21Geriatric Medicine Unit, Internal Medicine Department, Hospital Universitario de la Ribera, 2Medical School, Universidad Católica de Valencia San vicente Mártir, Valencia, SpainAbstract: Hip fractures are a very serious socio-economic problem in western countries. Since the 1950s, orthogeriatric units have introduced improvements in the care of geriatric patients admitted to hospital because of hip fractures. During this period, these units have reduced mean hospital stays, number of complications, and both in-hospital mortality and mortality over the middle term after hospital discharge, along with improvements in the quality of care and a reduction in costs. Likewise, a recent clinical trial has reported greater functional gains among the affected patients. Studies in this field have identified the prognostic factors present upon admission or manifesting themselves during admission and that increase the risk of patient mortality or disability. In addition, improved care afforded by orthogeriatric units has proved to reduce costs. Nevertheless, a number of management issues remain to be clarified, such as the optimum anesthetic, analgesic, and thromboprophylactic protocols; the type of diagnostic and therapeutic approach best suited to patients with cognitive problems; or the efficiency of the programs used in convalescence units or in home rehabilitation care. Randomized clinical trials are needed to consolidate the evidence in this regard. Keywords: hip fractures, geriatric assessment, orthogeriatric care, recovery of function, mortality

  15. Tacrolimus versus cyclosporin as primary immunosuppression for lung transplant recipients

    DEFF Research Database (Denmark)

    Penninga, Luit; Penninga, Ida Elisabeth Irene; Møller, Christian H

    2013-01-01

    Lung transplantation is a well-accepted treatment for people with most end-stage lung diseases. Although both tacrolimus and cyclosporin are used as primary immunosuppressive agents in lung transplant recipients, it is unclear which of these drugs is better in reducing rejection and death without...

  16. Atopic dermatitis: tacrolimus vs. topical corticosteroid use | Langa ...

    African Journals Online (AJOL)

    Despite this, the US Food and Drug Administration (FDA) black box warning of possible malignancies has resulted in much debate among experts. The main focus of this article is to compare the safety and efficacy of topical corticosteroids to calcineurin inhibitors, particularly tacrolimus. Furthermore, the aim is to evaluate ...

  17. Gut microbiota and tacrolimus dosing in kidney transplantation.

    Directory of Open Access Journals (Sweden)

    John R Lee

    Full Text Available Tacrolimus dosing to establish therapeutic levels in recipients of organ transplants is a challenging task because of much interpatient and intrapatient variability in drug absorption, metabolism, and disposition. In view of the reported impact of gut microbial species on drug metabolism, we investigated the relationship between the gut microbiota and tacrolimus dosing requirements in this pilot study of adult kidney transplant recipients. Serial fecal specimens were collected during the first month of transplantation from 19 kidney transplant recipients who either required a 50% increase from initial tacrolimus dosing during the first month of transplantation (Dose Escalation Group, n=5 or did not require such an increase (Dose Stable Group, n=14. We characterized bacterial composition in the fecal specimens by deep sequencing of the PCR amplified 16S rRNA V4-V5 region and we investigated the hypothesis that gut microbial composition is associated with tacrolimus dosing requirements. Initial tacrolimus dosing was similar in the Dose Escalation Group and in the Stable Group (4.2 ± 1.1 mg/day vs. 3.8 ± 0.8 mg/day, respectively, P=0.61, two-way between-group ANOVA using contrasts but became higher in the Dose Escalation Group than in the Dose Stable Group by the end of the first transplantation month (9.6 ± 2.4 mg/day vs. 3.3 ± 1.5 mg/day, respectively, P<0.001. Our systematic characterization of the gut microbial composition identified that fecal Faecalibacterium prausnitzii abundance in the first week of transplantation was 11.8% in the Dose Escalation Group and 0.8% in the Dose Stable Group (P=0.002, Wilcoxon Rank Sum test, P<0.05 after Benjamini-Hochberg correction for multiple hypotheses. Fecal Faecalibacterium prausnitzii abundance in the first week of transplantation was positively correlated with future tacrolimus dosing at 1 month (R=0.57, P=0.01 and had a coefficient ± standard error of 1.0 ± 0.6 (P=0.08 after multivariable linear

  18. Dried blood spot measurement: application in tacrolimus monitoring using limited sampling strategy and abbreviated AUC estimation.

    Science.gov (United States)

    Cheung, Chi Yuen; van der Heijden, Jaques; Hoogtanders, Karin; Christiaans, Maarten; Liu, Yan Lun; Chan, Yiu Han; Choi, Koon Shing; van de Plas, Afke; Shek, Chi Chung; Chau, Ka Foon; Li, Chun Sang; van Hooff, Johannes; Stolk, Leo

    2008-02-01

    Dried blood spot (DBS) sampling and high-performance liquid chromatography tandem-mass spectrometry have been developed in monitoring tacrolimus levels. Our center favors the use of limited sampling strategy and abbreviated formula to estimate the area under concentration-time curve (AUC(0-12)). However, it is inconvenient for patients because they have to wait in the center for blood sampling. We investigated the application of DBS method in tacrolimus level monitoring using limited sampling strategy and abbreviated AUC estimation approach. Duplicate venous samples were obtained at each time point (C(0), C(2), and C(4)). To determine the stability of blood samples, one venous sample was sent to our laboratory immediately. The other duplicate venous samples, together with simultaneous fingerprick blood samples, were sent to the University of Maastricht in the Netherlands. Thirty six patients were recruited and 108 sets of blood samples were collected. There was a highly significant relationship between AUC(0-12), estimated from venous blood samples, and fingerprick blood samples (r(2) = 0.96, P AUC(0-12) strategy as drug monitoring.

  19. Can we improve patient safety?

    Science.gov (United States)

    Corbally, Martin Thomas

    2014-01-01

    Despite greater awareness of patient safety issues especially in the operating room and the widespread implementation of surgical time out World Health Organization (WHO), errors, especially wrong site surgery, continue. Most such errors are due to lapses in communication where decision makers fail to consult or confirm operative findings but worryingly where parental concerns over the planned procedure are ignored or not followed through. The WHO Surgical Pause/Time Out aims to capture these errors and prevent them, but the combination of human error and complex hospital environments can overwhelm even robust safety structures and simple common sense. Parents are the ultimate repository of information on their child's condition and planned surgery but are traditionally excluded from the process of Surgical Pause and Time Out, perhaps to avoid additional stress. In addition, surgeons, like pilots, are subject to the phenomenon of "plan-continue-fail" with potentially disastrous outcomes. If we wish to improve patient safety during surgery and avoid wrong site errors then we must include parents in the Surgical Pause/Time Out. A recent pilot study has shown that neither staff nor parents found it added to their stress, but, moreover, 100% of parents considered that it should be a mandatory component of the Surgical Pause nor does it add to the stress of surgery. Surgeons should be required to confirm that the planned procedure is in keeping with the operative findings especially in extirpative surgery and this "step back" should be incorporated into the standard Surgical Pause. It is clear that we must improve patient safety further and these simple measures should add to that potential.

  20. Differential Antitumoral Properties and Renal-Associated Tissue Damage Induced by Tacrolimus and Mammalian Target of Rapamycin Inhibitors in Hepatocarcinoma: In Vitro and In Vivo Studies.

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    Elena Navarro-Villarán

    Full Text Available Orthotopic liver transplantation (OLT is the recommended treatment for patients at early stages of hepatocarcinoma (HCC with potential portal hypertension and/or bilirubinemia, but without vascular-associated diseases. The patients are receiving immunosuppressive therapy to reduce graft rejection, but differential side effects have been related to calcineurin and mTOR inhibitor administration regarding tumor recurrence and nephrotoxicity. The in vitro studies showed that Tacrolimus exerted a more potent pro-apoptotic effect than Everolimus (Huh 7>Hep 3B>HepG2, being sirolimus only active in Hep3B cell line. Tacrolimus and Everolimus exerted potent antiproliferative properties in Huh 7 and Hep3B in which cells Sirolimus was inactive. Interestingly, Tacrolimus- and Everolimus-dependent G0/G1 cell accumulation occurred as a consequence of drastic reduction in S, as well as in S and G2+M phases, respectively. The in vivo studies support data on the more effective antitumoral properties of Everolimus, eventual risk of pro-angiogenic tumoral properties and nephrotoxicity of Tacrolimus, and pro-proliferative properties of Sirolimus in tumors developed in nude mice.

  1. Time to reach tacrolimus maximum blood concentration,mean residence time, and acute renal allograft rejection: an open-label, prospective, pharmacokinetic study in adult recipients.

    Science.gov (United States)

    Kuypers, Dirk R J; Vanrenterghem, Yves

    2004-11-01

    The aims of this study were to determine whether disposition-related pharmacokinetic parameters such as T(max) and mean residence time (MRT) could be used as predictors of clinical efficacy of tacrolimus in renal transplant recipients, and to what extent these parameters would be influenced by clinical variables. We previously demonstrated, in a prospective pharmacokinetic study in de novo renal allograft recipients, that patients who experienced early acute rejection did not differ from patients free from rejection in terms of tacrolimus pharmacokinetic exposure parameters (dose interval AUC, preadministration trough blood concentration, C(max), dose). However, recipients with acute rejection reached mean (SD) tacrolimus T(max) significantly faster than those who were free from rejection (0.96 [0.56] hour vs 1.77 [1.06] hours; P clearance nor T(1/2) could explain this unusual finding, we used data from the previous study to calculate MRT from the concentration-time curves. As part of the previous study, 100 patients (59 male, 41 female; mean [SD] age, 51.4 [13.8] years;age range, 20-75 years) were enrolled in the study The calculated MRT was significantly shorter in recipients with acute allograft rejection (11.32 [031] hours vs 11.52 [028] hours; P = 0.02), just like T(max) was an independent risk factor for acute rejection in a multivariate logistic regression model (odds ratio, 0.092 [95% CI, 0.014-0.629]; P = 0.01). Analyzing the impact of demographic, transplantation-related, and biochemical variables on MRT, we found that increasing serum albumin and hematocrit concentrations were associated with a prolonged MRT (P calculated MRT were associated with a higher incidence of early acute graft rejection. These findings suggest that a shorter transit time of tacrolimus in certain tissue compartments, rather than failure to obtain a maximum absolute tacrolimus blood concentration, might lead to inadequate immunosuppression early after transplantation.

  2. Use of tacrolimus in rescue therapy of acute and chronic rejection in liver transplantation Uso de tacrolimus na terapia de resgate de rejeições agudas e crônicas no transplante de fígado

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    Fabricio Ferreira Coelho

    2003-01-01

    Full Text Available PURPOSE: To study the indications and results of tacrolimus as rescue therapy for acute cellular or chronic rejection in liver transplantation. PATIENTS AND METHODS: Eighteen liver transplant recipients who underwent rescue therapy with tacrolimus between March 1995 and August 1999 were retrospectively studied. The treatment indication, patients, and graft situation were recorded as of October 31st, 1999. The response to tacrolimus was defined as patient survival with a functional graft and histological reversal of acute cellular, or for chronic rejection, bilirubin serum levels decreasing to up to twice the upper normal limit. RESULTS: Fourteen cases (77.8% presented a good response. The response rate for the different indications was: (1 acute cellular + sepsis - 0/1 case; (2 recurrent acute cellular - 1/1 case; (3 OKT3-resistant acute cellular - 2/2 cases; (4 steroid-resistant acute cellular + active viral infection - 3/3 cases; (5 chronic rejection - 8/11 cases (72.7% response rate. The 4 patients who did not respond died. CONCLUSION: Tacrolimus rescue therapy was successful in most cases of acute cellular and chronic rejection in liver transplantation.OBJETIVO: Estudar os critérios de indicação e o resultado do uso de tacrolimus na terapia de resgate de rejeições agudas ou crônicas no transplante de fígado. CASUÍSTICA E MÉTODO: Foram estudados 18 pacientes transplantados de fígado, submetidos a terapia de resgate com tacrolimus entre março de 1995 e agosto de 1999. Foram registradas a indicação do tratamento e a situação de pacientes e enxertos em 31/10/1999. Considerou-se "respondendores" pacientes vivos, com enxerto funcionante e regressão histológica da terapia de resgate de rejeições agudas, ou com bilirrubina até 2 vezes o valor normal, no caso de terapia de resgate de rejeições crônicas. RESULTADO: Observou-se resposta em 14 casos (77,8%. A taxa de resposta nas diferentes indicações foi: (1 terapia de resgate

  3. A simple and highly sensitive on-line column extraction liquid chromatography-tandem mass spectrometry method for the determination of protein-unbound tacrolimus in human plasma samples.

    Science.gov (United States)

    Bittersohl, Heike; Schniedewind, Björn; Christians, Uwe; Luppa, Peter B

    2018-04-27

    Therapeutic drug monitoring (TDM) of the immunosuppressive drug tacrolimus is essential to avoid side effects and rejection of the allograft after transplantation. In the blood circulation, tacrolimus is largely located inside erythrocytes or bound to plasma proteins and less than 0.1% is protein-unbound (free). One basic principle of clinical pharmacology is that only free drug is pharmacologically active and monitoring this portion has the potential to better reflect the drug effect than conventional measurements of total tacrolimus in whole blood. To address this, a highly sensitive and straightforward on-line liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed, validated and applied to patient plasma samples. The sample preparation included ultracentrifugation and addition of the stable isotope labeled drug analogue D2,13C-tacrolimus, followed by on-line sample extraction and measurement using a Sciex QTRAP ® 6500 in the multiple reaction monitoring mode. Due to very low concentrations of protein-unbound tacrolimus, it was important to develop a highly sensitive, precise and accurate assay. Here, we first report the efficient formation of tacrolimus lithium adduct ions, which greatly increased assay sensitivity. A lower limit of quantification (LLOQ) of 1 pg/mL (10 fg on column) was achieved and the assay was linear between 1 and 200 pg/mL. There was no carry-over detected. The inaccuracy ranged from -9.8 to 7.4% and the greatest imprecision was 7.5%. The matrix factor was found to be smaller than 1.1%. In summary, this method represents a suitable tool to investigate the potential clinical value of free tacrolimus monitoring in organ transplant recipients. Copyright © 2018 Elsevier B.V. All rights reserved.

  4. Effects of tacrolimus on action potential configuration and transmembrane ion currents in canine ventricular cells.

    Science.gov (United States)

    Szabó, László; Szentandrássy, Norbert; Kistamás, Kornél; Hegyi, Bence; Ruzsnavszky, Ferenc; Váczi, Krisztina; Horváth, Balázs; Magyar, János; Bányász, Tamás; Pál, Balázs; Nánási, Péter P

    2013-03-01

    Tacrolimus is a commonly used immunosuppressive agent which causes cardiovascular complications, e.g., hypertension and hypertrophic cardiomyopathy. In spite of it, there is little information on the cellular cardiac effects of the immunosuppressive agent tacrolimus in larger mammals. In the present study, therefore, the concentration-dependent effects of tacrolimus on action potential morphology and the underlying ion currents were studied in canine ventricular cardiomyocytes. Standard microelectrode, conventional whole cell patch clamp, and action potential voltage clamp techniques were applied in myocytes enzymatically dispersed from canine ventricular myocardium. Tacrolimus (3-30 μM) caused a concentration-dependent reduction of maximum velocity of depolarization and repolarization, action potential amplitude, phase-1 repolarization, action potential duration, and plateau potential, while no significant change in the resting membrane potential was observed. Conventional voltage clamp experiments revealed that tacrolimus concentrations ≥3 μM blocked a variety of ion currents, including I(Ca), I(to), I(K1), I(Kr), and I(Ks). Similar results were obtained under action potential voltage clamp conditions. These effects of tacrolimus developed rapidly and were fully reversible upon washout. The blockade of inward currents with the concomitant shortening of action potential duration in canine myocytes is the opposite of those observed previously with tacrolimus in small rodents. It is concluded that although tacrolimus blocks several ion channels at higher concentrations, there is no risk of direct interaction with cardiac ion channels when applying tacrolimus in therapeutic concentrations.

  5. Tacrolimus is a class II low-solubility high-permeability drug: the effect of P-glycoprotein efflux on regional permeability of tacrolimus in rats.

    Science.gov (United States)

    Tamura, Shigeki; Ohike, Atsuo; Ibuki, Rinta; Amidon, Gordon L; Yamashita, Shinji

    2002-03-01

    The objective of this study is to investigate the role of P-glycoprotein (P-gp), a membrane efflux pump associated with multidrug resistance (MDR) and a known substrate for tacrolimus, in determining the regional intestinal permeability of tacrolimus in rats. Thus, isolated segments of rat jejunum, ileum, or colon were perfused with tacrolimus solutions containing polyethoxylated hydrogenated castor oil 60 surfactant, and with or without verapamil, a P-gp substrate used to reverse the MDR phenotype. The results indicated that the intrinsic permeability of tacrolimus in the jejunum, calculated on the basis of the concentration of non-micellized free tacrolimus, was quite high ( approximately 1.4 x 10(-4) cm/s). The apparent permeability (P(app)) in the jejunum was unaffected by the presence of verapamil; however, the P(app) in the ileum and the colon increased significantly in the presence of verapamil and were similar to the values observed in the jejunum. The results suggest that systemic absorption of tacrolimus from the gastrointestinal tract could be significantly affected by P-gp efflux mechanisms. It is also possible that differences in P-gp function at various intestinal sites in a subject or at a given intestinal site in various subjects could lead to large intra- and interindividual variability in bioavailability of tacrolimus following oral administration. Copyright 2002 Wiley-Liss, Inc. and the American Pharmaceutical Association .

  6. Treatment of patients with severe autoimmune hepatitis

    DEFF Research Database (Denmark)

    Larsen, Finn Stolze

    2008-01-01

    Autoimmune hepatitis (AIH) is a progressive inflammatory diseases of unknown origin that is characterised by a necro-inflammatory and fibrotic process and may result in liver failure or uncompensated liver cirrhosis. Normally AIH is responsive to immunosuppressive therapy, and treatment aims...... and tacrolimus) might salvage patients from transplantation. Mycophenolate mofetil may also improve liver tests and reduce the requirement for corticosteroids. Besides, sirolimus is effective for treatment of de novo autoimmune hepatitis that sometimes develops after liver transplantation. Initial experience...

  7. Tacrolimus increases Nox4 expression in human renal fibroblasts and induces fibrosis-related genes by aberrant TGF-beta receptor signalling.

    Directory of Open Access Journals (Sweden)

    Georg Kern

    Full Text Available Chronic nephrotoxicity of immunosuppressives is one of the main limiting factors in the long-term outcome of kidney transplants, leading to tissue fibrosis and ultimate organ failure. The cytokine TGF-β is considered a key factor in this process. In the human renal fibroblast cell line TK-173, the macrolide calcineurin inhibitor tacrolimus (FK-506 induced TGF-β-like effects, manifested by increased expression of NAD(PH-oxidase 4 (Nox4, transgelin, tropomyosin 1, and procollagen α1(V mRNA after three days. The macrolide mTOR inhibitor rapamycin had similar effects, while cyclosporine A did not induce fibrose-related genes. Concentration dependence curves were sigmoid, where mRNA expression was induced already at low nanomolar levels of tacrolimus, and reached saturation at 100-300 nM. The effects were independent of extracellular TGF-β as confirmed by the use of neutralizing antibodies, and thus most likely caused by aberrant TGF-β receptor signaling, where binding of tacrolimus to the regulatory FKBP12 protein results in a "leaky" TGF-β receptor. The myofibroblast marker α-smooth muscle actin was neither induced by tacrolimus nor by TGF-β1, indicating an incomplete activation of TK-173 fibroblasts under culture conditions. Tacrolimus- and TGF-β1-induced Nox4 protein upregulation was confirmed by Western blotting, and was accompanied by a rise in intracellular H2O2 concentration. Si-RNA mediated knock-down of Nox4 expression prevented up-regulation of procollagen α1(V mRNA in tacrolimus-treated cells, but induced procollagen α1(V expression in control cells. Nox4 knock-down had no significant effect on the other genes tested. TGF-β is a key molecule in fibrosis, and the constant activation of aberrant receptor signaling by tacrolimus might contribute to the long-term development of interstitial kidney fibrosis in immunosuppressed patients. Nox4 levels possibly play a regulatory role in these processes.

  8. The incidence of post-transplant cancer among kidney transplant recipients is associated with the level of tacrolimus exposure during the first year after transplantation.

    Science.gov (United States)

    Lichtenberg, Shelly; Rahamimov, Ruth; Green, Hefziba; Fox, Benjamin D; Mor, Eytan; Gafter, Uzi; Chagnac, Avry; Rozen-Zvi, Benaya

    2017-07-01

    Immunosuppressive therapy plays a major role in the development of post-transplant cancer. In this nested case-control study of kidney transplant recipients (KTRs), we investigated whether the incidence of post-transplant cancer is associated with the level of tacrolimus exposure over time. We screened the Rabin Medical Center database for adults who received kidney transplants between 2001 and 2014 and developed post-transplant cancer (excluding basal and squamous cell skin cancers). They were matched against KTRs without cancer. All patients received a maintenance immunosuppressive treatment with tacrolimus, mycophenolate mofetil and corticosteroids. The degree of exposure to tacrolimus was estimated as the time-weighted average (tTWA) value of tacrolimus blood levels. The tTWA was calculated as the area under the curve divided by time at 1, 6, and 12 months after transplantation and at time of cancer diagnosis. Thirty-two cases were matched against 64 controls. tTWA values above 11 ng/mL at 6 and 12 months after transplantation were associated with odds ratio (OR) of 3.1 (95% CI 1.1-9) and 11.7 (95% CI = 1.3-106), respectively, for post-transplant cancer; and with OR of 5.2 (95% CI 1.3-20.5) and 14.1 (95% CI = 1.5-134.3), respectively, for cancer diagnosed more than 3 years after transplantation. Exposure to a tacrolimus time-weighted average level above 11 ng/mL at 6 or 12 months after kidney transplantation is associated with an increased risk of developing cancer.

  9. Researchers' Roles in Patient Safety Improvement.

    Science.gov (United States)

    Pietikäinen, Elina; Reiman, Teemu; Heikkilä, Jouko; Macchi, Luigi

    2016-03-01

    In this article, we explore how researchers can contribute to patient safety improvement. We aim to expand the instrumental role researchers have often occupied in relation to patient safety improvement. We reflect on our own improvement model and experiences as patient safety researchers in an ongoing Finnish multi-actor innovation project through self-reflective narration. Our own patient safety improvement model can be described as systemic. Based on the purpose of the innovation project, our improvement model, and the improvement models of the other actors in the project, we have carried out a wide range of activities. Our activities can be summarized in 8 overlapping patient safety improvement roles: modeler, influencer, supplier, producer, ideator, reflector, facilitator, and negotiator. When working side by side with "practice," researchers are offered and engage in several different activities. The way researchers contribute to patient safety improvement and balance between different roles depends on the purpose of the study, as well as on the underlying patient safety improvement models. Different patient safety research paradigms seem to emphasize different improvement roles, and thus, they also face different challenges. Open reflection on the underlying improvement models and roles can help researchers with different backgrounds-as well as other actors involved in patient safety improvement-in structuring their work and collaborating productively.

  10. Relative bioavailability of single doses of prolonged-release tacrolimus administered as a suspension, orally or via a nasogastric tube, compared with intact capsules: a phase 1 study in healthy participants.

    Science.gov (United States)

    Undre, Nasrullah; Dickinson, James

    2017-04-04

    Tacrolimus, an immunosuppressant widely used in solid organ transplantation, is available as a prolonged-release capsule for once-daily oral administration. In the immediate postsurgical period, if patients cannot take intact capsules orally, tacrolimus therapy is often initiated as a suspension of the capsule contents, delivered orally or via a nasogastric tube. This study evaluated the relative bioavailability of prolonged-release tacrolimus suspension versus intact capsules in healthy participants. A phase 1, open-label, single-dose, cross-over study. A single clinical research unit. In total, 20 male participants, 18-55 years old, entered and completed the study. All participants received nasogastric administration of tacrolimus 10 mg suspension in treatment period 1, with randomisation to oral administration of suspension or intact capsules in periods 2 and 3. Blood concentration-time profile over 144 hours was used to estimate pharmacokinetic parameters. Primary end point: relative bioavailability of prolonged-release intact capsule versus oral or nasogastric administration of prolonged-release tacrolimus suspension (area under the concentration-time curve (AUC) from time 0 to infinity post-tacrolimus dose (AUC 0-∞ ); AUC measured until the last quantifiable concentration (AUC 0-tz ); maximum observed concentration (C max ); time to C max (T max )). Tolerability was assessed throughout the study. Relative bioavailability of prolonged-release tacrolimus suspension administered orally was similar to intact capsules, with a ratio of least-square means for AUC 0-tz and AUC 0-∞ of 1.05 (90% CI 0.96 to 1.14). Bioavailability was lower with suspension administered via a nasogastric tube versus intact capsules (17%; ratio 0.83; CI 0.76 to 0.92). C max was higher for oral and nasogastric suspension (30% and 28%, respectively), and median T max was shorter (difference 1.0 and 1.5 hours postdose, respectively) versus intact capsules (2.0 hours). Single 10

  11. Early Conversion from Tacrolimus to Belatacept in a Highly Sensitized Renal Allograft Recipient with Calcineurin Inhibitor-Induced de novo Post-Transplant Hemolytic Uremic Syndrome

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    Vasishta S. Tatapudi

    2018-01-01

    Full Text Available Background: Kidney transplantation is the first-line therapy for patients with end-stage renal disease since it offers greater long-term survival and improved quality of life when compared to dialysis. The advent of calcineurin inhibitor (CNI-based maintenance immunosuppression has led to a clinically significant decline in the rate of acute rejection and better short-term graft survival rates. However, these gains have not translated into improvement in long-term graft survival. CNI-related nephrotoxicity and metabolic side effects are thought to be partly responsible for this. Case Presentation: Here, we report the conversion of a highly sensitized renal transplant recipient with pretransplant donor-specific antibodies from tacrolimus to belatacept within 1 week of transplantation. This substitution was necessitated by the diagnosis of CNI-induced de novo post-transplant hemolytic uremic syndrome. Conclusion: Belatacept is a novel costimulation blocker that is devoid of the nephrotoxic properties of CNIs and has been shown to positively impact long-term graft survival and preserve renal allograft function in low-immunologic-risk kidney transplant recipients. Data regarding its use in patients who are broadly sensitized to human leukocyte antigens are scarce, and the increased risk of rejection associated with belatacept has been a deterrent to more widespread use of this immunosuppressive agent. This case serves as an example of a highly sensitized patient that has been successfully converted to a belatacept-based CNI-free regimen.

  12. Topical tacrolimus in combination with simulated solar radiation does not enhance photocarcinogenesis in hairless mice

    DEFF Research Database (Denmark)

    Lerche, C.M.; Philipsen, P.A.; Poulsen, T.

    2008-01-01

    tacrolimus ointment on squamous cell carcinoma formation in hairless female C3.Cg/TifBomTac immunocompetent mice exposed to solar simulated radiation (SSR). In a first experiment, mice (n = 200) had tacrolimus applied on their dorsal skin three times weekly followed by SSR (2, 4 or 6 standard erythema doses...

  13. The Pharmacogenetics of Tacrolimus in Corticosteroid-Sparse Pediatric and Adult Kidney Transplant Recipients

    DEFF Research Database (Denmark)

    Juul Madsen, Mads; Bergmann, Troels K; Brøsen, Kim

    2017-01-01

    INTRODUCTION: Tacrolimus is a calcineurin inhibitor used as an immunosuppressant drug in solid organ transplantation, and is mainly metabolized by cytochrome P450 (CYP) 3A4 and CYP3A5. Studies have shown an association between the CYP3A5 genotype and tacrolimus dose-adjusted trough concentrations...

  14. Safety of reduced dose of mycophenolate mofetil combined with tacrolimus in living-donor liver transplantation

    Directory of Open Access Journals (Sweden)

    Hyeyoung Kim

    2014-09-01

    Full Text Available Background/AimsThe dose of mycophenolate mofetil (MMF has been reduced in Asia due to side effects associated with the conventional fixed dose of 2-3 g/day. We aimed to determine the pharmacokinetics of a reduced dose of MMF and to validate its feasibility in combination with tacrolimus in living-donor liver transplantation (LDLT.MethodsTwo sequential studies were performed in adult LDLT between October 2009 and 2011. First, we performed a prospective pharmacokinetic study in 15 recipients. We measured the area under the curve from 0 to 12 hours (AUC0-12 for mycophenolic acid at postoperative days 7 and 14, and we performed a protocol biopsy before discharge. Second, among 215 recipients, we reviewed 74 patients who were initially administered a reduced dose of MMF (1.0 g/day with tacrolimus (trough, 8-12 ng/mL during the first month, and 5-8 ng/mL thereafter, with a 1-year follow-up. We performed protocol biopsies at 2 weeks and 1 year post-LDLT.ResultsIn the first part of study, AUC0-12 was less than 30 mgh/L in 93.3% of cases. In the second, validating study, 41.9% of the recipients needed dose reduction or cessation due to side effects within the first year after LDLT. At 12 months post-LDLT, 17.6% of the recipients were administered a lower dose of MMF (0.5 g/day, and 16.2% needed permanent cessation due to side effects. The 1- and 12-month rejection-free survival rates were 98.6% and 97.3%, respectively.ConclusionsA reduced dose of MMF was associated with low blood levels compared to the existing recommended therapeutic range. However, reducing the dose of MMF combined with a low level of tacrolimus was feasible clinically, with an excellent short-term outcome in LDLT.

  15. Tacrolimus and mycophenolate mofetil after nonmyeloablative matched-sibling donor allogeneic stem-cell transplantations conditioned with fludarabine and low-dose total body irradiation.

    Science.gov (United States)

    Nieto, Yago; Patton, Nigel; Hawkins, Timothy; Spearing, Ruth; Bearman, Scott I; Jones, Roy B; Shpall, Elizabeth J; Rabinovitch, Rachel; Zeng, Chan; Barón, Anna; McSweeney, Peter A

    2006-02-01

    We evaluated tacrolimus/mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis after a nonmyeloablative stem cell transplantation (NST) from a matched sibling donor (MSD). Thirty-two patients (median age, 57 years) with advanced hematologic malignancies, who were poor candidates for a conventional myeloablative transplantation, received fludarabine (30 mg/m(2), day -4 to day -2), total-body irradiation (TBI) (200 cGy, day 0), infusion of donor peripheral blood progenitor cells (day 0), oral tacrolimus 0.06 mg/kg twice daily (from day 3), and oral MMF at 15 mg/kg twice daily (days 0-+27). Tacrolimus was tapered from day +100 to day +180 in those patients with indolent malignancies (n = 25), and from day +35 to day +56 in those with aggressive tumors (n = 7). Regimen toxicities and myelosuppression were mild, allowing 75% of patients to have entirely outpatient transplantations. One patient (3%) experienced a nonfatal graft rejection. Rates of grades II-IV and III-IV acute GVHD were 15.6% and 3%, respectively. Acute GVHD was diagnosed at median day +78 (range, days +31-+84). Extensive chronic GVHD was observed in 10 of 24 evaluable patients (41.6%) at a median onset of day +198 (range, days +128-+277), either spontaneously (n = 5) or elicited after tumor progression (n = 5). Five patients experienced transplantation-related mortality (TRM) (15.6%) from either acute GVHD-related multiorgan failure (MOF) (n = 3) or infectious complications (n = 2). At median follow-up of 19 months (range, 2-41 months), the overall survival, progression-free survival, and disease-free survival rates are 62.5%, 50%, and 40%, respectively. In conclusion, the use of tacrolimus/MMF after MSD NST is associated with encouraging rates of GVHD control.

  16. Efficacy of topical application of 0.03% tacrolimus eye ointment in the management of allergic conjunctivitis.

    Science.gov (United States)

    Hazarika, Ajit Kumar; Singh, Prodip Kumar

    2015-08-01

    Allergic conjunctivitis is commonly observed eye diseases in Sikkim, India due to the abundance of seasonal pollens, environmental pollutants, and house dust. We evaluated the efficacy of topical 0.03% tacrolimus eye ointment in the management of simple allergic conjunctivitis. A prospective observational study was designed consisting of 41 patients with refractory simple allergic conjunctivitis, whose condition responded very poorly to conventional anti-allergic eye drops (azelastine, olopatadine, chlorpheniramine maleate, sodium chromoglycate). Simple allergic conjunctivitis cases were diagnosed and followed up evaluating both subjective and objective findings (itching, photophobia, tearing, chemosis, conjunctival congestion, tarsal papilla, and eyelid edema). Existing ocular treatment was discontinued at enrolment and 0.03% tacrolimus ointment was applied into the conjunctival sac of the affected eyes twice daily for 4 weeks followed by a 2 weeks washout period. Patients were followed up at the end of 1(st) week, 4(th) week, and at 7(th) week (2 weeks washout period). Symptoms of simple allergic conjunctivitis (itching, tearing and photophobia) were significantly reduced at the end of 1(st) week. Signs such as conjunctival chemosis, congestion, tarsal papillae, and eyelid edema were effectively treated in all cases at the end of 1(st) week. At the end of 4(th) week, all cases were fully cured and none of the patient had any recurrences up to 7(th) week. Mean score at 1(st) day (9.6 ± 3.27) was significantly (P < 0.0001) reduced by 7(th) day (1.35 ± 1.19) of treatment. Topical application of tacrolimus ointment is an excellent alternative to anti-allergic and steroids eye drops for the treatment of simple allergic conjunctivitis as it significantly reduces recurrences.

  17. The ORION study: comparison of two sirolimus-based regimens versus tacrolimus and mycophenolate mofetil in renal allograft recipients.

    Science.gov (United States)

    Flechner, S M; Glyda, M; Cockfield, S; Grinyó, J; Legendre, Ch; Russ, G; Steinberg, S; Wissing, K M; Tai, S S

    2011-08-01

    Safety and efficacy of two sirolimus (SRL)-based regimens were compared with tacrolimus (TAC) and mycophenolate mofetil (MMF). Renal transplantation recipients were randomized to Group 1 (SRL+TAC; week 13 TAC elimination [n = 152]), Group 2 (SRL + MMF [n = 152]) or Group 3 (TAC + MMF [n = 139]). Group 2, with higher-than-expected biopsy-confirmed acute rejections (BCARs), was sponsor-terminated; therefore, Group 2 two-year data were limited. At 1 and 2 years, respectively, graft (Group 1: 92.8%, 88.5%; Group 2: 90.6%, 89.9%; Group 3: 96.2%, 95.4%) and patient (Group 1: 97.3%, 94.4%; Group 2: 95.2%, 94.5%; Group 3: 97.0%, 97.0%) survival rates were similar. One- and 2-year BCAR incidence was: Group 1, 15.2%, 17.4%; Group 2, 31.3%, 32.8%; Group 3, 8.2%, 12.3% (Group 2 vs. 3, p < 0.001). Mean 1- and 2-year modified intent-to-treat glomerular filtration rates (mL/min) were similar. Primary reason for discontinuation was adverse events (Group 1, 34.2%; Group 2, 33.6%; Group 3, 22.3%; p < 0.05). In Groups 1 and 2, delayed wound healing and hyperlipidemia were more frequent. One-year post hoc analysis of new-onset diabetes posttransplantation was greater in TAC recipients (Groups 1 and 3 vs. 2, 17% vs. 6%; p = 0.004). Between-group malignancy rates were similar. The SRL-based regimens were not associated with improved outcomes for kidney transplantation patients. ©2011 The Authors Journal compilation©2011 The American Society of Transplantation and the American Society of Transplant Surgeons.

  18. Patient Education May Improve Perioperative Safety.

    NARCIS (Netherlands)

    de Haan, L.S.; Calsbeek, H; Wolff, André

    2016-01-01

    Importance: There is a growing interest in enabling ways for patients to participate in their own care to improve perioperative safety, but little is known about the effectiveness of interventions enhancing an active patient role. Objective: To evaluate the effect of patient participation on

  19. Can we Improve Patient Safety?

    Directory of Open Access Journals (Sweden)

    Martin Thomas Corbally

    2014-09-01

    Full Text Available Despite greater awareness of patient safety issues especially in the operating room and the widespread implementation of surgical time out (WHO,errors, especially wrong site surgery, continue. Most such errors are due to lapses in communication where decision makers fail to consult or confirm operative findings but worryingly where parental concerns over the planned procedure are ignored or not followed through. The WHO surgical pause / Time Out aims to capture these errors and prevent them but the combination of human error and complex hospital environments can overwhelm even robust safety structures and simple common sense. Parents are the ultimate repository of information on their child's condition and planned surgery but are traditionally excluded from the process of Surgical pause and Time Out perhaps to avoid additional stress. In addition surgeons, like pilots, are subject to the phenomenon of plan continue fail with potentially disastrous outcomes.

  20. Tacrolimus Updated Guidelines through popPK Modeling: How to Benefit More from CYP3A Pre-emptive Genotyping Prior to Kidney Transplantation

    Directory of Open Access Journals (Sweden)

    Jean-Baptiste Woillard

    2017-06-01

    Full Text Available Tacrolimus (Tac is a profoundly effective immunosuppressant that reduces the risk of rejection after solid organ transplantation. However, its use is hampered by its narrow therapeutic window along with its highly variable pharmacological (pharmacokinetic [PK] and pharmacodynamic [PD] profile. Part of this variability is explained by genetic polymorphisms affecting the metabolic pathway. The integration of CYP3A4 and CY3A5 genotype in tacrolimus population-based PK (PopPK modeling approaches has been proven to accurately predict the dose requirement to reach the therapeutic window. The objective of the present study was to develop an accurate PopPK model in a cohort of 59 kidney transplant patients to deliver this information to clinicians in a clear and actionable manner. We conducted a non-parametric non-linear effects PopPK modeling analysis in Pmetrics®. Patients were genotyped for the CYP3A4∗22 and CYP3A5∗3 alleles and were classified into 3 different categories [poor-metabolizers (PM, Intermediate-metabolizers (IM or extensive-metabolizers (EM]. A one-compartment model with double gamma absorption route described very accurately the tacrolimus PK. In covariate analysis, only CYP3A genotype was retained in the final model (Δ-2LL = -73. Our model estimated that tacrolimus concentrations were 33% IC95%[20–26%], 41% IC95%[36–45%] lower in CYP3A IM and EM when compared to PM, respectively. Virtually, we proved that defining different starting doses for PM, IM and EM would be beneficial by ensuring better probability of target concentrations attainment allowing us to define new dosage recommendations according to patient CYP3A genetic profile.

  1. Improving Value for Patients with Eczema.

    Science.gov (United States)

    Block, Julie

    2018-04-01

    Chronic diseases now represent a cost majority in the United States health care system. Contributing factors to rising costs include expensive novel and emerging therapies, under-treatment of disease, under-management of comorbidities, and patient dissatisfaction with care results. Critical to identifying replicable improvement methods is a reliable model to measure value. If we understand value within healthcare consumerism to be equal to a patient's health outcome improvement over costs associated with care (Value=Outcomes/Costs), we can use this equation to measure the improvement of value. Research and literature show that patient activation-the skills and confidence that equip patients to become actively engaged in their health care-impact health outcomes, costs, and patient experience. Reaching patient activation through engagement methods including shared decision-making (SDM) lead to improved value of care received. The National Eczema Association (NEA) Shared Decision-Making Resource Center can be a transformative strategy to measure and evaluate value of health care interventions for eczema patients to advance a value-driven health care system in the United States. Through this Resource Center, NEA will measure patient value through their own perceptions using validated PRO instruments and other patient-generated health data. Assessment of this data will reveal findings that can assist researchers in evaluating the impact this care framework on patient-perceived value across other chronic diseases. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  2. Primary tacrolimus (FK506) therapy and the long-term risk of post-transplant lymphoproliferative disease in pediatric liver transplant recipients.

    Science.gov (United States)

    Cacciarelli, T V; Reyes, J; Jaffe, R; Mazariegos, G V; Jain, A; Fung, J J; Green, M

    2001-10-01

    While the overall incidence of post-transplant lymphoproliferative disease (PTLD) in pediatric liver transplant recipients has been reported to be 4-11%, the long-term risk of PTLD associated with primary tacrolimus therapy is unknown. Therefore, in order to determine the incidence and long-term risk of PTLD, the present study examined 131 pediatric recipients who underwent liver transplantation (LTx) between October 1989 and December 1991 and received primary tacrolimus therapy. This cohort of children was evaluated over an extended time-period (until December 31 1996) with a mean follow-up of 6.3 yr. Actuarial Kaplan-Meier analysis was utilized to determine the risk of PTLD over time. The overall incidence of PTLD was 13% (17/131) with an average age of 4.3 +/- 0.75 yr at diagnosis. Pretransplant Epstein-Barr virus (EBV) serologies were negative in 82%, positive in 12%, and not available in 6% of the patients. The median time to diagnosis of PTLD post-Tx was 11.9 months (mean 16.4 +/- 3.9, range 1.7-63.0 months). Mean tacrolimus dose and plasma trough level (as evaluated by enzyme-linked immunosorbent assay [ELISA]) at the time of diagnosis was 0.32 +/- 0.06 mg/kg/day and 1.3 +/- 0.3 ng/mL, respectively. The cumulative long-term risk of PTLD was found to increase over time: 3% at 6 months, 8% at 1 yr, 12% at 2 yr, 14% at 3 yr, and 15% at 4 and 5 yr. Mortality from PTLD was 12% (two of 17 patients). Primary tacrolimus use in pediatric LTx has a long-term risk of PTLD approaching 15%, with the majority of episodes (78%) occurring in the first 2 yr, suggesting that intense EBV surveillance should occur early post-transplantation.

  3. Therapeutic drug monitoring of tacrolimus in pancreas transplantation at São Lucas Hospital Monitoramento terapêutico de tacrolimus em transplante de pâncreas no Hospital São Lucas

    Directory of Open Access Journals (Sweden)

    Luciana Mello de Oliveira

    2007-10-01

    Full Text Available Tacrolimus (FK 506, a potent immunosuppressive drug used in prevention and treatment of rejection of transplanted organs, exhibits efficacy related to its blood levels and has a narrow therapeutic index. These factors require frequent monitoring of patients blood levels, in attempt to adjust the dose to reach the best drug concentration with minimum side effects. In this historic study, the authors evaluated tacrolimus blood profile in patients submitted to pancreas transplantation between June 2002 and March 2004. The results show that blood levels were, mostly, within subtherapeutic (39.1% and toxic (43.4% ranges. Considering post-transplantation period, subtherapeutic levels were more frequent until three months after the graft receiving (51.1% and between three and six months (41.9%, whereas toxic levels were more common six months after the transplantation (63%. Patients who received pancreas/kidney transplantation showed a tendency to present toxic levels. The same did not happen with the patients who received isolated pancreas and pancreas after kidney; these patients presented subtherapeutic blood levels in all post-transplantation periods. The results found in this study reassure the importance of therapeutic monitoring to achieve the adequate blood levels of tacrolimus following pancreas transplantation.O tacrolimus (FK506, um potente imunossupressor utilizado na profilaxia e no tratamento de rejeições pós-transplante, exibe eficácia relacionada com sua concentração sangüínea e possui estreita janela terapêutica. Esses fatores requerem o freqüente monitoramento dos níveis sangüíneos em pacientes que fazem uso do fármaco, tendo como objetivo o ajuste de dose para uma concentração terapêutica ótima com efeitos colaterais mínimos. Este estudo retrospectivo foi realizado através do acesso à base de dados do Laboratório de Patologia Clínica do Hospital São Lucas, da Pontifícia Universidade Católica do Rio Grande do

  4. A Case of Left Renal Vein Ligation in a Patient with Solitary Left Kidney Undergoing Liver Transplantation to Control Splenorenal Shunt and Improve Portal Venous Flow.

    Science.gov (United States)

    Martino, Rodrigo B; Júnior, Eserval Rocha; Manuel, Valdano; Rocha-Santos, Vinicius; D'Albuquerque, Luis Augusto C; Andraus, Wellington

    2017-10-11

    BACKGROUND Adequate portal venous flow is required for successful liver transplantation. Reduced venous flow and blood flow 'steal' by collateral vessels are a concern, and when there is a prominent splenorenal shunt present, ligation of the left renal vein has been recommended to improve portal venous blood flow. CASE REPORT A 51-year-old man who had undergone right nephrectomy in childhood required liver transplantation for liver cirrhosis and hepatocellular carcinoma due to hepatitis C virus (HCV) infection. The patient had no other comorbidity and no history of hepatorenal syndrome. At transplantation surgery, portal venous flow was poor and did not improve with ligation of shunt veins, but ligation of the left renal vein improved portal venous flow. On the first and fifth postoperative days, the patient was treated with basiliximab, a chimeric monoclonal antibody to the IL-2 receptor, and methylprednisolone. The calcineurin inhibitor, tacrolimus, was introduced on the fifth postoperative day. On the sixteenth postoperative day, renal color Doppler ultrasound showed normal left renal parenchyma; hepatic Doppler ultrasound showed good portal vein flow and preserved hepatic parenchyma in the liver transplant. CONCLUSIONS This case report has shown that in a patient with a single left kidney, left renal vein ligation is feasible and safe in a patient with no other risk factors for renal impairment following liver transplantation. Modification of postoperative immunosuppression to avoid calcineurin inhibitors in the very early postoperative phase may be important in promoting good recovery of renal function and to avoid the need for postoperative renal dialysis.

  5. Improving Patient Satisfaction with Waiting Time

    Science.gov (United States)

    Eilers, Gayleen M.

    2004-01-01

    Waiting times are a significant component of patient satisfaction. A patient satisfaction survey performed in the author's health center showed that students rated waiting time lowest of the listed categories--A ratings of 58% overall, 63% for scheduled appointments, and 41% for the walk-in clinic. The center used a quality improvement process and…

  6. Improving patient satisfaction in glaucoma care

    Directory of Open Access Journals (Sweden)

    Islam S

    2017-12-01

    Full Text Available Samsul Islam, Ahmad Salha, Saeed Azizi Faculty of Medicine, St George’s Hospital Medical School, London, UKWe read the article by Foo et al1 with great interest. We were intrigued by the factors influencing satisfaction rates among glaucoma patients. It made us question what changes could be made in the future attempting to improve patient satisfaction.\tSimilar to Foo et al,1 we were also surprised to find a lower end-point intraocular pressure was linked with increased patient dissatisfaction. As stated by Foo et al,1 other studies exploring clinical outcomes and patient satisfaction found that a positive clinical state was linked to higher patient satisfaction. Prakash2 proposes a three-way association between patient satisfaction, increased compliance, and better clinical outcomes. Hence, in attempting to investigate patient satisfaction, it would be appropriate to assess patient compliance and clinical outcomes.View the original paper by Foo and colleagues.

  7. Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial.

    Directory of Open Access Journals (Sweden)

    Rita R Alloway

    2017-11-01

    Full Text Available Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokinetic properties of generic products and the innovator (that is, "brand" product in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and innovator may not ensure bioequivalence between generics, and high-risk patients may have specific bioequivalence concerns. Such concerns have been fueled by anecdotal observations and retrospective and uncontrolled published studies, while well-designed, controlled prospective studies testing the validity of the regulatory bioequivalence testing approach for narrow therapeutic index immunosuppressants in transplant recipients have been lacking. Thus, the present study prospectively assesses bioequivalence between innovator tacrolimus and 2 generics in individuals with a kidney or liver transplant.From December 2013 through October 2014, a prospective, replicate dosing, partially blinded, randomized, 3-treatment, 6-period crossover bioequivalence study was conducted at the University of Cincinnati in individuals with a kidney (n = 35 or liver transplant (n = 36. Abbreviated New Drug Applications (ANDA data that included manufacturing and healthy individual pharmacokinetic data for all generics were evaluated to select the 2 most disparate generics from innovator, and these were named Generic Hi and Generic Lo. During the 8-week study period, pharmacokinetic studies assessed the bioequivalence of Generic Hi and Generic Lo with the Innovator tacrolimus and with each other. Bioequivalence of the major tacrolimus metabolite was also assessed. All products fell within the US Food and Drug

  8. The Treatment of Tacrolimus (FK506 for Psoriasis: One Case Report and Literature Analysis

    Directory of Open Access Journals (Sweden)

    Cao Wei-gang

    2013-12-01

    Full Text Available Psoriasis is a chronic recurrent inflammatory dermatosis, which is characterized by epidermal proliferation and erythema scales. Its etiology and pathogenesis are still unknown and treatment is difficult. The concentration of tacrolimus for the treatment of psoriasis has not been reported at home and abroad. In this report, we detected the tacrolimus plasma concentration and hope to provide a certain reference value for the clinical treatment of psoriasis.

  9. 'Nudging' your patients toward improved oral health.

    Science.gov (United States)

    Scarbecz, Mark

    2012-08-01

    Behavioral economics combines research from the fields of psychology, neurology and economics to help people understand how people make choices in complex social and economic environments. The principles of behavioral economics increasingly are being applied in health care. The author describes how dental team members can use behavioral economics principles to improve patients' oral health. Dental patients must make complex choices about care, and dental team members must provide information to patients to help them make choices. Patients are subject to predictable biases and are prone to making errors. Dental team members can use this information to "nudge" patients in healthy directions by providing an appropriate mix of incentives, default options and feedback. Practice Implications. The suggestions the author presents may help dental team members choose strategies that maximize both patient welfare and the success of their practices, while preserving patient autonomy.

  10. Improving medication adherence in patients with hypertension

    DEFF Research Database (Denmark)

    Hedegaard, Ulla; Kjeldsen, Lene Juel; Pottegård, Anton

    2015-01-01

    BACKGROUND: and Purpose: In patients with hypertension, medication adherence is often suboptimal, thereby increasing the risk of ischemic heart disease and stroke. In a randomized trial, we investigated the effectiveness of a multifaceted pharmacist intervention in a hospital setting to improve...... medication adherence in hypertensive patients. Motivational interviewing was a key element of the intervention. METHODS: Patients (N=532) were recruited from 3 hospital outpatient clinics and randomized to usual care or a 6-month pharmacist intervention comprising collaborative care, medication review...... for persistence, blood pressure or hospital admission. CONCLUSIONS: A multifaceted pharmacist intervention in a hospital setting led to a sustained improvement in medication adherence for patients with hypertension. The intervention had no significant impact on blood pressure and secondary clinical outcomes....

  11. How benchmarking can improve patient nutrition.

    Science.gov (United States)

    Ellis, Jane

    Benchmarking is a tool that originated in business to enable organisations to compare their services with industry-wide best practice. Early last year the Department of Health published The Essence of Care, a benchmarking toolkit adapted for use in health care. It focuses on eight elements of care that are crucial to patients' experiences. Nurses and other health care professionals at a London NHS trust have begun a trust-wide benchmarking project. The aim is to improve patients' experiences of health care by sharing and comparing information, and by identifying examples of good practice and areas for improvement. The project began with two of the eight elements of The Essence of Care, with the intention of covering the rest later. This article describes the benchmarking process for nutrition and some of the consequent improvements in care.

  12. Multi-site analytical evaluation of the Abbott ARCHITECT tacrolimus assay.

    Science.gov (United States)

    Wallemacq, Pierre; Goffinet, Jean-Sebastien; O'Morchoe, Susan; Rosiere, Thomas; Maine, Gregory T; Labalette, Myriam; Aimo, Giuseppe; Dickson, Diana; Schmidt, Ed; Schwinzer, Reinhard; Schmid, Rainer W

    2009-04-01

    The objective of this study was to evaluate the analytical performance of the Abbott ARCHITECT Tacrolimus immunoassay. Proficiency panels and specimens from a population of organ transplant recipients were analyzed in 6 clinical laboratories in Europe and the United States, and the results were compared with other methods. The ARCHITECT assay requires a whole blood specimen pretreatment step with methanol/zinc sulfate to precipitate protein and extract the drug, followed by a 30-minute immunoassay using anti-tacrolimus antibody-coated paramagnetic microparticles and an acridinium-tacrolimus tracer. The assay was free from hematocrit interference in the range 25%-55% and from interference by extremes of cholesterol, triglycerides, bilirubin, total protein, and uric acid. The total percent of coefficient of variations of the assay were 4.9%-7.6% at 3 ng/mL, 2.9%-4.6% at 8.6 ng/mL, and 3.1%-8.2% at 15.5 ng/mL. Limit of detection was Abbott IMx Tacrolimus II immunoassay (4 sites) yielded average biases between -0.94 and +0.26 ng/mL; ARCHITECT assay versus the Dade Dimension Tacrolimus immunoassay (2 sites) yielded average biases of -0.46 and +0.11 ng/mL; and ARCHITECT assay versus LC-MSMS methods at 2 sites yielded average biases of +0.51 and +1.63 ng/mL. Spearman correlation coefficients were >/=0.90 on all method comparisons. The ARCHITECT Tacrolimus assay is a semiautomated, robust, and highly sensitive immunoassay, representing an alternative approach for laboratories not equipped with LC-MSMS, and meets the 1 ng/mL recommendation of LOQ by the European Consensus Conference on Tacrolimus Optimization.

  13. Combination of hydrotropic nicotinamide with nanoparticles for enhancing tacrolimus percutaneous delivery

    Directory of Open Access Journals (Sweden)

    Pan W

    2016-08-01

    the permeation of the drug into the skin. The cellular uptake performed in HaCaT cells presented a promoting effect of NPs on cellular uptake. These overall results demonstrated that HA–Chol–NPs–NIC can synergistically improve the percutaneous delivery of FK506, and it is a novel potential strategy based on a nano-sized carrier for FK506 to treat skin diseases. Keywords: tacrolimus, nicotinamide, hyaluronic acid, nanoparticles, percutaneous delivery

  14. Improving treatment in Hispanic/Latino patients.

    Science.gov (United States)

    Cersosimo, Eugenio; Musi, Nicolas

    2011-10-01

    The prevalence of type 2 diabetes mellitus is higher in Hispanic/Latino individuals living in the United States compared with their non-Hispanic white counterparts. Many factors contribute to the increased prevalence of type 2 diabetes, including biological characteristics, socioeconomic conditions, and cultural aspects. The contribution of genetics to the risk of type 2 diabetes in Hispanic/Latino patients is becoming increasingly clear, but this inherent risk factor cannot be modified. However, certain socioeconomic and cultural factors, such as reduced access to healthcare, language barriers, cultural beliefs, and lack of cultural competence by the healthcare provider, are modifiable and should be overcome in order to improve the management of type 2 diabetes in Hispanic/Latino patients. At the healthcare system level, policies should be put into place to reduce disparities between Hispanics/Latinos and non-Hispanic whites regarding health insurance coverage and access to healthcare. At the healthcare provider and patient level, cultural beliefs should be taken into consideration when selecting adequate treatment. Overall, type 2 diabetes management should be individualized by identifying the preferred language and level of acculturation for each patient. These considerations are necessary to further improve communication through culturally appropriate educational materials and programs. These strategies may help to overcome the barriers in the treatment of type 2 diabetes in Hispanic/Latino patients. Copyright © 2011 Elsevier Inc. All rights reserved.

  15. Síndrome de encefalopatía posterior reversible secundaria a tacrolimus

    Directory of Open Access Journals (Sweden)

    María J. Rodríguez-González

    2016-01-01

    Full Text Available Los inhibidores de la calcineurina, la ciclosporina y el tacrolimus han jugado un papel preponderante en la prevención de los episodios de rechazo y de la enfermedad de injerto contra el huésped en pacientes tratados mediante el trasplante de órgano sólido y de la médula ósea. No obstante, el tacrolimus presenta efectos adversos relacionados con la neurotoxicidad, siendo el síndrome de encefalopatía posterior reversible la consecuencia más severa de dicha neurotoxicidad. El reporte de nuestro caso es de una mujer de 30 años de edad, con 2 días de evolución de cefalea intensa en la frente, náuseas, emesis, hiporexia y epigastralgia, afebril. Antecedente de un trasplante cardiaco 45 días antes, en tratamiento inmunosupresor con tacrolimus y micofenolato mofetilo. Se documentan niveles de tacrolimus adecuados (12,1 ng/ml, los estudios imagenológicos normales y los resultados de laboratorio negativos para infección, lo que permite descartar las causas vasculares e infecciosas y la neurotoxicidad por el tacrolimus. Sin embargo, ante el desarrollo de alteraciones neuropsiquiátricas, y a pesar de niveles de tacrolimus < 5,5 ng/ml, se realiza nueva resonancia nuclear magnética cerebral con hallazgos que indican síndrome de leucoencefalopatía posterior reversible. Se suspende el tacrolimus y se inicia tratamiento con everolimus, lográndose remisión total. Este sería el primer caso reportado en el cual las alteraciones imagenológicas asociadas al síndrome de encefalopatía posterior reversible se desarrollaron en una paciente intervenida de trasplante cardiaco con niveles de tacrolimus < 10 ng/ml. El reporte de este caso permitirá a los grupos médicos tratantes considerar este diagnóstico a pesar de niveles de tacrolimus en rango terapéutico, de manera que se realice un reconocimiento y tratamiento oportuno, evitando así el desarrollo de complicaciones o secuelas neurológicas.

  16. Label-free quantification of Tacrolimus in biological samples by atomic force microscopy

    International Nuclear Information System (INIS)

    Menotta, Michele; Biagiotti, Sara; Streppa, Laura; Rossi, Luigia; Magnani, Mauro

    2015-01-01

    Highlights: • Tacrolimus is a potent immunosuppressant drug that has to be continually monitored. • We present an atomic force microscope approach for quantification of Tacrolimus in blood samples. • Detection and quantification have been successfully achieved. - Abstract: In the present paper we describe an atomic force microscopy (AFM)-based method for the quantitative analysis of FK506 (Tacrolimus) in whole blood (WB) samples. Current reference methods used to quantify this immunosuppressive drug are based on mass spectrometry. In addition, an immunoenzymatic assay (ELISA) has been developed and is widely used in clinic, even though it shows a small but consistent overestimation of the actual drug concentration when compared with the mass spectrometry method. The AFM biosensor presented herein utilises the endogen drug receptor, FKBP12, to quantify Tacrolimus levels. The biosensor was first assayed to detect the free drug in solution, and subsequently used for the detection of Tacrolimus in blood samples. The sensor was suitable to generate a dose–response curve in the full range of clinical drug monitoring. A comparison with the clinically tested ELISA assay is also reported

  17. Label-free quantification of Tacrolimus in biological samples by atomic force microscopy

    Energy Technology Data Exchange (ETDEWEB)

    Menotta, Michele, E-mail: michele.menotta@uniurb.it [Department of Biomolecular Sciences, University of Urbino “Carlo Bo” via Saffi 2, Urbino (Italy); Biagiotti, Sara [Department of Biomolecular Sciences, University of Urbino “Carlo Bo” via Saffi 2, Urbino (Italy); Streppa, Laura [Physics Laboratory, CNRS-ENS, UMR 5672, Lyon (France); Cell and Molecular Biology Laboratory, CNRS-ENS Lyon, UMR 5239, IFR128, Lyon (France); Rossi, Luigia; Magnani, Mauro [Department of Biomolecular Sciences, University of Urbino “Carlo Bo” via Saffi 2, Urbino (Italy)

    2015-07-16

    Highlights: • Tacrolimus is a potent immunosuppressant drug that has to be continually monitored. • We present an atomic force microscope approach for quantification of Tacrolimus in blood samples. • Detection and quantification have been successfully achieved. - Abstract: In the present paper we describe an atomic force microscopy (AFM)-based method for the quantitative analysis of FK506 (Tacrolimus) in whole blood (WB) samples. Current reference methods used to quantify this immunosuppressive drug are based on mass spectrometry. In addition, an immunoenzymatic assay (ELISA) has been developed and is widely used in clinic, even though it shows a small but consistent overestimation of the actual drug concentration when compared with the mass spectrometry method. The AFM biosensor presented herein utilises the endogen drug receptor, FKBP12, to quantify Tacrolimus levels. The biosensor was first assayed to detect the free drug in solution, and subsequently used for the detection of Tacrolimus in blood samples. The sensor was suitable to generate a dose–response curve in the full range of clinical drug monitoring. A comparison with the clinically tested ELISA assay is also reported.

  18. Improving patient safety through quality assurance.

    Science.gov (United States)

    Raab, Stephen S

    2006-05-01

    Anatomic pathology laboratories use several quality assurance tools to detect errors and to improve patient safety. To review some of the anatomic pathology laboratory patient safety quality assurance practices. Different standards and measures in anatomic pathology quality assurance and patient safety were reviewed. Frequency of anatomic pathology laboratory error, variability in the use of specific quality assurance practices, and use of data for error reduction initiatives. Anatomic pathology error frequencies vary according to the detection method used. Based on secondary review, a College of American Pathologists Q-Probes study showed that the mean laboratory error frequency was 6.7%. A College of American Pathologists Q-Tracks study measuring frozen section discrepancy found that laboratories improved the longer they monitored and shared data. There is a lack of standardization across laboratories even for governmentally mandated quality assurance practices, such as cytologic-histologic correlation. The National Institutes of Health funded a consortium of laboratories to benchmark laboratory error frequencies, perform root cause analysis, and design error reduction initiatives, using quality assurance data. Based on the cytologic-histologic correlation process, these laboratories found an aggregate nongynecologic error frequency of 10.8%. Based on gynecologic error data, the laboratory at my institution used Toyota production system processes to lower gynecologic error frequencies and to improve Papanicolaou test metrics. Laboratory quality assurance practices have been used to track error rates, and laboratories are starting to use these data for error reduction initiatives.

  19. Improving patient safety: lessons from rock climbing.

    Science.gov (United States)

    Robertson, Nic

    2012-02-01

    How to improve patient safety remains an intractable problem, despite large investment and some successes. Academics have argued that the root of the problem is a lack of a comprehensive 'safety culture' in hospitals. Other safety-critical industries such as commercial aviation invest heavily in staff training to develop such a culture, but comparable programmes are almost entirely absent from the health care sector. In rock climbing and many other dangerous activities, the 'buddy system' is used to ensure that safety systems are adhered to despite adverse circumstances. This system involves two or more people using simple checks and clear communication to prevent problems causing harm. Using this system as an example could provide a simple, original and entertaining way of introducing medical students to the idea that human factors are central to ensuring patient safety. Teaching the buddy system may improve understanding and acceptance of other patient safety initiatives, and could also be used by junior doctors as a tool to improve the safety of their practice. © Blackwell Publishing Ltd 2012.

  20. Age-Dependent Metabolic and Immunosuppressive Effects of Tacrolimus.

    Science.gov (United States)

    Krenzien, F; Quante, M; Heinbokel, T; Seyda, M; Minami, K; Uehara, H; Biefer, H R C; Schuitenmaker, J M; Gabardi, S; Splith, K; Schmelzle, M; Petrides, A K; Azuma, H; Pratschke, J; Li, X C; ElKhal, A; Tullius, S G

    2017-05-01

    Immunosuppression in elderly recipients has been underappreciated in clinical trials. Here, we assessed age-specific effects of the calcineurin inhibitor tacrolimus (TAC) in a murine transplant model and assessed its clinical relevance on human T cells. Old recipient mice exhibited prolonged skin graft survival compared with young animals after TAC administration. More important, half of the TAC dose was sufficient in old mice to achieve comparable systemic trough levels. TAC administration was able to reduce proinflammatory interferon-γ cytokine production and promote interleukin-10 production in old CD4 + T cells. In addition, TAC administration decreased interleukin-2 secretion in old CD4 + T cells more effectively while inhibiting the proliferation of CD4 + T cells in old mice. Both TAC-treated murine and human CD4 + T cells demonstrated an age-specific suppression of intracellular calcineurin levels and Ca 2+ influx, two critical pathways in T cell activation. Of note, depletion of CD8 + T cells did not alter allograft survival outcome in old TAC-treated mice, suggesting that TAC age-specific effects were mainly CD4 + T cell mediated. Collectively, our study demonstrates age-specific immunosuppressive capacities of TAC that are CD4 + T cell mediated. The suppression of calcineurin levels and Ca 2+ influx in both old murine and human T cells emphasizes the clinical relevance of age-specific effects when using TAC. © 2016 The American Society of Transplantation and the American Society of Transplant Surgeons.

  1. Improving patient safety in radiation oncology

    International Nuclear Information System (INIS)

    Hendee, William R.; Herman, Michael G.

    2011-01-01

    Beginning in the 1990s, and emphasized in 2000 with the release of an Institute of Medicine report, healthcare providers and institutions have dedicated time and resources to reducing errors that impact the safety and well-being of patients. But in January 2010 the first of a series of articles appeared in the New York Times that described errors in radiation oncology that grievously impacted patients. In response, the American Association of Physicists in Medicine and the American Society of Radiation Oncology sponsored a working meeting entitled ''Safety in Radiation Therapy: A Call to Action''. The meeting attracted 400 attendees, including medical physicists, radiation oncologists, medical dosimetrists, radiation therapists, hospital administrators, regulators, and representatives of equipment manufacturers. The meeting was cohosted by 14 organizations in the United States and Canada. The meeting yielded 20 recommendations that provide a pathway to reducing errors and improving patient safety in radiation therapy facilities everywhere.

  2. [Improving patient safety through voluntary peer review].

    Science.gov (United States)

    Kluge, S; Bause, H

    2015-01-01

    The intensive care unit (ICU) is one area of the hospital in which processes and communication are of primary importance. Errors in intensive care units can lead to serious adverse events with significant consequences for patients. Therefore quality and risk-management are important measures when treating critically ill patients. A pragmatic approach to support quality and safety in intensive care is peer review. This approach has gained significant acceptance over the past years. It consists of mutual visits by colleagues who conduct standardised peer reviews. These reviews focus on the systematic evaluation of the quality of an ICU's structure, its processes and outcome. Together with different associations, the State Chambers of Physicians and the German Medical Association have developed peer review as a standardized tool for quality improvement. The common goal of all stakeholders is the continuous and sustainable improvement in intensive care with peer reviews significantly increasing and improving communication between professions and disciplines. Peer reviews secure the sustainability of planned change processes and consequently lead the way to an improved culture of quality and safety.

  3. Incidence of Posttransplantation Diabetes Mellitus in De Novo Kidney Transplant Recipients Receiving Prolonged-Release Tacrolimus-Based Immunosuppression With 2 Different Corticosteroid Minimization Strategies: ADVANCE, A Randomized Controlled Trial.

    Science.gov (United States)

    Mourad, Georges; Glyda, Maciej; Albano, Laetitia; Viklický, Ondrej; Merville, Pierre; Tydén, Gunnar; Mourad, Michel; Lõhmus, Aleksander; Witzke, Oliver; Christiaans, Maarten H L; Brown, Malcolm W; Undre, Nasrullah; Kazeem, Gbenga; Kuypers, Dirk R J

    2017-08-01

    ADVANCE (NCT01304836) was a phase 4, multicenter, prospectively randomized, open-label, 24-week study comparing the incidence of posttransplantation diabetes mellitus (PTDM) with 2 prolonged-release tacrolimus corticosteroid minimization regimens. All patients received prolonged-release tacrolimus, basiliximab, mycophenolate mofetil and 1 bolus of intraoperative corticosteroids (0-1000 mg) as per center policy. Patients in arm 1 received tapered corticosteroids, stopped after day 10, whereas patients in arm 2 received no steroids after the intraoperative bolus. The primary efficacy variable was the diagnosis of PTDM as per American Diabetes Association criteria (2010) at any point up to 24 weeks postkidney transplantation. Secondary efficacy variables included incidence of composite efficacy failure (graft loss, biopsy-proven acute rejection or severe graft dysfunction: estimated glomerular filtration rate (Modification of Diet in Renal Disease-4) <30 mL/min per 1.73 m), acute rejection and graft and patient survival. The full-analysis set included 1081 patients (arm 1: n = 528, arm 2: n = 553). Baseline characteristics and mean tacrolimus trough levels were comparable between arms. Week 24 Kaplan-Meier estimates of PTDM were similar for arm 1 versus arm 2 (17.4% vs 16.6%; P = 0.579). Incidence of composite efficacy failure, graft and patient survival, and mean estimated glomerular filtration rate were also comparable between arms. Biopsy-proven acute rejection and acute rejection were significantly higher in arm 2 versus arm 1 (13.6% vs 8.7%, P = 0.006 and 25.9% vs 18.2%, P = 0.001, respectively). Tolerability profiles were comparable between arms. A prolonged-release tacrolimus, basiliximab, and mycophenolate mofetil immunosuppressive regimen is efficacious, with a low incidence of PTDM and a manageable tolerability profile over 24 weeks of treatment. A lower incidence of biopsy-proven acute rejection was seen in patients receiving corticosteroids tapered over 10

  4. Improving Outcomes in Patients With Sepsis.

    Science.gov (United States)

    Armen, Scott B; Freer, Carol V; Showalter, John W; Crook, Tonya; Whitener, Cynthia J; West, Cheri; Terndrup, Thomas E; Grifasi, Marissa; DeFlitch, Christopher J; Hollenbeak, Christopher S

    2016-01-01

    Sepsis mortality may be improved by early recognition and appropriate treatment based on evidence-based guidelines. An intervention was developed that focused on earlier identification of sepsis, early antimicrobial administration, and an educational program that was disseminated throughout all hospital units and services. There were 1331 patients with sepsis during the intervention period and 1401 patients with sepsis during the control period. After controlling for expected mortality, patients in the intervention period had 30% lower odds of dying (odds ratio = 0.70, 95% confidence interval [CI] = 0.57 to 0.84). They also had 1.07 fewer days on average in the intensive care unit (95% CI = -1.98 to -0.16), 2.15 fewer hospital days (95% CI = -3.45 to -0.86), and incurred on average $1949 less in hospital costs, although the effect on costs was not statistically significant. Continued incremental improvement and sustainment is anticipated through organizational oversight, continued education, and initiation of an automated electronic sepsis alert function. © The Author(s) 2014.

  5. Improving ICU risk management and patient safety.

    Science.gov (United States)

    Kielty, Lucy Ann

    2017-06-12

    Purpose The purpose of this paper is to describe a study which aimed to develop and validate an assessment method for the International Electrotechnical Commission (IEC) 80001-1 (IEC, 2010) standard (the Standard); raise awareness; improve medical IT-network project risk management processes; and improve intensive care unit patient safety. Design/methodology/approach An assessment method was developed and piloted. A healthcare IT-network project assessment was undertaken using a semi-structured group interview with risk management stakeholders. Participants provided feedback via a questionnaire. Descriptive statistics and thematic analysis was undertaken. Findings The assessment method was validated as fit for purpose. Participants agreed (63 per cent, n=7) that assessment questions were clear and easy to understand, and participants agreed (82 per cent, n=9) that the assessment method was appropriate. Participant's knowledge of the Standard increased and non-compliance was identified. Medical IT-network project strengths, weaknesses, opportunities and threats in the risk management processes were identified. Practical implications The study raised awareness of the Standard and enhanced risk management processes that led to improved patient safety. Study participants confirmed they would use the assessment method in future projects. Originality/value Findings add to knowledge relating to IEC 80001-1 implementation.

  6. Improving outcomes in patients with psoriasis.

    Science.gov (United States)

    Tidman, Michael J

    2013-01-01

    Psoriasis is a heterogeneous inflammatory disorder that targets the skin and joints. It affects 1.3-2% of the population. The diagnosis of plaque psoriasis is usually straightforward, a helpful diagnostic clue is the tendency for silver scales to appear after gentle scratching of a lesion. Stress, streptococcal infection and drugs including beta-blockers, antimalarials and lithium may precipitate or exacerbate psoriasis. Psoriasis, especially when severe, predisposes to metabolic syndrome, and patients with psoriasis are at increased risk of ischaemic heart disease, hypertension, stroke, type 2 diabetes and hyperlipidaemia. Additionally, psoriasis sufferers appear at increased risk of uveitis, inflammatory boweldisease, lymphoma, non-melanoma skin cancer, COPD and venous thromboembolism. Psoriasis should be assessed on the basis of: severity, impact on physical, psychological and social wellbeing, symptoms of arthritis and the presence of comorbidities. Poor response to topical therapy may be as much to do with lack of compliance as with lack of efficacy. The number of treatments each day should be kept to a minimum, and patients should be reviewed after four weeks when initiating or changing topical therapy to improve adherence to treatment and assess response. The majority of patients with psoriasis can be managed in primary care, although specialist care may be necessary at some point in up to 60% of cases. Patients with erythrodermic or generalised pustular psoriasis should be referred for a same day dermatological opinion, and if psoriatic arthritis is suspected, early referral for a rheumatological opinion is recommended.

  7. Vorinostat plus tacrolimus/methotrexate to prevent GVHD after myeloablative conditioning, unrelated donor HCT.

    Science.gov (United States)

    Choi, Sung Won; Braun, Thomas; Henig, Israel; Gatza, Erin; Magenau, John; Parkin, Brian; Pawarode, Attaphol; Riwes, Mary; Yanik, Greg; Dinarello, Charles A; Reddy, Pavan

    2017-10-12

    The oral histone deacetylase (HDAC) inhibitor (vorinostat) is safe and results in low incidence of acute graft-versus-host disease (GVHD) after reduced-intensity conditioning, related donor hematopoietic cell transplantation (HCT). However, its safety and efficacy in preventing acute GVHD in settings of heightened clinical risk that use myeloablative conditioning, unrelated donor (URD), and methotrexate are not known. We conducted a prospective, phase 2 study in this higher-risk setting. We enrolled 37 patients to provide 80% power to detect a significant difference in grade 2 to 4 acute GVHD of 50% compared with a reduction in target to 28%. Eligibility included adults with a hematological malignancy to receive myeloablative HCT from an available 8/8-HLA matched URD. Patients received GVHD prophylaxis with tacrolimus and methotrexate. Vorinostat (100 mg twice daily) was started on day -10 and continued through day +100 post-HCT. Median age was 56 years (range, 18-69 years), and 95% had acute myelogenous leukemia or high-risk myelodysplastic syndrome. Vorinostat was safe and tolerable. The cumulative incidence of grade 2 to 4 acute GVHD at day 100 was 22%, and for grade 3 to 4 it was 8%. The cumulative incidence of chronic GVHD was 29%; relapse, nonrelapse mortality, GVHD-free relapse-free survival, and overall survival at 1 year were 19%, 16%, 47%, and 76%, respectively. Correlative analyses showed enhanced histone (H3) acetylation in peripheral blood mononuclear cells and reduced interleukin 6 ( P = .028) and GVHD biomarkers (Reg3, P = .041; ST2, P = .002) at day 30 post-HCT in vorinostat-treated subjects compared with similarly treated patients who did not receive vorinostat. Vorinostat for GVHD prevention is an effective strategy that should be confirmed in a randomized phase 3 study. This trial was registered at www.clinicaltrials.gov as #NCT01790568. © 2017 by The American Society of Hematology.

  8. Improving inpatient environments to support patient sleep.

    Science.gov (United States)

    DuBose, Jennifer R; Hadi, Khatereh

    2016-10-01

    Although sleep is important for healing, sleep deprivation is a major concern for patients in hospitals. The purpose of this review is to consolidate the observational and interventional studies that have been done to understand exogenous, non-pharmacological strategies for improving sleep in hospitals. We searched Medline, CINAHL, PsycINFO and the Web of Science databases for peer-reviewed articles published between 1970 and 2015 in English. A title review of 13,113 articles from four databases resulted in 783 articles that were further culled to 277 based on a review of the abstracts. The net result after reading the articles and a hand search was 42 articles. From each article we recorded the independent variables, methods used for measuring sleep and specific sleep outcomes reported. Noise is a modifiable cause of some sleep disruptions in hospitals, and when reduced can lead to more sleep. Earplugs and eye masks may help, but changing the sound and light environment is more effective. Calming music in the evening has been shown to be effective as well as daytime bright light exposure. Nursing care activities cause sleep disruption, but efforts at limiting interventions have not been demonstrated to improve sleep conditions. The research is hard to consolidate due to the multitude of independent variables and outcome metrics, but overall points to the potential for making meaningful improvements in the quality of patient sleep. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  9. Health innovation for patient safety improvement

    Directory of Open Access Journals (Sweden)

    Renukha Sellappans

    2013-01-01

    Full Text Available Medication error has been identified as a major factor affecting patient safety. Many innovative efforts such as Computerised Physician Order Entry (CPOE, a Pharmacy Information System, automated dispensing machines and Point of Administration Systems have been carried out with the aim of improving medication safety. However, areas remain that require urgent attention. One main area will be the lack of continuity of care due to the breakdown of communication between multiple healthcare providers. Solutions may include consideration of “health smart cards” that carry vital patient medical information in the form of a “credit card” or use of the Malaysian identification card. However, costs and technical aspects associated with the implementation of this health smart card will be a significant barrier. Security and confidentiality, on the other hand, are expected to be of primary concern to patients. Challenges associated with the implementation of a health smart card might include physician buy-in for use in his or her everyday practice. Training and technical support should also be available to ensure the smooth implementation of this system. Despite these challenges, implementation of a health smart card moves us closer to seamless care in our country, thereby increasing the productivity and quality of healthcare.

  10. Health innovation for patient safety improvement.

    Science.gov (United States)

    Sellappans, Renukha; Chua, Siew Siang; Tajuddin, Nur Amani Ahmad; Mei Lai, Pauline Siew

    2013-01-01

    Medication error has been identified as a major factor affecting patient safety. Many innovative efforts such as Computerised Physician Order Entry (CPOE), a Pharmacy Information System, automated dispensing machines and Point of Administration Systems have been carried out with the aim of improving medication safety. However, areas remain that require urgent attention. One main area will be the lack of continuity of care due to the breakdown of communication between multiple healthcare providers. Solutions may include consideration of "health smart cards" that carry vital patient medical information in the form of a "credit card" or use of the Malaysian identification card. However, costs and technical aspects associated with the implementation of this health smart card will be a significant barrier. Security and confidentiality, on the other hand, are expected to be of primary concern to patients. Challenges associated with the implementation of a health smart card might include physician buy-in for use in his or her everyday practice. Training and technical support should also be available to ensure the smooth implementation of this system. Despite these challenges, implementation of a health smart card moves us closer to seamless care in our country, thereby increasing the productivity and quality of healthcare.

  11. Which genetic determinants should be considered for tacrolimus dose optimization in kidney transplantation?

    DEFF Research Database (Denmark)

    Bruckmueller, H; Werk, Anneke Nina; Renders, Lutz

    2014-01-01

    ). In addition, there are further polymorphic genes, possibly influencing CYP3A activity (pregnan x receptor NR1I2, P450 oxidoreductase POR and peroxisome proliferator-activator receptor alpha PPRA). We aimed to investigate combined effects of these gene variants on tacrolimus maintenance dose and PK in stable...

  12. Physiotherapy improves patient reported shoulder function and health status in patients with subacromial impingement syndrome

    DEFF Research Database (Denmark)

    Storgaard, Filip Holst; Pedersen, Christina Gravgaard; Jensen, Majbritt Lykke

    Physiotherapy improves patient reported shoulder function and health status in patients with subacromial impingement syndrome.......Physiotherapy improves patient reported shoulder function and health status in patients with subacromial impingement syndrome....

  13. Effects of Topical Corticosteroid and Tacrolimus on Ceramides and Irritancy to Sodium Lauryl Sulphate in Healthy Skin

    DEFF Research Database (Denmark)

    Jungersted, Jakob Mutanu; Høgh, Julie Kaae; Hellgren, Lars

    2011-01-01

    twice daily for one week with betamethasone, tacrolimus, emollient, or left untreated, respectively. After one week each area was challenged with a 24 h sodium lauryl sulphate patch test. The lipids were collected using the cyanoacrylate method and evaluated by high performance thin layer chromatography...... found between treatment regimes. Pretreatment with betamethasone (p = 0.01) or with tacrolimus (p = 0.001) causes a decreased inflammatory response to sodium lauryl sulphate compared with emollient. In conclusion, treatment with betamethasone and tacrolimus has a positive effect on the ceramide...

  14. Betel Nut Chewing Is Associated With Reduced Tacrolimus Concentration in Taiwanese Liver Transplant Recipients.

    Science.gov (United States)

    Chen, W-Y; Lee, C-Y; Lin, P-Y; Hsieh, C-E; Ko, C-J; Lin, K-H; Lin, C-C; Ming, Y-Z; Chen, Y-L

    2017-03-01

    Studies have shown that arecoline, the major alkaloid component of betel nuts, alters the activity of enzymes in the cytochrome P450 (CYP-450) family. Tacrolimus, an immunosuppressant that protects against organ rejection in transplant recipients, not only is mainly metabolized by CYP3A enzymes but also has a narrow therapeutic range. We aimed to investigate whether dose-adjusted blood trough levels of tacrolimus differed over time between betel nut-chewing and non-betel nut-chewing liver transplant recipients. In this retrospective case-control study, 14 active betel nut-using liver recipients were matched at a 1:2 ratio to 28 non-betel nut-using liver recipients by sex, age, graft source, duration of follow-up after liver transplantation, and estimated glomerular filtration rate. Differences in liver function index, renal function index, and dose-adjusted blood trough levels of tacrolimus over an 18-month period were compared between the 2 groups by using the Generalized Estimating Equation approach. Dose-adjusted blood trough levels of tacrolimus tended to be significantly (P = .04) lower in betel nut chewers (mean = 0.81, medium = 0.7, 95% confidence interval [CI] = 0.73 to 0.90) than in nonchewers (mean = 1.12, medium = 0.88, 95% CI = 1.03 to 1.22) during the 18-month study period. However, there was no significant difference in renal and liver function index between the 2 groups. Liver transplant recipients receiving tacrolimus tend to have lower blood trough levels of the drug over time if they chew betel nuts. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Pharmacological evaluation of tacrolimus (FK-506 on ischemia reperfusion induced vasculatic neuropathic pain in rats

    Directory of Open Access Journals (Sweden)

    Sood Shailja

    2010-06-01

    Full Text Available Abstract Background Ischemia reperfusion (I/R is common in various pathological conditions like diabetic complication, rheumatic arthritis, necrotizing vascular occlusive disease and trauma. Methods We have evaluated the effect of tacrolimus (1, 2 and 3 mg/kg, p.o. for 10 consecutive days on femoral arterial ischemic reperfusion (I/R induced neuropathic pain in rats. Behavioral parameters (i.e. hot plate, radiant heat, acetone drop, tail heat hyperalgesia, tail flick and tail cold allodynia tests were assessed at different time intervals (i.e. 0, 1, 4, 7, 10, 13 and 16th day and biochemical analysis in serum and tissue samples were also performed along with histopathological studies. Results Behavioral pain assessment revealed increase in the paw and tail withdrawal threshold in tacrolimus treated groups against hyperalgesic and allodynic stimuli as compared to the sham control group. We observed a decrease in the serum nitrate and thiobarbituric acid reactive substance (TBARS levels along with reduction in tissue myeloperoxidase (MPO and total calcium levels, whereas, rise in tissue reduced glutathione levels in tacrolimus treated groups. However, significant results were obtained in medium and high dose treated group as compared to sham control group. Histopathological study had revealed the increase in the neuronal edema and axonal degeneration in the I/R group whereas, tacrolimus ameliorate these effects. Conclusion Our results indicate the anti-oxidative, anti-inflammatory and calcium modulatory actions of tacrolimus. Therefore, it can be used as a therapeutic agent for the treatment of vascular inflammatory related neuropathic pain.

  16. A comparison of the extended-release and standard-release formulations of tacrolimus in de novo kidney transplant recipients: a 12-month outcome study.

    Science.gov (United States)

    Fanous, Helen; Zheng, Rebecca; Campbell, Carolyn; Huang, Michael; Nash, Michelle M; Rapi, Lindita; Zaltzman, Jeffrey S; Prasad, G V Ramesh

    2013-02-01

    BACKGROUND: Limited comparative data are available on the outcomes between extended-release and standard-release tacrolimus when used de novo in kidney transplant recipients (KTRs). METHODS: We identified KTRs transplanted at our institution during 2009-10 routinely prescribed extended-release tacrolimus and compared them with those transplanted during 2008-09 prescribed standard-release tacrolimus. Graft function (eGFR by MDRD-7 equation) at 12 months post-transplant (primary outcome); new-onset diabetes and other cardiovascular risk factors, BK viremia incidence, acute rejection, and graft survival to 12 months (secondary outcomes) were compared by intent-to-treat analysis. Time-to-steady-state concentration and number of dose adjustments required to attain steady state were recorded. RESULTS: There were no important demographic differences between the extended-release (N = 106) and standard-release (N = 95) cohorts. The estimated glomerular filtration rate (eGFR) at 12 months was similar (58.8 ± 17 versus 59.2 ± 18 mL/min/1.73 m(2), P = 0.307). There was no difference in new-onset diabetes (17 versus 20%, P = 0.581), BK viremia (10 versus 7%, P = 0.450), acute rejection (7 versus 16%, P = 0.067) or graft survival (97 versus 95%, P = 0.301). Time-to-steady state was similar (9.2 ± 1.1 versus 8.1 ± 4.7 days, P = 0.490) although extended-release patients required fewer adjustments to attain steady state (1.2 ± 1.7 [0-8] versus 1.7 ± 1.5 [0-7], P = 0.030) but a similar dose (7.2 ± 2.4 [2-17] versus 7 ± 2.7 [2-16] mg/day, P = 0.697). CONCLUSION: De novo KTRs prescribed extended-release or standard-release tacrolimus demonstrate similar 12-month outcomes.

  17. Efeito renoprotetor dos flavonoides do vinho na nefrotoxicidade do imunossupressor Tacrolimus Efecto renoprotector de los flavonoides del vino en la nefrotoxicidad del inmunosupresor Tacrolimus Renoprotective effects of wine flavonoids in nephrotoxicity of the immunosuppressant Tacrolimus

    Directory of Open Access Journals (Sweden)

    Wanessa Teixeira Silva

    2011-01-01

    Full Text Available OBJETIVO: Verificar o efeito renoprotetor do extrato de Vitis vinifera L na nefrotoxicidade induzida pelo Tacrolimus em estudos experimentais com ratos. MÉTODOS: Pesquisa quantitativa com modelo experimental, na qual foram utilizados ratos Wistar, machos, adultos, pesando entre 250g - 300g, tratados uma vez ao dia por cincodias, por gavagem, conforme segue: Salina (controle, cloreto de sódio 0,1ml; Vitis (Vitis vinifera L 3mg/kg, FK (0,5mg/kg e FK+Vitis (0,5mg/kg + 3mg/kg, respectivamente . A função renal foi avaliada por meio do clearance de creatinina (Clcr/ 100g, método Jaffé e a peroxidação lipídica pela mensuração de peróxidos urinários (PU, FOX-2. RESULTADOS: A administração de FK elevou a excreção de peróxidos e reduziu o clearance de creatinina, e a administração simultânea com Vitis vinifera L protegeu a função renal nesses parâmetros. CONCLUSÃO: Os dados confirmaram a lesão nefrotóxica induzida pelo Tacrolimus e demonstraram o efeito renoprotetor do Vitis Vinifera L.OBJETIVO: Verificar el efecto renoprotector del extracto de Vitis vinifera L en la nefrotoxicidad inducida por el Tacrolimus en estudios experimentales con ratas. MÉTODOS: Investigación cuantitativa con modelo experimental, en la cual fueron utilizadas ratas Wistar, machos, adultos, que pesaban entre 250g - 300g, tratados una vez al dia por cinco días, por alimentación forzada, conforme sigue: Salina (control, cloreto de sodio 0,1ml; Vitis (Vitis vinifera L 3mg/kg, FK (0,5mg/kg e FK+Vitis (0,5mg/kg + 3mg/kg, respectivamente . La función renal fue evaluada por medio del clearance de creatinina (Clcr/ 100g, método Jaffé y la peroxidación lipídica por la mensuración de peróxidos urinarios (PU, FOX-2. RESULTADOS: La administración de FK elevó la excreción de peróxidos y redujo el clearance de creatinina, y la administración simultánea con Vitis vinifera L protegió la función renal en esos parámetros. CONCLUSIÓN: Los datos

  18. Distinct deleterious effects of cyclosporine and tacrolimus and combined tacrolimus-sirolimus on endothelial cells: protective effect of defibrotide.

    Science.gov (United States)

    Carmona, Alba; Díaz-Ricart, Maribel; Palomo, Marta; Molina, Patricia; Pino, Marc; Rovira, Montserrat; Escolar, Ginés; Carreras, Enric

    2013-10-01

    Endothelial dysfunction seems to be a key factor in the development of several complications observed early after hematopoietic stem cell transplantation (HSCT). The conditioning regimen and many other factors associated with the procedure are responsible for this endothelial damage. The effects of immunosuppressive agents on endothelial function have not been explored in detail. We evaluated the effects of 3 drugs commonly used in HSCT: 2 calcineurin inhibitors, cyclosporine A (CSA) and tacrolimus (TAC), and an inhibitor of mTOR, sirolimus (SIR). We also evaluated the effect of the combination of TAC and SIR (TAC+SIR), which is used increasingly in clinical practice. Microvascular endothelial cells (HMEC-1) were exposed to these drugs to evaluate changes in (1) intercellular adhesion molecule (ICAM)-1 expression on the cell surface, assessed by immunofluorescence labeling and expressed as the mean gray value (MGV); (2) reactivity of the extracellular matrix (ECM) toward platelets, upon exposure of the ECM to circulating blood; and (3) whole-blood clot formation, assessed by thromboelastometry. Studies were conducted in the absence and presence of defibrotide (DF) to assess its possible protective effect. The exposure of HMEC-1 to CSA and TAC+SIR significantly increased the expression of ICAM-1 (157.5 ± 11.6 and 153.4 ± 9.5 MGV, respectively, versus 105.7 ± 6.5 MGV in controls [both P < .05]). TAC applied alone increased ICAM-1 slightly (120.3 ± 8.2 MGV), and SIR had no effect (108.9 ± 7.4 MGV). ECM reactivity increased significantly only in response to CSA (surface covered by platelets of 41.2% ± 5.4% versus 30.1% ± 2.0%, P < .05). DF attenuated all these changes. No significant changes in the viscoelastic properties of clot formation were observed in any condition with blood samples incubated in vitro. In conclusion, CSA and TAC+SIR had a proinflammatory effect, but only CSA exhibited an additional prothrombotic effect. Interestingly, DF exerted clear

  19. Efficacy of topical tacrolimus 0.1% in active plaque morphea: randomized, double-blind, emollient-controlled pilot study.

    NARCIS (Netherlands)

    Kroft, Ilse; Groeneveld, T.J.; Seyger, M.M.B.; Jong, E.M.G.J. de

    2009-01-01

    BACKGROUND: Tacrolimus, a calcineurin inhibitor, is an immunomodulating and anti-inflammatory drug that inhibits T-cell activation and production of cytokines. The elevated level of cytokines in morphea causes fibroblast proliferation and subsequent overproduction of collagen. Theoretically,

  20. Awake craniotomy: improving the patient's experience.

    Science.gov (United States)

    Potters, Jan-Willem; Klimek, Markus

    2015-10-01

    Awake craniotomy patients are exposed to various stressful stimuli while their attention and vigilance is important for the success of the surgery. We describe several recent findings on the perception of awake craniotomy patients and address nonpharmacological perioperative factors that enhance the experience of awake craniotomy patients. These factors could also be applicable to other surgical patients. Proper preoperative counseling gives higher patient satisfaction and should be individually tailored to the patient. Furthermore, there is a substantial proportion of patients who have significant pain or fear during an awake craniotomy procedure. There is a possibility that this could induce post-traumatic stress disorder or related symptoms. Preoperative preparation is of utmost importance in awake craniotomy patients, and a solid doctor-patient relationship is an important condition. Nonpharmacological intraoperative management should focus on reduction of fear and pain by adaptation of the environment and careful and well considered communication.

  1. A Comparative Evaluation of Efficacy of Tacrolimus and Triamcinolone Acetonide in the Management of Symptomatic Oral Lichen Planus

    Directory of Open Access Journals (Sweden)

    Y M Swarna

    2011-01-01

    Interpretation and conclusion Topical tacrolimus 0.03% ointment induced better initial therapeutic response than triamcinolone acetonide 0.1 % ointment. However, relapses occurred in two subjects in group ′A′ and three subjects in group ′B′ after the cessation of the respective treatments. Nevertheless, at present topical tacrolimus may be a valuable addition to the already existing therapeutic modalities for treating subjects with OLP.

  2. Comparative Effectiveness of Tacrolimus-Based Steroid Sparing versus Steroid Maintenance Regimens in Kidney Transplantation: Results from Discrete Event Simulation.

    Science.gov (United States)

    Desai, Vibha C A; Ferrand, Yann; Cavanaugh, Teresa M; Kelton, Christina M L; Caro, J Jaime; Goebel, Jens; Heaton, Pamela C

    2017-10-01

    Corticosteroids used as immunosuppressants to prevent acute rejection (AR) and graft loss (GL) following kidney transplantation are associated with serious cardiovascular and other adverse events. Evidence from short-term randomized controlled trials suggests that many patients on a tacrolimus-based immunosuppressant regimen can withdraw from steroids without increased AR or GL risk. To measure the long-term tradeoff between GL and adverse events for a heterogeneous-risk population and determine the optimal timing of steroid withdrawal. A discrete event simulation was developed including, as events, AR, GL, myocardial infarction (MI), stroke, cytomegalovirus, and new onset diabetes mellitus (NODM), among others. Data from the United States Renal Data System were used to estimate event-specific parametric regressions, which accounted for steroid-sparing regimen (avoidance, early 7-d withdrawal, 6-mo withdrawal, 12-mo withdrawal, and maintenance) as well as patients' demographics, immunologic risks, and comorbidities. Regression-equation results were used to derive individual time-to-event Weibull distributions, used, in turn, to simulate the course of patients over 20 y. Patients on steroid avoidance or an early-withdrawal regimen were more likely to experience AR (45.9% to 55.0% v. 33.6%, P events and other outcomes with no worsening of AR or GL rates compared with steroid maintenance.

  3. MRI in seven cases of tacrolimus (FK-506) encephalopathy: utility of FLAIR and diffusion-weighted imaging

    Energy Technology Data Exchange (ETDEWEB)

    Furukawa, M. [Dept. of Radiology, Yamaguchi University School of Medicine, Ube (Japan); Dept. of Radiology, Hokkaido University School of Medicine, Sapporo (Japan); Terae, S.; Chu, B.C.; Kaneko, K.; Kamada, H.; Miyasaka, K. [Dept. of Radiology, Hokkaido University School of Medicine, Sapporo (Japan)

    2001-08-01

    We assessed the utility of fluid-attenuated inversion-recovery (FLAIR) and diffusion-weighted (DWI) images in investigation of tacrolimus (FK-506) encephalopathy, and to see whether we could predict its cause from clinical and imaging data. In seven patients with presumed FK-506 toxicity the areas involved on MRI were similar to those in cyclosporin A (CsA) toxicity. The abnormal signal was most evident on FLAIR in all cases. In three of four patients who underwent DWI, no diffusion abnormalities were detected; in the remaining patient, increased diffusion was seen in the deep white matter bilaterally on the apparent diffusion coefficient map, consistent with the findings on T2-weighted spin-echo and FLAIR images. Five of the six patients for whom we had clinical data showed sudden changes in electrolyte or fluid equilibrium due to diarrhoea, a polyuria or oliguria one day before or on the day of onset of the central nervous system disturbances. We speculate that FK-506 encephalopathy is triggered by the disturbance of the electrolyte and/or fluid equilibrium, given a certain serum level of FK-506. (orig.)

  4. MRI in seven cases of tacrolimus (FK-506) encephalopathy: utility of FLAIR and diffusion-weighted imaging

    International Nuclear Information System (INIS)

    Furukawa, M.; Terae, S.; Chu, B.C.; Kaneko, K.; Kamada, H.; Miyasaka, K.

    2001-01-01

    We assessed the utility of fluid-attenuated inversion-recovery (FLAIR) and diffusion-weighted (DWI) images in investigation of tacrolimus (FK-506) encephalopathy, and to see whether we could predict its cause from clinical and imaging data. In seven patients with presumed FK-506 toxicity the areas involved on MRI were similar to those in cyclosporin A (CsA) toxicity. The abnormal signal was most evident on FLAIR in all cases. In three of four patients who underwent DWI, no diffusion abnormalities were detected; in the remaining patient, increased diffusion was seen in the deep white matter bilaterally on the apparent diffusion coefficient map, consistent with the findings on T2-weighted spin-echo and FLAIR images. Five of the six patients for whom we had clinical data showed sudden changes in electrolyte or fluid equilibrium due to diarrhoea, a polyuria or oliguria one day before or on the day of onset of the central nervous system disturbances. We speculate that FK-506 encephalopathy is triggered by the disturbance of the electrolyte and/or fluid equilibrium, given a certain serum level of FK-506. (orig.)

  5. Transferring skills in quality collaboratives focused on improving patient logistics

    NARCIS (Netherlands)

    J.W.M. Weggelaar-Jansen (Anne Marie); J.D.H. van Wijngaarden (Jeroen)

    2018-01-01

    textabstractA quality improvement collaborative, often used by the Institute for Healthcare Improvement, is used to educate healthcare professionals and improve healthcare at the same time. Our research focused on quality improvement collaboratives aiming to improve patient logistics and tried to

  6. Conversion from tacrolimus-mycophenolate mofetil to tacrolimus-mTOR immunosuppression after kidney-pancreas transplantation reduces the incidence of both BK and CMV viremia.

    Science.gov (United States)

    Knight, Richard J; Graviss, Edward A; Nguyen, Duc T; Kuten, Samantha A; Patel, Samir J; Gaber, Lillian; Gaber, A Osama

    2018-04-19

    We sought to determine whether conversion from tacrolimus/mycophenolate mofetil (TAC-MMF) into tacrolimus/mTOR inhibitor (TAC-mTOR) immunosuppression would reduce the incidences of BK and CMV viremia after kidney/pancreas (KP) transplantation. In this single-center review, the TAC-mTOR cohort (n = 39) was converted at 1 month post-transplant to an mTOR inhibitor and reduced-dose tacrolimus. Outcomes were compared to a cohort of KP recipients (n = 40) maintained on TAC-MMF. At 3 years post-transplant, KP survivals and incidences of kidney/pancreas rejection were equivalent between mTOR and MMF-treated cohorts. (P = ns). BK viremia-free survival was better for the mTOR vs MMF-treated group (P = .004). In multivariate analysis, MMF vs mTOR immunosuppression was an independent risk factor for BK viremia (hazard ratio 12.27, P = .02). Similarly, mTOR-treated recipients displayed better CMV infection-free survival compared to the MMF-treated cohort (P = .01). MMF vs mTOR immunosuppression (hazard ratio 18.77, P = .001) and older recipient age (hazard ratio 1.13 per year, P = .006) were independent risk factors for CMV viremia. Mean estimated GFR and HgbA1c levels were equivalent between groups at 1, 2, and 3 years post-transplantation. Conversion from TAC/MMF into TAC/mTOR immunosuppression after KP transplantation reduced the incidences of BK and CMV viremia with an equivalent risk of acute rejection and similar renal/pancreas function. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. COMPARATIVE ANALYSIS OF SOLUBLE OF CD40 LIGAND LEVELS IN HEART RECIPIENTS TREATED WITH CYCLOSPORINE A AND TACROLIMUS

    Directory of Open Access Journals (Sweden)

    O. P. Shevchenko

    2012-01-01

    Full Text Available Soluble form of CD40L is platelet activating factor, which is a marker of inflammation and thrombosis. Elevated levels of sCD40L before the heart transplantation are associated with the risk of early development of cardiova- scular complications. The study included 54 patients who had received heart transplants. All recipients received a triple heart immu- nosuppressive therapy, including methylprednisolone, mycophenolate mofetil and cyclosporine A (20 recipients or methylprednisolone, mycophenolate mofetil and tacrolimus (34 recipients. Patients were not differed by age, gender, etiology of heart failure before heart transplantation (p > 0,05. In the first group of transplant recipients, the relative risk of cardiovascular events with high sCD40L levels before transplantation was 3 2 (95% CI 1,4; 12,0. In the second group of recipients, respectively, 2.69 (95% CI 1,1; 8,5. SCD40L level after heart transplan- tation was significantly higher for patients receiving cyclosporine (P < 0.05. Increasing concentrations of sCD40L are associated with a higher incidence of cardiovascular complications. 

  8. Plaque-Like Sclerodermiform Localized Mucinosis Rapidly Responsive to Topical Tacrolimus

    Directory of Open Access Journals (Sweden)

    R. Schmaltz

    2010-08-01

    Full Text Available We report the successful treatment of plaque-like sclerodermiform mucinosis using tacrolimus ointment topically. We present a 70-year-old male with a large chronic erythema and hardening of the nuchal skin and shoulder area. Subjective symptoms were a moderate pruritus and a rather disabling stiffness. A biopsy specimen revealed typical features of lichen myxedematosus. In a subsequent clinical examination, no associated illnesses such as hypothyroidism or gammopathy were found. Since no established therapy exists for this condition, and as there was a lack of response to potent topical glucocorticosteroids, tacrolimus 0.03% ointment was used off-label twice daily. Surprisingly, this resulted in a rapid, almost complete clearance of the skin within three weeks of treatment.

  9. Ação do tacrolimus na pancreatite aguda experimental induzida pela arginina

    Directory of Open Access Journals (Sweden)

    Marlus Moreira

    Full Text Available OBJETIVO: verificar se o tacrolimus administrado em ratos, em vigência de pancreatite induzida pela L-Arginina, interfere nos níveis séricos da amilase e glicose e no padrão histológico do parênquima pancreático. MÉTODOS: quarenta ratos Wistar foram distribuídos em quatro grupos com 10 ratos cada. Grupo controle (C, grupo tacrolimus (T, grupo pancreatite (P e grupo pancreatite-tacrolimus (PT. Foram avaliados os níveis séricos de amilase, glicose e tacrolimus e feitas avaliações histológicas do pâncreas, A indução de pancreatite foi feita pela inoculação de L-Arginina na dose de 500mg/100g de peso corporal por via intraperitoneal e o tratamento com tacrolimus na dose de 1ìg/kg por via subcutânea durante quatro dias. RESULTADOS: a amilasemia estava mais elevada (p=0,0000 nos grupos PT, T e P do que no grupo controle. A média do grupo PT foi maior (p=0,0009 que a do grupo T, mas não diferiu (p=0,6802 da média do grupo P. Entre os grupos P e T não houve diferença (p=0,2568. Não houve diferença nas médias de glicemia entre os grupos (p=0,4920 e os níveis séricos de tacrolimus foram similares nos grupos PT e T (p=0,7112. Não ocorreram alterações histológicas nos grupos T e C e não ocorreu hemorragia no pâncreas dos ratos dos grupos P e PT. No grupo P, em 30% não se observou edema, em 20% observou-se a forma leve e em 50%, a moderada; quanto à infiltração inflamatória, em 80% moderada e em 20% não ocorreu, e a atrofia do parênquima foi de 60% moderada e 40% acentuada. No grupo PT, houve ocorrência de edema, infiltração inflamatória e atrofia do pâncreas em todos os ratos. CONCLUSÃO: o tratamento pelo tacrolimus induziu aumento nos níveis séricos de amilase em ratos normais, não alterou a glicemia nem o padrão histológico do parênquima pancreático. Na vigência de pancreatite induzida pela L-Arginina o tacrolimus induziu edema, infiltração inflamatória e atrofia com maior gravidade no par

  10. Improving Patient Safety With the Military Electronic Health Record

    National Research Council Canada - National Science Library

    Charles, Marie-Jocelyne; Harmon, Bart J; Jordan, Pamela S

    2005-01-01

    The United States Department of Defense (DoD) has transformed health care delivery in its use of information technology to automate patient data documentation, leading to improvements in patient safety...

  11. Beyond consent--improving understanding in surgical patients.

    LENUS (Irish Health Repository)

    Mulsow, Jürgen J W

    2012-01-01

    Little is known of the actual understanding that underlies patient choices with regard to their surgical treatment. This review explores current knowledge of patient understanding and techniques that may be used to improve this understanding.

  12. Synergistic Antitumor Effect of Doxorubicin and Tacrolimus (FK506 on Hepatocellular Carcinoma Cell Lines

    Directory of Open Access Journals (Sweden)

    Francesca Capone

    2014-01-01

    Full Text Available Hepatocellular carcinoma is the fifth most common cancer worldwide and shows a complex clinical course, poor response to pharmacological treatment, and a severe prognosis. Thus, the aim of this study was to investigate whether tacrolimus (FK506 has synergistic antitumor effects with doxorubicin on two human hepatocellular carcinoma cell lines, Huh7 and HepG2. Cell viability was analyzed by Sulforhodamine B assay and synergic effect was evaluated by the software CalcuSyn. Cell apoptosis was evaluated using Annexin V and Dead Cell assay. Apoptosis-related protein PARP-1 cleaved and autophagy-related protein expressions (Beclin-1 and LC3B were measured by western blotting analysis. Cytokines concentration in cellular supernatants after treatments was studied by Bio-Plex assay. Interestingly the formulation with doxorubicin and tacrolimus induced higher cytotoxicity level on tumor cells than single treatment. Moreover, our results showed that the mechanisms involved were (i a strong cell apoptosis induction, (ii contemporaneous decrease of autophagy activation, understood as prosurvival process, and (iii downregulation of proinflammatory cytokines. In conclusion, future studies could relate to the doxorubicin/tacrolimus combination effects in mice models bearing HCC in order to see if this formulation could be useful in HCC treatment.

  13. High Intrapatient Variability of Tacrolimus Exposure in the Early Period After Liver Transplantation Is Associated With Poorer Outcomes.

    Science.gov (United States)

    Rayar, Michel; Tron, Camille; Jézéquel, Caroline; Beaurepaire, Jean Marie; Petitcollin, Antoine; Houssel-Debry, Pauline; Camus, Christophe; Verdier, Marie Clémence; Dehlawi, Ammar; Lakéhal, Mohamed; Desfourneaux, Véronique; Meunier, Bernard; Sulpice, Laurent; Bellissant, Eric; Boudjema, Karim; Lemaitre, Florian

    2018-03-01

    Tacrolimus (TAC) is the cornerstone of immunosuppressive regimen in liver transplantation (LT). Its pharmacokinetics is characterized by a high interpatient and intrapatient variability (IPV) leading to an unpredictable dose-response relationship. The aim of our study was to evaluate the impact of TAC IPV (IPV) on graft and patient outcomes after LT. We retrospectively analyzed 812 LT recipients treated with TAC. The IPV of TAC concentrations was estimated by calculating the coefficient of variation (CV) of whole blood trough concentrations. Patients were categorized in 2 groups: low IPV (CV < 40%) and high IPV (CV ≥ 40%). There were significantly more neurologic complications (31.2% vs 16.6%, P < 0.001), cardiovascular complications (19.7% vs 9.7%, P < 0.001), and acute renal failure requiring dialysis (8.5% vs 2.2%, P < 0.001) in the high CV group than in the low CV group. Moreover, graft survival was significantly poorer in the high CV group (hazard ratio, 1.42; 95% confidence interval, 1.04-1.95; P = 0.03). A pretransplantation elevated Model for End-Stage Liver Disease score (P < 0.001) and Child-Pugh grade (P < 0.001) were identified as risk factors for presenting a high CV. A high CV of TAC concentrations was found to be predictive of TAC-related toxicity and poorer survival.

  14. Age and Early Graft Function Relate With Risk-Benefit Ratio of Allogenic Islet Transplantation Under Antithymocyte Globulin-Mycophenolate Mofetil-Tacrolimus Immune Suppression.

    Science.gov (United States)

    Lee, DaHae; Keymeulen, Bart; Hilbrands, Robert; Ling, Zhidong; Van de Velde, Ursule; Jacobs-Tulleneers-Thevissen, Daniel; Maleux, Geert; Lapauw, Bruno; Crenier, Laurent; De Block, Christophe; Mathieu, Chantal; Pipeleers, Daniel; Gillard, Pieter

    2017-09-01

    Induction therapy with a T cell-depleting agent followed by mycophenolate mofetil and tacrolimus is presently the most frequently used immune suppression (IS) regimen in islet transplantation. This study assesses its safety and tolerability in nonuremic type 1 diabetic recipients. Fifty-one patients (age, between 29 and 63 years) with high glycemic variability and problematic hypoglycemia received intraportal islet grafts under anti-thymocyte globulin-mycophenolate mofetil-tacrolimus protocol. They were followed up for over 48 months for function of the implant and adverse events. Severe hypoglycemia and diabetic ketoacidosis were absent in patients with functioning graft. Immune suppressive therapy was maintained for 48 months in 29 recipients with sustained function (group A), whereas 16 patients stopped earlier due to graft failure (group B) and in 6 for other reasons. Group A was significantly older at the time of implantation and achieved higher graft function at posttransplantation month 6 under similar dose of IS. Prevalence of IS-related side effects was similar in groups A and B, occurring predominantly during the first year posttransplantation. IS-related serious adverse events (SAE) were reported in 47% of patients, with 4 presenting with cytomegalovirus infection and 4 (age, 42-59 years) diagnosed with cancer. Except in 1 patient with cancer, all SAEs resolved after appropriate treatment. These risk/benefit data serve as a basis for clinical decision-making before entering an intraportal islet transplantation protocol. A longer benefit is observed in recipients of higher age (≥40 years), but it is not associated with more side effects and SAE.

  15. A cohort study on the risk of lymphoma and skin cancer in users of topical tacrolimus, pimecrolimus, and corticosteroids (Joint European Longitudinal Lymphoma and Skin Cancer Evaluation – JOELLE study

    Directory of Open Access Journals (Sweden)

    Castellsague J

    2018-03-01

    -years were 10.4 events in children and 41.0 events in adults using tacrolimus and 3.0 events in children and 27.0 events in adults using pimecrolimus. The IRR (95% confidence interval [CI] for lymphoma, tacrolimus versus TCSs, was 3.74 (1.00–14.06 in children and 1.27 (0.94–1.71 in adults. By lymphoma type, the highest IRR was 3.17 (0.58–17.23 for Hodgkin lymphoma in children and 1.76 (95% CI, 0.81–3.79 for cutaneous T-cell lymphoma (CTCL in adults. For pimecrolimus versus TCSs, the highest IRR was 1.31 (95% CI, 0.33–5.14 for CTCL in adults. Compared with untreated subjects, adults using TCSs had a higher incidence of CTCL (IRR, 10.66; 95% CI, 2.60–43.75. Smaller associations were found between tacrolimus and pimecrolimus use and the risk of malignant melanoma or nonmelanoma skin cancer.Conclusion: Use of topical tacrolimus and pimecrolimus was associated with an increased risk of lymphoma. The low IRs imply that even if the increased risk is causal, it represents a small excess risk for individual patients. Residual confounding by severity of atopic dermatitis, increased monitoring of severe patients, and reverse causation could have affected the results. Keywords: topical calcineurin inhibitors, cutaneous T-cell lymphoma, malignant melanoma skin cancer, database study

  16. Sugammadex Improves Neuromuscular Function in Patients ...

    African Journals Online (AJOL)

    2018-02-23

    Feb 23, 2018 ... aminoglycosides), history of allergy to neuromuscular blocking agents, opioids or other drugs, and alcohol and drug dependence. Patients were divided into two ... titration microcalorimetry investigated the likelihood of the formation of complexes between sugammadex and other steroidal and nonsteroidal ...

  17. Improved patient selection by stratified surgical intervention

    DEFF Research Database (Denmark)

    Wang, Miao; Bünger, Cody E; Li, Haisheng

    2015-01-01

    BACKGROUND CONTEXT: Choosing the best surgical treatment for patients with spinal metastases remains a significant challenge for spine surgeons. There is currently no gold standard for surgical treatments. The Aarhus Spinal Metastases Algorithm (ASMA) was established to help surgeons choose...... the most appropriate surgical intervention for patients with spinal metastases. PURPOSE: The purpose of this study was to evaluate the clinical outcome of stratified surgical interventions based on the ASMA, which combines life expectancy and the anatomical classification of patients with spinal metastases...... survival times in the five surgical groups determined by the ASMA were 2.1 (TS 0-4, TC 1-7), 5.1 (TS 5-8, TC 1-7), 12.1 (TS 9-11, TC 1-7 or TS 12-15, TC 7), 26.0 (TS 12-15, TC 4-6), and 36.0 (TS 12-15, TC 1-3) months. The 30-day mortality rate was 7.5%. Postoperative neurological function was maintained...

  18. Improving quality of life in patients with hidradenitis suppurativa

    DEFF Research Database (Denmark)

    Dufour, D.N.; Esmann, S.; Jemec, G.B.

    2012-01-01

    Hidradenitis suppurativa is a chronic recurrent inflammatory skin disease with abscess formation and scarring predominantly in the inverse areas. The disease is often difficult to treat and patients experience a decreased quality of life (QoL) and related psychosocial morbidity. Current knowledge...... on improving QoL in patients with hidradenitis suppurativa is therefore reviewed. The literature is limited but indicates that there are two ways of improving patients' QoL: therapy of the somatic disease or psychosocial interventions....

  19. Lean Manufacturing Improves Emergency Department Throughput and Patient Satisfaction.

    Science.gov (United States)

    Kane, Marlena; Chui, Kristen; Rimicci, Janet; Callagy, Patrice; Hereford, James; Shen, Sam; Norris, Robert; Pickham, David

    2015-09-01

    A multidisciplinary team led by nursing leadership and physicians developed a plan to meet increasing demand and improve the patient experience in the ED without expanding the department's current resources. The approach included Lean tools and engaged frontline staff and physicians. Applying Lean management principles resulted in quicker service, improved patient satisfaction, increased capacity, and reduced resource utilization. Incorporating continuous daily management is necessary for sustainment of continuous improvement activities.

  20. Improving patient-centredness in partnership with female patients: a cluster RCT in fertility care

    NARCIS (Netherlands)

    Huppelschoten, A.G.; Nelen, W.L.D.M.; Westert, G.P.; Golde, R.J.T. van; Adang, E.M.M.; Kremer, J.A.M.

    2015-01-01

    QUESTION: What is the effect of a multifaceted intervention with participation of patients on improvement of patient-centredness in fertility care? SUMMARY ANSWER: A multifaceted intervention with participation of patients did not improve total patient-centredness scores provided by women in

  1. Nephro and neurotoxicity of calcineurin inhibitors and mechanisms of rejections: A review on tacrolimus and cyclosporin in organ transplantation.

    Science.gov (United States)

    Tolou-Ghamari, Zahra

    2012-04-01

    In the meadow of medical sciences substituting a diseased organ with a healthy one from another individual, dead or alive, to allow a human to stay alive could be consider as the most string event. In this article we review the history of transplantation, mechanisms of rejection, nephro-neurotoxicity of tacrolimus and cyclosporin in organ transplantations. Directory of Open Access Journals (DOAJ), Google Scholar, Pubmed (NLM), LISTA (EBSCO) and Web of Science have been searched. The first reference to the concept of organ transplantation and replacement for therapeutic purposes appears to be to Hua-To (136 to 208 A.D), who replaced diseased organs with healthy ones in patients under analgesia induced with a mixture of Indian hemp. In 1936, the first human renal transplant performed by Voronoy in Russia. The first liver transplant in humans was performed on March 1, 1963 by Starzl in Denver, USA. Medawar was the first to assert that rejection was an immunological response, with the inflammatory reaction due to lymphocyte infiltration. Consequently, rational immunosuppressive therapies could inhibit deleterious T-cell responses in an antigen specific manner. Searching related to the history of organ transplantation from mythic to modern times suggests that, to prevent graft rejection, minimize nephro and neuro toxicity monitoring of immunosupressive concentrations could provide an invaluable and essential aid in adjusting dosage to ensure adequate immunosuppression.

  2. Tacrolimus Modulates TGF-β Signaling to Induce Epithelial-Mesenchymal Transition in Human Renal Proximal Tubule Epithelial Cells

    Directory of Open Access Journals (Sweden)

    Jason Bennett

    2016-04-01

    Full Text Available Epithelial-mesenchymal transition (EMT, a process which describes the trans-differentiation of epithelial cells into motile mesenchymal cells, is pivotal in stem cell behavior, development and wound healing, as well as contributing to disease processes including fibrosis and cancer progression. Maintenance immunosuppression with calcineurin inhibitors (CNIs has become routine management for renal transplant patient, but unfortunately the nephrotoxicity of these drugs has been well documented. HK-2 cells were exposed to Tacrolimus (FK506 and EMT markers were assessed by RT PCR and western blot. FK506 effects on TGF-β mRNA were assessed by RT PCR and TGF-β secretion was measured by ELISA. The impact of increased TGF-β secretion on Smad signaling pathways was investigated. The impact of inhibition of TGF-β signaling on EMT processes was assessed by scratch-wound assay. The results presented in this study suggest that FK506 initiates EMT processes in the HK-2 cell line, with altered expression of epithelial and myofibroblast markers evident. Additionally, the study demonstrates that FK506 activation of the TGF-β/ SMAD pathways is an essential step in the EMT process. Overall the results demonstrate that EMT is heavily involved in renal fibrosis associated with CNI nephrotoxicity.

  3. Simultaneous Determination of Cyclosporine A, Tacrolimus, Sirolimus, and Everolimus in Whole-Blood Samples by LC-MS/MS

    Directory of Open Access Journals (Sweden)

    Mustafa Karapirli

    2012-01-01

    Full Text Available Objectives. Cyclosporine A (CyA, tacrolimus (TRL, sirolimus (SIR, and everolimus (RAD are immunosuppressive drugs frequently used in organ transplantation. Our aim was to confirm a robust sensitive and selective liquid chromatography-tandem mass spectrometry (LC-MS/MS method for determination of CyA, TRL, SIR, and RAD in whole-blood samples. Materials and Methods. We used an integrated online solid-phase extraction-LC-MS/MS system and atmospheric pressure ionization tandem mass spectrometry (API-MS/MS in the multiple reaction monitoring (MRM detection mode. CyA, TRL, SIR, and RAD were simultaneously analyzed in whole blood treated with precipitation reagent taken from transplant patients. Results. System performance parameters were suitable for using this method as a high-throughput technique in clinical practice. The high concentration of one analyte in the sample did not affect the concentration of other analytes. Total analytical time was 2.5 min, and retention times of all analytes were shorter than 2 minutes. Conclusion. This LC-MS/MS method can be preferable for therapeutic drug monitoring of these immunosuppressive drugs (CyA, TRL, SRL, and RAD in whole blood. Sample preparation was too short and simple in this method, and it permits robust, rapid, sensitive, selective, and simultaneous determination of these drugs.

  4. Calcineurin inhibitors acutely improve insulin sensitivity without affecting insulin secretion in healthy human volunteers

    DEFF Research Database (Denmark)

    Øzbay, Aygen; Møller, Niels; Juhl, Claus

    2012-01-01

    and tacrolimus has been attributed to both beta cell dysfunction and impaired insulin sensitivity. WHAT THIS STUDY ADDS: This is the first trial to investigate beta cell function and insulin sensitivity using gold standard methodology in healthy human volunteers treated with clinically relevant doses...... of ciclosporin and tacrolimus. We document that both drugs acutely increase insulin sensitivity, while first phase and pulsatile insulin secretion remain unaffected. This study demonstrates that ciclosporin and tacrolimus have similar acute effects on glucose metabolism in healthy humans. AIM The introduction...... of calcineurin inhibitors (CNIs) ciclosporin (CsA) and tacrolimus (Tac) has improved the outcome of organ transplants, but complications such as new onset diabetes mellitus after transplantation (NODAT) cause impairment of survival rates. The relative contribution of each CNI to the pathogenesis and development...

  5. Involving patients in care decisions improves satisfaction: an outcomes-based quality improvement project.

    Science.gov (United States)

    Leff, Ellen W

    2004-05-01

    A home care agency used quality improvement processes to improve patient satisfaction survey ratings. The focus was on involving patients in decisions about their care. A multidisciplinary team developed creative strategies to increase staff awareness and enhance customer service skills, which had dramatic results.

  6. Utilizing a disease management approach to improve ESRD patient outcomes.

    Science.gov (United States)

    Anand, Shaan; Nissenson, Allen R

    2002-01-01

    In this era of processes and systems to improve quality, disease management is one methodology to improve care delivery and outcomes for patients with chronic kidney disease (CKD). In most disease management systems a senior renal nurse coordinates all aspects of the patient's care and ensures that the prescribed and necessary care is delivered for both CKD-related and comorbid conditions. The nurse also continually monitors outcomes on quality indicators and key performance measures. These outcome data are then aggregated and analyzed, are compared with local and national benchmarks, and drive the continuous quality improvement (CQI) process. Such a system attempts to centralize the currently fragmented care delivery system, continually improve patient outcomes, and conserve scarce economic resources. Early data suggest a disease management approach may improve both the morbidity and mortality of CKD patients.

  7. Improved patient-reported health impact of multiple sclerosis

    DEFF Research Database (Denmark)

    Macdonell, Richard; Nagels, Guy; Laplaud, David-Axel

    2016-01-01

    BACKGROUND: Multiple sclerosis (MS) is a debilitating disease that negatively impacts patients' lives. OBJECTIVE: ENABLE assessed the effect of long-term prolonged-release (PR) fampridine (dalfampridine extended release in the United States) treatment on patient-perceived health impact in patients...... with MS with walking impairment. METHODS: ENABLE was a 48-week, open-label, Phase 4 study of PR-fampridine 10 mg twice daily. Patients who showed any improvement in Timed 25-Foot Walk walking speed at weeks 2 and 4 and any improvement in 12-item MS Walking Scale score at week 4 remained on treatment....... The primary endpoint was change from baseline in 36-Item Short-Form Health Survey (SF-36) physical component summary (PCS) score. RESULTS: At week 4, 707/901 (78.5%) patients met the criteria to remain on treatment. Patients on treatment demonstrated significant and clinically meaningful improvements in SF-36...

  8. Patient web portals to improve diabetes outcomes: a systematic review.

    Science.gov (United States)

    Osborn, Chandra Y; Mayberry, Lindsay Satterwhite; Mulvaney, Shelagh A; Hess, Rachel

    2010-12-01

    Patient web portals (PWPs), defined as the integration of electronic medical records and patient health records, have been related to enhanced patient outcomes. A literature review was conducted to characterize the design and evaluation of PWPs to improve health care processes and outcomes in diabetes. A summary of 26 articles revealed the positive impact PWPs have on patient outcomes, patient-provider communication, disease management, and access to and patient satisfaction with health care. Innovative and useful approaches included the evaluation of specific components of the PWPs, assessing the impact of PWPs on mediators of health behaviors, such as patient distress, identification of barriers to use, and patient willingness to pay for access. Future research should focus on relevant processes that mediate patient and provider use, impact on health care utilization, and a patient-centered approach to the design and integration of educational opportunities afforded through PWPs.

  9. Quality Improvement Project to Improve Patient Satisfaction With Pain Management: Using Human-Centered Design.

    Science.gov (United States)

    Trail-Mahan, Tracy; Heisler, Scott; Katica, Mary

    2016-01-01

    In this quality improvement project, our health system developed a comprehensive, patient-centered approach to improving inpatient pain management and assessed its impact on patient satisfaction across 21 medical centers. Using human-centered design principles, a bundle of 6 individual and team nursing practices was developed. Patient satisfaction with pain management, as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems pain composite score, increased from the 25th to just under the 75th national percentile.

  10. Preoperative patient education: can we improve satisfaction and reduce anxiety?

    Directory of Open Access Journals (Sweden)

    Jaime Ortiz

    2015-02-01

    Full Text Available BACKGROUND AND OBJECTIVES: Patients' knowledge deficits concerning anesthesia and the anesthesiologist's role in their care may contribute to anxiety. The objective of this study was to develop anesthesia patient education materials that would help improve patient's satisfaction regarding their knowledge of the perioperative process and decrease anxiety in a community hospital with a large Spanish-speaking population. METHODS: A survey (Survey A in English and Spanish was administered to all adult anesthesiology preoperative clinic patients during a 4-week period. The data were analyzed and then a patient education handout was developed in both English and Spanish to assist with our patients' major concerns. A second survey (Survey B was administered that was completed after the education handout had been put into use at the clinic. The survey asked for basic demographic information and included questions on satisfaction with regard to understanding of anesthesia as well as worries regarding surgery and pain. RESULTS: In the patients who received the handout, statistically significant improvement was found in the questions that asked about satisfaction with regard to understanding of type of anesthesia, options for pain control, what patients are supposed to do on the day of surgery, and the amount of information given with regard to anesthetic plan. There was no difference in anxiety related to surgery in patients who received the educational handout compared to those patients who did not. CONCLUSIONS: Patient education handouts improved patient's satisfaction regarding their knowledge of the perioperative process but did not reduce anxiety related to surgery.

  11. Stability of tacrolimus injection diluted in 0.9% sodium chloride injection and stored in Excel bags.

    Science.gov (United States)

    Myers, Alan L; Zhang, Yanping; Kawedia, Jitesh D; Shank, Brandon R; Deaver, Melissa A; Kramer, Mark A

    2016-12-15

    The chemical stability and physical compatibility of tacrolimus i.v. infusion solutions prepared in Excel bags and stored at 23 or 4 °C for up to nine days were studied. Tacrolimus admixtures (2, 4, and 8 μg/mL) were prepared in Excel bags using 0.9% sodium chloride injection and stored at 23 °C without protection from light or at 4 °C in the dark. Test samples were withdrawn from triplicate bag solutions immediately after preparation and at predetermined time intervals (1, 3, 5, 7, and 9 days). Chemical stability was assessed by measuring tacrolimus concentrations using a validated stability-indicating high-performance liquid chromatography assay. The physical stability of the admixtures was assessed by visual examination and by measuring turbidity, particle size, and drug content. All test solutions stored at 23 or 4 °C had a no greater than 6% loss of the initial tacrolimus concentration throughout the nine-day study period. All test samples of tacrolimus admixtures, under both storage conditions, were without precipitation and remained clear initially and throughout the nine-day observation period. Changes in turbidities were minor; measured particulates remained few in number in all samples throughout the study. Extemporaneously prepared infusion solutions of tacrolimus 2, 4, and 8 μg/mL in 0.9% sodium chloride injection in Excel bags were chemically and physically stable for at least nine days when stored at room temperature (23 °C) without protection from light and when stored in a refrigerator (4 °C) in the dark. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  12. TEL4Health – Mobile tools to improve patient safety

    NARCIS (Netherlands)

    Drachsler, Hendrik; Kalz, Marco; Specht, Marcus

    2013-01-01

    Drachsler, H., Kalz, M., & Specht, M. (2013, 10 October). TEL4Health – Mobile tools to improve patient safety. Presentation given at the blended learning platform of the Netherlands Organisation for Hospitals (Nederlandse Vereniging van Ziekenhuizen), Utrecht, The Netherlands.

  13. Inhaler Reminders Significantly Improve Asthma Patients' Use of Controller Medications

    Science.gov (United States)

    ... controller medications Share | Inhaler reminders significantly improve asthma patients’ use of controller medications Published Online: July 22, ... the burden and risk of asthma, but many patients do not use them regularly. This poor adherence ...

  14. Improving stroke care for patients at Cavan hospital [poster

    LENUS (Irish Health Repository)

    Murugasu, G Dr.

    2013-07-01

    Under the Quality and Continuing Care Directorate (QCCD) in stroke care Cavan General Hospital was identified as a hospital that received a large number of stroke and TIA patients. A programme was established to improve services to this population.

  15. Does external evaluation of laboratories improve patient safety?

    Science.gov (United States)

    Noble, Michael A

    2007-01-01

    Laboratory accreditation and External Quality Assessment (also called proficiency testing) are mainstays of laboratory quality assessment and performance. Both practices are associated with examples of improved laboratory performance. The relationship between laboratory performance and improved patient safety is more difficult to assess because of the many variables that are involved with patient outcome. Despite this difficulty, the argument to continue external evaluation of laboratories is too compelling to consider the alternative.

  16. Tumid lupus erythematosus: An intriguing dermatopathological connotation treated successfully with topical tacrolimus and hydroxyxhloroquine combination

    Directory of Open Access Journals (Sweden)

    Prashant Verma

    2014-01-01

    Full Text Available Tumid lupus erythematosus (LE is a rare variant of lupus erythematosus, which often follows a favorable course. A case of a young woman is illustrated, who presented with an asymptomatic erythematous, solitary plaque over her face. Histopathological and direct immunofluorescence examination established a diagnosis of tumid lupus erythematosus. She responded slowly and near-completely to hydroxychloroquine sulfate; however, a flare up occurred a month later. Addition of topical tacrolimus 0.1% resulted in complete regression without leaving any residual changes. No recurrence was seen subsequently.

  17. Tumid Lupus Erythematosus: An Intriguing Dermatopathological Connotation Treated Successfully with Topical Tacrolimus and Hydroxyxhloroquine Combination

    Science.gov (United States)

    Verma, Prashant; Sharma, Sonal; Yadav, Pravesh; Namdeo, Chaitanya; Mahajan, Garima

    2014-01-01

    Tumid lupus erythematosus (LE) is a rare variant of lupus erythematosus, which often follows a favorable course. A case of a young woman is illustrated, who presented with an asymptomatic erythematous, solitary plaque over her face. Histopathological and direct immunofluorescence examination established a diagnosis of tumid lupus erythematosus. She responded slowly and near-completely to hydroxychloroquine sulfate; however, a flare up occurred a month later. Addition of topical tacrolimus 0.1% resulted in complete regression without leaving any residual changes. No recurrence was seen subsequently. PMID:24700961

  18. Improving patient satisfaction with pain management using Six Sigma tools.

    Science.gov (United States)

    DuPree, Erin; Martin, Lisa; Anderson, Rebecca; Kathuria, Navneet; Reich, David; Porter, Carol; Chassin, Mark R

    2009-07-01

    Patient satisfaction as a direct and public measure of quality of care is changing the way hospitals address quality improvement. The feasibility of using the Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) methodology to improve patient satisfaction as it relates to pain management was evaluated. This project used the DMAIC methodology to improve patients' overall satisfaction with pain management on two inpatient units in an urban academic medical center. Pre- and postintervention patient surveys were conducted. The DMAIC methodology provided a data-driven structure to determine the optimal improvement strategies, as well as a long-term plan for maintaining any improvements. In addition, the Change Acceleration Process (CAP) was used throughout the project's various DMAIC stages to further the work of the team by creating a shared need to meet the objectives of the project. Overall satisfaction with pain management "excellent" ratings increased from 37% to 54%. Both units surpassed the goal of at least 50% of responses in the "excellent" category. Several key drivers of satisfaction with pain management were uncovered in the Analyze phase of the project, and each saw rating increases from the pre-intervention to postintervention surveys. Ongoing monitoring by the hospital inpatient satisfaction survey showed that the pain satisfaction score improved in subsequent quarters as compared with the pre-intervention period. The Six Sigma DMAIC methodology can be used successfully to improve patient satisfaction. The project led to measurable improvements in patient satisfaction with pain management, which have endured past the duration of the Six Sigma project. The Control phase of DMAIC allows the improvements to be incorporated into daily operations.

  19. Analytical performance evaluation of the Elecsys® Cyclosporine and Elecsys® Tacrolimus assays on the cobas e411 analyzer

    Directory of Open Access Journals (Sweden)

    Maki Sasano

    2017-08-01

    Full Text Available Background: Cyclosporine (CsA and tacrolimus (TAC are immunosuppressant drugs that are often used to treat autoimmune diseases and as transplantation therapy; therefore, their concentrations need to be monitored carefully. We herein evaluated the analytical performance of the Elecsys® Cyclosporine and Elecsys® Tacrolimus assay kits, which have been newly developed to measure CsA and TAC concentrations in the whole blood. Methods: We used residual whole blood samples from autoimmune disease and transplantation patients who were being treated with CsA or TAC. CsA concentrations were measured using an affinity chrome-mediated immunoassay (ACMIA and an electrochemiluminescence immunoassay (ECLIA. TAC concentrations were measured using a chemiluminescence immunoassay (CLIA and ECLIA. We investigated assay precision, linearity, lower limit of quantitation (LOQ, stability of calibration, influence of interference substances and the hematocrit, correlation of ACMIA with ECLIA, and correlation of CLIA with ECLIA. Results: Within-assay coefficients of variation were 1.8−3.6% (CsA: 94−1238 ng/mL and 2.9−3.9% (TAC: 2.1−17.8 ng/mL, whereas day-to-day coefficients of variation ranged between 3.0−4.1% (CsA and 2.8−3.9% (TAC. The limits of quantitation were defined as the concentration at which the CV was approximately 10%. Each lower LOQ obtained was 16 ng/mL (CsA, and 0.95 ng/mL (TAC. CsA and TAC calibrations were stable for at least 21 days. Neither the presence of conjugated bilirubin, unconjugated bilirubin, chyle, and rheumatoid factor nor the hematocrit affected these assays. A method comparison using a standardized major axis regression analysis of ACMIA and ECLIA was r=0.995, y=0.924x −1.175, n=200 (CsA, while that of CLIA and ECLIA was r=0.994, y=1.080x −0.197, n=200 (TAC. Conclusions: The analytical performances of the Elecsys® Cyclosporine and Elecsys®Tacrolimus assays were acceptable

  20. Improving Pharmacy Student Communication Outcomes Using Standardized Patients.

    Science.gov (United States)

    Gillette, Chris; Rudolph, Michael; Rockich-Winston, Nicole; Stanton, Robert; Anderson, H Glenn

    2017-08-01

    Objective. To examine whether standardized patient encounters led to an improvement in a student pharmacist-patient communication assessment compared to traditional active-learning activities within a classroom setting. Methods. A quasi-experimental study was conducted with second-year pharmacy students in a drug information and communication skills course. Student patient communication skills were assessed using high-stakes communication assessment. Results. Two hundred and twenty students' data were included. Students were significantly more likely to have higher scores on the communication assessment when they had higher undergraduate GPAs, were female, and taught using standardized patients. Similarly, students were significantly more likely to pass the assessment on the first attempt when they were female and when they were taught using standardized patients. Conclusion. Incorporating standardized patients within a communication course resulted in improved scores as well as first-time pass rates on a communication assessment than when using different methods of active learning.

  1. Kinesthetic taping improves walking function in patients with stroke

    DEFF Research Database (Denmark)

    Boeskov, Birgitte; Carver, Line Tornehøj; von Essen-Leise, Anders

    2014-01-01

    BACKGROUND: Stroke is an important cause of severe disability and impaired motor function. Treatment modalities that improve motor function in patients with stroke are needed. The objective of this study was to investigate the effect of kinesthetic taping of the anterior thigh and knee on maximal...... be a valuable adjunct in physical therapy and rehabilitation of patients with stroke....

  2. Which patients improve the most from arthritis rehabilitation?

    DEFF Research Database (Denmark)

    Hagel, Sofia; Lindqvist, Elisabet; Petersson, Ingemar F

    2014-01-01

    Objective: To study health-related quality of life (HRQoL) in arthritis rehabilitation performed by multidisciplinary teams in patients with chronic inflammatory arthritis. Predictors of change in health-related quality of life and the proportion of patients with clinical improvement were investi...

  3. Using Cognitive Load Theory to Understand and Improve Patient Handoffs

    NARCIS (Netherlands)

    Young, J.Q.

    2016-01-01

    Introduction Transfers of patients from one physician to another (handovers) are ubiquitous and occur with increasing frequency. Handovers are a common source of communication failures, which lead to medical errors and harm to patients. Considerable attention has focused on interventions to improve

  4. Improving Patient Safety Culture in Primary Care: A Systematic Review

    NARCIS (Netherlands)

    Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J. M.; Wagner, Cordula; Zwart, Dorien L. M.

    Background: Patient safety culture, described as shared values, attitudes and behavior of staff in a health-care organization, gained attention as a subject of study as it is believed to be related to the impact of patient safety improvements. However, in primary care, it is yet unknown, which

  5. Patient and provider perspectives on improving the linkage of HIV ...

    African Journals Online (AJOL)

    This study examined barriers and facilitators to the linkage of HIV-positive pregnant women from antenatal care (ANC) to long-term HIV care from patient and provider perspectives, following the implementation of a collaborative quality improvement project in Eastern Uganda. It also solicited recommendations for improving ...

  6. Improving patient satisfaction through physician education, feedback, and incentives.

    Science.gov (United States)

    Banka, Gaurav; Edgington, Sarah; Kyulo, Namgyal; Padilla, Tony; Mosley, Virgie; Afsarmanesh, Nasim; Fonarow, Gregg C; Ong, Michael K

    2015-08-01

    Patient satisfaction has been associated with improved outcomes and become a focus of reimbursement. Evaluate an intervention to improve patient satisfaction. Nonrandomized, pre-post study that took place from 2011 to 2012. Large tertiary academic medical center. Internal medicine (IM) resident physicians, non-IM resident physicians, and adult patients of the resident physicians. IM resident physicians were provided with patient satisfaction education through a conference, real-time individualized patient satisfaction score feedback, monthly recognition, and incentives for high patient-satisfaction scores. Patient satisfaction on physician-related and overall satisfaction questions on the HCAHPS survey. We conducted a difference-in-differences regression analysis comparing IM and non-IM patient responses, adjusting for differences in patient characteristics. In our regression analysis, the percentage of patients who responded positively to all 3 physician-related Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) questions increased by 8.1% in the IM and 1.5% in the control cohorts (absolute difference 6.6%, P = 0.04). The percentage of patients who would definitely recommend this hospital to friends and family increased by 7.1% in the IM and 1.5% in the control cohorts (absolute difference 5.6%, P = 0.02). The national average for the HCAHPS outcomes studied improved by no more than 3.1%. This study was nonrandomized and was conducted at a single site. To our knowledge, this is the first intervention associated with a significant improvement in HCAHPS scores. This may serve as a model to increase patient satisfaction, hospital revenue, and train resident physicians. © 2015 Society of Hospital Medicine.

  7. TWO TOPICAL CALCINEURIN INHIBITORS FOR THE TREATMENT OF ATOPIC DERMATITIS IN PEDIATRIC PATIENTS: A META-ANALYSIS OF RANDOMIZED CLINICAL TRIALS (VARIANT OF THE ARTICLE IN RUSSIAN

    Directory of Open Access Journals (Sweden)

    S.L. Chen

    2011-01-01

    Full Text Available Two new topical immunomodulators, pimecrolimus cream and tacrolimus ointment for atopic dermatitis (AD in pediatric patients, have provided alternatives to topical corticosteroids without the associated adverse events. Objective: To evaluate the efficacy and safety of tacrolimus ointment and pimecrolimus cream for the treatment of AD in pediatric patients. MEDLINE, Embase, the CNKI and Cochrane Library databases were searched up to December 2008. Additional data sources were manual searches of abstract proceedings and personal contact with investigators and pharmaceutical companies. Two investigators assessed the quality of trials with unified tables independently. Disagreements on validity assessment were resolved through discussion or consultation with the third author. Quality analysis of methodology was evaluated according to the Jadad scale, including randomization, blinding and patients’ discontinuation. Twenty trials involving 6288 infants and children with AD met the inclusion criteria. More patients using tacrolimus had a good response than those in control groups including vehicle, 1% hydrocortisone acetate and 1% pimecrolimus, the corresponding OR were (4.56; 95%CI: 2.80 to 7.44, (3.92; 95% CI: 2.96 to 5.20 and (1.58; 95% CI: 1.18 to 2.12. The effect difference between 0.03% tacrolimus and 0.1% tacrolimus ointments was not statistically significant (OR = 0.90; 95% CI: 0.55 to 1.48. The incidence of adverse events of tacrolimus ointment or pimecrolimus cream was similar to the vehicle. The major adverse events were burning and pruritus. Both tacrolimus ointment and pimecrolimus cream are safe and effective in the treatment of AD in pediatric patients. Tacrolimus ointments were superior to pimecrolimus cream.Key words: atopic dermatitis, children, meta-analysis, pimecrolimus, tacrolimus.

  8. Improved quality of life in hyperthyroidism patients after surgery.

    Science.gov (United States)

    Bukvic, Branka; Zivaljevic, Vladan; Sipetic, Sandra; Diklic, Aleksandar; Tausanovic, Katarina; Stojanovic, Dragos; Stevanovic, Dejan; Paunovic, Ivan

    2015-02-01

    The most common causes of hyperthyroidism are Graves disease (GD) and toxic nodular goiter (TNG). GD and TNG might influence patients' quality of life (QoL). The aim of our study was to analyze and compare the QoL of patients with GD with that of TNG patients and to evaluate the influence of surgical treatment on their QoL. A prospective case-control study was conducted at the Center for Endocrine surgery in Belgrade, Serbia. The ThyPRO questionnaire was used in the QoL assessment of the GD and TNG patients (31 and 28, respectively) pre- and post-operatively. All patients were receiving antithyroid drugs, and none of the patients were overtly hyperthyroid at the time of completing the preoperative questionnaire. The QoL of the GD patients was worse than that of the TNG patients, with significant differences in eye symptoms, anxiety, and sex life domains (P < 0.001, P = 0.005, and P = 0.004, respectively), preoperatively, and in eye symptoms, anxiety, emotional susceptibility, and overall QoL (P = 0.001, P = 0.027, P = 0.005 and P = 0.013, respectively), postoperatively. The improvement in QoL in the GD patients was significant after surgical treatment in all ThyPRO domains. In the TNG patients, the improvement was significant in all but one ThyPRO domain, sex life (P = 0.066). The QoL of GD patients is worse than those of TNG patients. Surgery may improve QoL in patients with GD and TNG even if they have achieved satisfying thyroid status with medication treatment, preoperatively. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. Does receiving a copy of correspondence improve patients' satisfaction with their out-patient consultation?

    NARCIS (Netherlands)

    Saunders, N. C.; Georgalas, C.; Blaney, S. P. A.; Dixon, H.; Topham, J. H.

    2003-01-01

    It is standard practice to write to a patient's general practitioner (GP) following an out-patients consultation. This study set out to assess whether sending a copy of this letter to the patient improves their satisfaction with the consultation. Two hundred patients were randomly assigned to

  10. Patient handover in orthopaedics, improving safety using Information Technology.

    Science.gov (United States)

    Pearkes, Tim

    2015-01-01

    Good inpatient handover ensures patient safety and continuity of care. An adjunct to this is the patient list which is routinely managed by junior doctors. These lists are routinely created and managed within Microsoft Excel or Word. Following the merger of two orthopaedic departments into a single service in a new hospital, it was felt that a number of safety issues within the handover process needed to be addressed. This quality improvement project addressed these issues through the creation and implementation of a new patient database which spanned the department, allowing trouble free, safe, and comprehensive handover. Feedback demonstrated an improved user experience, greater reliability, continuity within the lists and a subsequent improvement in patient safety.

  11. Improving patients' and staff's experiences of acute care.

    Science.gov (United States)

    Chaplin, Rob; Crawshaw, Jacob; Hood, Chloe

    2015-03-01

    The aim of this audit was to assess the effect of the Quality Mark programme on the quality of acute care received by older patients by comparing the experiences of staff and older adults before and after the programme. Data from 31 wards in 12 acute hospitals were collected over two stages. Patients and staff completed questionnaires on the perceived quality of care on the ward. Patients rated improved experiences of nutrition, staff availability and dignity. Staff received an increase in training and reported better access to support, increased time and skill to deliver care and improved morale, leadership and teamwork. Problems remained with ward comfort and mealtimes. Overall, results indicated an improvement in ratings of care quality in most domains during Quality Mark data collection. Further audits need to explore ways of improving ward comfort and mealtime experience.

  12. Leveraging Interactive Patient Care Technology to Improve Pain Management Engagement.

    Science.gov (United States)

    Rao-Gupta, Suma; Kruger, David; Leak, Lonna D; Tieman, Lisa A; Manworren, Renee C B

    2017-12-15

    Most children experience pain in hospitals; and their parents report dissatisfaction with how well pain was managed. Engaging patients and families in the development and evaluation of pain treatment plans may improve perceptions of pain management and hospital experiences. The aim of this performance improvement project was to engage patients and families to address hospitalized pediatric patients' pain using interactive patient care technology. The goal was to stimulate conversations about pain management expectations and perceptions of treatment plan effectiveness among patients, parents, and health care teams. Plan-Do-Study-Act was used to design, develop, test, and pilot new workflows to integrate the interactive patient care technology system with the automated medication dispensing system and document actions from both systems into the electronic health record. The pediatric surgical unit and hematology/oncology unit of a free-standing, university-affiliated, urban children's hospital were selected to pilot this performance improvement project because of the high prevalence of pain from surgeries and hematologic and oncologic diseases, treatments, and invasive procedures. Documentation of pain assessments, nonpharmacologic interventions, and evaluation of treatment effectiveness increased. The proportion of positive family satisfaction responses for pain management significantly increased from fiscal year 2014 to fiscal year 2016 (p = .006). By leveraging interactive patient care technologies, patients and families were engaged to take an active role in pain treatment plans and evaluation of treatment outcomes. Improved active communication and partnership with patients and families can effectively change organizational culture to be more sensitive to patients' pain and patients' and families' hospital experiences. Copyright © 2017 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

  13. Educate patients on billing policies to improve your bottom line.

    Science.gov (United States)

    May, Jonathan

    2006-01-01

    In no other industry are the consumers of goods or services so unaware and uninvolved in the reimbursement for the goods or services received. The United States healthcare industry has created and allowed to perpetuate a "hands-off" compensation approach that has created a consumer mentality proving quite difficult to change. In this article, the author describes the origin of this outdated approach and suggests a restructured office and clear communication with patients as starting points to change this deep-rooted mind-set. He describes how an up-front approach to patients' financial responsibilities and proactive staff can help reduce miscommunication between provider, patient, and insurance carrier and improve your practice's cash flow. The author also suggests that the patient's financial burden will continue to increase and offers tips to maintain positive patient relationships, improve your accounts receivable management, and protect you financially.

  14. How patients can improve the accuracy of their medical records.

    Science.gov (United States)

    Dullabh, Prashila M; Sondheimer, Norman K; Katsh, Ethan; Evans, Michael A

    2014-01-01

    Assess (1) if patients can improve their medical records' accuracy if effectively engaged using a networked Personal Health Record; (2) workflow efficiency and reliability for receiving and processing patient feedback; and (3) patient feedback's impact on medical record accuracy. Improving medical record' accuracy and associated challenges have been documented extensively. Providing patients with useful access to their records through information technology gives them new opportunities to improve their records' accuracy and completeness. A new approach supporting online contributions to their medication lists by patients of Geisinger Health Systems, an online patient-engagement advocate, revealed this can be done successfully. In late 2011, Geisinger launched an online process for patients to provide electronic feedback on their medication lists' accuracy before a doctor visit. Patient feedback was routed to a Geisinger pharmacist, who reviewed it and followed up with the patient before changing the medication list shared by the patient and the clinicians. The evaluation employed mixed methods and consisted of patient focus groups (users, nonusers, and partial users of the feedback form), semi structured interviews with providers and pharmacists, user observations with patients, and quantitative analysis of patient feedback data and pharmacists' medication reconciliation logs. (1) Patients were eager to provide feedback on their medications and saw numerous advantages. Thirty percent of patient feedback forms (457 of 1,500) were completed and submitted to Geisinger. Patients requested changes to the shared medication lists in 89 percent of cases (369 of 414 forms). These included frequency-or dosage changes to existing prescriptions and requests for new medications (prescriptions and over-the counter). (2) Patients provided useful and accurate online feedback. In a subsample of 107 forms, pharmacists responded positively to 68 percent of patient requests for

  15. [Application of Fourier amplitude sensitivity test in Chinese healthy volunteer population pharmacokinetic model of tacrolimus].

    Science.gov (United States)

    Guan, Zheng; Zhang, Guan-min; Ma, Ping; Liu, Li-hong; Zhou, Tian-yan; Lu, Wei

    2010-07-01

    In this study, we evaluated the influence of different variance from each of the parameters on the output of tacrolimus population pharmacokinetic (PopPK) model in Chinese healthy volunteers, using Fourier amplitude sensitivity test (FAST). Besides, we estimated the index of sensitivity within whole course of blood sampling, designed different sampling times, and evaluated the quality of parameters' and the efficiency of prediction. It was observed that besides CL1/F, the index of sensitivity for all of the other four parameters (V1/F, V2/F, CL2/F and k(a)) in tacrolimus PopPK model showed relatively high level and changed fast with the time passing. With the increase of the variance of k(a), its indices of sensitivity increased obviously, associated with significant decrease in sensitivity index for the other parameters, and obvious change in peak time as well. According to the simulation of NONMEM and the comparison among different fitting results, we found that the sampling time points designed according to FAST surpassed the other time points. It suggests that FAST can access the sensitivities of model parameters effectively, and assist the design of clinical sampling times and the construction of PopPK model.

  16. PRES (posterior reversible encephalopathy syndrome), a rare complication of tacrolimus therapy.

    LENUS (Irish Health Repository)

    Hodnett, P

    2009-11-01

    With increasing numbers of solid organ and hematopoietic stem cell transplantations being performed, there have been significant increases in the use of immunosuppressive agents such as cyclosporine and tacrolimus. Posterior reversible encephalopathy syndrome (PRES) is a serious complication of immunosuppressive therapy use following solid organ or stem cell transplants. Clinical findings including headache, mental status changes, focal neurological deficits, and\\/or visual disturbances. Associated with these are characteristic imaging features of subcortical white matter lesions on computed tomography (CT) or magnetic resonance imaging (MRI). The changes in the subcortical white matter are secondary to potentially reversible vasogenic edema, although conversion to irreversible cytotoxic edema has been described. These imaging findings predominate in the territory of the posterior cerebral artery. Many studies have shown that the neurotoxicity associated with tacrolimus may occur at therapeutic levels. In most cases of PRES, the symptom complex is reversible by reducing the dosage or withholding the drug for a few days. While PRES is an uncommon complication, it is associated with significant morbidity and mortality if it is not expeditiously recognized. MRI represents the most sensitive imaging technique for recognizing PRES. This report highlights the value of MRI in prompt recognition of this entity, which offers the best chance of avoiding long-term sequelae.

  17. Improved nutritional status in elderly patients 6 months after stroke

    DEFF Research Database (Denmark)

    Brynningsen, P K; Damsgaard, Else Marie; Husted, Steen

    2007-01-01

    INTRODUCTION: Nutritional status among stroke patients has received limited attention despite the fact, that it may have an influence on clinical outcome. Previous studies have estimated that 15-20 % of patients suffer from malnutrition in the acute phase of stroke, but so far no studies have...... focused on the late rehabilitation phase after stroke in the patients own home, where the attention on nutrition may be reduced. AIMS: To determine the prevalence of malnutrition during 6 months of stroke rehabilitation, and to investigate the association between nutritional status, functional recovery...... improvement for serum proteins, and 22 % of the patients were malnourished 6 months after stroke. Udgivelsesdato: null-null...

  18. Topical pimecrolimus and tacrolimus do not accelerate photocarcinogenesis in hairless mice after UVA or simulated solar radiation

    DEFF Research Database (Denmark)

    Lerche, C.M.; Philipsen, P.A.; Poulsen, T.

    2009-01-01

    in combination with UVA. We used 11 groups of 25 hairless female C3.Cg/TifBomTac immunocompetent mice (n = 275). Pimecrolimus cream or tacrolimus ointment was applied on their dorsal skin three times weekly followed by SSR (2, 4, or 6 standard erythema doses, SED) or UVA (25 J/cm(2)) 3-4 h later. This was done...

  19. The Effects of Tacrolimus on T-Cell Proliferation Are Short-Lived: A Pilot Analysis of Immune Function Testing

    Directory of Open Access Journals (Sweden)

    Benjamin L. Laskin, MD, MS

    2017-08-01

    Conclusions. T-cell proliferation is currently not suitable to measure immunosuppression because sample processing diminishes observable effects. Future immune function testing should focus on fresh samples with minimal washing steps. Our results also emphasize the importance of adherence to immunosuppressive treatment, because T-cell proliferation recovered substantially after even brief discontinuation of tacrolimus.

  20. Leveraging information technology to drive improvement in patient satisfaction.

    Science.gov (United States)

    Nash, Mary; Pestrue, Justin; Geier, Peter; Sharp, Karen; Helder, Amy; McAlearney, Ann Scheck

    2010-01-01

    A healthcare organization's commitment to quality and the patient experience requires senior leader involvement in improvement strategies, and accountability for goals. Further, improvement strategies are most effective when driven by data, and in the world of patient satisfaction, evidence is growing that nurse leader rounding and discharge calls are strategic tactics that can improve patient satisfaction. This article describes how The Ohio State University Medical Center (OSUMC) leveraged health information technology (IT) to apply a data-driven strategy execution to improve the patient experience. Specifically, two IT-driven approaches were used: (1) business intelligence reporting tools were used to create a meaningful reporting system including dashboards, scorecards, and tracking reports and (2) an improvement plan was implemented that focused on two high-impact tactics and data to hardwire accountability. Targeted information from the IT systems enabled clinicians and administrators to execute these strategic tactics, and senior leaders to monitor achievement of strategic goals. As a result, OSUMC's inpatient satisfaction scores on the Hospital Consumer Assessment of Healthcare Providers and Systems survey improved from 56% nines and tens in 2006 to 71% in 2009. © 2010 National Association for Healthcare Quality.

  1. Thymoglobulin induction in liver transplant recipients with a tacrolimus, mycophenolate mofetil, and steroid immunosuppressive regimen: a five-year randomized prospective study.

    Science.gov (United States)

    Boillot, Olivier; Seket, Belhassen; Dumortier, Jérôme; Pittau, Gabriella; Boucaud, Catherine; Bouffard, Yves; Scoazec, Jean-Yves

    2009-11-01

    This randomized, comparative study assessed the long-term efficacy and tolerability of thymoglobulin (TMG) induction in 93 liver transplant patients with an initial regimen of tacrolimus (Tac), mycophenolate mofetil (MMF), and steroids. Forty-four patients were randomly allocated to the TMG+ group, and 49 patients were randomly allocated to the TMG- group. In both groups, Tac was given orally at the initial daily dose of 0.075 mg/kg twice daily, and MMF was given at the initial daily dose of 2 g/day. Steroid withdrawal was planned at 3 months after liver transplantation. The results were evaluated with respect to acute rejection incidence, patient and graft survival, graft function, and medical complications until 5 years or death for all patients. No significant differences were found between groups for the incidence of acute rejection at 5 years (11.4% versus 14.3%), 5-year patient survival (77.3% versus 87.8%), graft function, or postoperative renal function. One patient in the TMG- group underwent retransplantation. There was no difference between groups with respect to the incidence of medical complications, excepted for a higher rate of leukopenia in the TMG+ group, during the 5-year follow-up. In conclusion, the results of this prospective randomized study suggest that the addition of TMG to a triple immunosuppressive regimen (Tac, MMF, and steroids) did not modify the incidence of acute rejection episodes or long-term survival and was responsible for increased leukopenia rates.

  2. Will Incremental Hemodialysis Preserve Residual Function and Improve Patient Survival?

    Science.gov (United States)

    Davenport, Andrew

    2015-01-01

    The progressive loss of residual renal function in peritoneal dialysis patients is associated with increased mortality. It has been suggested that incremental dialysis may help preserve residual renal function and improve patient survival. Residual renal function depends upon both patient related and dialysis associated factors. Maintaining patients in an over-hydrated state may be associated with better preservation of residual renal function but any benefit comes with a significant risk of cardiovascular consequences. Notably, it is only observational studies that have reported an association between dialysis patient survival and residual renal function; causality has not been established for dialysis patient survival. The tenuous connections between residual renal function and outcomes and between incremental hemodialysis and residual renal function should temper our enthusiasm for interventions in this area. PMID:25385441

  3. Interprofessional simulation to improve patient participation in transitional care.

    Science.gov (United States)

    Dyrstad, Dagrunn Nåden; Storm, Marianne

    2017-06-01

    Educating and training healthcare professionals is known to improve the quality of transitional care for older adults. Arranging interprofessional meetings for healthcare professionals might be useful to improve patient participation skills in transitional care. To describe the learning activities used in The Meeting Point programme, focusing on patient participation in transitional care, and assess whether they increase healthcare professionals' awareness of and competencies relating to patient participation in the transitional care of older patients. Data were collected as part of an educational intervention programme, The Meeting Point, including three seminars on 'Patient participation in the transitional care of older patients' and four follow-up meetings. Participants were nurses, care assistants, doctors, physiotherapists, patient coordinators and administrative personnel from hospital, nursing homes and home-based care services. The Meeting Point was organised around four pillars: introduction, teaching session, group work activity and plenary discussion. Qualitative data included log reports, summaries of meetings, notes from group work activities, and reports from participants and from follow-up meetings. Feedback from participants shows that they were satisfied with meeting healthcare professionals from other units of care. A film scenario was perceived relevant for group work activity and useful in focusing participants' attention to patient participation. Follow-up meetings show that some nursing home wards, the emergency department and one medical ward at the hospital continued with ongoing work to improve quality of care. Efforts included implementation of an observational waiting room with comfortable chairs, planning for discharge in hospital admission, a daily patient flow registration system and motivational interviewing during admission to nursing home. The description of the learning activities used at The Meeting Point seminars shows that they

  4. Multi-modal intervention improved oral intake in hospitalized patients

    DEFF Research Database (Denmark)

    Holst, M; Beermann, T; Mortensen, M N

    2015-01-01

    BACKGROUND: Good nutritional practice (GNP) includes screening, nutrition plan and monitoring, and is mandatory for targeted treatment of malnourished patients in hospital. AIMS: To optimize energy- and protein-intake in patients at nutritional risk and to improve GNP in a hospital setting. METHODS......: A 12-months observational multi-modal intervention study was done, using the top-down and bottom-up principle. All hospitalized patients (>3 days) were included. Setting: A university hospital with 758 beds and all specialities. Measurements: Record audit of GNP, energy- and protein-intake by 24-h...... recall, patient interviews and staff questionnaire before and after the intervention. Interventions: Based on pre-measurements, nutrition support teams in each department made targeted action plans, supervised by an expert team. Education, diagnose-specific nutrition plans, improved menus and eating...

  5. Does Music Therapy Improve Anxiety and Depression in Alzheimer's Patients?

    Science.gov (United States)

    de la Rubia Ortí, José Enrique; García-Pardo, María Pilar; Iranzo, Carmen Cabañés; Madrigal, José Joaquin Cerón; Castillo, Sandra Sancho; Rochina, Mariano Julián; Gascó, Vicente Javier Prado

    2018-01-01

    To evaluate the effectiveness of the implementation of a short protocol of music therapy as a tool to reduce stress and improve the emotional state in patients with mild Alzheimer's disease. A sample of 25 patients with mild Alzheimer's received therapy based on the application of a music therapy session lasting 60 min. Before and after the therapy, patient saliva was collected to quantify the level of salivary cortisol using the Enzyme-Linked ImmunoSorbent Assay (ELISA) immunoassay technique and a questionnaire was completed to measure anxiety and depression (Hospital Anxiety and Depression Scale). The results show that the application of this therapy lowers the level of stress and decreases significantly depression and anxiety, establishing a linear correlation between the variation of these variables and the variation of cortisol. A short protocol of music therapy can be an alternative medicine to improve emotional variables in Alzheimer patients.

  6. Methods to improve patient recruitment and retention in stroke trials

    DEFF Research Database (Denmark)

    Berge, Eivind; Stapf, Christian; Al-Shahi Salman, Rustam

    2016-01-01

    Background: The success of randomized-controlled stroke trials is dependent on the recruitment and retention of a sufficient number of patients, but fewer than half of all trials meet their target number of patients. Methods: We performed a search and review of the literature, and conducted...... a survey and workshop among 56 European stroke trialists, to identify barriers, suggest methods to improve recruitment and retention, and make a priority list of interventions that merit further evaluation. Results: The survey and workshop identified a number of barriers to patient recruitment...... and retention, from patients’ incapacity to consent, to handicaps that prevent patients from participation in trial-specific follow-up. Methods to improve recruitment and retention may include simple interventions with individual participants, funding of research networks, and reimbursement of new treatments...

  7. Multidisciplinary in-hospital teams improve patient outcomes: A review.

    Science.gov (United States)

    Epstein, Nancy E

    2014-01-01

    The use of multidisciplinary in-hospital teams limits adverse events (AE), improves outcomes, and adds to patient and employee satisfaction. Acting like "well-oiled machines," multidisciplinary in-hospital teams include "staff" from different levels of the treatment pyramid (e.g. staff including nurses' aids, surgical technicians, nurses, anesthesiologists, attending physicians, and others). Their enhanced teamwork counters the "silo effect" by enhancing communication between the different levels of healthcare workers and thus reduces AE (e.g. morbidity/mortality) while improving patient and healthcare worker satisfaction. Multiple articles across diverse disciplines incorporate a variety of concepts of "teamwork" for staff covering emergency rooms (ERs), hospital wards, intensive care units (ICUs), and most critically, operating rooms (ORs). Cohesive teamwork improved communication between different levels of healthcare workers, and limited adverse events, improved outcomes, decreased the length of stay (LOS), and yielded greater patient "staff" satisfaction. Within hospitals, delivering the best medical/surgical care is a "team sport." The goals include: Maximizing patient safety (e.g. limiting AE) and satisfaction, decreasing the LOS, and increasing the quality of outcomes. Added benefits include optimizing healthcare workers' performance, reducing hospital costs/complications, and increasing job satisfaction. This review should remind hospital administrators of the critical need to keep multidisciplinary teams together, so that they can continue to operate their "well-oiled machines" enhancing the quality/safety of patient care, while enabling "staff" to optimize their performance and enhance their job satisfaction.

  8. Patients' expectations and solutions for improving primary diabetes care.

    Science.gov (United States)

    Vachon, Brigitte; Huynh, Ai-Thuy; Breton, Mylaine; Quesnel, Louise; Camirand, Michel; Leblanc, Jeannette; Tardif, Sylvie

    2017-07-10

    Purpose The purpose of this paper is to document health care needs expressed by people living with diabetes, describe the solutions they envisaged for improving the quality of primary care (PC) services and empower them to make better use of PC services. Design/methodology/approach A participatory research approach was used. Six workshops were organised to provide diabetes patients with knowledge on available services and to engage them in sharing their experience. Group discussions were recorded. Data were analysed using the thematic analysis method. Findings In total, 79 persons living with diabetes for a mean of 13 years participated. Needs expressed were grouped under seven themes: assurance of satisfactory follow-up by a family physician, continuous access to services adapted to evolving needs, motivation to adopt and maintain healthy behaviours, maintenance of knowledge about diabetes, psychological support, financial constraints, and collaboration with secondary-level services. Patients proposed solutions for improving services that were grouped under five themes: facilitating access to services, disseminating information about available services, centralising diabetes information on the internet, offering personalised services and improving interprofessional collaboration. Practical implications Needs expressed by diabetic patients concern different aspects of care such as accessibility, organisation, coordination, and better dissemination and visibility of services. The solutions proposed by patients focussed on better access to information and interprofessional services. Originality/value The workshop format used in this study offers an original and interesting approach and tool for actively engaging patients in quality improvement of services.

  9. Managing multimorbidity: how can the patient experience be improved?

    Directory of Open Access Journals (Sweden)

    Stanimir Hasardzhiev

    2016-02-01

    Full Text Available Abstract The patient’s experience of their own healthcare is an important aspect of care quality that has been shown to improve clinical and other outcomes. Very little is currently known about patient experience in the management of multimorbidity, although preliminary evidence suggests that it may be poor. Individuals with multimorbidity report better experiences of care when they are knowledgeable and involved in the decision-making, when their care is well coordinated, and communication is good. A greater focus on disease prevention, stronger collaboration between health and social care services, and the provision of more integrated care for people with mental and physical health problems would also help to improve the patient experience. Advocacy groups can amplify the patient voice and improve access to care, as well as provide information and support to patients and their families. Patients have an important role in preventing multimorbidity and improving its management, and should be involved in the development of health policies and the delivery of healthcare services. Inequalities in access to quality healthcare must also be addressed. Journal of Comorbidity 2016;6(128–32

  10. [Does simulator-based team training improve patient safety?].

    Science.gov (United States)

    Trentzsch, H; Urban, B; Sandmeyer, B; Hammer, T; Strohm, P C; Lazarovici, M

    2013-10-01

    Patient safety became paramount in medicine as well as in emergency medicine after it was recognized that preventable, adverse events significantly contributed to morbidity and mortality during hospital stay. The underlying errors cannot usually be explained by medical technical inadequacies only but are more due to difficulties in the transition of theoretical knowledge into tasks under the conditions of clinical reality. Crew Resource Management and Human Factors which determine safety and efficiency of humans in complex situations are suitable to control such sources of error. Simulation significantly improved safety in high reliability organizations, such as the aerospace industry.Thus, simulator-based team training has also been proposed for medical areas. As such training is consuming in cost, time and human resources, the question of the cost-benefit ratio obviously arises. This review outlines the effects of simulator-based team training on patient safety. Such course formats are not only capable of creating awareness and improvements in safety culture but also improve technical team performance and emphasize team performance as a clinical competence. A few studies even indicated improvement of patient-centered outcome, such as a reduced rate of adverse events but further studies are required in this respect. In summary, simulator-based team training should be accepted as a suitable strategy to improve patient safety.

  11. Cooling improves the writing performance of patients with writer's cramp.

    Science.gov (United States)

    Pohl, Christoph; Happe, Jörg; Klockgether, Thomas

    2002-11-01

    Cooling of hand and forearm muscles by immersion in 15 degrees C cold water for 5 minutes improved the writing performance of patients with writer's cramp. Since abnormal processing of muscle spindle afferent discharges contributes to the pathology of writer's cramp, this effect might result from a reduction in muscle spindle activity by lowering muscle temperature. Cooling is a simple, cheap, and safe procedure, providing temporary relief for patients with writer's cramp. Copyright 2002 Movement Disorder Society

  12. Improving organizational climate for excellence in patient care.

    Science.gov (United States)

    Arnold, Edwin

    2013-01-01

    Managers in health care organizations today are expected to achieve higher-quality patient care at a lower cost. Developing and maintaining a positive organizational climate can help improve motivation and foster higher employee performance. In turn, this will help the organization deliver better patient care at a lower cost. This article offers metrics for assessing organizational climate, analyzes barriers to a positive climate, and explores strategies that managers can use to build the type of climate that fosters high performance.

  13. [Strategies for improving care of oncologic patients: SHARE Project results].

    Science.gov (United States)

    Reñones Crego, María de la Concepción; Fernández Pérez, Dolores; Vena Fernández, Carmen; Zamudio Sánchez, Antonio

    2016-01-01

    Cancer treatment is a major burden for the patient and its family that requires an individualized management by healthcare professionals. Nurses are in charge of coordinating care and are the closest healthcare professionals to patient and family; however, in Spain, there are not standard protocols yet for the management of oncology patients. The Spanish Oncology Nursing Society developed between 2012 and 2014 the SHARE project, with the aim of establishing strategies to improve quality of life and nursing care in oncology patients. It was developed in 3 phases. First, a literature search and review was performed to identify nursing strategies, interventions and tools to improve cancer patients' care. At the second stage, these interventions were agreed within a group of oncology nursing experts; and at the third phase, a different group of experts in oncology care categorized the interventions to identify the ones with highest priority and most feasible to be implemented. As a result, 3 strategic actions were identified to improve nursing care during cancer treatment: To provide a named nurse to carry out the follow up process by attending to the clinic or telephonic consultation, develop therapeutic education with adapted protocols for each tumor type and treatment and ensure specific training for nurses on the management of the cancer patients. Strategic actions proposed in this paper aim to improve cancer patients' healthcare and quality of life through the development of advanced nursing roles based on a higher level of autonomy, situating nurses as care coordinators to assure an holistic care in oncology patients. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  14. Improving patient safety culture in Saudi Arabia (2012-2015): trending, improvement and benchmarking.

    Science.gov (United States)

    Alswat, Khalid; Abdalla, Rawia Ahmad Mustafa; Titi, Maher Abdelraheim; Bakash, Maram; Mehmood, Faiza; Zubairi, Beena; Jamal, Diana; El-Jardali, Fadi

    2017-08-02

    Measuring patient safety culture can provide insight into areas for improvement and help monitor changes over time. This study details the findings of a re-assessment of patient safety culture in a multi-site Medical City in Riyadh, Kingdom of Saudi Arabia (KSA). Results were compared to an earlier assessment conducted in 2012 and benchmarked with regional and international studies. Such assessments can provide hospital leadership with insight on how their hospital is performing on patient safety culture composites as a result of quality improvement plans. This paper also explored the association between patient safety culture predictors and patient safety grade, perception of patient safety, frequency of events reported and number of events reported. We utilized a customized version of the patient safety culture survey developed by the Agency for Healthcare Research and Quality. The Medical City is a tertiary care teaching facility composed of two sites (total capacity of 904 beds). Data was analyzed using SPSS 24 at a significance level of 0.05. A t-Test was used to compare results from the 2012 survey to that conducted in 2015. Two adopted Generalized Estimating Equations in addition to two linear models were used to assess the association between composites and patient safety culture outcomes. Results were also benchmarked against similar initiatives in Lebanon, Palestine and USA. Areas of strength in 2015 included Teamwork within units, and Organizational Learning-Continuous Improvement; areas requiring improvement included Non-Punitive Response to Error, and Staffing. Comparing results to the 2012 survey revealed improvement on some areas but non-punitive response to error and Staffing remained the lowest scoring composites in 2015. Regression highlighted significant association between managerial support, organizational learning and feedback and improved survey outcomes. Comparison to international benchmarks revealed that the hospital is performing at or

  15. Using Patient-Reported Information to Improve Clinical Practice.

    Science.gov (United States)

    Schlesinger, Mark; Grob, Rachel; Shaller, Dale

    2015-12-01

    To assess what is known about the relationship between patient experience measures and incentives designed to improve care, and to identify how public policy and medical practices can promote patient-valued outcomes in health systems with strong financial incentives. Existing literature (gray and peer-reviewed) on measuring patient experience and patient-reported outcomes, identified from Medline and Cochrane databases; evaluations of pay-for-performance programs in the United States, Europe, and the Commonwealth countries. We analyzed (1) studies of pay-for-performance, to identify those including metrics for patient experience, and (2) studies of patient experience and of patient-reported outcomes to identify evidence of influence on clinical practice, whether through public reporting or private reporting to clinicians. First, we identify four forms of "patient-reported information" (PRI), each with distinctive roles shaping clinical practice: (1) patient-reported outcomes measuring self-assessed physical and mental well-being, (2) surveys of patient experience with clinicians and staff, (3) narrative accounts describing encounters with clinicians in patients' own words, and (4) complaints/grievances signaling patients' distress when treatment or outcomes fall short of expectations. Because these forms vary in crucial ways, each must be distinctively measured, deployed, and linked with financial incentives. Second, although the literature linking incentives to patients experience is limited, implementing pay-for-performance systems appears to threaten certain patient-valued aspects of health care. But incentives can be made compatible with the outcomes patients value if: (a) a sufficient portion of incentives is tied to patient-reported outcomes and experiences, (b) incentivized forms of PRI are complemented by other forms of patient feedback, and (c) health care organizations assist clinicians to interpret and respond to PRI. Finally, we identify roles for the

  16. Improving pain assessment and managment in stroke patients.

    Science.gov (United States)

    Nesbitt, Julian; Moxham, Sian; Ramadurai, Gopinath; Williams, Lucy

    2015-01-01

    Stroke patients can experience a variety of pain. Many stroke patients have co-morbidities such as osteoporosis, arthritis or diabetes causing diabetic neuropathy. As well as pain from other long term conditions, stroke patients can experience central post-stroke pain, headaches, and musculoskeletal issues such as hypertonia, contractures, spasticity, and subluxations. These stroke patients can also have communication difficulties in the form of expressive dysphasia and/or global aphasia. Communication difficulties can result in these patients not expressing their pain and therefore not having it assessed, leading to inadequate pain relief that could impact their rehabilitation and recovery. By implementing an observational measurement of pain such as the Abbey pain scale, patients with communication difficulties can have their pain assessed and recorded. Initially 30% of patients on the acute stroke ward did not have their pain assessed and adequately recorded and 15% of patients had inadequate pain relief. The patient was assessed if they were in pain and therefore not receiving adequate pain relief by measuring their pain on the Abbey pain scale. After introducing the Abbey pain scale and creating a nurse advocate, an improvement was shown such that only 5% of patients did not have their pain recorded and all had adequate pain relief.

  17. Assessment of nerve regeneration across nerve allografts treated with tacrolimus.

    Science.gov (United States)

    Haisheng, Han; Songjie, Zuo; Xin, Li

    2008-01-01

    Although regeneration of nerve allotransplant is a major concern in the clinic, there have been few papers quantitatively assessing functional recovery of animals' nerve allografts in the long term. In this study, functional recovery, histopathological study, and immunohistochemistry changes of rat nerve allograft with FK506 were investigated up to 12 weeks without slaughtering. C57 and SD rats were used for transplantation. The donor's nerve was sliced and transplanted into the recipient. The sciatic nerve was epineurally sutured with 10-0 nylon. In total, 30 models of transplantation were performed and divided into 3 groups that were either treated with FK506 or not. Functional recovery of the grafted nerve was serially assessed by the pin click test, walking track analysis and electrophysiological evaluations. A histopathological study and immunohistochemistry study were done in the all of the models. Nerve allografts treated with FK506 have no immune rejection through 12 weeks. Sensibility had similarly improved in both isografts and allografts. There has been no difference in each graft. Walk track analysis demonstrates significant recovery of motor function of the nerve graft. No histological results of difference were found up to 12 weeks in each graft. In the rodent nerve graft model, FK506 prevented nerve allograft rejection across a major histocompatibility barrier. Sensory recovery seems to be superior to motor function. Nerve isograft and allograft treated with FK506 have no significant difference in function recovery, histopathological result, and immunohistochemistry changes.

  18. Improving patient handover between teams using a business improvement model: PDSA cycle.

    Science.gov (United States)

    Luther, Vishal; Hammersley, Daniel; Chekairi, Ahmed

    2014-01-01

    Medical admission units are continuously under pressure to move patients off the unit to outlying medical wards and allow for new admissions. In a typical district general hospital, doctors working in these medical wards reported that, on average, three patients each week arrived from the medical admission unit before any handover was received, and a further two patients arrived without any handover at all. A quality improvement project was therefore conducted using a 'Plan, Do, Study, Act' cycle model for improvement to address this issue. P - Plan: as there was no framework to support doctors with handover, a series of standard handover procedures were designed. D - Do: the procedures were disseminated to all staff, and championed by key stakeholders, including the clinical director and matron of the medical admission unit. S - STUDY: Measurements were repeated 3 months later and showed no change in the primary end points. A - ACT: The post take ward round sheet was redesigned, creating a checkbox for a medical admission unit doctor to document that handover had occurred. Nursing staff were prohibited from moving the patient off the ward until this had been completed. This later evolved into a separate handover sheet. Six months later, a repeat study revealed that only one patient each week was arriving before or without a verbal handover. Using a 'Plan, Do, Study, Act' business improvement tool helped to improve patient care.

  19. Patients' involvement in improvement initiatives: a qualitative systematic review.

    Science.gov (United States)

    van, Claire; McInerney, Patricia; Cooke, Richard

    2015-10-01

    Over the last 20 years, quality improvement in health has become an important strategy in health services in many countries. With the emphasis on quality health care, there has been a shift in social paradigms towards including service users in their own health on different levels. There is growing evidence in literature on the positive impact on health outcomes where patients are active participants in their personal care. There is however less information available on the broader influence of users on improvement in systems. The objective of this review was to identify the barriers and enablers to patients being involved in quality improvement efforts directed towards their own health care. This review considered studies that included adults and children of any age experiencing any health problem.The review considered studies that explored patient or user participation in quality improvement and the factors enabling and hindering this processThe qualitative component of this review considered studies that focused on qualitative data, including, but not limited to, designs such as phenomenology, grounded theory, ethnography, action research and feminist research. Other texts such as opinion papers and reports were also considered. The search strategy aimed to find both published and unpublished studies. A three-step search strategy was utilized in this review. The searches using all identified keywords and index terms included the databases PubMed, PsycINFO, Medline, Scopus, EBSCOhost and CINAHL.Qualitative, text and opinion papers were considered for inclusion in this review.Closely related concepts like community involvement, family involvement, patients' involvement in their own care (for example, in the case of shared decision making), and patient centeredness in the context of a consultation were excluded. Qualitative and textual papers selected for retrieval were assessed by two independent reviewers for authenticity prior to inclusion in the review using

  20. A Complicated Case of Tacrolimus-Induced Rapid Remission after Cesarean Section in the Early Third Trimester for Refractory Severe Ulcerative Colitis Flaring in the Initial Period of Gestation

    Directory of Open Access Journals (Sweden)

    Takashi Mizushima

    2011-04-01

    Full Text Available A 36-year-old woman who had been diagnosed with ulcerative colitis at the age of 17 years was referred to our hospital because of severe abdominal pain and repeated bloody diarrhea that persisted during pregnancy despite combination therapy with high-dose corticosteroids and weekly granulocyte and monocyte adsorptive apheresis (GMA. She underwent combination therapy consisting of high-dose corticosteroids, intensive GMA (two sessions per week and vancomycin, which was used to eradicate Clostridium difficile, under total parenteral nutrition control until the estimated weight of her fetus reached 1,000 g. This combination therapy was partially successful, resulting in almost complete disappearance of abdominal pain and a marked decrease in stool frequency. However bloody diarrhea persisted and the patient developed anemia and hypoalbuminemia and was unable to prolong her gestation time. Cesarean section was conducted at 28 weeks of gestation without any congenital abnormalities or neurological defects. Oral administration of tacrolimus was begun 7 days after cesarean section, which was followed by rapid induction of remission. Corticosteroids were then gradually tapered off. Tacrolimus is one therapeutic option after cesarean section in pregnant patients who do not respond well to GMA and high-dose corticosteroids for persistent active ulcerative colitis.

  1. Improving a newly developed patient-reported outcome for thyroid patients, using cognitive interviewing

    DEFF Research Database (Denmark)

    Watt, Torquil; Rasmussen, Ase Krogh; Groenvold, Mogens

    2008-01-01

    Objective To improve a newly developed patient-reported outcome measure for thyroid patients using cognitive interviewing. Methods Thirty-one interviews using immediate retrospective and expansive probing were conducted among patients with non-toxic goiter (n = 4), nodular toxic goiter (n = 5) Gr...

  2. Improving Quality of Care in Patients with Liver Cirrhosis.

    Science.gov (United States)

    Saberifiroozi, Mehdi

    2017-10-01

    Liver cirrhosis is a major chronic disease in the field of digestive diseases. It causes more than one million deaths per year. Despite established evidence based guidelines, the adherence to standard of care or quality indicators are variable. Complete adherence to the recommendations of guidelines is less than 50%. To improve the quality of care in patients with cirrhosis, we need a more holistic view. Because of high rate of death due to cardiovascular disease and neoplasms, the care of comorbid conditions and risk factors such as smoking, hypertension, high blood sugar or cholesterol, would be important in addition to the management of primary liver disease. Despite a holistic multidisciplinary approach for this goal, the management of such patients should be patient centered and individualized. The diagnosis of underlying etiology and its appropriate treatment is the most important step. Definition and customizing the quality indicators for quality measure in patients are needed. Because most suggested quality indicators are designed for measuring the quality of care in decompensated liver cirrhosis, we need special quality indicators for compensated and milder forms of chronic liver disease as well. Training the patients for participation in their own management, design of special clinics with dedicated health professionals in a form of chronic disease model, is suggested for improvement of quality of care in this group of patients. Special day care centers by a dedicated gastroenterologist and a trained nurse may be a practical model for better management of such patients.

  3. The Psychosocial Improvement after Strabismus Surgery in Iranian Patients

    Directory of Open Access Journals (Sweden)

    Guita Ghiasi

    2013-10-01

    Full Text Available Purpose: To compare the psychosocial status before and after successful strabismus surgery on Iranian strabismic patientsMethods: One hundred twenty-four strabismic patients, older than 15 years were evaluated between 2009 and 2010. They were asked to complete a questionnaire about their psychosocial experiences, before and three months after successful strabismus surgery. Effects of strabismus on self-esteem, self-confidence, and self-assessment of intelligence, employment and interpersonal relationships were compared.Results: Fifty-six percent of patients had problems in adjusting to society, and 71% had developed a mannerism to camouflage their misalignment before surgery. The preoperative scores of self-esteem, self-confidence, and interpersonal relationship were 4.33±2.07, 4.23±2.53 and 6.06±2.33 which changed to 8.33±3.02, 7.29±2.89 and 6.72±3.17 after surgery, respectively (p<0.001 for all of values. More esotropic patients reported to be discriminated against compared to exotropic patients. Postoperatively, 79% of patients reported improvements in their ability to meet new people, and 82% in interpersonal relationships. Scores of self-confidence and self-esteem increased up to three and four units, respectively (p<0.001 for both values.Conclusion: Patients with strabismus have psychosocial problems and successful strabismus surgery improves their psychosocial status.

  4. Effect of cyclosporine, tacrolimus and sirolimus on cellular senescence in renal epithelial cells.

    Science.gov (United States)

    Koppelstaetter, Christian; Kern, Georg; Leierer, Gisela; Mair, Sabine Maria; Mayer, Gert; Leierer, Johannes

    2018-04-01

    In transplantation medicine calcineurin inhibitors (CNI) still represent the backbone of immunosuppressive therapy. The nephrotoxic potential of the CNI Cyclosporine A (CsA) and Tacrolimus (FK506) is well recognized and CNI not only have been linked with toxicity, but also with cellular senescence which hinders parenchymal tissue regeneration and thus may prime kidneys for subsequent insults. To minimize pathological effects on kidney grafts, alternative immunosuppressive agents like mTOR inhibitors or the T-cell co-stimulation blocker Belatacept have been introduced. We compared the effects of CsA, FK506 and Sirolimus on the process of cellular senescence in different human renal tubule cell types (HK2, RPTEC). Telomere length (by real time PCR), DNA synthesis (by BrdU incorporation), cell viability (by Resazurin conversion), gene expression (by RT-PCR), protein (by western blotting), Immuncytochemistry and H 2 O 2 production (by Amplex Red® conversion) were evaluated. DNA synthesis was significantly reduced when cells were treated with cyclosporine but not with tacrolimus and sirolimus. Resazurin conversion was not altered by all three immunosuppressive agents. The gene expression as well as protein production of the cell cycle inhibitor p21 (CDKN1A) but not p16 (CDKN2A) was significantly induced by cyclosporine compared to the other two immunosuppressive agents when determined by western blotting an immuncytochemistry. Relative telomere length was reduced and hydrogen peroxide production increased after treatment with CsA but not with FK506 or sirolimus. In summary, renal tubule cells exposed to CsA show clear signs of cellular senescence where on the contrary the second calcineurin inhibitor FK506 and the mTOR inhibitor sirolimus are not involved in such mechanisms. Chronic renal allograft dysfunction could be in part triggered by cellular senescence induced by immunosuppressive medication and the choice of drug could therefore influence long term outcome

  5. Concurrent Chemoradiotherapy Improves Survival in Patients With Hypopharyngeal Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Paximadis, Peter, E-mail: ppaximad@med.wayne.edu [Department of Radiation Oncology, Wayne State University, Detroit, MI (United States); Yoo, George; Lin, Ho-Sheng; Jacobs, John [Department of Otolaryngology, Barbara Ann Karmanos Cancer Institute, Detroit, MI (United States); Sukari, Ammar [Department of Medical Oncology, Barbara Ann Karmanos Cancer Institute, Detroit, MI (United States); Dyson, Greg [Department of Oncology, Barbara Ann Karmanos Cancer Institute, Detroit, MI (United States); Christensen, Michael; Kim, Harold [Department of Radiation Oncology, Wayne State University, Detroit, MI (United States)

    2012-03-15

    Purpose: To retrospectively review our institutional experience with hypopharyngeal carcinoma with respect to treatment modality. Methods and Materials: A total of 70 patients with hypopharyngeal cancer treated between 1999 and 2009 were analyzed for functional and survival outcomes. The treatments included surgery alone (n = 5), surgery followed by radiotherapy (RT) (n = 3), surgery followed by chemoradiotherapy (CRT) (n = 13), RT alone (n = 2), CRT alone (n = 22), induction chemotherapy followed by RT (n = 3), and induction chemotherapy followed by CRT (n = 22). Results: The median follow-up was 18 months. The median overall survival and disease-free survival for all patients was 28.3 and 17.6 months, respectively. The 1- and 2-year local control rate for all patients was 87.1% and 80%. CRT, given either as primary therapy or in the adjuvant setting, improved overall survival and disease-free survival compared with patients not receiving CRT. The median overall survival and disease-free survival for patients treated with CRT was 36.7 and 17.6 months vs. 14.0 and 8.0 months, respectively (p < .01). Of the patients initially treated with an organ-preserving approach, 4 (8.2%) required salvage laryngectomy for local recurrence or persistent disease; 8 (16.3%) and 12 (24.5%) patients were dependent on a percutaneous gastrostomy and tracheostomy tube, respectively. The 2-year laryngoesophageal dysfunction-free survival rate for patients treated with an organ-preserving approach was estimated at 31.7%. Conclusions: Concurrent CRT improves survival in patients with hypopharyngeal cancer. CRT given with conventional radiation techniques yields poor functional outcomes, and future efforts should be directed at determining the feasibility of pharyngeal-sparing intensity-modulated radiotherapy in patients with hypopharyngeal tumors.

  6. How to improve patient satisfaction when patients are already satisfied: a continuous process-improvement approach.

    Science.gov (United States)

    Friesner, Dan; Neufelder, Donna; Raisor, Janet; Bozman, Carl S

    2009-01-01

    The authors present a methodology that measures improvement in customer satisfaction scores when those scores are already high and the production process is slow and thus does not generate a large amount of useful data in any given time period. The authors used these techniques with data from a midsized rehabilitation institute affiliated with a regional, nonprofit medical center. Thus, this article functions as a case study, the findings of which may be applicable to a large number of other healthcare providers that share both the mission and challenges faced by this facility. The methodology focused on 2 factors: use of the unique characteristics of panel data to overcome the paucity of observations and a dynamic benchmarking approach to track process variability over time. By focusing on these factors, the authors identify some additional areas for process improvement despite the institute's past operational success.

  7. Virtual sensory feedback for gait improvement in neurological patients

    Directory of Open Access Journals (Sweden)

    Yoram eBaram

    2013-10-01

    Full Text Available We review a treatment modality for movement disorders by sensory feedback. The natural closed-loop sensory-motor feedback system is imitated by a wearable virtual reality apparatus, employing body-mounted inertial sensors and responding dynamically to the patient’s own motion. Clinical trials have shown a significant gait improvement in patients with Parkinson's disease using the apparatus. In contrast to open-loop devices, which impose constant-velocity visual cues in a treadmill fashion, or rhythmic auditory cues in a metronome fashion, requiring constant vigilance and attention strategies, and in some cases, instigating freezing in Parkinson’s patients, the closed-loop device improved gait parameters and eliminated freezing in most patients, without side effects. Patients with multiple sclerosis, previous stroke, senile gait and cerebral palsy using the device also improved their balance and gait substantially. Training with the device has produced a residual improvement, suggesting virtual sensory feedback for the treatment of neurological movement disorders.

  8. Team Ward Rounds for Quality Improvement in Patient-Centred ...

    African Journals Online (AJOL)

    In this paper we describe a clinical practice change for evaluation and continuous quality improvement of in-patient services in our ACE unit, such as daily geriatrics (multi disciplinary) team ward rounds preceding traditional ward rounds by other managing teams. The geriatrics team rounds enabled the identification of ...

  9. Laparoscopic Sleeve Gastrectomy Improves Olfaction Sensitivity in Morbidly Obese Patients.

    Science.gov (United States)

    Hancı, Deniz; Altun, Huseyin; Altun, Hasan; Batman, Burcin; Karip, Aziz Bora; Serin, Kursat Rahmi

    2016-03-01

    Olfactory abilities of the patients are known to be altered by eating and metabolic disorders, including obesity. There are only a number of studies investigating the effect of obesity on olfaction, and there is limited data on the changes in olfactory abilities of morbidly obese patients after surgical treatment. Here we investigated the changes in olfactory abilities of 54 morbidly obese patients (M/F, 22/32; age range 19-57 years; body mass index (BMI) range 30.5-63.0 kg/m(2)) after laparoscopic sleeve gastrectomy. A laparoscopic sleeve gastrectomy was performed by the same surgeon using five-port technique. Olfactory abilities were tested preoperatively and 1, 3, and 6 months after the surgery using a standardized Sniffin' Sticks Extended Test kit. Analyses of variance indicated statistically significant improvement in T, D, and I scores of morbidly obese patients within time factors (preoperative vs. 1, 3, and 6 months; 1 vs. 3 and 6 months; and 3 vs. 6 months; p < 0.001 for all). There was a statistically significant improvement in overall TDI scores with an increase from 25 to 41 during the 6 months follow-up period (p < 0.001 for all). Here, for the first time in literature, we were able to show the significant improvement in olfactory abilities of morbidly obese patients after laparoscopic sleeve gastrectomy.

  10. Transcranial Direct Current Stimulation Improves Audioverbal Memory in Stroke Patients.

    Science.gov (United States)

    Kazuta, Toshinari; Takeda, Kotaro; Osu, Rieko; Tanaka, Satoshi; Oishi, Ayako; Kondo, Kunitsugu; Liu, Meigen

    2017-08-01

    The aim of this study was to investigate whether anodal transcranial direct current stimulation over the left temporoparietal area improved audioverbal memory performance in stroke patients. Twelve stroke patients with audioverbal memory impairment participated in a single-masked, crossover, and sham-controlled experiment. The anodal or sham transcranial direct current stimulation was applied during the Rey Auditory Verbal Learning Test, which evaluates the ability to recall a list of 15 heard words over five trials. The number of correctly recalled words was compared between the anodal and sham conditions and the influence of transcranial direct current stimulation on serial position effect of the 15 words was also examined. The increase in the number of correctly recalled words from the first to the fifth trial was significantly greater in the anodal condition than in the sham condition (P transcranial direct current stimulation over the left temporoparietal area improved audioverbal memory performance and induced the primacy effect in stroke patients.

  11. Improving Patients Experience in Peadiatric Emergency Waiting Room.

    Science.gov (United States)

    Ehrler, Frederic; Siebert, Johan; Wipfli, Rolf; Duret, Cyrille; Gervaix, Alain; Lovis, Christian

    2016-01-01

    When visiting the emergency department, the perception of the time spent in the waiting room before the beginning of the care, may influence patients' experience. Based on models of service evaluation, highlighting the importance of informing people about their waiting process and their place in the queue, we have developed an innovative information screen aiming at improving perception of time by patients. Following an iterative process, a group of experts including computer scientists, ergonomists and caregivers designed a solution adapted to the pediatric context. The solution includes a screen displaying five lanes representing triage levels. Patients are represented by individual avatars, drawn sequentially in the appropriate line. The interface has been designed using gamification principle, aiming at increasing acceptance, lowering learning curve and improving satisfaction. Questionnaire based evaluation results revealed high satisfaction from the 278 respondents even if the informative content was not always completely clear.

  12. The potential of crowdsourcing to improve patient-centered care.

    Science.gov (United States)

    Weiner, Michael

    2014-01-01

    Crowdsourcing (CS) is the outsourcing of a problem or task to a crowd. Although patient-centered care (PCC) may aim to be tailored to an individual's needs, the uses of CS for generating ideas, identifying values, solving problems, facilitating research, and educating an audience represent powerful roles that can shape both allocation of shared resources and delivery of personalized care and treatment. CS can often be conducted quickly and at relatively low cost. Pitfalls include bias, risks of research ethics, inadequate quality of data, inadequate metrics, and observer-expectancy effect. Health professionals and consumers in the US should increase their attention to CS for the benefit of PCC. Patients' participation in CS to shape health policy and decisions is one way to pursue PCC itself and may help to improve clinical outcomes through a better understanding of patients' perspectives. CS should especially be used to traverse the quality-cost curve, or decrease costs while preserving or improving quality of care.

  13. Can pegylated interferon improve the outcome of polycythemia vera patients?

    Directory of Open Access Journals (Sweden)

    Elena Crisà

    2017-01-01

    Full Text Available Abstract Pegylated interferon (peg-IFN was proven by phase II trials to be effective in polycythemia vera (PV; however, it is not clear whether it could improve patient outcome compared to hydroxyurea (HU. Here, we present an observational study on 65 PV patients aged 65 years or younger, who received either peg-IFN (30 or HU (35 according to the physician choice. Median follow-up was 75 months. The two cohorts were comparable for patient and disease characteristics. Eighty-seven percent of the patients treated with peg-INF responded, with a CR rate of 70% as compared to 100 and 49% with HU, respectively. Discontinuation rate was similar in the two groups (20% in peg-IFN vs 17% in HU. JAK2 allele burden was monitored in peg-INF arm only, and a reduction was observed in 88% of the patients. No thrombotic events were observed during peg-IFN treatment compared to three on HU. Disease progression to myelofibrosis or acute myeloid leukemia occurred to a patient only in peg-INF, compared to three in HU. Overall, three second malignancies were observed during the study, two in patients who received HU only, and one in a patient largely treated HU who received also peg-IFN for 3 months. Overall survival was significantly better for peg-IFN patients compared to HU, p = 0.027. Our study, albeit limited by small patient and event number and lack of randomization, confirms the efficacy of peg-INF in PV and shows a significant survival advantage for peg-INF-treated patients. Waiting for confirming data from the ongoing phase III trials, our study can support peg-INF as a first-line treatment option for PV, at least for younger patients.

  14. Investigating the use of patient involvement and patient experience in quality improvement in Norway

    DEFF Research Database (Denmark)

    Wiig, Siri; Storm, Marianne; Aase, Karina

    2013-01-01

    -fold: 1) to describe and analyze how governmental organizations expect acute hospitals to incorporate patient involvement and patient experiences into their quality improvement (QI) efforts and 2) to analyze how patient involvement and patient experiences are used by hospitals to try to improve...... the quality of care they provide. METHODS: This multi-level case study combines analysis of national policy documents and regulations at the macro level with semi-structured interviews and non-participant observation of key meetings and shadowing of staff at the meso and micro levels in two purposively...... in hospitals. The expectations span from systematic collection of patients' and family members' experiences for the purpose of improving service quality through establishing patient-oriented arenas for ongoing collaboration with staff to the support of individual involvement in decision making. However...

  15. Caring for LGBTQ patients: Methods for improving physician cultural competence.

    Science.gov (United States)

    Klein, Elizabeth W; Nakhai, Maliheh

    2016-05-01

    This article summarizes the components of a curriculum used to teach family medicine residents and faculty about LGBTQ patients' needs in a family medicine residency program in the Pacific Northwest region of the United States. This curriculum was developed to provide primary care physicians and physicians-in-training with skills to provide better health care for LGBTQ-identified patients. The curriculum covers topics that range from implicit and explicit bias and appropriate terminology to techniques for crafting patient-centered treatment plans. Additionally, focus is placed on improving the understanding of specific and unique barriers to competent health care encountered by LGBTQ patients. Through facilitated discussion, learners explore the health disparities that disproportionately affect LGBTQ individuals and develop skills that will improve their ability to care for LGBTQ patients. The goal of the curriculum is to teach family medicine faculty and physicians in training how to more effectively communicate with and treat LGBTQ patients in a safe, non-judgmental, and welcoming primary care environment. © The Author(s) 2016.

  16. Domiciliary humidification improves lung mucociliary clearance in patients with bronchiectasis.

    Science.gov (United States)

    Hasani, A; Chapman, T H; McCool, D; Smith, R E; Dilworth, J P; Agnew, J E

    2008-01-01

    Inspired air humidification has been reported to show some benefit in bronchiectatic patients. We have investigated the possibility that one effect might be to enhance mucociliary clearance. Such enhancement might, if it occurs, help to lessen the risks of recurrent infective episodes. Using a radioaerosol technique, we measured lung mucociliary clearance before and after 7 days of domiciliary humidification. Patients inhaled high flow saturated air at 37 degrees C via a patient-operated humidification nasal inhalation system for 3 h per day. We assessed tracheobronchial mucociliary clearance from the retention of (99m)Tc-labelled polystyrene tracer particles monitored for 6 h, with a follow-up 24-h reading. Ten out of 14 initially recruited patients (age 37-75 years; seven females) completed the study (two withdrew after their initial screening and two prior to the initial clearance test). Seven patients studied were non-smokers; three were ex-smokers (1-9 pack-years). Initial tracer radioaerosol distribution was closely similar between pre- and post-treatment. Following humidification, lung mucociliary clearance significantly improved, the area under the tracheobronchial retention curve decreased from 319 +/- 50 to 271 +/- 46%h (p humidification treatment improved lung mucociliary clearance in our bronchiectatic patients. Given this finding plus increasing laboratory and clinical interest in humidification mechanisms and effects, we believe further clinical trials of humidification therapy are desirable, coupled with analysis of humidification effects on mucus properties and transport.

  17. Developing patient-centred care: an ethnographic study of patient perceptions and influence on quality improvement.

    Science.gov (United States)

    Renedo, Alicia; Marston, Cicely

    2015-04-23

    Understanding quality improvement from a patient perspective is important for delivering patient-centred care. Yet the ways patients define quality improvement remains unexplored with patients often excluded from improvement work. We examine how patients construct ideas of 'quality improvement' when collaborating with healthcare professionals in improvement work, and how they use these understandings when attempting to improve the quality of their local services. We used in-depth interviews with 23 'patient participants' (patients involved in quality improvement work) and observations in several sites in London as part of a four-year ethnographic study of patient and public involvement (PPI) activities run by Collaborations for Leadership in Applied Health Research and Care for Northwest London. We took an iterative, thematic and discursive analytical approach. When patient participants tried to influence quality improvement or discussed different dimensions of quality improvement their accounts and actions frequently started with talk about improvement as dependent on collective action (e.g. multidisciplinary healthcare professionals and the public), but usually quickly shifted away from that towards a neoliberal discourse emphasising the role of individual patients. Neoliberal ideals about individual responsibility were taken up in their accounts moving them away from the idea of state and healthcare providers being held accountable for upholding patients' rights to quality care, and towards the idea of citizens needing to work on self-improvement. Participants portrayed themselves as governed by self-discipline and personal effort in their PPI work, and in doing so provided examples of how neoliberal appeals for self-regulation and self-determination also permeated their own identity positions. When including patient voices in measuring and defining 'quality', governments and public health practitioners should be aware of how neoliberal rationalities at the

  18. Practice improvement, part II: update on patient communication technologies.

    Science.gov (United States)

    Roett, Michelle A; Coleman, Mary Thoesen

    2013-11-01

    Patient portals (ie, secure web-based services for patient health record access) and secure messaging to health care professionals are gaining popularity slowly. Advantages of web portals include timely communication and instruction, access to appointments and other services, and high patient satisfaction. Limitations include inappropriate use, security considerations, organizational costs, and exclusion of patients who are uncomfortable with or unable to use computers. Attention to the organization's strategic plan and office policies, patient and staff expectations, workflow and communication integration, training, marketing, and enrollment can facilitate optimal use of this technology. Other communication technologies that can enhance patient care include automated voice or text reminders and brief electronic communications. Social media provide another method of patient outreach, but privacy and access are concerns. Incorporating telehealthcare (health care provided via telephone or Internet), providing health coaching, and using interactive health communication applications can improve patient knowledge and clinical outcomes and provide social support. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.

  19. ECG Markers of Hemodynamic Improvement in Patients with Pulmonary Hypertension

    Directory of Open Access Journals (Sweden)

    Marcin Waligóra

    2018-01-01

    Full Text Available Introduction. Several diagnostic tests have been recommended for risk assessment in pulmonary hypertension (PH, but the role of electrocardiography (ECG in monitoring of PH patients has not been yet established. Therefore the aim of the study was to evaluate which ECG patterns characteristic for pulmonary hypertension can predict hemodynamic improvement in patients treated with targeted therapies. Methods. Consecutive patients with pulmonary arterial hypertension (PAH or chronic thromboembolic pulmonary hypertension (CTEPH were eligible to be included if they had had performed two consecutive right heart catheterization (RHC procedures before and after starting of targeted therapies. Patients were followed up from June 2009 to July 2017. ECG patterns of right ventricular hypertrophy according to American College of Cardiology Foundation were assessed. Results. We enrolled 80 patients with PAH and 11 patients with inoperable CTEPH. The follow-up RHC was performed within 12.6±10.0 months after starting therapy. Based on median change of pulmonary vascular resistance, we divided our patients into two subgroups: with and without significant hemodynamic improvement. RV1, max⁡RV1,2 + max⁡SI,aVL-SV1, and PII improved along with the improvement of hemodynamic parameters including PVR. They predicted hemodynamic improvement with similarly good accuracy as shown in ROC analysis: RV1 (AUC: 0.75; 95% CI: 0.63–0.84, PII (AUC: 0.67, 95% CI: 0.56–0.77, and max⁡RV1,2+max⁡SI,aVL-SV1 (0.73; 95% CI: 0.63–0.82. In Cox regression only change in RV1 remained significant mortality predictor (HR: 1.12, 95% CI: 1.01–1.24. Conclusion. Electrocardiogram may be useful in predicting hemodynamic effects of targeted therapy in precapillary pulmonary hypertension. Decrease of RV1, max⁡RV1,2+max⁡SI,aVL-SV1, and PII corresponds with hemodynamic improvement after treatment. Of these changes a decrease of R wave amplitude in V1 is associated with better

  20. Improving patient care through student leadership in team quality improvement projects.

    Science.gov (United States)

    Tschannen, Dana; Aebersold, Michelle; Kocan, Mary Jo; Lundy, Francene; Potempa, Kathleen

    2015-01-01

    In partnership with a major medical center, senior-level nursing students completed a root cause analysis and implementation plan to address a unit-specific quality issue. To evaluate the project, unit leaders were asked their perceptions of the value of the projects and impact on patient care, as well as to provide exemplars depicting how the student root cause analysis work resulted in improved patient outcome and/or unit processes. Liaisons noted benefits of having an RCA team, with positive impact on patient outcomes and care processes.

  1. Association of the PPP3CA c.249G>A variant with clinical outcomes of tacrolimus-based therapy in kidney transplant recipients

    Directory of Open Access Journals (Sweden)

    Salgado PC

    2017-03-01

    Full Text Available Patricia C Salgado,1 Fabiana DV Genvigir,1 Claudia R Felipe,2 Helio Tedesco-Silva Jr,2 Jose O Medina-Pestana,2 Sonia Q Doi,3 Mario H Hirata,1 Rosario DC Hirata1 1Department of Clinical and Toxicological Analysis, School of Pharmaceutical Sciences, University of Sao Paulo, 2Division of Nephrology, Hospital do Rim, Federal University of Sao Paulo, Sao Paulo, Brazil; 3School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD, USA Background: The effects of genetic variants related to the pharmacodynamic mechanisms of immunosuppressive drugs on their therapeutic efficacy and safety have been poorly explored. This study was performed to investigate the influence of the PPP3CA c.249G>A variant on the clinical outcomes of kidney transplant recipients. Patients and methods: A total of 148 Brazilian patients received tacrolimus (TAC-based immunosuppressive therapy for 90 days post-kidney transplantation. The PPP3CA rs3730251 (c.249G>A polymorphism was determined by real-time polymerase chain reaction. Single-nucleotide polymorphism (SNP data for CYP3A5 rs776746 (CYP3A5*3C; g.6986A>G were used to eliminate the confounding effects of this variant. Results: The PPP3CA c.249G>A SNP did not influence early TAC exposure, renal function, or other laboratory parameters, including levels of urea, creatinine, glucose, and lipids, and blood counts. This variant also did not account for the cumulative incidence of biopsy-confirmed acute rejection or delayed graft function. Regarding adverse events, PPP3CA c.249A allele carriers initially had a 3.05-fold increased probability of treatment-induced blood and lymphatic system disorders compared with c.249GG genotype individuals (95% confidence interval: 1.10–8.48, p=0.032. However, this result was not maintained after adjusting for body weight and CYP3A5*3C SNP status (p=0.086. Conclusion: The PPP3CA c.249G>A variant does not influence the clinical outcomes of Brazilian patients in the

  2. Improved quality of life in patients treated with Peptide radionuclides.

    Science.gov (United States)

    Traub-Weidinger, T; Raderer, M; Uffmann, M; Angelberger, P; Kurtaran, A; Leimer, M; Preitfellner, J; Dudczak, R; Virgolini, I

    2011-07-01

    10 patients after 3.7 GBq, and a skin reaction in one patient. Total accumulated kidney dose ranged between 4 and 64 Gy, with reduced creatinine clearance in two patients. Pain relief was achieved in three of three patients after ~3.7 GBq ERT within 4-6 months. Appetite, weight, Karnofsky score and general well-being had improved in patients with SD during and after therapy. Based on the results of this study conducted on a small group of patients, we conclude that PRRT may offer an alternative treatment option for SSTR-positive tumors, with only mild transient side-effects and a marked improvement in the quality of life.

  3. Improved Quality of Life in Patients Treated with Peptide Radionuclides

    International Nuclear Information System (INIS)

    Traub-Weidinger, T; Raderer, M.; Uffmann, M.; Angelberger, P.; Kurtaran, A.; Leimer, M.; Preitfellner, J.; Dudczak, R.; Virgolini, I.

    2011-01-01

    patients after 3.7 GBq, and a skin reaction in one patient. Total accumulated kidney dose ranged between 4 and 64 Gy, with reduced creatinine clearance in two patients. Pain relief was achieved in three of three patients after ~3.7 GBq ERT within 4–6 months. Appetite, weight, Karnofsky score and general well-being had improved in patients with SD during and after therapy. Based on the results of this study conducted on a small group of patients, we conclude that PRRT may offer an alternative treatment option for SSTR-positive tumors, with only mild transient side-effects and a marked improvement in the quality of life

  4. Transferring skills in quality collaboratives focused on improving patient logistics.

    Science.gov (United States)

    Weggelaar-Jansen, Anne Marie; van Wijngaarden, Jeroen

    2018-04-02

    A quality improvement collaborative, often used by the Institute for Healthcare Improvement, is used to educate healthcare professionals and improve healthcare at the same time. However, no prior research has been done on the knowledge and skills healthcare professionals need to achieve improvements or the extent to which quality improvement collaboratives help enhance both knowledge and skills. Our research focused on quality improvement collaboratives aiming to improve patient logistics and tried to identify which knowledge and skills are required and to what extent these were enhanced during the QIC. We defined skills important for logistic improvements in a three-phase Delphi study. Based on the Delphi results we made a questionnaire. We surveyed participants in a national quality improvement collaborative to assess the skills rated as 1) important, 2) available and 3) improved during the collaborative. At two sense-making meetings, experts reflected on our findings and hypothesized on how to improve (logistics) collaboratives. The Delphi study found 18 skills relevant for reducing patient access time and 21 for reducing throughput time. All skills retrieved from the Delphi study were scored as 'important' in the survey. Teams especially lacked soft skills connected to project and change management. Analytical skills increased the most, while more reflexive skills needed for the primary goal of the collaborative (reduce access and throughput times) increased modestly. At two sense-making meetings, attendees suggested four improvements for a quality improvement collaborative: 1) shift the focus to project- and change management skills; 2) focus more on knowledge transfer to colleagues; 3) teach participants to adapt the taught principles to their own situations; and 4) foster intra-project reflexive learning to translate gained insights to other projects (inter-project learning). Our findings seem to suggest that Quality collaboratives could benefit if more

  5. Virtual Patient Technology: Engaging Primary Care in Quality Improvement Innovations.

    Science.gov (United States)

    Blok, Amanda C; May, Christine N; Sadasivam, Rajani S; Houston, Thomas K

    2017-02-15

    Engaging health care staff in new quality improvement programs is challenging. We developed 2 virtual patient (VP) avatars in the context of a clinic-level quality improvement program. We sought to determine differences in preferences for VPs and the perceived influence of interacting with the VP on clinical staff engagement with the quality improvement program. Using a participatory design approach, we developed an older male smoker VP and a younger female smoker VP. The older male smoker was described as a patient with cardiovascular disease and was ethnically ambiguous. The female patient was younger and was worried about the impact of smoking on her pregnancy. Clinical staff were allowed to choose the VP they preferred, and the more they engaged with the VP, the more likely the VP was to quit smoking and become healthier. We deployed the VP within the context of a quality improvement program designed to encourage clinical staff to refer their patients who smoke to a patient-centered Web-assisted tobacco intervention. To evaluate the VPs, we used quantitative analyses using multivariate models of provider and practice characteristics and VP characteristic preference and analyses of a brief survey of positive deviants (clinical staff in practices with high rates of encouraging patients to use the quit smoking innovation). A total of 146 clinical staff from 76 primary care practices interacted with the VPs. Clinic staff included medical providers (35/146, 24.0%), nurse professionals (19/146, 13.0%), primary care technicians (5/146, 3.4%), managerial staff (67/146, 45.9%), and receptionists (20/146, 13.7%). Medical staff were mostly male, and other roles were mostly female. Medical providers (OR 0.031; CI 0.003-0.281; P=.002) and younger staff (OR 0.411; CI 0.177-0.952; P=.038) were less likely to choose the younger, female VP when controlling for all other characteristics. VP preference did not influence online patient referrals by staff. In high

  6. Analysis of tacrolimus and creatinine from a single dried blood spot using liquid chromatography tandem mass spectrometry.

    Science.gov (United States)

    Koop, Dennis R; Bleyle, Lisa A; Munar, Myrna; Cherala, Ganesh; Al-Uzri, Amira

    2013-05-01

    Long term therapeutic drug monitoring and assessment of renal function are required in renal transplant recipients on immunosuppressant therapy such as tacrolimus. Dry blood spots (DBS) have been used successfully in the clinic for many years and offers a convenient, simple and non-invasive method for repeated blood tests. We developed and performed a preliminary validation of a method for the analysis of tacrolimus and creatinine from a single DBS using liquid chromatography-tandem mass spectrometric (LC-MS/MS). Tacrolimus and creatinine were extracted from a 6mm punch with a mixture of methanol/acetonitrile containing ascomycin and deuterated creatinine as internal standards. A 10 μl aliquot of the extract was analyzed directly after dilution for creatinine with normal phase high performance liquid chromatography and multiple reaction monitoring. The remainder of the extract was processed and analyzed for tacrolimus. The lower limit of quantification for tacrolimus was 1 ng/ml with accuracy of 0.34% bias and precision (CV) of 11.1%. The precision ranged from 1.33% to 7.68% and accuracy from -4.44% to 11.6% bias for the intra- and inter-day analysis. The lower limit of quantification of creatinine was 0.01 mg/dL with precision of 7.94%. Accuracy was based on recovery of additional creatinine spiked into whole blood samples and ranged from -2.45% bias at 5 mg/dL to 3.75% bias at 0.5 mg/dL. Intra- and inter-day precision was from 3.48 to 4.11%. The assay was further validated with DBS prepared from pediatric renal transplant recipients. There was excellent correlation between the levels of tacrolimus and creatinine obtained from the clinical laboratory and the DBS method developed. After additional validation, this assay may have a significant impact on compliance with medication intake as well as potentially lowering the cost associated with intravenous blood draws in clinical laboratories. Copyright © 2013 Elsevier B.V. All rights reserved.

  7. A Scholarly Pathway in Quality Improvement and Patient Safety.

    Science.gov (United States)

    Ferguson, Catherine C; Lamb, Geoffrey

    2015-10-01

    There are several challenges to teaching quality improvement (QI) and patient safety material to medical students, as successful programs should combine didactic and experiential teaching methods, integrate the material into the preclinical and clinical years, and tailor the material to the schools' existing curriculum. The authors describe the development, implementation, and assessment of the Quality Improvement and Patient Safety (QuIPS) Scholarly Pathway-a faculty-mentored, three-year experience for students interested in gaining exposure to QI and patient safety concepts at the Medical College of Wisconsin (MCW). The QuIPS pathway capitalized on the existing structure of scholarly pathways for MCW medical students, allowing QI and patient safety to be incorporated into the existing curriculum using didactic and experiential instruction and spanning preclinical and clinical education. Student reaction to the QuIPS pathway has been favorable. Preliminary data demonstrate that student knowledge as measured by the Quality Improvement Knowledge Assessment Tool significantly increased after the first year of implementation. A novel curriculum such as the QuIPS pathway provides an important opportunity to develop and test new assessment tools for curricula in systems-based practice and practice-based learning and improvement. The authors also hope that by bringing together local QI and patient safety experts and stakeholders during the curricular development process, they have laid the groundwork for the creation of a more pervasive curriculum that will reach all MCW students in the future. The model may be generalizable to other U.S. medical schools with scholarly pathways as well.

  8. Empowering Post-Surgical Patients to Improve Opioid Disposal: A Before and After Quality Improvement Study.

    Science.gov (United States)

    Hasak, Jessica M; Roth Bettlach, Carrie L; Santosa, Katherine B; Larson, Ellen L; Stroud, Jean; Mackinnon, Susan E

    2018-03-01

    Our country is in the midst of an opioid epidemic. Although the problem is multifactorial, one issue is the presence of excess prescription opioid medications circulating in our communities. Our objective was to determine whether dissemination of an educational brochure would improve the disposal of unused opioids after surgery. Eligible surgery patients from an upper extremity/peripheral nerve clinic were enrolled into this prospective before and after study between February 2017 and September 2017. Patients who reported opioid use preoperatively were excluded from this study. The same survey was administered to the group of patients who did not receive the intervention and to those who did receive the intervention. Our primary endpoint was the proportion of patients who disposed of unused opioid medications. A total of 334 patients were studied: 164 who did not receive the brochure and 170 who received the brochure. Seventy-six patients were excluded for preoperative opioid use. After dissemination of the brochure, there was a significant increase in the proportion of patients who disposed of their unused opioids (11% vs 22%, p = 0.02). Of those who disposed of their opioids, there was no significant difference in the proportion of patients from each group who disposed in a manner that was recommended by the brochure (43% vs 64%, p = 0.19). Dissemination of the educational brochure improved disposal of unused opioids after surgery. This low-cost, easily implemented intervention can improve disposal of unused opioids and ultimately, decrease the amount of excess opioids circulating in our communities. Copyright © 2017 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  9. Commitment to COT verification improves patient outcomes and financial performance.

    Science.gov (United States)

    Maggio, Paul M; Brundage, Susan I; Hernandez-Boussard, Tina; Spain, David A

    2009-07-01

    After an unsuccessful American College of Surgery Committee on Trauma visit, our level I trauma center initiated an improvement program that included (1) hiring new personnel (trauma director and surgeons, nurse coordinator, orthopedic trauma surgeon, and registry staff), (2) correcting deficiencies in trauma quality assurance and process improvement programs, and (3) development of an outreach program. Subsequently, our trauma center had two successful verifications. We examined the longitudinal effects of these efforts on volume, patient outcomes and finances. The Trauma Registry was used to derive data for all trauma patients evaluated in the emergency department from 2001 to 2007. Clinical data analyzed included number of admissions, interfacility transfers, injury severity scores (ISS), length of stay, and mortality for 2001 to 2007. Financial performance was assessed for fiscal years 2001 to 2007. Data were divided into patients discharged from the emergency department and those admitted to the hospital. Admissions increased 30%, representing a 7.6% annual increase (p = 0.004), mostly due to a nearly fivefold increase in interfacility transfers. Severe trauma patients (ISS >24) increased 106% and mortality rate for ISS >24 decreased by 47% to almost half the average of the National Trauma Database. There was a 78% increase in revenue and a sustained increase in hospital profitability. A major hospital commitment to Committee on Trauma verification had several salient outcomes; increased admissions, interfacility transfers, and acuity. Despite more seriously injured patients, there has been a major, sustained reduction in mortality and a trend toward decreased intensive care unit length of stay. This resulted in a substantial increase in contribution to margin (CTM), net profit, and revenues. With a high level of commitment and favorable payer mix, trauma center verification improves outcomes for both patients and the hospital.

  10. Integrating patient satisfaction into performance measurement to meet improvement challenges.

    Science.gov (United States)

    Smith, J E; Fisher, D L; Endorf-Olson, J J

    2000-05-01

    A Value Compass has been proposed to guide health care data collection. The "compass corners" represent the four types of data needed to meet health care customer expectations: appropriate clinical outcomes, improved functional status, patient satisfaction, and appropriate costs. Collection of all four types of data is necessary to select processes in need of improvement, guide improvement teams, and monitor the success of improvement efforts. INTEGRATED DATA AT BRYANLGH: BryanLGH Medical Center in Lincoln, Nebraska, has adopted multiple performance measurement systems to collect clinical outcome, financial, and patient satisfaction data into integrated databases. Data integration allows quality professionals at BryanLGH to identify quality issues from multiple perspectives and track the interrelated effects of improvement efforts. A CASE EXAMPLE: Data from the fourth quarter of 1997 indicated the need to improve processes related to cesarean section (C-section) deliveries. An interdisciplinary team was formed, which focused on educating nurses, physicians, and the community about labor support measures. Physicians were given their own rates of C-section deliveries. The C-section rate decreased from 27% to 19%, but per-case cost increased. PickerPLUS+ results indicated that BryanLGH obstetric patients reported fewer problems with receiving information than the Picker norm, but they reported more problems with the involvement of family members and friends. The data collected so far have indicated a decrease in the C-section rate and a need to continue to work on cost and psychosocial issues. A complete analysis of results was facilitated by integrated performance management systems. Successes have been easily tracked over time, and the need for further work on related processes has been clearly identified.

  11. Traditional Japanese Medicine Daikenchuto Improves Functional Constipation in Poststroke Patients

    Directory of Open Access Journals (Sweden)

    Takehiro Numata

    2014-01-01

    Full Text Available Poststroke patients with functional constipation, assessed by the Rome III criteria, from 6 hospitals were recruited in a study on the effects of the traditional Japanese medicine Daikenchuto (DKT on constipation. Thirty-four patients (17 men and 17 women; mean age: 78.1 ± 11.6 years were randomly assigned to 2 groups; all patients received conventional therapy for constipation, and patients in the DKT group received 15 g/day of DKT for 4 weeks. Constipation scoring system (CSS points and the gas volume score (GVS (the measure of the intestinal gas volume calculated from plain abdominal radiographs were recorded before and after a 4-week observation period. The total score on the CSS improved significantly in the DKT group compared to the control (P<0.01. In addition, scores for some CSS subcategories (frequency of bowel movements, feeling of incomplete evacuation, and need for enema/disimpaction significantly improved in the DKT group (P<0.01, P=0.049, and P=0.03, resp.. The GVS was also significantly reduced in the DKT group compared to the control (P=0.03. DKT in addition to conventional therapy is effective in treating functional constipation in poststroke patients. This study was a randomized controlled trial and was registered in the UMIN Clinical Trial Registry (no. UMIN000007393.

  12. How to Improve Patient Safety Culture in Croatian Hospitals?

    Science.gov (United States)

    Šklebar, Ivan; Mustajbegović, Jadranka; Šklebar, Duška; Cesarik, Marijan; Milošević, Milan; Brborović, Hana; Šporčić, Krunoslav; Petrić, Petar; Husedžinović, Ino

    2016-09-01

    Patient safety culture (PCS) has a crucial impact on the safety practices of healthcare delivery systems. The purpose of this study was to assess the state of PSC in Croatian hospitals and compare it with hospitals in the United States. The study was conducted in three public general hospitals in Croatia using the Croatian translation of the Hospital Survey of Patient Safety Culture (HSOPSC). A comparison of the results from Croatian and American hospitals was performed using a T-square test. We found statistically significant differences in all 12 PSC dimensions. Croatian responses were more positive in the two dimensions of Handoff s and Transitions and Overall Perceptions of Patient Safety. In the remaining ten dimensions, Croatian responses were less positive than in US hospitals, with the most prominent areas being Nonpunitive Response to Error, Frequency of Events Reported, Communication Openness, Teamwork within Units, Feedback & Communication about Error, Management Support for Patient Safety, and Staffing. Our findings show that PSC is significantly lower in Croatian than in American hospitals, particularly in the areas of Nonpunitive Response to Error, Leadership, Teamwork, Communication Openness and Staffing. This suggests that a more comprehensive system for the improvement of patient safety within the framework of the Croatian healthcare system needs to be developed. Our findings also help confirm that HSOPSC is a useful and appropriate tool for the assessment of PSC. HSOPSC highlights the PSC components in need of improvement and should be considered for use in national and international benchmarking.

  13. Spironolactone in chronic hemodialysis patients improves cardiac function

    International Nuclear Information System (INIS)

    Taheri, Shahram; Mortazavi, Mojhgan; Shahidi Shahrzad; Seirafian, Shiva; Pourmoghadas, Ali; Garakyaraghi, Mohammad; Eshaghian, Afrooz; Ghassami, Maryam

    2009-01-01

    We performed this study to assess whether low dose spironolactone could be administered in hemodialysis (HD) patients with moderate to severe heart failure to improve cardiovascular function and reduce hospitalization without inducing hyperkalemia. We enrolled 16 chronic HD patients with moderate to severe heart failure and left ventricle ejection fraction :5 45%. In a double blinded randomized placebo controlled study, one group of 8 patients received 25 mg of spironolactone after each dialysis session within six months, and the rest received a placebo. Echocardiography was performed on all the patients to assess ejection fraction and left ventricular mass during 12 hours after completion of hemodialysis at the beginning and the end of study. Serum potassium was measured predialysis every 4 weeks. The mean ejection fraction increased significantly more in spironolactone group during the study period than in the placebo group (6.2 + - 1.64 vs. 0.83 + - 4.9, P0.046). The mean left ventricular mass decreased in the spironolactone group, but increased significantly in the placebo group during the period (-8.4 + - 4.72 vs. 3 + -7.97. 95%, P= 0.021). The incidence of hyperkalemia was not significantly increased in the study or controlled groups. In conclusion, we found in this study that administration of spironolactone in chronic HD patients with moderate to severe heart failure substantially improved their cardiac function and decreases left ventricular mass without development of significant hyperkalemia. (author)

  14. Does stapes surgery improve tinnitus in patients with otosclerosis?

    Science.gov (United States)

    Ismi, Onur; Erdogan, Osman; Yesilova, Mesut; Ozcan, Cengiz; Ovla, Didem; Gorur, Kemal

    Otosclerosis (OS) is the primary disease of the human temporal bone characterized by conductive hearing loss and tinnitus. The exact pathogenesis of tinnitus in otosclerosis patients is not known and factors affecting the tinnitus outcome in otosclerosis patients are still controversial. To find the effect of stapedotomy on tinnitus for otosclerosis patients. Fifty-six otosclerosis patients with preoperative tinnitus were enrolled to the study. Pure tone average Air-Bone Gap values, preoperative tinnitus pitch, Air-Bone Gap closure at tinnitus frequencies were evaluated for their effect on the postoperative outcome. Low pitch tinnitus had more favorable outcome compared to high pitch tinnitus (p=0.002). Postoperative average pure tone thresholds Air-Bone Gap values were not related to the postoperative tinnitus (p=0.213). There was no statistically significant difference between postoperative Air-Bone Gap closure at tinnitus frequency and improvement of high pitch tinnitus (p=0.427). There was a statistically significant difference between Air-Bone Gap improvement in tinnitus frequency and low pitch tinnitus recovery (p=0.026). Low pitch tinnitus is more likely to be resolved after stapedotomy for patients with otosclerosis. High pitch tinnitus may not resolve even after closure of the Air-Bone Gap at tinnitus frequencies. Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  15. Approaches to improve adherence to pharmacotherapy in patients with schizophrenia.

    Science.gov (United States)

    Shuler, Kimberly M

    2014-01-01

    In patients with schizophrenia, nonadherence to prescribed medications increases the risk of patient relapse and hospitalization, key contributors to the costs associated with treatment. The objectives of this review were to evaluate the impact of nonadherence to pharmacotherapy in patients with schizophrenia as it relates to health care professionals, particularly social workers, and to identify effective team approaches to supporting patients based on studies assessing implementation of assertive community treatment teams. A systematic review of the medical literature was conducted by searching the Scopus database to identify articles associated with treatment adherence in patients with schizophrenia. Articles included were published from January 1, 2003, through July 15, 2013, were written in English, and reported findings concerning any and all aspects of nonadherence to prescribed treatment in patients with schizophrenia. Of 92 unique articles identified and formally screened, 47 met the inclusion criteria for the systematic review. The burden of nonadherence in schizophrenia is significant. Factors with the potential to affect adherence include antipsychotic drug class and formulation, patient-specific factors, and family/social support system. There is inconclusive evidence suggesting superior adherence with an atypical versus typical antipsychotic or with a long-acting injectable versus an oral formulation. Patient-specific factors that contribute to adherence include awareness/denial of illness, cognitive issues, stigma associated with taking medication, substance abuse, access to health care, employment/poverty, and insurance status. Lack of social or family support may adversely affect adherence, necessitating the assistance of health care professionals, such as social workers. Evidence supports the concept that an enhanced team-oriented approach to managing patients with schizophrenia improves adherence and supports corresponding reductions in relapse

  16. Improving quality of care among patients hospitalised with schizophrenia

    DEFF Research Database (Denmark)

    Jørgensen, Mette; Mainz, Jan; Svendsen, Marie Louise

    2015-01-01

    BACKGROUND: The effectiveness of systematic quality improvement initiatives in psychiatric care remains unclear. AIMS: To examine whether quality of care has changed following implementation of a systematic monitoring programme of hospital performance measures. METHOD: In a nationwide population.......27-1.62), psychoeducation (RR: 1.33, 95% CI: 1.19-1.48), psychiatric aftercare (RR: 1.06, 95% CI: 1.01-1.11) and suicide risk assessment (RR: 1.31, 95% CI: 1.21-1.42). CONCLUSIONS: Quality of care improved from 2004 to 2011 among patients hospitalised with schizophrenia in Denmark. DECLARATION OF INTEREST: None. COPYRIGHT...

  17. Financial versus Non-Financial Incentives for Improving Patient Experience.

    Science.gov (United States)

    Lee, Thomas H

    2015-05-01

    Delivering compassionate and coordinated care is a goal for all health care providers. Humans are not always consistent, though, both individually and collectively, and this is why everyone needs incentives to be at their best and to try to always be improving. The endlessly interesting question in patient experience is, what should those incentives look like? Should they be financial or nonfinancial? Dr. Thomas H. Lee explores what is most effective in regard to engaging and motivating physicians. While different approaches will work in different organizational cultures, financial incentives have their role in performance improvement. Compassionate coordinated care should be a social norm and be pursued by all health care organizations.

  18. The readability of psychosocial wellness patient resources: improving surgical outcomes.

    Science.gov (United States)

    Kugar, Meredith A; Cohen, Adam C; Wooden, William; Tholpady, Sunil S; Chu, Michael W

    2017-10-01

    Patient education is increasingly accessed with online resources and is essential for patient satisfaction and clinical outcomes. The average American adult reads at a seventh grade level, and the National Institute of Health (NIH) and the American Medical Association (AMA) recommend that information be written at a sixth-grade reading level. Health literacy plays an important role in the disease course and outcomes of all patients, including those with depression and likely other psychiatric disorders, although this is an area in need of further study. The purpose of this study was to collect and analyze written, online mental health resources on the Veterans Health Administration (VA) website, and other websites, using readability assessment instruments. An internet search was performed to identify written patient education information regarding mental health from the VA (the VA Mental Health Website) and top-rated psychiatric hospitals. Seven mental health topics were included in the analysis: generalized anxiety disorder, bipolar, major depressive disorder, posttraumatic stress disorder, schizophrenia, substance abuse, and suicide. Readability analyses were performed using the Gunning Fog Index, the Flesch-Kincaid Grade Level, the Coleman-Liau Index, the SMOG Readability Formula, and the Automated Readability Index. These scores were then combined into a Readability Consensus score. A two-tailed t-test was used to compare the mean values, and statistical significance was set at P readability consensus than six of the top psychiatric hospitals (P readability consensus for mental health information on all websites analyzed was 9.52. Online resources for mental health disorders are more complex than recommended by the NIH and AMA. Efforts to improve readability of mental health and psychosocial wellness resources could benefit patient understanding and outcomes, especially in patients with lower literacy. Surgical outcomes are correlated with patient mental

  19. [Primary care for diabetic patients: a quality improvement cycle].

    Science.gov (United States)

    Navarro-Martínez, A; Suárez-Beke, M P; Sánchez-Nicolás, J A; Lázaro-Aragues, P; de Jesús Jiménez-Vázquez, E; Huertas-de Mora, O

    2014-01-01

    The aim of this study was to evaluate and improve the quality of medical care provided to diabetic patients following the standards proposed by the American Diabetes Association. The study was conducted in three phases by analyzing data from the computerized clinical history of a sample of 340 patients. First phase (2010): cross-sectional, descriptive study which assessed the proportion of patients who met the standards related to the screening of diabetes, and goals of control and treatment. Subsequently, health professionals reviewed the results in order to promote the implementation of corrective action. Finally (2012), a new assessment with the same standards was performed. An increase in the number of patients treated with insulin (12.7% in 2010 and 20.2% in 2012) was observed (P < .01). There were also percentage increases in the number of patients who met the screening standards as regards analytical determinations: glycosylated hemoglobin (from 44.4% to 68.2%), lipid profile (47.6%-73.8%), creatinine (32.5% - 73.5%), and albumin-creatinine ratio (9.2%-24.4%) (P < .001). Only 6.4% (CI: 3.2- 9.8) of diabetic patients attained the composite target of glycosylated hemoglobin < 7%, blood pressure < 130/80 mmHg and low-density lipoprotein cholesterol < 100 mg/dl in 2012. This study shows that medical care has improved the goals related to analytical determinations and the number of insulin-treated diabetic type 2 patients. An optimal level was also maintained in metabolic control of diabetes, but there was still poor control of risk factors for cardiovascular disease. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

  20. How to improve effectiveness of pegvisomant treatment in acromegalic patients.

    Science.gov (United States)

    Ragonese, M; Grottoli, S; Maffei, P; Alibrandi, A; Ambrosio, M R; Arnaldi, G; Bianchi, A; Puglisi, S; Zatelli, M C; De Marinis, L; Ghigo, E; Giustina, A; Maffezzoni, F; Martini, C; Trementino, L; Cannavo, S

    2018-05-01

    Pegvisomant (PEGV) treatment in acromegaly patients resistant to somatostatin analogues is less effective in the real life than in clinical trials. This is a multicenter, observational, retrospective, longitudinal study. The aim was to detect characteristics which improve long-term PEGV effectiveness. 87 acromegalic patients treated with PEGV have been enrolled in seven referral Italian centres. PEGV was administered for up to 4 years, at doses up titrated until IGF-1 normalization or to ≥ 30 mg/day. The rate of patients who reached IGF-1 normalization at last visit has been calculated. IGF-1 was normalized in 75.9% of patients after 1 year and in 89.6% at last visit. Disease control was associated with lower baseline GH, IGF-1 and IGF-1 xULN and was more frequent when baseline IGF-1 was  2.7 × ULN (p  1.0 mg/BMI/day were administered more frequently when baseline IGF-1 was > 2.0 × ULN (p = 0.03). PEGV resistance was associated with higher BMI (p = 0.006) and was more frequent when BMI was > 30 kg/m 2 (p = 0.07). There were no significant differences between patients treated with monotherapy or combined treatment. IGF-1 normalization, PEGV dose and rate of associated treatment were similar between males and females. PEGV effectiveness was independent from previous management. Diabetic patients needed higher doses of PEGV than non-diabetic ones. PEGV effectiveness improves when up titration is appropriate. Higher PEGV doses at start and a more rapid up-titration are necessary in patients with obesity and/or IGF-1 > 2.7 × ULN.

  1. Improving Patient Safety in Anesthesia: A Success Story?

    International Nuclear Information System (INIS)

    Botney, Richard

    2008-01-01

    Anesthesia is necessary for surgery; however, it does not deliver any direct therapeutic benefit. The risks of anesthesia must therefore be as low as possible. Anesthesiology has been identified as a leader in improving patient safety. Anesthetic mortality has decreased, and in healthy patients can be as low as 1:250,000. Trends in anesthetic morbidity have not been as well defined, but it appears that the risk of injury is decreasing. Studies of error during anesthesia and Closed Claims studies have identified sources of risk and methods to reduce the risks associated with anesthesia. These include changes in technology, such as anesthetic delivery systems and monitors, the application of human factors, the use of simulation, and the establishment of reporting systems. A review of the important events in the past 50 years illustrates the many steps that have contributed to the improvements in anesthesia safety

  2. Improving Researcher-Patient Collaboration through Social Network Websites

    OpenAIRE

    Akindayo, Olayiwola; Dopgima, Cynthia

    2012-01-01

    Purpose: The main purpose of this study/thesis is to, through an interview with researchers in medical field in Jönköping,  provide an empirical analysis of the link or relationship between medical researcher and patient through social networking sites specifically for collaboration in order to improve relationships, dissemination of information and knowledge sharing. Background: The importance of social networking websites as a means of interaction between groups of individuals cannot be und...

  3. Diaphragm pacing improves sleep in patients with amyotrophic lateral sclerosis.

    Science.gov (United States)

    Gonzalez-Bermejo, Jesus; Morélot-Panzini, Capucine; Salachas, François; Redolfi, Stefania; Straus, Christian; Becquemin, Marie-Hélène; Arnulf, Isabelle; Pradat, Pierre-François; Bruneteau, Gaëlle; Ignagni, Anthony R; Diop, Moustapha; Onders, Raymond; Nelson, Teresa; Menegaux, Fabrice; Meininger, Vincent; Similowski, Thomas

    2012-01-01

    In amyotrophic lateral sclerosis (ALS) patients, respiratory insufficiency is a major burden. Diaphragm conditioning by electrical stimulation could interfere with lung function decline by promoting the development of type 1 muscle fibres. We describe an ancillary study to a prospective, non-randomized trial (NCT00420719) assessing the effects of diaphragm pacing on forced vital capacity (FVC). Sleep-related disturbances being early clues to diaphragmatic dysfunction, we postulated that they would provide a sensitive marker. Stimulators were implanted laparoscopically in the diaphragm close to the phrenic motor point in 18 ALS patients for daily conditioning. ALS functioning score (ALSFRS), FVC, sniff nasal inspiratory pressure (SNIP), and polysomnographic recordings (PSG, performed with the stimulator turned off) were assessed before implantation and after four months of conditioning (n = 14). Sleep efficiency improved (69 ± 15% to 75 ± 11%, p = 0.0394) with fewer arousals and micro-arousals. This occurred against a background of deterioration as ALSFRS-R, FVC, and SNIP declined. There was, however, no change in NIV status or the ALSFRS respiratory subscore, and the FVC decline was mostly due to impaired expiration. Supporting a better diaphragm function, apnoeas and hypopnoeas during REM sleep decreased. In conclusion, in these severe patients not expected to experience spontaneous improvements, diaphragm conditioning improved sleep and there were hints at diaphragm function changes.

  4. Use of Patient-Authored Prehistory to Improve Patient Experiences and Accommodate Federal Law.

    Science.gov (United States)

    Warner, Michael J; Simunich, Thomas J; Warner, Margaret K; Dado, Joseph

    2017-02-01

    Although federal law grants patients the right to view and amend their medical records, few studies have proposed a process for patients to coauthor their subjective history in their medical record. Allowing patients to fully disclose and document their medical history is an important step to improve the diagnostic process. To evaluate patients' office experience before and after they authored their subjective medical history for the electronic health record. Patients were mailed a prehistory form and presurvey to be completed before their family medicine office visit. On arrival to the office, the prehistory form was scanned into the electronic health record while the content was transcribed by hospital staff into the appropriate fields in the history component of the encounter note. Postsurveys were given to patients to be completed after their visit. Pre- and postsurveys measured the patients' perception of office visit quality as well as completeness and accuracy of their electronic health record documentation before and after their appointment. Medical staff surveys were collected weekly to measure the staff's viewpoint of the federal law that allows patients to view and amend their medical records. Of 405 patients who were asked to participate, 263 patients aged 14 to 94 years completed a presurvey and a prehistory form. Of those 263 patients, 134 completed a postsurvey. The pre- and postsurveys showed improved patient satisfaction with the office visit and high scores for documentation accuracy and completeness. Before filling out the prehistory form, 116 of 249 patients (46.6%) agreed or strongly agreed that they felt more empowered in their health care by completing the prehistory form compared with 110 of 131 (84.0%) who agreed or strongly agreed after the visit (Pprehistory form beforehand to improve the patient experience while accommodating federal law.

  5. A Comparison of Short- and Long-Term Therapeutic Outcomes of Infliximab- versus Tacrolimus-Based Strategies for Steroid-Refractory Ulcerative Colitis

    Directory of Open Access Journals (Sweden)

    Katsuya Endo

    2016-01-01

    Full Text Available Background/Aims. Antitumor necrosis factor antibodies and calcineurin inhibitors have shown good therapeutic efficacy for steroid-refractory ulcerative colitis (UC. Although some studies have compared the efficacy of infliximab (IFX and cyclosporin A, there are no published studies comparing IFX and tacrolimus (Tac. This study aimed to compare therapeutic efficacies between IFX- and Tac-based strategies for steroid-refractory UC. Methods. Between July 2009 and August 2013, 95 patients with steroid-refractory UC received either IFX (n=48 or Tac (n=47 in our hospital. In the IFX group, the patients continued to receive maintenance treatment with IFX. In the Tac group, patients discontinued Tac treatment up to 3 months and subsequently received thiopurine. We retrospectively compared the therapeutic outcomes between the groups. Results. There was no significant difference in the colectomy-free rate, clinical remission rate, and clinical response rate at 2 months between the groups. However, relapse-free survival was significantly higher in the IFX group than in the Tac group (p<0.001; log-rank test. The proportions of serious adverse events did not differ between the groups. Conclusion. The findings of our study showed that IFX and Tac have similar short-term therapeutic efficacy for steroid-refractory UC. Maintenance treatment with IFX, however, yields better long-term outcomes than Tac-thiopurine bridging treatment.

  6. TWO TOPICAL CALCINEURIN INHIBITORS FOR THE TREATMENT OF ATOPIC DERMATITIS IN PEDIATRIC PATIENTS: A META-ANALYSIS OF RANDOMIZED CLINICAL TRIALS (ARTICLE IN ENGLISH

    Directory of Open Access Journals (Sweden)

    S.L. Chen

    2011-01-01

    Full Text Available Two new topical immunomodulators, pimecrolimus cream and tacrolimus ointment for atopic dermatitis (AD in pediatric patients, have provided alternatives to topical corticosteroids without the associated adverse events. Objective: To evaluate the efficacy and safety of tacrolimus ointment and pimecrolimus cream for the treatment of AD in pediatric patients. MEDLINE, Embase, the CNKI and Cochrane Library databases were searched up to December 2008. Additional data sources were manual searches of abstract proceedings and personal contact with investigators and pharmaceutical companies. Two investigators assessed the quality of trials with unified tables independently. Disagreements on validity assessment were resolved through discussion or consultation with the third author. Quality analysis of methodology was evaluated according to the Jadad scale, including randomization, blinding and patients’ discontinuation. Twenty trials involving 6288 infants and children with AD met the inclusion criteria. More patients using tacrolimus had a good response than those in control groups including vehicle, 1% hydrocortisone acetate and 1% pimecrolimus, the corresponding OR were (4.56; 95%CI: 2.80 to 7.44, (3.92; 95% CI: 2.96 to 5.20 and (1.58; 95% CI: 1.18 to 2.12. The effect difference between 0.03% tacrolimus and 0.1% tacrolimus ointments was not statistically significant (OR = 0.90; 95% CI: 0.55 to 1.48. The incidence of adverse events of tacrolimus ointment or pimecrolimus cream was similar to the vehicle. The major adverse events were burning and pruritus. Both tacrolimus ointment and pimecrolimus cream are safe and effective in the treatment of AD in pediatric patients. Tacrolimus ointments were superior to pimecrolimus cream.

  7. Improvement of emergency department patient flow using lean thinking.

    Science.gov (United States)

    Sánchez, Miquel; Suárez, Montse; Asenjo, María; Bragulat, Ernest

    2018-05-01

    To apply lean thinking in triage acuity level-3 patients in order to improve emergency department (ED) throughtput and waiting time. A prospective interventional study. An ED of a tertiary care hospital. Triage acuity level-3 patients. To apply lean techniques such as value stream mapping, workplace organization, reduction of wastes and standardization by the frontline staff. Two periods were compared: (i) pre-lean: April-September, 2015; and (ii) post-lean: April-September, 2016. Variables included: median process time (time from beginning of nurse preparation to the end of nurse finalization after doctor disposition) of both discharged and transferred to observation patients; median length of stay; median waiting time; left without being seen, 72-h revisit and mortality rates, and daily number of visits. There was no additional staff or bed after lean implementation. Despite an increment in the daily number of visits (+8.3%, P lean implementation. No significant differences were registered in left without being seen rate (5.23% vs 4.95%), 72-h revisit rate (3.41% vs 3.93%), and mortality rate (0.23% vs 0.15%). Lean thinking is a methodology that can improve triage acuity level-3 patient flow in the ED, resulting in better throughput along with reduced waiting time.

  8. Strategies to improve self-management in heart failure patients.

    Science.gov (United States)

    Toback, Mehnosh; Clark, Nancy

    2017-02-01

    Heart failure is one of the most common causes of hospitalization, hospital readmission and death. Patients with heart failure have many complications, with multiple co-existing diagnoses which result in polypharmacy. Following instructions provided by many physicians, medication adjustments based on changes in their symptoms are required. Behavioral adjustments concerning diet and exercise regime are recommended. Therefore, the patient plays a crucial role in the management of heart failure. To review the available studies on heart failure self-management, and investigate educational, behavioral and psychosocial strategies that plays an important role to improve patient self-management. A literature review was conducted based upon the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidance. The articles identified through an extensive search using PubMed and UpToDate from 1999 to 2016. Improved self-management will increase compliance, promote patient quality-of-life, advance clinical outcomes, reduce hospital re-admission and will decrease hospitalization costs.

  9. Improving outpatient access and patient experiences in academic ambulatory care.

    Science.gov (United States)

    O'Neill, Sarah; Calderon, Sherry; Casella, Joanne; Wood, Elizabeth; Carvelli-Sheehan, Jayne; Zeidel, Mark L

    2012-02-01

    Effective scheduling of and ready access to doctor appointments affect ambulatory patient care quality, but these are often sacrificed by patients seeking care from physicians at academic medical centers. At one center, Beth Israel Deaconess Medical Center, the authors developed interventions to improve the scheduling of appointments and to reduce the access time between telephone call and first offered appointment. Improvements to scheduling included no redirection to voicemail, prompt telephone pickup, courteous service, complete registration, and effective scheduling. Reduced access time meant being offered an appointment with a physician in the appropriate specialty within three working days of the telephone call. Scheduling and access were assessed using monthly "mystery shopper" calls. Mystery shoppers collected data using standardized forms, rated the quality of service, and transcribed their interactions with schedulers. Monthly results were tabulated and discussed with clinical leaders; leaders and frontline staff then developed solutions to detected problems. Eighteen months after the beginning of the intervention (in June 2007), which is ongoing, schedulers had gone from using 60% of their registration skills to over 90%, customer service scores had risen from 2.6 to 4.9 (on a 5-point scale), and average access time had fallen from 12 days to 6 days. The program costs $50,000 per year and has been associated with a 35% increase in ambulatory volume across three years. The authors conclude that academic medical centers can markedly improve the scheduling process and access to care and that these improvements may result in increased ambulatory care volume.

  10. Patient-Centered Prescription Model to improve therapeutic adherence in patients with multimorbidity

    Directory of Open Access Journals (Sweden)

    Javier González-Bueno

    2018-05-01

    Full Text Available To date, interventions to improve medication adherence in patients with multimorbidity have shown modest and inconsistent efficacy among available studies. Thereby, we should define new approaches aimed at improving medication adherence tailored to effective prescribing, with a multidisciplinary approach and patient-centered. In this regard, the Patient-Centered Prescription Model has shown its usefulness on improving appropriateness of drug treatments in patients with clinical complexity. For that, this strategy addresses the following four steps: 1 Patient-Centered assessment; 2 Diagnosis-Centered assessment; 3 Medication-Centered assessment; and 4 Therapeutic Plan. We propose through a clinical case an adaptation of the Patient-Centered Prescription Model to enhance both appropriateness and medication adherence in patients with multimorbidity. To this end, we have included on its first step the Spanish version of a cross-culturally adapted scale for the multidimensional assessment of medication adherence. Furthermore, we suggest a set of interventions to be applied in the three remaining steps of the model. These interventions were firstly identified by an overview of systematic reviews and then selected by a panel of experts based on Delphi methodology. All of these elements have been considered appropriate in patients with multimorbidity according to three criteria: strength of their supporting evidence, usefulness in the target population and feasibility of implementation in clinical practice. The proposed approach intends to lay the foundations for an innovative way in tackling medication adherence in patients with multimorbidity.

  11. Improving the care of patients with cystic fibrosis (CF)

    Science.gov (United States)

    Khan, Ahsan Aftab; Nash, Edward F; Whitehouse, Joanna; Rashid, Rifat

    2017-01-01

    Background The West Midlands Adult Cystic Fibrosis (CF) Centre based at Birmingham Heartlands Hospital provides care for adults with CF in the West Midlands. People with CF are prone to pulmonary exacerbations, which often require inpatient admission for intravenous antibiotics. We observed that the admission process was efficient during working hours (9:00–17:00, Monday–Friday) when the CF team are routinely available, but out-of-working hours, there were delays in these patients being clerked and receiving their first antibiotic dose. We were concerned that this was resulting in quality and potential safety issues by causing delays in starting treatment and prolonging hospital inpatient stays. We therefore undertook a quality improvement project (QIP) aimed at addressing these issues. An initial survey showed median time to clerk of 5 hours, with 60% of patients missing their first dose of antibiotics and mean length of stay of 16 days. Methods We applied the Plan-Do-Study-Act (PDSA) cycle approach, with the first PDSA cycle involving raising awareness of the issue through education to doctors, nurses and patients. Results This led to a reduction of median time to clerk from 5 to 2 hours with 23% of patients missing their first antibiotic dose and mean length of stay reducing to 14 days. The second cycle involved introducing an admissions checklist and displaying education posters around the hospital, resulting in median time to clerk remaining at 2 hours but only 20% of patients missing their first antibiotic dose and the mean length of stay remaining at 14 days. Conclusion This QIP has improved the out-of-hours admissions process for adults with CF in our centre. We plan to review the longer term effects of the project including sustainability, effects on clinical outcomes and patient satisfaction. PMID:28959778

  12. Quality improvement in practice: improving diabetes care and patient outcomes in Aboriginal Community Controlled Health Services.

    Science.gov (United States)

    Stoneman, Alice; Atkinson, David; Davey, Maureen; Marley, Julia V

    2014-10-07

    Management of chronic disease, including diabetes, is a central focus of most Aboriginal Community Controlled Health Services (ACCHSs) in Australia. We have previously demonstrated that diabetes monitoring and outcomes can be improved and maintained over a 10-year period at Derby Aboriginal Health Service (DAHS). While continuous quality improvement (CQI) has been shown to improve service delivery rates and clinical outcome measures, the process of interpreting audit results and developing strategies for improvement is less well described. This paper describes the evaluation of care of patients with type 2 diabetes mellitus (T2DM) and features of effective CQI in ACCHSs in the remote Kimberley region of north Western Australia. Retrospective audit of records for Aboriginal and Torres Strait Islander primary care patients aged ≥15 years with a confirmed diagnosis of T2DM at four Kimberley ACCHSs from 1 July 2011 to 30 June 2012. Interviews with health service staff and focus group discussions with patients post audit. diabetes care related activities, clinical outcome measures and factors influencing good diabetes related care and effective CQI. A total of 348 patients from the four ACCHSs were included in the study. Clinical care activities were generally high across three of the four health services (at least 71% of patients had cholesterol recorded, 89% blood pressure, 84% HbA1c). Patients from DAHS had lower median cholesterol levels (4.4 mmol/L) and the highest proportion of patients meeting clinical targets for HbA1c (31% v 16% ACCHS-3; P = 0.02). Features that facilitated good care included clearly defined staff roles for diabetes management, support and involvement of Aboriginal Health Workers, efficient recall systems, and well-coordinated allied health services. Effective CQI features included seamless and timely data collection, local ownership of the process, openness to admitting deficiencies and willingness to embrace change. Well

  13. Can asthma control be improved by understanding the patient's perspective?

    Directory of Open Access Journals (Sweden)

    Østrem Anders

    2007-05-01

    agreement between the healthcare professional and patient on a predefined target regarding asthma control and a treatment plan to achieve this. Summary Optimum review of asthma is essential to improve control. A key priority is the development of simple and effective tools for identifying poor control for individual patients coupled with a tailored approach to treatment to enable patients to set and achieve realistic goals for asthma control.

  14. Communication Skills Training for Physicians Improves Patient Satisfaction.

    Science.gov (United States)

    Boissy, Adrienne; Windover, Amy K; Bokar, Dan; Karafa, Matthew; Neuendorf, Katie; Frankel, Richard M; Merlino, James; Rothberg, Michael B

    2016-07-01

    Skilled physician communication is a key component of patient experience. Large-scale studies of exposure to communication skills training and its impact on patient satisfaction have not been conducted. We aimed to examine the impact of experiential relationship-centered physician communication skills training on patient satisfaction and physician experience. This was an observational study. The study was conducted at a large, multispecialty academic medical center. Participants included 1537 attending physicians who participated in, and 1951 physicians who did not participate in, communication skills training between 1 August 2013 and 30 April 2014. An 8-h block of interactive didactics, live or video skill demonstrations, and small group and large group skills practice sessions using a relationship-centered model. Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CGCAHPS), Jefferson Scale of Empathy (JSE), Maslach Burnout Inventory (MBI), self-efficacy, and post course satisfaction. Following the course, adjusted overall CGCAHPS scores for physician communication were higher for intervention physicians than for controls (92.09 vs. 91.09, p communication scores (83.95 vs. 82.73, p = 0.22). Physicians reported high course satisfaction and showed significant improvement in empathy (116.4 ± 12.7 vs. 124 ± 11.9, p communication skills training improved patient satisfaction scores, improved physician empathy, self-efficacy, and reduced physician burnout. Further research is necessary to examine longer-term sustainability of such interventions.

  15. A case of vesicular cutaneous lupus erythematosus in a Border collie successfully treated with topical tacrolimus and nicotinamide-tetracycline.

    Science.gov (United States)

    Lehner, Georg M; Linek, Monika

    2013-12-01

    Canine vesicular cutaneous lupus erythematosus (VCLE) is an autoimmune skin disease of the Shetland sheepdog and rough collie, which manifests as an erosive dermatitis of sparsely haired skin of the ventrum and concave pinnae. Reported treatment consists of immunosuppression with glucocorticoids alone or in combination with azathioprine, but successful treatment is unpredictable. To report on the treatment of VCLE in a Border collie dog with topical 0.1% tacrolimus and nicotinamide in combination with tetracycline. An 8-year-old male neutered Border collie was presented with multiple coalescing erosions on the ventral abdomen, groin and axillae and ulceration on the oral commissures. Clinical presentation, routine diagnostics, histology and immunohistochemistry were consistent with VCLE. Remission was achieved with topical 0.1% tacrolimus and combination therapy of nicotinamide and tetracycline. This dog responded well to treatment with topical 0.1% tacrolimus, nicotinamide-tetracycline and sun avoidance. Complete remission was achieved after 2.5 months, and the dog was lesion free during a 1 year follow-up period. © 2013 ESVD and ACVD.

  16. Traditional Japanese medicine daikenchuto improves functional constipation in poststroke patients.

    Science.gov (United States)

    Numata, Takehiro; Takayama, Shin; Tobita, Muneshige; Ishida, Shuichi; Katayose, Dai; Shinkawa, Mitsutoshi; Oikawa, Takashi; Aonuma, Takanori; Kaneko, Soichiro; Tanaka, Junichi; Kanemura, Seiki; Iwasaki, Koh; Ishii, Tadashi; Yaegashi, Nobuo

    2014-01-01

    Poststroke patients with functional constipation, assessed by the Rome III criteria, from 6 hospitals were recruited in a study on the effects of the traditional Japanese medicine Daikenchuto (DKT) on constipation. Thirty-four patients (17 men and 17 women; mean age: 78.1 ± 11.6 years) were randomly assigned to 2 groups; all patients received conventional therapy for constipation, and patients in the DKT group received 15 g/day of DKT for 4 weeks. Constipation scoring system (CSS) points and the gas volume score (GVS) (the measure of the intestinal gas volume calculated from plain abdominal radiographs) were recorded before and after a 4-week observation period. The total score on the CSS improved significantly in the DKT group compared to the control (P DKT group (P DKT group compared to the control (P = 0.03). DKT in addition to conventional therapy is effective in treating functional constipation in poststroke patients. This study was a randomized controlled trial and was registered in the UMIN Clinical Trial Registry (no. UMIN000007393).

  17. Improved Functional Performance in Geriatric Patients During Hospital Stay

    DEFF Research Database (Denmark)

    Karlsen, Anders; Loeb, Mads Rohde; Andersen, Kristine Bramsen

    2017-01-01

    OBJECTIVE: The aim of this work was to evaluate the time course of changes in strength and functional performance in elderly hospitalized medical patients. DESIGN: This was a prospective observational study in elderly medical patients of age 65 years or older at a geriatric department.Measurement......OBJECTIVE: The aim of this work was to evaluate the time course of changes in strength and functional performance in elderly hospitalized medical patients. DESIGN: This was a prospective observational study in elderly medical patients of age 65 years or older at a geriatric department.......Measurements were obtained on days 2 to 4, day 5 to 8, and days 9 to 13. Functional performance was measured with De Morton Mobility Index (DEMMI) test and a 30-second chair stand test (30-s CST). Muscular strength was measured with handgrip strength. Activity level was determined with accelerometry (Activ...... in 30-s CST (P performance of the lower extremities in geriatric patients improves moderately over the time of a hospital stay...

  18. Improved survival using specialized multidisciplinary board in sarcoma patients.

    Science.gov (United States)

    Blay, J-Y; Soibinet, P; Penel, N; Bompas, E; Duffaud, F; Stoeckle, E; Mir, O; Adam, J; Chevreau, C; Bonvalot, S; Rios, M; Kerbrat, P; Cupissol, D; Anract, P; Gouin, F; Kurtz, J-E; Lebbe, C; Isambert, N; Bertucci, F; Toumonde, M; Thyss, A; Piperno-Neumann, S; Dubray-Longeras, P; Meeus, P; Ducimetière, F; Giraud, A; Coindre, J-M; Ray-Coquard, I; Italiano, A; Le Cesne, A

    2017-11-01

    Sarcomas are rare but aggressive diseases. Specialized multidisciplinary management is not implemented for all patients in most countries. We investigated the impact of a multidisciplinary tumor board (MDTB) presentation before treatment in a nationwide study over 5 years. NETSARC (netsarc.org) is a network of 26 reference sarcoma centers with specialized MDTB, funded by the French National Cancer Institute to improve the outcome of sarcoma patients. Since 2010, presentation to an MDTB and second pathological review are mandatory for sarcoma patients in France. Patients' characteristics and follow-up are collected in a database regularly monitored and updated. The management and survival of patients presented to these MDTB before versus after initial treatment were analyzed. Out of the 12 528 patients aged ≥15 years, with a first diagnosis of soft tissue and visceral sarcoma obtained between 1 January 2010 and 31 December 2014, 5281 (42.2%) and 7247 (57.8%) were presented to the MDTB before and after the initiation of treatment, respectively. The former group had generally worse prognostic characteristics. Presentation to a MDTB before treatment was associated with a better compliance to clinical practice guidelines, for example, biopsy before surgery, imaging, quality of initial surgery, and less reoperations (all P sarcoma patients are significantly better when the initial treatment is guided by a pre-therapeutic specialized MDTB. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  19. Improving Pharmacists’ Targeting of Patients for Medication Review and Deprescription

    Directory of Open Access Journals (Sweden)

    Vanessa Marvin

    2018-04-01

    Full Text Available Background: In an acute hospital setting, a multi-disciplinary approach to medication review can improve prescribing and medicine selection in patients with frailty. There is a need for a clear understanding of the roles and responsibilities of pharmacists to ensure that interventions have the greatest impact on patient care. Aim: To use a consensus building process to produce guidance for pharmacists to support the identification of patients at risk from their medicines, and to articulate expected actions and escalation processes. Methods: A literature search was conducted and evidence used to establish a set of ten scenarios often encountered in hospitalised patients, with six or more possible actions. Four consultant physicians and four senior pharmacists ranked their levels of agreement with the listed actions. The process was redrafted and repeated until consensus was reached and interventions were defined. Outcome: Generalised guidance for reviewing older adults’ medicines was developed, alongside escalation processes that should be followed in a specific set of clinical situations. The panel agreed that both pharmacists and physicians have an active role to play in medication review, and face-to-face communication is always preferable to facilitate informed decision making. Only prescribers should deprescribe, however pharmacists who are not also trained as prescribers may temporarily “hold” medications in the best interests of the patient with appropriate documentation and a follow up discussion with the prescribing team. The consensus was that a combination of age, problematic polypharmacy, and the presence of medication-related problems, were the most important factors in the identification of patients who would benefit most from a comprehensive medication review. Conclusions: Guidance on the identification of patients on inappropriate medicines, and subsequent pharmacist-led intervention to prompt and promote deprescribing, has

  20. An Integrated Care Initiative to Improve Patient Outcome in Schizophrenia.

    Science.gov (United States)

    Mayer-Amberg, Norbert; Woltmann, Rainer; Walther, Stefanie

    2015-01-01

    The optimal treatment of schizophrenia patients requires integration of medical and psychosocial inputs. In Germany, various health-care service providers and institutions are involved in the treatment process. Early and continuous treatment is important but often not possible because of the fragmented medical care system in Germany. The Integrated Care Initiative Schizophrenia has implemented a networked care concept in the German federal state of Lower Saxony that integrates various stakeholders of the health care system. In this initiative, office-based psychiatrists, specialized nursing staff, psychologists, social workers, hospitals, psychiatric institutional outpatient's departments, and other community-based mental health services work together in an interdisciplinary approach. Much emphasis is placed on psychoeducation. Additional efforts cover socio-therapy, visiting care, and family support. During the period from October 2010 (start of the initiative) to December 2012, first experiences and results of quality indicators were collected of 713 registered patients and summarized in a quality monitoring report. In addition, standardized patient interviews were conducted, and duration of hospital days was recorded in 2013. By the end of 2012, patients had been enrolled for an average of 18.7 months. The overall patient satisfaction measured in a patient survey in June 2013 was high and the duration of hospital days measured in a pre-post analysis in July 2013 was reduced by 44%. Two years earlier than planned, the insurance fund will continue the successfully implemented Integrated Care Initiative and adopt it in the regular care setting. This initiative can serve as a learning case for how to set up and measure integrated care systems that may improve outcomes for patients suffering from schizophrenia.

  1. An Integrated Care Initiative to Improve Patient Outcome in Schizophrenia

    Directory of Open Access Journals (Sweden)

    Norbert eMayer-Amberg

    2016-01-01

    Full Text Available The optimal treatment of schizophrenia patients requires integration of medical and psychosocial inputs. In Germany, various healthcare service providers and institutions are involved in the treatment process. Early and continuous treatment is important but often not possible because of the fragmented medical care system in Germany. The current work is a quality monitoring report of a novel care setting, called Integrated Care Initiative Schizophrenia. It has implemented a networked care concept in the German federal state of Lower Saxony that integrates various stakeholders of the health care system. In this initiative, office-based psychiatrists, specialised nursing staff, psychologists, social workers, hospitals, psychiatric institutional outpatient’s departments and other community-based mental health services work together in an interdisciplinary approach. Much emphasis is placed on psychoeducation. Additional efforts cover socio-therapy, visiting care, and family support. During the period from October 2010 (start of the initiative to December 2012, first experiences and results of quality indicators were collected of 713 registered patients and summarised in a quality monitoring report. In addition, standardised patient interviews were conducted, and duration of hospital days was recorded in 2013. By the end of 2012, patients had been enrolled for an average of 18.7 months. The overall patient satisfaction measured in a patient survey in June 2013 was high and the duration of hospital days measured in a pre-post analysis in July 2013 was reduced by 44%. Two years earlier than planned, the insurance fund will continue the successfully implemented integrated care initiative and adopt it in the regular care setting. This initiative can serve as a learning case for how to set up and measure integrated care systems that may improve outcomes for patients suffering from schizophrenia.

  2. [Renal transplantation in HIV-infected patients in Spain].

    Science.gov (United States)

    Mazuecos, A; Pascual, J; Gómez, E; Sola, E; Cofán, F; López, F; Puig-Hooper, C E; Baltar, J M; González-Molina, M; Oppenheimer, F; Marcén, R; Rivero, M

    2006-01-01

    HIV infection has experienced dramatic improvement in morbidity and mortality with the highly active antiretroviral therapy (HAART). This prompted a reevaluation of organ-solid transplantation as a treatment option for HIV-infected patients. Some trials in the United States have shown that one- and 2-year graft and patient survival is comparable to HIV-negative transplant population. In Europe the experience is still scarce. The aim of this study is to analyse the outcome and the clinical characteristics of HIV-infected patients who received kidney transplantation in Spain in the HAART era. Ten patients were transplanted in our country since 2001. Only one patient was black. The main cause of end-stage renal disease reported was glomerulonephritis. Six of the recipients were coinfected by hepatitis C virus. Inclusion criteria included undetectable HIV viral load and CD4 counts greater than 200/pL. Immunosuppression consisted of steroids, tacrolimus and mycophenolate mofetil, with antibody induction in 4 cases. The median and mean follow-up was 11 and 16.3+/-15.6 (3-46) months, respectively. One recipient lost his graft because of early renal venous thrombosis. The remaining patients are functioning graft with mean serum creatinina level of 1.5 +/- 0.5 mg/dl. Biopsy-proven acute rejection was diagnosed in 4 recipients and was reversed in all cases with antirejection treatment. The plasma HIV RNA levels have remained controlled and CD4 counts have been stable in excess of 200 cell/microL. None of patients have developed AIDS complications. Recipients receiving protease inhibitor-based HAART regimens required significant dosing modification to maintain appropriate tacrolimus levels. Our results show that renal transplantation can be a safe and effective treatment in select HIV-infected patients. Like other series, the acute rejection rate was higher than in non-HIV recipients. The reasons of this rejection incidence remain unknown.

  3. Kinetic therapy improves oxygenation in critically ill pediatric patients.

    Science.gov (United States)

    Schultz, Theresa Ryan; Lin, Richard; Francis, Barbara A; Hales, Roberta L; Colborn, Shawn; Napoli, Linda A; Helfaer, Mark A

    2005-07-01

    To compare changes in oxygenation after manual turning and percussion (standard therapy) and after automated rotation and percussion (kinetic therapy). Randomized crossover trial. General and cardiac pediatric intensive care units. Intubated and mechanically ventilated pediatric patients who had an arterial catheter and no contraindications to using a PediDyne bed. Patients were placed on a PediDyne bed (Kinetic Concepts) and received 18 hrs blocks of standard and kinetic therapy in an order determined by randomization. Arterial blood gases were measured every 2 hrs during each phase of therapy. Oxygenation index and arterial-alveolar oxygen tension difference [P(A-a)O(2)] were calculated. Indexes calculated at baseline and after each 18-hr phase of therapy were analyzed. Fifty patients were enrolled. Data from 15 patients were either not collected or not used due to reasons that included violation of protocol and inability to tolerate the therapies in the study. Indexes of oxygenation were not normally distributed and were compared using Wilcoxon signed rank testing. Both therapies led to improvements in oxygenation, but only those from kinetic therapy achieved statistical significance. In patients receiving kinetic therapy first, median oxygenation index decreased from 7.4 to 6.19 (p = .015). The median P(A-a)O(2) decreased from 165.2 to 126.4 (p = .023). There were continued improvements in oxygenation after the subsequent period of standard therapy, with the median oxygenation index decreasing to 5.52 and median P(A-a)O(2) decreasing to 116.0, but these changes were not significant (p = .365 and .121, respectively). When standard therapy was first, the median oxygenation index decreased from 8.83 to 8.71 and the median P(a-a)o(2) decreased from 195.4 to 186.6. Neither change was significant. Median oxygenation index after the subsequent period of kinetic therapy was significantly lower (7.91, p = .044) and median P(A-a)O(2) trended lower (143.4, p = .077

  4. Improving the quality of care for patients with hypertension in Moshupa District, Botswana: Quality improvement cycle

    Directory of Open Access Journals (Sweden)

    Cathy Kande

    2014-01-01

    Full Text Available Background: Although there are no prevalence studies on hypertension in Botswana, this condition is thought to be common and the quality of care to be poor.Aim: The aim of this project was to assess and improve the quality of primary care forhypertension.Setting: Moshupa clinic and catchment area, Botswana.Methods: Quality improvement cycle.Results: Two hundred participants were included in the audit. Sixty-eight per cent were women with a mean age of 55 years. In the baseline audit none of the target standards were met. During the re-audit six months later, six out of nine structural target standards, five out of 11 process target standards and one out of two outcome target standards were achieved. Statistically-significant improvement in performance (p < 0.05 was shown in 10 criteria although the target standard was not always met. In the re-audit, the target of achieving blood pressure control (< 140/90 in 70% of patients was achieved.Conclusion: The quality of care for hypertension was suboptimal in our setting. Simple interventions were designed and implemented to improve the quality of care. These interventions led to significant improvement in structural and process criteria. A corresponding significant improvement in the control of blood pressure was also seen.

  5. Improving patient access to an interventional US clinic.

    Science.gov (United States)

    Steele, Joseph R; Clarke, Ryan K; Terrell, John A; Brightmon, Tonya R

    2014-01-01

    A continuous quality improvement project was conducted to increase patient access to a neurointerventional ultrasonography (US) clinic. The clinic was experiencing major scheduling delays because of an increasing patient volume. A multidisciplinary team was formed that included schedulers, medical assistants, nurses, technologists, and physicians. The team created an Ishikawa diagram of the possible causes of the long wait time to the next available appointment and developed a flowchart of the steps involved in scheduling and completing a diagnostic US examination and biopsy. The team then implemented a staged intervention that included adjustments to staffing and room use (stage 1); new procedures for scheduling same-day add-on appointments (stage 2); and a lead technician rotation to optimize patient flow, staffing, and workflow (stage 3). Six months after initiation of the intervention, the mean time to the next available appointment had decreased from 25 days at baseline to 1 day, and the number of available daily appointments had increased from 38 to 55. These improvements resulted from a coordinated provider effort and had a net present value of more than $275,000. This project demonstrates that structural changes in staffing, workflow, and room use can substantially reduce scheduling delays for critical imaging procedures. © RSNA, 2014.

  6. Errors in laboratory medicine: practical lessons to improve patient safety.

    Science.gov (United States)

    Howanitz, Peter J

    2005-10-01

    Patient safety is influenced by the frequency and seriousness of errors that occur in the health care system. Error rates in laboratory practices are collected routinely for a variety of performance measures in all clinical pathology laboratories in the United States, but a list of critical performance measures has not yet been recommended. The most extensive databases describing error rates in pathology were developed and are maintained by the College of American Pathologists (CAP). These databases include the CAP's Q-Probes and Q-Tracks programs, which provide information on error rates from more than 130 interlaboratory studies. To define critical performance measures in laboratory medicine, describe error rates of these measures, and provide suggestions to decrease these errors, thereby ultimately improving patient safety. A review of experiences from Q-Probes and Q-Tracks studies supplemented with other studies cited in the literature. Q-Probes studies are carried out as time-limited studies lasting 1 to 4 months and have been conducted since 1989. In contrast, Q-Tracks investigations are ongoing studies performed on a yearly basis and have been conducted only since 1998. Participants from institutions throughout the world simultaneously conducted these studies according to specified scientific designs. The CAP has collected and summarized data for participants about these performance measures, including the significance of errors, the magnitude of error rates, tactics for error reduction, and willingness to implement each of these performance measures. A list of recommended performance measures, the frequency of errors when these performance measures were studied, and suggestions to improve patient safety by reducing these errors. Error rates for preanalytic and postanalytic performance measures were higher than for analytic measures. Eight performance measures were identified, including customer satisfaction, test turnaround times, patient identification

  7. Approaches to improve adherence to pharmacotherapy in patients with schizophrenia

    Directory of Open Access Journals (Sweden)

    Shuler KM

    2014-05-01

    enhanced team-oriented approach to managing patients with schizophrenia improves adherence and supports corresponding reductions in relapse rates, inpatient admissions, and associated costs. Conclusion: Optimization of medication and involvement of caregivers are important to promoting adherence. A multidisciplinary team approach may be invaluable in identifying barriers to adherence and helping schizophrenia patients overcome them. Keywords: medication adherence, schizophrenia, community mental health services, social work, psychiatric

  8. Trends in patient satisfaction in Dutch university medical centers: room for improvement for all

    NARCIS (Netherlands)

    Kleefstra, Sophia M.; Zandbelt, Linda C.; de Haes, Hanneke J. C. J. M.; Kool, Rudolf B.

    2015-01-01

    Results of patient satisfaction research provide hospitals areas for quality improvement. Although it may take several years to achieve such improvement, not all hospitals analyze changes in patient satisfaction over time structurally. Consequently, they lack information from patients' perspective

  9. Action of tacrolimus on Wistar rat kidneys implanted with Walker 256 carcinosarcoma Estudo da ação do tacrolimus em rins de ratos Wistar implantados com carcinossarcoma de Walker

    Directory of Open Access Journals (Sweden)

    Cristiano Machado Inácio

    2010-02-01

    Full Text Available PURPOSE: To evaluate the development of Walker 256 tumor in male Wistar rats treated with tacrolimus using an experimental kidney tumor model. METHODS: 40 male Wistar rats were divided into four groups: Tumor group (TU (n=10, Tacrolimus-Tumor group (TT (n=10, Tacrolimus group (TC (n=10 and Control group (C (n=10. Treatment with tacrolimus was performed in groups TT and TC. Under anesthesia, the right kidney of each animal of TU and TT was accessed through a supraumbilical incision and inoculated with a 0.1mL solution containing 2x10(6 tumor cells (Walker 256 carcinosarcoma tumor cells. Group TC was treated with a saline solution. All the animals of groups TC and TT were treated with tacrolimus (5mg/kg/day by gavage for 15 days. TU group animals received saline by gavage for 15 days. On the 15th postoperative day, all animals were submitted to euthanasia and blood sampling for analysis of serum creatinine (Cr and blood urea nitrogen (BUN. Abdominal gross examination was performed, the right kidney removed and prepared for histological analysis by hematoxylin-eosin staining. The resulting data were submitted to statistical analysis by ANOVA. RESULTS: Statistical significance was found when comparing creatinine level between groups TU, TT and TC -TT group culminated with a marked increased in creatinine levels (Cr=1.013 ± 0.3028 mg/mL, TU group (Cr=0.5670 ± 0.03536 mg/dL P=0.00256, TC group (Cr =0.711 ± 0.1653 mg/mL P= 0.02832. Statistical significance was found when comparing BUN levels in TT group (71.32 ± 17.14 mg/mL, compared with TU group (45.83 ± 5.046 mg/dL, P=0.000318. There were no statistically significant differences between groups TT and TC (61.23 ± 9.503 mg/mL P=0.7242. Histological analysis showed a poor evolution in TT group with multiple foci of hemorrhage and cortical invasion by the Walker tumor. CONCLUSION: The Tacrolimus-treated group developed a more aggressive tumor and a drug-related nephrotoxic effect.OBJETIVO: Avaliar

  10. Patient reminder and recall interventions to improve immunization rates.

    Science.gov (United States)

    Jacobson Vann, Julie C; Jacobson, Robert M; Coyne-Beasley, Tamera; Asafu-Adjei, Josephine K; Szilagyi, Peter G

    2018-01-18

    Immunization rates for children and adults are rising, but coverage levels have not reached optimal goals. As a result, vaccine-preventable diseases still occur. In an era of increasing complexity of immunization schedules, rising expectations about the performance of primary care, and large demands on primary care providers, it is important to understand and promote interventions that work in primary care settings to increase immunization coverage. One common theme across immunization programs in many nations involves the challenge of implementing a population-based approach and identifying all eligible recipients, for example the children who should receive the measles vaccine. However, this issue is gradually being addressed through the availability of immunization registries and electronic health records. A second common theme is identifying the best strategies to promote high vaccination rates. Three types of strategies have been studied: (1) patient-oriented interventions, such as patient reminder or recall, (2) provider interventions, and (3) system interventions, such as school laws. One of the most prominent intervention strategies, and perhaps best studied, involves patient reminder or recall systems. This is an update of a previously published review. To evaluate and compare the effectiveness of various types of patient reminder and recall interventions to improve receipt of immunizations. We searched CENTRAL, MEDLINE, Embase and CINAHL to January 2017. We also searched grey literature and trial registers to January 2017. We included randomized trials, controlled before and after studies, and interrupted time series evaluating immunization-focused patient reminder or recall interventions in children, adolescents, and adults who receive immunizations in any setting. We included no-intervention control groups, standard practice activities that did not include immunization patient reminder or recall, media-based activities aimed at promoting immunizations

  11. Nasal highflow improves ventilation in patients with COPD

    Directory of Open Access Journals (Sweden)

    Bräunlich J

    2016-05-01

    Full Text Available Jens Bräunlich,* Marcus Köhler,* Hubert WirtzDepartment of Respiratory Medicine, University of Leipzig, Leipzig, Germany *These authors contributed equally to this workBackground: Nasal highflow (NHF provides a warmed and humidified air stream up to 60 L/min. Recent data demonstrated a positive effect in patients with acute hypoxemic respiratory failure, especially when caused by pneumonia. Preliminary data show a decrease in hypercapnia in patients with COPD. Therefore, NHF should be evaluated as a new ventilatory support device. This study was conducted to assess the impact of different flow rates on ventilatory parameters in patients with COPD.Materials and methods: This interventional clinical study was performed with patients suffering from severe COPD. The aim was to characterize flow-dependent changes in mean airway pressure, breathing volumes, breathing frequency, and decrease in partial pressure of CO2 (pCO2. Mean airway pressure was measured in the nasopharyngeal space (19 patients. To evaluate breathing volumes, we used a polysomnographic device (18 patients. All patients received 20 L/min, 30 L/min, 40 L/min, and 50 L/min and – to illustrate the effects – nasal continuous positive airway pressure and nasal bilevel positive airway pressure. Capillary blood gas analyses were performed in 54 patients with hypercapnic COPD before and two hours after the use of NHF. We compared the extent of decrease in pCO2 when using 20 L/min and 30 L/min. Additionally, comfort and dyspnea during the use of NHF were surveyed.Results: NHF resulted in a minor flow dependent increase in mean airway pressure. Tidal volume increased, and breathing rate decreased. The calculated minute volume decreased under NHF breathing. In spite of this fact, hypercapnia decreased with increasing flow (20 L/min vs 30 L/min. Additionally, an improvement in dyspnea was observed. The rapid shallow breathing index shows a decrease when using NHF.Conclusion: NHF

  12. Probiotic yogurt improves antioxidant status in type 2 diabetic patients.

    Science.gov (United States)

    Ejtahed, Hanie S; Mohtadi-Nia, Javad; Homayouni-Rad, Aziz; Niafar, Mitra; Asghari-Jafarabadi, Mohammad; Mofid, Vahid

    2012-05-01

    Oxidative stress plays a major role in the pathogenesis and progression of diabetes. Among various functional foods with an antioxidant effect, probiotic foods have been reported to repress oxidative stress. The objective of this clinical trial was to assess the effects of probiotic and conventional yogurt on blood glucose and antioxidant status in type 2 diabetic patients. Sixty-four patients with type 2 diabetes mellitus, 30 to 60 y old, were assigned to two groups in this randomized, double-blind, controlled clinical trial. The patients in the intervention group consumed 300 g/d of probiotic yogurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 and those in the control group consumed 300 g/d of conventional yogurt for 6 wk. Fasting blood samples, 24-h dietary recalls, and anthropometric measurements were collected at the baseline and at the end of the trial. Probiotic yogurt significantly decreased fasting blood glucose (P activities and total antioxidant status (P activity within either group (P > 0.05). The consumption of probiotic yogurt improved fasting blood glucose and antioxidant status in type 2 diabetic patients. These results suggest that probiotic yogurt is a promising agent for diabetes management. Copyright © 2012 Elsevier Inc. All rights reserved.

  13. Process efficiency. Redesigning social networks to improve surgery patient flow.

    Science.gov (United States)

    Samarth, Chandrika N; Gloor, Peter A

    2009-01-01

    We propose a novel approach to improve throughput of the surgery patient flow process of a Boston area teaching hospital. A social network analysis was conducted in an effort to demonstrate that process efficiency gains could be achieved through redesign of social network patterns at the workplace; in conjunction with redesign of organization structure and the implementation of workflow over an integrated information technology system. Key knowledge experts and coordinators in times of crisis were identified and a new communication structure more conducive to trust and knowledge sharing was suggested. The new communication structure is scalable without compromising on coordination required among key roles in the network for achieving efficiency gains.

  14. Computed tomographic simulation of craniospinal fields in pediatric patients: improved treatment accuracy and patient comfort.

    Science.gov (United States)

    Mah, K; Danjoux, C E; Manship, S; Makhani, N; Cardoso, M; Sixel, K E

    1998-07-15

    To reduce the time required for planning and simulating craniospinal fields through the use of a computed tomography (CT) simulator and virtual simulation, and to improve the accuracy of field and shielding placement. A CT simulation planning technique was developed. Localization of critical anatomic features such as the eyes, cribriform plate region, and caudal extent of the thecal sac are enhanced by this technique. Over a 2-month period, nine consecutive pediatric patients were simulated and planned for craniospinal irradiation. Four patients underwent both conventional simulation and CT simulation. Five were planned using CT simulation only. The accuracy of CT simulation was assessed by comparing digitally reconstructed radiographs (DRRs) to portal films for all patients and to conventional simulation films as well in the first four patients. Time spent by patients in the CT simulation suite was 20 min on average and 40 min maximally for those who were noncompliant. Image acquisition time was absence of the patient, virtual simulation of all fields took 20 min. The DRRs were in agreement with portal and/or simulation films to within 5 mm in five of the eight cases. Discrepancies of > or =5 mm in the positioning of the inferior border of the cranial fields in the first three patients were due to a systematic error in CT scan acquisition and marker contouring which was corrected by modifying the technique after the fourth patient. In one patient, the facial shield had to be moved 0.75 cm inferiorly owing to an error in shield construction. Our analysis showed that CT simulation of craniospinal fields was accurate. It resulted in a significant reduction in the time the patient must be immobilized during the planning process. This technique can improve accuracy in field placement and shielding by using three-dimensional CT-aided localization of critical and target structures. Overall, it has improved staff efficiency and resource utilization.

  15. Computed tomographic simulation of craniospinal fields in pediatric patients: improved treatment accuracy and patient comfort

    International Nuclear Information System (INIS)

    Mah, Katherine; Danjoux, Cyril E.; Manship, Sharan; Makhani, Nadiya; Cardoso, Marlene; Sixel, Katharina E.

    1998-01-01

    Purpose: To reduce the time required for planning and simulating craniospinal fields through the use of a computed tomography (CT) simulator and virtual simulation, and to improve the accuracy of field and shielding placement. Methods and Materials: A CT simulation planning technique was developed. Localization of critical anatomic features such as the eyes, cribriform plate region, and caudal extent of the thecal sac are enhanced by this technique. Over a 2-month period, nine consecutive pediatric patients were simulated and planned for craniospinal irradiation. Four patients underwent both conventional simulation and CT simulation. Five were planned using CT simulation only. The accuracy of CT simulation was assessed by comparing digitally reconstructed radiographs (DRRs) to portal films for all patients and to conventional simulation films as well in the first four patients. Results: Time spent by patients in the CT simulation suite was 20 min on average and 40 min maximally for those who were noncompliant. Image acquisition time was <10 min in all cases. In the absence of the patient, virtual simulation of all fields took 20 min. The DRRs were in agreement with portal and/or simulation films to within 5 mm in five of the eight cases. Discrepancies of ≥5 mm in the positioning of the inferior border of the cranial fields in the first three patients were due to a systematic error in CT scan acquisition and marker contouring which was corrected by modifying the technique after the fourth patient. In one patient, the facial shield had to be moved 0.75 cm inferiorly owing to an error in shield construction. Conclusions: Our analysis showed that CT simulation of craniospinal fields was accurate. It resulted in a significant reduction in the time the patient must be immobilized during the planning process. This technique can improve accuracy in field placement and shielding by using three-dimensional CT-aided localization of critical and target structures. Overall

  16. Error identification and recovery by student nurses using human patient simulation: opportunity to improve patient safety.

    Science.gov (United States)

    Henneman, Elizabeth A; Roche, Joan P; Fisher, Donald L; Cunningham, Helene; Reilly, Cheryl A; Nathanson, Brian H; Henneman, Philip L

    2010-02-01

    This study examined types of errors that occurred or were recovered in a simulated environment by student nurses. Errors occurred in all four rule-based error categories, and all students committed at least one error. The most frequent errors occurred in the verification category. Another common error was related to physician interactions. The least common errors were related to coordinating information with the patient and family. Our finding that 100% of student subjects committed rule-based errors is cause for concern. To decrease errors and improve safe clinical practice, nurse educators must identify effective strategies that students can use to improve patient surveillance. Copyright 2010 Elsevier Inc. All rights reserved.

  17. Improving patient safety in radiotherapy through error reporting and analysis

    International Nuclear Information System (INIS)

    Findlay, Ú.; Best, H.; Ottrey, M.

    2016-01-01

    Aim: To improve patient safety in radiotherapy (RT) through the analysis and publication of radiotherapy errors and near misses (RTE). Materials and methods: RTE are submitted on a voluntary basis by NHS RT departments throughout the UK to the National Reporting and Learning System (NRLS) or directly to Public Health England (PHE). RTE are analysed by PHE staff using frequency trend analysis based on the classification and pathway coding from Towards Safer Radiotherapy (TSRT). PHE in conjunction with the Patient Safety in Radiotherapy Steering Group publish learning from these events, on a triannual and summarised on a biennial basis, so their occurrence might be mitigated. Results: Since the introduction of this initiative in 2010, over 30,000 (RTE) reports have been submitted. The number of RTE reported in each biennial cycle has grown, ranging from 680 (2010) to 12,691 (2016) RTE. The vast majority of the RTE reported are lower level events, thus not affecting the outcome of patient care. Of the level 1 and 2 incidents reported, it is known the majority of them affected only one fraction of a course of treatment. This means that corrective action could be taken over the remaining treatment fractions so the incident did not have a significant impact on the patient or the outcome of their treatment. Analysis of the RTE reports demonstrates that generation of error is not confined to one professional group or to any particular point in the pathway. It also indicates that the pattern of errors is replicated across service providers in the UK. Conclusion: Use of the terminology, classification and coding of TSRT, together with implementation of the national voluntary reporting system described within this report, allows clinical departments to compare their local analysis to the national picture. Further opportunities to improve learning from this dataset must be exploited through development of the analysis and development of proactive risk management strategies

  18. Pioglitazone Improves Survival In Patients With Cancer: The Hypothesis

    Directory of Open Access Journals (Sweden)

    Banshi Saboo

    2015-12-01

    Full Text Available Pioglitazone is currently the only thiazolidinedione approved by regulatory agencies worldwide for the treatment of type 2 diabetes mellitus (T2DM. The use of pioglitazone in patients with T2DM has been limited because earlier studies showed moderate weight gain and an increased incidence of heart failure, osteoporotic fractures, and bladder cancer. However, new studies have shown that pioglitazone improves both systolic and diastolic left ventricular function and that there is no association between pioglitazone and bladder cancer. Furthermore, pioglitazone is associated with a reduced risk of all-cause mortality in patients with T2DM. Pioglitazone was also found to reduce the incidence of lung, head and neck, breast, colorectal, and hepatocellular cancer. There is tremendous preclinical evidence that links thiazolidinediones with anti-cancer effects. Three possible mechanisms of anti-proliferative effects induced by peroxisome proliferator activated receptor gamma (PPARG agonists emerge: 1 activation of PPARG and epidermal growth factor receptor, which actives several intracellular pathways involved in carcinogenesis; 2 increase in serum adiponectin levels and decrease in serum leptin levels, which are associated with lower cancer risk and more favorable outcomes in patients with cancer; 3 modulate insulin-like growth factor 1 (IGF-1 receptor signaling by decreasing IGF-1 levels and increasing the expression of IGF binding protein 1. To date, there are no prospective, placebo-controlled trials that have analyzed the efficacy of pioglitazone in chemotherapy and chemoprevention. Only one ongoing study has shown that pioglitazone has an excellent capability of eradicating quiescent leukemia stem cells in patients with chronic myeloid leukemia and achieving a complete molecular response. Current evidence supports our theory that future case-control studies examining pioglitazone as chemotherapy, or adjuvant chemotherapy, should be performed in

  19. Patient perspectives of patient-controlled analgesia (PCA) and methods for improving pain control and patient satisfaction.

    Science.gov (United States)

    Patak, Lance S; Tait, Alan R; Mirafzali, Leela; Morris, Michelle; Dasgupta, Sunavo; Brummett, Chad M

    2013-01-01

    This study aimed to (1) identify patient-controlled analgesia (PCA) attributes that negatively impact patient satisfaction and ability to control pain while using PCA and (2) obtain data on patient perceptions of new PCA design features. We conducted a prospective survey study of postoperative pain control among patients using a PCA device. The survey was designed to evaluate patient satisfaction with pain control, understanding of PCA, difficulties using PCA, lockout-period management, and evaluation of new PCA design features. A total of 350 eligible patients completed the survey (91%). Patients who had difficulties using PCA were less satisfied (P PCA. Forty-nine percent of patients reported not knowing if they would receive medicine when they pushed the PCA button, and of these, 22% believed that this uncertainty made their pain worse. The majority of patients preferred the proposed PCA design features for easier use, including a light on the button, making it easier to find (57%), and a PCA button that vibrates (55%) or lights up (70%), alerting the patient that the PCA pump is able to deliver more medicine. A majority of patients, irrespective of their satisfaction with PCA, preferred a new PCA design. Certain attributes of current PCA technology may negatively impact patient experience, and modifications could potentially address these concerns and improve patient outcomes.

  20. Comparison of sirolimus plus tacrolimus versus sirolimus plus cyclosporine in high-risk renal allograft recipients: results from an open-label, randomized trial.

    Science.gov (United States)

    Gaber, A Osama; Kahan, Barry D; Van Buren, Charles; Schulman, Seth L; Scarola, Joseph; Neylan, John F

    2008-11-15

    The efficacy and safety of sirolimus (SRL) plus tacrolimus (TAC) versus SRL plus cyclosporine (CsA) were compared in high-risk renal allograft recipients. Evaluable patients (448) were randomly assigned (1:1) before transplant to receive SRL+TAC or SRL+CsA with corticosteroids. Eligible patients were black and/or repeat transplant recipients, and/or those with high titer of panel-reactive antibodies. Demographics were similar between groups. Both treatments demonstrated equivalent efficacy of the composite endpoint at 12 months with efficacy failure rates of 21.9% vs. 23.2% (SRL+TAC vs. SRL+CsA, respectively, 95% CI -10.0 to 7.1, P=0.737). Biopsy-confirmed acute rejection rate (13.8% vs. 17.4%) and graft survival rate (89.7% vs. 90.2%) were similar (SRL+TAC vs. SRL+CsA, respectively). In evaluable patients (received at least 1 dose of study drug), renal function (calculated Nankivell glomerular filtration rate) was not superior in SRL+TAC versus SRL+CsA (54.5 vs. 52.6 mL/min, P=0.466); however, in on-therapy patients, glomerular filtration rate was significantly higher in SRL+TAC at most time points. At 12 months, there were no significant differences in rates of death, discontinuation because of adverse events, hypercholesterolemia, hyperlipemia, or proteinuria. Diarrhea and herpes simplex infections occurred significantly more often in SRL+TAC patients. Hypertension, cardiomegaly, increased creatinine, overdose (primarily calcineurin inhibitor toxicity), acne, urinary tract disorders, lymphocele, and ovarian cysts occurred significantly more often in SRL+CsA patients. This study demonstrated that SRL-based therapy was efficacious in high-risk renal allograft recipients in the first year after transplant, providing equivalent efficacy with CsA or TAC, similar graft survival, low biopsy-confirmed acute rejection rates, excellent renal function, and an acceptable safety profile.

  1. Improving health outcomes with better patient understanding and education

    Directory of Open Access Journals (Sweden)

    Robert John Adams

    2010-10-01

    Full Text Available Robert John AdamsThe Health Observatory, The Queen Elizabeth Hospital Campus, The University of Adelaide, Woodville, South Australia, AustraliaAbstract: A central plank of health care reform is an expanded role for educated consumers interacting with responsive health care teams. However, for individuals to realize the benefits of health education also requires a high level of engagement. Population studies have documented a gap between expectations and the actual performance of behaviours related to participation in health care and prevention. Interventions to improve self-care have shown improvements in self-efficacy, patient satisfaction, coping skills, and perceptions of social support. Significant clinical benefits have been seen from trials of self-management or lifestyle interventions across conditions such as diabetes, coronary heart disease, heart failure and rheumatoid arthritis. However, the focus of many studies has been on short-term outcomes rather that long term effects. There is also some evidence that participation in patient education programs is not spread evenly across socio economic groups. This review considers three other issues that may be important in increasing the public health impact of patient education. The first is health literacy, which is the capacity to seek, understand and act on health information. Although health literacy involves an individual’s competencies, the health system has a primary responsibility in setting the parameters of the health interaction and the style, content and mode of information. Secondly, much patient education work has focused on factors such as attitudes and beliefs. That small changes in physical environments can have large effects on behavior and can be utilized in self-management and chronic disease research. Choice architecture involves reconfiguring the context or physical environment in a way that makes it more likely that people will choose certain behaviours. Thirdly

  2. Intentional Weight Loss Improved Performance in Obese Ischaemic Heart Patient

    DEFF Research Database (Denmark)

    Geiker, Nina; Myint, Khin Swe; Heck, Patrick

    2014-01-01

    Aims: The risk of heart failure (HF) increases with BMI, but paradoxically obesity has been associated with reduced mortality in patients with HF. The effect of intentional or therapeutic weight loss on HF is not well known. We examined the effect of weight loss induced by low energy diet (LED......) on physical performance and cardiovascular risk factors in obese patients with moderate-to-severe HF and/or ischaemic heart disease (IHD). Methods and Results: Results from two weight loss interventions at two centres, one in Denmark (DK - 12 week intervention in 21 subjects (14 LED, 7 controls)) and one.......1 in the intervention group versus -22.1% ± 25.6 in the control group (P=0.000). Treatment also improved triglycerides (P=0.000), very low lipoprotein (P=0.001) and C-reactive protein (P=0.010). Conclusion: Weight loss induced by LED in obese patients with moderate-to-severe HF or IHD resulted in clinically significant...

  3. Medication abortion: Potential for improved patient access through pharmacies.

    Science.gov (United States)

    Raifman, Sarah; Orlando, Megan; Rafie, Sally; Grossman, Daniel

    2018-05-08

    To discuss the potential for improving access to early abortion care through pharmacies in the United States. Despite the growing use of medications to induce termination of early pregnancy, pharmacist involvement in abortion care is currently limited. The Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) for Mifeprex® (mifepristone 200 mg), the principal drug used in early medication abortion, prohibits the dispensing of the drug by prescription at pharmacies. This commentary reviews the pharmacology of medication abortion with the use of mifepristone and misoprostol, as well as aspects of service delivery and data on safety, efficacy, and acceptability. Given its safety record, mifepristone no longer fits the profile of a drug that requires an REMS. The recent implementation of pharmacy dispensing of mifepristone in community pharmacies in Australia and some provinces of Canada has improved access to medication abortion by increasing the number of medication abortion providers, particularly in rural areas. Provision of mifepristone in pharmacies, which involves dispensing and patient counseling, would likely improve access to early abortion in the United States without increasing risks to women. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  4. Improving patient outcomes through registered dietitian order writing.

    Science.gov (United States)

    Roberts, Susan R

    2013-10-01

    Traditionally, registered dietitians (RD) have not had order writing privileges in most patient-care facilities and rely on physicians to implement their recommendations. Research has demonstrated that this model results in a high percentage of RD recommendations not being ordered. Timely nutrition interventions are important due to the prevalence of malnutrition in the hospital setting and when RD recommendations are implemented, important outcomes are improved. In addition, several studies have demonstrated that when RDs have order writing privileges, which allows more assurance that an intervention will occur and timely interventions, improved outcomes, such as improved nutrition status, better management of electrolytes and glycemic control, reaching goal calories sooner, reduction in inappropriate parenteral nutrition use, cost savings, and less error with electronic order entry. The process for implementation and outcomes of an RD order writing program at 1 large, urban, tertiary medical center is described. The program has been successful, but the implementation process required multiple years and ongoing monitoring through data collection to ensure success. RDs interested in order writing privileges must consider federal and state regulations, their individual scope of practice (relevant training and competency assessment), and how to obtain approval from the appropriate hospital governing committees. RDs who obtain order writing privileges must understand "with privilege comes responsibility" and should plan to conduct outcomes research to promote the value and acceptance of RD order writing by regulatory agencies at all levels and hospital leaders, for instance physicians and administrators.

  5. Higher tacrolimus trough levels on days 2-5 post-renal transplant are associated with reduced rates of acute rejection.

    LENUS (Irish Health Repository)

    O'Seaghdha, C M

    2011-04-06

    We analyzed the association between whole-blood trough tacrolimus (TAC) levels in the first days post-kidney transplant and acute cellular rejection (ACR) rates. Four hundred and sixty-four consecutive, deceased-donor kidney transplant recipients were included. All were treated with a combination of TAC, mycophenolate mofetil and prednisolone. Patients were analyzed in four groups based on quartiles of the mean TAC on days 2 and 5 post-transplant: Group 1: median TAC 11 ng\\/mL (n = 122, range 2-13.5 ng\\/mL), Group 2: median 17 ng\\/mL (n = 123, range 14-20 ng\\/mL), Group 3: median 24 ng\\/mL (n = 108, range 20.5-27 ng\\/mL) and Group 4: median 33.5 ng\\/mL (n = 116, range 27.5-77.5 ng\\/mL). A graded reduction in the rates of ACR was observed for each incremental days 2-5 TAC. The one-yr ACR rate was 24.03% (95% CI 17.26-32.88), 22.20% (95% CI 15.78-30.70), 13.41% (95% CI 8.15-21.63) and 8.69% (95% CI 4.77-15.55) for Groups 1-4, respectively (p = 0.003). This study suggests that higher early TACs are associated with reduced rates of ACR at one yr.

  6. Differing manifestations of hepatitis C and tacrolimus on hospitalized diabetes mellitus occurring after kidney transplantation.

    Science.gov (United States)

    Abbott, Kevin C; Bernet, Victor J; Agodoa, Lawrence Y; Yuan, Christina M

    2005-09-01

    Previous studies suggest the association of recipient hepatitis C seropositivity (HCV+) and use of tacrolimus (TAC) with post-transplant diabetes mellitus (PTDM) may differ by manifestations of type I or type II diabetes, but this has not been assessed in the era of current immunosuppression. We performed a retrospective cohort study of 10,342 Medicare primary renal transplantation recipients without evidence of diabetes at the time of listing in the United States Renal Data System between January 1, 1998 and July 31, 2000, followed until December 31, 2000. Outcomes were hospitalizations for a primary diagnosis of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS). Cox regression analysis was used to calculate adjusted hazard ratios (AHR) for time to DKA or HHS, stratified by diabetes status at the time of transplant. In Cox regression analysis, use of TAC at discharge was independently associated with shorter time to DKA (AHR, 1.88; 95% CI, 1.05-3.37, p=0.034) but not HHS. In contrast, recipient HCV+ was independently associated with shorter time to HHS (AHR, 3.90; 1.59-9.60, p=.003), but not DKA. There was no interaction between TAC and HCV+ for either outcome. These results confirm earlier findings that TAC and HCV+ may mediate the risk of PTDM through different mechanisms, even in the modern era.

  7. Training and Action for Patient Safety: Embedding Interprofessional Education for Patient Safety within an Improvement Methodology

    Science.gov (United States)

    Slater, Beverley L.; Lawton, Rebecca; Armitage, Gerry; Bibby, John; Wright, John

    2012-01-01

    Introduction: Despite an explosion of interest in improving safety and reducing error in health care, one important aspect of patient safety that has received little attention is a systematic approach to education and training for the whole health care workforce. This article describes an evaluation of an innovative multiprofessional, team-based…

  8. Improving patient knowledge about sacral nerve stimulation using a patient based educational video.

    Science.gov (United States)

    Jeppson, Peter Clegg; Clark, Melissa A; Hampton, Brittany Star; Raker, Christina A; Sung, Vivian W

    2013-10-01

    We developed a patient based educational video to address the information needs of women considering sacral nerve stimulation for overactive bladder. Five semistructured focus groups were used to identify patient knowledge gaps, information needs, patient acceptable terminology and video content preferences for a patient based sacral nerve stimulation educational video. Each session was transcribed, independently coded by 2 coders and examined using an iterative method. A 16-minute educational video was created to address previously identified knowledge gaps and information needs using patient footage, 3-dimensional animation and peer reviewed literature. We developed a questionnaire to evaluate participant sacral nerve stimulation knowledge and therapy attitudes. We then performed a randomized trial to assess the effect of the educational video vs the manufacturer video on patient knowledge and attitudes using our questionnaire. We identified 10 patient important domains, including 1) anatomy, 2) expectations, 3) sacral nerve stimulation device efficacy, 4) surgical procedure, 5) surgical/device complications, 6) post-procedure recovery, 7) sacral nerve stimulation side effects, 8) postoperative restrictions, 9) device maintenance and 10) general sacral nerve stimulation information. A total of 40 women with overactive bladder were randomized to watch the educational (20) or manufacturer (20) video. Knowledge scores improved in each group but the educational video group had a greater score improvement (76.6 vs 24.2 points, p <0.0001). Women who watched the educational video reported more favorable attitudes and expectations about sacral nerve stimulation therapy. Women with overactive bladder considering sacral nerve stimulation therapy have specific information needs. The video that we developed to address these needs was associated with improved short-term patient knowledge. Copyright © 2013 American Urological Association Education and Research, Inc

  9. Vitamin K for improved anticoagulation control in patients receiving warfarin.

    Science.gov (United States)

    Mahtani, Kamal R; Heneghan, Carl J; Nunan, David; Roberts, Nia W

    2014-05-15

    Effective use of warfarin involves keeping the international normalised ratio (INR) within a relatively narrow therapeutic range. However, patients respond widely to their dose of warfarin. Overcoagulation can lead to an increased risk of excessive bleeding, while undercoagulation can lead to increased clot formation. There is some evidence that patients with a variable response to warfarin may benefit from a concomitant low dose of vitamin K. To assess the effects of concomitant supplementation of low-dose oral vitamin K for anticoagulation control in patients being initiated on or taking a maintenance dose of warfarin. To identify previous reviews, we searched the Database of Abstracts of Reviews of Effects (DARE via The Cochrane Library, Wiley) (Issue 2, 2011). To identify primary studies, we searched the Cochrane Central Register of Controlled Trials (CENTRAL via The Cochrane Library, Wiley) (Issue 2, 2014), Ovid MEDLINE (R) In-Process & Other Non-Indexed Citations database and Ovid MEDLINE (R) (OvidSP) (1946 to 25 February 2014), Embase (OvidSP) (1974 to week 8 of 2014), Science Citation Index Expanded™ & Conference Proceedings Citation Index - Science (Web of Science™) (1945 to 27 February 2014), and the NHS Economics Evaluations Database (NHS EED) (via The Cochrane Library, Wiley) (Issue 2, 2014). We did not apply any language or date restrictions. We used additional methods to identify grey literature and ongoing studies. Randomised controlled trials comparing the addition of vitamin K versus placebo in patients initiating warfarin or already taking warfarin. Two review authors independently selected and extracted data from included studies. When disagreement arose, a third author helped reached a consensus. We also assessed risk of bias. We identified two studies with a total of 100 participants for inclusion in the review. We found the overall risk of bias to be unclear in a number of domains. Neither study reported the time taken to the first INR in

  10. [Improving care for cleft lip and palate patients: uniform and patient-orientated outcome measures].

    Science.gov (United States)

    Haj, M; de Gier, H H W; van Veen-van der Hoek, M; Versnel, S L; van Adrichem, L N; Wolvius, E B; Hazelzet, J A; Koudstaal, M J

    2018-02-01

    The quality of care for patients with cleft lip and palate is extremely variable across the world. Treatment protocols differ and methods of data registration are not uniform. Improving this care by means of comparative research is challenging. The best treatment programmes can be identified by uniformly registering patient-orientated outcomes and comparing the outcomes with those of other treatment centres. That knowledge can be used to improve one's own care. An international team consisting of specialists and cleft lip and palate patients has developed a set of outcome measures that are considered by patients to be most important. This team is coordinated by the International Consortium of Health Outcomes Measurement (ICHOM). The cleft lip and palate outcome set can be used by all centres worldwide in following up on cleft lip and palate patients. In the Erasmus Medical Centre in Rotterdam, the 'Zorgmonitor Schisis' (Care Monitor Cleft Lip and Palate) has been built, an application in which these outcome measures are collected at fixed times. Implementing this set of outcome measures in other cleft lip and palate treatment centres and using the outcomes as (inter)national benchmarks will result in transparency and the improvement of the treatment of cleft lip and palate worldwide.

  11. [Errors in medicine. Causes, impact and improvement measures to improve patient safety].

    Science.gov (United States)

    Waeschle, R M; Bauer, M; Schmidt, C E

    2015-09-01

    The guarantee of quality of care and patient safety is of major importance in hospitals even though increased economic pressure and work intensification are ubiquitously present. Nevertheless, adverse events still occur in 3-4 % of hospital stays and of these 25-50 % are estimated to be avoidable. The identification of possible causes of error and the development of measures for the prevention of medical errors are essential for patient safety. The implementation and continuous development of a constructive culture of error tolerance are fundamental.The origins of errors can be differentiated into systemic latent and individual active causes and components of both categories are typically involved when an error occurs. Systemic causes are, for example out of date structural environments, lack of clinical standards and low personnel density. These causes arise far away from the patient, e.g. management decisions and can remain unrecognized for a long time. Individual causes involve, e.g. confirmation bias, error of fixation and prospective memory failure. These causes have a direct impact on patient care and can result in immediate injury to patients. Stress, unclear information, complex systems and a lack of professional experience can promote individual causes. Awareness of possible causes of error is a fundamental precondition to establishing appropriate countermeasures.Error prevention should include actions directly affecting the causes of error and includes checklists and standard operating procedures (SOP) to avoid fixation and prospective memory failure and team resource management to improve communication and the generation of collective mental models. Critical incident reporting systems (CIRS) provide the opportunity to learn from previous incidents without resulting in injury to patients. Information technology (IT) support systems, such as the computerized physician order entry system, assist in the prevention of medication errors by providing

  12. Our trial to improve patient positioning during mammography

    International Nuclear Information System (INIS)

    Nakayama, Takashi; Kotsuma, Yoshikazu; Hiramatsu, Sawako

    2007-01-01

    For effective breast cancer screening, reading of high-quality mammograms is essential, and for this purpose proper patient positioning during mammography is important. At our Shin-Osaka Mammography Seminar, which includes eight institutions, a physician and nine radiology technicians get together weekly in order to critically review mammogram reading and techniques for obtaining good mammograms. We have recognized that patient positioning has a great effect on mammogram quality, particularly for women in their 40 s who have dense mammary glands, and we have adopted a digital mammography system, or comparative mammography for such patients. Since July 2005, we have critically reviewed positioning every 3 or 4 months with the aim of improving our technique. Eight institutions have participated in this trial, each contributing mammograms taken recently from 20 to 30 consecutive participants, and the grade of positioning has been determined according to the Institutional Mammogram Estimation Standard (6 items, each scoring a maximum of 4 points, total 24 points) proposed by the Central Committee for Quality Control of Mammography Screening. The estimation has been done by both ourselves and committee members. When a total of 20 points or more is obtained and all 6 items score 3 points or more, it is considered that the positioning has been good, and this is termed ''Positioning A'' (P-A). On the other hand, if the total score is less than 20 points, and any one of the 6 items scores less than 3 points, it is considered that positioning has been inadequate, and this is termed ''Positioning-D'' (P-D). At the first review meeting, which was held before our critical study, P-A accounted for 48% of cases, and this had improved to 72% at the second meeting, and to 66% at the third. P-D accounted for 41% of cases at the first meeting, 20% at the second, and 21% at the third. Thus our trial involving discussion between a physician and technicians to critically review good

  13. Impact of maintenance immunosuppressive therapy on the fecal microbiome of renal transplant recipients: Comparison between an everolimus- and a standard tacrolimus-based regimen.

    Directory of Open Access Journals (Sweden)

    Gianluigi Zaza

    Full Text Available The gut microbiome is the full set of microbes living in the gastrointestinal tract and is emerging as an important dynamic/fluid system that, if altered by environmental, dietetic or pharmacological factors, could considerably influence drug response. However, the immunosuppressive drug-induced modifications of this system are still poorly defined.We employed an innovative bioinformatics approach to assess differences in the whole-gut microbial metagenomic profile of 20 renal transplant recipients undergoing maintenance treatment with two different immunosuppressive protocols. Nine patients were treated with everolimus plus mycophenolate mofetil (EVE+MMF group, and 11 patients were treated with a standard therapy with tacrolimus plus mycophenolate mofetil (TAC+MMF group.A statistical analysis of comparative high-throughput data demonstrated that although similar according to the degree of Shannon diversity (alpha diversity at the taxonomic level, three functional genes clearly discriminated EVE+MMF versus TAC+MMF (cutoff: log2 fold change≥1, FDR≤0.05. Flagellar motor switch protein (fliNY and type IV pilus assembly protein pilM (pilM were significantly enriched in TAC+MMF-treated patients, while macrolide transport system mrsA (msrA was more abundant in patients treated with EVE+MMF. Finally, PERMANOVA revealed that among the variables analyzed and included in our model, only the consumption of sugar significantly influenced beta diversity.Our study, although performed on a relatively small number of patients, showed, for the first time, specific immunosuppressive-related effects on fecal microbiome of renal transplant recipients and it suggested that the analysis of the gut microbes community could represent a new tool to better understand the effects of drugs currently employed in organ transplantations. However, multicenter studies including healthy controls should be undertaken to better address this objective.

  14. Impact of maintenance immunosuppressive therapy on the fecal microbiome of renal transplant recipients: Comparison between an everolimus- and a standard tacrolimus-based regimen.

    Science.gov (United States)

    Zaza, Gianluigi; Dalla Gassa, Alessandra; Felis, Giovanna; Granata, Simona; Torriani, Sandra; Lupo, Antonio

    2017-01-01

    The gut microbiome is the full set of microbes living in the gastrointestinal tract and is emerging as an important dynamic/fluid system that, if altered by environmental, dietetic or pharmacological factors, could considerably influence drug response. However, the immunosuppressive drug-induced modifications of this system are still poorly defined. We employed an innovative bioinformatics approach to assess differences in the whole-gut microbial metagenomic profile of 20 renal transplant recipients undergoing maintenance treatment with two different immunosuppressive protocols. Nine patients were treated with everolimus plus mycophenolate mofetil (EVE+MMF group), and 11 patients were treated with a standard therapy with tacrolimus plus mycophenolate mofetil (TAC+MMF group). A statistical analysis of comparative high-throughput data demonstrated that although similar according to the degree of Shannon diversity (alpha diversity) at the taxonomic level, three functional genes clearly discriminated EVE+MMF versus TAC+MMF (cutoff: log2 fold change≥1, FDR≤0.05). Flagellar motor switch protein (fliNY) and type IV pilus assembly protein pilM (pilM) were significantly enriched in TAC+MMF-treated patients, while macrolide transport system mrsA (msrA) was more abundant in patients treated with EVE+MMF. Finally, PERMANOVA revealed that among the variables analyzed and included in our model, only the consumption of sugar significantly influenced beta diversity. Our study, although performed on a relatively small number of patients, showed, for the first time, specific immunosuppressive-related effects on fecal microbiome of renal transplant recipients and it suggested that the analysis of the gut microbes community could represent a new tool to better understand the effects of drugs currently employed in organ transplantations. However, multicenter studies including healthy controls should be undertaken to better address this objective.

  15. Impact of maintenance immunosuppressive therapy on the fecal microbiome of renal transplant recipients: Comparison between an everolimus- and a standard tacrolimus-based regimen

    Science.gov (United States)

    Dalla Gassa, Alessandra; Felis, Giovanna; Granata, Simona; Torriani, Sandra; Lupo, Antonio

    2017-01-01

    Background The gut microbiome is the full set of microbes living in the gastrointestinal tract and is emerging as an important dynamic/fluid system that, if altered by environmental, dietetic or pharmacological factors, could considerably influence drug response. However, the immunosuppressive drug-induced modifications of this system are still poorly defined. Methods We employed an innovative bioinformatics approach to assess differences in the whole-gut microbial metagenomic profile of 20 renal transplant recipients undergoing maintenance treatment with two different immunosuppressive protocols. Nine patients were treated with everolimus plus mycophenolate mofetil (EVE+MMF group), and 11 patients were treated with a standard therapy with tacrolimus plus mycophenolate mofetil (TAC+MMF group). Results A statistical analysis of comparative high-throughput data demonstrated that although similar according to the degree of Shannon diversity (alpha diversity) at the taxonomic level, three functional genes clearly discriminated EVE+MMF versus TAC+MMF (cutoff: log2 fold change≥1, FDR≤0.05). Flagellar motor switch protein (fliNY) and type IV pilus assembly protein pilM (pilM) were significantly enriched in TAC+MMF-treated patients, while macrolide transport system mrsA (msrA) was more abundant in patients treated with EVE+MMF. Finally, PERMANOVA revealed that among the variables analyzed and included in our model, only the consumption of sugar significantly influenced beta diversity. Conclusions Our study, although performed on a relatively small number of patients, showed, for the first time, specific immunosuppressive-related effects on fecal microbiome of renal transplant recipients and it suggested that the analysis of the gut microbes community could represent a new tool to better understand the effects of drugs currently employed in organ transplantations. However, multicenter studies including healthy controls should be undertaken to better address this

  16. Improving stroke patients' care: a patient held record is not enough

    Directory of Open Access Journals (Sweden)

    Lampe Fiona

    2001-03-01

    after discharge from hospital. Conclusions Stroke patients received poor information and explanations regardless of whether they received a PHR. A PHR did not appear to improve patient satisfaction or discharge planning, and may have reduced opportunities for communication and explanation.

  17. Organising a manuscript reporting quality improvement or patient safety research.

    Science.gov (United States)

    Holzmueller, Christine G; Pronovost, Peter J

    2013-09-01

    Peer-reviewed publication plays important roles in disseminating research findings, developing generalisable knowledge and garnering recognition for authors and institutions. Nonetheless, many bemoan the whole manuscript writing process, intimidated by the arbitrary and somewhat opaque conventions. This paper offers practical advice about organising and writing a manuscript reporting quality improvement or patient safety research for submission to a peer-reviewed journal. Each section of the paper discusses a specific manuscript component-from title, abstract and each section of the manuscript body, through to reference list and tables and figures-explaining key principles, offering content organisation tips and providing an example of how this section may read. The paper also offers a checklist of common mistakes to avoid in a manuscript.

  18. Provider and Patient Directed Financial Incentives to Improve Care and Outcomes for Patients with Diabetes

    Science.gov (United States)

    Lorincz, Ilona S.; Lawson, Brittany C. T.

    2012-01-01

    Incentive programs directed at both providers and patients have become increasingly widespread. Pay-for-performance (P4P) where providers receive financial incentives to carry out specific care or improve clinical outcomes has been widely implemented. The existing literature indicates they probably spur initial gains which then level off or partially revert if incentives are withdrawn. The literature also indicates that process measures are easier to influence through P4P programs but that intermediate outcomes such as glucose, blood pressure, and cholesterol control are harder to influence, and the long term impact of P4P programs on health is largely unknown. Programs directed at patients show greater promise as a means to influence patient behavior and intermediate outcomes such as weight loss; however, the evidence for long term effects are lacking. In combination, both patient and provider incentives are potentially powerful tools but whether they are cost-effective has yet to be determined. PMID:23225214

  19. Driving improvement in patient care: lessons from Toyota.

    Science.gov (United States)

    Thompson, Debra N; Wolf, Gail A; Spear, Steven J

    2003-11-01

    Nurses today are attempting to do more with less while grappling with faulty error-prone systems that do not focus on patients at the point of care. This struggle occurs against a backdrop of rising national concern over the incidence of medical errors in healthcare. In an effort to create greater value with scarce resources and fix broken systems that compromise quality care, UPMC Health System is beginning to master and implement the Toyota Production System (TPS)--a method of managing people engaged in work that emphasizes frequent rapid problem solving and work redesign that has become the global archetype for productivity and performance. The authors discuss the rationale for applying TPS to healthcare and implementation of the system through the development of "learning unit" model lines and initial outcomes, such as dramatic reductions in the number of missing medications and thousands of hours and dollars saved as a result of TPS-driven changes. Tracking data further suggest that TPS, with sufficient staff preparation and involvement, has the potential for continuous, lasting, and accelerated improvement in patient care.

  20. [Interventions to improve quality of life in oncological patients].

    Science.gov (United States)

    Klinkhammer-Schalke, Monika; Steinger, Brunhilde; Koller, Michael; Lindberg, Patricia

    2017-05-01

    The assessment of quality of life is a central aspect in the current debate in support groups, certified cancer centres, benefit assessment, and also in palliative care. Accordingly, quality of life has become an essential part of clinical trials for more than two decades. But most of the time results are presented in a descriptive manner without any concrete therapeutic consequences for the improvement of quality of life. Likewise, there are no uniform recommendations for considering quality of life data in the decision-making process. Therefore, a guide with recommendations for the assessment of quality of life in trials has been developed. Its implementation is illustrated by a complex intervention for a targeted diagnosis and therapy of quality of life in patients with breast cancer or colorectal cancer. The basis is a standardised quality of life assessment and the presentation of results in an intelligible fashion as well as the close collaboration of all healthcare providers to create regional network structures for the targeted support of patients in both the inpatient and outpatient sector. Copyright © 2017. Published by Elsevier GmbH.

  1. Application of Bow-tie methodology to improve patient safety.

    Science.gov (United States)

    Abdi, Zhaleh; Ravaghi, Hamid; Abbasi, Mohsen; Delgoshaei, Bahram; Esfandiari, Somayeh

    2016-05-09

    Purpose - The purpose of this paper is to apply Bow-tie methodology, a proactive risk assessment technique based on systemic approach, for prospective analysis of the risks threatening patient safety in intensive care unit (ICU). Design/methodology/approach - Bow-tie methodology was used to manage clinical risks threatening patient safety by a multidisciplinary team in the ICU. The Bow-tie analysis was conducted on incidents related to high-alert medications, ventilator associated pneumonia, catheter-related blood stream infection, urinary tract infection, and unwanted extubation. Findings - In total, 48 potential adverse events were analysed. The causal factors were identified and classified into relevant categories. The number and effectiveness of existing preventive and protective barriers were examined for each potential adverse event. The adverse events were evaluated according to the risk criteria and a set of interventions were proposed with the aim of improving the existing barriers or implementing new barriers. A number of recommendations were implemented in the ICU, while considering their feasibility. Originality/value - The application of Bow-tie methodology led to practical recommendations to eliminate or control the hazards identified. It also contributed to better understanding of hazard prevention and protection required for safe operations in clinical settings.

  2. Effective colonoscopy training techniques: strategies to improve patient outcomes

    Directory of Open Access Journals (Sweden)

    Papanikolaou IS

    2016-03-01

    Full Text Available Ioannis S Papanikolaou,1 Pantelis S Karatzas,2 Lazaros T Varytimiadis,2 Athanasios Tsigaridas,2 Michail Galanopoulos,2 Nikos Viazis,2 Dimitrios G Karamanolis21Hepato-gastroenterology Unit, 2nd Department of Internal Medicine, Attikon University General Hospital, University of Athens, 2Gastroenterology Department, Evangelismos Hospital, Athens, GreeceAbstract: Colonoscopy has substantially evolved during the last 20 years and many different training techniques have been developed in order to improve the performance of endoscopists. The most known are mechanical simulators, virtual reality simulators, computer-simulating endoscopy, magnetic endoscopic imaging, and composite and explanted animal organ simulators. Current literature generally indicates that the use of simulators improves performance of endoscopists and enhances safety of patients, especially during the initial phase of training. Moreover, newer endoscopes and imaging techniques such as high-definition colonoscopes, chromocolonoscopy with dyes spraying, and third-eye retroscope have been incorporated in everyday practice, offering better visualization of the colon and detection of polyps. Despite the abundance of these different technological features, training devices are not widely used and no official guideline or specified training algorithm or technique for lower gastrointestinal endoscopy has been evolved. In this review, we present the most important training methods currently available and evaluate these using existing literature. We also try to propose a training algorithm for novice endoscopists.Keywords: endoscopy, colonoscopy, teaching techniques, simulator, endoscopists, colon, polyps

  3. Effective colonoscopy training techniques: strategies to improve patient outcomes.

    Science.gov (United States)

    Papanikolaou, Ioannis S; Karatzas, Pantelis S; Varytimiadis, Lazaros T; Tsigaridas, Athanasios; Galanopoulos, Michail; Viazis, Nikos; Karamanolis, Dimitrios G

    2016-01-01

    Colonoscopy has substantially evolved during the last 20 years and many different training techniques have been developed in order to improve the performance of endoscopists. The most known are mechanical simulators, virtual reality simulators, computer-simulating endoscopy, magnetic endoscopic imaging, and composite and explanted animal organ simulators. Current literature generally indicates that the use of simulators improves performance of endoscopists and enhances safety of patients, especially during the initial phase of training. Moreover, newer endoscopes and imaging techniques such as high-definition colonoscopes, chromocolonoscopy with dyes spraying, and third-eye retroscope have been incorporated in everyday practice, offering better visualization of the colon and detection of polyps. Despite the abundance of these different technological features, training devices are not widely used and no official guideline or specified training algorithm or technique for lower gastrointestinal endoscopy has been evolved. In this review, we present the most important training methods currently available and evaluate these using existing literature. We also try to propose a training algorithm for novice endoscopists.

  4. Learning from errors in radiology to improve patient safety.

    Science.gov (United States)

    Saeed, Shaista Afzal; Masroor, Imrana; Shafqat, Gulnaz

    2013-10-01

    To determine the views and practices of trainees and consultant radiologists about error reporting. Cross-sectional survey. Radiology trainees and consultant radiologists in four tertiary care hospitals in Karachi approached in the second quarter of 2011. Participants were enquired as to their grade, sub-specialty interest, whether they kept a record/log of their errors (defined as a mistake that has management implications for the patient), number of errors they made in the last 12 months and the predominant type of error. They were also asked about the details of their department error meetings. All duly completed questionnaires were included in the study while the ones with incomplete information were excluded. A total of 100 radiologists participated in the survey. Of them, 34 were consultants and 66 were trainees. They had a wide range of sub-specialty interest like CT, Ultrasound, etc. Out of the 100 responders, 49 kept a personal record/log of their errors. In response to the recall of approximate errors they made in the last 12 months, 73 (73%) of participants recorded a varied response with 1 - 5 errors mentioned by majority i.e. 47 (64.5%). Most of the radiologists (97%) claimed receiving information about their errors through multiple sources like morbidity/mortality meetings, patients' follow-up, through colleagues and consultants. Perceptual error 66 (66%) were the predominant error type reported. Regular occurrence of error meetings and attending three or more error meetings in the last 12 months was reported by 35% participants. Majority among these described the atmosphere of these error meetings as informative and comfortable (n = 22, 62.8%). It is of utmost importance to develop a culture of learning from mistakes by conducting error meetings and improving the process of recording and addressing errors to enhance patient safety.

  5. Intensive care nurses' perceptions of Inter Specialty Trauma Nursing Rounds to improve trauma patient care-A quality improvement project.

    Science.gov (United States)

    Jennings, Fiona L; Mitchell, Marion

    2017-06-01

    Trauma patient management is complex and challenging for nurses in the Intensive Care Unit. One strategy to promote quality and evidence based care may be through utilising specialty nursing experts both internal and external to the Intensive Care Unit in the form of a nursing round. Inter Specialty Trauma Nursing Rounds have the potential to improve patient care, collaboration and nurses' knowledge. The purpose of this quality improvement project was to improve trauma patient care and evaluate the nurses perception of improvement. The project included structured, weekly rounds that were conducted at the bedside. Nursing experts and others collaborated to assess and make changes to trauma patients' care. The rounds were evaluated to assess the nurse's perception of improvement. There were 132 trauma patients assessed. A total of 452 changes to patient care occurred. On average, three changes per patient resulted. Changes included nursing management, medical management and wound care. Nursing staff reported an overall improvement of trauma patient care, trauma knowledge, and collaboration with colleagues. Inter Specialty Trauma Nursing Rounds utilizes expert nursing knowledge. They are suggested as an innovative way to address the clinical challenges of caring for trauma patients and are perceived to enhance patient care and nursing knowledge. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. Multimodal Perioperative Analgesia Regimen to Improve Patient Outcomes After Total Knee Arthroplasty: A Multidisciplinary Quality Improvement Project.

    Science.gov (United States)

    Donahue, Rebecca E; Bradbury, George R; Zychowicz, Michael E; Muckler, Virginia C

    2018-04-01

    The primary aim of this quality improvement project was to improve mobilization for patients after total knee arthroscopy by developing and implementing a standardized, evidence-based, multimodal analgesia regimen and patient-educational video. Secondary outcomes included opioid consumption, pain, and length of stay. A pre-post implementation design was used to compare two independent samples. Patients were screened based on inclusion and exclusion criteria 1-2 weeks before surgery. The anesthesia provider made the final determination for inclusion. Data were collected by retrospective chart review. Following implementation, patients displayed significantly improved mobilization, reduced opioid consumption, and reduced length of stay. Patient-reported pain scores were similar or significantly lower in the postimplementation group. Variability of patient outcomes was reduced, and quality of care was improved by standardizing care and incorporating the best available evidence, consistent with organization's resources in the nonacademic-affiliated, community hospital setting. Published by Elsevier Inc.

  7. Organizational interventions to implement improvements in patient care: a structured review of reviews.

    NARCIS (Netherlands)

    Wensing, M.J.P.; Wollersheim, H.C.H.; Grol, R.P.T.M.

    2006-01-01

    BACKGROUND: Changing the organization of patient care should contribute to improved patient outcomes as functioning of clinical teams and organizational structures are important enablers for improvement. OBJECTIVE: To provide an overview of the research evidence on effects of organizational

  8. Selection of indicators for continuous monitoring of patient safety: recommendations of the project 'safety improvement for patients in Europe'

    DEFF Research Database (Denmark)

    Kristensen, Solvejg; Mainz, Jan; Bartels, Paul

    2009-01-01

    such as culture, infections, surgical complications, medication errors, obstetrics, falls and specific diagnostic areas. CONCLUSION: The patient safety indicators recommended present a set of possible measures of patient safety. One of the future perspectives of implementing patient safety indicators...... for systematic monitoring is that it will be possible to continuously estimate the prevalence and incidence of patient safety quality problems. The lesson learnt from quality improvement is that it will pay off in terms of improving patient safety....

  9. Editorial: Advances in healthcare provider and patient training to improve the quality and safety of patient care

    OpenAIRE

    Elizabeth M. Borycki

    2015-01-01

    This special issue of the Knowledge Management & E-Learning: An International Journal is dedicated to describing “Advances in Healthcare Provider and Patient Training to Improve the Quality and Safety of Patient Care.” Patient safety is an important and fundamental requirement of ensuring the quality of patient care. Training and education has been identified as a key to improving healthcare provider patient safety competencies especially when working with new technologies such as electronic ...

  10. Improving transfusion practice in transfusion dependent thalassaemia patients

    Directory of Open Access Journals (Sweden)

    Chathupa Wickremaarachchi

    2017-10-01

    Full Text Available The aim of this study was to improve current transfusion practice in transfusiondependent thalassaemia patients by determining whether safe transition from triplewashed red cells (TWRC to leucodepleted red cells (LDRC, increasing transfusion rates, reducing the use of frusemide and creating uniform practice across patients is possible. In patients receiving regular transfusions (50, triple-washed red blood cells were changed to LDRC, transfusion rates were increased to 5 mL/kg/h (in line with the Cooley’s Foundation guidelines to a maximum of 300 mL/h and frusemide was ceased. Medical review occurred at completion of the transfusion. Of the 20 patients on TWRC, 18 were transitioned to leucodepleted red cells (90%. Recurrent allergic reactions in 2 patients required re-institution of TWRC. 7 of the 8 patients on regular frusemide ceased this practice with no documented transfusion-related fluid overload. One patient refused. Of the eligible 50 patients, 20 patients (40% were increased to the maximum transfusion rate of 300 mLs/h; 6 (12% increased rate but refused to go to the maximum; 9 (18% refused a change in practice and 15 (30% were already at the maximum rate. There was only one documented transfusion reaction (palpitations however this patient was able to tolerate a higher transfusion rate on subsequent transfusions. Thalassemia patients on TWRC were safely transitioned to LDRC. Transfusion rates were safely increased, with a calculated reduction in day-stay bed time of 17.45 h per month. This confirms a guideline of 5 mL/kg/h for transfusion-dependant thalassaemia patients with preserved cardiac function is well tolerated and may be translated to other centres worldwide.   本研究的目的是通过确定是否有可能进行从三洗红细胞(TWRC)到去白细胞红细胞(LDRC)的安全过渡,提高输血速率,减少速尿的使用,并在患者中实施统一规则,从而改进输血依赖型地中海贫血患者中

  11. A win for the patient: Direct patient notification improves treatment rates of active Helicobacter pylori infection.

    Science.gov (United States)

    Selvaratnam, Sriharan; Yeoh, Joey; Hsiang, John; Patrick, Alasdair B

    2014-01-01

    Current international guidelines recommend the commencement of effective eradication therapy as soon as active Helicobacter pylori (H. pylori) infection is confirmed. At our institution, all positive Campylobacter-like Organism (CLO) test results were automatically communicated to general practitioners (GPs) via a standardised letter, which also advised the commencement of eradication therapy. Despite this endeavour, a clinical audit conducted in 2011 demonstrated that only 66 per cent of confirmed H. pylori-positive South Auckland patients received eradication treatment and only 83 per cent of these patients received treatment within one month. Improve the timely initiation of H. pylori eradication therapy through direct patient notification. A prospective clinical audit of 109 consecutive outpatients with a positive CLO test identified at gastroscopy. In addition to standard general practitioner notification, patients were also directly notified of their positive CLO test result via a standardised letter, which provided information about H. pylori and its disease associations as well as advising patients to seek consultation with their GP to commence eradication therapy. Dispensing data was examined using Test Safe electronic records to determine the total uptake and timing of treatment compared to data from a preliminary 2011 audit. Ninety-five per cent of H. pylori-positive patients received standard triple therapy; therefore, treatment of active H. pylori infection was significantly higher when patients were directly notified in addition to standard GP notification, when compared to GP notification alone (95 per cent vs 66 per cent, paudit in 2011 (100 per cent vs. 83 per cent, pstrategy that significantly improves the timely initiation of eradication therapy for active H. pylori infection. This has since been integrated into standard practice at our District Health Board (DHB).

  12. Effects of topical corticosteroid and tacrolimus on ceramides and irritancy to sodium lauryl sulphate in healthy skin

    DEFF Research Database (Denmark)

    Jungersted, Jakob Mutanu; Høgh, Julie Kaae; Hellegren, Lars I

    2011-01-01

    twice daily for one week with betamethasone, tacrolimus, emollient, or left untreated, respectively. After one week each area was challenged with a 24 h sodium lauryl sulphate patch test. The lipids were collected using the cyanoacrylate method and evaluated by high performance thin layer chromatography......The skin barrier, located in the stratum corneum, is influenced mainly by the lipid and protein composition of this layer. In eczematous diseases impairment of the skin barrier is thought to be of prime importance. Topical anti-inflammatory drugs and emollients are the most widely used eczema...

  13. Improving patient safety: patient-focused, high-reliability team training.

    Science.gov (United States)

    McKeon, Leslie M; Cunningham, Patricia D; Oswaks, Jill S Detty

    2009-01-01

    Healthcare systems are recognizing "human factor" flaws that result in adverse outcomes. Nurses work around system failures, although increasing healthcare complexity makes this harder to do without risk of error. Aviation and military organizations achieve ultrasafe outcomes through high-reliability practice. We describe how reliability principles were used to teach nurses to improve patient safety at the front line of care. Outcomes include safety-oriented, teamwork communication competency; reflections on safety culture and clinical leadership are discussed.

  14. Impact Of Patient Counseling And Education Of Diabetic Patients In Improving Their Quality Of Life

    Directory of Open Access Journals (Sweden)

    Nalini Pais

    2010-12-01

    Full Text Available Objectives: The current study which is randomized comparative intervention (concurrent control attempts to study the effect of counseling and education provided by clinical pharmacist regarding the disease and related issues to achieve glycemic control and ultimately better quality of life of Diabetic patients; which was carried out for a period of 6months in the out-patient medicine department of St.Martha’sHospital, Bangalore.Materials and Method: A total of 98 (53 intervention, 45control patients were randomized into intervention and control group by chit method. Intervention group received counseling and education along with the information leaflet;follow up was done at intervals of 2nd, 4th & 6th month after baseline. Pre-validated questionnaires for KAP & QoL were administered at the baseline and last follow up. In a group of25 patients HbA1c was recorded at baseline & last follow-up.All the parameters (FBS, PPBS, HbA1c and scores were compared between intervention & control group postcounseling. Significant improvement (P<0.05 was observed inthe intervention group in terms of glycemic control and HbA1cvalues in comparison with the control group.Results: In the intervention group; Knowledge about the disease improved (P<0.05 along with better compliance to diet, however change in attitude towards need for exercise and regular checkups could not be achieved but significant improvement (p<0.05 in Quality of Life (QoL was achieved with education and counseling.Conclusion: The findings revealed that the clinical pharmacist can contribute to the better management of diabetes through patient education and counseling.

  15. The calcineurin pathway inhibitor tacrolimus enhances the in vitro activity of azoles against Mucorales via apoptosis.

    Science.gov (United States)

    Shirazi, F; Kontoyiannis, D P

    2013-09-01

    The calcineurin pathway regulates antifungal drug resistance and the virulence of several major human-pathogenic fungi, including the recalcitrant Mucorales. We hypothesized that the fungistatic triazoles posaconazole (PCZ) and itraconazole (ICZ) become fungicidal in the setting of the calcineurin inhibitor tacrolimus (TCR) and that such an effect is mediated through apoptosis. Fungicidal activity and apoptosis were studied using standard microbiological techniques and hyphal metabolic and vital dye reduction assays at 37°C in RPMI 1640. Apoptosis was characterized by detecting intracellular Ca(2+), phosphatidylserine (PS) externalization, DNA fragmentation, plasma membrane integrity, chromatin condensation, reactive oxygen species (ROS) generation, caspase-like activity, ATP, and cytochrome c release. MICs for PCZ and ICZ alone were significantly higher (8 to 128 μg/ml) than those of PCZ or ICZ plus TCR (0.25 to 4 μg/ml) for Rhizopus oryzae, Cunninghamella bertholletiae, and Mucor circinelloides. Both PCZ and ICZ in combination with TCR became fungicidal, and their activity was mediated through increased apoptotic cell death of R. oryzae (10 to 50%), C. bertholletiae (5 to 50%), and M. circinelloides (5 to 55%) germlings, with morphological apoptotic changes characterized by externalization of PS, nuclear condensation, and DNA fragmentation. Moreover, activation of the caspase-like activity was correlated with cell death induced by TCR plus PCZ or ICZ. These changes correlated with elevated intracellular Ca(2+) and ROS levels and disturbance of mitochondrial potential. We found that PCZ or ICZ in combination with TCR renders Mucorales sensitive to triazoles via apoptotic death. These observations could serve as a new paradigm for the development of new therapeutic strategies.

  16. Differential Effects of Tacrolimus versus Sirolimus on the Proliferation, Activation and Differentiation of Human B Cells.

    Directory of Open Access Journals (Sweden)

    Opas Traitanon

    Full Text Available The direct effect of immunosuppressive drugs calcineurin inhibitor (Tacrolimus, TAC and mTOR inhibitor (Sirolimus, SRL on B cell activation, differentiation and proliferation is not well documented. Purified human B cells from healthy volunteers were stimulated through the B Cell Receptor with Anti-IgM + anti-CD40 + IL21 in the absence / presence of TAC or SRL. A variety of parameters of B cell activity including activation, differentiation, cytokine productions and proliferation were monitored by flow cytometry. SRL at clinically relevant concentrations (6 ng/ml profoundly inhibited CD19(+ B cell proliferation compared to controls whereas TAC at similar concentrations had a minimal effect. CD27(+ memory B cells were affected more by SRL than naïve CD27- B cells. SRL effectively blocked B cell differentiation into plasma cells (CD19(+CD138(+ and Blimp1(+/Pax5(low cells even at low dose (2 ng/ml, and totally eliminated them at 6 ng/ml. SRL decreased absolute B cell counts, but the residual responding cells acquired an activated phenotype (CD25(+/CD69(+ and increased the expression of HLA-DR. SRL-treated stimulated B cells on a per cell basis were able to enhance the proliferation of allogeneic CD4(+CD25(- T cells and induce a shift toward the Th1 phenotype. Thus, SRL and TAC have different effects on B lymphocytes. These data may provide insights into the clinical use of these two agents in recipients of solid organ transplants.

  17. Fingertip touch improves postural stability in patients with peripheral neuropathy.

    Science.gov (United States)

    Dickstein, R; Shupert, C L; Horak, F B

    2001-12-01

    The purpose of this work was to determine whether fingertip touch on a stable surface could improve postural stability during stance in subjects with somatosensory loss in the feet from diabetic peripheral neuropathy. The contribution of fingertip touch to postural stability was determined by comparing postural sway in three touch conditions (light, heavy and none) in eight patients and eight healthy control subjects who stood on two surfaces (firm or foam) with eyes open or closed. In the light touch condition, fingertip touch provided only somatosensory information because subjects exerted less than 1 N of force with their fingertip to a force plate, mounted on a vertical support. In the heavy touch condition, mechanical support was available because subjects transmitted as much force to the force plate as they wished. In the no touch condition, subjects held the right forefinger above the force plate. Antero-posterior (AP) and medio-lateral (ML) root mean square (RMS) of center of pressure (CoP) sway and trunk velocity were larger in subjects with somatosensory loss than in control subjects, especially when standing on the foam surface. The effects of light and heavy touch were similar in the somatosensory loss and control groups. Fingertip somatosensory input through light touch attenuated both AP and ML trunk velocity as much as heavy touch. Light touch also reduced CoP sway compared to no touch, although the decrease in CoP sway was less effective than with heavy touch, particularly on the foam surface. The forces that were applied to the touch plate during light touch preceded movements of the CoP, lending support to the suggestion of a feedforward mechanism in which fingertip inputs trigger the activation of postural muscles for controlling body sway. These results have clinical implications for understanding how patients with peripheral neuropathy may benefit from a cane for postural stability in stance.

  18. Radiographer's impact on improving clinical decision-making, patient care and patient diagnosis: a pilot study

    International Nuclear Information System (INIS)

    Lam, Daniel; Egan, Ingrid; Baird, Marilyn

    2004-01-01

    This pilot study attempts to quantify the benefits of a documented radiographic clinical history through the use of the clinical history template form designed by Egan and Baird. Six radiographers completed the clinical history template for 40 patients and four radiologists included the recorded information as part of their reporting process. A focus discussion group was held between the radiographers to ascertain the level of satisfaction and benefits encountered with the use of the template form. A questionnaire was designed for the radiologists to complete regarding the usefulness of the template form with respect to the radiological reporting process. Results/Discussion: 15 cases for which the form was used demonstrated a direct benefit in respect to improved radiographic clinical decision-making. Radiographers agreed the template form aided the establishment of a stronger radiographer-patient relationship during the radiographic examination. Two radiologists agreed the form aided in establishing a radiological diagnosis and suggested the form be implemented as part of the standard departmental protocol. Despite the small sample size, there is evidence the form aided radiographic decision-making and assisted in the establishment of an accurate radiological diagnosis. The overall consensus amongst radiographers was that it enhanced radiographer-patient communication and improved the level of patient care. Copyright (2004) Australian Institute of Radiography

  19. Addition of gemtuzumab ozogamicin to induction chemotherapy improves survival in older patients with acute myeloid leukemia

    DEFF Research Database (Denmark)

    Burnett, Alan K; Russell, Nigel H; Hills, Robert K

    2012-01-01

    PURPOSE There has been little survival improvement in older patients with acute myeloid leukemia (AML) in the last two decades. Improving induction treatment may improve the rate and quality of remission and consequently survival. In our previous trial, in younger patients, we showed improved...

  20. Steroid withdrawal in renal transplant patients: the Irish experience.

    LENUS (Irish Health Repository)

    Phelan, P J

    2012-02-01

    BACKGROUND: Steroid therapy is associated with significant morbidity in renal transplant recipients. However, there is concern that steroid withdrawal will adversely affect outcome. METHODS: We report on 241 renal transplant recipients on different doses of corticosteroids at 3 months (zero, <\\/= 5 mg\\/day, > 5 mg\\/day). Parameters analysed included blood pressure, lipid profile, weight change, new onset diabetes after transplantation (NODAT), allograft survival and acute rejection. RESULTS: Elimination of corticosteroids had no impact on allograft survival at 1 year. There were no cases of NODAT in the steroid withdrawal group compared with over 7% in each of the steroid groups. There were no significant improvements in weight gain, blood pressure control or total cholesterol with withdrawal of steroids before 3 months. CONCLUSIONS: In renal transplant patients treated with tacrolimus and mycophenolate, early withdrawal of steroids does not appear to adversely affect allograft outcome at 1 year. It may result in less NODAT.

  1. [Human factors and crisis resource management: improving patient safety].

    Science.gov (United States)

    Rall, M; Oberfrank, S

    2013-10-01

    A continuing high number of patients suffer harm from medical treatment. In 60-70% of the cases the sources of harm can be attributed to the field of human factors (HFs) and teamwork; nevertheless, those topics are still neither part of medical education nor of basic and advanced training even though it has been known for many years and it has meanwhile also been demonstrated for surgical specialties that training in human factors and teamwork considerably reduces surgical mortality.Besides the medical field, the concept of crisis resource management (CRM) has already proven its worth in many other industries by improving teamwork and reducing errors in the domain of human factors. One of the best ways to learn about CRM and HFs is realistic simulation team training with well-trained instructors in CRM and HF. The educational concept of the HOTT (hand over team training) courses for trauma room training offered by the DGU integrates these elements based on the current state of science. It is time to establish such training for all medical teams in emergency medicine and operative care. Accompanying safety measures, such as the development of a positive culture of safety in every department and the use of effective critical incident reporting systems (CIRs) should be pursued.

  2. Sensory stimulation programme to improve recovery in comatose patients.

    Science.gov (United States)

    Oh, Hyunsoo; Seo, Whasook

    2003-05-01

    The purpose of this study was to examine whether positive changes in consciousness level after applying a sensory stimulation programme exceed natural recovery. A single experimental group interrupted time series design was used. Subjects were brain-injured patients who were hospitalized at a university hospital in South Korea. The sensory stimulation programme was composed of auditory, visual, olfactory, gustatory, tactile and physical stimulation. Levels of consciousness were evaluated using the Glasgow Coma Scale. The intervention was carried out twice, first for 4 weeks, then a recession period was allowed for 4 weeks, and immediately after this the second intervention was implemented for 4 weeks. Results showed significant alterations in consciousness levels 2 weeks after starting intervention 1. This effect increased gradually and was maintained for 3-4 weeks. However, consciousness levels began to decrease 2 weeks after terminating intervention 1 and this decrement continued until starting intervention 2. The pattern of improvement of intervention 1 could be represented as a gradual onset and temporary duration model. At the beginning of intervention 2, consciousness levels were maintained at a low level. However, they began to increase again after 2 weeks and this increment continued even after terminating intervention 2. Therefore, the effect of intervention 2 could be represented as a gradual onset and permanent duration model. These results suggest that an intervention programme should be applied for more than 1 month to achieve a permanent effect on consciousness levels and that at least 2 weeks are required for any significant effect.

  3. Interprofessional Collaborative Practice to Improve Patient Outcomes: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Jennifer Styron

    2014-06-01

    Full Text Available This project focused on a pilot project implemented during the 2013-2014 academic year. The overall purpose was to facilitate interprofessional collaborative practice innovations through the development of leadership, core competencies, and the use of technology, especially among nurses. Nursing, medicine, and physician assistant students were educated on the IOM competencies for interprofessional teams and the core competencies identified by the Interprofessional Education Collaborative Expert Panel [1] to develop knowledge, skills, and attitudes needed to practice in the collaborative practice environments. The project addressed four goals: Develop faculty expertise and leadership in interprofessional collaborative practice to provide a current, high quality education to nursing, physician assistant, and medical students; Implement a culturally responsive and respectful collaborative interprofessional practice curriculum to prepare nurses, physician assistants, and medical students to deliver high quality, efficient, team-based care in a dynamically evolving environment; Focus interprofessional collaborative practice education on models and practices that lead to improvement in patient outcomes; and Evaluate the program and disseminate best practices. Findings from this pilot include strategies to engage different health professions' students and faculty, partnering with community agencies, building an effective interprofessional team to guide the project, and seeking funding for extension and expansion of the offerings.

  4. Patient dosimetry improvements in longitudinal field MRI linear accelerators

    International Nuclear Information System (INIS)

    Oborn, B.M.; Metcalfe, P.E.; Butson, M.J.; Keall, P.

    2010-01-01

    Full text: Many studies exist of the often undesirable dosimetry changes in transverse field MRI-Linacs. Currently there are plans by different groups around the world to develop longitudinal MRT-Linac systems as dosimetry is potentially superior to transverse field sy tems. The objective of this study is to investigate via Monte Carlo simulations, the potential dosimetry improvements expected in lo gitudinal MRI-Linac designs over transverse field designs for advanced image-guided radiotherapy (IGRT). Geant4 Monte Carlo simulations have been performed of the dosimetry from a Varian 2100c 6 MV photon beam in lo gitudinal magnetic field typical of expected MRI-Linac designs. A 30 x 30 x 20 cm' phantom has been simulated in magnetic fields between 0 and 3 T. Beam profiles and skin dose calculations have been performed and compared with transverse field systems. Results The longitudinal magnetic field acts to reduce lateral dose spread in all locations within a patient. As well as this, the electron return effcct is absent. This equates to reductions in penumbral widths and reductions in skin dose. When compared with transverse field systems the dosimetry is superior. This will also allow for further reductions in trcatment margins as compared to transverse field MRI Linac designs.

  5. Pectus patient information website has improved access to care and patient reported outcomes.

    Science.gov (United States)

    Tikka, Theofano; Webb, Joanne; Agostini, Paula; Kerr, Amy; Mannion, Glenn; Steyn, Richard S; Bishay, Ehab; Kalkat, Maninder S; Rajesh, Pala B; Naidu, Babu

    2016-04-26

    patient information website has significantly improved access to specialised services. Patients are overall highly satisfied with the surgical outcomes.

  6. A Strategic Framework for Improving the Patient Experience in Hospitals.

    Science.gov (United States)

    Birkelien, Natalie L

    Hospitals are taking new approaches to satisfy consumers and deliver on customer expectations by enhancing their patients' comprehensive experience. The HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) survey and value-based purchasing initiatives have tied reimbursement to patient satisfaction scores, bringing patient perspectives on care to the forefront of hospitals' strategic priorities. This essay reviews the patient experience literature and argues that hospitals should adopt an expanded approach beyond HCAHPS measures to enhance the patient experience. Such an approach allows providers to deliver quality outcomes that satisfy patients' wants and needs.

  7. Bevacizumab improves survival for patients with advanced cervical cancer

    Science.gov (United States)

    Patients with advanced, recurrent, or persistent cervical cancer that was not curable with standard treatment who received the drug bevacizumab (Avastin) lived 3.7 months longer than patients who did not receive the drug, according to an interim analysis

  8. [Experience feedback committee: a method for patient safety improvement].

    Science.gov (United States)

    François, P; Sellier, E; Imburchia, F; Mallaret, M-R

    2013-04-01

    An experience feedback committee (CREX, Comité de Retour d'EXpérience) is a method which contributes to the management of safety of care in a medical unit. Originally used for security systems of civil aviation, the method has been adapted to health care facilities and successfully implemented in radiotherapy units and in other specialties. We performed a brief review of the literature for studies reporting data on CREX established in hospitals. The review was performed using the main bibliographic databases and Google search results. The CREX is designed to analyse incidents reported by professionals. The method includes monthly meetings of a multi-professional committee that reviews the reported incidents, chooses a priority incident and designates a "pilot" responsible for investigating the incident. The investigation of the incident involves a systemic analysis method and a written synthesis presented at the next meeting of the committee. The committee agrees on actions for improvement that are suggested by the analysis and follows their implementation. Systems for the management of health care, including reporting systems, are organized into three levels: the medical unit, the hospital and the country as a triple loop learning process. The CREX is located in the base level, short loop of risk management and allows direct involvement of care professionals in patient safety. Safety of care has become a priority of health systems. In this context, the CREX can be a useful vehicle for the implementation of a safety culture in medical units. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  9. Patient satisfaction and suggestions for improvement of remote ICD monitoring

    DEFF Research Database (Denmark)

    Petersen, Helen Høgh; Larsen, Mie Christa Jensen; Nielsen, Olav Wendelboe

    2012-01-01

    PURPOSE: The study aim was to evaluate patient acceptance and content with remote follow-up (FU) of their implantable cardioverter defibrillator (ICD) and to estimate patients' wish for changes in remote follow-up routines. METHODS: Four hundred seventy-four ICD patients at the device follow-up c...

  10. Transferring skills in quality collaboratives focused on improving patient logistics

    NARCIS (Netherlands)

    J.W.M. Weggelaar-Jansen (Anne Marie); J.D.H. van Wijngaarden (Jeroen)

    2018-01-01

    textabstractBackground: A quality improvement collaborative, often used by the Institute for Healthcare Improvement, is used to educate healthcare professionals and improve healthcare at the same time. However, no prior research has been done on the knowledge and skills healthcare professionals need

  11. CYP3A5 genotyping may reduce the cost of care and guide dosing in paediatric renal transplant recipients treated with tacrolimus: A report of two paediatric renal transplant cases

    Directory of Open Access Journals (Sweden)

    Stephen M. Roper

    2017-05-01

    Full Text Available Therapeutic tacrolimus blood levels are often difficult to achieve immediately after transplant. Pharmacogenetic testing is an option to predict the metabolism of tacrolimus; however the clinical benefits of this approach have not been extensively studied. We describe two paediatric renal transplant recipients who were initially treated with a standard dosing equation for tacrolimus, but required increased frequency of therapeutic drug monitoring and multiple dose adjustments leading to increased cost of hospitalization. A novel perspective is that pharmacogenetic testing is appropriate to reduce length of hospitalization and the total cost of care.

  12. Minimizing tacrolimus decreases the risk of new-onset diabetes mellitus after liver transplantation.

    Science.gov (United States)

    Song, Jiu-Lin; Gao, Wei; Zhong, Yan; Yan, Lu-Nan; Yang, Jia-Yin; Wen, Tian-Fu; Li, Bo; Wang, Wen-Tao; Wu, Hong; Xu, Ming-Qing; Chen, Zhe-Yu; Wei, Yong-Gang; Jiang, Li; Yang, Jian

    2016-02-14

    To investigate the impact of minimum tacrolimus (TAC) on new-onset diabetes mellitus (NODM) after liver transplantation (LT). We retrospectively analyzed the data of 973 liver transplant recipients between March 1999 and September 2014 in West China Hospital Liver Transplantation Center. Following the exclusion of ineligible recipients, 528 recipients with a TAC-dominant regimen were included in our study. We calculated and determined the mean trough concentration of TAC (cTAC) in the year of diabetes diagnosis in NODM recipients or in the last year of the follow-up in non-NODM recipients. A cutoff of mean cTAC value for predicting NODM 6 mo after LT was identified using a receptor operating characteristic curve. TAC-related complications after LT was evaluated by χ(2) test, and the overall and allograft survival was evaluated using the Kaplan-Meier method. Risk factors for NODM after LT were examined by univariate and multivariate Cox regression. Of the 528 transplant recipients, 131 (24.8%) developed NODM after 6 mo after LT, and the cumulative incidence of NODM progressively increased. The mean cTAC of NODM group recipients was significantly higher than that of recipients in the non-NODM group (7.66 ± 3.41 ng/mL vs 4.47 ± 2.22 ng/mL, P 50 years), hypertension pre-LT, and high mean cTAC (≥ 5.89 ng/mL) after 6 mo after LT were independent risk factors for developing NODM. Concurrently, recipients with a low cTAC (< 5.89 ng/mL) were less likely to become obese (21.3% vs 30.2%, P < 0.05) or to develop dyslipidemia (27.5% vs 44.8%, P <0.05), chronic kidney dysfunction (14.6% vs 22.7%, P < 0.05), and moderate to severe infection (24.7% vs 33.1%, P < 0.05) after LT than recipients in the high mean cTAC group. However, the two groups showed no significant difference in the incidence of acute and chronic rejection, hypertension, cardiovascular events and new-onset malignancy. A minimal TAC regimen can decrease the risk of long-term NODM after LT. Maintaining a c

  13. Improved prognosis in type 1 diabetic patients with nephropathy

    DEFF Research Database (Denmark)

    Astrup, Anne Sofie; Tarnow, Lise; Rossing, Peter

    2005-01-01

    and aspirin were not prescribed routinely until April 2002. The primary end point was cardiovascular mortality and morbidity. Secondary end points were all-cause mortality and ESRD. RESULTS: During follow-up, 79 patients (40%) with nephropathy reached the primary end point versus 19 (10%) of normoalbuminuric...... patients, log rank test P blood pressure (1.13; 1.03 to 1.24). In the nephropathy group, 60 patients (30...

  14. Approaches to improve adherence to pharmacotherapy in patients with schizophrenia

    OpenAIRE

    Shuler, Kimberly M

    2014-01-01

    Kimberly M Shuler Shuler Counseling and Consulting, Fayetteville, AR, USA Purpose: In patients with schizophrenia, nonadherence to prescribed medications increases the risk of patient relapse and hospitalization, key contributors to the costs associated with treatment. The objectives of this review were to evaluate the impact of nonadherence to pharmacotherapy in patients with schizophrenia as it relates to health care professionals, particularly social workers, and to identify effective tea...

  15. [A blood glucose slide chart for improving diabetes patient education].

    Science.gov (United States)

    Potteau, Marie-Hélène

    2015-03-01

    A blood glucose slide chart has been developed in order to help patients with type 2 diabetes who do not speak French or who have comprehension difficulties. Combined with pictograms to help patients visualise the action they need to take depending on the recorded glucose level, it constitutes a therapeutic education tool which can be useful on a day-to-day basis both for patients as well as caregivers.

  16. Digital audio recordings improve the outcomes of patient consultations

    DEFF Research Database (Denmark)

    Wolderslund, Maiken; Kofoed, Poul-Erik; Holst, René

    2017-01-01

    OBJECTIVES: To investigate the effects on patients' outcome of the consultations when provided with: a Digital Audio Recording (DAR) of the consultation and a Question Prompt List (QPL). METHODS: This is a three-armed randomised controlled cluster trial. One group of patients received standard care......, while the other two groups received either the QPL in combination with a recording of their consultation or only the recording. Patients from four outpatient clinics participated: Paediatric, Orthopaedic, Internal Medicine, and Urology. The effects were evaluated by patient-administered questionnaires...

  17. Can audio recording of outpatient consultations improve patient outcome?

    DEFF Research Database (Denmark)

    Wolderslund, Maiken; Kofoed, Poul-Erik; Axboe, Mette

    different departments: Orthopedics, Urology, Internal Medicine and Pediatrics. A total of 5,460 patients will be included from the outpatient clinics. All patients randomized to an intervention group are offered audio recording of their consultation. An Interactive Voice Response platform enables an audio....... The intervention will be evaluated using a questionnaire measuring different aspect of patients recall and understanding of the information given, patients need for additional information subsequent to the consultation and their overall satisfaction with the consultation. Results The study will be conducted from...

  18. Can audio recording improve patients' recall of outpatient consultations?

    DEFF Research Database (Denmark)

    Wolderslund, Maiken; Kofoed, Poul-Erik; Axboe, Mette

    Introduction In order to give patients possibility to listen to their consultation again, we have designed a system which gives the patients access to digital audio recordings of their consultations. An Interactive Voice Response platform enables the audio recording and gives the patients access...... and those who have not (control).The audio recordings and the interviews are coded according to six themes: Test results, Treatment, Risks, Future tests, Advice and Plan. Afterwards the extent of patients recall is assessed by comparing the accuracy of the patient’s statements (interview...

  19. A Novel Cast Removal Training Simulation to Improve Patient Safety.

    Science.gov (United States)

    Brubacher, Jacob W; Karg, Jeffrey; Weinstock, Peter; Bae, Donald S

    2016-01-01

    Cast application and removal are essential to orthopedics and performed by providers of variable training. Simulation training and practice of proper cast application and removal may reduce injury, optimize outcomes, and reduce health care costs. The purpose of this educational initiative was to develop, validate, and implement a novel simulation trainer and curriculum to improve safety during cast removal. In all, 30 thermocouples (Omega, Stamford, CT) were applied to a radius fracture model (Sawbones, Vashon, WA). After reduction and cast application, a saw (Stryker, Kalamazoo, MI) was used to cut the cast with temperature recording. Both "good" and "poor" techniques-as established by consensus best practices-were used. Maximal temperatures were compared to known thresholds for thermal injury; humans experience pain at temperatures exceeding 47°C and contact temperatures exceeding 60°C may lead to epidermal necrosis. Construct validity was evaluated by assessing novice (postgraduate year 1), intermediate (postgraduate year 3), and expert (pediatric orthopedic attending) performance. With the "good" technique, mean peak temperatures were 43°C + 4.3°C. The highest recorded was 51.9°C. With the "poor" technique, mean peak temperature was 75.2°C + 17.3°C. The maximum temperature recorded with the "poor" technique was 112.4°C. Construct validity testing showed that novices had the highest increases in temperatures (12.9°C). There was a decline in heat generation as experience increased with the intermediate group (9.7°C), and the lowest heat generation was seen in the expert group (5.0°C). A novel task simulator and curriculum have been developed to assess competency and enhance performance in the application and removal of casts. There was a 32.2°C temperature decrease when the proper cast saw technique was used. Furthermore, the "poor" technique consistently achieved temperatures that would cause epidermal necrosis in patients. Clinical experience was a

  20. A simple intervention to improve patient safety, save time and improve staff experience in the AMU procedure room.

    Science.gov (United States)

    Misselbrook, Gary Peter; Kause, Juliane; Yeoh, Su-Ann

    2016-01-01

    Over the last decade, operating theatres and Intensive Care Units (ICUs) have established systematic methods for performing procedures on patients that have been shown to reduce complications and improve patient safety. Whilst the use of procedure rooms on Acute Medicine Units (AMUs) is highly recommended by patient safety groups and Royal College publications, they are not universally available or appropriately utilised. In this article we discuss a quality improvement project that was undertaken on an AMU at a large university teaching hospital in the United Kingdom, highlighting its successes and challenges.

  1. Validation of an LC-MS/MS method to measure tacrolimus in rat kidney and liver tissue and its application to human kidney biopsies.

    Science.gov (United States)

    Noll, Benjamin D; Coller, Janet K; Somogyi, Andrew A; Morris, Raymond G; Russ, Graeme R; Hesselink, Dennis A; Van Gelder, Teun; Sallustio, Benedetta C

    2013-10-01

    Tacrolimus (TAC) has a narrow therapeutic index and high interindividual and intraindividual pharmacokinetic variability, necessitating therapeutic drug monitoring to individualize dosage. Recent evidence suggests that intragraft TAC concentrations may better predict transplant outcomes. This study aimed to develop a method for the quantification of TAC in small biopsy-sized samples of rat kidney and liver tissue, which could be applied to clinical biopsy samples from kidney transplant recipients. Kidneys and livers were harvested from Mrp2-deficient TR- Wistar rats administered TAC (4 mg·kg·d for 14 days, n = 8) or vehicle (n = 10). Tissue samples (0.20-1.00 mg of dry weight) were solubilized enzymatically and underwent liquid-liquid extraction before analysis by liquid chromatography tandem mass spectrometry method. TAC-free tissue was used in the calibrator and quality control samples. Analyte detection was accomplished using positive electrospray ionization (TAC: m/z 821.5 → 768.6; internal standard ascomycin m/z 809.3 → 756.4). Calibration curves (0.04-2.6 μg/L) were linear (R > 0.99, n = 10), with interday and intraday calibrator coefficients of variation and bias <17% at the lower limit of quantification and <15% at all other concentrations (n = 6-10). Extraction efficiencies for TAC and ascomycin were approximately 70%, and matrix effects were minimal. Rat kidney TAC concentrations were higher (range 109-190 pg/mg tissue) than those in the liver (range 22-53 pg/mg of tissue), with median tissue/blood concentrations ratios of 72.0 and 17.6, respectively. In 2 transplant patients, kidney TAC concentrations ranged from 119 to 285 pg/mg of tissue and were approximately 20 times higher than whole blood trough TAC concentrations. The method displayed precision and accuracy suitable for application to TAC measurement in human kidney biopsy tissue.

  2. [The TPE nurse improving the patient's quality of life].

    Science.gov (United States)

    Mira, Thierry

    The impact of interventions by therapeutic education nurses on compliance and the quality of life of patients with chronic diseases has been proven. These different perspectives of caregivers and patients highlight the specific case of the treatment of HIV. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  3. Interventions for improving older patients' involvement in primary care episodes.

    NARCIS (Netherlands)

    Wetzels, R.V.; Harmsen, M.; Weel, C. van; Grol, R.P.T.M.; Wensing, M.J.P.

    2007-01-01

    BACKGROUND: There is a growing expectation among patients that they should be involved in the delivery of medical care. Accumulating evidence from empirical studies shows that patients of average age who are encouraged to participate more actively in treatment decisions have more favourable health

  4. Levetiracetam improves verbal memory in high-grade glioma patients

    NARCIS (Netherlands)

    de Groot, Marjolein; Douw, Linda; Sizoo, Eefje M; Bosma, Ingeborg; Froklage, Femke E; Heimans, Jan J; Postma, Tjeerd J; Klein, Martin; Reijneveld, Jaap C

    BACKGROUND: Treatment of high-grade glioma (HGG) patients with anti-epileptic drugs (AEDs) has met with various side effects, such as cognitive deterioration. The cognitive effects of both older and newer AEDs in HGG patients are largely unknown. The aim of this study was to determine the effect of

  5. Use of Care Paths to Improve Patient Management

    Science.gov (United States)

    Campbell, Suzann K.

    2013-01-01

    The purpose of this special issue of Physical & Occupational Therapy in Pediatrics is to present an evidence-based system to guide the physical therapy management of patients in the Neonatal Intensive Care Unit (NICU). Two systematic guides to patient management will be presented. The first is a care path intended primarily for use by physical…

  6. Improving Patient Satisfaction Through Computer-Based Questionnaires.

    Science.gov (United States)

    Smith, Matthew J; Reiter, Michael J; Crist, Brett D; Schultz, Loren G; Choma, Theodore J

    2016-01-01

    Patient-reported outcome measures are helping clinicians to use evidence-based medicine in decision making. The use of computer-based questionnaires to gather such data may offer advantages over traditional paper-based methods. These advantages include consistent presentation, prompts for missed questions, reliable scoring, and simple and accurate transfer of information into databases without manual data entry. The authors enrolled 308 patients over a 16-month period from 3 orthopedic clinics: spine, upper extremity, and trauma. Patients were randomized to complete either electronic or paper validated outcome forms during their first visit, and they completed the opposite modality at their second visit, which was approximately 7 weeks later. For patients with upper-extremity injuries, the Penn Shoulder Score (PSS) was used. For patients with lower-extremity injuries, the Foot Function Index (FFI) was used. For patients with lumbar spine symptoms, the Oswestry Disability Index (ODI) was used. All patients also were asked to complete the 36-Item Short Form Health Survey (SF-36) Health Status Survey, version 1. The authors assessed patient satisfaction with each survey modality and determined potential advantages and disadvantages for each. No statistically significant differences were found between the paper and electronic versions for patient-reported outcome data. However, patients strongly preferred the electronic surveys. Additionally, the paper forms had significantly more missed questions for the FFI (P<.0001), ODI (P<.0001), and PSS (P=.008), and patents were significantly less likely to complete these forms (P<.0001). Future research should focus on limiting the burden on responders, individualizing forms and questions as much as possible, and offering alternative environments for completion (home or mobile platforms). Copyright 2016, SLACK Incorporated.

  7. 3D printing of patient-specific anatomy: A tool to improve patient consent and enhance imaging interpretation by trainees.

    Science.gov (United States)

    Liew, Yaoren; Beveridge, Erin; Demetriades, Andreas K; Hughes, Mark A

    2015-01-01

    We report the use of three-dimensional or 3D printed, patient-specific anatomy as a tool to improve informed patient consent and patient understanding in a case of posterior lumbar fixation. Next, we discuss its utility as an educational tool to enhance imaging interpretation by neurosurgery trainees.

  8. Efficacy and safety of early tacrolimus conversion to sirolimus after kidney transplantation: Long-term results of a prospective randomized study

    Directory of Open Access Journals (Sweden)

    A E El-Agroudy

    2017-01-01

    Full Text Available We report a prospective, open-label, randomized study to evaluate the safety and efficacy of converting patients with a stable renal function from tacrolimus (Tac-based regimen to a sirolimus (SRL-based regimen after kidney transplantation. Fifty-eight low-risk renal allograft recipients who receiving Tac 6 months posttransplant, were randomly assigned to continue Tac (n = 29 or convert to SRL (n = 29. We evaluated the 3-year outcomes including patient and graft survival, graft function, and safety profile. Three-year patient and graft survival in SRL and Tac groups were 93.1% versus 100% (P = 0.32, and 89.7% versus 100% (P = 0.11, respectively. However, the SRL group had a significantly better renal function, from the 2nd year posttransplant until the last follow-up. Four (13.8% patients in the SRL group and 3 (10.3% in the Tac group (P = 0.5 developed biopsy-proven acute rejection. Mean urinary protein excretion increased significantly after SRL conversion. Diastolic blood pressure was significantly lower at the end of the study in patients who eliminated Tac (80.4 vs. 75.6 mmHg in Tac and SRL group, respectively (P = 0.03. Mean hemoglobin concentrations decreased after SRL conversion and remained significantly lower from 12 months to 36 months (P = 0.01. The mean serum cholesterol (540 ± 44 mg/dl and triglyceride (177 ± 27 mg/dl increased significantly in the SRL group, compared to Tac group (487 ± 62 mg/dl (P = 0.03 and (141 ± 26 mg/dl (P = 0.04. Our experience demonstrates that conversion to SRL from calcineurin inhibitors-based therapy may result in better renal function and blood pressure control in renal transplant recipients without an increased risk of acute rejection. However, these benefits have not resulted in a growing advantage in graft or patient survival.

  9. [Can the vascular specialist improve patient awareness about advanced directives?].

    Science.gov (United States)

    Sanson, H; Priollet, P

    2016-05-01

    In France, the Leonetti law, adopted on April 22, 2005, stipulates the regulations concerning advanced directives. This is a patient's right that is not well known and rarely applied. In 2015, a new law project was thus presented in which the French National Authority for Health recommended that doctors, including all specialists, bring up the subject, especially during consultation. To evaluate the vascular specialist's possibility to mention the topic of advanced directives during consultations. A single and non-interventional prospective study conducted with the help of patients who consulted a private practitioner vascular specialist: recurrent patients regularly consulting a private practitioner vascular specialist were included. First-time consultants, minors and patients to whom it was not adapted to speak about the subject were not included. Between July 27 and September 23, 2015, 159 consecutive patients were examined. Fifty-five first-time consultants and four patients for whom the interview was unsuitable were excluded. In all, 100 patients were questioned. None of them refused to talk about the subject. Women made up a majority of the population (63 %) with an average age of 67 years (23-97). The principal diagnostics were common to vascular medicine consultations: deep vein thrombosis (20 %), peripheral arterial disease (15 %), varicose veins (11 %), lymphedema (11 %) and leg ulcers (9 %). Thirteen percent of the people had a history of cancer. Half of the patients had had follow-ups for over 10 years. The average time devoted to discussing the topic was 12minutes (5-40). Only 22 % of the patients declared having been familiar with advance directives. Once informed however, 78 % chose to write up an adapted form: 36 % with the help of their doctor and 42 % with a doctor and a relative. Seventy-three percent of the consultants thought that talking about the advance directives would reinforce the confidence link between the doctor and the

  10. Improved nutritional status in elderly patients 6 months after stroke

    DEFF Research Database (Denmark)

    Brynningsen, Peter Krogh; Husted, Steen; Damsgaard, Else Marie Skjøde

    2007-01-01

    focused on the late rehabilitation phase after stroke in the patients own home, where the attention on nutrition may be reduced. AIMS: To determine the prevalence of malnutrition during 6 months of stroke rehabilitation, and to investigate the association between nutritional status, functional recovery......INTRODUCTION: Nutritional status among stroke patients has received limited attention despite the fact, that it may have an influence on clinical outcome. Previous studies have estimated that 15-20 % of patients suffer from malnutrition in the acute phase of stroke, but so far no studies have......, length of stay in hospital and infectious complications. SUBJECTS AND METHODS: 89 patients with ischemic stroke consecutively admitted to a geriatric stroke rehabilitation unit had their nutritional status evaluated in the hospital at 1 week and 5 weeks after stroke, and in their own home at 3 months...

  11. Visitation by physicians did not improve triage in trauma patients

    DEFF Research Database (Denmark)

    Holm Burén, Lars Andreas; Daugaard, Morten; Larsen, Jens Rolighed

    2013-01-01

    Introduction: A formalized trauma response team is designed to optimize the quality and progress of patient care for severely injured patients in order to reduce mortality and morbidity. The goal of this study was to determine over- and undertriage and to evaluate if a physicianmanned pre......-hospital response (MD-EMS) would reduce overtriage. Overtriage was defined as the process of overestimating the level of injury sustained by an individual. Material and methods: This was a retrospective study. All patients admitted with trauma team activation (TTA) (n = 1,468) during a four-year period (2007......-2011) were included. Undertriage was estimated by assessing the fraction of major trauma patients (New Injury Severity Score (NISS) > 15) admitted to Viborg Regional Hospital in the project period without TTA. RESULTS : For each year, overtriage was 88.3% (2007), 89.9% (2008), 92.8% (2009) and 88.2% (2010...

  12. Improved nutritional status in elderly patients 6 months after stroke

    DEFF Research Database (Denmark)

    Brynningsen, P K; Damsgaard, Else Marie; Husted, Steen

    2007-01-01

    INTRODUCTION: Nutritional status among stroke patients has received limited attention despite the fact, that it may have an influence on clinical outcome. Previous studies have estimated that 15-20 % of patients suffer from malnutrition in the acute phase of stroke, but so far no studies have...... focused on the late rehabilitation phase after stroke in the patients own home, where the attention on nutrition may be reduced. AIMS: To determine the prevalence of malnutrition during 6 months of stroke rehabilitation, and to investigate the association between nutritional status, functional recovery...... and 6 months. Nutritional status was evaluated by body weight, body mass index (BMI), mid upper arm circumference (MAC), triceps skinfold thickness (TSF) and serum concentrations of albumin and transferrin. Malnutrition was defined if the patients had 2 or more abnormal nutritional variables. RESULTS...

  13. Radium-223 Improves Survival in Patients with Advanced Prostate Cancer

    Science.gov (United States)

    ... This well-executed study shows a clear survival benefit in patients who had received the treatments that were available when the study was conducted, including standard chemotherapy,” said Bhupinder Mann, MBBS, of NCI’s Division of ...

  14. [Herpetic infection in patients with psoriasis: the improvement of therapy].

    Science.gov (United States)

    Shul'diakov, A A; Barkhatova, T S; Satarova, S A; Perminova, T A

    2012-01-01

    The aim of the study was to estimate the efficacy of liniment cycloferon included in combined therapy of herpetic infection in 30 patients with psoriasis divided into 2 groups. Combined treatment of patients with recurrent herpetic infection promoted elimination of general infection syndrome, shortened duration of eruption and local inflammation, accelerated epithelization of herpetic erosion, and decreased the frequency of relapses during the follow-up.

  15. Patient-Therapist Value Congruence and Ratings of Client Improvement

    Science.gov (United States)

    Martini, Janie L.

    1978-01-01

    It can be concluded from the results of the two studies described here that value similarity between client and therapist is related to therapists' ratings of client improvement. This phenomenon can be expected in therapies irrespective of theoretical orientation. (Author)

  16. Rib fractures in trauma patients: does operative fixation improve outcome?

    Science.gov (United States)

    Majak, Peter; Næss, Pål A

    2016-12-01

    Renewed interest in surgical fixation of rib fractures has emerged. However, conservative treatment is still preferred at most surgical departments. We wanted to evaluate whether operative treatment of rib fractures may benefit severely injured patients. Several studies report a reduction in mechanical ventilation time, ICU length of stay (LOS), hospital LOS, pneumonia, need for tracheostomy, pain and costs in operatively treated patients with multiple rib fractures compared with patients treated nonoperatively. Although patient selection and timing of the operation seem crucial for successful outcome, no consensus exists. Mortality reduction has only been shown in a few studies. Most studies are retrospective cohort and case-control studies. Only four randomized control trials exist. Conservative treatment, consisting of respiratory assistance and pain control, is still the treatment of choice in the vast majority of patients with multiple rib fractures. In selected patients, operative fixation of fractured ribs within 72 h postinjury may lead to better outcome. More randomized control trials are needed to further determine who benefits from surgical fixation of rib fractures.

  17. [New methods of patient selection for improved anticholinergic therapy].

    Science.gov (United States)

    Neuhaus, J; Schwalenberg, T; Schlichting, N; Schulze, M; Horn, L-C; Stolzenburg, J-U

    2007-09-01

    M3-specific inhibitors are currently preferred for anticholinergic therapy of OAB. However, not all of the patients profit from this regimen. This might reflect a heterogeneity of the patient group. The aim of this work is to define subgroups of patients with specific alterations of receptor expression and to profile the receptor expression individually. These receptor profiles might be used for the development of evidence-based "tailored" therapies. Detrusor probes from bladder carcinoma patients (BCa, n=9 F, n=7 male) and interstitial cystitis patients (IC, n=9 female) were examined using confocal immunofluorescence and PCR. M2, M3, P2X1-3, and H1-3 mRNAs were demonstrated in detrusor tissue. As revealed by immunofluorescence, the M2 receptor expression was significantly higher in female compared to male BCa tissues. In addition, the M2 receptor was further upregulated in IC vs BCa in female detrusor. IC patients showed specific alterations of their receptor profile. Individual receptor profiles might be used to optimize medicinal therapies.

  18. Rehabilitation of limb apraxia improves daily life activities in patients with stroke.

    Science.gov (United States)

    Smania, N; Aglioti, S M; Girardi, F; Tinazzi, M; Fiaschi, A; Cosentino, A; Corato, E

    2006-12-12

    We randomly assigned 33 patients with left hemisphere stroke, limb apraxia, and aphasia to an apraxia or a control (aphasia) treatment group. Before and after each treatment, patients underwent a comprehensive neuropsychological testing battery and a caregiver evaluation of patient's activities of daily life (ADL) independence. Apraxia severity was related with ADL independence. Control (aphasia) treatment improved patients' language and intelligence performance. Apraxia treatment specifically improved praxic function and ADL.

  19. The use of nationwide on-line prescription records improves the drug history in hospitalized patients

    DEFF Research Database (Denmark)

    Glintborg, Bente; Poulsen, Henrik E; Dalhoff, Kim P

    2008-01-01

    What is already known about this subject: Structured medication interviews improve the medication history upon hospitalization. Pharmacy records are valid lists of the prescribed medications available to individual patients. In Denmark, treating doctors now have access to their patients' pharmacy...... records through a real-time online electronic database What this study adds: Omission errors are frequent among hospitalized patients despite structured drug interviews and home visits. Pharmacy records may be used to minimize patients' recall bias and improve the medication lists....

  20. Editorial: Advances in healthcare provider and patient training to improve the quality and safety of patient care

    Directory of Open Access Journals (Sweden)

    Elizabeth M. Borycki

    2015-09-01

    Full Text Available This special issue of the Knowledge Management & E-Learning: An International Journal is dedicated to describing “Advances in Healthcare Provider and Patient Training to Improve the Quality and Safety of Patient Care.” Patient safety is an important and fundamental requirement of ensuring the quality of patient care. Training and education has been identified as a key to improving healthcare provider patient safety competencies especially when working with new technologies such as electronic health records and mobile health applications. Such technologies can be harnessed to improve patient safety; however, if not used properly they can negatively impact on patient safety. In this issue we focus on advances in training that can improve patient safety and the optimal use of new technologies in healthcare. For example, use of clinical simulations and online computer based training can be employed both to facilitate learning about new clinical discoveries as well as to integrate technology into day to day healthcare practices. In this issue we are publishing papers that describe advances in healthcare provider and patient training to improve patient safety as it relates to the use of educational technologies, health information technology and on-line health resources. In addition, in the special issue we describe new approaches to training and patient safety including, online communities, clinical simulations, on-the-job training, computer based training and health information systems that educate about and support safer patient care in real-time (i.e. when health professionals are providing care to patients. These educational and technological initiatives can be aimed at health professionals (i.e. students and those who are currently working in the field. The outcomes of this work are significant as they lead to safer care for patients and their family members. The issue has both theoretical and applied papers that describe advances in patient

  1. [Improvement of parodontitis therapy of patients with HIV-infection].

    Science.gov (United States)

    Soboleva, L A; Oseeva, A O; Shul'diakov, A A; Bulkina, N V

    2010-01-01

    For the purpose to determine the clinic-pathogenetic efficacy of cycloferon liniment in the combined therapy of periodontitis of patients with subclinical stage of HIV-infection medical examination and treatment of 40 patients was carried out. It was established that use of liniment cycloferon in the combined treatment of patients with subclinical stage of HIV-infection allowed to accelerate process of normalization of lipid peroxidation parameters and antioxidant potential of blood, to decrease infection load (herpes symplex virus I, Candida albicans, Staphylococcus aureus) in parodontal recess and evidence of local inflammation with reduction of activity of the tumours necrosis factor and interleukin 1beta, what provided acceleration of recuperation processes, lowering the frequency of parodontitis relapses.

  2. Synergistic effects of tacrolimus and azole antifungal compounds in fluconazole-susceptible and fluconazole-resistant Candida glabrata isolates

    Directory of Open Access Journals (Sweden)

    Laura Bedin Denardi

    2015-03-01

    Full Text Available In vitro interaction between tacrolimus (FK506 and four azoles (fluconazole, ketoconazole, itraconazole and voriconazole against thirty clinical isolates of both fluconazole susceptible and -resistant Candida glabrata were evaluated by the checkerboard microdilution method. Synergistic, indifferent or antagonism interactions were found for combinations of the antifungal agents and FK506. A larger synergistic effect was observed for the combinations of FK506 with itraconazole and voriconazole (43%, followed by that of the combination with ketoconazole (37%, against fluconazole-susceptible isolates. For fluconazole-resistant C. glabrata, a higher synergistic effect was obtained from FK506 combined with ketoconazole (77%, itraconazole (73%, voriconazole (63% and fluconazole (60%. The synergisms that we observed in vitro, notably against fluconazole-resistant C. glabrata isolates, are promising and warrant further analysis of their applications in experimental in vivo studies.

  3. The role of the psychiatrist in improving patient compliance.

    Science.gov (United States)

    Hotujac, Ljubomir

    2007-02-01

    Compliance, usually referring to how well the patient takes the medication as prescribed, is an important issue in clinical practice. However, many patients, especially those with a psychiatric illness, stop taking their medications despite physician advice to continue. This cessation can lead to a deterioration in the condition, a relapse, or a recurrence of the illness. In the literature, many different factors contributing to poor compliance have been described, but the doctor's role and responsibilities are hardly mentioned. These factors will be discussed here with special emphasis on what a doctor should do and what a doctor should avoid.

  4. HYPERTENSION IMPROVEMENT PROJECT (HIP): RANDOMIZED TRIAL OF QUALITY IMPROVEMENT FOR PHYSICIANS AND LIFESTYLE MODIFICATION FOR PATIENTS

    Science.gov (United States)

    Svetkey, Laura P.; Pollak, Kathryn I.; Yancy, William S.; Dolor, Rowena J.; Batch, Bryan C.; Samsa, Greg; Matchar, David B.; Lin, Pao-Hwa

    2009-01-01

    Despite widely publicized hypertension treatment guidelines for physicians and lifestyle recommendations for patients, blood pressure control rates remain low. In community-based primary care clinics, we performed a nested, 2×2 randomized, controlled trial of physician intervention vs. control and/or patient intervention vs. control. Physician Intervention included internet-based training, self-monitoring, and quarterly feedback reports. Patient Intervention included 20 weekly group sessions followed by 12 monthly phone counseling contacts, and focused on weight loss, DASH dietary pattern, exercise, and reduced sodium intake. The primary outcome was change in systolic blood pressure at 6 months. Eight primary care practices (32 physicians) were randomized to Physician Intervention or Control. Within those practices, 574 patients were randomized to Patient Intervention or Control. Patients’ mean age was 60 years, 61% female, 37% African American. BP data were available for 91% of patients at 6 months. The main effect of Physician Intervention on systolic blood pressure at 6 months, adjusted for baseline pressure, was 0.3 mmHg (95% CI −1.5 to 2.2; p = 0.72). The main effect of the Patient Intervention was −2.6 mmHg (95% CI −4.4, −0.7; p = 0.01). The interaction of the 2 interventions was significant (p = 0.03); the largest impact was observed with the combination of Physician and Patient Intervention (−9.7 ± 12.7 mmHg). Differences between treatment groups did not persist at 18 months. Combined physician and patient intervention lowers blood pressure; future research should focus on enhancing effectiveness and sustainability of these interventions. PMID:19920081

  5. The networked patient : Sharing data to improve health?

    NARCIS (Netherlands)

    Heerings, M.

    2014-01-01

    For diabetes type 1 the development towards stricter regulation of blood-glucose levels is associated with lower risk of long term complications (such as neuropathy, nephropathy, retinopathy, cardiovascular disease). A stricter regulation changes disease management practices of patients and health

  6. Improvement of herpetic stomatitis therapy in patients with chronic tonsillitis

    Directory of Open Access Journals (Sweden)

    Lepilin А.V.

    2011-12-01

    Full Text Available The research goal is to determine the clinical and pathogenetic efficacy of Cycloferon liniment in the combined therapy in patients with herpetic stomatitis accompanied by chronic tonsillitis. Materials and methods: Medical examination and treatment of 60 patients have been carried out. The marker of endogenous intoxication, infectious severity and immunity has been investigated. Results. It has been established that use of Cycloferon liniment in the combined therapy in patients with herpetic stomatitis accompanied by chronic tonsillitis has allowed to decrease infectious severity in par-odontal recess and evidence of local inflammation, to normalize immunity indices and reduce the level of endogenous intoxication that has been liable for acceleration of recuperation processes and lowering of frequency of stomatitis recurrences. Conclusion. The clinical efficacy of Cycloferon liniment in the therapy in patients with herpetic stomatitis accompanied by chronic tonsillitis conditioned by the decreasing of activity of local inflammatory process according to the reducing of level pro-inflammatory cytokines, infectious burden of the mouth cavity, endogenous intoxication

  7. Patient-focused quality improvement in primary health care ...

    African Journals Online (AJOL)

    Method: Secondary analyses of data obtained from a cross-sectional national representative exit survey of patients' experiences of PHC which was conducted with the PES. The PES QUALISTAT is an array of analytic procedures and approaches for presenting data on PHC performance. Colour coding of performance (red ...

  8. An App Supporting Psoriasis Patients Improves Adherence to Topical Treatment

    DEFF Research Database (Denmark)

    Svendsen, M T; Andersen, F; Pottegård, A

    2018-01-01

    Physician's Global Assessment (LS-PGA), and quality of life was measured by Dermatology Life Quality Index (DLQI) scales at all visits. RESULTS: Intention to treat analyses using regression was performed. PRIMARY OUTCOME: more patients in the intervention group were adherent to Cal/BD cutaneous foam...

  9. Epidermal hydration levels in rosacea patients improve after minocycline therapy.

    LENUS (Irish Health Repository)

    Ní Raghallaigh, S

    2013-12-06

    Patients with rosacea frequently report increased skin sensitivity, with features suggestive of an abnormal stratum corneum (SC) permeability barrier. Sebum, pH and hydration levels influence epidermal homeostasis. The correlation of the change in these parameters with clinically effective treatment has not been previously analysed.

  10. Role of clinical nurse leadership in improving patient care.

    Science.gov (United States)

    Murphy, Jill; Quillinan, Bernie; Carolan, Mary

    2009-12-01

    Leadership in nursing plays a crucial part in the provision of good patient care. However, the terms 'nursing leadership' and 'nursing management' are often confused. This article discusses the difficulties in defining 'clinical leadership', outlines its development in the Republic of Ireland, and identifies issues that must be addressed if clinical nurse leaders are to be effective.

  11. Improvement with Duloxetine in an Adult ADHD Patient

    Science.gov (United States)

    Tourjman, Smadar Valerie; Bilodeau, Mathieu

    2009-01-01

    Introduction: Attention-deficit/hyperactivity disorder (ADHD) is a common and disabling disorder among adults and is treated with stimulant and non stimulant medication. Objective: To report the case of a patient with ADHD showing good clinical response to duloxetine, a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). Case…

  12. Serving the Customer – Do Patient Feedback and Questionnaires Improve Quality?

    Science.gov (United States)

    Keshtgar, Asma; D’Cruz, Len

    2017-01-01

    This review article aims to analyse whether patient feedback and questionnaires improve quality of care. It is recognized that patients cannot assess the medical competence of the clinician, yet patient experience provides an insight into the process of care through the patients’ eyes. Patient experience measures are more reliable for use to assess quality than patient satisfaction surveys. It is inappropriate to use patient satisfaction surveys as a basis for remuneration of dentists within the NHS. Patient Reported Outcome Measures (PROMs) have been a successful measure of patient experience in medicine and their introduction to dentistry needs to be considered. Clinical relevance: This article will enable clinicians to understand the importance of patient experience measures as a more reliable way of improving the quality of clinical care than patient satisfaction surveys.

  13. Supervised exercise improves cutaneous reinnervation capacity in metabolic syndrome patients.

    Science.gov (United States)

    Singleton, J Robinson; Marcus, Robin L; Lessard, Margaret K; Jackson, Justin E; Smith, A Gordon

    2015-01-01

    Unmyelinated cutaneous axons are vulnerable to physical and metabolic injury, but also capable of rapid regeneration. This balance may help determine risk for peripheral neuropathy associated with diabetes or metabolic syndrome. Capsaicin application for 48 hours induces cutaneous fibers to die back into the dermis. Regrowth can be monitored by serial skin biopsies to determine intraepidermal nerve fiber density (IENFD). We used this capsaicin axotomy technique to examine the effects of exercise on cutaneous regenerative capacity in the setting of metabolic syndrome. Baseline ankle IENFD and 30-day cutaneous regeneration after thigh capsaicin axotomy were compared for participants with type 2 diabetes (n = 35) or metabolic syndrome (n = 32) without symptoms or examination evidence of neuropathy. Thirty-six participants (17 with metabolic syndrome) then joined twice weekly observed exercise and lifestyle counseling. Axotomy regeneration was repeated in month 4 during this intervention. Baseline distal leg IENFD was significantly reduced for both metabolic syndrome and diabetic groups. With exercise, participants significantly improved exercise capacity and lower extremity power. Following exercise, 30-day reinnervation rate improved (0.051 ± 0.027 fibers/mm/day before vs 0.072 ± 0.030 after exercise, p = 0.002). Those who achieved improvement in more metabolic syndrome features experienced a greater degree of 30-day reinnervation (p Metabolic syndrome was associated with reduced baseline IENFD and cutaneous regeneration capacity comparable to that seen in diabetes. Exercise-induced improvement in metabolic syndrome features increased cutaneous regenerative capacity. The results underscore the potential benefit to peripheral nerve function of a behavioral modification approach to metabolic improvement. © 2014 American Neurological Association.

  14. Orthognathic surgery improves quality of life and depression, but not anxiety, and patients with higher preoperative depression scores improve less.

    Science.gov (United States)

    Brunault, P; Battini, J; Potard, C; Jonas, C; Zagala-Bouquillon, B; Chabut, A; Mercier, J-M; Bedhet, N; Réveillère, C; Goga, D; Courtois, R

    2016-01-01

    This study assessed quality of life (QoL), depression, and anxiety before and after orthognathic surgery and identified risk factors for poorer postoperative outcome. This multicentre prospective study included 140 patients from five French medical centres. We assessed patients before surgery (T1), 3 months after surgery (T2), and 12 months after surgery (T3). We assessed the severity of the orofacial deformity, physical, psychological, social, and environmental QoL (WHOQOL-BREF), and depression and anxiety (GHQ-28). Risk factors for poorer outcome were identified using linear mixed models. Between baseline and 12 months, there was significant improvement in psychological and social QoL and in depression (although below the norms reported in the general population), but not in anxiety. Physical QoL was poorer in patients who were younger, who had a mild orofacial deformity, and who were depressed. Psychological QoL was poorer in younger patients and in depressed patients. Social QoL was poorer in patients who were single, who had a mild orofacial deformity, and who were depressed. Although orthognathic surgery provides a moderate improvement in psychological and social QoL, the systematic screening and treatment of depression could further improve QoL after surgery because it is a major predictor of poor QoL in this population. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  15. Are patient surveys valuable as a service-improvement tool in health services? An overview

    Directory of Open Access Journals (Sweden)

    Patwardhan A

    2012-05-01

    Full Text Available Anjali Patwardhan,1 Charles H Spencer21Nationwide Children’s Hospital Columbus, 2Ohio State University, Columbus, OH, USAAbstract: Improving the quality of care in international health services was made a high priority in 1977. The World Health Assembly passed a resolution to greatly improve “Health for all” by the year 2000. Since 1977, the use of patient surveys for quality improvement has become a common practice in the health-care industry. The use of surveys reflects the concept that patient satisfaction is closely linked with that of organizational performance, which is in turn closely linked with organizational culture. This article is a review of the role of patient surveys as a quality-improvement tool in health care. The article explores the characteristics, types, merits, and pitfalls of various patient surveys, as well as the impact of their wide-ranging application in dissimilar scenarios to identify gaps in service provision. It is demonstrated that the conducting of patient surveys and using the results to improve the quality of care are two different processes. The value of patient surveys depends on the interplay between these two processes and several other factors that can influence the final outcome. The article also discusses the business aspect of the patient surveys in detail. Finally, the authors make future recommendations on how the patient survey tool can be best used to improve the quality of care in the health-care sector.Keywords: patient surveys, quality improvement, service gaps 

  16. Radiation exposure in gastroenterology: improving patient and staff protection.

    LENUS (Irish Health Repository)

    Ho, Immanuel K H

    2014-08-01

    Medical imaging involving the use of ionizing radiation has brought enormous benefits to society and patients. In the past several decades, exposure to medical radiation has increased markedly, driven primarily by the use of computed tomography. Ionizing radiation has been linked to carcinogenesis. Whether low-dose medical radiation exposure will result in the development of malignancy is uncertain. This paper reviews the current evidence for such risk, and aims to inform the gastroenterologist of dosages of radiation associated with commonly ordered procedures and diagnostic tests in clinical practice. The use of medical radiation must always be justified and must enable patients to be exposed at the lowest reasonable dose. Recommendations provided herein for minimizing radiation exposure are based on currently available evidence and Working Party expert consensus.

  17. Improving Decision Making for Advanced Heart Failure Patients and Caregivers.

    Science.gov (United States)

    McIlvennan, Colleen K

    2017-04-01

    In this month's Magnet® Perspectives column, Colleen K. McIlvennan, DNP, ANP, lead nurse practitioner, Advanced Heart Failure and Transplantation at the University of Colorado, discusses her groundbreaking research encompassing patients' and caregivers' emotional, rational, and fundamental beliefs when considering a left ventricular assist device (LVAD). Results have led to the development of 2 innovative decision aids that are currently in use by LVAD programs across the United States and Canada. Dr McIlvennan's efforts led to a $2 million grant from the Patient-Centered Outcomes Research Institute, as well as national recognition from the American Heart Association and the Heart Failure Society of America. Last year, she received the 2016 National Magnet Nurse of the Year® Award in the Empirical Outcomes category. In addition to sharing her findings, Dr McIlvennan examines the value of performing research in a Magnet-recognized organization.

  18. An Integrated Care Initiative to Improve Patient Outcome in Schizophrenia

    OpenAIRE

    Mayer-Amberg, Norbert; Woltmann, Rainer; Walther, Stefanie

    2016-01-01

    The optimal treatment of schizophrenia patients requires integration of medical and psychosocial inputs. In Germany, various healthcare service providers and institutions are involved in the treatment process. Early and continuous treatment is important but often not possible because of the fragmented medical care system in Germany. The current work is a quality monitoring report of a novel care setting, called Integrated Care Initiative Schizophrenia. It has implemented a networked care con...

  19. Improving Patient Safety With the Military Electronic Health Record

    Science.gov (United States)

    2005-01-01

    Consolidated Health Informatics (CHI) project, one of the 24 electronic government ( eGov ) Internet- based technology initiatives supporting the president’s...United States Department of Defense (DoD) has transformed health care delivery in its use of information technology to automate patient data...use throughout the Federal Government . The importance of standards in EHR systems was further recognized in an IOM report, which stated, “Electronic

  20. Towards Automatic Improvement of Patient Queries in Health Retrieval Systems

    Directory of Open Access Journals (Sweden)

    Nesrine KSENTINI

    2016-07-01

    Full Text Available With the adoption of health information technology for clinical health, e-health is becoming usual practice today. Users of this technology find it difficult to seek information relevant to their needs due to the increasing amount of the clinical and medical data on the web, and the lack of knowledge of medical jargon. In this regards, a method is described to improve user's needs by automatically adding new related terms to their queries which appear in the same context of the original query in order to improve final search results. This method is based on the assessment of semantic relationships defined by a proposed statistical method between a set of terms or keywords. Experiments were performed on CLEF-eHealth-2015 database and the obtained results show the effectiveness of our proposed method.

  1. Improving patient safety in radiology: a work in progress

    International Nuclear Information System (INIS)

    Sze, Raymond W.

    2008-01-01

    The purpose of this paper is to share the experiences, including successes and failures, as well as the ongoing process of developing and implementing a safety program in a large pediatric radiology department. Building a multidisciplinary pediatric radiology safety team requires successful recruitment of team members, selection of a team leader, and proper and ongoing training and tools, and protected time. Challenges, including thorough examples, are presented on improving pediatric radiology safety intradepartmentally, interdepartmentally, and institutionally. Finally, some major challenges to improving safety in pediatric radiology, and healthcare in general, are presented along with strategies to overcome these challenges. Our safety program is a work in progress; this article is a personal account and the reader is asked for tolerance of its occasional subjective tone and contents. (orig.)

  2. Partnering with diabetes educators to improve patient outcomes

    OpenAIRE

    Burke SD; Sherr D; Lipman RD

    2014-01-01

    Sandra D Burke,1,2 Dawn Sherr,3 Ruth D Lipman3 1American Association of Diabetes Educators, Chicago, IL, USA; 2University of Illinois at Chicago College of Nursing, Urbana, IL, USA; 3Science and Practice, American Association of Diabetes Educators, Chicago, IL, USA Abstract: Diabetes is a chronic, progressive disease that affects millions worldwide. The paradigm of diabetes management has shifted to focus on empowering the person with diabetes to manage the disease successfully and to improv...

  3. A Checklist to Improve Patient Safety in Interventional Radiology

    International Nuclear Information System (INIS)

    Koetser, Inge C. J.; Vries, Eefje N. de; Delden, Otto M. van; Smorenburg, Susanne M.; Boermeester, Marja A.; Lienden, Krijn P. van

    2013-01-01

    To develop a specific RADiological Patient Safety System (RADPASS) checklist for interventional radiology and to assess the effect of this checklist on health care processes of radiological interventions. On the basis of available literature and expert opinion, a prototype checklist was developed. The checklist was adapted on the basis of observation of daily practice in a tertiary referral centre and evaluation by users. To assess the effect of RADPASS, in a series of radiological interventions, all deviations from optimal care were registered before and after implementation of the checklist. In addition, the checklist and its use were evaluated by interviewing all users. The RADPASS checklist has two parts: A (Planning and Preparation) and B (Procedure). The latter part comprises checks just before starting a procedure (B1) and checks concerning the postprocedural care immediately after completion of the procedure (B2). Two cohorts of, respectively, 94 and 101 radiological interventions were observed; the mean percentage of deviations of the optimal process per intervention decreased from 24 % before implementation to 5 % after implementation (p < 0.001). Postponements and cancellations of interventions decreased from 10 % before implementation to 0 % after implementation. Most users agreed that the checklist was user-friendly and increased patient safety awareness and efficiency. The first validated patient safety checklist for interventional radiology was developed. The use of the RADPASS checklist reduced deviations from the optimal process by three quarters and was associated with less procedure postponements.

  4. Sugammadex Improves Neuromuscular Function in Patients Receiving Perioperative Steroids.

    Science.gov (United States)

    Ozer, A B; Bolat, E; Erhan, O L; Kilinc, M; Demirel, I; Toprak, G Caglar

    2018-02-01

    Sugammadex has steroid-encapsulating effect. This study was undertaken to assess whether the clinical efficacy of sugammadex was altered by the administration of steroids. Sixty patients between 18 and 60 years of age with the American Society of Anesthesiologists I-IV and undergoing elective direct laryngoscopy/biopsy were included in this study. Patients were assigned to two groups based on the intraoperative steroid use: those who received steroid (Group S) and who did not (Group C). After standard general anesthesia, patients were monitored with the train of four (TOF) monitoring. The preferred steroid and its dose, timing of steroid administration, and TOF value before and after sugammadex as well as the time to recovery (TOF of 0.9) were recorded. SPSS software version 17.0 was used for statistical analysis. There is no statistically significant difference between groups in terms of age, gender, preoperative medication use, and TOF ratio just before administering sugammadex. The reached time to TOF 0.9 after sugammadex administration was significantly shorter in Group S than Group C (P sugammadex as well as the dose of sugammadex in those who received prednisolone; time to TOF 0.9 was higher in prednisolone receivers as compared to dexamethasone receivers (P sugammadex was found, in contrast with what one expect. Further studies are required to determine the cause of this effect which is probably due to a potential interaction between sugammadex and steroids.

  5. In Connecticut: improving patient medication management in primary care.

    Science.gov (United States)

    Smith, Marie; Giuliano, Margherita R; Starkowski, Michael P

    2011-04-01

    Medications are a cornerstone of the management of most chronic conditions. However, medication discrepancies and medication-related problems-some of which can cause serious harm-are common. Pharmacists have the expertise to identify, resolve, monitor, and prevent these problems. We present findings from a Centers for Medicare and Medicaid Services demonstration project in Connecticut, in which nine pharmacists worked closely with eighty-eight Medicaid patients from July 2009 through May 2010. The pharmacists identified 917 drug therapy problems and resolved nearly 80 [corrected] percent of them after four encounters. The result was an estimated annual saving of $1,123 per patient on medication claims and $472 per patient on medical, hospital, and emergency department expenses-more than enough to pay for the contracted pharmacist services. We recommend that the Center for Medicare and Medicaid Innovation support the evaluation of pharmacist-provided medication management services in primary care medical homes, accountable care organizations, and community health and care transition teams, as well as research to explore how to enhance team-based care.

  6. Using financial incentives to improve the care of tuberculosis patients.

    Science.gov (United States)

    Lee, Cheng-Yi; Chi, Mei-Ju; Yang, Shiang-Lin; Lo, Hsiu-Yun; Cheng, Shou-Hsia

    2015-01-01

    Tuberculosis (TB) is a serious public health concern, and Taiwan has implemented a pay-for-performance (P4P) program to incentivize healthcare professionals to provide comprehensive care to TB patients. This study aims to examine the effects of the TB P4P program on treatment outcomes and related expenses. A population-based natural experimental design with intervention and comparison groups. Propensity score matching was conducted to increase the comparability between the P4P and non-P4P group. A total of 12,018 subjects were included in the analysis, with 6009 cases in each group. Generalized linear models and multinomial logistic regression were employed to examine the effects of the P4P program. The regression models indicated that patients enrolled in the P4P program had 14% more ambulatory visits than non-P4P patients (P ratio, 1.56; P financial incentives to healthcare institutions could be a feasible model for better TB control.

  7. Budget Impact of a Comprehensive Nutrition-Focused Quality Improvement Program for Malnourished Hospitalized Patients.

    Science.gov (United States)

    Sulo, Suela; Feldstein, Josh; Partridge, Jamie; Schwander, Bjoern; Sriram, Krishnan; Summerfelt, Wm Thomas

    2017-07-01

    Nutrition interventions can alleviate the burden of malnutrition by improving patient outcomes; however, evidence on the economic impact of medical nutrition intervention remains limited. A previously published nutrition-focused quality improvement program targeting malnourished hospitalized patients showed that screening patients with a validated screening tool at admission, rapidly administering oral nutritional supplements, and educating patients on supplement adherence result in significant reductions in 30-day unplanned readmissions and hospital length of stay. To assess the potential cost-savings associated with decreased 30-day readmissions and hospital length of stay in malnourished inpatients through a nutrition-focused quality improvement program using a web-based budget impact model, and to demonstrate the clinical and fiscal value of the intervention. The reduction in readmission rate and length of stay for 1269 patients enrolled in the quality improvement program (between October 13, 2014, and April 2, 2015) were compared with the pre-quality improvement program baseline and validation cohorts (4611 patients vs 1319 patients, respectively) to calculate potential cost-savings as well as to inform the design of the budget impact model. Readmission rate and length-of-stay reductions were calculated by determining the change from baseline to post-quality improvement program as well as the difference between the validation cohort and the post-quality improvement program, respectively. As a result of improved health outcomes for the treated patients, the nutrition-focused quality improvement program led to a reduction in 30-day hospital readmissions and length of stay. The avoided hospital readmissions and reduced number of days in the hospital for the patients in the quality improvement program resulted in cost-savings of $1,902,933 versus the pre-quality improvement program baseline cohort, and $4,896,758 versus the pre-quality improvement program in the

  8. Innovative perioperative role improves patient and organisational outcomes in minimal invasive surgery.

    Science.gov (United States)

    Abraham, Jenny

    2011-05-01

    The drive to improve clinical care and productivity in the NHS has required an innovative approach in the use of the resources and skills of the workforce. With rapidly evolving technology, surgical and anaesthetic techniques, concentration is increasingly being placed on improving patient focused pathways, aiming to return patients back to normal activities as soon as possible. The article highlights the exciting new perioperative role developed at University Hospitals Coventry and Warwickshire (UHCW) NHS Trust in the care of patients undergoing laparoscopic cholecystectomy. It includes the history and development of the post and its current impact in improving the care of patients.

  9. Digital mobile technology facilitates HIPAA-sensitive perioperative messaging, improves physician-patient communication, and streamlines patient care.

    Science.gov (United States)

    Gordon, Chad R; Rezzadeh, Kameron S; Li, Andrew; Vardanian, Andrew; Zelken, Jonathan; Shores, Jamie T; Sacks, Justin M; Segovia, Andres L; Jarrahy, Reza

    2015-01-01

    Mobile device technology has revolutionized interpersonal communication, but the application of this technology to the physician-patient relationship remains limited due to concerns over patient confidentiality and the security of digital information. Nevertheless, there is a continued focus on improving communication between doctors and patients in all fields of medicine as a means of improving patient care. In this study, we implement a novel communications platform to demonstrate that instantaneously sharing perioperative information with surgical patients and members of their support networks can improve