Complaints from emergency department patients largely result from treatment and communication problems.

PubMed

Taylor, David McD; Wolfe, Rory; Cameron, Peter A

2002-03-01

Emergency department patient complaints are often justified and may lead to apology, remedial action or compensation. The aim of the present study was to analyse emergency department patient complaints in order to identify procedures or practices that require change and to make recommendations for intervention strategies aimed at decreasing complaint rates. We undertook a retrospective analysis of patient complaints from 36 Victorian emergency departments during a 61 month period. Data were obtained from the Health Complaint Information Program (Health Services Commissioner). In all, 2,419 emergency department patients complained about a total of 3,418 separate issues (15.4% of all issues from all hospital departments). Of these, 1,157 complaints (47.80%) were received by telephone and 829 (34.3%) were received by letter; 1,526 (63.1 %) complaints were made by a person other than the patient. Highest complaint rates were received from patients who were female, born in non-English-speaking countries and very young or very old. One thousand one hundred and forty-one issues (33.4%) related to patient treatment, including inadequate treatment (329 issues) and inadequate diagnosis (249 issues); 1079 (31.6%) issues related to communication, including poor staff attitude, discourtesy and rudeness (444 issues); 407 (11.9%) issues related to delay in treatment. Overall, 2516 issues (73.6%) were resolved satisfactorily, usually by explanation or apology. Only 59 issues (1.7%) resulted in a procedure or policy change. Remedial action was taken in 109 issues (3.2%) and compensation was paid to eight patients. Communication remains a significant factor in emergency department patient dissatisfaction. While patient complaints have resulted in major changes to policy and procedure, research and intervention strategies into communication problems are indicated. In the short term, focused staff training is recommended.

Estimated medical expenditure and risk of job loss among rheumatoid arthritis patients undergoing tofacitinib treatment: post hoc analyses of two randomized clinical trials.

PubMed

Rendas-Baum, Regina; Kosinski, Mark; Singh, Amitabh; Mebus, Charles A; Wilkinson, Bethany E; Wallenstein, Gene V

2017-08-01

RA causes high disability levels and reduces health-related quality of life, triggering increased costs and risk of unemployment. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. These post hoc analyses of phase 3 data aimed to assess monthly medical expenditure (MME) and risk of job loss for tofacitinib treatment vs placebo. Data analysed were from two randomized phase 3 studies of RA patients (n = 1115) with inadequate response to MTX or TNF inhibitors (TNFi) receiving tofacitinib 5 or 10 mg twice daily, adalimumab (one study only) or placebo, in combination with MTX. Short Form 36 version 2 Health Survey physical and mental component summary scores were translated into predicted MME via an algorithm and concurrent inability to work and job loss risks at 6, 12 and 24 months, using Medical Outcomes Study data. MME reduction by month 3 was $100 greater for tofacitinib- than placebo-treated TNFi inadequate responders (P < 0.001); >20 and 6% reductions from baseline, respectively. By month 3 of tofacitinib treatment, the odds of inability to work decreased ⩾16%, and risk of future job loss decreased ∼20% (P < 0.001 vs placebo). MME reduction by month 3 was $70 greater for tofacitinib- than placebo-treated MTX inadequate responders (P < 0.001); ⩾23 and 13% reductions from baseline, respectively. By month 3 of tofacitinib treatment, the odds of inability to work decreased ⩾31% and risk of future job loss decreased ⩾25% (P < 0.001 vs placebo). Tofacitinib treatment had a positive impact on estimated medical expenditure and risk of job loss for RA patients with inadequate response to MTX or TNFi. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Inadequate treatment practices for pain relief and adverse event management in cancer patients across 10 countries/regions in Asia: a call for greater efforts to improve standards for patient care.

PubMed

Ho, Kok Yuen; Ahn, Jin Seok; Calimag, Maria Minerva; Chao, Ta-Chung; Kim, Yong-Chul; Moon, Hanlim; Tho, Lye Mun; Xia, Zhong-Jun; You, Dora

2018-06-01

To examine the treatment practices for cancer pain relief and adverse event management, and the factors related to patient outcomes in the participating countries/regions. The study was a cross-sectional survey conducted between September and December 2013 in 10 countries/regions across Asia. Adult patients with a history of cancer pain at least 1 month before study entry completed the survey questionnaire. A total of 1190 patients were included. The mean Box Scale-11 (BS-11) pain score was 6.0 (SD 2.1), with 86.2% experiencing moderate-to-severe pain and 53.2% receiving opioids at time of the survey. The mean BS-11 scores were 5.3 (SD 2.1) in the "others" (single non-opioid medication or untreated) group, 6.3 (SD 2.0) in the ≥2 non-opioids group and 6.7 (SD 1.9) in the opioid group. The proportions of patients experiencing moderate-to-severe pain were 79.1%, 87.3% and 93.7%, respectively. About 70% of patients reported adverse events due to their pain medications, about half had received medications to manage these symptoms. Adverse events were negatively associated with activities of daily living (P < 0.0001). Pain and hindrance to activities of daily living were negatively associated with employment status (P = 0.003 and 0.021). Unemployment was significantly associated with poorer quality of life (P < 0.0001). This analysis demonstrates inadequate management of cancer pain and treatment-related adverse events in the participating cohort. Pain and inadequate management of adverse events were negatively associated with patients' overall well-being. More collaborative efforts should be taken to optimize pain treatment and increase awareness of adverse event management in physicians. © 2017 John Wiley & Sons Australia, Ltd.

Cardiovascular risk management in rheumatoid arthritis patients still suboptimal: the Implementation of Cardiovascular Risk Management in Rheumatoid Arthritis project.

PubMed

van den Oever, Inge A M; Heslinga, Maaike; Griep, Ed N; Griep-Wentink, Hanneke R M; Schotsman, Rob; Cambach, Walter; Dijkmans, Ben A C; Smulders, Yvo M; Lems, Willem F; Boers, Maarten; Voskuyl, Alexandre E; Peters, Mike J L; van Schaardenburg, Dirkjan; Nurmohamed, Micheal T

2017-09-01

To assess the 10-year cardiovascular (CV) risk score and to identify treatment and undertreatment of CV risk factors in patients with established RA. Demographics, CV risk factors and prevalence of cardiovascular disease (CVD) were assessed by questionnaire. To calculate the 10-year CV risk score according to the Dutch CV risk management guideline, systolic blood pressure was measured and cholesterol levels were determined from fasting blood samples. Patients were categorized into four groups: indication for treatment but not treated; inadequately treated, so not meeting goals (systolic blood pressure ⩽140 mmHg and/or low-density lipoprotein ⩽2.5 mmol/l); adequately treated; or no treatment necessary. A total of 720 consecutive RA patients were included, 375 from Reade and 345 from the Antonius Hospital. The mean age of patients was 59 years (s.d. 12) and 73% were female. Seventeen per cent of the patients had a low 10-year CV risk (<10%), 21% had an intermediate risk (10-19%), 53% a high risk (⩾20%) and 9% had CVD. In total, 69% had an indication for preventive treatment (cholesterol-lowering or antihypertensive drugs). Of those, 42% received inadequate treatment and 40% received no treatment at all. Optimal CV risk management remains a major challenge and better awareness and management are urgently needed to reduce the high risk of CVD in the RA population. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Patient education: a tool in the outpatient management of deep vein thrombosis.

PubMed

Haines, S T

1998-01-01

A key to effective outpatient management of thromboembolic disease is patient education. Although highly effective for the treatment of deep vein thrombosis (DVT), antithrombotic treatment may fail as a result of inadequate patient education. The risk of hemorrhage from antithrombotic drugs is related to a number of factors including intensity of anticoagulation achieved, comorbid illness, concurrent drug therapy, and lifestyle. When patients receive inadequate antithrombotic treatment, the risk of recurrent thromboembolic events and long-term complications are substantially increased. A well-organized, structured education program enables patients to learn the necessary skills that permit complex and valuable therapies to be managed on an outpatient basis. Health care professionals who are part of an outpatient DVT treatment program should possess working knowledge of adult learning theory and instructional design. To be effective, education programs should be systematically planned, have an educationally sound structure, and attempt to meet specific objectives. In addition, they should build on patients' existing knowledge, skills, and attitudes. Periodic evaluation of the education program is important to ensure that overall goals are being adequately met and to identify areas of weakness.

Efficacy and Safety of Vildagliptin as an Add-On Therapy in Inadequately Controlled Type 2 Diabetes Patients Treated With Basal Insulin.

PubMed

Saito, Daisuke; Kanazawa, Akio; Shigihara, Nayumi; Sato, Fumihiko; Uchida, Toyoyoshi; Sato, Junko; Goto, Hiromasa; Miyatsuka, Takeshi; Ikeda, Fuki; Ogihara, Takeshi; Ohmura, Chie; Watada, Hirotaka

2017-03-01

The aim of this study was to investigate the efficacy and safety of vildagliptin as an add-on therapy for patients with type 2 diabetes mellitus inadequately controlled with basal insulin. Twenty-four patients treated with basal insulin and oral anti-diabetes drugs were randomly allocated into two groups: the control group (did not receive any add-on drugs) and vildagliptin group (received vildagliptin 100 mg/day for 6 months). The primary outcome was changes in hemoglobin A1c (HbA1c) from baseline to end of study. Treatment with vildagliptin significantly reduced HbA1c from 8.1±0.7% at baseline to 7.1±0.7% (P < 0.01), while there was no significant change of HbA1c in the control group. Vildagliptin group showed significant reduction of HbA1c compared with control group (-1.0±0.3% vs. 0.2±0.8%, P < 0.01). In addition, vildagliptin group showed a significant increase in 1,5-anhydroglucitol compared with the control group (4.5 ± 3.4 vs. 0.5 ± 4.1 μg/mL, P < 0.05). Mild hypoglycemia was reported in one patient of the vildagliptin group and two patients of the control group. Vildagliptin improved glycemic control without increasing hypoglycemia in Japanese type 2 diabetes inadequately controlled with basal insulin treatment and other oral anti-diabetes drugs. This study was registered with UMIN (University Hospital Medical Information Network ID#000010849).

Specific antibody deficiency in children with recurrent respiratory infections: a controlled study with follow-up

PubMed Central

Ruuskanen, O; Nurkka, A; Helminen, M; Viljanen, M K; Käyhty, H; Kainulainen, L

2013-01-01

Specific antibody deficiency (SAD) to unconjugated pneumococcal vaccine (PPV) is an established primary B cell immunodeficiency. The occurrence and natural history of SAD in children is unclear. We conducted an observational study to identify SAD in children with recurrent respiratory infections. Ninety-nine children, mean age 5·9 (range 2–16) years, with recurrent or severe infections were vaccinated with PPV; serum antibody concentrations for serotypes 4, 6B, 9V, 14, 18C, 19F and 23F were measured before and 2 weeks after vaccination with enzyme immunoassay. The retrospective control group consisted of 89 healthy children matched for age and gender. No children had received previous conjugated pneumococcal vaccine (PCV) or PPV. The structured history of infectious diseases of all participants was collected. Ten of 91 (11%) children (eight excluded due to immunoglobulin G subclass deficiency) with recurrent respiratory infections had SAD. In the control group, three children (3%) responded inadequately to PPV (P = 0·05). Most children with SAD also had many other minor immune defects. After 0·5–5 years (medium 3·8), eight children with SAD were revaccinated with PPV; five responded adequately and three inadequately. Two SAD children were revaccinated with PCV, one developed an adequate and one an inadequate response. Two children with SAD received treatment with intravenous immunoglobulin; the remaining eight children recovered without replacement therapy during the follow-up. SAD is common in young children with recurrent respiratory infections, but it is often transient and resolves itself within a few years without specific treatment. PMID:23574320

Empirical use of antibiotics and adjustment of empirical antibiotic therapies in a university hospital: a prospective observational study

PubMed Central

Mettler, Julian; Simcock, Mathew; Sendi, Pedram; Widmer, Andreas F; Bingisser, Roland; Battegay, Manuel; Fluckiger, Ursula; Bassetti, Stefano

2007-01-01

Background Several strategies to optimise the use of antibiotics have been developed. Most of these interventions can be classified as educational or restrictive. Restrictive measures are considered to be more effective, but the enforcement of these measures may be difficult and lead to conflicts with prescribers. Any intervention should be aimed at targets with the highest impact on antibiotic prescribing. The aim of the present study was to assess the adequacy of empirical and adjusted antibiotic therapies in a Swiss university hospital where no antibiotic use restrictions are enforced, and to identify risk factors for inadequate treatment and targets for intervention. Methods A prospective observational study was performed during 9 months. All patients admitted through the emergency department who received an antibiotic therapy within 24 hours of admission were included. Data on demographic characteristics, diagnoses, comorbidities, systemic inflammatory response syndrome (SIRS) parameters, microbiological tests, and administered antibiotics were collected prospectively. Antibiotic therapy was considered adequate if spectrum, dose, application modus, and duration of therapy were appropriate according to local recommendations or published guidelines. Results 2943 admitted patients were evaluated. Of these, 572 (19.4%) received antibiotics within 24 hours and 539 (94%) were analysed in detail. Empirical antibiotic therapy was inadequate in 121 patients (22%). Initial therapy was adjusted in 168 patients (31%). This adjusted antibiotic therapy was inadequate in 46 patients (27%). The main reason for inadequacy was the use of antibiotics with unnecessarily broad spectrum (24% of inadequate empirical, and 52% of inadequate adjusted therapies). In 26% of patients with inadequate adjusted therapy, antibiotics used were either ineffective against isolated pathogenic bacteria or antibiotic therapy was continued despite negative results of microbiological investigations. Conclusion The rate of inadequate antibiotic therapies was similar to the rates reported from other institutions despite the absence of a restrictive antibiotic policy. Surprisingly, adjusted antibiotic therapies were more frequently inappropriate than empirical therapies. Interventions aiming at improving antibiotic prescribing should focus on both initial empirical therapy and streamlining and adjustment of therapy once microbiological results become available. PMID:17386104

Consequences of misdiagnosis: inaccurate treatment and poor patient outcomes in bipolar disorder.

PubMed

Nasrallah, Henry A

2015-10-01

Bipolar depression is difficult to diagnose and is often mistaken for unipolar depression. Unfortunately, this misdiagnosis creates a cascade of negative outcomes. Patients will probably receive inadequate or inappropriate treatment that will not alleviate the symptoms or impairment of the disorder and may even further destabilize their mood. These individuals are then at risk for experiencing numerous social and occupational impairments, alcohol or substance abuse, and suicidal behavior. An accurate diagnosis and appropriate treatment of bipolar disorder are necessary to prevent this chain of potentially disastrous events. © Copyright 2015 Physicians Postgraduate Press, Inc.

Cost-utility evaluation of vortioxetine in patients with Major Depressive Disorder experiencing inadequate response to alternative antidepressants in the United Kingdom.

PubMed

Young, A H; Evitt, L; Brignone, M; Diamand, F; Atsou, K; Campbell, R; Cure, S; Danchenko, N

2017-08-15

Patients frequently require several lines of therapy for treatment of major depressive episodes. This economic analysis details the management of patients who responded inadequately due to lack of efficacy or intolerability to two previous antidepressants in the UK. The model included a decision tree and a Markov component. Health states considered in the decision tree were remission, response, no response, withdrawal due to adverse events, relapse, recovery, and recurrence. The time horizon was 24 months. Patients were on third-line treatment for up to a 3-month acute phase and a 6-month maintenance phase. As third-line efficacy data were not available, inputs were calculated by adjusting original second-line data to third-line based on proportionate reductions observed in STAR*D. Equivalent efficacy was assumed for all comparators. Healthcare resource use and utilities were based on UK estimates. Vortioxetine was a cost-effective treatment option at a threshold of £20,000/QALY vs. escitalopram, citalopram, sertraline, and was associated with more health benefits, less costs (was dominant) versus relevant third-line comparators venlafaxine and duloxetine. Agomelatine was found not to be a cost-effective option. The 22-month maintenance phase treatment scenario results were similar to the 6-month base case. Third-line efficacy data were not available. This highlights the need for studies in patients receiving third-line treatment. This model provides an overview for the management of patients receiving third-line treatment where limited evidence currently exists. Vortioxetine, with its novel mechanism of action, is expected to be a dominant treatment option versus relevant comparators in the UK. Copyright © 2017. Published by Elsevier B.V.

[Candidemias: multicentre analysis in 16 hospitals in Andalusia (Spain)].

PubMed

Rodríguez-Hernández, M Jesús; Ruiz-Pérez de Pipaon, Maite; Márquez-Solero, Manuel; Martín-Rico, Patricia; Castón-Osorio, Juan José; Guerrero-Sánchez, Francisca M; Vidal-Verdú, Elisa; García-Figueras, Carolina; Del Arco-Jiménez, Alfonso; Rodríguez-Baño, Jesús; Martín-Mazuelos, Estrella; Cisneros-Herreros, José Miguel

2011-05-01

Candidemia is a nosocomial infection with high associated mortality. There have been changes in microbiology, epidemiology and treatment over the last few years, which has led us to analyse our own situation. Prospective, multicentre and observational study. All episodes of candidemia in adult patients seen in 17 Andalusian hospitals from 1 October 2005 to 30 September 2006 were included. Were detected 220 cases, the incidence was 0.58 cases/1,000 hospital discharges. Candida albicans was the most frecuent species (53% of cases). The majority of isolates (89%) was susceptibility to fluconazole. Sepsis was the most frequent clinical manifestation (65.7%). The treatment was inadequate in 38.7% of cases. Overall mortality was 40%. On univarite analysis death was found to be significantly associated with: aged > 60 years, unknown candidemia focus, Pitt score ≥ 2, APACHE II, shock at onset, persistents positive second blood cultures, non-removal of the central venous catheter and Candida species different of C. parasilopsis, among others. In the multivariate analysis death was found to be significantly associated with: aged > 60 years, Pitt score ≥ 2, Candida species different of C.parasilopsis and inadequate treatment. The candidemia clinical epidemiology in our region is similar to other areas and receiving inadequate treatment is the only modifiable risk factor associated with higher odds of mortality. Therefore, this modifiable factor needs to be improved to reduce the mortality. Copyright © 2010 Elsevier España, S.L. All rights reserved.

A record-based analysis of 803 patients treated for depression in psychiatric care.

PubMed

Rytsälä, H J; Melartin, T K; Leskelä, U S; Lestelä-Mielonen, P S; Sokero, T P; Isometsä, E T

2001-09-01

New antidepressants emerged and became widely used during the 1990s. The present study investigated quality-of-care problems in the treatment of depression in a current psychiatric setting. We investigated the treatment received for depression by all 803 inpatients or outpatients with a clinical diagnosis of ICD-10 depressive episode or recurrent depressive disorder in 1996 in the Peijas Medical Care District, which provides psychiatric services for citizens of Vantaa, a city in southern Finland. Most patients (84%) in the sample were found to have received antidepressants, generally in adequate, albeit low, doses. Inadequate antidepressant treatment was common only with tricyclic antidepressants. Most patients received a single antidepressant for extended periods; only 22% had 2 or more antidepressant trials. During the treatment period, disability pension was granted to 19% of those not already pensioned, two thirds (67%) of whom had received only 1 antidepressant trial prior to being granted a pension. The present study supports the emerging perception of improved quality of pharmacotherapy in psychiatric settings, with the exception of treatment with tricyclic antidepressants. Problems of quality of care now appear to be related to the suboptimal intensity and monitoring of the treatment provided. which may eventually result in considerable costs to society due to permanent disability.

Satisfaction with Subcutaneous Golimumab and its Auto-Injector among Rheumatoid Arthritis Patients with Inadequate Response to Adalimumab or Etanercept.

PubMed

Dehoratius, Raphael J; Brent, Lawrence H; Curtis, Jeffrey R; Ellis, Lorie A; Tang, Kezhen L

2018-06-01

Patient perceptions of treatment success, including satisfaction/preference, may complement clinical efficacy assessments. Our objective was to evaluate satisfaction with subcutaneous golimumab and its auto-injector in patients with rheumatoid arthritis (RA) and an inadequate adalimumab/etanercept response. In the multicenter, assessor-blinded GO-SAVE study, 433 patients with active RA (28-joint Disease Activity Score incorporating erythrocyte sedimentation rate [DAS28-ESR] ≥ 3.6 and six or more swollen and six or more tender joints) despite methotrexate and past adalimumab/etanercept treatment received open-label subcutaneous golimumab 50 mg every 4 weeks (q4w) through week 12. Week 16 responders (DAS28-ESR improvement from baseline > 1.2 and score ≤ 3.2) continued therapy through week 52; nonresponders were randomized (1:2) to double-blind subcutaneous golimumab 50 mg q4w or intravenous golimumab 2 mg/kg [weeks 16, 20, every 8 weeks (q8w)]. Patients rated satisfaction with their injection experience on a 5-point scale (1 = very dissatisfied; 5 = very satisfied) at screening, week 8 (all enrolled patients), and week 44 (for patients continuing open-label subcutaneous golimumab 50 mg q4w). Discomfort, pain, stinging, burning, and redness related to injection were assessed (none, mild, moderate, severe). Similar proportions of patients (N = 433) had most recently received adalimumab (50.3%) or etanercept (49.7%) prior to golimumab. Overall satisfaction (somewhat/very) with the golimumab injection experience was reported by 84.4% of patients at week 8 versus 63.4% of patients who were satisfied with prior adalimumab/etanercept. Patients receiving open-label subcutaneous golimumab through week 44 (N = 75) reported much less discomfort (60.9%), redness (60.9%), pain (59.4%), stinging (67.2%), and burning (65.6%) with the golimumab injection than with their previous tumor necrosis factor antagonist medication injection. Most patients with RA receiving golimumab following adalimumab/etanercept inadequate response were satisfied with their overall golimumab experience, including its auto-injector versus their previous injection device. CLINICAL TRIALS.GOV: NCT01004432; EudraCT 2009-010582-23.

Cost Effectiveness of Naloxegol for Opioid-Induced Constipation in the UK.

PubMed

Lawson, Richard; Ryan, James; King, Frederic; Goh, Jo Wern; Tichy, Eszter; Marsh, Kevin

2017-02-01

Opioid-induced constipation (OIC) is the most common adverse effect reported in patients receiving opioids to manage pain. Initial treatment with laxatives provides inadequate response in some patients. Naloxegol is a peripherally acting µ-opioid receptor antagonist used to treat patients with inadequate response to laxative(s) (laxative inadequate responder [LIR]). A cost-effectiveness model was constructed from the UK payer perspective to compare oral naloxegol 25 mg with placebo in non-cancer LIR patients receiving opioids for chronic pain, and a scenario analysis of naloxegol 25 mg with rescue laxatives compared with placebo with rescue laxatives in the same patient population. The model comprised a decision tree for the first 4 weeks of treatment, followed by a Markov model with a 4-week cycle length and the following states: 'OIC', 'non-OIC (on treatment)', 'non-OIC (untreated)' and 'death'. Two phase III trials with a follow-up period of 12 weeks provided data on treatment efficacy, transition probabilities, adverse event frequency and patient utility. Resource utilisation data were sourced from a UK-based burden of illness study and physician surveys. A UK National Health Service and Personal Social Service perspective was adopted; costs and health-related quality of life gains were discounted at a rate of 3.5 %. The model was run over a time horizon of 5 years, reflecting the average period of opioid use. Naloxegol has an incremental cost-effectiveness ratio of £10,849 per quality-adjusted life-year gained versus placebo, and £11,179 when rescue laxatives are made available in both arms (2014 values). Model outcomes were only sensitive to variations in utility inputs. However, the probabilistic sensitivity analyses indicate that naloxegol has a 91 % probability of being cost effective at a £20,000 threshold when compared with placebo. Naloxegol is likely a cost-effective treatment option for LIR patients with OIC. This assessment should be supported by further work on the utility of patients with OIC, including how utility varies with more granular measures of OIC.

Missed opportunities for preventing congenital syphilis infection in New York City.

PubMed

Patel, Sameer J; Klinger, Ellen J; OʼToole, Dana; Schillinger, Julia A

2012-10-01

To describe health care providers' missed opportunities for preventing and treating congenital syphilis in New York City. Review of congenital syphilis cases reported to the New York City Department of Health and Mental Hygiene from January 1, 2000 to December 31, 2009. Receipt and timing of prenatal care, serologic testing, and treatment of mothers and newborns were reviewed. Missed opportunities were defined as receipt of prenatal care plus one of the following: 1) lack of documented treatment for syphilis infection diagnosed before pregnancy; 2) absence of serologic testing during pregnancy; 3) late maternal treatment; 4) maternal treatment with a nonpenicillin regimen; or 5) lack of maternal treatment. In total, 195 newborns with congenital syphilis were born to 190 mothers with 191 pregnancies. Overall, 80% (95% confidence interval [CI] 74-86%, 152 of 190) of all mothers received prenatal care; 63% (95% CI 56-71%, 96 of 152) of these had one or more missed opportunities for prevention. Twelve mothers received inadequate treatment or no treatment during the case pregnancy for documented syphilis infection before pregnancy, and 42 mothers without previous syphilis diagnosis did not have serologic testing during the case pregnancy. Of 103 mothers with syphilis diagnosed before 30 weeks of gestation, 12 received late penicillin therapy, 27 received no therapy, and 3 received inappropriate (nonpenicillin) therapy. Seventeen percent (95% CI 12-22%, 33 of 193) of liveborn newborns received no treatment during their hospitalization. Providers missed well-defined opportunities to prevent congenital syphilis for the majority of cases. Combined efforts to prevent future cases include provider education and better integration of care between obstetricians and pediatricians. III.

Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial.

PubMed

Fleischmann, Roy; Mysler, Eduardo; Hall, Stephen; Kivitz, Alan J; Moots, Robert J; Luo, Zhen; DeMasi, Ryan; Soma, Koshika; Zhang, Richard; Takiya, Liza; Tatulych, Svitlana; Mojcik, Christopher; Krishnaswami, Sriram; Menon, Sujatha; Smolen, Josef S

2017-07-29

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. The Oral Rheumatoid Arthritis triaL (ORAL) Strategy aimed to assess the comparative efficacy of tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate for the treatment of rheumatoid arthritis in patients with a previous inadequate response to methotrexate. ORAL Strategy was a 1 year, double-blind, phase 3b/4, head-to-head, non-inferiority, randomised controlled trial in patients aged 18 years or older with active rheumatoid arthritis despite methotrexate therapy. Patients were randomly assigned (1:1:1) to receive oral tofacitinib (5 mg twice daily) monotherapy, oral tofacitinib (5 mg twice daily) plus methotrexate, or subcutaneous adalimumab (40 mg every other week) plus methotrexate at 194 centres in 25 countries. Eligible patients received live zoster vaccine at investigators' discretion. The primary endpoint was the proportion of patients who attained an American College of Rheumatology response of at least 50% (ACR50) at month 6 in the full analysis set (patients who were randomly assigned to a group and received at least one dose of the study treatment). Non-inferiority between groups was shown if the lower bound of the 98·34% CI of the difference between comparators was larger than -13·0%. This trial is registered with ClinicalTrials.gov, number NCT02187055. 1146 patients received treatment (384 had tofacitinib monotherapy; 376 had tofacitinib and methotrexate; and 386 had adalimumab and methotrexate). At 6 months, ACR50 response was attained in 147 (38%) of 384 patients with tofacitinib monotherapy, 173 (46%) of 376 patients with tofacitinib and methotrexate, and 169 (44%) of 386 patients with adalimumab and methotrexate. Non-inferiority was declared for tofacitinib and methotrexate versus adalimumab and methotrexate (difference 2% [98·34% CI -6 to 11]) but not for tofacitinib monotherapy versus either adalimumab and methotrexate (-6 [-14 to 3]) or tofacitinib and methotrexate (-8 [-16 to 1]). In total, 23 (6%) of 384 patients receiving tofacitinib monotherapy, 26 (7%) of 376 patients receiving tofacitinib plus methotrexate, and 36 (9%) of 386 patients receiving adalimumab plus methotrexate discontinued due to adverse events. Two (1%) of the 384 patients receiving tofacitinib monotherapy died. No new or unexpected safety issues were reported for either treatment in this study for up to 1 year. Tofacitinib and methotrexate combination therapy was non-inferior to adalimumab and methotrexate combination therapy in the treatment of rheumatoid arthritis in patients with an inadequate response to methotrexate in this trial. Tofacitinib monotherapy was not shown to be non-inferior to either combination. Pfizer Inc. Copyright © 2017 Elsevier Ltd. All rights reserved.

Transoral bisected resection for T1-2 oral tongue squamous cell carcinoma to secure adequate deep margin.

PubMed

Choi, Nayeon; Cho, Jae-Keun; Lee, Eun Kyu; Won, Sung Jun; Kim, Bo Young; Baek, Chung-Hwan

2017-10-01

To investigate the clinical usefulness of transoral bisected resection (TBR) asa new method to secure adequate deep resection margin in T1-2 oral tongue squamous cell carcinomas (SCC). Among 75 patients with cT1-2N0 oral tongue SCCs, 45 (60%) received transoral en-bloc resection (TER) while 30 (40%) received patients underwent TBR. Primary tumor resection was performed with 1.5-cm surgical resection margin for both groups. Mucosal and deep resection margins, adjuvant treatments including re-resection of the tongue and cheomoradiotherapy, local and regional recurrence free survival, and overall survival were compared between the two groups. Mean deep resection margin in the TBR group was 9.9mm (95% CI: 8.4-11.4mm), which was significantly (P<0.001) wider than that of the TER group (mean: 5.4mm, 95% CI: 4.5-6.3mm). However, mucosal resection margins were not significantly (P=0.153) different between the two groups. Re-resection of tongue was performed for 6 (13.3%) of 17 (37.8%) patients with inadequate deep resection margin in the TER group and none (0%) in 4 (13.3%) patients with inadequate deep resection margin in the TBR group. Adjuvant radiation due to inadequate deep resection margin was performed for 6.7% of patients in both groups. The TBR group had better local recurrence free survival than the TER group. However, regional recurrence free survival and overall survival were not significantly different between the two groups. TBR could provide adequate deep resection margin for early stage tongue cancers with better local tumor control than TER. It can decrease the necessity of adjuvant treatment for re-resection of the tongue. Copyright © 2017 Elsevier Ltd. All rights reserved.

APPETITE PREDICTS INTAKE AND NUTRITIONAL STATUS IN PATIENTS RECEIVING PERITONEAL DIALYSIS.

PubMed

Young, Valerie; Balaam, Sarah; Orazio, Linda; Bates, Annerley; Badve, Sunil V; Johnson, David W; Campbell, Katrina L

2016-06-01

Sub-optimal nutrition status is common amongst patients receiving peritoneal dialysis (PD) and leads to poor clinical outcome. This population experiences multi-factorial challenges to achieving optimal nutritional status, particularly driven by inadequate intake. The aim of this investigation was to identify factors associated with inadequate protein intake and sub-optimal nutritional status in patients undergoing PD. This was a cross-sectional study of 67 adult patients receiving PD (mean age 59 ± 14 years; 57% male) within a single centre. Participants were consecutively recruited and interviewed by renal dietitians, collecting: Subjective Global Assessment (SGA); quality of life (using EQ-5D); dietary intake (via dietary interview); and appetite (using Appetite and Diet Assessment Tool). Participant demographics were obtained via survey or medical charts. Main outcome measures were inadequate dietary protein intake (<1.1 g/kg adjusted body weight/day) and malnutrition (as defined by SGA rating B or C). Overall, 15 (22%) patients were malnourished and 29 (43%) had inadequate protein intake. Poor appetite (anorexia) was reported in 62% (18/29) of participants with inadequate protein malnourished patients reported anorexia versus 12 (23%) of the well-nourished patients (p = 0.0001). Anorexia was a key risk factor for inadequate protein intake and malnutrition in patients undergoing PD. These findings highlight a need to closely monitor patients with appetite disturbances. © 2016 European Dialysis and Transplant Nurses Association/European Renal Care Association.

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.

PubMed

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). ClinicalTrials.gov identifier: NCT01325571.

Cognitive Attributes, Attention, and Self-Efficacy of Adequate and Inadequate Responders in a Fourth Grade Reading Intervention

ERIC Educational Resources Information Center

Cho, Eunsoo; Roberts, Garrett J.; Capin, Philip; Roberts, Greg; Miciak, Jeremy; Vaughn, Sharon

2015-01-01

We examined cognitive attributes, attention, and self-efficacy of fourth grade struggling readers who were identified as adequate responders (n = 27), inadequate responders with comprehension only deficits (n = 46), and inadequate responders with comprehension and word reading deficits (n = 52) after receiving a multicomponent reading…

Inadequate humidification of respiratory gases during mechanical ventilation of the newborn.

PubMed Central

Tarnow-Mordi, W O; Sutton, P; Wilkinson, A R

1986-01-01

Proximal airway humidity was measured during mechanical ventilation in 14 infants using an electronic hygrometer. Values below recommended minimum humidity of adult inspired gas were recorded on 251 of 396 occasions. Inadequate humidification, largely due to inadequate proximal airway temperature, is commoner than recognised in infants receiving mechanical ventilation. PMID:3740912

A cluster-analytic profiling of heroin-dependent patients based on level, clinical adequacy, and patient-desired adjustment of buprenorphine dosage during buprenorphine-naloxone maintenance treatment in sixteen Spanish centers.

PubMed

Alcaraz, Saul; González-Saiz, Francisco; Trujols, Joan; Vergara-Moragues, Esperanza; Siñol, Núria; Pérez de Los Cobos, José

2018-06-01

Buprenorphine dosage is a crucial factor influencing outcomes of buprenorphine treatment for heroin use disorders. Therefore, the aim of the present study is to identify naturally occurring profiles of heroin-dependent patients regarding individualized management of buprenorphine dosage in clinical practice of buprenorphine-naloxone maintenance treatment. 316 patients receiving buprenorphine-naloxone maintenance treatment were surveyed at 16 Spanish centers during the stabilization phase of this treatment. Patients were grouped using cluster analysis based on three key indicators of buprenorphine dosage management: dose, adequacy according to physician, and adjustment according to patient. The clusters obtained were compared regarding different facets of patient clinical condition. Four clusters were identified and labeled as follows (buprenorphine average dose and percentage of participants in each cluster are given in brackets): "Clinically Adequate and Adjusted to Patient Desired Low Dosage" (2.60 mg/d, 37.05%); "Clinically Adequate and Adjusted to Patient Desired High Dosage" (10.71 mg/d, 29.18%); "Clinically Adequate and Patient Desired Reduction of Low Dosage" (3.38 mg/d, 20.0%); and "Clinically Inadequate and Adjusted to Patient Desired Moderate Dosage" (7.55 mg/d, 13.77%). Compared to patients from the other three clusters, participants in the latter cluster reported more frequent use of heroin and cocaine during last week, lower satisfaction with buprenorphine-naloxone as a medication, higher prevalence of buprenorphine-naloxone adverse effects and poorer psychological adjustment. Our results show notable differences between clusters of heroin-dependent patients regarding buprenorphine dosage management. We also identified a group of patients receiving clinically inadequate buprenorphine dosage, which was related to poorer clinical condition. Copyright © 2018 Elsevier B.V. All rights reserved.

Tocilizumab in patients with active rheumatoid arthritis and inadequate response to disease-modifying antirheumatic drugs or tumor necrosis factor inhibitors: subanalysis of Spanish results of an open-label study close to clinical practice.

PubMed

Álvaro-Gracia, José M; Fernández-Nebro, Antonio; García-López, Alicia; Guzmán, Manuel; Blanco, Francisco J; Navarro, Francisco J; Bustabad, Sagrario; Armendáriz, Yolanda; Román-Ivorra, José A

2014-01-01

To analyze the Spanish experience in an international study which evaluated tocilizumab in patients with rheumatoid arthritis (RA) and an inadequate response to conventional disease-modifying antirheumatic drugs (DMARDs) or tumor necrosis factor inhibitors (TNFis) in a clinical practice setting. Subanalysis of 170 patients with RA from Spain who participated in a phase IIIb, open-label, international clinical trial. Patients presented inadequate response to DMARDs or TNFis. They received 8mg/kg of tocilizumab every 4 weeks in combination with a DMARD or as monotherapy during 20 weeks. Safety and efficacy of tocilizumab were analyzed. Special emphasis was placed on differences between failure to a DMARD or to a TNFi and the need to switch to tocilizumab with or without a washout period in patients who had previously received TNFi. The most common adverse events were infections (25%), increased total cholesterol (38%) and transaminases (15%). Five patients discontinued the study due to an adverse event. After six months of tocilizumab treatment, 71/50/30% of patients had ACR 20/50/70 responses, respectively. A higher proportion of TNFi-naive patients presented an ACR20 response: 76% compared to 64% in the TNFi group with previous washout and 66% in the TNFi group without previous washout. Safety results were consistent with previous results in patients with RA and an inadequate response to DMARDs or TNFis. Tocilizumab is more effective in patients who did not respond to conventional DMARDs than in patients who did not respond to TNFis. Copyright © 2013 Elsevier España, S.L. All rights reserved.

A Phase IIb Study of ABT‐494, a Selective JAK‐1 Inhibitor, in Patients With Rheumatoid Arthritis and an Inadequate Response to Anti–Tumor Necrosis Factor Therapy

PubMed Central

Emery, Paul; Camp, Heidi S.; Friedman, Alan; Wang, Li; Othman, Ahmed A.; Khan, Nasser; Pangan, Aileen L.; Jungerwirth, Steven; Keystone, Edward C.

2016-01-01

Objective To compare the efficacy and safety of ABT‐494, a novel selective JAK‐1 inhibitor, with placebo in patients with moderate‐to‐severe rheumatoid arthritis (RA) and an inadequate response or intolerance to at least 1 anti–tumor necrosis factor (anti‐TNF) agent. Methods In this 12‐week, double‐blind, placebo‐controlled, dose‐ranging study, 276 RA patients receiving a stable dose of methotrexate (MTX) who had previously received treatment with at least 1 anti‐TNF agent were randomized equally to receive immediate‐release ABT‐494 at 3, 6, 12, or 18 mg twice daily or matching placebo twice daily. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 12. Results At week 12, significantly more patients receiving ABT‐494 (53–71%) than those receiving placebo (34%) achieved an ACR20 response (by nonresponder imputation analysis) (P < 0.05), with a dose‐response relationship among all ABT‐494 doses (P < 0.001). ACR50 and ACR70 response rates were significantly higher in those receiving ABT‐494 (36–42% and 22–26%, respectively) than in those receiving placebo (16% and 4%, respectively). Changes from baseline in the Disease Activity Score in 28 joints using the C‐reactive protein level (DAS28‐CRP) were significantly greater for all doses of ABT‐494 than for placebo (P ≤ 0.01). Onset of action of ABT‐494 was rapid, with significant differences from placebo at week 2 both in ACR20 response rate (for 12 and 18 mg) and in change in the DAS28‐CRP (P < 0.001 for 6–18 mg). The most frequent adverse events (AEs) were headache, nausea, upper respiratory tract infection, and urinary tract infection. Infection rates were higher at higher doses of ABT‐494, but no infections were serious. No deaths were reported among those receiving ABT‐494. Conclusion In patients with an inadequate response or intolerance to anti‐TNF agents, ABT‐494 added to MTX showed rapid, dose‐dependent improvements in RA signs and symptoms, with safety and tolerability similar to those of other drugs of this class. No new AEs were identified. PMID:27389975

Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial.

PubMed

Thaçi, Diamant; Simpson, Eric L; Beck, Lisa A; Bieber, Thomas; Blauvelt, Andrew; Papp, Kim; Soong, Weily; Worm, Margitta; Szepietowski, Jacek C; Sofen, Howard; Kawashima, Makoto; Wu, Richard; Weinstein, Steven P; Graham, Neil M H; Pirozzi, Gianluca; Teper, Ariel; Sutherland, E Rand; Mastey, Vera; Stahl, Neil; Yancopoulos, George D; Ardeleanu, Marius

2016-01-02

Data from early-stage studies suggested that interleukin (IL)-4 and IL-13 are requisite drivers of atopic dermatitis, evidenced by marked improvement after treatment with dupilumab, a fully-human monoclonal antibody that blocks both pathways. We aimed to assess the efficacy and safety of several dose regimens of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments. In this randomised, placebo-controlled, double-blind study, we enrolled patients aged 18 years or older who had an Eczema Area and Severity Index (EASI) score of 12 or higher at screening (≥16 at baseline) and inadequate response to topical treatments from 91 study centres, including hospitals, clinics, and academic institutions, in Canada, Czech Republic, Germany, Hungary, Japan, Poland, and the USA. Patients were randomly assigned (1:1:1:1:1:1), stratified by severity (moderate or severe, as assessed by Investigator's Global Assessment) and region (Japan vs rest of world) to receive subcutaneous dupilumab: 300 mg once a week, 300 mg every 2 weeks, 200 mg every 2 weeks, 300 mg every 4 weeks, 100 mg every 4 weeks, or placebo once a week for 16 weeks. We used a central randomisation scheme, provided by an interactive voice response system. Drug kits were coded, providing masking to treatment assignment, and allocation was concealed. Patients on treatment every 2 weeks and every 4 weeks received volume-matched placebo every week when dupilumab was not given to ensure double blinding. The primary outcome was efficacy of dupilumab dose regimens based on EASI score least-squares mean percentage change (SE) from baseline to week 16. Analyses included all randomly assigned patients who received one or more doses of study drug. This trial is registered with ClinicalTrials.gov, number NCT01859988. Between May 15, 2013, and Jan 27, 2014, 452 patients were assessed for eligibility, and 380 patients were randomly assigned. 379 patients received one or more doses of study drug (300 mg once a week [n=63], 300 mg every 2 weeks [n=64], 200 mg every 2 weeks [n=61], 300 mg every 4 weeks [n=65], 100 mg every 4 weeks [n=65]; placebo [n=61]). EASI score improvements favoured all dupilumab regimens versus placebo (p<0·0001): 300 mg once a week (-74% [SE 5·16]), 300 mg every 2 weeks (-68% [5·12]), 200 mg every 2 weeks (-65% [5·19]), 300 mg every 4 weeks (-64% [4·94]), 100 mg every 4 weeks (-45% [4·99]); placebo (-18% [5·20]). 258 (81%) of 318 patients given dupilumab and 49 (80%) of 61 patients given placebo reported treatment-emergent adverse events; nasopharyngitis was the most frequent (28% and 26%, respectively). Dupilumab improved clinical responses in adults with moderate-to-severe atopic dermatitis in a dose-dependent manner, without significant safety concerns. Our findings show that IL-4 and IL-13 are key drivers of atopic dermatitis. Sanofi and Regeneron Pharmaceuticals. Copyright © 2016 Elsevier Ltd. All rights reserved.

Environmental gram-positive mastitis treatment: in vitro sensitivity and bacteriologic cure.

PubMed

Cattell, M B; Dinsmore, R P; Belschner, A P; Carmen, J; Goodell, G

2001-09-01

A clinical trial was conducted in a large dairy herd to determine the efficacy of intramammary pirlimycin hydrochloride administration during lactation for bacteriologic clearance of gram-positive environmental clinical and subclinical mastitis infections. Quarters infected with environmental streptococci that received pirlimycin therapy (13/28) were 1.8 times more likely to resolve infection than untreated quarters (5/14). The small numbers of quarters infected with coagulase-negative staphylococci resulted in inadequate power to assess treatment differences in cure rate. Although the association was not statistically significant, quarters from cows with sensitive environmental streptococci isolates from composite samples (8/13) resolved infection with treatment at approximately twice the rate of treated quarters with resistant isolates (3/10).

Auricular syncope.

PubMed

Thakar, A; Deepak, K K; Kumar, S Shyam

2008-10-01

To describe a previously unreported syndrome of recurrent syncopal attacks provoked by light stimulation of the external auditory canal. A 13-year-old girl had been receiving treatment for presumed absence seizures, with inadequate treatment response. Imaging was normal. Careful history taking indicated that the recurrent syncopal attacks were precipitated by external auditory canal stimulation. Targeted autonomic function tests confirmed a hyperactive vagal response, with documented significant bradycardia and lightheadedness, provoked by mild stimulation of the posterior wall of the left external auditory canal. Abstinence from ear scratching led to complete alleviation of symptoms without any pharmacological treatment. Reflex syncope consequent to stimulation of the auricular branch of the vagus nerve is proposed as the pathophysiological mechanism for this previously undocumented syndrome.

Assessment of cognitive function in patients with essential hypertension treated with lercanidipine

PubMed Central

Tisaire-Sánchez, J; Roma, J; CamachoAzcargorta, Ignacio; Bueno-Gómez, J; Mora-Maciá, J; Navarro, Angel

2006-01-01

Objectives The aim of this longitudinal, open-label, comparative, multicenter study was to assess cognitive function in hypertensive patients receiving mid-term treatment with lercanidipine. Methods Hypertensive patients aged 40 years or older were treated with lercanidipine (10mg daily) after 7–10 days washout period. The duration of the study was 6 months. Blood pressure (BP) was measured every 4 weeks (JNC 6th report). In patients with inadequate BP control, doxazosin was added and up-titrated. At baseline and after 6 months of treatment, cognitive function was evaluated using the Spanish validated version of the Mini-Mental State Examination (MMSE) and the Trail Making Test (TMT). Results In the study population of 467 patients, BP decreased from 154.4/95.3 mmHg at baseline to 134.8/80.7 mmHg at 6 months. At the end of the study, 98% of patients were receiving lercanidipine, 20% an angiotensin-converting enzyme inhibitor, and 6% doxazosin. Adequate BP control was obtained in 68% of patients. The mean (standard deviation) MMSE scores improved from 32.35 (2.59) to 33.25 (2.36) (p<0.0001). Patients with good BP control scored significantly better than those with inadequate BP control (p<0.05), which was already observed at the first month. Conclusions The third-generation calcium channel antagonist, lercanidipine, improved cognitive function after 6 months of treatment especially in patients with good BP control, suggesting that improvements in cognitive function may be associated with a decrease in BP. PMID:17323604

A randomized clinical trial of the safety and efficacy of sitagliptin in patients with type 2 diabetes mellitus inadequately controlled by acarbose alone.

PubMed

Wang, Weiqing; Ning, Guang; Ma, Jianhua; Liu, Xiaomin; Zheng, Shaoxiong; Wu, Fan; Xu, Lei; O'Neill, Edward A; Fujita, Kenji P; Engel, Samuel S; Kaufman, Keith D; Shankar, R Ravi

2017-04-01

To evaluate the safety and efficacy of sitagliptin when added to the treatment of patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on acarbose monotherapy. This was a multicenter, randomized, placebo-controlled, double-blind clinical trial. Patients (N = 381) with T2DM and inadequate glycemic control (glycated hemoglobin [HbA1c] ≥ 7.0% and ≤10.0%) on acarbose monotherapy (at least 50 mg three times daily) were randomized in a 1:1 ratio to receive the addition of sitagliptin 100 mg or matching placebo once daily for 24 weeks. Changes from baseline in HbA1c and fasting plasma glucose (FPG) at Week 24. The mean baseline HbA1c in randomized patients was 8.1%. At Week 24, the placebo-controlled, least squares mean changes from baseline (95% confidence interval) in HbA1c and FPG in the sitagliptin group were -0.62% and -0.8 mmol/L (p < .001), respectively. At Week 24, 37.8% of patients in the sitagliptin group were at HbA1c goal of <7% compared with 17.2% in the placebo group (p < .001). Sitagliptin was generally well tolerated, and there were no significant between-group differences in prespecified safety parameters (symptomatic hypoglycemia, diarrhea, abdominal pain, nausea, vomiting). A higher incidence of serious adverse events was observed in the sitagliptin group (5.2%) relative to placebo (0.5%); all but one, in the sitagliptin group, were not considered related to drug. Sitagliptin was generally well tolerated and provided statistically superior and clinically meaningful improvements in glycemic control after 24 weeks of treatment compared to placebo when added to treatment of patients with inadequate glycemic control on acarbose monotherapy. Clinicaltrials.gov: NCT01177384.

Evaluation of the duration of thromboembolic prophylaxis after high-risk orthopaedic surgery: the ETHOS observational study.

PubMed

Bergqvist, David; Arcelus, Juan I; Felicissimo, Paulo

2012-02-01

Real-life data on post-discharge venous thromboembolism (VTE) prophylaxis practices and treatments are lacking. We assessed post-operative VTE prophylaxis prescribed and received in a prospective registry, compared with the 2004 American College of Chest Physicians (ACCP) guidelines in high-risk orthopaedic surgery patients. Consecutive patients undergoing total hip arthroplasty (THA), hip fracture surgery (HFS), or knee arthroplasty (KA) were enrolled at discharge from 161 centres in 17 European countries if they had received in-hospital VTE prophylaxis that was considered in accordance with the ACCP guidelines by the treating physician. Data on prescribed and actual prophylaxis were obtained from hospital charts and patient post-discharge diaries. Post-operative prophylaxis prescribed and actual prophylaxis received were considered adherent or adequate, respectively, if recommended therapies were used for ≥28 days (HFS and THA) or ≥10 days (KA). Among 4,388 patients, 69.9% were prescribed ACCP-adherent VTE prophylaxis (THA: 1,411/2,217 [63.6%]; HFS: 701/1,112 [63.0%]; KA: 955/1,059 [90.2%]). Actual prophylaxis received was described in 3,939 patients with an available diary after discharge (non-evaluability rate of 10%). Mean actual durations of pharmacological prophylaxis from surgery were: 28.4 ± 13.7 (THA), 29.3 ± 13.9 (HFS), and 28.7 ± 14.1 days (KA). ACCP-adequate VTE prophylaxis was received by 66.5% of patients (60.9% THA, 55.4% HFS, and 88.7% KA). Prophylaxis inadequacies were mainly due to inadequate prescription, non-recommended prophylaxis prescription at discharge, or too short prophylaxis prescribed. In high-risk orthopaedic surgery patients with hospital-initiated prophylaxis, there is a gap between ACCP recommendations, prescribed and actual prophylaxis received, mainly due to inadequate prescription at discharge.

Fixed-dose combination of sitagliptin and metformin for the treatment of type 2 diabetes

PubMed Central

Reynolds, Jonathan K

2009-01-01

JanumetTM, a fixed dose combination of sitagliptin/metformin HCL manufactured by Merck Pharmaceuticals, has received US Food and Drug Administration approval for treatment of patients with type 2 diabetes, that are inadequately controlled, either by sitagliptin or metformin alone or together in free-dose combination form. Sitagliptin, an inhibitor of the enzyme DDP-4, assists patients with type 2 diabetes mellitus to achieve glycemic control. It has been shown to be safe and effective at 100 mg daily doses. The effect of giving sitagliptin in combination with metformin is thought to have a complimentary and possibly additive effect on glycemic control. PMID:21437126

Ruxolitinib is effective and safe in Japanese patients with hydroxyurea-resistant or hydroxyurea-intolerant polycythemia vera with splenomegaly.

PubMed

Kirito, Keita; Suzuki, Kenshi; Miyamura, Koichi; Takeuchi, Masahiro; Handa, Hiroshi; Okamoto, Shinichiro; Gadbaw, Brian; Yamauchi, Kyosuke; Amagasaki, Taro; Ito, Kazuo; Hino, Masayuki

2018-02-01

Ruxolitinib, a potent JAK1/JAK2 inhibitor, was found to be superior to the best available therapy (BAT) in controlling hematocrit, reducing splenomegaly, and improving symptoms in the phase 3 RESPONSE study of patients with polycythemia vera with splenomegaly who experienced an inadequate response to or adverse effects from hydroxyurea. We report findings from a subgroup analysis of Japanese patients in RESPONSE (n = 18). The composite response rate (hematocrit control and spleen response) was higher in patients receiving ruxolitinib (50.0%) than in those receiving BAT (8.3%). A total of 50.0% of patients randomized to ruxolitinib achieved a spleen response vs 8.3% of those receiving BAT; 100 and 33.3% of patients in the respective groups achieved hematocrit control, with mean hematocrit in ruxolitinib-treated patients remaining stable at < 45% throughout the study. Similarly, a higher proportion of ruxolitinib-treated patients achieved complete hematologic remission (33.3 vs 16.7%). Ruxolitinib also led to rapid improvements in pruritus. All responses with ruxolitinib were durable to week 80, and its safety profile was consistent with that in the overall study. These findings suggest that ruxolitinib is an effective and well-tolerated treatment option for Japanese patients with polycythemia vera with an inadequate response to or adverse effects from hydroxyurea.

An assessment of care provided by a public sector STD clinic in Cape Town.

PubMed

Mathews, C; van Rensburg, A; Schierhout, G; Coetzee, N; Lombard, C J; Fehler, H G; Ballard, R C

1998-11-01

A study was undertaken in a Cape Town public sector STD clinic to evaluate the content and quality of care provided since it has been recognized that appropriate improvements in the management of conventional sexually transmitted diseases (STDs), including provision of correct therapy, health education, condom promotion and partner notification, could result in a reduced incidence of HIV infection. Our objectives were to assess patients' needs for health education and to assess the quality of STD management in terms of health education, condom promotion, partner notification, the validity of the clinical diagnoses and the adequacy of the treatments prescribed. The study subjects were sampled systematically, according to their gender. Patients included in the study were given a standardized interview and their clinical records reviewed. Specimens were collected for laboratory investigations. For each STD detected, the treatment was defined as adequate if drugs currently known to be active against that infection were prescribed. One hundred and seventy men and 161 women were included in the study (median age: females 22 years, males 26 years). While almost all patients believed their STD may have been caused by unprotected sexual intercourse, many also believed it may have been caused by other factors, such as bewitchment with traditional medicine. Only 21% of male and 37% of female patients received any education about STD transmission during the clinic visit, and only 25% of male and 36% of female patients received education about condom use. As a result of the low sensitivity of the clinicians' diagnoses, 16% of men and 61% of women left the clinic with at least one infection inadequately treated. The majority of patients were not receiving education for the prevention of STDs including HIV. Many were not receiving adequate treatment for their infections. The introduction of a syndromic management protocol in this setting would substantially reduce the proportion of inadequately-treated patients. However, syndromic protocols, and the means by which they are implemented, need to take into account problems with the clinical detection of genital ulcerative disease and candidiasis in women.

Risk Factors Associated with Very Low Birth Weight in a Large Urban Area, Stratified by Adequacy of Prenatal Care.

PubMed

Xaverius, Pamela; Alman, Cameron; Holtz, Lori; Yarber, Laura

2016-03-01

This study examined risk and protective factors associated with very low birth weight (VLBW) for babies born to women receiving adequate or inadequate prenatal care. Birth records from St. Louis City and County from 2000 to 2009 were used (n = 152,590). Data was categorized across risk factors and stratified by adequacy of prenatal care (PNC). Multivariate logistic regression and population attributable risk (PAR) was used to explore risk factors for VLBW infants. Women receiving inadequate prenatal care had a higher prevalence of delivering a VLBW infant than those receiving adequate PNC (4.11 vs. 1.44 %, p < .0001). The distribution of risk factors differed between adequate and inadequate PNC regarding Black race (36.4 vs. 79.0 %, p < .0001), age under 20 (13.0 vs. 33.6 %, p < .0001), <13 years of education (35.9 vs. 77.9 %, p < .0001), Medicaid status (35.7 vs. 74.9, p < .0001), primiparity (41.6 vs. 31.4 %, p < .0001), smoking (9.7 vs. 24.5 %, p < .0001), and diabetes (4.0 vs. 2.4 %, p < .0001), respectively. Black race, advanced maternal age, primiparity and gestational hypertension were significant predictors of VLBW, regardless of adequate or inadequate PNC. Among women with inadequate PNC, Medicaid was protective against (aOR 0.671, 95 % CI 0.563-0.803; PAR -32.6 %) and smoking a risk factor for (aOR 1.23, 95 % CI 1.01, 1.49; PAR 40.1 %) VLBW. When prematurity was added to the adjusted models, the largest PAR shifts to education (44.3 %) among women with inadequate PNC. Community actions around broader issues of racism and social determinants of health are needed to prevent VLBW in a large urban area.

Battlefield pain management: A view of 17 years in Israel Defense Forces.

PubMed

Benov, Avi; Salas, Margaux M; Nakar, Helit; Antebi, Ben; Tarif, Bader; Yitzhak, Avraham; Glassberg, Elon

2017-07-01

Pain control in trauma is an integral part of treatment in combat casualty care (CCC). More soldiers injured on the battlefield will need analgesics for pain than those who will need lifesaving interventions (LSI). It has been shown that early treatment of pain improves outcomes after traumatic injury, whereas inadequate treatment leads to higher rates of PTSD. The purpose of this article is to report the Israel Defense Forces Medical Corps (IDF-MC) experience with point of injury (POI) use of analgesia. All cases documented in the IDF Trauma Registry (ITR) between January 1997 and December 2014 were examined. All cases of POI pain medications were extracted. Data collection included mechanism of injury, wound distribution, pain medication administered, mortality, and provider type. Of 8,576 patients, 1,056 (12.3%) patients who had at least one documented pain management treatment were included in this study. Demographics of the study population included 94.2% men and 5.8% women with a median age of 21 years. Injury mechanisms included 40.3% blast injuries (n = 426) and 29% gunshot injuries (306). Of 1,513 injured body regions reported, 52% (787) were extremity wounds (upper and lower), 23% (353) were truncal wounds, and 17.7% (268) were head and neck injuries. A total of 1,469 episodes of analgesic treatment were reported. The most common types of analgesics were morphine (74.7%, 1,097 episodes), ketamine (9.6%, 141 episodes), and fentanyl (13.6%, 200 episodes). Of the patients, 39% (413) received more than one type of analgesic. In 90.5% of cases, analgesia was administered by a physician or a paramedic. Over the span of the study period (1997-2014), types of analgesics given by providers at POI had changed, as fentanyl was introduced to providers. A total of 801 LSIs were performed on 379 (35.9%) patients receiving analgesia, and no adverse events were found in any of the casualties. Most casualties at POI did not receive any analgesics while on the battlefield. The most common analgesics administered at POI were opioids and the most common route of administration was intravenously. This study provides evidence that over time analgesic administration has gained acceptance and has been more common place on the battlefield. Increasingly, more casualties are receiving pain management treatment early in CCC along with LSIs. We hope that this shift will impact CCC by reducing PTSD and overall morbidity resulting from inadequate management of acute pain.

Combination chemotherapy with Regorafenib in metastatic colorectal cancer treatment: A single center, retrospective study

PubMed Central

Lin, Chun-Yu; Lin, Tseng-Hsi; Chen, Chou-Chen; Chen, Ming-Cheng

2018-01-01

Background Regorafenib has been demonstrated as effective in refractory metastatic colorectal cancer. Combination use with chemotherapy has not been reported. We examined the efficacy and safety of adding chemotherapy to Regorafenib for the treatment of metastatic colorectal cancer(mCRC) patients. Methods We recruited mCRC patients at our institute who received either regorafenib monotherapy or regorafenib in combination with other chemotherapies. All patients had received chemo and target therapies and presented with disease progression before regorafenib treatment. The primary end point was overall survival. Findings Between September1, 2015 and May 31, 2017, 100 mCRC patients at our institute received regorafenib treatment. 39 patients were excluded due to poor performance, lack of timely treatment, or inadequate clinical data. A total of 34 patients received regorafenib combined with other chemotherapies, and 27 patients received regorafenib alone. Median follow up time was 10.4 and 6.1 months, respectively. The primary end point of median OS was higher in the combination group than in the single use group (20.9m vs 10.3m, p = 0.015). The most frequent adverse events were hand-foot skin reactions(16[47.1%]vs 12[44.4%]), fatigue(6[17.6%] vs 7[25.9%]), gastrointestinal discomfort (7[20.6%] vs 6[22.2%]), neutropenia (4[11.8%] vs 1[3.7%]), diarrhea(4[11.8%] vs 1[3.7%]), and mucositis(5[14.7%] vs 1[3.7%]). Conclusion The present study showed the efficacy and side effects of regorafenib combination treatment. Superiority in median OS and median PFS was noted in the combination group. The sampling difference between the study and observation groups effects justifies the comparison. Further clinical evidence of combination therapy efficacy is pending future studies. PMID:29304109

Factors influencing non-adherence to tuberculosis treatment in Jepara, central Java, Indonesia.

PubMed

Rondags, Angelique; Himawan, Ari Budi; Metsemakers, Job Fm; Kristina, Tri Nur

2014-07-01

One of the most serious problems for tuberculosis (TB) control is non-adherence to TB treatment. We studied the factors influencing non-adherence to TB treatment in Indonesia to inform TB treatment adherence strategies. We con- ducted semi-structured interviews with non-adherent patients and key informants in Jepara, Central Java, Indonesia. Three major themes were found in reasons for non-adherence to TB treatment: 1) knowledge about TB, 2) knowledge about TB treatment and 3) choosing and changing a health care treatment facility. Respondents had an inadequate knowledge about TB and its treatment. Feeling healthy and having financial problems were the most common reasons for TB treatment non-adherence. Respondents sought treatment from many different health care providers, and often changed the treatment facility location. TB treatment adherence might improve by providing better education about the disease and its treatment to those undergoing treatment. Providing information about where to receive treatment and that treatment is free could also improve compliance.

[Who benefits from systemic therapy with a reflecting team?].

PubMed

Höger, C; Temme, M; Geiken, G

1994-03-01

In an evaluation study we investigated the effectiveness of the reflecting team approach compared to eclectic child psychiatric treatment in an outpatient setting and the indications for each type of treatment. The relationship between treatment outcome and diagnostic data obtained with the Multi-axial Classification Scheme was examined in 22 families treated with the reflecting team approach and in a second group of families matched on all important sociodemographic and diagnostic variables but receiving eclectic treatment. No difference was found between the two groups regarding symptom improvement or changes in family functioning. Regarding satisfaction with treatment, the reflecting team approach was superior to the eclectic modality. In the reflecting team group parental mental disorder and inadequate intra-familial communication (according to the new fifth axis of the Multi-axial Classification Scheme) had a negative effect on outcome.

Effect of salt supplementation on the rate of inadequate sweat collection for infants less than 3 months of age referred for the sweat test.

PubMed

Guglani, Lokesh; Abdulhamid, Ibrahim

2015-01-01

Sweat testing in young infants (≤ 3 months) with a positive newborn screen for Cystic Fibrosis (CF) can yield higher rates of inadequate sweat collection. The role of salt supplements in improving sweat collection has not been studied before. All young infants referred to our CF center for sweat testing were randomized to either receive salt supplements {1/8th teaspoon salt (750 mg)} mixed in formula feeds 1 day prior to sweat testing (study group) or no salt supplement (controls). Of the 151 young infants that underwent sweat testing over 18 months, 75 received salt supplements, while 76 did not. A total of 9 (11.8%) infants in the salt supplement group had inadequate sweat collection, as compared to 4 (5.2%) infants in the control group (p = 0.16, Fisher's Exact Test). Oral salt supplementation for young infants prior to sweat testing does not help to reduce the rates of inadequate sweat collection.

Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study.

PubMed

Pratley, Richard E; Nauck, Michael A; Barnett, Anthony H; Feinglos, Mark N; Ovalle, Fernando; Harman-Boehm, Illana; Ye, June; Scott, Rhona; Johnson, Susan; Stewart, Murray; Rosenstock, Julio

2014-04-01

As new members of a drug class are developed, head-to-head trials are an important strategy to guide personalised treatment decisions. We assessed two glucagon-like peptide-1 receptor agonists, once-weekly albiglutide and once-daily liraglutide, in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs. We undertook this 32-week, open-label, phase 3 non-inferiority study at 162 sites in eight countries: USA (121 sites), Australia (9 sites), Peru (7 sites), Philippines (7 sites), South Korea (5 sites), UK (5 sites), Israel (4 sites), and Spain (4 sites). 841 adult participants (aged ≥18 years) with inadequately controlled type 2 diabetes and a BMI between 20 and 45 kg/m(2) were enrolled and randomised in a 1:1 ratio to receive albiglutide 30 mg once weekly titrated to 50 mg at week 6, or liraglutide 0·6 mg once daily titrated to 1·2 mg at week 1 and 1·8 mg at week 2. The randomisation schedule was generated by an independent randomisation team by the permuted block method with a fixed block size of 16. Participants and investigators were unmasked to treatment. The primary endpoint was change from baseline in HbA1c for albiglutide versus liraglutide, with a 95% CI non-inferiority upper margin of 0·3%. The primary analysis was by modified intention to treat. The study is registered with ClinicalTrials.gov, number NCT01128894. 422 patients were randomly allocated to the albigultide group and 419 to the liraglutide group; 404 patients in the abliglutide group and 408 in the liraglutide group received the study drugs. The primary endpoint analysis was done on the modified intention-to-treat population, which included 402 participants in the albiglutide group and 403 in the liraglutide group. Model-adjusted change in HbA1c from baseline to week 32 was -0·78% (95% CI -0·87 to -0·69) in the albigludite group and -0·99% (-1·08 to -0·90) in the liraglutide group; treatment difference was 0·21% (0·08-0·34; non-inferiority p value=0·0846). Injection-site reactions occurred in more patients given albiglutide than in those given liraglutide (12·9% vs 5·4%; treatment difference 7·5% [95% CI 3·6-11·4]; p=0·0002), whereas the opposite was the case for gastrointestinal events, which occurred in 49·0% of patients in the liraglutide group versus 35·9% in the albiglutide group (treatment difference -13·1% [95% CI -19·9 to -6·4]; p=0·00013). Patients who received once-daily liraglutide had greater reductions in HbA1c than did those who received once-weekly albiglutide. Participants in the albiglutide group had more injection-site reactions and fewer gastrointestinal events than did those in the liraglutide group. GlaxoSmithKline. Copyright © 2014 Elsevier Ltd. All rights reserved.

Treatment of fevers prior to introducing rapid diagnostic tests for malaria in registered drug shops in Uganda.

PubMed

Mbonye, Anthony K; Lal, Sham; Cundill, Bonnie; Hansen, Kristian Schultz; Clarke, Siân; Magnussen, Pascal

2013-04-16

Since drug shops play an important role in treatment of fever, introducing rapid diagnostic tests (RDTs) for malaria at drug shops may have the potential of targeting anti-malarial drugs to those with malaria parasites and improve rational drug use. As part of a cluster randomized trial to examine impact on appropriate treatment of malaria in drug shops in Uganda and adherence to current malaria treatment policy guidelines, a survey was conducted to estimate baseline prevalence of, and factors associated with, appropriate treatment of malaria to enable effective design and implementation of the cluster randomized trial. A survey was conducted within 20 geographical clusters of drug shops from May to September 2010 in Mukono district, central Uganda. A cluster was defined as a parish representing a cluster of drug shops. Data was collected using two structured questionnaires: a provider questionnaire to capture data on drug shops (n=65) including provider characteristics, knowledge on treatment of malaria, previous training received, type of drugs stocked, reported drug sales, and record keeping practices; and a patient questionnaire to capture data from febrile patients (n=540) exiting drug shops on presenting symptoms, the consultation process, treatment received, and malaria diagnoses. Malaria diagnosis made by drug shop vendors were confirmed by the study team through microscopy examination of a blood slide to ascertain whether appropriate treatment was received. Among febrile patients seen at drug shops, 35% had a positive RDT result and 27% had a positive blood slide. Many patients (55%) had previously sought care from another drug shop prior to this consultation. Three quarters (73%) of all febrile patients seen at drug shops received an anti-malarial, of whom 39% received an ACT and 33% received quinine. The rest received another non-artemisinin monotherapy. Only one third (32%) of patients with a positive blood slide had received treatment with Coartem® while 34% of those with a negative blood slide had not received an anti-malarial. Overall appropriate treatment was 34 (95% CI: 28 - 40) with substantial between-cluster variation, ranging from 1% to 55%. In this setting, the proportion of malaria patients receiving appropriate ACT treatment at drug shops was low. This was due to the practice of presumptive treatment, inadequate training on malaria management and lack of knowledge that Coartem® was the recommended first-line treatment for malaria. There is urgent need for interventions to improve treatment of malaria at these outlets.

Treatment of fevers prior to introducing rapid diagnostic tests for malaria in registered drug shops in Uganda

PubMed Central

2013-01-01

Background Since drug shops play an important role in treatment of fever, introducing rapid diagnostic tests (RDTs) for malaria at drug shops may have the potential of targeting anti-malarial drugs to those with malaria parasites and improve rational drug use. As part of a cluster randomized trial to examine impact on appropriate treatment of malaria in drug shops in Uganda and adherence to current malaria treatment policy guidelines, a survey was conducted to estimate baseline prevalence of, and factors associated with, appropriate treatment of malaria to enable effective design and implementation of the cluster randomized trial. Methods A survey was conducted within 20 geographical clusters of drug shops from May to September 2010 in Mukono district, central Uganda. A cluster was defined as a parish representing a cluster of drug shops. Data was collected using two structured questionnaires: a provider questionnaire to capture data on drug shops (n=65) including provider characteristics, knowledge on treatment of malaria, previous training received, type of drugs stocked, reported drug sales, and record keeping practices; and a patient questionnaire to capture data from febrile patients (n=540) exiting drug shops on presenting symptoms, the consultation process, treatment received, and malaria diagnoses. Malaria diagnosis made by drug shop vendors were confirmed by the study team through microscopy examination of a blood slide to ascertain whether appropriate treatment was received. Results Among febrile patients seen at drug shops, 35% had a positive RDT result and 27% had a positive blood slide. Many patients (55%) had previously sought care from another drug shop prior to this consultation. Three quarters (73%) of all febrile patients seen at drug shops received an anti-malarial, of whom 39% received an ACT and 33% received quinine. The rest received another non-artemisinin monotherapy. Only one third (32%) of patients with a positive blood slide had received treatment with Coartem® while 34% of those with a negative blood slide had not received an anti-malarial. Overall appropriate treatment was 34 (95% CI: 28 – 40) with substantial between-cluster variation, ranging from 1% to 55%. Conclusion In this setting, the proportion of malaria patients receiving appropriate ACT treatment at drug shops was low. This was due to the practice of presumptive treatment, inadequate training on malaria management and lack of knowledge that Coartem® was the recommended first-line treatment for malaria. There is urgent need for interventions to improve treatment of malaria at these outlets. PMID:23587179

Does overprotection cause cardiac invalidism after acute myocardial infarction?

PubMed

Riegel, B J; Dracup, K A

1992-01-01

To determine if overprotection on the part of the patient's family and friends contributes to the development of cardiac invalidism after acute myocardial infarction. Longitudinal survey. Nine hospitals in the southwestern United States. One hundred eleven patients who had experienced a first acute myocardial infarction. Subjects were predominantly male, older-aged, married, caucasian, and in functional class I. Eighty-one patients characterized themselves as being overprotected (i.e., receiving more social support from family and friends than desired), and 28 reported receiving inadequate support. Only two patients reported receiving as much support as they desired. Self-esteem, emotional distress, health perceptions, interpersonal dependency, return to work. Overprotected patients experienced less anxiety, depression, anger, confusion, more vigor, and higher self-esteem than inadequately supported patients 1 month after myocardial infarction (p < 0.05). Inadequately supported patients were more dependent 4 months after the event. Overprotection on the part of family and friends may facilitate psychosocial adjustment in the early months after an acute myocardial infarction rather than lead to cardiac invalidism.

Longterm Safety and Efficacy of Subcutaneous Abatacept in Patients with Rheumatoid Arthritis: 5-year Results from a Phase IIIb Trial.

PubMed

Genovese, Mark C; Pacheco-Tena, César; Covarrubias, Arturo; Leon, Gustavo; Mysler, Eduardo; Keiserman, Mauro; Valente, Robert M; Nash, Peter; Simon-Campos, J Abraham; Box, Jane; Legerton, Clarence W; Nasonov, Evgeny; Durez, Patrick; Elegbe, Ayanbola; Wong, Robert; Li, Xiaohui; Banerjee, Subhashis; Alten, Rieke

2018-04-15

To assess 5-year safety, tolerability, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate (MTX)-refractory patients with rheumatoid arthritis (RA). The Abatacept Comparison of sub[QU]cutaneous versus intravenous in Inadequate Responders to methotrexatE (ACQUIRE) phase IIIb, randomized, double-dummy, multinational trial compared efficacy and safety of SC and intravenous (IV) ABA in patients with RA. In the initial 6-month double-blind (DB) period, patients received IV or SC ABA, plus MTX, and in the subsequent open-label longterm extension (LTE) period, all patients received SC ABA (125 mg/wk). The final 5-year safety, tolerability, and efficacy analyses are reported. Of 1385 patients who completed the DB period, 1372 entered LTE and 945 (68.8%) completed ≥ 5 years of treatment. During LTE, 97 (7.1%) patients discontinued treatment because of an adverse event (AE). Incidence rate (IR; event/100 patient-yrs of exposure; based on LTE data, 95% CI) for AE of interest were the following: serious AE 7.73 (6.96-8.58), infection 38.60 (36.24-41.12), serious infection 1.68 (1.35-2.07), malignancies 1.09 (0.84-1.42), and autoimmune disorders 1.33 (1.05-1.69), and were stable over time. No association between immunogenicity and either worsening of ABA safety or loss of efficacy was noted. Efficacy in the LTE was consistent with the DB period and was maintained to the end of the study. These 5-year data establish that SC ABA (125 mg/wk) has a consistent safety profile and durable efficacy for longterm treatment of patients with RA who had an inadequate response to MTX.

Periodontal treatment in a generalized severe chronic periodontitis patient: A case report with 7-year follow-up.

PubMed

Agrali, Omer Birkan; Kuru, Bahar Eren

2015-01-01

The aim of the periodontal treatment is to provide healthy and functional dentition all through a lifetime. In this report, periodontal treatment of a 42-year-old male patient with generalized severe chronic periodontitis is presented. He received initial periodontal treatment together with adjunctive antimicrobials. The devital teeth were endodontically treated, and free gingival grafts were placed at the inadequate keratinized tissue zones before regenerative surgery. Following the surgical treatment using enamel matrix derivatives and xenogenic bone graft combination, the patient was put on a strict recall program. After 12 months, favorable clinical and radiographical improvements were obtained. The 7-year maintenance of the present case with several initially hopeless teeth has been shown and discussed in this report. It can be concluded that optimum oral hygiene level as well as the positive cooperation of the patient enhanced the success of periodontal treatment results even in extremely severe periodontal destruction.

Knowledge and Attitudes of Patients and Their Relatives Toward Electroconvulsive Therapy in China.

PubMed

Li, Yang; An, Feng-Rong; Zhu, Hui; Chiu, Helen F K; Ungvari, Gabor S; H Ng, Chee; Lai, Kelly Y C; Xiang, Yu-Tao

2016-10-01

To examine the knowledge and attitudes of patients and their relatives as well as patients' subjective experience with electroconvulsive therapy (ECT) in China. Up to 420 responders including patients receiving ECT (n = 210) and their relatives (n = 210) were assessed with self-reported questionnaires. Patients and their relatives did not receive adequate information before ECT, particularly about the mode of its delivery, risks, and adverse effects. The most common adverse effect of ECT reported by patients was memory impairment. Both patients and their relatives had positive attitudes toward ECT and appeared satisfied with its therapeutic effects. Mental health professionals need to address the inadequate information on ECT provided to patients and their relatives prior to the treatment. © 2015 Wiley Periodicals, Inc.

Reduction of the use of antimicrobial drugs following the rapid detection of Streptococcus agalactiae in the vagina at delivery by real-time PCR assay.

PubMed

Poncelet-Jasserand, E; Forges, F; Varlet, M-N; Chauleur, C; Seffert, P; Siani, C; Pozzetto, B; Ros, A

2013-08-01

To assess whether the determination of the presence of group B streptococci (GBS) in the vagina using a rapid polymerase chain reaction (PCR) assay at delivery was able to spare useless antimicrobial treatments, as compared with conventional culture at 34-38 weeks of gestation. Practical evaluation and prospective cost-effectiveness analysis. A university hospital in France. A cohort of 225 women in labour at the University-Hospital of Saint-Etienne. Each woman had a conventional culture performed at 34-38 weeks of gestation. At the beginning of labour, two vaginal swabs were sampled for rapid PCR testing and culture. The decision to prescribe a prophylactic antimicrobial treatment or not was taken according to the result of the PCR test. A comparative cost-effectiveness analysis of the two diagnostic strategies was carried out. Number of women receiving inadequate prophylactic antimicrobial drugs following each testing strategy, costs of PCR testing and culture, frequency of vaginal GBS, and diagnostic performance of the PCR test at delivery. The percentage of unnecessarily treated women was significantly reduced using the rapid test versus conventional culture (4.5 and 13.6%, respectively; P < 0.001). The rate of vaginal GBS at delivery was 12.5%. The incremental cost-effectiveness ratio (ICER) for each inadequate management avoided was €36 and €173 from the point of view of the healthcare system and hospital, respectively. The PCR assay reduced the number of inadequate antimicrobial treatments aimed to prevent the early onset of GBS disease. However, this strategy generates extra costs that must be put into balance with its clinical benefits. © 2013 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2013 RCOG.

Continuing evidence for poorer treatment outcomes for single male patients: retreatment data from RTOG 97-14.

PubMed

Konski, Andre; Desilvio, Michelle; Hartsell, William; Watkins-Bruner, Deborah; Coyne, James; Scarantino, Charles; Janjan, Nora

2006-09-01

The specific aim of this study was to evaluate outcome differences by gender and partner status for patients treated on Radiation Therapy Oncology Group (RTOG) protocol 97-14. RTOG 97-14 randomized patients with metastatic breast or prostate cancer to bone to receive 8 Gy in 1 fraction or 30 Gy in 10 fractions. Retreatment rates and overall survival were made based upon gender, marital status, and Karnofsky Performance Status (KPS). The cumulative incidence method was used to estimate retreatment time at 36 months from enrollment, and Gray's test was used to test for treatment differences within the same groupings. Marital status, gender, KPS, and treatment were variables tested in a univariate Cox model evaluating the time to retreatment. Married men and women and single women receiving 30 Gy had significantly longer time to retreatment, p = 0.0067, p = 0.0052, and p = 0.0009 respectively. We failed to show a difference in retreatment rates over time in single men receiving either 30 Gy or 8 Gy. Univariate analysis of the entire group determined patients receiving 30 Gy in 10 fractions significantly less likely to receive retreatment, p < 0.0001, with a trend toward single patients less likely to be re-treated, p = 0.07. Non-disease-related variables, such as social support, might influence the results of clinical trials with subjective endpoints such as retreatment rates. The statistically nonsignificant difference in the 36-month retreatment rates observed in single male patients receiving 8 Gy may be a result of inadequate social support systems in place to facilitate additional care. Patients receiving 8 Gy in a single fraction had significantly higher retreatment rates compared with patients receiving 30 Gy in 10 fractions.

Diagnosing and treatment planning inadequate tooth display.

PubMed

Spear, F

2016-10-21

Some of the most challenging patients to produce a pleasing smile for are those who present with inadequate tooth display (either due to tooth position, the patient has normal size teeth, but they aren't exposed adequately to fill out the smile) or due to tooth size (the teeth are small, often due to tooth wear). The key to understanding how to manage these patients is to learn to understand the possible aetiologies that could produce the condition, and learn how to diagnose which aetiologies exist for your patient. Potential aetiologies for inadequate tooth display in patients with normal length unworn anterior teeth: excessive lip length; inadequate lip mobility; inadequate vertical eruption of the anterior teeth; inadequate facial prominence of the maxillary anterior teeth; vertical maxillary deficiency; and anterior maxillary deficiency.This article, the first in a British Dental Journal series on the topic of aesthetic dentistry, reviews the clinical findings consistent with diagnosing each of the above etiologies, and then reviews the treatment options available for correcting the inadequate tooth display.

Vedolizumab: first global approval.

PubMed

Poole, Raewyn M

2014-07-01

Vedolizumab [Entyvio(®) (US, Europe)], a humanized monoclonal antibody α4β7 integrin receptor antagonist, has been developed by Millennium Pharmaceuticals (d/b/a Takeda Pharmaceuticals International) for the treatment of ulcerative colitis and Crohn's disease. Vedolizumab has received its first global approval for the treatment of ulcerative colitis and Crohn's disease in the US, for use in adult patients with moderate-to-severe disease who have had an inadequate response, loss of response or intolerance to one or more standard therapies (corticosteroids, immunomodulators or tumour necrosis factor-α inhibitor) or demonstrated dependence on corticosteroids. Vedolizumab has since been approved for ulcerative colitis and Crohn's disease in the EU, Norway, Iceland and Liechtenstein. This article summarizes the milestones in the development of vedolizumab leading to its first approval for the treatment of ulcerative colitis and Crohn's disease.

Cognitive Attributes, Attention, and Self-Efficacy of Adequate and Inadequate Responders in a Fourth Grade Reading Intervention

PubMed Central

Cho, Eunsoo; Roberts, Garrett J.; Capin, Philip; Roberts, Greg; Miciak, Jeremy; Vaughn, Sharon

2015-01-01

We examined cognitive attributes, attention, and self-efficacy of fourth grade struggling readers who were identified as adequate responders (n = 27), inadequate responders with comprehension only deficits (n = 46), and inadequate responders with comprehension and word reading deficits (n = 52) after receiving a multicomponent reading intervention. We also included typical readers (n = 40). These four groups were compared on measures of nonverbal reasoning, working memory, verbal knowledge, listening comprehension, phonological awareness, and rapid naming as well as on teacher ratings of attention problems and self-reported self-efficacy. The two inadequate responder groups demonstrated difficulties primarily with verbal knowledge and listening comprehension compared to typical readers and adequate responders. Phonological awareness and rapid naming differentiated the two inadequate responder groups. In addition, both inadequate responder groups showed more attention problems and low self-efficacy compared to typical readers. PMID:26997755

Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea.

PubMed

Lukashevich, V; Del Prato, S; Araga, M; Kothny, W

2014-05-01

The broadly used combination of metformin and sulphonylurea (SU) often fails to bring patients to glycaemic goal. This study assessed the efficacy and safety of vildagliptin as add-on therapy to metformin plus glimepiride combination in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control. A multicentre, double-blind, placebo-controlled study randomized patients to receive treatment with vildagliptin 50 mg bid (n = 158) or placebo (n = 160) for 24 weeks. After 24 weeks, the adjusted mean change in haemoglobin A1c (HbA1c) was -1.01% with vildagliptin (baseline 8.75%) and -0.25% with placebo (baseline 8.80%), with a between-treatment difference of -0.76% (p < 0.001). Significantly more patients on vildagliptin achieved the HbA1c target <7% (28.3% vs. 5.6%; p < 0.001). The difference in fasting plasma glucose reduction between vildagliptin and placebo was -1.13 mmol/l (p < 0.001). In subgroup of patients with baseline HbA1c ≤8%, vildagliptin reduced HbA1c by 0.74% from baseline 7.82% (between-treatment difference: -0.97%; p < 0.001) with significantly more patients achieving the HbA1c target <7% (38.6% vs. 13.9%; p = 0.014). Vildagliptin was well tolerated with low incidence of hypoglycaemia, slightly higher than with placebo (5.1% vs. 1.9%) and no clinically relevant weight gain. Vildagliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin plus glimepiride combination. The addition of vildagliptin was well tolerated with low risk of hypoglycaemia and weight gain. This makes vildagliptin an attractive treatment option for patients failing on metformin plus SU particularly in patients with baseline HbA1c ≤8%. © 2013 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea

PubMed Central

Lukashevich, V; Del Prato, S; Araga, M; Kothny, W

2014-01-01

Aim The broadly used combination of metformin and sulphonylurea (SU) often fails to bring patients to glycaemic goal. This study assessed the efficacy and safety of vildagliptin as add-on therapy to metformin plus glimepiride combination in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control. Methods A multicentre, double-blind, placebo-controlled study randomized patients to receive treatment with vildagliptin 50 mg bid (n = 158) or placebo (n = 160) for 24 weeks. Results After 24 weeks, the adjusted mean change in haemoglobin A1c (HbA1c) was −1.01% with vildagliptin (baseline 8.75%) and −0.25% with placebo (baseline 8.80%), with a between-treatment difference of −0.76% (p < 0.001). Significantly more patients on vildagliptin achieved the HbA1c target <7% (28.3% vs. 5.6%; p < 0.001). The difference in fasting plasma glucose reduction between vildagliptin and placebo was −1.13 mmol/l (p < 0.001). In subgroup of patients with baseline HbA1c ≤8%, vildagliptin reduced HbA1c by 0.74% from baseline 7.82% (between-treatment difference: –0.97%; p < 0.001) with significantly more patients achieving the HbA1c target <7% (38.6% vs. 13.9%; p = 0.014). Vildagliptin was well tolerated with low incidence of hypoglycaemia, slightly higher than with placebo (5.1% vs. 1.9%) and no clinically relevant weight gain. Conclusions Vildagliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin plus glimepiride combination. The addition of vildagliptin was well tolerated with low risk of hypoglycaemia and weight gain. This makes vildagliptin an attractive treatment option for patients failing on metformin plus SU particularly in patients with baseline HbA1c ≤8%. PMID:24199686

Prevention and treatment of nutritional rickets.

PubMed

Shaw, N J

2016-11-01

Nutritional rickets continues to be a significant health problem for children worldwide with recent evidence of increasing incidence in many developed countries. It is due to vitamin D deficiency and/or inadequate dietary calcium intake with variation in the relative contributions of each of these dependant on environmental factors such a dietary intake and sunlight exposure. Key to the prevention of rickets is ensuring that pregnant women and their infants receive vitamin D supplementation with good evidence from randomised controlled trials that infants who receive 400iu daily can achieve levels of 25 hydroxyvitamin D of >50nmol/l. However, public health implementation of daily supplementation is more challenging with a need to revisit food fortification strategies to ensure optimal vitamin D status of the population. Treatment of nutritional rickets has traditionally been with vitamin D2 or D3, often given as a daily oral dose for several weeks until biochemical and radiological evidence of healing. However, other treatment regimes with single or intermittent high doses have also proved to be effective. It is now recognised that oral calcium either as dietary intake or supplements should be routinely used in conjunction with vitamin D for treatment. Copyright © 2015 Elsevier Ltd. All rights reserved.

Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors.

PubMed

Gladman, Dafna; Rigby, William; Azevedo, Valderilio F; Behrens, Frank; Blanco, Ricardo; Kaszuba, Andrzej; Kudlacz, Elizabeth; Wang, Cunshan; Menon, Sujatha; Hendrikx, Thijs; Kanik, Keith S

2017-10-19

Tofacitinib is an oral Janus kinase inhibitor that is under investigation for the treatment of psoriatic arthritis. We evaluated tofacitinib in patients with active psoriatic arthritis who had previously had an inadequate response to tumor necrosis factor (TNF) inhibitors. In this 6-month randomized, placebo-controlled, double-blind, phase 3 trial, we randomly assigned 395 patients, in a 2:2:1:1 ratio, to four regimens: 5 mg of tofacitinib administered orally twice daily (132 patients); 10 mg of tofacitinib twice daily (132 patients); placebo, with a switch to 5 mg of tofacitinib twice daily at 3 months (66 patients); or placebo, with a switch to 10 mg of tofacitinib twice daily at 3 months (65 patients). Data from the patients who received placebo during the first 3 months of the trial were pooled. The primary end points were the percentage of patients who had at least 20% improvement according to the criteria of the American College of Rheumatology (ACR20 response) and the change from baseline score on the Health Assessment Questionnaire-Disability Index (HAQ-DI; scores range from 0 to 3, with higher scores indicating greater disability) at the month 3 analysis. At 3 months, the rates of ACR20 response were 50% with the 5-mg dose of tofacitinib and 47% with the 10-mg dose, as compared with 24% with placebo (P<0.001 for both comparisons); the corresponding mean changes from baseline in HAQ-DI score were -0.39 and -0.35, as compared with -0.14 (P<0.001 for both comparisons). Serious adverse events occurred in 4% of the patients who received the 5-mg dose of tofacitinib continuously and in 6% who received the 10-mg dose continuously. Over the course of 6 months, there were four serious infections, three herpes zoster infections, one myocardial infarction, and one ischemic stroke among the patients who received tofacitinib continuously. Elevations of aspartate and alanine aminotransferase concentrations of three or more times the upper limit of the normal range occurred in more patients who received tofacitinib continuously than in patients who received placebo followed by tofacitinib. In this trial involving patients with active psoriatic arthritis who had had an inadequate response to TNF inhibitors, tofacitinib was more effective than placebo over 3 months in reducing disease activity. Adverse events were more frequent with tofacitinib than with placebo. (Funded by Pfizer; OPAL Beyond ClinicalTrials.gov number, NCT01882439 .).

Therapist, Parent, and Youth Perspectives of Treatment Barriers to Family-Focused Community Outpatient Mental Health Services

PubMed Central

Jenkins, Melissa M.; Haine-Schlagel, Rachel

2012-01-01

This exploratory qualitative study describes treatment barriers to receiving family-focused child mental health services for youths with disruptive behavior problems from multiple perspectives. Data were collected during a series of focus groups and interviews, including: 4 therapist focus groups, 3 parent focus groups, and 10 youth semi-structured interviews. Therapist, parent, and youth stakeholder participants discussed perceived barriers to effective treatment, the problems with current child outpatient therapy, and desired changes (i.e., policy, intervention, etc.) to improve mental health services. Results indicate similar themes around treatment barriers and dissatisfaction with services within and across multiple stakeholder groups, including inadequate support and lack of family involvement; however, parents and therapists, in particular, identified different contributing factors to these barriers. Overall, stakeholders reported much frustration and dissatisfaction with current community-based outpatient child therapy services. Study findings can inform service provision, intervention development, and future research. PMID:24019737

Rapid amelioration of severe manic episodes with right unilateral ultrabrief pulse ECT: a case series of four patients.

PubMed

Sidorov, Alexey; Mayur, Prashanth

2017-02-01

The aim of this small case series is to describe four cases of severe mania, where ultrabrief pulse electroconvulsive therapy (ECT) was used as a primary mode of treatment. A retrospective file review was undertaken of four patients identified as having received ultrabrief pulse ECT for severe mania. The outcome measures for treatment efficacy were the Young Mania Rating Scale (YMRS) and Clinical Global Impression (CGI). All the patients showed significant clinical improvement. A comparison of pre- and post-treatment YMRS and CGI scores showed a dramatic decrease in all four cases. However, one patient was shifted to brief pulse ECT due to inadequate response. Ultrabrief pulse ECT may be an effective treatment in cases of severe mania. Due to the very small number of cases in the current case series, no specific conclusions regarding efficacy may be drawn; however, larger, controlled studies would be indicated.

A Review of the Oncology Patient's Challenges for Utilizing Fertility Preservation Services

PubMed Central

Flink, Dina M.; Sheeder, Jeanelle

2017-01-01

Purpose: The American Society of Clinical Oncology issued practice guidelines in 2006 to provide critical information about fertility impact to adolescents and young adults (AYA) at the time of cancer diagnosis. Survivors continue to express concerns about their long-term reproductive health after cancer therapy even as treatment options for fertility preservation evolve. An underutilization of fertility preservation methods by cancer patients continues to persist. A review of the literature cites barriers and challenges that limit fertility information and preservation options for AYA cancer patients. Methods: A review of medical literature was conducted to examine current practice for patients receiving fertility information and the barriers to patients receiving fertility preservation services. Results: A total of 69 publications were included in this review. The review summarizes (1) patient experiences with receiving fertility information and (2) patient desires, barriers, and challenges to utilizing fertility preservation services. Conclusions: Despite advances in fertility preservation, there are challenges for patients to utilizing fertility preservation services. Barriers include the following: urgency to initiate treatment, inadequate information, clinic time constraints, and perceptions around patients' gender, age, cost, parity, race, relationship, and sociodemographic status influence whether patients receive fertility preservation consultation. Patients report a lack of adequate information to make informed fertility decisions. PMID:27529573

Controlled trial of hyposensitisation in children with food-induced hyperkinetic syndrome.

PubMed

Egger, J; Stolla, A; McEwen, L M

1992-05-09

Food intolerance seems to be an important cause of the hyperkinetic syndrome, but restricted diets are expensive, socially disruptive, and often nutritionally inadequate. Enzyme-potentiated desensitisation (EPD) may overcome some of these difficulties. EPD was tested in a double-blind placebo-controlled trial among 40 children with food-induced hyperkinetic behaviour disorder. A total of 185 children with established hyperkinetic syndrome underwent oligoantigenic dietary treatment for four weeks. 116 whose behaviour responded had provoking foods identified by sequential reintroduction. Foods that reproducibly provoked overactivity were avoided. 40 patients who were then invited to take part in the hyposensitisation trial were randomly assigned to treated and control groups. Treated patients received three doses of EPD (beta-glucuronidase and small quantities of food antigens) intradermally at two-monthly intervals. Controls received buffer only. Thereafter, patients were allowed to eat known provoking foods. Of 20 patients who received active treatment, 16 became tolerant towards provoking foods compared with 4 of 20 who received placebo (p less than 0.001). Our results show that EPD permits children with food-induced hyperkinetic syndrome to eat foods that had previously been identified as responsible for their symptoms. These results also support the notion that food allergy is a possible mechanism of the hyperkinetic syndrome.

Healthcare professionals' perceptions on the emotional impact of having an inadequate response to antidepressant medications: survey and prospective patient audit.

PubMed

Mago, Rajnish; Fagiolini, Andrea; Weiller, Emmanuelle; Weiss, Catherine

2018-01-01

Despite the availability of effective antidepressants, about half of patients with major depressive disorder (MDD) display an inadequate response to their initial treatment. A large patient survey recently reported that 29.8% of MDD patients experiencing an inadequate treatment response felt frustrated about their medication and 19.2% were frustrated with their healthcare provider. This survey and chart audit evaluated healthcare professionals' (HCP) views on the emotional impact of having an inadequate response to antidepressant medication. HCPs who frequently treat patients with MDD completed a survey and chart audit of their MDD patients currently experiencing an inadequate response to antidepressant treatment. 287 HCPs completed 1336 chart audits. HCPs reported that 38% of their patients were trusting/accepting of their MDD medications and 41% of their patients trusted/felt confident with their healthcare provision. Conversely, HCPs reported that 11% of their patients were frustrated with their medication and 5% with their healthcare benefits. HCPs cited impact on daily life (53%) and treatment issues (lack of efficacy and side effects; 50%) as the main drivers for their patients' feelings of frustration. When HCPs recognized patients' feelings of frustration, the top concerns of the HCPs were worsening of symptoms (43%) and non-compliance (41%). This survey and chart audit highlights the emotional burden associated with inadequate responses to MDD treatment in addition to persistent symptoms. Differences between the views of the HCPs and patients are highlighted and suggest that HCPs may underestimate the full impact that having to try numerous medications has on their patients.

Treatment choice, satisfaction and quality of life in patients with Graves' disease.

PubMed

Conaglen, Helen M; Tamatea, Jade A U; Conaglen, John V; Elston, Marianne S

2018-04-06

Thyrotoxicosis, most often caused by Graves' disease (GD), when treated inadequately may result in premature mortality. There is little consensus as to which of the 3 treatment options available - antithyroid drugs (ATD), radioactive iodine (RAI) and surgery, is better. (i) To assess factors involved in treatment choice and treatment satisfaction in patients treated for Graves' disease; (ii) To assess quality of life (QoL) following treatment of Graves' disease. Participants were selected from a prospective study cohort assessing thyrotoxicosis incidence and severity. Of the 172 eligible patients with Graves' disease, 123 treated patients participated (64% had received ATD only, 11% RAI and 25% total thyroidectomy, the latter 2 usually after a period of ATD), along with 18 untreated patients with newly diagnosed Graves' disease (overall participation rate, 73%). Consented patients completed a questionnaire detailing factors involved in treatment choice, QoL and satisfaction with treatment. Participants reported that the most important factors in choosing a treatment were the following: the effects on activities of daily living, concern about use of radioiodine, possibility of depression or anxiety, and doctor's recommendations. Satisfaction levels were high across all 3 treatment types. QoL 1-year following treatment was higher than in untreated patients, and comparable with other international studies. Patient satisfaction with therapy and QoL does not differ by treatment type. Therefore, clinical and social factors, in combination with patient choice and resource availability, should determine which treatment modality patients with Graves' disease should receive. © 2018 John Wiley & Sons Ltd.

[To inadequate indication of blood transfusion in a reference hospital in Lima, Peru].

PubMed

Flores-Paredes, Wilfredo

2011-12-01

To determine frequency and clinical criteria associated to the inadequate indication of blood products. A cross-sectional study was performed between June and October 2002. Clinical charts and the laboratory tests from patients receiving blood transfusions were examined. A blood transfusion guideline was elaborated based on published consensus, and used to determine whether the indications for blood products transfusion was adequate or inadequate. A total of 311 blood transfusions were evaluated. The global prevalence of inappropriate indication was of 33.8 %. Red blood cells (RBC) were used inappropriately in 25 %, fresh frozen plasma (FFP) in 59 %, platelets in 13 % and cryoprecipitate in 88 %. From surgery related transfusions half of the indications were inadequate. In internal medicine, ICU and emergency related transfusions, approximately one third of the indications were inadequate. The FFP is the worst used blood product. We found a high frequency of inadequate blood transfusion. The identification of the specific clinical criteria used in inadequate indications transfusions will help in designing a better educational strategy towards a more rational use of the blood products.

Dupilumab with concomitant topical corticosteroid treatment in adults with atopic dermatitis with an inadequate response or intolerance to ciclosporin A or when this treatment is medically inadvisable: a placebo-controlled, randomized phase III clinical trial (LIBERTY AD CAFÉ).

PubMed

de Bruin-Weller, M; Thaçi, D; Smith, C H; Reich, K; Cork, M J; Radin, A; Zhang, Q; Akinlade, B; Gadkari, A; Eckert, L; Hultsch, T; Chen, Z; Pirozzi, G; Graham, N M H; Shumel, B

2018-05-01

Atopic dermatitis is a chronic inflammatory skin disease that may require systemic therapy. Ciclosporin A (CsA) is a widely used, potent immunosuppressant but it is not effective in all patients with atopic dermatitis, and side-effects limit its use. Dupilumab, a fully human anti-interleukin 4 receptor-alpha monoclonal antibody, inhibits signaling of IL-4 and IL-13, key drivers of Type 2/Th2-mediated inflammation, and is approved in the U.S.A. and the European Union for the treatment of inadequately-controlled moderate-to-severe atopic dermatitis in adults. To evaluate efficacy and safety of dupilumab with concomitant topical corticosteroids (TCS) in adults with atopic dermatitis with inadequate response to/intolerance of CsA, or for whom CsA treatment was medically inadvisable. In this 16-week, double-blind, randomized, placebo-controlled, phase III trial, patients were randomized 1 : 1 : 1 to subcutaneous dupilumab 300 mg weekly (qw) or every 2 weeks (q2w) or placebo. All received concomitant medium-potency TCS from Week -2 through Week 16; dosage could be tapered if lesions cleared, or stopped for adverse reactions to TCS. In total, 390 patients were screened, 325 were randomized, and 318 completed the trial. Treatment groups had similar baseline characteristics. Significantly more patients in the dupilumab qw + TCS and q2w + TCS groups achieved ≥ 75% improvement from baseline in the Eczema Area and Severity Index at Week 16 vs. the placebo + TCS group (primary end point) (59·1% and 62·6% vs. 29·6%, respectively; P < 0·001 vs. placebo + TCS, both doses). Other clinical outcomes and atopic dermatitis symptoms were significantly improved in the dupilumab qw + TCS and q2w + TCS groups, including pruritus, pain, sleep disturbance, symptoms of anxiety and depression, and quality of life (QoL). Treatment groups had similar overall rates of adverse events (qw + TCS, q2w + TCS and placebo + TCS groups: 69·1%, 72·0% and 69·4%, respectively) and serious adverse events (1·8%, 1·9% and 1·9%, respectively). Conjunctivitis was more frequent with dupilumab + TCS; skin infections were more frequent with placebo + TCS. Dupilumab + TCS significantly improved signs and symptoms of atopic dermatitis and QoL in adults with a history of inadequate response to/intolerance of CsA, or for whom CsA treatment was medically inadvisable. No new safety signals were identified. © 2017 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

Current therapy for laser-induced retinal injury: overview of clinical and experimental approaches

NASA Astrophysics Data System (ADS)

Schuschereba, Steven T.; Scales, David K.

1997-05-01

Adequate treatment strategies do not exist for retinal laser injuries. To gain a better understanding of available treatments, data form a variety of human laser accident cases and relevant experimental work was evaluated. Most laser eye injury cases are not attended by an ophthalmologist for several hours to days after injury and most patients are not treated.Of the few cases receiving treatment; only the FDA approved glucocortocoids are available for use. Their use, however, is still controversial. Experimental animal work during the acute phase of injury indicates that productive efforts have targeted neuroprotection, inflammation, ischemia- reperfusion, and lipid peroxidation. Late stage issues for treatment are scarring, retinal hole persistence and expansion, and traction. In summary, treatments for acute and late phase injury are currently inadequate. Preserving existing neural elements should be the top priority in these injuries. We recommend that relevant treatments begin immediately after injury. Other approaches are necessary to target early and late phase secondary damage events that are entrenched.

Complete physico-chemical treatment for coke plant effluents.

PubMed

Ghose, M K

2002-03-01

Naturally found coal is converted to coke which is suitable for metallurgical industries. Large quantities of liquid effluents produced contain a large amount of suspended solids, high COD, BOD, phenols, ammonia and other toxic substances which are causing serious pollution problem in the receiving water to which they are discharged. There are a large number of coke plants in the vicinity of Jharia Coal Field (JCF). Characteristics of the effluents have been evaluated. The present effluent treatment systems were found to be inadequate. Physico-chemical treatment has been considered as a suitable option for the treatment of coke plant effluents. Ammonia removal by synthetic zeolite, activated carbon for the removal of bacteria, viruses, refractory organics, etc. were utilized and the results are discussed. A scheme has been proposed for the complete physico-chemical treatment, which can be suitably adopted for the recycling, reuse and safe disposal of the treated effluent. Various unit process and unit operations involved in the treatment system have been discussed. The process may be useful on industrial scale at various sites.

Incorporating Exercise Into the Cancer Treatment Paradigm.

PubMed

Haas, Barbara K; Hermanns, Melinda; Kimmel, Gary

2016-12-01

The benefits of exercise for patients with cancer are well documented. However, exercise is still not a standard of care for this population. Several factors contribute to the lack of exercise prescriptions for patients with cancer, including challenges posed by treatment-related side effects, lack of knowledge among healthcare providers and the laypeople, and inadequate resources. This article reviews the benefits of exercise in general and specifically to patients with cancer, discusses the specific challenges and considerations required in recommending exercise to this population, and provides specific recommendations for healthcare providers to incorporate exercise into treatment plans. Using a case study exemplar, this article discusses the benefits and challenges to exercise while undergoing treatment for cancer and proposes specific solutions and recommendations. Oncology practitioners can provide the opportunity for patients to safely engage in exercise with the appropriate resources and trained personnel using a successful model of delivering exercise to patients undergoing treatment for cancer. Exercise improves quality of life in all patients, including those with advanced-stage cancers and those actively receiving treatment.

Inadequate gestational weight gain and adverse pregnancy outcomes among normal weight women in China

PubMed Central

Wen, Tingyuan; Lv, Yanwei

2015-01-01

Objective: The objective of the paper is to find the association between inadequate gestational weight gain and pregnancy outcomes in normal weight women in China. Method: A retrospective study was conducted among 13,776 normal weight pregnant women who received antenatal care and delivered singleton infants at the participating hospital during August, 2009 to July, 2013. Adverse pregnancy outcomes like low birth weight (LBW), preterm birth, birth asphyxia, neonatal intensive care unit (NICU) admission and length of hospital stay were compared and analyzed between two groups with inadequate and adequate gestational weight gain. Results: According to the IOM recommendations, inadequate gestational weight gain was found to be 14.7% in this study. Women with inadequate gestational weight gain (GWG) were found to be at a higher risk for LBW (aOR = 2.13, 95% CI: 1.75, 2.86) and preterm birth (aOR = 1.44, 95% CI: 1.21, 1.67) than those in the adequate gestational weight gain group, after adjusting for monthly family income, maternal education, occupation, and whether they received any advice regarding benefits of gestational weight gain and residential area. However, inadequate GWG was not associated with longer hospital stay (aOR = 1.13, 95% CI: 0.91-1.43) in adjusted model. In addition, the rate of birth asphyxia and NICU admission were similar in both groups (P > 0.05). Conclusions: Normal weight pregnant women with GWG below the recommended AIOM 2009 guidelines were found to be at an increased risk of low birth weight and preterm birth. PMID:25932249

Inadequate gestational weight gain and adverse pregnancy outcomes among normal weight women in China.

PubMed

Wen, Tingyuan; Lv, Yanwei

2015-01-01

The objective of the paper is to find the association between inadequate gestational weight gain and pregnancy outcomes in normal weight women in China. A retrospective study was conducted among 13,776 normal weight pregnant women who received antenatal care and delivered singleton infants at the participating hospital during August, 2009 to July, 2013. Adverse pregnancy outcomes like low birth weight (LBW), preterm birth, birth asphyxia, neonatal intensive care unit (NICU) admission and length of hospital stay were compared and analyzed between two groups with inadequate and adequate gestational weight gain. According to the IOM recommendations, inadequate gestational weight gain was found to be 14.7% in this study. Women with inadequate gestational weight gain (GWG) were found to be at a higher risk for LBW (aOR = 2.13, 95% CI: 1.75, 2.86) and preterm birth (aOR = 1.44, 95% CI: 1.21, 1.67) than those in the adequate gestational weight gain group, after adjusting for monthly family income, maternal education, occupation, and whether they received any advice regarding benefits of gestational weight gain and residential area. However, inadequate GWG was not associated with longer hospital stay (aOR = 1.13, 95% CI: 0.91-1.43) in adjusted model. In addition, the rate of birth asphyxia and NICU admission were similar in both groups (P > 0.05). Normal weight pregnant women with GWG below the recommended AIOM 2009 guidelines were found to be at an increased risk of low birth weight and preterm birth.

The Relationship between Prenatal Care, Personal Alcohol Abuse and Alcohol Abuse in the Home Environment

ERIC Educational Resources Information Center

Grekin, Emily R.; Ondersma, Steven J.

2009-01-01

Aims: Nearly one-fourth of African-American women receive no prenatal care during the first trimester of pregnancy. The aim of the current study is to identify factors that underlie inadequate prenatal care among African-American women. Maternal alcohol abuse has been examined as one risk factor for inadequate prenatal care, but findings have been…

Racial and ethnic differences in lymph node examination after colon cancer resection do not completely explain disparities in mortality.

PubMed

Rhoads, Kim F; Cullen, Jennifer; Ngo, Justine V; Wren, Sherry M

2012-01-15

In 1999, a multidisciplinary panel of experts in colorectal cancer reviewed the relevant medical literature and issued a consensus recommendation for a 12-lymph node (LN) minimum examination after resection for colon cancer. Some authors have shown racial/ethnic differences in receipt of this evidence-based care. To date, however, none has investigated the correlation between disparities in LN examination and disparities in outcomes after colon cancer treatment. This retrospective analysis used California Cancer Registry linked to California Office of Statewide Health Planning and Development discharge data (1996-2006). Chi-square analysis, logistic regression, and Cox proportional hazard models predicted disparities in receipt of an adequate examination and the effect of an inadequate exam on mortality and disparities. Patients with stage I and II colon cancers undergoing surgery in California were included; patients with stage III and IV disease were excluded. A total of 37,911 records were analyzed. Adequate staging occurred in fewer than half of cases. An inadequate examination (<12 LNs) was associated with higher mortality rates. Hispanics had the lowest odds of receiving an adequate exam; however, blacks, not Hispanics, had the highest risk of mortality compared with whites. This disparity was not completely explained by inadequate LN examination. Inadequate LN exam occurs often and is associated with increased mortality. There are disparities in receipt of the minimum exam, but this only explains a small part of the observed disparity in mortality. Improving the quality of LN examination alone is unlikely to correct colon cancer disparities. Copyright © 2011 American Cancer Society.

Nutrition care-related practices and factors affecting nutritional intakes in hospital patients at risk of pressure ulcers.

PubMed

Roberts, S; Chaboyer, W; Desbrow, B

2015-08-01

Malnutrition is common in hospitals and is a risk factor for pressure ulcers. Nutrition care practices relating to the identification and treatment of malnutrition have not been assessed in patients at risk of pressure ulcers. The present study describes nutrition care practices and factors affecting nutritional intakes in this patient group. The study was conducted in four wards at two hospitals in Queensland, Australia. Adult patients at risk of pressure ulcers as a result of restricted mobility were observed for 24 h to determine their daily oral intake and practices such as nutrition screening, documentation and intervention. Independent samples t-tests and chi-squared tests were used to analyse dietary intake and nutrition care-related data. Predictors of receiving a dietitian referral were identified using logistic regression analyses. Two hundred and forty-one patients participated in the present study. The observed nutritional screening rate was 59% (142 patients). Weight and height were documented in 71% and 34% of cases. Sixty-nine patients (29%) received a dietitian referral. Predictors of receiving a dietitian referral included lower body mass index and longer length of stay. On average, patients consumed 73% and 72% of the energy and protein provided, respectively. Between 22% and 38% of patients consumed <50% of food provided at main meals. Nutrition care practices including malnutrition risk screening and documentation of nutritional parameters appear to be inadequate in patients at risk of pressure ulcers. A significant proportion of these patients eat inadequately at main meals, further increasing their risk of malnutrition and pressure ulcers. © 2014 The British Dietetic Association Ltd.

Influence of health beliefs and stigma on choosing internet support groups over formal mental health services.

PubMed

Townsend, Lisa; Gearing, Robin Edward; Polyanskaya, Olga

2012-04-01

As the Internet has become a ubiquitous tool for health information, the use of Internet support groups for mental health concerns has grown. Despite the widespread use of these groups, little research has examined the efficacy and effectiveness of online communities for ameliorating mental health symptoms or factors that prompt people to seek online support rather than formal treatment. Our study addresses this gap in the literature by investigating Internet support group use as an alternative to formal mental health services. Logistic regression was conducted with data from the 2008 National Survey on Drug Use and Health (NSDUH) to examine relationships among treatment beliefs, practical variables such as time and affordability, stigma, and use of Internet support groups among 2,532 survey participants who reported a need for mental health treatment but were not receiving formal services. Four significant predictors of Internet support group use emerged: fear of being hospitalized or taking medication (adjusted odds ratio [AOR]=8.81, 95% confidence interval [CI]=4.25-18.27), inadequate insurance coverage (AOR=3.22, CI=1.44-7.20), age 26-34 years (AOR=.22, CI=.07-.69), and age 35 or older (AOR=.21, CI=.08-.56). Fear of coercion and the costs of traditional mental health services were important predictors of Internet support group use. The finding that inadequate insurance coverage prompted people to seek Internet support aligns with a substantial literature regarding lack of financial resources and reduced access to treatment. Individuals' fears of hospitalization and of taking medication suggested that they may view formal treatment as potentially coercive. Further work is needed to decrease public stigma regarding mental health services and the conditions under which involuntary treatment occurs.

Secukinumab in Active Rheumatoid Arthritis: A Phase III Randomized, Double-Blind, Active Comparator- and Placebo-Controlled Study.

PubMed

Blanco, Francisco J; Möricke, Rüdiger; Dokoupilova, Eva; Codding, Christine; Neal, Jeffrey; Andersson, Mats; Rohrer, Susanne; Richards, Hanno

2017-06-01

To evaluate the efficacy and safety of secukinumab in patients with active rheumatoid arthritis (RA) who had an inadequate response to or intolerance of tumor necrosis factor (TNF) inhibitors. In this phase III study, 551 patients were randomized (1:1:1:1) to receive intravenous secukinumab at a dose of 10 mg/kg (at baseline and weeks 2 and 4) followed by subcutaneous secukinumab at a dose of either 150 mg or 75 mg every 4 weeks or, alternatively, abatacept or placebo on the same dosing schedule. The primary end point was the proportion of patients achieving 20% improvement in disease activity according to the American College of Rheumatology response criteria (ACR20) at week 24 in the secukinumab 150 mg or 75 mg treatment groups as compared with placebo. Key secondary end points included change from baseline to week 24 in the Disease Activity Score in 28 joints using C-reactive protein level (DAS28-CRP) and the Health Assessment Questionnaire disability index (HAQ DI), as well as the ACR 50% improvement (ACR50) response rate at week 24. The primary efficacy end point was met in patients receiving 150 mg secukinumab, in whom the ACR20 response rate at week 24 was significantly higher than that in the placebo group. The ACR20 response rates at week 24 were 30.7% in patients receiving 150 mg secukinumab (P = 0.0305), 28.3% in those receiving 75 mg secukinumab (P = 0.0916), and 42.8% in those receiving abatacept, compared with 18.1% in the placebo group. A significant reduction in the DAS28-CRP was seen in patients treated with 150 mg secukinumab (P = 0.0495), but not in patients treated with 75 mg secukinumab. Improvements in the HAQ DI and ACR50 response rates were not significant in the 2 secukinumab dose groups compared with the placebo group. The overall safety profile was similar across all treatment groups. Secukinumab at a dose of 150 mg resulted in improvement in signs and symptoms and reduced disease activity in patients with active RA who had an inadequate response to TNF inhibitors. Improvements observed with abatacept were numerically higher than with secukinumab. There were no new or unexpected safety signals with secukinumab in this study. © 2017, American College of Rheumatology.

Dementia correlates with anticoagulation underuse in older patients with atrial fibrillation.

PubMed

Viscogliosi, Giovanni; Ettorre, Evaristo; Chiriac, Iulia Maria

2017-09-01

Stroke prevention in older atrial fibrillation (AF) patients remains a challenge. This study aimed to investigate whether a dementia diagnosis is an independent correlate of lower prescription rate of oral anticoagulant treatment (OAT) in a sample of older AF patients. Cross-sectional retrospective study. Consecutive older community-dwelling AF patients referred for a comprehensive geriatric assessment, were considered. Evaluation of physical, social and mental health, and administration of the Cumulative Illness Rating Scale (CIRS) and Barthel Index were performed. Dementia cases were ascertained by consensus of 2 experienced geriatricians. Dementia severity was assessed using the Clinical Dementia Rating scale (CDR). 316 AF patients (ages 74.7±7.0years, 55.7% women) with high stroke risk (77.5% had a CHA 2 DS 2 VASC score ≥3), low bleeding and falling risk, and no neuropsychiatric/behavioral symptoms, were included. 60.1% were prescribed with OAT. Among patients with dementia (n=86, 27.2%), 22.0% received inadequate antithrombotic prophylaxis (i.e. antiplatelet) and 38.5% no treatment. Proportion of those receiving inadequate or no prophylaxis increased at increasing CDR score. By multiple regression models, either dementia (yes vs no), OR=1.33, 95%CI=1.11-1.46, p<0.001, and dementia severity (CDR>1), OR=2.38, 95%CI=2.19-2.60, p<0.001, were associated with lack of OAT prescription independently of age, paroxysmal AF, and comorbidity burden. Dementia might be associated with underuse of OAT in older AF patients even in the absence of established contraindications. Future studies are needed to assess the real dimension of the problem and clinician's barriers to prescribing OAT in demented patients. Copyright © 2017. Published by Elsevier B.V.

Alternative dosing of prophylactic enoxaparin in the trauma patient: is more the answer?

PubMed

Kopelman, Tammy R; O'Neill, Patrick J; Pieri, Paola G; Salomone, Jeffrey P; Hall, Scott T; Quan, Asia; Wells, Jordan R; Pressman, Melissa S

2013-12-01

Inadequate anti-factor Xa levels and increased venous thromboembolic events occur in trauma patients receiving standard prophylactic enoxaparin dosing. The aim of this study was to test the hypothesis that higher dosing (40 mg twice daily) would improve peak anti-Xa levels and decrease venous thromboembolism. A retrospective review was performed of trauma patients who received prophylactic enoxaparin and peak anti-Xa levels over 27 months. Patients were divided on the basis of dose: group A received 30 mg twice daily, and group B received 40 mg twice daily. Demographics and rates of venous thromboembolism were compared between dose groups and patients with inadequate or adequate anti-Xa levels. One hundred twenty-four patients were included, 90 in group A and 34 in group B. Demographics were similar, except that patients in group B had a higher mean body weight. Despite this, only 9% of group B patients had inadequate anti-Xa levels, compared with 33% of those in group A (P = .01). Imaging studies were available in 69 patients and revealed 8 venous thromboembolic events (P = NS, group A vs group B) with significantly more venous thromboembolic events occurring in patients with low anti-Xa levels (P = .02). Although higher dosing of enoxaparin led to improved anti-Xa levels, this did not equate to a statistical decrease in venous thromboembolism. Copyright © 2013 Elsevier Inc. All rights reserved.

The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye.

PubMed

Blackie, Caroline A; Coleman, Christy A; Holland, Edward J

2016-01-01

To evaluate the sustained effect (up to 1 year) of a single, 12-minute vectored thermal pulsation (VTP) treatment in improving meibomian gland function and dry eye symptoms in patients with meibomian gland dysfunction and evaporative dry eye. The prospective, multicenter, open-label clinical trial included 200 subjects (400 eyes) who were randomized to a single VTP treatment (treatment group) or twice-daily, 3-month, conventional warm compress and eyelid hygiene therapy (control group). Control group subjects received crossover VTP treatment at 3 months (crossover group). Effectiveness measures of meibomian gland secretion (MGS) and dry eye symptoms were evaluated at baseline and 1, 3, 6, 9, and 12 months. Subjects with inadequate symptom relief could receive additional meibomian gland dysfunction therapy after 3 (treatment group) and 6 months (crossover group). At 3 months, the treatment group had greater mean improvement in MGS (P<0.0001) and dry eye symptoms (P=0.0068), compared to controls. At 12 months, 86% of the treatment group had received only one VTP treatment, and sustained a mean improvement in MGS from 6.4±3.7 (baseline) to 17.3±9.1 (P<0.0001) and dry eye symptoms from 44.1±20.4 to 21.6±21.3 (P<0.0001); 89% of the crossover group had received only one VTP treatment with sustained mean improvement in MGS from 6.3±3.6 to 18.4±11.1 (P<0.0001) and dry eye symptoms from 49.1±21.0 to 24.0±23.2 (P<0.0001). Greater mean improvement in MGS was associated with less severe baseline MGS (P=0.0017) and shorter duration of time between diagnosis and treatment (P=0.0378). A single VTP treatment can deliver a sustained mean improvement in meibomian gland function and mean reduction in dry eye symptoms, over 12 months. A single VTP treatment provides significantly greater mean improvement in meibomian gland function and dry eye symptoms as compared to a conventional, twice-daily, 3-month regimen. Early VTP intervention for meibomian gland dysfunction is associated with improved treatment outcomes.

Tofacitinib 5 mg Twice Daily in Patients with Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs: A Comprehensive Review of Phase 3 Efficacy and Safety.

PubMed

Bird, Paul; Bensen, William; El-Zorkany, Bassel; Kaine, Jeffrey; Manapat-Reyes, Bernadette Heizel; Pascual-Ramos, Virginia; Witcombe, David; Soma, Koshika; Zhang, Richard; Thirunavukkarasu, Krishan

2018-05-24

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We performed a comprehensive review of phase 3 studies of tofacitinib 5 mg twice daily (BID) (approved dose in many countries) in patients with moderate to severe RA and inadequate response to prior disease-modifying antirheumatic drugs. A search of PubMed and ClinicalTrials.gov identified 5 studies: ORAL Solo (NCT00814307), ORAL Sync (NCT00856544), ORAL Standard (included adalimumab 40 mg once every 2 weeks; NCT00853385), ORAL Scan (NCT00847613), and ORAL Step (NCT00960440). Efficacy and safety data for tofacitinib 5 mg BID, placebo, and adalimumab were analyzed. Across the 5 studies, 1216 patients received tofacitinib 5 mg BID, 681 received placebo, and 204 received adalimumab. At month 3, tofacitinib demonstrated significantly higher 20%, 50%, and 70% improvement in American College of Rheumatology response criteria (ACR20, ACR50, and ACR70, respectively) response rates, greater improvement in Health Assessment Questionnaire-Disability Index, and a higher proportion of Disease Activity Score-defined remission than placebo. Frequencies of adverse events (AEs), serious AEs, and discontinuations due to AEs were similar for tofacitinib and placebo at month 3; serious infection events were more frequent for tofacitinib. In ORAL Standard, although not powered for formal comparisons, tofacitinib and adalimumab had numerically similar efficacy and AEs; serious AEs and serious infection events were more frequent with tofacitinib. Tofacitinib 5 mg BID reduced RA signs and symptoms and improved physical function versus placebo in patients with inadequate response to prior disease-modifying antirheumatic drugs. Tofacitinib 5 mg BID had a consistent, manageable safety profile across studies, with no new safety signals identified.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

[Tuberculosis in HIV-infected and AIDS patients].

PubMed

Rakhmanova, A G; Stepanova, E V; Romanova, E I; Evseeva, I D

2003-01-01

The course of the combined infection (tuberculosis plus HIV-infection) has been analysed in 41 patients. Of them, 24 patients developed tuberculosis in the presence of HIV-infection (group 1) and 17 were infected with HIV when they already had tuberculosis running up to 5 years. HIV-infection in group 1 ran a more severe course, the patients developed generalized, disseminated and complicated forms of tuberculosis with more frequent lethal outcome. 39 patients of both groups received specific antituberculous therapy including 1-5 drugs. A response to treatment was achieved in 23 (60%) patients (52 and 47.8% at early and late HIV-infection stages, respectively). Treatment failure was explained by development of severe opportunistic infections and secondary diseases (generalized cytomegalovirus infection, advanced candidiasis, toxoplasmosis), poor compliance, asocial life style, advanced tuberculosis process, late diagnosis, inadequate treatment. It is shown that in late HIV-infection positive results of treatment can be expected only in early detection of tuberculosis and active long-term treatment.

An external evaluation of the Diarrhea Alleviation through Zinc and ORS Treatment (DAZT) program in Gujarat and Uttar Pradesh, India.

PubMed

Lamberti, Laura M; Taneja, Sunita; Mazumder, Sarmila; LeFevre, Amnesty; Black, Robert E; Walker, Christa L Fischer

2015-12-01

To address inadequate coverage of oral rehydration salts (ORS) and zinc supplements for the treatment of diarrhea among children under-five, the Diarrhea Alleviation through Zinc and ORS Treatment (DAZT) program was carried out from 2011-2013 in Gujarat and from 2011-2014 in Uttar Pradesh (UP), India. The program focused on improving the diarrhea treatment practices of public and private sector providers. We conducted cross-sectional household surveys in program districts at baseline and endline and constructed state-specific logistic regression models with generalized estimating equations to assess changes in ORS and zinc treatment during the program period. Between baseline and endline, zinc coverage increased from 2.5% to 22.4% in Gujarat and from 3.1% to 7.0% in UP; ORS coverage increased from 15.3% to 39.6% in Gujarat but did not change in UP. In comparison to baseline, children with diarrhea in the two-weeks preceding the endline survey had higher odds of receiving zinc treatment in both Gujarat (odds ratio, OR = 11.2; 95% confidence interval (CI) 6.4-19.3) and UP (OR = 2.4; 95% CI 1.4-3.9), but the odds of receiving ORS only increased in Gujarat (OR = 3.6; 95% CI 2.7-4.8; UP OR = 0.9; 95% CI 0.7-1.2). Seeking care outside the home, especially from a public sector source, was associated with higher odds of receiving ORS and zinc. During the duration of the DAZT program, there were modest improvements in the treatment of diarrhea among young children. Future programs should build upon and accelerate this trend with continued investment in public and private sector provider training and supply chain sustainability, in addition to targeted caregiver demand generation activities.

Eluxadoline Efficacy in IBS-D Patients Who Report Prior Loperamide Use.

PubMed

Lacy, Brian E; Chey, William D; Cash, Brooks D; Lembo, Anthony J; Dove, Leonard S; Covington, Paul S

2017-06-01

Irritable bowel syndrome with diarrhea (IBS-D) is often managed with over-the-counter therapies such as loperamide, though with limited success. This analysis evaluated the efficacy of eluxadoline in patients previously treated with loperamide in two phase 3 studies. Adults with IBS-D (Rome III criteria) were enrolled and randomized to placebo or eluxadoline (75 or 100 mg) twice daily for 26 (IBS-3002) or 52 (IBS-3001) weeks. Patients reported loperamide use over the previous year and recorded their rescue loperamide use during the studies. The primary efficacy end point was the proportion of patients with a composite response of simultaneous improvement in abdominal pain and reduction in diarrhea. A total of 2,428 patients were enrolled; 36.0% reported prior loperamide use, of whom 61.8% reported prior inadequate IBS-D symptom control with loperamide. Among patients with prior loperamide use, a greater proportion treated with eluxadoline (75 and 100 mg) were composite responders vs. those treated with placebo with inadequate prior symptom control, over weeks 1-12 (26.3% (P=0.001) and 27.0% (P<0.001) vs. 12.7%, respectively); similar results were observed over weeks 1-26. When daily rescue loperamide use was imputed as a nonresponse day, the composite responder rate was still higher in patients receiving eluxadoline (75 and 100 mg) vs. placebo over weeks 1-12 (P<0.001) and weeks 1-26 (P<0.001). Adverse events included nausea and abdominal pain. Eluxadoline effectively and safely treats IBS-D symptoms of abdominal pain and diarrhea in patients who self-report either adequate or inadequate control of their symptoms with prior loperamide treatment, with comparable efficacy and safety irrespective of the use of loperamide as a rescue medication during eluxadoline treatment.

Suppurative cervical lymphadenitis in infancy: microbiology and sociology.

PubMed

Worley, Mitchell L; Seif, Joseph M; Whigham, Amy S; Mims, James W; Shetty, Avinash K; Evans, Adele K

2015-06-01

To investigate the associations between patient age, sociological factors, and the microbiology of pediatric neck infections. Retrospective chart review of children up to 5 years old who underwent surgical management of suppurative cervical lymphadenitis. A total of 76 individuals met inclusion criteria; 93% of culture-positive infections were caused by Staphylococcus aureus in infants, compared with 59% in children between 13 months and 5 years of age (P = .002). Of the S aureus isolates, 51% were methicillin-resistant S aureus (MRSA) and 49% were methicillin-sensitive S aureus. Methicillin resistance was associated with African American race (P = .004); 67% of participants received empirical antibiotics prior to admission. Of these, 73% received antibiotics in the β-lactam class, and 25% received treatment with clindamycin. Incidence of MRSA is high in infants with cervical lymphadenitis who fail empirical antibiotic therapy and require surgical management. Empirical coverage for cervical lymphadenitis with β-lactam antibiotics may provide inadequate coverage for early infection in this population. © The Author(s) 2015.

The use of electroconvulsive therapy in the elderly: a study from the psychiatric unit of a north Indian teaching hospital.

PubMed

Jain, Gaurav; Kumar, Vineet; Chakrabarti, Subho; Grover, Sandeep

2008-06-01

There are very little data on elderly patients receiving electroconvulsive therapy (ECT) in India. This study was a preliminary attempt at characterizing the clinical and demographic profile of elderly subjects (>or=60 years) who received ECT in the psychiatric department of a teaching hospital in north India. A retrospective case-note review was carried out to identify patients 60 years or older who had received ECT over an 8-year period at the Postgraduate Institute of Medical Education and Research, Chandigarh, India. Several details about their demographic and clinical profile, indications for ECT, response patterns, and adverse effects were extracted. Over the 8 years, 373 patients received ECT, of which 56 (15%) were 60 years or older. Complete records were available for only 50 of these patients. The majority (96%) had depression. The index depressive episode for which ECT was used was severe in 91.6% of the subjects, and 68% had not responded to adequate psychotropic treatment before ECT. Comorbid medical illnesses were present in 66% of cases and were associated with significantly higher risk of cognitive side effects. However, side effects were usually mild; there were no serious untoward events caused by ECT. About 80% to 90% showed some response to treatment. Those who had received inadequate antidepressant treatment before ECT were significantly more likely to respond to ECT. Elderly with depression constitute a substantial proportion of those receiving ECT in India. Use of ECT in this population seemed to be mainly restricted to those who were very severely ill and poorly responsive to medications. Electroconvulsive therapy seemed to be a safe and effective treatment in such situations. However, particular care may be required in the subgroup with comorbid physical problems that may be more vulnerable to cognitive adverse effects.

Factors associated with an inadequate hypoglycemia in the insulin tolerance test in Japanese patients with suspected or proven hypopituitarism.

PubMed

Takahashi, Kiyohiko; Nakamura, Akinobu; Miyoshi, Hideaki; Nomoto, Hiroshi; Kameda, Hiraku; Cho, Kyu Yong; Nagai, So; Shimizu, Chikara; Taguri, Masataka; Terauchi, Yasuo; Atsumi, Tatsuya

2017-04-29

We attempted to identify the predictors of an inadequate hypoglycemia in insulin tolerance test (ITT), defined as a blood glucose level higher than 2.8 mmol/L after insulin injection, in Japanese patients with suspected or proven hypopituitarism. A total of 78 patients who had undergone ITT were divided into adequate and inadequate hypoglycemia groups. The relationships between the subjects' clinical parameters and inadequate hypoglycemia in ITT were analyzed. Stepwise logistic regression analysis identified high systolic blood pressure (SBP) and high homeostasis model assessment of insulin resistance (HOMA-IR) as being independent factors associated with inadequate hypoglycemia in ITT. Receiver operating characteristic (ROC) curve analysis revealed the cutoff value for inadequate hypoglycemia was 109 mmHg for SBP and 1.4 for HOMA-IR. The areas under ROC curve for SBP and HOMA-IR were 0.72 and 0.86, respectively. We confirmed that high values of SBP and HOMA-IR were associated with inadequate hypoglycemia in ITT, regardless of the degree of reduction of pituitary hormone levels. Furthermore, the strongest predictor of inadequate hypoglycemia was obtained by using the cutoff value of HOMA-IR. Our results suggest that HOMA-IR is a useful pre-screening tool for ITT in these populations.

Low-Burden Strategies to Promote Smoking Cessation Treatment Among Patients With Serious Mental Illness.

PubMed

Chen, Li-Shiun; Baker, Timothy B; Korpecki, Jeanette M; Johnson, Kelly E; Hook, Jaime P; Brownson, Ross C; Bierut, Laura J

2018-06-01

Patients with serious mental illness have high smoking prevalence and early mortality. Inadequate implementation of evidence-based smoking cessation treatment in community mental health centers (CMHCs) contributes to this disparity. This column describes a study of the effects of quality improvement strategies on treatment and cessation outcomes among patients with serious mental illness at four CMHCs. Two low-burden strategies, decision support and academic detailing with data-driven feedback, were implemented in the CMHCs' clinics from 2014 to 2016. Pre- and postimplementation data from pharmacy and medical records were analyzed. The percentage of patients receiving cessation medication increased from 5% to 18% (p≤.001), and smoking prevalence decreased from 57% to 54% (p≤.001). This quality improvement approach holds great potential for increasing the level of smoking cessation care for patients treated in CMHC settings. Decision support and academic detailing with feedback may be effective strategies to promote best practices.

Prolonged fasting with fluid therapy is related to poorer outcomes in medical patients.

PubMed

Kyriakos, Georgios; Calleja-Fernández, Alicia; Ávila-Turcios, Dalia; Cano-Rodríguez, Isidoro; Ballesteros Pomar, María D; Vidal-Casariego, Alfonso

2013-01-01

An inadequate fluid therapy can worsen the outcomes of surgical patients, but there are no data in medical patients. The aim of this study was to determine the adequacy of fluid therapy in hospitalised patients of medical wards, and its influence on outcomes. Cross-sectional study including nil-per-os patients admitted in medical wards of the Complejo Asistencial Universitario de León. The administered fluid therapy was compared with the standardised requirements. Nutritional status was evaluated with Subjective Global Assessment. Fasting was considered inappropriate if it lasted > 7 days in well-nourished, and >5 days in malnourished patients if nutritional support had not been provided. Fluid therapy lasted 4 (IQR = 2) days, and fasting was inadequately maintained in 27% of patients. Fluid requirements were correctly fulfilled, but patients received an excess of sodium (+58.4%) and chloride (+62.2%), and potassium administration was insufficient (-35.1%). Glucose supply was 68.8 (29.2) g/d, and 99% received < 130 g/d. Patients with an inadequate duration of fasting had a longer hospital stay after adjusting for sex, age, nutritional status, infused volume, electrolytes, glucose and diseases. Only malnutrition predicted mortality during hospitalisation (OR 10.5; 95%CI 1.3 to 83.2), when multivariate analysis was performed. Fasting medical patients receive an inadequate supply of glucose and electrolytes. Prolonged fluid therapy and malnutrition may worsen the outcomes of these patients, independently of other conditions like age or diseases. Copyright © AULA MEDICA EDICIONES 2013. Published by AULA MEDICA. All rights reserved.

Metastatic extraskeletal Ewing's sarcoma treated with trabectedin: A case report.

PubMed

Hernando-Cubero, Jorge; Sanz-Moncasi, Pilar; Hernández-García, Alba; Pajares-Bernard, Isabel; Martínez-Trufero, Javier

2016-10-01

The Ewing's sarcoma family of tumors (ESFT) comprises a number of rare malignant tumors. Standard first-line treatment for patients with these tumors includes chemotherapy with a five-drug regimen of vincristine, doxorubicin (Adriamycin ® ) and cyclophosphamide, alternating with ifosfamide and etoposide (VAC/IE). In cases of inadequate response, there are a number of second-line regimens available. However, further treatment options are required for those patients with disease unresponsive to standard treatment. Trabectedin is a novel treatment option for patients with ESFT. The present study reports the case of a Caucasian 69-year-old female patient who presented with a soft tissue mass on the chest wall that had developed 7 months earlier. A computed tomography scan revealed a 9×8×7-cm mass on the anterior chest wall above the pectoral muscle. Histopathological evaluations and molecular analysis indicated that it was consistent with a metastatic extraskeletal Ewing's sarcoma. The patient was treated with an alternating VAC/IE regimen; however, an inadequate response was observed. The patient received second-line treatment with a gemcitabine and dacarbazine combination regimen, but the disease progressed. Subsequently, treatment with trabectedin (1.5 mg/m 2 as a 24-h continuous infusion every 3 weeks) was initiated. Trabectedin treatment resulted in long-lasting (18 months) progression-free survival. It is vital that novel drugs continue to being developed for patients with ESFT following progression subsequent to standard chemotherapy. The current report presents a case of a patient with metastatic, pre-treated Ewing's sarcoma achieving disease stabilization with trabectedin. Based on these results and the observed tolerability profile, trabectedin represents an alternative treatment for patients with ESFT. Further studies are required in order to determine the efficacy of trabectedin as monotherapy or in combination with other drugs. It is also important to identify which tumor subtypes, specific translocations and patient profiles will benefit the most from treatment with trabectedin.

Comparison of Vildagliptin and Pioglitazone in Korean Patients with Type 2 Diabetes Inadequately Controlled with Metformin.

PubMed

Kim, Jong Ho; Kim, Sang Soo; Baek, Hong Sun; Lee, In Kyu; Chung, Dong Jin; Sohn, Ho Sang; Bae, Hak Yeon; Kim, Mi Kyung; Park, Jeong Hyun; Choi, Young Sik; Kim, Young Il; Hahm, Jong Ryeal; Lee, Chang Won; Jo, Sung Rae; Park, Mi Kyung; Lee, Kwang Jae; Kim, In Joo

2016-06-01

We compared the efficacies of vildagliptin (50 mg twice daily) relative to pioglitazone (15 mg once daily) as an add-on treatment to metformin for reducing glycosylated hemoglobin (HbA1c) levels in Korean patients with type 2 diabetes. The present study was a multicenter, randomized, active-controlled investigation comparing the effects of vildagliptin and pioglitazone in Korean patients receiving a stable dose of metformin but exhibiting inadequate glycemic control. Each patient underwent a 16-week treatment period with either vildagliptin or pioglitazone as an add-on treatment to metformin. The mean changes in HbA1c levels from baseline were -0.94% in the vildagliptin group and -0.6% in the pioglitazone group and the difference between the treatments was below the non-inferiority margin of 0.3%. The mean changes in postprandial plasma glucose (PPG) levels were -60.2 mg/dL in the vildagliptin group and -38.2 mg/dL in the pioglitazone group and these values significantly differed (P=0.040). There were significant decreases in the levels of total, low density lipoprotein, high density lipoprotein (HDL), and non-HDL cholesterol in the vildagliptin group but increases in the pioglitazone group. The mean change in body weight was -0.07 kg in the vildagliptin group and 0.69 kg in the pioglitazone group, which were also significantly different (P=0.002). As an add-on to metformin, the efficacy of vildagliptin for the improvement of glycemic control is not inferior to that of pioglitazone in Korean patients with type 2 diabetes. In addition, add-on treatment with vildagliptin had beneficial effects on PPG levels, lipid profiles, and body weight compared to pioglitazone.

[Profile of prescription and adequacy of treatment with non-steroidal anti-inflammatory drugs in diabetic patients].

PubMed

Navarro-Martínez, A; Vidal-Martínez, M; García-Rosa, I; Lázaro-Gómez, M J; Brotons-Román, J

2015-01-01

The aim of this study was to quantify and describe the prescription profile, as well as to assess the adequacy of treatment with non-steroidal anti-inflammatory drugs (NSAIDs) in the diabetic population of a health district. This is a descriptive, cross-sectional study aimed at a target population of 2,795 diabetic patients. Data were collected from the computerised clinical records of a sample of 380 individuals. The adequacy of treatment was assessed using the recommendations proposed by the Spanish societies of Rheumatology, Cardiology and Gastroenterology. More than one-quarter (28%) of the diabetic patients received treatment with NSAIDs. The most commonly used ones were ibuprofen, naproxen, and dexketoprofen, with a defined daily dose per 1,000 inhabitants per day of 35.3, 17.2, and 13.2, respectively. In patients with a history of chronic kidney disease and cardiovascular high risk, fewer NSAIDs were prescribed, while they were used most frequently in patients with a risk for gastrointestinal adverse events. The prescription was considered adequate in 46.5% of diabetic patients. The main causes of inappropriate use were the inadequate prescription of NSAIDs (25.2%), and the use of any NSAID other than naproxen (20.6%). The most prescribed NSAIDs were those showing a low cardiovascular risk profile. Treatment with NSAIDs was inadequate in more than half of the patients. Risk factors for cardiovascular, and especially gastrointestinal, events must be considered in order to avoid its use when not indicated, as well as the use of any NSAIDs other than naproxen. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

The Impact of Pre-Existing Mental Health Disorders on the Diagnosis, Treatment and Survival among Lung Cancer Patients in the U.S. Military Health System

PubMed Central

Lin, Jie; McGlynn, Katherine A.; Carter, Corey A.; Nations, Joel A.; Anderson, William F.; Shriver, Craig D.; Zhu, Kangmin

2018-01-01

Background Higher cancer-related mortality has been observed among people with mental health disorders than in the general population. Both delay in diagnosis and inadequate treatment due to health care access have been found to explain the higher mortality. The U.S. Military Health System (MHS), in which all beneficiaries have equal access to health care, provides an ideal system to study this disparity where there are no or minimal barriers to health care access. This study assessed pre-existing mental health disorders and stage at diagnosis, receipt of cancer treatment and overall survival among non-small cell lung cancer (NSCLC) patients in the U.S. MHS. Methods The study used data from the linked database from the Department of Defense’s Central Cancer Registry and the MHS Data Repository (MDR). The study subjects included 5,054 patients with histologically confirmed primary NSCLC diagnosed between 1998 and 2007. Results Patients with a pre-existing mental disorder did not present with more advanced disease at diagnosis than those without. There were no significant differences in receiving cancer treatments between the two groups. However, patients with a mental health disorder had a higher mortality than those without (Adjusted Hazard ratio (HR) =1.11, 95% CI=1.03 to 1.20). Conclusions Poor survival in NSCLC in patients with a pre-existing mental health disorder is not necessarily associated with delay in diagnosis and/or inadequate cancer treatment. Impact This study contributes to the current understanding that health care access is not sufficient to explain the poor survival among NSCLC patients with pre-existing mental health disorder. PMID:27566418

The role of eszopiclone in the treatment of insomnia.

PubMed

Morin, Anna K; Willett, Kristine

2009-05-01

Insomnia is a common and underdiagnosed condition that can result in significant economic and clinical consequences. Despite numerous behavioral and pharmacotherapeutic treatment options available for insomnia, few receive adequate treatment, and sleep maintenance (staying asleep) remains a significant problem. To date, available sedative-hypnotic agents have limitations that have lead to inadequate treatment of insomnia. This review provides an overview of eszopiclone and its role in the treatment of insomnia. Electronic databases (MEDLINE, EMBASE, International Pharmaceutical Abstracts) were searched for applicable primary literature and review articles. Mechanisms of action at the gamma-amino butyric acid (GABA) receptor sites and pharmacologic and pharmacokinetic characteristics are presented. Eszopiclone, a nonbenzodiazepine S-enantiomer of racemic zopiclone, is highlighted as the first sedative-hypnotic agent to be approved by the United States Food and Drug Administration for the treatment of sleep onset latency and sleep maintenance insomnia with no short-term restrictions. Recently, the European Medicines Agency recommended marketing authorization of eszopiclone. Eszopiclone has been shown to be an efficacious and cost-effective option for the treatment of transient and chronic insomnia in adults.

Who Gets Needed Mental Health Care? Use of Mental Health Services among Adults with Mental Health Need in California

PubMed Central

Ponce, Ninez A.

2017-01-01

Background Timely and appropriate treatment could help reduce the burden of mental illness. Purpose This study describes mental health services use among Californians with mental health need, highlights underserved populations, and discusses policy opportunities. Methods Four years of California Health Interview Survey data (2011, 2012, 2013, 2014) were pooled and weighted to the 2013 population to estimate mental health need and unmet need (n=82,706). Adults with mental health need had “unmet need” if they did not use prescription medication and did not have at least four or more mental health visits in the past year. Multivariable logistic regression analysis was performed to predict the probability adults with mental health need did not receive past-year treatment (n=5,315). Results Seventy-seven percent of Californians with mental health need received no or inadequate mental health treatment in 2013. Men, Latinos, Asians, young people, older adults, people with less education, uninsured adults, and individuals with limited English proficiency were significantly more likely to have unmet need. Cost of treatment and mental health stigma were common reasons for lack of care. Conclusion Unmet mental health need is predominant in California. Policy recommendations include continued expansion of mental health coverage, early identification, and ensuring that treatment is culturally and linguistically appropriate. PMID:28729814

Predicting Patients with Inadequate 24- or 48-Hour Urine Collections at Time of Metabolic Stone Evaluation.

PubMed

McGuire, Barry B; Bhanji, Yasin; Sharma, Vidit; Frainey, Brendan T; McClean, Megan; Dong, Caroline; Rimar, Kalen; Perry, Kent T; Nadler, Robert B

2015-06-01

We aimed to understand the characteristics of patients who are less likely to submit adequate urine collections at metabolic stone evaluation. Inadequate urine collection was defined using two definitions: (1) Reference ranges for 24-hour creatinine/kilogram (Cr/24) and (2) discrepancy in total 24-hour urine Cr between 24-hour urine collections. There were 1502 patients with ≥1 kidney stone between 1998 and 2014 who performed a 24- or 48-hour urine collection at Northwestern Memorial Hospital and who were identified retrospectively. Multivariate analysis was performed to analyze predictor variables for adequate urine collection. A total of 2852 urine collections were analyzed. Mean age for males was 54.4 years (range 17-86), and for females was 50.2 years (range 8-90). One patient in the study was younger than 17 years old. (1) Analysis based on the Cr 24/kg definition: There were 50.7% of patients who supplied an inadequate sample. Females were nearly 50% less likely to supply an adequate sample compared with men, P<0.001. Diabetes (odds ratio [OR] 1.42 [1.04-1.94], P=0.026) and vitamin D supplementation (OR 0.64 [0.43-0.95], P=0.028) predicted receiving an adequate/inadequate sample, respectively. (2) Analysis based on differences between total urinary Cr: The model was stratified based on percentage differences between samples up to 50%. At 10%, 20%, 30%, 40%, and 50% differences, inadequate collections were achieved in 82.8%, 66.9%, 51.7%, 38.5%, and 26.4% of patients, respectively. Statistical significance was observed based on differences of ≥40%, and this was defined as the threshold for an inadequate sample. Female sex (OR 0.73 [0.54-0.98], P=0.037) predicted supplying inadequate samples. Adequate collections were more likely to be received on a Sunday (OR 1.6 [1.03-2.58], P=0.038) and by sedentary workers (OR 2.3 [1.12-4.72], P=0.023). Urine collections from patients during metabolic evaluation for nephrolithiasis may be considered inadequate based on two commonly used clinical definitions. This may have therapeutic or economic ramifications and the propensity for females to supply inadequate samples should be investigated further.

F45. THE EFFICACY AND SAFETY OF BLONASERIN AFTER SWITCHING FROM OTHER ATYPICAL ANTIPSYCHOTICS IN SCHIZOPHRENIC INPATIENTS: AN OPEN-LABEL, MULTI-CENTER TRIAL

PubMed Central

Yoon, Bo-Hyun; Bahk, Won-Myong; Kwon, Young Joon; Lee, Sang-Yeol; Lee, Kwanghun; Kim, Moon Doo; Park, Sung-Yong; Song, Min-Kyu

2018-01-01

Abstract Background The aim of this study was to investigate the efficacy and safety of blonanserin treatment after switching from other atypical antipsychotics in schizophrenic inpatients who showed inadequate efficacy and poor tolerability. Methods A total of 63 schizophrenic inpatients (inadequate response group=45 and poor tolerability group=18) were included in this study. They were already treated with atypical antipsychotics except blonanserin and not favored due to inadequate responses or intolerable adverse effects. Blonanserin was administered during 12 weeks after switching from their previous antispsychotics. Treatment response was evaluated with Brief Psychiatric Rating Scale (BPRS) and CGI-S, and safety profile were measured with Abnormal Involuntary Movement Scale (AIMS), Simpson-Angus Extrapyramidal Side effects Scale (SAR)S and Barnes Akathisia Rating Scale (BARS). Drug Attitude Inventory (DAI-10) and Subjective Well-being Under Neuroleptic Treatment (SWN) were used for subjective estimates. Assessments were done at baseline, 1, 2, 4, 8 and 12 weeks after blonanserin treatment. Repeated measures of ANOVA were done to analyze the group (inadequate vs. intolerable group) and time effects. Results CGI and BPRS were showed significant treatment responses after switching to Blonaserin. Time effects were significant at 2, 4, 8, 12 weeks after switching and group by time effect were also significant at that time. Mean changes of AIMS, SARS and BARS scores were not significant throughout test trial. Although SWN was significantly improved after switching to Blonaserin, it was not found significant group by time effect. Discussion The results suggest that blonanserin may be effective and well tolerable in schizophrenic patients who showed inadequate treatment response or poor tolerability.

Individualised motivational counselling to enhance adherence to antiretroviral therapy is not superior to didactic counselling in South African patients: findings of the CAPRISA 058 randomised controlled trial.

PubMed

van Loggerenberg, Francois; Grant, Alison D; Naidoo, Kogieleum; Murrman, Marita; Gengiah, Santhanalakshmi; Gengiah, Tanuja N; Fielding, Katherine; Abdool Karim, Salim S

2015-01-01

Concerns that standard didactic adherence counselling may be inadequate to maximise antiretroviral therapy (ART) adherence led us to evaluate more intensive individualised motivational adherence counselling. We randomised 297 HIV-positive ART-naïve patients in Durban, South Africa, to receive either didactic counselling, prior to ART initiation (n = 150), or an intensive motivational adherence intervention after initiating ART (n = 147). Study arms were similar for age (mean 35.8 years), sex (43.1 % male), CD4+ cell count (median 121.5 cells/μl) and viral load (median 119,000 copies/ml). Virologic suppression at 9 months was achieved in 89.8 % of didactic and 87.9 % of motivational counselling participants (risk ratio [RR] 0.98, 95 % confidence interval [CI] 0.90-1.07, p = 0.62). 82.9 % of didactic and 79.5 % of motivational counselling participants achieved >95 % adherence by pill count at 6 months (RR 0.96, 95 % CI 0.85-1.09, p = 0.51). Participants receiving intensive motivational counselling did not achieve higher treatment adherence or virological suppression than those receiving routinely provided didactic adherence counselling. These data are reassuring that less resource intensive didactic counselling was adequate for excellent treatment outcomes in this setting.

Individualised motivational counselling to enhance adherence to antiretroviral therapy is not superior to didactic counselling in South African patients: Findings of the CAPRISA 058 randomised controlled trial

PubMed Central

van Loggerenberg, Francois; Grant, Alison D.; Naidoo, Kogieleum; Murrman, Marita; Gengiah, Santhanalakshmi; Gengiah, Tanuja N.; Fielding, Katherine; Karim, Salim S. Abdool

2014-01-01

Concerns that standard didactic adherence counselling may be inadequate to maximise antiretroviral therapy (ART) adherence led us to evaluate more intensive individualised motivational adherence counselling. We randomised 297 HIV-positive ART-naïve patients in Durban, South Africa, to receive either didactic counselling, prior to ART initiation (n=150), or an intensive motivational adherence intervention after initiating ART (n=147). Study arms were similar for age (mean 35.8 years), sex (43.1% male), CD4+ cell count (median 121.5 cells/μl) and viral load (median 119 000 copies/ml). Virologic suppression at nine months was achieved in 89.8% of didactic and 87.9% of motivational counselling participants (risk ratio [RR] 0.98, 95% confidence interval [CI] 0.90-1.07, p=0.62). 82.9% of didactic and 79.5% of motivational counselling participants achieved >95% adherence by pill count at six months (RR 0.96, 95%CI 0.85-1.09, p=0.51). Participants receiving intensive motivational counselling did not achieve higher treatment adherence or virological suppression than those receiving routinely provided didactic adherence counselling. These data are reassuring that less resource intensive didactic counselling was adequate for excellent treatment outcomes in this setting. PMID:24696226

Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial.

PubMed

Nash, Peter; Kirkham, Bruce; Okada, Masato; Rahman, Proton; Combe, Benard; Burmester, Gerd-Ruediger; Adams, David H; Kerr, Lisa; Lee, Chin; Shuler, Catherine L; Genovese, Mark

2017-06-10

Patients who have had inadequate response to tumour necrosis factor inhibitors have fewer treatment options and are generally more treatment refractory to subsequent therapeutic interventions than previously untreated patients. We report the efficacy and safety of ixekizumab, a monoclonal antibody that selectively targets interleukin-17A, in patients with active psoriatic arthritis and previous inadequate response to tumour necrosis factor inhibitors. In this double-blind, multicentre, randomised, placebo-controlled, phase 3 study (SPIRIT-P2), patients were recruited from 109 centres across ten countries in Asia, Australia, Europe, and North America. Patients were aged 18 years or older, had a confirmed diagnosis of psoriatic arthritis for at least 6 months, and had a previous inadequate response, distinguished by being refractory to therapy or had loss of efficacy, or were intolerant to tumour necrosis factor inhibitors. Patients were randomly assigned (1:1:1) by a computer-generated random sequence to receive a subcutaneous injection of 80 mg ixekizumab every 4 weeks or every 2 weeks after a 160 mg starting dose or placebo. The primary endpoint was the proportion of patients who attained at least 20% improvement in the American College of Rheumatology response criteria (ACR-20) at week 24. This study is registered with ClinicalTrials.gov, number NCT02349295. Between March 3, 2015, to March 22, 2016, 363 patients were randomly assigned to placebo (n=118), ixekizumab every 4 weeks (n=122), or ixekizumab every 2 weeks (n=123). At week 24, a higher proportion of patients attained ACR-20 with ixekizumab every 4 weeks (65 [53%] patients; effect size vs placebo 33·8% [95% CI 22·4-45·2]; p<0·0001) and ixekizumab every 2 weeks (59 [48%] patients; 28.5% [17·1-39.8]; p<0·0001) than did patients with placebo (23 [20%] patients). Up to week 24, serious adverse events were reported in three (3%) patients with ixekizumab every 4 weeks, eight (7%) with ixekizumab every 2 weeks, and four (3%) with placebo; no deaths were reported. Infections were reported in 47 (39%) patients with ixekizumab every 4 weeks, 47 (38%) with ixekizumab every 2 weeks, and 35 (30%) with placebo. Three (2%) serious infections, all in patients in the ixekizumab every 2 weeks group, were reported. Both the 2-week and 4-week ixekizumab dosing regimens improved the signs and symptoms of patients with active psoriatic arthritis and who had previously inadequate response to tumour necrosis factor inhibitors, with a safety profile consistent with previous studies investigating ixekizumab. Eli Lilly and Company. Copyright © 2017 Elsevier Ltd. All rights reserved.

Disabilities in Written Expression

ERIC Educational Resources Information Center

Gardner, Teresa J.

2011-01-01

Regular education teachers may have received inadequate preparation to work with the variety of student disabilities encountered in the classroom, or they may have received limited training regarding the full range of learning disabilities and their effects on classroom performance. Along with problems in the area of math, students may also have…

75 FR 48967 - Proposed Administrative Settlement Agreement Under Section 122(h) of the Comprehensive...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-12

... settlement agreement (``Settlement Agreement'') with Peter S. Austin, the William E. Austin Trust, and Austin... notice, EPA will receive written comments relating to the proposed Settlement Agreement. EPA will..., improper or inadequate. EPA's response to any comments received will be available for public inspection at...

Determinants of Integrated Management of Childhood Illness (IMCI) non-severe pneumonia classification and care in Malawi health facilities: Analysis of a national facility census.

PubMed

Johansson, Emily White; Nsona, Humphreys; Carvajal-Aguirre, Liliana; Amouzou, Agbessi; Hildenwall, Helena

2017-12-01

Research shows inadequate Integrated Management of Childhood Illness (IMCI)-pneumonia care in various low-income settings but evidence is largely from small-scale studies with limited evidence of patient-, provider- and facility-levels determinants of IMCI non-severe pneumonia classification and its management. The Malawi Service Provision Assessment 2013-2014 included 3149 outpatients aged 2-59 months with completed observations, interviews and re-examinations. Mixed-effects logistic regression models quantified the influence of patient-, provider and facility-level determinants on having IMCI non-severe pneumonia and its management in observed consultations. Among 3149 eligible outpatients, 590 (18.7%) had IMCI non-severe pneumonia classification in re-examination. 228 (38.7%) classified cases received first-line antibiotics and 159 (26.9%) received no antibiotics. 18.6% with cough or difficult breathing had 60-second respiratory rates counted during consultations, and conducting this assessment was significantly associated with IMCI training ever received (odds ratio (OR) = 2.37, 95% confidence interval (CI): 1.29-4.31) and negative rapid diagnostic test results (OR = 3.21, 95% CI: 1.45-7.13). Older children had lower odds of assessments than infants (OR = 48-59 months: 0.35, 95% CI: 0.16-0.75). Children presenting with any of the following complaints also had reduced odds of assessment: fever, diarrhea, skin problem or any danger sign. First-line antibiotic treatment for classified cases was significantly associated with high temperatures (OR = 3.26, 95% CI: 1.24-8.55) while older children had reduced odds of first-line treatment compared to infants (OR = 48-59 months: 0.29, 95% CI: 0.10-0.83). RDT-confirmed malaria was a significant predictor of no antibiotic receipt for IMCI non-severe pneumonia (OR = 10.65, 95% CI: 2.39-47.36). IMCI non-severe pneumonia care was sub-optimal in Malawi health facilities in 2013-2014 with inadequate assessments and prescribing practices that must be addressed to reduce this leading cause of mortality. Child's symptoms and age, malaria diagnosis and provider training were primary influences on assessment and treatment practices. Current evidence could be used to better target IMCI training and support to improve pneumonia care for sick children in Malawi facilities.

Faecal pollution loads in the wastewater effluents and receiving water bodies: a potential threat to the health of Sedibeng and Soshanguve communities, South Africa.

PubMed

Teklehaimanot, Giorgis Z; Coetzee, Martie A A; Momba, Maggy N B

2014-01-01

The discharge of untreated or inadequately treated effluents has been identified among the activities responsible for the spread of a wide range of potentially infectious agents. The aim of this study was to determine whether inadequate treatment of wastewater and the faecal pollution load of effluents and receiving water bodies in Sedibeng District and Soshanguve peri-urban area of the Tshwane Metropolitan Municipality could be a potential threat to the health of the surrounding communities. Variations in the counts of faecal indicator bacteria and pathogenic microorganisms and compliance of the effluents and receiving water bodies with South African and World Health Organization standards were assessed between August 2011 and May 2012 using culture-based methods and molecular techniques. The overall quality of effluents did not comply with the South African special standard of no risk for unrestricted irrigation (zero Escherichia coli/100 ml). The quality of the receiving water bodies did not comply with South African regulatory limits set for domestic purposes (zero E. coli/100 ml, <30 faecal enterococci/100 ml and <1 somatic coliphages/100 ml), for full contact recreation (<20 somatic coliphages/100 ml) and aquaculture (<10 E. coli/100 ml) and WHO standards for full and intermediate contact recreational use (<1 E. coli/100 ml and <40 faecal enterococci/100 ml, respectively). The PCR results revealed the prevalence of pathogenic microorganisms; between 0 and 60 % of samples tested positive for Salmonella Typhimurium and Shigella dysenteriae, and between 20 and 60% of samples tested positive for Vibrio cholerae. These findings demonstrated that potential health risks might be associated with the use of the target river waters for domestic, recreational and irrigation purposes. This study calls for a prompt intervention to improve wastewater management.

Vildagliptin as add-on therapy to insulin improves glycemic control without increasing risk of hypoglycemia in Asian, predominantly Chinese, patients with type 2 diabetes mellitus.

PubMed

Ning, Guang; Wang, Weiqing; Li, Ling; Ma, Jianhua; Lv, Xiaofeng; Yang, Ming; Wang, Wei; Woloschak, Michael; Lukashevich, Valentina; Kothny, Wolfgang

2016-05-01

The aim of the present study was to investigate the efficacy and safety of vildagliptin added onto insulin with or without metformin in an Asian, predominantly Chinese, population with type 2 diabetes mellitus (T2DM). In this 24-week, multicenter, double-blind, placebo-controlled trial, patients with T2DM inadequately controlled (HbA1c 7.5%-11.0%) on stable therapy with long-acting, intermediate-acting, or premixed insulin, with or without concomitant metformin, were randomized to receive vildagliptin 50 mg b.i.d. or placebo. Of 293 patients randomized, 146 received vildagliptin and 147 received placebo treatment. At baseline, the overall mean age of patients was 58.1 years, mean T2DM duration was 11.3 years, and mean HbA1c was 8.7%. The adjusted mean (±SE) change in HbA1c at Week 24 in the vildagliptin and placebo groups was -1.08 ± 0.12% and -0.38 ± 0.12%, respectively (between-treatment difference -0.70 ± 0.16%; P < 0.001). The between-group difference in fasting plasma glucose was -0.43 ± 0.38 mmol/L (P = 0.259). Significantly, more patients achieved HbA1c <7.0% with vildagliptin than with placebo (23.6% vs. 11.2%; P = 0.006). The incidence of adverse events in the vildagliptin and placebo groups was 43.8% and 46.3%, whereas that of serious adverse events was 3.4% and 6.8%, respectively. The frequency of hypoglycemia was lower in the vildagliptin than placebo group (2.7% vs. 5.4%). The addition of vildagliptin 50 mg b.i.d. significantly improved glycemic control without an increased risk of hypoglycemia in Asian, predominantly Chinese, patients with T2DM inadequately controlled on insulin, with or without metformin. © 2016 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley Sons Australia, & Ltd.

User survey of Nanny Angel Network, a free childcare service for mothers with cancer.

PubMed

Cohen, L; Schwartz, N; Guth, A; Kiss, A; Warner, E

2017-08-01

The purpose of the present study was to determine user satisfaction with Nanny Angel Network (nan), a free childcare service for mothers undergoing cancer treatment. All 243 living mothers who had used the nan service were invited by telephone to participate in an online research survey; 197 mothers (81%) consented to participate. The survey, sent by e-mail, consisted of 39 items divided into these categories: demographics, supports, use, satisfaction, and general comments. Of the 197 mothers who consented to receive the e-mailed survey, 104 (53%) completed it. More than 90% of the mothers were very satisfied with the help and support from their Nanny Angel. Many mothers mentioned that the Nanny Angel was most helpful during treatment and medical appointments, with 75% also mentioning that their Nanny Angel helped them to adhere to their scheduled medical appointments. However, 64% felt that they had not received enough visits from their Nanny Angel. Satisfaction with the nan childcare provider was high, but mothers wished the service had been available to them more often. Our study highlights the importance of providing childcare to mothers with inadequate support systems, so as to allow for greater adherence to treatment and medical appointments, and for more time to recover.

Comparison of acarbose and voglibose in diabetes patients who are inadequately controlled with basal insulin treatment: randomized, parallel, open-label, active-controlled study.

PubMed

Lee, Mi Young; Choi, Dong Seop; Lee, Moon Kyu; Lee, Hyoung Woo; Park, Tae Sun; Kim, Doo Man; Chung, Choon Hee; Kim, Duk Kyu; Kim, In Joo; Jang, Hak Chul; Park, Yong Soo; Kwon, Hyuk Sang; Lee, Seung Hun; Shin, Hee Kang

2014-01-01

We studied the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetes patients whose blood glucose levels were inadequately controlled with basal insulin alone or in combination with metformin (or a sulfonylurea). This study was a 24-week prospective, open-label, randomized, active-controlled multi-center study. Participants were randomized to receive either acarbose (n=59, 300 mg/day) or voglibose (n=62, 0.9 mg/day). The mean HbA1c at week 24 was significantly decreased approximately 0.7% from baseline in both acarbose (from 8.43% ± 0.71% to 7.71% ± 0.93%) and voglibose groups (from 8.38% ± 0.73% to 7.68% ± 0.94%). The mean fasting plasma glucose level and self-monitoring of blood glucose data from 1 hr before and after each meal were significantly decreased at week 24 in comparison to baseline in both groups. The levels 1 hr after dinner at week 24 were significantly decreased in the acarbose group (from 233.54 ± 69.38 to 176.80 ± 46.63 mg/dL) compared with the voglibose group (from 224.18 ± 70.07 to 193.01 ± 55.39 mg/dL). In conclusion, both acarbose and voglibose are efficacious and safe in patients with type 2 diabetes who are inadequately controlled with basal insulin. (ClinicalTrials.gov number, NCT00970528).

Comparison of Acarbose and Voglibose in Diabetes Patients Who Are Inadequately Controlled with Basal Insulin Treatment: Randomized, Parallel, Open-Label, Active-Controlled Study

PubMed Central

Lee, Mi Young; Lee, Moon Kyu; Lee, Hyoung Woo; Park, Tae Sun; Kim, Doo Man; Chung, Choon Hee; Kim, Duk Kyu; Kim, In Joo; Jang, Hak Chul; Park, Yong Soo; Kwon, Hyuk Sang; Lee, Seung Hun; Shin, Hee Kang

2014-01-01

We studied the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetes patients whose blood glucose levels were inadequately controlled with basal insulin alone or in combination with metformin (or a sulfonylurea). This study was a 24-week prospective, open-label, randomized, active-controlled multi-center study. Participants were randomized to receive either acarbose (n=59, 300 mg/day) or voglibose (n=62, 0.9 mg/day). The mean HbA1c at week 24 was significantly decreased approximately 0.7% from baseline in both acarbose (from 8.43% ± 0.71% to 7.71% ± 0.93%) and voglibose groups (from 8.38% ± 0.73% to 7.68% ± 0.94%). The mean fasting plasma glucose level and self-monitoring of blood glucose data from 1 hr before and after each meal were significantly decreased at week 24 in comparison to baseline in both groups. The levels 1 hr after dinner at week 24 were significantly decreased in the acarbose group (from 233.54 ± 69.38 to 176.80 ± 46.63 mg/dL) compared with the voglibose group (from 224.18 ± 70.07 to 193.01 ± 55.39 mg/dL). In conclusion, both acarbose and voglibose are efficacious and safe in patients with type 2 diabetes who are inadequately controlled with basal insulin. (ClinicalTrials.gov number, NCT00970528) PMID:24431911

Systematic review of nutrient intake and growth in children with multiple IgE-mediated food allergies.

PubMed

Sova, Cassandra; Feuling, Mary Beth; Baumler, Megan; Gleason, Linda; Tam, Jonathan S; Zafra, Heidi; Goday, Praveen S

2013-12-01

Food allergies affect up to 8% of American children. The current recommended treatment for food allergies is strict elimination of the allergens from the diet. Dietary elimination of nutrient-dense foods may result in inadequate nutrient intake and impaired growth. The purpose of this review was to critically analyze available research on the effect of an elimination diet on nutrient intake and growth in children with multiple food allergies. A systematic review of the literature was conducted and a workgroup was established to critically analyze each relevant article. The findings were summarized and a conclusion was generated. Six studies were analyzed. One study found that children with food allergies are more likely to be malnourished than children without food allergies. Three studies found that children with multiple food allergies were shorter than children with 1 food allergy. Four studies assessed nutrient intake of children with multiple food allergies, but the inclusion and comparison criteria were different in each of the studies and the findings were conflicting. One study found that children with food allergies who did not receive nutrition counseling were more likely to have inadequate intake of calcium and vitamin D. Children with multiple food allergies have a higher risk of impaired growth and may have a higher risk of inadequate nutrient intake than children without food allergies. Until more research is available, we recommend monitoring of nutrition and growth of children with multiple food allergies to prevent possible nutrient deficiencies and to optimize growth.

Screening for Syphilis and Other Sexually Transmitted Infections in Pregnant Women - Guam, 2014.

PubMed

Cha, Susan; Malik, Tasneem; Abara, Winston E; DeSimone, Mia S; Schumann, Bernadette; Mallada, Esther; Klemme, Michael; Aguon, Vince; Santos, Anne Marie; Peterman, Thomas A; Bolan, Gail; Kamb, Mary L

2017-06-23

Prenatal screening and treatment for sexually transmitted infections (STIs) can prevent adverse perinatal outcomes. In Guam, the largest of the three U.S. territories in the Pacific, primary and secondary syphilis rates among women increased 473%, from 1.1 to 6.3 per 100,000 during 2009-2013 (1). In 2013, the first congenital syphilis case after no cases since 2008 was reported (1,2). Little is known about STI screening coverage and factors associated with inadequate screening among pregnant women in Guam. This study evaluated the prevalence of screening for syphilis, human immunodeficiency virus (HIV), chlamydia, and gonorrhea, and examined correlates of inadequate screening among pregnant women in Guam. Data came from the medical records of a randomly selected sample of mothers with live births in 2014 at a large public hospital. Bivariate analyses and multivariable models using Poisson regression were conducted to determine factors associated with inadequate screening for syphilis and other STIs. Although most (93.5%) women received syphilis screening during pregnancy, 26.8% were not screened sufficiently early to prevent adverse pregnancy outcomes. Many women were not screened for HIV infection (31.1%), chlamydia (25.3%), or gonorrhea (25.7%). Prenatal care and insurance were important factors affecting STI screening during pregnancy. Prenatal care providers play an important role in preventing congenital infections. Policies and programs increasing STI and HIV services for pregnant women and improved access to and use of prenatal care are essential for promoting healthy mothers and infants.

The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye

PubMed Central

Blackie, Caroline A; Coleman, Christy A; Holland, Edward J

2016-01-01

Purpose To evaluate the sustained effect (up to 1 year) of a single, 12-minute vectored thermal pulsation (VTP) treatment in improving meibomian gland function and dry eye symptoms in patients with meibomian gland dysfunction and evaporative dry eye. Methods The prospective, multicenter, open-label clinical trial included 200 subjects (400 eyes) who were randomized to a single VTP treatment (treatment group) or twice-daily, 3-month, conventional warm compress and eyelid hygiene therapy (control group). Control group subjects received crossover VTP treatment at 3 months (crossover group). Effectiveness measures of meibomian gland secretion (MGS) and dry eye symptoms were evaluated at baseline and 1, 3, 6, 9, and 12 months. Subjects with inadequate symptom relief could receive additional meibomian gland dysfunction therapy after 3 (treatment group) and 6 months (crossover group). Results At 3 months, the treatment group had greater mean improvement in MGS (P<0.0001) and dry eye symptoms (P=0.0068), compared to controls. At 12 months, 86% of the treatment group had received only one VTP treatment, and sustained a mean improvement in MGS from 6.4±3.7 (baseline) to 17.3±9.1 (P<0.0001) and dry eye symptoms from 44.1±20.4 to 21.6±21.3 (P<0.0001); 89% of the crossover group had received only one VTP treatment with sustained mean improvement in MGS from 6.3±3.6 to 18.4±11.1 (P<0.0001) and dry eye symptoms from 49.1±21.0 to 24.0±23.2 (P<0.0001). Greater mean improvement in MGS was associated with less severe baseline MGS (P=0.0017) and shorter duration of time between diagnosis and treatment (P=0.0378). Conclusion A single VTP treatment can deliver a sustained mean improvement in meibomian gland function and mean reduction in dry eye symptoms, over 12 months. A single VTP treatment provides significantly greater mean improvement in meibomian gland function and dry eye symptoms as compared to a conventional, twice-daily, 3-month regimen. Early VTP intervention for meibomian gland dysfunction is associated with improved treatment outcomes. PMID:27555745

The Role of Obesity Training in Medical School and Residency on Bariatric Surgery Knowledge in Primary Care Physicians

PubMed Central

Stanford, Fatima Cody; Johnson, Erica D.; Claridy, Mechelle D.; Earle, Rebecca L.; Kaplan, Lee M.

2015-01-01

Objective. US primary care physicians are inadequately educated on how to provide obesity treatment. We sought to assess physician training in obesity and to characterize the perceptions, beliefs, knowledge, and treatment patterns of primary care physicians. Methods. We administered a cross-sectional web-based survey from July to October 2014 to adult primary care physicians in practices affiliated with the Massachusetts General Hospital (MGH). We evaluated survey respondent demographics, personal health habits, obesity training, knowledge of bariatric surgery care, perceptions, attitudes, and beliefs regarding the etiology of obesity and treatment strategies. Results. Younger primary care physicians (age 20–39) were more likely to have received some obesity training than those aged 40–49 (OR: 0.08, 95% CI: 0.008–0.822) or those 50+ (OR: 0.03, 95% CI: 0.004–0.321). Physicians who were young, had obesity, or received obesity education in medical school or postgraduate training were more likely to answer bariatric surgery knowledge questions correctly. Conclusions. There is a need for educational programs to improve physician knowledge and competency in treating patients with obesity. Obesity is a complex chronic disease, and it is important for clinicians to be equipped with the knowledge of the multiple treatment modalities that may be considered to help their patients achieve a healthy weight. PMID:26339506

[Overdose of modified-release paracetamol calls for changed treatment routines. New guidelines from the Swedish Poisons Information Centre].

PubMed

Höjer, Jonas; Salmonson, Helene; Sjöberg, Gunilla; Tellerup, Markus; Brogren, Jacob

2016-11-10

Overdose of modified-release paracetamol calls for changed treatment routines. New guidelines from the Swedish Poisons Information Centre  The sales of modified-release paracetamol tablets are steadily increasing in Sweden as are the number of overdose cases with this formulation. The Swedish Poisons Information Centre has noted that the standard treatment protocol with N-acetylcysteine (NAC), which is based on overdoses with immediate-release paracetamol formulations, is often inadequate in this setting. In this paper, an adult who overdosed on 66.5 grams of modified-release paracetamol tablets and developed severe liver impairment (max ALT 6,660 U/l) despite timely and rigorous NAC treatment is presented. The patient's peak S-paracetamol of 2,800 µmol/l was delayed to 19 hours post-ingestion. Moreover, a pharmacokinetic and clinical study of similar cases showed that seven (21%) of the 34 patients who received NAC treatment within 8 hours after ingestion developed liver impairment. Finally, new Swedish guidelines for management of these cases are presented. The guidelines are also available on www.giftinfo.se.

Spiritual Needs in Health Care Settings: A Qualitative Meta-Synthesis of Clients' Perspectives

ERIC Educational Resources Information Center

Hodge, David R.; Horvath, Violet E.

2011-01-01

Spiritual needs often emerge in the context of receiving health or behavioral health services. Yet, despite the prevalence and salience of spiritual needs in service provision, clients often report their spiritual needs are inadequately addressed. In light of research suggesting that most social workers have received minimal training in…

Ruxolitinib for the treatment of inadequately controlled polycythaemia vera without splenomegaly (RESPONSE-2): a randomised, open-label, phase 3b study.

PubMed

Passamonti, Francesco; Griesshammer, Martin; Palandri, Francesca; Egyed, Miklos; Benevolo, Giulia; Devos, Timothy; Callum, Jeannie; Vannucchi, Alessandro M; Sivgin, Serdar; Bensasson, Caroline; Khan, Mahmudul; Mounedji, Nadjat; Saydam, Guray

2017-01-01

In the pivotal RESPONSE study, ruxolitinib, a Janus kinase (JAK)1 and JAK2 inhibitor, was superior to best available therapy at controlling haematocrit and improving splenomegaly and symptoms in patients with polycythaemia vera with splenomegaly who were inadequately controlled with hydroxyurea. In this study, we assessed the efficacy and safety of ruxolitinib in controlling disease in patients with polycythaemia vera without splenomegaly who need second-line therapy. RESPONSE-2 is a randomised, open-label, phase 3b study assessing ruxolitinib versus best available therapy in patients with polycythaemia vera done in 48 hospitals or clinics across 12 countries in Asia, Australia, Europe, and North America. Eligible patients (aged ≥18 years) with polycythaemia vera, no palpable splenomegaly, and hydroxyurea resistance or intolerance were stratified by their hydroxyurea therapy status (resistance vs intolerance) and randomly assigned (1:1) by an interactive response technology provider using a validated system to receive either oral ruxolitinib 10 mg twice daily or investigator-selected best available therapy (hydroxyurea [at the maximum tolerated dose], interferon or pegylated interferon, pipobroman, anagrelide, approved immunomodulators, or no cytoreductive treatment). Investigators and patients were not masked to treatment assignment; however, the study sponsor was masked to treatment assignment until database lock. The primary endpoint was the proportion of patients achieving haematocrit control at week 28. Analyses were done according to an intention-to-treat principle, including data from all patients randomly assigned to treatment. This study is registered with ClinicalTrials.gov (NCT02038036) and is ongoing but not recruiting patients. Between March 25, 2014, and Feb 11, 2015, of 173 patients assessed for eligibility, 74 patients were randomly assigned to receive ruxolitinib and 75 to receive best available therapy. At randomisation, best available therapy included hydroxyurea (37 [49%] of 75 in the best available therapy group), interferon or pegylated interferon (ten [13%] of 75), pipobroman (five [7%] of 75), lenalidomide (one [1%] of 75), no treatment (21 [28%] of 75), and other (one [1%] of 75). Haematocrit control was achieved in 46 (62%) of 74 ruxolitinib-treated patients versus 14 (19%) of 75 patients who received best available therapy (odds ratio 7·28 [95% CI 3·43-15·45]; p<0·0001). The most frequent haematological adverse events of any grade were anaemia (ten [14%] of 74 in the ruxolitinib group vs two [3%] of 75 in the best available therapy group) and thrombocytopenia (two [3%] vs six [8%]). No cases of grade 3-4 anaemia or thrombocytopenia occurred with ruxolitinib; one patient (1%) reported grade 3-4 anaemia and three patients (4%) reported grade 3-4 thrombocytopenia in the group receiving best available therapy. Frequent grade 3-4 non-haematological adverse events were hypertension (five [7%] of 74 vs three [4%] of 75) and pruritus (0 of 74 vs two [3%] of 75). Serious adverse events occurring in more than 2% of patients in either group, irrespective of cause, included thrombocytopenia (none in the ruxolitinib group vs two [3%] of 75 in the best available therapy group) and angina pectoris (two [3%] of 74 in the ruxolitinib group vs none in the best available therapy group). Two deaths occurred, both in the best available therapy group. RESPONSE-2 met its primary endpoint. The findings of this study indicate that ruxolitinib could be considered a standard of care for second-line therapy in this post-hydroxyurea patient population. Novartis. Copyright © 2017 Elsevier Ltd. All rights reserved.

Estimating drug treatment needs among state prison inmates.

PubMed

Belenko, Steven; Peugh, Jordon

2005-03-07

Growing prison populations in the U.S. are largely due to drug-related crime and drug abuse. Yet, relatively few inmates receive treatment, existing interventions tend to be short-term or non-clinical, and better methods are needed to match drug-involved inmates to level of care. Using data from the 1997 Survey of Inmates in State Correctional Facilities, a nationally representative sample of 14,285 inmates from 275 state prisons, we present a framework for estimating their levels of treatment need. The framework is drawn partly from the American Society of Addiction Medicine Patient Placement Criteria and other client matching protocols, incorporating drug use severity, drug-related behavioral consequences, and other social and health problems. The results indicate high levels of drug involvement, but considerable variation in severity/recency of use and health and social consequences. We estimate that one-third of male and half of female inmates need residential treatment, but that half of male and one-third of female inmates may need no treatment or short-term interventions. Treatment capacity in state prisons is quite inadequate relative to need, and improvements in assessment, treatment matching, and inmate incentives are needed to conserve scarce treatment resources and facilitate inmate access to different levels of care.

Pharmacist intervention reduces gastropathy risk in patients using NSAIDs.

PubMed

Ibañez-Cuevas, Victoria; Lopez-Briz, Eduardo; Guardiola-Chorro, M Teresa

2008-12-01

To establish a detection and intervention strategy in order to reduce the number of non-steroidal anti-inflammatory drug (NSAIDs) users at risk of gastropathy from receiving either inadequate or no gastroprotection. Community Pharmacies in Valencia, Spain. Prospective longitudinal intervention study without control group carried out by 79 Community Pharmacies. Patients over 18 who asked for any systemic NSAID were interviewed according to standard procedure. Pharmacist intervention was carried out when a patient at risk of serious NSAID-induced gastrointestinal complications due to inadequate or no gastric protection was identified. The doctor responsible was informed in order to then be able to assess the need to prescribe gastroprotection or change it if inadequate. In the case of over-the-counter (OTC) drugs, pharmacist intervention mainly involved replacing NSAIDs for safer medications. Firstly, the number of patients who had no prescribed gastroprotection or inadequate gastroprotection was determined. Pharmacist intervention then brought about changes in pharmacotherapy in this situation. Of the 6,965 patients who asked for NSAIDs during the study period, 3,054 (43.9%) presented NSAID gastropathy risk factors. 35.6% of the latter (1,089) were not prescribed gastroprotection or were prescribed inadequate gastroprotection. Pharmacist intervention was carried out in 1,075 of these cases. On 391 occasions such risk situations were reported to doctors, who accepted pharmacist intervention on 309 occasions (79.0%) and then either prescribed gastroprotection (77% of cases); changed it (13.9%); withdrew the NSAID (5.8%) or substituted it (3.2%). 235 Pharmacist interventions took place when dispensing OTC NSAIDs. Our strategy allowed us to identify a large number of patients who asked for NSAIDs in Community Pharmacies and who were at risk of NSAID gastropathy, as they received either inadequate gastroprotection or no gastroprotection whatsoever. Moreover, the pharmacist intervention carried out has reduced the number of these risk situations.

Once-daily treatment of ADHD with guanfacine: patient implications

PubMed Central

Strange, Brandon C

2008-01-01

The standard of care for treating ADHD is to use a psychostimulant as the first line agent. Recent medical literature reports that approximately 70%–90% of patients with ADHD received some benefit from a stimulant medication. Even though psychostimulants have a high rate of efficacy, an estimated 30%–50% of children and adults may discontinue psychostimulants secondary to adverse effects or inadequate response. Guanfacine has been used for a number of years as an off label alternative to psychostimulants. This article reviews the current literature on the effectiveness of guanfacine in treating ADHD. It also introduces the preliminary data for guanfacine extended release and its effectiveness in decreasing the symptoms of ADHD. PMID:18830439

Valsartan addition to amlodipine is more effective than losartan addition in hypertensive patients inadequately controlled by amlodipine.

PubMed

Fogari, Roberto; Mugellini, Amedeo; Preti, Paola; Zoppi, Annalisa; Derosa, Giuseppe

2010-03-03

This study evaluated the effects on blood pressure (BP) of valsartan 160 mg or losartan 100 mg addition to amlodipine 5 mg in hypertensive patients. 221 patients with inadequately controlled BP (DBP >or= 90 mmHg) after 4 weeks of treatment with amlodipine 5 mg were randomized to receive losartan/amlodipine combination therapy or valsartan/amlodipine combination therapy for 4 weeks in a cross-over study design. At the end of the wash-out period and of each treatment period, clinic and ambulatory BP measurements were recorded. 166 patients completed the study. Both combination treatments induced a greater ambulatory BP reduction than did monotherapy. However, the further mean reductions in BP versus monotherapy were significantly greater with the valsartan/amlodipine combination (SBP/DBP: -7.9 +/- 3.4/-6.5 +/- 2.6 mmHg for 24-hour, -8.0 +/- 3.4/-6.6 +/- 2.7 mmHg for daytime; -7.7 +/- 3.3/-6.4 +/- 2.7 mmHg for nighttime) than with the losartan/amlodipine combination (SBP/DBP: -5.5 +/- 2.8/-4.2 +/- 2.1 mmHg for 24-hour, -5.7 +/- 2.9/-4.4 +/- 2.2 mmHg for daytime; -4.8 +/- 2.8/-3.7 +/- 2.2 mmHg for nighttime; P < 0.01 vs valsartan/amlodipine). The incidence of adverse events with valsartan/amlodipine (8%) and losartan/amlodipine (9%) was lower than that observed with amlodipine monotherapy (17%; P < 0.05 vs combinations). Valsartan 160 mg plus amlodipine 5 mg produced greater BP reductions than losartan 100 mg plus amlodipine 5 mg.

Long-term efficacy and safety of certolizumab pegol in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: 52-week results from an open-label extension of the J-RAPID study

PubMed Central

Tanaka, Yoshiya; Yamamoto, Kazuhiko; Takeuchi, Tsutomu; Yamanaka, Hisashi; Ishiguro, Naoki; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Shoji, Toshiharu; Miyasaka, Nobuyuki; Koike, Takao

2014-01-01

Abstract Objectives. To evaluate the long-term efficacy and safety of certolizumab pegol (CZP) plus methotrexate treatment and to assess the efficacy of two CZP maintenance dosing schedules in Japanese rheumatoid arthritis (RA) patients with an inadequate response to methotrexate. Methods. J-RAPID double-blind patients were entered into an open-label extension (OLE) study. Patients withdrawn due to lack of efficacy at 16 weeks and double-blind completers without a week-24 American College of Rheumatology (ACR) 20 response received CZP 200 mg every other week (Q2W) plus methotrexate. Double-blind completers with week-24 ACR20 responses were randomized to CZP 200 mg Q2W plus methotrexate or CZP 400 mg every 4 weeks plus methotrexate. Results. The ACR20/ACR50/ACR70 response rates of double-blind completers (n = 204) were 89.7%/67.2%/36.3% at OLE entry and 95.6%/84.8%/58.3% at 52 weeks, respectively. Other clinical, functional and radiographic outcomes were sustained with long-term CZP plus methotrexate. Long-term treatment with CZP was well-tolerated with no new unexpected adverse events observed. The efficacy and safety of CZP treatment were similar between the two dosing schedules. Conclusions. Continued CZP administration with methotrexate maintained efficacy over 52 weeks and was well-tolerated for Japanese RA patients. No obvious differences in clinical efficacy and safety were observed between the two dosing schedules, giving flexibility in maintenance administration schedules. PMID:24593170

Inadequate management of pregnancy-associated listeriosis: lessons from four case reports.

PubMed

Charlier, C; Goffinet, F; Azria, E; Leclercq, A; Lecuit, M

2014-03-01

Listeria monocytogenes infection during pregnancy can lead to dramatic fetal or neonatal outcomes. No clinical trial has evaluated treatment options, and retrospective studies of cases are therefore important to define optimal regimens. We report four cases of materno-neonatal listeriosis illustrating inadequate antimicrobial therapy management and discuss recommended treatment options. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

Ruxolitinib versus standard therapy for the treatment of polycythemia vera.

PubMed

Vannucchi, Alessandro M; Kiladjian, Jean Jacques; Griesshammer, Martin; Masszi, Tamas; Durrant, Simon; Passamonti, Francesco; Harrison, Claire N; Pane, Fabrizio; Zachee, Pierre; Mesa, Ruben; He, Shui; Jones, Mark M; Garrett, William; Li, Jingjin; Pirron, Ulrich; Habr, Dany; Verstovsek, Srdan

2015-01-29

Ruxolitinib, a Janus kinase (JAK) 1 and 2 inhibitor, was shown to have a clinical benefit in patients with polycythemia vera in a phase 2 study. We conducted a phase 3 open-label study to evaluate the efficacy and safety of ruxolitinib versus standard therapy in patients with polycythemia vera who had an inadequate response to or had unacceptable side effects from hydroxyurea. We randomly assigned phlebotomy-dependent patients with splenomegaly, in a 1:1 ratio, to receive ruxolitinib (110 patients) or standard therapy (112 patients). The primary end point was both hematocrit control through week 32 and at least a 35% reduction in spleen volume at week 32, as assessed by means of imaging. The primary end point was achieved in 21% of the patients in the ruxolitinib group versus 1% of those in the standard-therapy group (P<0.001). Hematocrit control was achieved in 60% of patients receiving ruxolitinib and 20% of those receiving standard therapy; 38% and 1% of patients in the two groups, respectively, had at least a 35% reduction in spleen volume. A complete hematologic remission was achieved in 24% of patients in the ruxolitinib group and 9% of those in the standard-therapy group (P=0.003); 49% versus 5% had at least a 50% reduction in the total symptom score at week 32. In the ruxolitinib group, grade 3 or 4 anemia occurred in 2% of patients, and grade 3 or 4 thrombocytopenia occurred in 5%; the corresponding percentages in the standard-therapy group were 0% and 4%. Herpes zoster infection was reported in 6% of patients in the ruxolitinib group and 0% of those in the standard-therapy group (grade 1 or 2 in all cases). Thromboembolic events occurred in one patient receiving ruxolitinib and in six patients receiving standard therapy. In patients who had an inadequate response to or had unacceptable side effects from hydroxyurea, ruxolitinib was superior to standard therapy in controlling the hematocrit, reducing the spleen volume, and improving symptoms associated with polycythemia vera. (Funded by Incyte and others; RESPONSE ClinicalTrials.gov number, NCT01243944.).

Androgen deprivation in veterans with prostate cancer: implications for skeletal health.

PubMed

Wilcox, Andrew; Carnes, Molly L; Moon, Timothy D; Tobias, Renee; Baade, Heather; Stamos, Emily; Elliott, Mary E

2006-12-01

Common risk factors for osteoporosis in older men include smoking, heavy use of alcohol, propensity to falls, and use of bone-toxic medications such as prednisone. There is also increasing appreciation of the skeletal risk faced by men receiving androgen deprivation therapy (ADT) for prostate cancer. Measures to prevent bone loss in such patients are available. To test the following hypotheses in a population of veterans receiving ADT for prostate cancer: (1) fracture risk factors in addition to androgen deprivation would be found in most patients, (2) bone mass measurements would be assessed in a minority of patients, and (3) a minority of the subjects would receive bisphosphonate therapy or have contraindications for such treatment. We conducted a retrospective chart review of male veterans receiving ADT from 1993 through 2001, at the Veterans Affairs Medical Center, Madison, WI. One hundred and seventy-four subjects met study criteria, with a mean age of 76 years and median duration of 21 months of ADT. Eighty-one percent had risk factors in addition to ADT. Only 13% underwent bone density measurement by dual energy X-ray absorptiometry (DXA) and, of those measured, more than half had osteoporosis. Only 19% of the men received both calcium and vitamin D supplements. Antiresorptive therapy was provided to 11% of men, although more than two-thirds had no contraindications to therapy. A total of 24 men sustained a fracture after starting ADT. For men who did undergo bone density measurement, 77% received antiresorptive therapy. Of those who exhibited osteoporosis by DXA scan, 85% received antiresorptive therapy. Male veterans receiving ADT for prostate cancer received inadequate evaluation and treatment for osteoporosis. Based on our data, a simple and practical strategy to prompt further evaluation and improved care may be to undertake bone density measurements in men prior to or soon after commencing ADT.

Management of familial hypercholesterolemia in children and adolescents. Position paper of the Polish Lipid Expert Forum.

PubMed

Myśliwiec, Małgorzata; Walczak, Mieczysław; Małecka-Tendera, Ewa; Dobrzańska, Anna; Cybulska, Barbara; Filipiak, Krzysztof; Mazur, Artur; Jarosz-Chobot, Przemysława; Szadkowska, Agnieszka; Rynkiewicz, Andrzej; Chybicka, Alicja; Socha, Piotr; Brandt, Agnieszka; Bautembach-Minkowska, Joanna; Zdrojewski, Tomasz; Limon, Janusz; Gidding, Samuel S; Banach, Maciej

2014-01-01

Familial hypercholesterolemia (FH) affects on average 1 in 500 individuals in European countries, and it is estimated that FH in Poland may affect more than 80,000 people. However, in Poland, only about 20% of the population is estimated to have been diagnosed with FH, of which only a small number receive adequate treatment. FH results in more rapid development of atherosclerosis and is associated with a high risk of cardiovascular events. Atherosclerosis develops beginning in childhood in patients with FH and reaches advanced stages before clinical manifestations develop. Inadequate diagnostics and treatment of FH in Polish children suggests a need for raising the level of awareness and understanding of the condition in both society and among health professionals. These recommendations present the current epidemiological status, guidelines for diagnosing FH in Polish children and adolescents, and effective treatment options. Copyright © 2014 National Lipid Association. Published by Elsevier Inc. All rights reserved.

[Congenital syphilis in Ceará: epidemiological analysis of one decade].

PubMed

da Costa, Camila Chaves; Freitas, Lydia Vieira; Sousa, Deise Maria do Nascimento; de Oliveira, Lara Leite; Chagas, Ana Carolina Maria Araújo; Lopes, Marcos Venícios de Oliveira; Damasceno, Ana Kelve de Castro

2013-02-01

This study evaluates the incidence of congenital syphilis in the Brazilian state of Ceará from 2000 to 2009, describes the epidemiologic profile of pregnant women whose newborns had congenital syphilis and verifies the receipt of prenatal care and treatment of their partners. It is a retrospective study that was conducted in July 2010 using a Center for Information and Analysis in Health database that contains information on National Notifiable Diseases. There were 2,930 reported cases of congenital syphilis, demonstrating an annual ascending historical series. The majority of the pregnant women were 20 to 34 years of age (n=1,836, 62.7%), illiterate or with little education (n=1623, 55.4%) and had received prenatal care (n=2077, 70.9%). The inadequate treatment of women and the lack of treatment for their partners is a reality in Ceará. The incidence of congenital syphilis is a quality indicator of prenatal care. Therefore, its increase in the last ten years highlights the necessity of syphilis control.

Integrated management of major depression for people with cancer.

PubMed

Walker, Jane; Sharpe, Michael

2014-12-01

Major depression is an important complication of cancer. However, it is frequently inadequately treated. There are challenges both in identifying which cancer patients are depressed, and in ensuring that these patients receive effective treatment for their depression. Integration of depression management into cancer care has been advocated as a way to address these challenges. Such integrated approaches must include both the systematic identification of cases and the delivery of treatment. We describe here a system of depression care that includes both a screening programme to identify patients with depression and a linked treatment programme, based on the collaborative care model, called 'Depression Care for People with Cancer' (DCPC). The system of care was designed to be fully integrated with specialist cancer services and has been robustly evaluated in randomized trials. We describe how the system operates and explain why it is designed as it is. We also summarize the evidence for its effectiveness and cost-effectiveness and discuss its implementation in routine clinical practice.

OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder.

PubMed

Sievert, K-D; Chapple, C; Herschorn, S; Joshi, M; Zhou, J; Nardo, C; Nitti, V W

2014-10-01

A prespecified pooled analysis of two placebo-controlled, phase 3 trials evaluated whether the number of prior anticholinergics used or reason for their discontinuation affected the treatment response to onabotulinumtoxinA 100U in overactive bladder (OAB) patients with urinary incontinence (UI). Patients with symptoms of OAB received intradetrusor injections of onabotulinumtoxinA 100U or placebo, sparing the trigone. Change from baseline at week 12 in UI episodes/day, proportion of patients reporting a positive response ('greatly improved' or 'improved') on the treatment benefit scale (TBS), micturition and urgency were evaluated by number of prior anticholinergics (1, 2 or ≥ 3) and reason for their discontinuation (insufficient efficacy or side effects). Adverse events (AE) were assessed. Patients had taken an average of 2.4 anticholinergics before study enrolment. OnabotulinumtoxinA reduced UI episodes/day from baseline vs. placebo, regardless of the number of prior anticholinergics (-2.82 vs. -1.52 for one prior anticholinergic; -2.58 vs. -0.58 for two prior anticholinergics; and -2.92 vs. -0.73 for three or more prior anticholinergics; all p < 0.001). The proportion of TBS responders was higher with onabotulinumtoxinA vs. placebo (69.0% vs. 37.2% for one prior anticholinergic; 58.8% vs. 24.8% for two prior anticholinergics and 56.4% vs. 22.5% for three or more prior anticholinergics; all p < 0.001). Similar results were observed regardless of the reason for discontinuation. OnabotulinumtoxinA reduced the episodes of urgency and frequency of micturition vs. placebo in all groups. AEs were well tolerated, with a comparable incidence in all groups. In patients with symptoms of OAB who were inadequately managed by one or more anticholinergics, onabotulinumtoxinA 100U provided significant and similar treatment benefit and safety profile regardless of the number of prior anticholinergics used or reason for inadequate management of OAB. ClinicalTrials.gov: NCT00910845, NCT00910520. © 2014 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd.

Understanding nurses' decisions to treat pain in nursing home residents with dementia.

PubMed

Gilmore-Bykovskyi, Andrea L; Bowers, Barbara J

2013-04-01

Nursing home (NH) residents with dementia continue to receive inadequate pain treatment. The purpose of this qualitative study was to examine how nurses make decisions to pharmacologically treat pain in NH residents with dementia. Using Grounded Dimensional Analysis, 15 in-depth interviews were conducted with 13 nurses from four skilled nursing facilities in Wisconsin. Nurses experienced varying levels of certainty regarding suspected pain in response to particular resident characteristics and whether pain was perceived as visible/obvious or nonvisible/not obvious. Nurses felt highly uncertain about pain in residents with dementia. Suspected pain in residents with dementia was nearly always conceptualized as a change in behavior to which nurses responded by trialing multiple interventions in attempts to return the resident to baseline, which despite current recommendations, did not include pain relief trials. Residents with dementia were described as being at greatest risk for experiencing underassessment, undertreatment, and delayed treatment for pain Copyright 2013, SLACK Incorporated.

Randomized, Double-Blind Trial of Triple Therapy With Saxagliptin Add-on to Dapagliflozin Plus Metformin in Patients With Type 2 Diabetes.

PubMed

Matthaei, Stephan; Catrinoiu, Doina; Celiński, Aleksander; Ekholm, Ella; Cook, William; Hirshberg, Boaz; Chen, Hungta; Iqbal, Nayyar; Hansen, Lars

2015-11-01

The objective of this study was to assess the efficacy and safety of triple therapy with saxagliptin add-on versus placebo add-on to dapagliflozin plus metformin in adults with type 2 diabetes. Patients on stable metformin (≥1,500 mg/day) for ≥8 weeks with glycated hemoglobin (HbA1c) 8.0-11.5% (64-102 mmol/mol) at screening received open-label dapagliflozin (10 mg/day) plus metformin immediate release (IR) for 16 weeks. Patients with inadequate glycemic control (HbA1c 7-10.5% [53-91 mmol/mol]) were then randomized to receive placebo (n = 153) or saxagliptin 5 mg/day (n = 162) in addition to background dapagliflozin plus metformin IR. The primary efficacy end point was change in HbA1c from baseline to week 24. There was a significantly greater reduction in HbA1c at 24 weeks with saxagliptin add-on (-0.51% [-5.6 mmol/mol]) versus placebo (-0.16% [-1.7 mmol/mol]) add-on to dapagliflozin plus metformin (difference, -0.35% [95% CI -0.52% to -0.18%] and -3.8 [-5.7 to -2.0 mmol/mol], respectively; P < 0.0001). Reductions in fasting plasma glucose and 2-h postprandial glucose were similar between treatment arms. A larger proportion of patients achieved HbA1c <7% (53 mmol/mol) with saxagliptin add-on (35.3%) versus placebo add-on (23.1%) to dapagliflozin plus metformin. Adverse events were similar between treatment groups. Episodes of hypoglycemia were infrequent in both treatment arms, and there were no episodes of major hypoglycemia. Triple therapy with the addition of saxagliptin to dapagliflozin plus metformin was well tolerated and produced significant improvements in HbA1c in patients with type 2 diabetes inadequately controlled with dapagliflozin plus metformin. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

A Review of On-Site Wastewater Treatment Systems in Western Australia from 1997 to 2011

PubMed Central

Gunady, Maria; Shishkina, Natalia; Tan, Henry; Rodriguez, Clemencia

2015-01-01

On-site wastewater treatment systems (OWTS) are widely used in Western Australia (WA) to treat and dispose of household wastewater in areas where centralized sewerage systems are unavailable. Septic tanks, aerobic treatment units (ATUs), and composting toilets with greywater systems are among the most well established and commonly used OWTS. However, there are concerns that some OWTS installed in WA are either performing below expected standards or failing. Poorly performing OWTS are often attributed to inadequate installation, inadequate maintenance, poor public awareness, insufficient local authority resources, ongoing wastewater management issues, or inadequate adoption of standards, procedures, and guidelines. This paper is to review the installations and failures of OWTS in WA. Recommendations to the Department of Health Western Australia (DOHWA) and Local Government (LG) in regard to management strategies and institutional arrangements of OWTS are also highlighted. PMID:25960745

Sources of Social Capital: Effects of Altruistic Citizenship Behavior and Job Involvement on Advice Network Centrality

ERIC Educational Resources Information Center

Zhang, Mian; Zheng, Wei; Wei, Jun

2009-01-01

Social capital has been receiving increasing attention in HRD research. However, the sources of social capital have received inadequate attention. Little has been done to reveal how people obtain their social capital in the workplace. This study investigated the effects of employees' altruistic citizenship behavior and job involvement on their…

Treatment of rheumatoid arthritis with biologic DMARDS (Rituximab and Etanercept).

PubMed

Gashi, Afrim A; Rexhepi, Sylejman; Berisha, Idriz; Kryeziu, Avni; Ismaili, Jehona; Krasniqi, Gezim

2014-01-01

To determine efficacy and safety of treatment with Rituximab and Etanercept plus Methotrexate in patients with active Rheumatoid Arthritis (RA), who had an inadequate response to nonbiologic DMARDS therapies and to explore the pharmacogenetics and pharmacodynamics of Rituximab and Etanercept in our populations. Study was done at Rheumatology Clinic of University Clinical Centre in Prishtina during 2009-2011 years. We evaluated primary efficacy and safety at 24 weeks in patients enrolled in the study of long-term efficacy of Rituximab and Etanercept. Patients with active Rheumatoid Arthritis and an inadequate response to 1 or more non biologic DMARDS were randomized to receive intravenous Rituximab (1 course consisting of 2 infusions of 1.000 mg each -one group, and Etanercept 25 mg twice weekly -second group, but both groups with background MTX. The primary efficacy end point was a response on the ACR 20%, improvement criteria at 24 weeks, Secondary end points were responses on the ACR 50 and ACR 70, improvement criteria, the DAS 28, and EULAR response criteria at 24 weeks. During our investigations we treated 20 patients, 15 females and 5 males, in the treated group with RTX and 13 patients 8 females and 5 males in the treated group with ETN. Patients of group 1 and group 2 were of ages 37-69 years old and 19-69 years old (average 47-44) Most of the patients belong in 2nd and 3rd functional stage according to Steinbrocker. All ACR response parameters were significantly improved in RTX treated patients who also had clinically meaningful improvement in fatigue, disability and quality of life. Patients showed a trend less progression in radiographic end points. Most adverse events occurred with the first RTX infusion and were mild to moderate severity. At 24 weeks, a single course of RTX and ETN provided significant and clinically meaningful improvements in disease activity in patients with active, longstanding RA who had an inadequate response to 1 or more nonbiologic DMARDS.

Dose Titration of Pregabalin in Patients with Painful Diabetic Peripheral Neuropathy: Simulation Based on Observational Study Patients Enriched with Data from Randomized Studies.

PubMed

Alexander, Joe; Edwards, Roger A; Manca, Luigi; Grugni, Roberto; Bonfanti, Gianluca; Emir, Birol; Whalen, Edward; Watt, Stephen; Parsons, Bruce

2018-03-01

Achieving a therapeutic response to pregabalin in patients with painful diabetic peripheral neuropathy (pDPN) requires adequate upward dose titration. Our goal was to identify relationships between titration and response to pregabalin in patients with pDPN. Data were integrated from nine randomized, placebo-controlled clinical trials as well as one 6-week open-label observational study conducted by 5808 physicians (2642 patients with pDPN) in standard outpatient settings in Germany. These studies evaluated pregabalin for treatment of pDPN. Using these data, we examined "what if" scenarios using a microsimulation platform that integrates data from randomized and observational sources as well as autoregressive-moving-average with exogenous inputs models that predict pain outcomes, taking into account weekly changes in pain, sleep interference, dose, and other patient characteristics that were unchanging. Final pain levels were significantly different depending on dose changes (P < 0.0001), with greater proportions improving with upward titration regardless of baseline pain severity. Altogether, 78.5% of patients with pDPN had 0-1 dose change, and 15.2% had ≥ 2 dose changes. Simulation demonstrated that the 4.8% of inadequately titrated patients who did not improve/very much improve their pain levels would have benefited from ≥ 2 dose changes. Patient satisfaction with tolerability (range 90.3-96.2%) was similar, regardless of baseline pain severity, number of titrations, or extent of improvement, suggesting that tolerability did not influence treatment response patterns. Upward dose titration reduced pain in patients with pDPN who actually received it. Simulation also predicted pain reduction in an inadequately titrated nonresponder subgroup of patients had they actually received adequate titration. The decision not to uptitrate must have been driven by factors other than tolerability. Pfizer, Inc.

Assessment of physicochemical parameters and prevalence of virulent and multiple-antibiotic-resistant Escherichia coli in treated effluent of two wastewater treatment plants and receiving aquatic milieu in Durban, South Africa.

PubMed

Pillay, Leanne; Olaniran, Ademola O

2016-05-01

The poor operational status of some wastewater treatment plants often result in the discharge of inadequately treated effluent into receiving surface waters. This is of significant public health concern as there are many informal settlement dwellers (ISDs) that rely on these surface waters for their domestic use. This study investigated the treatment efficiency of two independent wastewater treatment plants (WWTPs) in Durban, South Africa and determined the impact of treated effluent discharge on the physicochemical and microbial quality of the receiving water bodies over a 6-month period. Presumptive Escherichia coli isolates were identified using biochemical tests and detection of the mdh gene via PCR. Six major virulence genes namely eae, hly, fliC, stx1, stx2, and rfbE were also detected via PCR while antibiotic resistance profiles of the isolates were determined using Kirby-Bauer disc diffusion assay. The physicochemical parameters of the wastewater samples ranged variously between 9 and 313.33 mg/L, 1.52 and 76.43 NTUs, and 6.30 and 7.87 for COD, turbidity, and pH respectively, while the E. coli counts ranged between 0 and 31.2 × 10(3) CFU/ml. Of the 200 selected E. coli isolates, the hly gene was found in 28 %, fliC in 20 %, stx2 in 17 %, eae in 14 %, with stx1 and rfbE in only 4 % of the isolates. Notable resistance was observed toward trimethoprim (97 %), tetracycline (56 %), and ampicillin (52.5 %). These results further highlight the poor operational status of these WWTPs and outline the need for improved water quality monitoring and enforcement of stringent guidelines.

Trend of Occupational Injuries/Diseases in Pakistan: Index Value Analysis of Injured Employed Persons from 2001-02 to 2012-13.

PubMed

Abbas, Mohsin

2015-09-01

The present study aimed to analyze the index value trends of injured employed persons (IEPs) covered in Pakistan Labour Force Surveys from 2001-02 to 2012-13. The index value method based on reference years and reference groups was used to analyze the IEP trends in terms of different criteria such as gender, area, employment status, industry types, occupational groups, types of injury, injured body parts, and treatment received. The Pearson correlation coefficient analysis was also performed to investigate the inter-relationship of different occupational variables. The values of IEP increased at the end of the studied year in industry divisions such as agriculture, forestry, hunting, and fishing, followed by in manufacturing and construction industry divisions. People associated with major occupations (such as skilled agricultural and fishery workers) and elementary (unskilled) occupations were found to be at an increasing risk of occupational injuries/diseases with an increasing IEP trend. Types of occupational injuries such as sprain or strain, superficial injury, and dislocation increased during the studied years. Major injured parts of body such as upper limb and lower limb found with increasing trend. Types of treatment received, including hospitalization and no treatment, were found to decrease. Increased IEP can be justified due to inadequate health care facilities, especially in rural areas by increased IEP in terms of gender, areas, received treatment, occupational groups and employment status as results found after Pearson correlation coefficient analysis. The increasing trend in the IEP% of the total employed persons due to agrarian activities shows that there is a need to improve health care setups in rural areas of Pakistan.

Trend of Occupational Injuries/Diseases in Pakistan: Index Value Analysis of Injured Employed Persons from 2001–02 to 2012–13

PubMed Central

Abbas, Mohsin

2015-01-01

Background The present study aimed to analyze the index value trends of injured employed persons (IEPs) covered in Pakistan Labour Force Surveys from 2001–02 to 2012–13. Methods The index value method based on reference years and reference groups was used to analyze the IEP trends in terms of different criteria such as gender, area, employment status, industry types, occupational groups, types of injury, injured body parts, and treatment received. The Pearson correlation coefficient analysis was also performed to investigate the inter-relationship of different occupational variables. Results The values of IEP increased at the end of the studied year in industry divisions such as agriculture, forestry, hunting, and fishing, followed by in manufacturing and construction industry divisions. People associated with major occupations (such as skilled agricultural and fishery workers) and elementary (unskilled) occupations were found to be at an increasing risk of occupational injuries/diseases with an increasing IEP trend. Types of occupational injuries such as sprain or strain, superficial injury, and dislocation increased during the studied years. Major injured parts of body such as upper limb and lower limb found with increasing trend. Types of treatment received, including hospitalization and no treatment, were found to decrease. Increased IEP can be justified due to inadequate health care facilities, especially in rural areas by increased IEP in terms of gender, areas, received treatment, occupational groups and employment status as results found after Pearson correlation coefficient analysis. Conclusion The increasing trend in the IEP% of the total employed persons due to agrarian activities shows that there is a need to improve health care setups in rural areas of Pakistan. PMID:26929831

30-day readmission, antibiotics costs and costs of delay to adequate treatment of Enterobacteriaceae UTI, pneumonia, and sepsis: a retrospective cohort study.

PubMed

Zilberberg, Marya D; Nathanson, Brian H; Sulham, Kate; Fan, Weihong; Shorr, Andrew F

2017-01-01

Enterobacteriaceae are common pathogens in pneumonia, sepsis and urinary tract infection (UTI). Though rare, carbapenem resistance (CRE) among these organisms complicates efforts to ensure adequate empiric antimicrobial therapy. In turn this negatively impacts such outcomes as mortality and hospital costs. We explored proportion of total costs represented by antibiotics, 30-day readmission rates, and per-day costs of inadequate antimicrobial coverage among patients with Enterobacteriaceae pneumonia, sepsis and/or UTI in the context of inappropriate (IET) vs. appropriate empiric (non-IET) therapy and carbapenem resistance (CRE) vs. susceptibility (CSE). We conducted a retrospective cohort study in the Premier Research database (2009-2013) of 175 US hospitals. We included all adult patients admitted with a culture-confirmed UTI, pneumonia, or sepsis as principal diagnosis, or as a secondary diagnosis in the setting of respiratory failure. Patients with hospital acquired infections or transfers from other acute facilities were excluded. IET was defined as failure to administer an antibiotic therapy in vitro active against the culture-confirmed pathogen within 2 days of admission. Among 40,137 patients with Enterobacteriaceae infections (54.2% UTI), 4984 (13.2%) received IET. CRE (3.1%) was more frequent in patients given IET (13.0%) than non-IET (1.6%, p  < 0.001). The proportions of total costs represented by antibiotics were similar in IET and non-IET (3.3% vs. 3.4%, p  = 0.01), and higher among the group with CRE than CSE (4.2% vs. 3.4%, p  < 0.001). The 30-day readmission rates were higher in both IET than non-IET (25.6% vs. 21.1%, p  < 0.001) and CRE than CSE (29.7% vs. 21.5%, p < 0.001) groups. Each additional day of inadequate therapy cost an additional $766 (95% CI $661, $870, p  < 0.001) relative to adequate treatment. In this large US cohort of Enterobacteriaceae infections, the cost of antibiotics was a small component of total costs, irrespective of whether empiric treatment was appropriate or whether a CRE was isolated. In contrast, each extra day of inadequate treatment added >$750 to hospital costs. Both CRE and IET were associated with an increased risk of readmission within 30 days.

[Provision of information to patients. Legal and humanitarian requirements].

PubMed

Schara, J; Brandt, L

2008-09-01

Any treatment to which the patient has not expressly consented constitutes an assault according to our legal system. The patient's agreement is therefore necessary for every elective treatment. Patients cannot give meaningful consent until they have received detailed information on their illness, its presumed course, the treatment options and the risks they are exposed to both with and without treatment. This requires provision of information to allow self-determination. The requirement for the patient alone to make decisions arises from the personal rights in our [German] Constitution. If the information provided has been inadequate the doctor is liable for all negative-including life-changing-consequences, regardless of whether or not the risk that has been realised is one that is expressly required to be explained. The Federal Court of Justice requires the doctor to address each patient's personality and their fate when providing information (BGH, NHW 1983, 328, 329). It is not permissible for the duty to provide information to be delegated to a third party unless strict obligations are fulfilled (BGH 7.11.2006 VI ZR 206/05).

[Provision of information to patients - legal and humanitarian requirements].

PubMed

Schara, J; Brandt, L

2008-02-01

Any treatment to which the patient has not expressly consented constitutes an assault according to our legal system. The patient's agreement is therefore necessary for every elective treatment. Patients cannot give meaningful consent until they have received detailed information on their illness, its presumed course, the treatment options and the risks they are exposed to both with and without treatment. This requires provision of information to allow self-determination. The requirement for the patient alone to make decisions arises from the personal rights in our [German] Constitution. If the information provided has been inadequate the doctor is liable for all negative-including life-changing-consequences, regardless of whether or not the risk that has been realised is one that is expressly required to be explained. The Federal Court of Justice requires the doctor to address each patient's personality and their fate when providing information (BGH, NHW 1983, 328, 329). It is not permissible for the duty to provide information to be delegated to a third party unless strict obligations are fulfilled (BGH 7.11.2006 VI ZR 206/05).

The effects of simultaneous exercise and psychotherapy on depressive symptoms in inpatient, psychiatric older adults.

PubMed

Jacquart, Son D; Marshak, Helen H; Dos Santos, Hildemar; Luu, Sen M; Berk, Lee S; McMahon, Paul T; Riggs, Matt

2014-01-01

Depression is the leading cause of early death, affecting 15% of Americans older than 65 y and costing $43 billion each year. The current mental health service system for seniors, particularly for the population hospitalized in acute inpatient psychiatric units, is fragmented because of poor funding and a shift to a transitory health care paradigm, leading to inadequate treatment modalities, questionable quality of care, and lack of research demonstrating the superiority of a particular treatment. These issues are likely to lead to a public health crisis in the coming years. To investigate the effectiveness of combining exercise and psychotherapy in improving acute depressive symptoms among older adults who were receiving treatment in an inpatient psychiatric unit. Based on rolling admissions, inpatients were randomly assigned to 1 of 3 treatment groups. The study was blinded and controlled. This study took place in inpatient psychiatric units at the Loma Linda University's Behavioral Medicine Center (LLUBMC) in Redlands, California. Participants were 78 inpatients, aged 50-89 y. Participants in the simultaneous exercise and psychotherapy (STEP) group (n = 26) took part in exercise and received psychotherapy for 30 min per session, whereas those in the TALK group (n = 26) received individual psychotherapy for 30 min per session. Participants in the control group (n = 26) served as a comparison group, receiving standard therapy. The effects of the interventions were determined by assessing differences from baseline to postintervention in the symptomatology of all 3 groups. The research team also administered the Behavioral and Symptom Identification Scale (BASIS-32) and the Geriatric Depression Scale (GDS) pre- and postintervention. At posttest, the STEP group (M = 4.24, SE = 0.62) had a better response than the TALK group (M = 11.34, SE = 0.62, P < .001), which in turn showed greater improvement than the control group (M = 14.84, SE = 0.62, P < .001). Overall, these results indicate that patients' posttreatment depression scores were significantly lower in those receiving the STEP treatment compared with those receiving individual psychotherapy only or standard care. A short-term exercise program consisting of 30 min of walking in conjunction with individual psychotherapy was an effective intervention for depression among older adults in inpatient psychiatric units.

Which children receive vigabatrin? Characteristics of pediatric patients enrolled in the mandatory FDA registry.

PubMed

Pellock, John M; Faught, Edward; Foroozan, Rod; Sergott, Robert C; Shields, W Donald; Ziemann, Adam; Lee, Deborah; Dribinsky, Yekaterina; Torri, Sarah; Othman, Feisal; Isojarvi, Jouko

2016-07-01

Vigabatrin (Sabril®) is an antiepileptic drug (AED) currently indicated in the US as a monotherapy for patients 1month to 2years of age with infantile spasms (IS) and as adjunctive therapy for patients ≥10years of age with refractory complex partial seizures (rCPS) whose seizures have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. The approval required an FDA mandated registry. This article describes 5years of demographic and treatment exposure data from US pediatric patients (<17years). Participation is mandatory for all US Sabril® prescribers and patients. A benefit-risk assessment must be documented for patient progression to maintenance therapy. This includes demographic diagnosis and reports of ophthalmologic assessments (where available). Patient data were grouped by age as proxies for indication (IS: <3years, rCPS: ≥3 to <17years). As of August 26, 2014, 5546/6823 enrolled patients were pediatric/total; 4472 (81%) were vigabatrin-naïve. Seventy-one percent of patients were <3years of age; 29% were ≥3 to <17years of age. Etiologies of IS were identified as cryptogenic (21%), symptomatic tuberous sclerosis (17%), and symptomatic other (42%). The majority of patients with IS (56%) attempted no prior treatments; 16% received adrenocorticotropic hormone prior to vigabatrin. A third of patients with IS were receiving 1 concomitant treatment with vigabatrin. For patients with rCPS, 39% attempted 1-3 prior treatments; 27% were receiving 2 concomitant treatments at enrollment. A total of 1852 (41%) patients did not undergo baseline ophthalmological assessment; 25% of patients with IS and 42% of patients with rCPS were exempted for neurologic disabilities. Kaplan-Meier estimates predict that 71% and 65% of vigabatrin-naïve patients with IS and rCPS, respectively, would remain in the registry at 6months. Most pediatric vigabatrin patients have IS as an underlying diagnosis, especially those <3years of age. A proportion of those with rCPS remain on long-term vigabatrin despite the risk of adverse events. Copyright © 2016. Published by Elsevier Inc.

Cognitive Attributes of Adequate and Inadequate Responders to Reading Intervention in Middle School

PubMed Central

Miciak, Jeremy; Stuebing, Karla K.; Vaughn, Sharon; Roberts, Greg; Barth, Amy Elizabeth; Fletcher, Jack M.

2016-01-01

No studies have investigated the cognitive attributes of middle school students who are adequate and inadequate responders to Tier 2 reading intervention. We compared students in Grades 6 and 7 representing groups of adequate responders (n = 77) and inadequate responders who fell below criteria in (a) comprehension (n = 54); (b) fluency (n = 45); and (c) decoding, fluency, and comprehension (DFC; n = 45). These students received measures of phonological awareness, listening comprehension, rapid naming, processing speed, verbal knowledge, and nonverbal reasoning. Multivariate comparisons showed a significant Group-by-Task interaction: the comprehension-impaired group demonstrated primary difficulties with verbal knowledge and listening comprehension, the DFC group with phonological awareness, and the fluency-impaired group with phonological awareness and rapid naming. A series of regression models investigating whether responder status explained unique variation in cognitive skills yielded largely null results consistent with a continuum of severity associated with level of reading impairment, with no evidence for qualitative differences in the cognitive attributes of adequate and inadequate responders. PMID:28579668

Cognitive Attributes of Adequate and Inadequate Responders to Reading Intervention in Middle School.

PubMed

Miciak, Jeremy; Stuebing, Karla K; Vaughn, Sharon; Roberts, Greg; Barth, Amy Elizabeth; Fletcher, Jack M

2014-12-01

No studies have investigated the cognitive attributes of middle school students who are adequate and inadequate responders to Tier 2 reading intervention. We compared students in Grades 6 and 7 representing groups of adequate responders ( n = 77) and inadequate responders who fell below criteria in (a) comprehension ( n = 54); (b) fluency ( n = 45); and (c) decoding, fluency, and comprehension (DFC; n = 45). These students received measures of phonological awareness, listening comprehension, rapid naming, processing speed, verbal knowledge, and nonverbal reasoning. Multivariate comparisons showed a significant Group-by-Task interaction: the comprehension-impaired group demonstrated primary difficulties with verbal knowledge and listening comprehension, the DFC group with phonological awareness, and the fluency-impaired group with phonological awareness and rapid naming. A series of regression models investigating whether responder status explained unique variation in cognitive skills yielded largely null results consistent with a continuum of severity associated with level of reading impairment, with no evidence for qualitative differences in the cognitive attributes of adequate and inadequate responders.

Ultrasound-guided core needle biopsy in diagnosis of abdominal and pelvic neoplasm in pediatric patients.

PubMed

Wang, Hailing; Li, Fangxuan; Liu, Juntian; Zhang, Sheng

2014-01-01

Ultrasound-guided core needle biopsy of abdominal and pelvic masses in adults has gained tremendous popularity. However, the application of the same treatment in children is not as popular because of apprehensions regarding inadequate tissues for the biopsy and accidental puncture of vital organs. Data of the application of ultrasound-guided core needle biopsy in 105 pediatric patients with clinically or ultrasound-diagnosed abdominopelvic masses were reviewed. Diagnostic procedures were conducted in our institution from May 2011 to May 2013. The biopsies were conducted on 86 malignant lesions and 19 benign lesions. 86 malignant tumors comprised neuroblastomas (30 cases), hepatoblastomas (15 cases), nephroblastomas (11 cases), and primitive neuroectodermal tumors/malignant small round cells (6 cases). Among malignant tumor cases, only a pelvic primitive neuroectodermal tumor did not receive a pathological diagnosis. Therefore, the biopsy accuracy was 98.8 % in malignant tumor. However, the biopsies for one neuroblastomas and one malignant small round cell tumor were inadequate for cytogenetic analysis. Therefore, 96.5 % of the malignant tumor patients received complete diagnosis via biopsy. 19 benign tumors comprised mature teratoma (10 cases), hemangioendothelioma (3 cases), paraganglioma (2 cases), and infection (2 cases). The diagnostic accuracy for benign neoplasm was 100 %. Five patients experienced postoperative complications, including pain (2 patients), bleeding from the biopsy site (2 patients), and wound infection (1 patient). Ultrasound-guided core needle biopsy is an efficient, minimally invasive, accurate, and safe diagnostic method that can be applied in the management of abdominal or pelvic mass of pediatric patients.

Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial.

PubMed

Genovese, Mark C; Fleischmann, Roy; Combe, Bernard; Hall, Stephen; Rubbert-Roth, Andrea; Zhang, Ying; Zhou, Yijie; Mohamed, Mohamed-Eslam F; Meerwein, Sebastian; Pangan, Aileen L

2018-06-12

Phase 2 studies with upadacitinib, a selective Janus kinase 1 (JAK1) inhibitor, have shown safety and efficacy in the treatment of patients with active rheumatoid arthritis. We did this study to further assess the safety and efficacy of upadacitinib in patients with an inadequate response to biologic disease-modifying anti-rheumatic drugs (bDMARDs). We did this double-blind, randomised controlled phase 3 trial at 153 sites in 26 countries. Patients were aged 18 years or older, had active rheumatoid arthritis and previous inadequate response or intolerance to bDMARDs, and were receiving concomitant background conventional synthetic DMARDS (csDMARDs). We randomly assigned patients (2:2:1:1) by interactive response technology to receive once-daily oral extended-release upadacitinib 15 mg or 30 mg or placebo for 12 weeks, followed by upadacitinib 15 mg or 30 mg from week 12 onwards. The two separate primary endpoints were the proportions of patients achieving a 20% improvement in American College of Rheumatology criteria (ACR20) at week 12 and the proportion of patients achieving a 28-joint disease activity score using C-reactive protein (DAS28[CRP]) of 3·2 or less at week 12. Efficacy and safety analyses were done in the modified intention-to-treat population of all patients who received at least one dose of study drug. Data are presented up to week 24 of this ongoing study. The trial is registered with ClinicalTrials.gov (NCT02706847). Between March 15, 2016, and Jan 10, 2017, 499 patients were randomly assigned (n=165 upadacitinib 15 mg; n=165 upadacitinib 30 mg; n=85 placebo then upadacitinib 15 mg; and n=84 placebo then upadacitinib 30 mg) and one patient was withdrawn from the 15 mg upadacitinib group before the start of study treatment. Mean disease duration was 13·2 years (SD 9·5); 235 (47%) of 498 patients had received one previous bDMARD, 137 (28%) had received two, and 125 (25%) had received at least three; 451 (91%) patients completed treatment up to week 12 and 419 (84%) patients completed treatment up to week 24. At week 12, ACR20 was achieved by 106 (65%; 95% CI 57-72) of 164 patients receiving upadacitinib 15 mg and 93 (56%; 49-64) of 165 patients receiving upadacitinib 30 mg compared with 48 (28%; 22-35) of 169 patients receiving placebo (p<0·0001 for each dose vs placebo). DAS28(CRP) of 3·2 or less was achieved by 71 (43%; 95% CI 36-51) of 164 patients receiving upadacitinib 15 mg and 70 (42%; 35-50) of 165 patients receiving upadacitinib 30 mg versus 24 (14%; 9-20) of 169 patients receiving placebo (p<0·0001 for each dose vs placebo). Up to week 12, overall numbers of patients with adverse events were similar for the placebo group (95 [56%] of 169) and the upadacitinib 15 mg group (91 [55%] of 164), but higher in the upadacitinib 30 mg group (111 [67%] of 165). At week 12, the most common adverse events occurring in at least 5% of patients in any treatment group were upper respiratory tract infection (13 [8%] of 169 in the placebo group; 13 [8%] of 164 in the upadacitinib 15 mg group; ten [6%] of 165 in the upadacitinib 30 mg group), nasopharyngitis (11 [7%]; seven [4%]; nine [5%]), urinary tract infection (ten [6%]; 15 [9%]; nine [5%]), and worsening of rheumatoid arthritis (ten [6%]; four [2%]; six [4%]). The number of patients with serious adverse events was higher in the upadacitinib 30 mg group (12 [7%]) than in the upadacitinib 15 mg group (eight [5%]); no serious adverse events were reported in patients receiving placebo. More patients in the upadacitinib 30 mg group had serious infections, herpes zoster, and adverse events leading to discontinuation than in the upadacitinib 15 mg and placebo groups. During the placebo-controlled phase of the study, one case of pulmonary embolism, three malignancies, one major adverse cardiovascular event, and one death were reported in patients receiving upadacitinib; none were reported in patients receiving placebo. Both doses of upadacitinib led to rapid and significant improvements compared with placebo over 12 weeks in patients with refractory rheumatoid arthritis. AbbVie Inc. Copyright © 2018 Elsevier Ltd. All rights reserved.

A comparative evaluation of pain and anxiety levels in 2 different anesthesia techniques: locoregional anesthesia using conventional syringe versus intraosseous anesthesia using a computer-controlled system (Quicksleeper).

PubMed

Özer, Senem; Yaltirik, Mehmet; Kirli, Irem; Yargic, Ilhan

2012-11-01

The aim of this study was to compare anxiety and pain levels during anesthesia and efficacy of Quicksleeper intraosseous (IO) injection system, which delivers computer-controlled IO anesthesia and conventional inferior alveolar nerve block (IANB) in impacted mandibular third molars. Forty subjects with bilateral impacted mandibular third molars randomly received IO injection or conventional IANB at 2 successive appointments. The subjects received 1.8 mL 2% articaine. IO injection has many advantages, such as enabling painless anesthesia with less soft tissue numbness and quick onset of anesthesia as well as lingual and palatal anesthesia with single needle penetration. Although IO injection is a useful technique commonly used during various treatments in dentistry, the duration of injection takes longer than conventional techniques, there is a possibility of obstruction at the needle tip, and, the duration of the anesthetic effect is inadequate for prolonged surgical procedures. Copyright © 2012 Elsevier Inc. All rights reserved.

Prevalence, Predictors, and Same Day Treatment of Positive VIA Enhanced by Digital Cervicography and Histopathology Results in a Cervical Cancer Prevention Program in Cameroon

PubMed Central

DeGregorio, Geneva A.; Bradford, Leslie S.; Manga, Simon; Tih, Pius M.; Wamai, Richard; Ogembo, Rebecca; Sando, Zacharie; Liu, Yuxin; Schwaiger, Constance; Rao, Sowmya R.; Kalmakis, Karen; Kennedy Sheldon, Lisa; Nulah, Kathleen; Welty, Edith; Welty, Thomas; Ogembo, Javier Gordon

2016-01-01

Background In 2007, the Cameroon Baptist Convention Health Services (CBCHS) implemented a screen-and-treat cervical cancer prevention program using visual inspection with acetic acid enhanced by digital cervicography (VIA-DC). Methods We retrospectively analyzed 46,048 medical records of women who received care through the CBCHS Women’s Health Program from 2007 through 2014 to determine the prevalence and predictors of positive VIA-DC, rates of same day treatment, and cohort prevalence of invasive cervical cancer (ICC). Results Of the 44,979 women who were screened for cervical cancer, 9.0% were VIA-DC-positive, 66.8% were VIA-DC-negative, 22.0% were VIA-DC-inadequate (normal ectocervix, but portions of the transformation zone were obscured), and 2.2% were VIA-DC-uncertain (cervical abnormalities confounding VIA-DC interpretation). Risk factors significantly associated with VIA-DC-positive screen were HIV-positivity, young age at sexual debut, higher lifetime number of sexual partners, low education status and higher gravidity. In 2014, 31.1% of women eligible for cryotherapy underwent same day treatment. Among the 32,788 women screened from 2007 through 2013, 201 cases of ICC were identified corresponding to a cohort prevalence of 613 per 100,000. Conclusions High rate of VIA-DC-positive screens suggests a significant burden of potential cervical cancer cases and highlights the need for expansion of cervical cancer screening and prevention throughout the 10 regions of Cameroon. VIA-DC-inadequate rates were also high, especially in older women, and additional screening methods are needed to confirm whether these results are truly negative. In comparison to similar screening programs in sub-Saharan Africa there was low utilization of same day cryotherapy treatment. Further studies are required to characterize possible program specific barriers to treatment, for example cultural demands, health system challenges and cost of procedure. The prevalence of ICC among women who presented for screening was high and requires further investigation. PMID:27280882

Prevalence, Predictors, and Same Day Treatment of Positive VIA Enhanced by Digital Cervicography and Histopathology Results in a Cervical Cancer Prevention Program in Cameroon.

PubMed

DeGregorio, Geneva A; Bradford, Leslie S; Manga, Simon; Tih, Pius M; Wamai, Richard; Ogembo, Rebecca; Sando, Zacharie; Liu, Yuxin; Schwaiger, Constance; Rao, Sowmya R; Kalmakis, Karen; Kennedy Sheldon, Lisa; Nulah, Kathleen; Welty, Edith; Welty, Thomas; Ogembo, Javier Gordon

2016-01-01

In 2007, the Cameroon Baptist Convention Health Services (CBCHS) implemented a screen-and-treat cervical cancer prevention program using visual inspection with acetic acid enhanced by digital cervicography (VIA-DC). We retrospectively analyzed 46,048 medical records of women who received care through the CBCHS Women's Health Program from 2007 through 2014 to determine the prevalence and predictors of positive VIA-DC, rates of same day treatment, and cohort prevalence of invasive cervical cancer (ICC). Of the 44,979 women who were screened for cervical cancer, 9.0% were VIA-DC-positive, 66.8% were VIA-DC-negative, 22.0% were VIA-DC-inadequate (normal ectocervix, but portions of the transformation zone were obscured), and 2.2% were VIA-DC-uncertain (cervical abnormalities confounding VIA-DC interpretation). Risk factors significantly associated with VIA-DC-positive screen were HIV-positivity, young age at sexual debut, higher lifetime number of sexual partners, low education status and higher gravidity. In 2014, 31.1% of women eligible for cryotherapy underwent same day treatment. Among the 32,788 women screened from 2007 through 2013, 201 cases of ICC were identified corresponding to a cohort prevalence of 613 per 100,000. High rate of VIA-DC-positive screens suggests a significant burden of potential cervical cancer cases and highlights the need for expansion of cervical cancer screening and prevention throughout the 10 regions of Cameroon. VIA-DC-inadequate rates were also high, especially in older women, and additional screening methods are needed to confirm whether these results are truly negative. In comparison to similar screening programs in sub-Saharan Africa there was low utilization of same day cryotherapy treatment. Further studies are required to characterize possible program specific barriers to treatment, for example cultural demands, health system challenges and cost of procedure. The prevalence of ICC among women who presented for screening was high and requires further investigation.

Reasons for Treatment Changes in Patients With Moderate to Severe Psoriasis.

PubMed

Anderson, Kathryn L; Feldman, Steven R

2015-01-01

Psoriasis treatment involves multiple treatment arms. Treatment choice depends on many factors and may change, due to the chronicity of psoriasis. The purpose of our study is to explore reasons for treatment changes in patients with moderate to severe psoriasis. Ten charts of patients with moderate to severe psoriasis were reviewed. The medication changes and reasons for change were extracted. A "treatment change" was defined as switching between medication classes, adding or removing a medication class, or switching medications within the oral or biologic medication class. Seventy-seven treatment changes were identified. On average, 1 treatment change occurred per year of follow-up. The most common reason for treatment change was inadequate disease control. Inadequate disease control with current therapy is the most common reason a physician changes treatment for moderate to severe psoriasis. More efficacious treatments or ways to improve efficacy may help improve the long-term outcomes of psoriasis. © The Author(s) 2015.

2014 Space Human Factors Engineering Standing Review Panel

NASA Technical Reports Server (NTRS)

Steinberg, Susan

2014-01-01

The 2014 Space Human Factors Engineering (SHFE) Standing Review Panel (from here on referred to as the SRP) participated in a WebEx/teleconference with members of the Space Human Factors and Habitability (SHFH) Element, representatives from the Human Research Program (HRP), the National Space Biomedical Research Institute (NSBRI), and NASA Headquarters on November 17, 2014 (list of participants is in Section XI of this report). The SRP reviewed the updated research plans for the Risk of Incompatible Vehicle/Habitat Design (HAB Risk) and the Risk of Performance Errors Due to Training Deficiencies (Train Risk). The SRP also received a status update on the Risk of Inadequate Critical Task Design (Task Risk), the Risk of Inadequate Design of Human and Automation/Robotic Integration (HARI Risk), and the Risk of Inadequate Human-Computer Interaction (HCI Risk).

Using Complementary and Alternative Medicine to Treat Pain and Agitation in Dementia: A Review of Randomized Controlled Trials from Long-Term Care with Potential Use in Critical Care.

PubMed

Anderson, Alison R; Deng, Jie; Anthony, Robert S; Atalla, Sebastian A; Monroe, Todd B

2017-12-01

The risk of pain in adults with dementia worsens with advancing age. Painful comorbidities may be underassessed and inadequately treated. Receiving treatment in critical care settings may indicate greater occurrences of pain and complications. Pain may exacerbate behavioral and psychological symptoms of dementia (BPSD), such as agitation. Complementary and alternative medicine (CAM) therapies may alleviate pain and BPSD, and continuity of therapy may bolster these therapeutic effects. This review did not reveal an apparent benefit of aromatherapy; however, improvements in BPSD have been shown previously. Massage and human interaction did demonstrate efficacy in reducing BPSD and pain. Copyright © 2017 Elsevier Inc. All rights reserved.

Determinants of Integrated Management of Childhood Illness (IMCI) non–severe pneumonia classification and care in Malawi health facilities: Analysis of a national facility census

PubMed Central

Johansson, Emily White; Nsona, Humphreys; Carvajal–Aguirre, Liliana; Amouzou, Agbessi; Hildenwall, Helena

2017-01-01

Background Research shows inadequate Integrated Management of Childhood Illness (IMCI)–pneumonia care in various low–income settings but evidence is largely from small–scale studies with limited evidence of patient–, provider– and facility–levels determinants of IMCI non–severe pneumonia classification and its management. Methods The Malawi Service Provision Assessment 2013–2014 included 3149 outpatients aged 2–59 months with completed observations, interviews and re–examinations. Mixed–effects logistic regression models quantified the influence of patient–, provider and facility–level determinants on having IMCI non–severe pneumonia and its management in observed consultations. Findings Among 3149 eligible outpatients, 590 (18.7%) had IMCI non–severe pneumonia classification in re–examination. 228 (38.7%) classified cases received first–line antibiotics and 159 (26.9%) received no antibiotics. 18.6% with cough or difficult breathing had 60–second respiratory rates counted during consultations, and conducting this assessment was significantly associated with IMCI training ever received (odds ratio (OR) = 2.37, 95% confidence interval (CI): 1.29–4.31) and negative rapid diagnostic test results (OR = 3.21, 95% CI: 1.45–7.13). Older children had lower odds of assessments than infants (OR = 48–59 months: 0.35, 95% CI: 0.16–0.75). Children presenting with any of the following complaints also had reduced odds of assessment: fever, diarrhea, skin problem or any danger sign. First–line antibiotic treatment for classified cases was significantly associated with high temperatures (OR = 3.26, 95% CI: 1.24–8.55) while older children had reduced odds of first–line treatment compared to infants (OR = 48–59 months: 0.29, 95% CI: 0.10–0.83). RDT–confirmed malaria was a significant predictor of no antibiotic receipt for IMCI non–severe pneumonia (OR = 10.65, 95% CI: 2.39–47.36). Conclusions IMCI non–severe pneumonia care was sub–optimal in Malawi health facilities in 2013–2014 with inadequate assessments and prescribing practices that must be addressed to reduce this leading cause of mortality. Child’s symptoms and age, malaria diagnosis and provider training were primary influences on assessment and treatment practices. Current evidence could be used to better target IMCI training and support to improve pneumonia care for sick children in Malawi facilities. PMID:29163934

Combination of Permanent Interstitial 125I-Seed Brachytherapy and Surgery for the Treatment of Large Hepatocellular Carcinoma

PubMed Central

Li, Xiaogang; Li, Bo; Yang, Rong; Luo, Kaiyuan

2017-01-01

The treatment methods available for large primary hepatocellular carcinomas (diameter >5 cm) are inadequate. Here, we report the successful management of 80 cases of large hepatocellular carcinoma, using a combination of custom-designed permanent interstitial iodine-125 seed brachytherapy and palliative surgery. Patients were enrolled in the study between 2011 and 2014. All patients underwent surgical treatment along with permanent interstitial iodine-125 seed brachytherapy; for the latter, patients received minimum doses covering 90% of the target (D90 s) of iodine-125 seeds ranging from 100 to 160 Gy (median: 110 Gy). All patients received 6 cycles of chemotherapy and were followed up at 6, 12, 24, and 36 months postoperatively. The clinical symptom remission rate was 95.3% (61 of 64). Alanine aminotransferase and aspartate aminotransferase levels decreased to normal in 80% (50 of 60) and 75% of the patients (45 of 60), respectively. The posttreatment alpha-fetoprotein levels decreased by 50% in 80% of the patients (40 of 50). The effective therapy rates were 80% (76 of 95) for 95 tumor nodules (diameters 5-10 cm) and 78.6% (33 of 42) for 42 tumor nodules (diameters >10 cm). The 3-year disease-free survival rate was 66.6%. Palliative surgery plus permanent interstitial iodine-125 seed brachytherapy appears to be a reasonable therapeutic alternative for large hepatocellular carcinoma. PMID:28585493

Non-adherence to subcutaneous allergen immunotherapy: inadequate health insurance coverage is the leading cause.

PubMed

Vaswani, Ravi; Garg, Akshay; Parikh, Leena; Vaswani, Surender

2015-09-01

To sustain the long-lasting beneficial effects of subcutaneous allergen immunotherapy, the recommended duration of treatment is 3 to 5 years. Nevertheless, many patients discontinue allergy injections prematurely and therefore might not appreciate the full therapeutic benefit. To examine factors leading to premature discontinuation of subcutaneous allergen immunotherapy (cessation before completion of the recommended duration). Patients who discontinued immunotherapy before the completion of the prescribed duration and received their final injection from January 2008 through September 2013 were contacted to identify the reason for stopping the allergy injections. Phase of treatment (escalation or maintenance) was used to measure the duration of treatment at the time of cessation and patients were grouped accordingly. The study population consisted of 555 patients with allergic rhinitis and/or asthma who terminated immunotherapy prematurely. Two hundred thirteen (38%) were men and 342 (62%) were women. The following reasons were cited by patients for non-adherence to immunotherapy: requirement of copayment for allergy injections and/or payment for allergen extract by their health insurer (40%); inconvenience of travel (15%); change of residence (8%); concurrent health problems (5%); patient-perceived ineffectiveness (4%); patient-perceived lack of need to continue immunotherapy (2%); adverse effects from injection (local reaction 1%; systemic allergic reaction 0.5%); and trial of alternative medicine (0.1%). The remaining 24.4% did not provide a reason for discontinuation. Of the various factors, inadequate reimbursement for allergen extract and allergy injections by health insurers is the most common reason cited for non-adherence to subcutaneous allergen immunotherapy. Copyright © 2015 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Assessment of anticoagulation treatments in non-valvular atrial fibrillation patients diagnosed in a basic health area.

PubMed

Aguilera Alcaraz, Beatriz M; Abellán Huerta, José; Carbayo Herencia, Julio Antonio; Ariza Copado, Consuelo; Hernández Menárguez, Fernando; Abellán Alemán, José

Atrial fibrillation (AF) is the most common cardiac arrhythmia. To assess the need for anticoagulation is essential for its management. Our objective was to investigate whether the indication of anticoagulation was adequate in patients diagnosed with non-valvular AF, given the CHA2-DS2-VASc scale, measuring the International Normalizad Ratio range (INR) in patients treated with anti-vitamin K drugs. This is an observational and cross sectional study. 232 patients with atrial fibrillation were included. We analyzed demographic, the CHA2-DS2-VASc and HAS-BLED variables, the treatment and INR values for 6 consequentive months. The confrontation of variables was performed using chi-square and Mantel-Haenzel test. The prevalence of AF was 1.05%. The 88.4% had CHA2-DS2-VASc ≥ 2. The 71.1% were taking anticoagulants, of which 58.2% were under antivitamin k. The 46.7% of patients taking antivitamin K, presented inadequate range of INR. There was a greater prescription of antivitamin k in patients with persistent or permanent AF compared to the paroxysmal form (62.8 vs. 37.2% p<.001). The use of drugs that increase bleeding was associated with a worse control of INR after adjustment for the main variables of clinical relevance (odds ratio 2.17 [1.02-4.59], p=.043). The level of anticoagulation with antivitamin K was inadequate in our sample, despite a proper follow up and adherence to treatment. Patients with paroxysmal AF received less antivitamin K than those with persistent/permanent AF. Copyright © 2017 Sociedad Española de Arteriosclerosis. Publicado por Elsevier España, S.L.U. All rights reserved.

Antiretroviral Resistance in HIV/AIDS Patients

NASA Astrophysics Data System (ADS)

Manosuthi, W.; MD

2018-03-01

The higher prevalence of HIV drug resistance was observed in areas with greater ART coverage. The HIV resistance-associated mutations occur when people have inadequate levels of antiretroviral drugs as well as inadequate potency, inadequate adherence, and preexisting resistance. The degree to drug cross-resistance is observed depends on the specific mutations and number of mutation accumulation. In the Southeast Asia region, the challenging of people with treatment failure is the availability and accessibility to subsequent new antiretroviral drugs to construct he second and salvage regimen. Genotypic resistance testing is a useful tool because it can identify the existing drug resistance-associated mutations under the selective drug pressure. Thus, understanding the basic interpretation of HIV drug resistance- associated mutation is useful in guiding clinical decisions for treatment-experienced people living with HIV.

Inhaled beclomethasone dipropionate improves acoustic measures of voice in patients with asthma.

PubMed

Balter, M S; Adams, S G; Chapman, K R

2001-12-01

Inhaled corticosteroids have the potential to produce upper-airway side effects such as hoarseness. As new compounds and delivery devices are developed and compared, it is difficult to quantify their adverse upper-airway effects. We undertook the following study to test the ability of an acoustic analysis technique to quantify changes in vocal function in steroid-naive patients with asthma who receive inhaled beclomethasone dipropionate (BDP), 1,000 microg/d for 4 months. Patients self-administered one of four regimens of inhaled BDP. Group 1 patients received one 250-microg puff qid via metered-dose inhaler (MDI); group 2 patients received one 250-microg puff qid via MDI with a holding chamber; group 3 patients received two 250-microg puffs bid via MDI; and group 4 patients received two 250-microg puffs bid via MDI with a holding chamber. A smaller cohort of nonsmoking asthmatic patients was managed without steroid intervention for 4 months. At baseline and again at 8 weeks and 16 weeks after the initiation of BDP treatment, patients underwent spirometry and methacholine challenge. At baseline and again at 2, 4, 8, 12, and 16 weeks, patients underwent voice recording for analysis of voice parameters. The recorded vowels were low-pass filtered (10 KHz), digitized (22 KHz), and analyzed by software to obtain two acoustic measures: (1) jitter, the cycle-to-cycle variation in the time period of the voice signal; and (2) shimmer, the cycle-to-cycle variation in voice signal amplitude. We recruited 77 patients for randomization to inhaled steroid therapy and 10 patients who continued to receive only occasional inhaled bronchodilator therapy. In all active treatment groups, FEV(1), FVC, and provocative concentration of methacholine causing a 20% fall in FEV(1) improved significantly after BDP treatment. Mean jitter scores, a measurement of variation in voice pitch, were not significantly influenced by BDP treatment. However, mean shimmer scores, a reflection of perturbation in vocal amplitude, fell significantly (p < 0.05) in the active treatment groups. These reductions in shimmer scores were not significantly different in the active treatment groups. Shimmer scores in the bronchodilator-treated group were unchanged during the 16 weeks of follow-up. Our data show that a simple and noninvasive acoustic analysis of voice is sensitive to subclinical changes associated with inhaled corticosteroid therapy. We have shown that 1,000 microg/d of inhaled BDP actually improves specific acoustic measures of voice in patients with inadequately controlled asthma. These improvements were uninfluenced by dosing schedule and whether a spacing chamber was used.

Cost-effectiveness of dapagliflozin versus DPP-4 inhibitors as an add-on to Metformin in the Treatment of Type 2 Diabetes Mellitus from a UK Healthcare System Perspective.

PubMed

Charokopou, M; McEwan, P; Lister, S; Callan, L; Bergenheim, K; Tolley, K; Postema, R; Townsend, R; Roudaut, M

2015-11-05

Type 2 diabetes mellitus (T2DM) is a chronic, progressive condition where the primary treatment goal is to maintain control of glycated haemoglobin (HbA1c). In order for healthcare decision makers to ensure patients receive the highest standard of care within the available budget, the clinical benefits of each treatment option must be balanced against the economic consequences. The aim of this study was to assess the cost-effectiveness of dapagliflozin, the first-in-class sodium-glucose co-transporter 2 (SGLT2) inhibitor, compared with a dipeptidyl peptidase-4 inhibitor (DPP-4i), when added to metformin for the treatment of patients with T2DM inadequately controlled on metformin alone. The previously published and validated Cardiff diabetes model was used as the basis for this economic evaluation, with treatment effect parameters sourced from a systematic review and network meta-analysis. Costs, derived from a UK healthcare system perspective, and quality-adjusted life years (QALYs), were used to present the final outcome as an incremental cost-effectiveness ratio (ICER) over a lifetime horizon. Univariate and probabilistic sensitivity analyses (PSA) were carried out to assess uncertainty in the model results. Compared with DPP-4i, dapagliflozin was associated with a mean incremental benefit of 0.032 QALYs (95% confidence interval [CI]: -0.022, 0.140) and with an incremental cost of £216 (95% CI: £-258, £795). This resulted in an ICER point estimate of £6,761 per QALY gained. Sensitivity analysis determined incremental costs to be insensitive to variation in most parameters, with only the treatment effect on weight having a notable impact on the incremental QALYs; however, there were no scenarios which raised the ICER above £15,000 per QALY. The PSA estimated that dapagliflozin had an 85% probability of being cost-effective at a willingness-to-pay threshold of £20,000 per QALY gained. Dapagliflozin in combination with metformin was shown to be a cost-effective treatment option from a UK healthcare system perspective for patients with T2DM who are inadequately controlled on metformin alone.

40 CFR 403.16 - Upset provision.

Code of Federal Regulations, 2010 CFR

2010-07-01

... operational error, improperly designed treatment facilities, inadequate treatment facilities, lack of... usual exercise of prosecutorial discretion, Agency enforcement personnel should review any claims that...

Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design.

PubMed

Rush, A John; Fava, Maurizio; Wisniewski, Stephen R; Lavori, Philip W; Trivedi, Madhukar H; Sackeim, Harold A; Thase, Michael E; Nierenberg, Andrew A; Quitkin, Frederic M; Kashner, T Michael; Kupfer, David J; Rosenbaum, Jerrold F; Alpert, Jonathan; Stewart, Jonathan W; McGrath, Patrick J; Biggs, Melanie M; Shores-Wilson, Kathy; Lebowitz, Barry D; Ritz, Louise; Niederehe, George

2004-02-01

STAR*D is a multisite, prospective, randomized, multistep clinical trial of outpatients with nonpsychotic major depressive disorder. The study compares various treatment options for those who do not attain a satisfactory response with citalopram, a selective serotonin reuptake inhibitor antidepressant. The study enrolls 4000 adults (ages 18-75) from both primary and specialty care practices who have not had either a prior inadequate response or clear-cut intolerance to a robust trial of protocol treatments during the current major depressive episode. After receiving citalopram (level 1), participants without sufficient symptomatic benefit are eligible for randomization to level 2 treatments, which entail four switch options (sertraline, bupropion, venlafaxine, cognitive therapy) and three citalopram augment options (bupropion, buspirone, cognitive therapy). Those who receive cognitive therapy (switch or augment options) at level 2 without sufficient improvement are eligible for randomization to one of two level 2A switch options (venlafaxine or bupropion). Level 2 and 2A participants are eligible for random assignment to two switch options (mirtazapine or nortriptyline) and to two augment options (lithium or thyroid hormone) added to the primary antidepressant (citalopram, bupropion, sertraline, or venlafaxine) (level 3). Those without sufficient improvement at level 3 are eligible for level 4 random assignment to one of two switch options (tranylcypromine or the combination of mirtazapine and venlafaxine). The primary outcome is the clinician-rated, 17-item Hamilton Rating Scale for Depression, administered at entry and exit from each treatment level through telephone interviews by assessors masked to treatment assignments. Secondary outcomes include self-reported depressive symptoms, physical and mental function, side-effect burden, client satisfaction, and health care utilization and cost. Participants with an adequate symptomatic response may enter the 12-month naturalistic follow-up phase with brief monthly and more complete quarterly assessments.

Influence of maternal health literacy on child participation in social welfare programs: the Philadelphia experience.

PubMed

Pati, Susmita; Mohamad, Zeinab; Cnaan, Avital; Kavanagh, Jane; Shea, Judy A

2010-09-01

We examined the influence of maternal health literacy on child participation in social welfare programs. In this cohort, 20% of the mothers had inadequate or marginal health literacy. Initially, more than 50% of the families participated in Temporary Assistance for Needy Families (TANF), the Food Stamp Program, and Special Supplemental Nutrition Program for Women, Infants, and Children, whereas fewer than 15% received child care subsidies or public housing. In multivariate regression, TANF participation was more than twice as common among children whose mothers had adequate health literacy compared with children whose mothers had inadequate health literacy.

A Computerized Decision Support System for Depression in Primary Care

PubMed Central

Kurian, Benji T.; Trivedi, Madhukar H.; Grannemann, Bruce D.; Claassen, Cynthia A.; Daly, Ella J.; Sunderajan, Prabha

2009-01-01

Objective: In 2004, results from The Texas Medication Algorithm Project (TMAP) showed better clinical outcomes for patients whose physicians adhered to a paper-and-pencil algorithm compared to patients who received standard clinical treatment for major depressive disorder (MDD). However, implementation of and fidelity to the treatment algorithm among various providers was observed to be inadequate. A computerized decision support system (CDSS) for the implementation of the TMAP algorithm for depression has since been developed to improve fidelity and adherence to the algorithm. Method: This was a 2-group, parallel design, clinical trial (one patient group receiving MDD treatment from physicians using the CDSS and the other patient group receiving usual care) conducted at 2 separate primary care clinics in Texas from March 2005 through June 2006. Fifty-five patients with MDD (DSM-IV criteria) with no significant difference in disease characteristics were enrolled, 32 of whom were treated by physicians using CDSS and 23 were treated by physicians using usual care. The study's objective was to evaluate the feasibility and efficacy of implementing a CDSS to assist physicians acutely treating patients with MDD compared to usual care in primary care. Primary efficacy outcomes for depression symptom severity were based on the 17-item Hamilton Depression Rating Scale (HDRS17) evaluated by an independent rater. Results: Patients treated by physicians employing CDSS had significantly greater symptom reduction, based on the HDRS17, than patients treated with usual care (P < .001). Conclusions: The CDSS algorithm, utilizing measurement-based care, was superior to usual care for patients with MDD in primary care settings. Larger randomized controlled trials are needed to confirm these findings. Trial Registration: clinicaltrials.gov Identifier: NCT00551083 PMID:19750065

A computerized decision support system for depression in primary care.

PubMed

Kurian, Benji T; Trivedi, Madhukar H; Grannemann, Bruce D; Claassen, Cynthia A; Daly, Ella J; Sunderajan, Prabha

2009-01-01

In 2004, results from The Texas Medication Algorithm Project (TMAP) showed better clinical outcomes for patients whose physicians adhered to a paper-and-pencil algorithm compared to patients who received standard clinical treatment for major depressive disorder (MDD). However, implementation of and fidelity to the treatment algorithm among various providers was observed to be inadequate. A computerized decision support system (CDSS) for the implementation of the TMAP algorithm for depression has since been developed to improve fidelity and adherence to the algorithm. This was a 2-group, parallel design, clinical trial (one patient group receiving MDD treatment from physicians using the CDSS and the other patient group receiving usual care) conducted at 2 separate primary care clinics in Texas from March 2005 through June 2006. Fifty-five patients with MDD (DSM-IV criteria) with no significant difference in disease characteristics were enrolled, 32 of whom were treated by physicians using CDSS and 23 were treated by physicians using usual care. The study's objective was to evaluate the feasibility and efficacy of implementing a CDSS to assist physicians acutely treating patients with MDD compared to usual care in primary care. Primary efficacy outcomes for depression symptom severity were based on the 17-item Hamilton Depression Rating Scale (HDRS(17)) evaluated by an independent rater. Patients treated by physicians employing CDSS had significantly greater symptom reduction, based on the HDRS(17), than patients treated with usual care (P < .001). The CDSS algorithm, utilizing measurement-based care, was superior to usual care for patients with MDD in primary care settings. Larger randomized controlled trials are needed to confirm these findings. clinicaltrials.gov Identifier: NCT00551083.

Health literacy in familial hypercholesterolemia: A cross-national study.

PubMed

Hagger, Martin S; Hardcastle, Sarah J; Hu, Miao; Kwok, See; Lin, Jie; Nawawi, Hapizah M; Pang, Jing; Santos, Raul D; Soran, Handrean; Su, Ta-Chen; Tomlinson, Brian; Watts, Gerald F

2018-06-01

Background High rates of inadequate health literacy are associated with maladaptive health outcomes in chronic disease including increased mortality and morbidity rates, poor treatment adherence and poor health. Adequate health literacy may be an important factor in the effective treatment and management of familial hypercholesterolemia, and may also be implicated in genetic screening for familial hypercholesterolemia among index cases. The present study examined the prevalence and predictors of health literacy in familial hypercholesterolemia patients attending clinics in seven countries. Design Cross-sectional survey. Methods Consecutive FH patients attending clinics in Australia, Brazil, China, Hong Kong, Malaysia, Taiwan and the UK completed measures of demographic variables (age, gender, household income and highest education level) and a brief three-item health literacy scale. Results Rates of inadequate health literacy were lowest in the UK (7.0%), Australia (10.0%), Hong Kong (15.7%) and Taiwan (18.0%) samples, with higher rates in the Brazil (22.0%), Malaysia (25.0%) and China (37.0%) samples. Income was an independent predictor of health literacy levels, accounting for effects of age. Health literacy was also independently related to China national group membership. Conclusions Findings indicate non-trivial levels of inadequate health literacy in samples of familial hypercholesterolemia patients. Consistent with previous research in chronic illness, inadequate health literacy is related to income as an index of health disparities. Chinese familial hypercholesterolemia patients are more likely to have high rates of inadequate health literacy independent of income. Current findings highlight the imperative of education interventions targeting familial hypercholesterolemia patients with inadequate health literacy.

Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: results of two Phase 2 randomised controlled trials.

PubMed

Wallenstein, Gene V; Kanik, Keith S; Wilkinson, Bethanie; Cohen, Stanley; Cutolo, Maurizio; Fleischmann, Roy; Genovese, Mark C; Gomez Reino, Juan; Gruben, David; Kremer, Joel; Krishnaswami, Sriram; Lee, Eun Bong; Pascual-Ramos, Virginia; Strand, Vibeke; Zwillich, Samuel H

2016-01-01

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we investigated the effects of tofacitinib on patient-reported outcomes (PRO) in patients with active RA. Two, 6-month, double-blind, placebo-controlled Phase 2b studies were performed. The combination study evaluated patients with inadequate response to methotrexate who received tofacitinib 1-15 mg twice daily (BID), 20 mg once daily or placebo, on background methotrexate. In the monotherapy study, patients with inadequate response to disease-modifying anti-rheumatic drugs received tofacitinib 1-15 mg BID, adalimumab 40 mg once every other week or placebo. PROs measured were: Patient's Assessment of Arthritis Pain (PAAP), Patient's Assessment of Disease Activity, HAQ-DI, FACIT-F and SF-36. In the combination study (n=507), significant improvements (p<0.05) versus placebo were observed at Week 12 in PAAP (visual analogue scale) and HAQ-DI for all tofacitinib groups. In the monotherapy study (n=384), significant improvements in PAAP were observed at Week 12 for tofacitinib 5, 10 and 15 mg BID, and in HAQ-DI for tofacitinib 3, 5, 10 and 15 mg BID. Significant improvements versus placebo were seen at Week 2 in PAAP (both studies) and HAQ‑DI (monotherapy study) with tofacitinib, and were maintained throughout each study. In both studies, improvements in several domains of the SF-36 in the tofacitinib groups were observed at Weeks 12 and 24. In patients with active RA, tofacitinib, either in combination with methotrexate or as monotherapy, demonstrated rapid and sustained improvement in pain, physical functioning and health-related quality of life.

Current practice in the diagnosis and management of IBD-associated anaemia and iron deficiency in Germany: the German AnaemIBD Study.

PubMed

Blumenstein, Irina; Dignass, Axel; Vollmer, Stephan; Klemm, Wolfgang; Weber-Mangal, Susanne; Stein, Juergen

2014-10-01

Anaemia is a common complication in inflammatory bowel disease (IBD), frequently resulting from iron deficiency. IBD guidelines advocate intravenous iron administration although some patients respond to oral supplementation. This non-interventional study investigates the current status of anaemia management in German IBD patients. Baseline data on pre-study treatment for anaemia were retrospectively analysed in IBD patients with anaemia participating in a prospective trial of the efficacy and safety of ferric carboxymaltose. Data were collected from 55 German gastroenterological centres up to August 2010. Subjects had received care at their centre for at least 12 months prior to baseline. 193 cases of IBD-associated anaemia (115 Crohn's disease, 77 ulcerative colitis) were analysed (mean age: 39 years (18-83), 79 (41%) males). Anaemia and iron status were usually assessed by haemoglobin (100%), serum ferritin (97%), and transferrin saturation (82%). In the previous 6 months, only 84 patients (43.5%) had been treated for anaemia: 47 (56%) with oral iron, 13 (15%) parenteral iron, 16 (19%) oral plus parenteral iron and 8 (10%) transfusions. No patients received erythropoietin stimulating agents. Although intravenous iron supplementation is recommended in IBD patients, current German practice still relies on oral therapy, even in severe anaemia. The high incidence of severe anaemia in this cohort reflects inadequate iron replacement and status monitoring. While the proportion of IBD patients with inadequately treated anaemia/iron deficiency is unknown, greater awareness of existing guidelines for iron deficiency management in IBD patients appears necessary. Copyright © 2014 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.

Alemtuzumab CARE-MS II 5-year follow-up

PubMed Central

Cohen, Jeffrey A.; Fox, Edward J.; Giovannoni, Gavin; Hartung, Hans-Peter; Havrdova, Eva; Schippling, Sven; Selmaj, Krzysztof W.; Traboulsee, Anthony; Compston, D. Alastair S.; Margolin, David H.; Thangavelu, Karthinathan; Chirieac, Madalina C.; Jody, Darlene; Xenopoulos, Panos; Hogan, Richard J.; Panzara, Michael A.; Arnold, Douglas L.

2017-01-01

Objective: To evaluate 5-year efficacy and safety of alemtuzumab in patients with active relapsing-remitting multiple sclerosis and inadequate response to prior therapy. Methods: In the 2-year Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) II study (NCT00548405), alemtuzumab-treated patients received 2 courses (baseline and 12 months later). Patients could enter an extension (NCT00930553), with as-needed alemtuzumab retreatment for relapse or MRI activity. Annualized relapse rate (ARR), 6-month confirmed disability worsening (CDW; ≥1-point Expanded Disability Status Scale [EDSS] score increase [≥1.5 if baseline EDSS = 0]), 6-month confirmed disability improvement (CDI; ≥1-point EDSS decrease [baseline score ≥2.0]), no evidence of disease activity (NEDA), brain volume loss (BVL), and adverse events (AEs) were assessed. Results: Most alemtuzumab-treated patients (92.9%) who completed CARE-MS II entered the extension; 59.8% received no alemtuzumab retreatment. ARR was low in each extension year (years 3–5: 0.22, 0.23, 0.18). Through 5 years, 75.1% of patients were free of 6-month CDW; 42.9% achieved 6-month CDI. In years 3, 4, and 5, proportions with NEDA were 52.9%, 54.2%, and 58.2%, respectively. Median yearly BVL remained low in the extension (years 1–5: −0.48%, −0.22%, −0.10%, −0.19%, −0.07%). AE exposure-adjusted incidence rates in the extension were lower than in the core study. Thyroid disorders peaked at year 3, declining thereafter. Conclusions: Alemtuzumab provides durable efficacy through 5 years in patients with an inadequate response to prior therapy in the absence of continuous treatment. Classification of evidence: This study provides Class III evidence that alemtuzumab provides efficacy and slowing of brain atrophy through 5 years. PMID:28835403

Examining the Efficacy of a Family Peer Advocate Model for Black and Hispanic Caregivers of Children with Autism Spectrum Disorder.

PubMed

Jamison, J M; Fourie, E; Siper, P M; Trelles, M P; George-Jones, Julia; Buxbaum Grice, A; Krata, J; Holl, E; Shaoul, J; Hernandez, B; Mitchell, L; McKay, M M; Buxbaum, J D; Kolevzon, Alexander

2017-05-01

Autism spectrum disorder (ASD) affects individuals across all racial and ethnic groups, yet rates of diagnosis are disproportionately higher for Black and Hispanic children. Caregivers of children with ASD experience significant stressors, which have been associated with parental strain, inadequate utilization of mental health services and lower quality of life. The family peer advocate (FPA) model has been utilized across service delivery systems to provide family-to-family support, facilitate engagement, and increase access to care. This study used a randomized controlled design to examine the efficacy of FPAs in a racially and ethnically diverse sample. Results demonstrate significantly increased knowledge of ASD and reduced levels of stress for caregivers who received the FPA intervention as compared to treatment as usual.

Cost-effectiveness analysis of oral anti-viral drugs used for treatment of chronic hepatitis B in Turkey.

PubMed

Kockaya, Guvenc; Kose, Akin; Yenilmez, Fatma Betul; Ozdemir, Oktay; Kucuksayrac, Ece

2015-01-01

All international guidelines suggested that Tenofovir and Entecavir are the primary drugs at the first line therapy for the treatment of chronic hepatitis B (CHB). However, in Turkey these medications reimbursed at the second line therapy according to the Healthcare Implementation Notification. The aim of this study is to compare the cost effectiveness of oral antiviral treatment strategies in CHB for Turkey using lamuvidine, telbuvidine, entecavir, and tenofovir as medications. The analysis was conducted using Markov models. The analysis scenarios based on first line treatment options with Lamuvidine, Telbuvidine, Entecavir, and Tenofovir as the medications. In the analysis, inadequate response or resistance after receiving 12 months of the treatment with Entecavir and Telbivudine were compared to the results found from switching from Entecavir to Tenofovir or from switching from Telbuvidine to Tenofovir. In additional, inadequate response or resistance after receiving 6 months of the treatment for Lamivudine was compared to the results found from switching from Lamivudine to Tenofovir. The study population included men and women, who were 40 years of age. The patients` compliance was estimated 100 % for all of the therapy options. The model duration was constructed to evaluate, treatment strategy duration of 40 years. The cost of medications, examinations/follow-ups and complications were included in the model. Years of Potential Life Lost was used as the health outcome. An incremental cost-effectiveness ratio analysis has been conducted. While the minimum years of life lost was found as 0.22 with tenofovir treatment in 5 years, treatment cost was calculated as 12,169 TL. These values were detected as 0.56 years and 7727 TL, 0.37 years and 12,770 TL, respectively for lamuvidine and telbuvidine treatments. The maximum years of life lost and treatment cost was with lamuvidine treatment were detected as 1.60 years and 18,813 TL and, secondly 0.89 years and 24,007 TL for lamuvidine-tenofovir treatment during 10 years. The minimum years of life lost and cost are 0.54 year and 35,821 TL for tenofovir treatment during 10 years. The minimum years of life lost and cost were determined as 1.21 years and 52,839 TL for tenofovir treatment strategy during 20 years. During 30 years period, tenofovir treatment was found to have the minimum years of life lost (1.73 years) and minimum cost (84,149 TL). When the results of 40 years period were analyzed, years of life lost and costs are 2.06 years and 119,604 TL, 2.13 years and 162,115 TL, 2.13 years and 161,642 TL, 6.52 years and 147,245 TL, 3.20 years and 132,157 TL, 4.10 years and 151,059 TL and 3.05 years and 138,182 TL for tenofovir, entecavir, entecavir-tenofovir, lamuvidine, lamuvidine-tenofovir, telbivudine and telbivudine-tenofovir. In the model presented in this study, in cost effectiveness analysis about CHB treatments, Tenofovir was found to be one of the cost effective methods in comparison with other treatment strategies different time intervals. Beyond this achievement Tenofovir has shown to reduce cumulative treatment cost in first line CHB treatment when compared with regard to 40 year cumulative treatment cost.

How We Identify and Manage Patients with Inadequately Controlled Polycythemia Vera.

PubMed

Reiter, Andreas; Harrison, Claire

2016-10-01

Polycythemia vera (PV) is a chronic myeloproliferative neoplasm (MPN) characterized by an overactive Janus kinase/signal transducer and activator of transcription (JAK/STAT) pathway through mutations in JAK2 exons 12 or 14 (JAK2 V617F). The dominant clinical characteristics include erythrocytosis (with or without leukocytosis/thrombocytosis), thrombotic events, and symptoms. Increased risk of mortality is mainly caused by thrombotic events and progression to post-polycythemia vera myelofibrosis (PPV-MF) or secondary acute myeloid leukemia (sAML). The most important prognostic factors include age and a history of thrombotic events, although recent evidence has indicated that leukocytosis and additional cytogenetic aberrations may also be of significant prognostic value. First-line therapies include aspirin and phlebotomies, which significantly reduce the incidence of thrombotic events and prolong survival. Cytoreductive treatment with hydroxyurea (approved) and conventional or pegylated interferon-α (effective, but not approved in many countries) is initiated for high-risk or inadequately controlled disease, e.g., uncontrolled hematocrit, leukocytosis, thrombocytosis, thrombotic events, splenomegaly, or symptoms. However, some patients may not receive initial benefit from first-line therapy or may become resistant or intolerant in due course. Although second-line treatment options are limited, clinical trials have shown the efficacy of ruxolitinib toward improving blood counts, enlarged spleen, and symptoms and potentially reducing thrombotic events. Identification of patients with uncontrolled PV is important for clinical care, as such patients have a high risk of complications, and future studies with JAK inhibitors or other agents alone or in combination are needed to test their potential to reduce rates of thrombotic events and transformation to PPV-MF or sAML.

Evaluation of complications of root canal treatment performed by undergraduate dental students.

PubMed

AlRahabi, Mothanna K

2017-12-01

This study evaluated the technical quality of root canal treatment (RCT) and detected iatrogenic errors in an undergraduate dental clinic at the College of Dentistry, Taibah University, Saudi Arabia. Dental records of 280 patients who received RCT between 2013 and 2016 undertaken by dental students were investigated by retrospective chart review. Root canal obturation was evaluated on the basis of the length of obturation being ≤2 mm from the radiographic apex, with uniform radiodensity and good adaptation to root canal walls. Inadequate root canal obturation included cases containing procedural errors such as furcal perforation, ledge, canal transportation, strip perforation, root perforation, instrument separation, voids in the obturation, or underfilling or overfilling of the obturation. In 193 (68.9%) teeth, RCT was adequate and without procedural errors. However, in 87 (31.1%) teeth, RCT was inadequate and contained procedural errors. The frequency of procedural errors in the entire sample was 31.1% as follows: underfilling, 49.9%; overfilling, 24.1%; voids, 12.6%; broken instruments, 9.2%; apical perforation, 2.3%; and root canal transportation, 2.3%. There were no significant differences (p > 0.05) in the type or frequency of procedural errors between the fourth- and fifth-year students. Lower molars (43.1%) and upper incisors (19.2%) exhibited the highest and lowest frequencies of procedural errors, respectively. The technical quality of RCT performed by undergraduate dental students was classified as 'adequate' in 68.9% of the cases. There is a need for improvement in the training of students at the preclinical and clinical levels.

Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE)).

PubMed

Emery, P; Deodhar, A; Rigby, W F; Isaacs, J D; Combe, B; Racewicz, A J; Latinis, K; Abud-Mendoza, C; Szczepanski, L J; Roschmann, R A; Chen, A; Armstrong, G K; Douglass, W; Tyrrell, H

2010-09-01

This phase III study evaluated the efficacy and safety of rituximab plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who had an inadequate response to MTX and who were naïve to prior biological treatment. Patients with active disease on stable MTX (10-25 mg/week) were randomised to rituximab 2 x 500 mg (n=168), rituximab 2 x 1000 mg (n=172), or placebo (n=172). From week 24, patients not in remission (Disease Activity Score (28 joints) > or =2.6) received a second course of rituximab; patients initially assigned to placebo switched to rituximab 2 x 500 mg. The primary end point was American College of Rheumatology 20 (ACR20) response at week 24. All patients were followed until week 48. At week 24, both doses of rituximab showed statistically superior efficacy (p<0.0001) to placebo (ACR20: 54%, 51% and 23%; rituximab (2 x 500 mg) + MTX, rituximab (2 x 1000 mg) + MTX and placebo + MTX, respectively). Secondary end points were also significantly improved for both rituximab groups compared with placebo. Further improvements in both rituximab arms were observed from week 24 to week 48. Rituximab + MTX was well tolerated, demonstrating comparable safety to placebo + MTX through to week 24, and between rituximab doses through to week 48. Rituximab (at 2 x 500 mg and 2 x 1000 mg) plus MTX significantly improved clinical outcomes at week 24, which were further improved by week 48. No significant differences in either clinical or safety outcomes were apparent between the rituximab doses.

Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naïve with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE))

PubMed Central

Emery, P; Deodhar, A; Rigby, W F; Isaacs, J D; Combe, B; Racewicz, A J; Latinis, K; Abud-Mendoza, C; Szczepański, L J; Roschmann, R A; Chen, A; Armstrong, G K; Douglass, W; Tyrrell, H

2010-01-01

Objectives This phase III study evaluated the efficacy and safety of rituximab plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who had an inadequate response to MTX and who were naïve to prior biological treatment. Methods Patients with active disease on stable MTX (10–25 mg/week) were randomised to rituximab 2×500 mg (n=168), rituximab 2×1000 mg (n=172), or placebo (n=172). From week 24, patients not in remission (Disease Activity Score (28 joints) ≥2.6) received a second course of rituximab; patients initially assigned to placebo switched to rituximab 2×500 mg. The primary end point was American College of Rheumatology 20 (ACR20) response at week 24. All patients were followed until week 48. Results At week 24, both doses of rituximab showed statistically superior efficacy (p<0.0001) to placebo (ACR20: 54%, 51% and 23%; rituximab (2×500 mg) + MTX, rituximab (2×1000 mg) + MTX and placebo + MTX, respectively). Secondary end points were also significantly improved for both rituximab groups compared with placebo. Further improvements in both rituximab arms were observed from week 24 to week 48. Rituximab + MTX was well tolerated, demonstrating comparable safety to placebo + MTX through to week 24, and between rituximab doses through to week 48. Conclusions Rituximab (at 2×500 mg and 2×1000 mg) plus MTX significantly improved clinical outcomes at week 24, which were further improved by week 48. No significant differences in either clinical or safety outcomes were apparent between the rituximab doses. PMID:20488885

Health Information-Seeking Behavior Among Hypothyroid Patients at Saveetha Medical College and Hospital.

PubMed

Perumal, S S; Prasad, S; Surapaneni, K M; Joshi, A

2015-04-01

Hypothyroidism causes considerable morbidity. Low knowledge coupled with inadequate health literacy may lead to poor prevention and management. This study aimed to assess health information-seeking behavior and hypothyroid knowledge among South Indian hypothyroid patients. This cross-sectional study was conducted in October 2013 in Saveetha Medical College, Chennai, India. Hundred clinically diagnosed hypothyroid patients ≥18 years were interviewed in a hospital using a 57-item questionnaire to gather information on their socio-demographics, self-reported disease history, hypothyroid-related knowledge, health information sources, health literacy and health information-seeking behavior. Hypothyroidism was assessed by free T3 and T4 levels. Mean age of participants was 38 years (SD=12) with median age of 39.5 years, majority of the participants being females (77%) and living in urban setting (52%). Mean free T3 level was 0.0137ng/dl (SD= 0.003) and mean free T4 was 0.7ng/dl (SD= 0.06). Ninety three percent of the participants received initial hypothyroidism education from their physicians at the time of diagnosis. Half of the participants had incorrect hypothyroidism-related knowledge; similar between both genders. Participants with inadequate health literacy had poor knowledge about the hypothyroidism. Hypothyroidism-related health information was sought almost exclusively from health professionals, predominantly regarding treatment, linked to their faith in qualified medical assistance. Economic status primarily determined healthcare-seeking behavior. Marital status, education level, annual household income and health literacy were significantly associated with knowledge. Participants having higher educational qualification, higher annual household income and adequate health literacy had considerable knowledge about hypothyroidism. Developing multi-factorial and tailored health education for patients with marginal or inadequate health literacy is needed. Exploring healthcare institutions as a medium for delivery of such education should be explored.

Pregabalin monotherapy in patients with partial-onset seizures

PubMed Central

Kwan, Patrick; Fakhoury, Toufic; Pitman, Verne; DuBrava, Sarah; Knapp, Lloyd; Yurkewicz, Lorraine

2014-01-01

Objective: To assess pregabalin monotherapy for partial-onset seizures using a historical-controlled conversion-to-monotherapy design. Methods: Adults with inadequately controlled partial-onset seizures while receiving 1 or 2 antiepileptic drugs during an 8-week prospective baseline were randomized to double-blind monotherapy with pregabalin 600 or 150 mg/d (4:1) for 20 weeks (8-week conversion and 12-week monotherapy period). The primary endpoint was the seizure-related exit rate for pregabalin 600 mg/d, based on discontinuations due to predefined criteria. Efficacy was declared if the upper limit of the 95% confidence interval for the exit rate was below a historical-control threshold of 74%, with stepwise evaluation using a threshold of 68%. Results: The trial was stopped early for positive efficacy after an interim analysis in 125 patients. The full study population included 161 patients, with 148 evaluable for efficacy. The mean time since epilepsy diagnosis was 14 years. Overall, 54.3% (600 mg/d) and 46.9% (150 mg/d) of patients completed 20 weeks of double-blind treatment. Seizure-related exit rate in the 600 mg/d group (27.5%; 95% confidence interval, 17.8%–37.2%) was significantly below the 74% and 68% thresholds (p < 0.001 for both). Eight patients on 600 mg/d and 2 on 150 mg/d were seizure-free throughout pregabalin monotherapy. Pregabalin's overall safety profile was consistent with prior trials. Conclusions: Pregabalin monotherapy was safe and efficacious for patients with inadequately controlled partial-onset seizures. Classification of evidence: This study provides Class III evidence that patients with inadequately controlled partial-onset seizures switched to pregabalin monotherapy have fewer seizure-related exit events compared with historical controls switched to pseudo-placebo monotherapy. PMID:24415567

The 11-β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor INCB13739 Improves Hyperglycemia in Patients With Type 2 Diabetes Inadequately Controlled by Metformin Monotherapy

PubMed Central

Rosenstock, Julio; Banarer, Salomon; Fonseca, Vivian A.; Inzucchi, Silvio E.; Sun, William; Yao, Wenqing; Hollis, Gregory; Flores, Robert; Levy, Richard; Williams, William V.; Seckl, Jonathan R.; Huber, Reid

2010-01-01

OBJECTIVE 11-β-hydroxysteroid dehydrogenase type 1 (11βHSD1) converts inactive cortisone into active cortisol, thereby amplifying intracellular glucocorticoid action. The efficacy and safety of the 11βHSD1 inhibitor INCB13739 were assessed when added to ongoing metformin monotherapy in patients with type 2 diabetes exhibiting inadequate glycemic control (A1C 7–11%). RESEARCH DESIGN AND METHODS This double-blind placebo-controlled paralleled study randomized 302 patients with type 2 diabetes (mean A1C 8.3%) on metformin monotherapy (mean 1.5 g/day) to receive one of five INCB13739 doses or placebo once daily for 12 weeks. The primary end point was the change in A1C at study end. Other end points included changes in fasting glucose, lipids, weight, adverse events, and safety. RESULTS After 12 weeks, 200 mg of INCB13739 resulted in significant reductions in A1C (−0.6%), fasting plasma glucose (−24 mg/dl), and homeostasis model assessment–insulin resistance (HOMA-IR) (−24%) compared with placebo. Total cholesterol, LDL cholesterol, and triglycerides were all significantly decreased in hyperlipidemic patients. Body weight decreased relative to placebo after INCB13739 therapy. A reversible dose-dependent elevation in adrenocorticotrophic hormone, generally within the normal reference range, was observed. Basal cortisol homeostasis, testosterone in men, and free androgen index in women were unchanged by INCB13739. Adverse events were similar across all treatment groups. CONCLUSIONS INCB13739 added to ongoing metformin therapy was efficacious and well tolerated in patients with type 2 diabetes who had inadequate glycemic control with metformin alone. 11βHSD1 inhibition offers a new potential approach to control glucose and cardiovascular risk factors in type 2 diabetes. PMID:20413513

Long-term effects of treatment on endocrine function in children with brain tumors

DOE Office of Scientific and Technical Information (OSTI.GOV)

Duffner, P.K.; Cohen, M.E.; Anderson, S.W.

1983-11-01

Fourteen children with brain tumors received endocrine evaluations at least one year following completion of cranial irradiation. Treatment consisted of operation (13 patients), craniospinal irradiation (6), whole brain irradiation (5), posterior fossa irradiation (3), and chemotherapy (10). Endocrine evaluation included bone age roentgenography and measurement of growth hormone (using sequential arginine and insulin stimulation), thyroxine, thyroid-stimulating hormone, plasma cortisol, testosterone, prolactin, and urinary follicle-stimulating hormone and luteinizing hormone. Ten of 12 children (83%) had abnormal responses to both tests of growth hormone stimulation. All growth hormone-deficient patients treated prior to puberty and tested at least 2 years following completion ofmore » cranial irradiation had decelerated linear growth. Results of thyroid function tests were abnormal in 4 patients: 2 patients had evidence of primary hypothyroidism, and 2 showed secondary or tertiary hypothyroidism. Two patients had inadequate cortisol responses to insulin hypoglycemia. Urinary follicle-stimulating hormone and luteinizing hormone, serum prolactin, and serum testosterone levels were appropriate for age in all patients.« less

[Hypertension in Mexican adults: prevalence, diagnosis and type of treatment. Ensanut MC 2016.

PubMed

Campos-Nonato, Ismael; Hernández-Barrera, Lucía; Pedroza-Tobías, Andrea; Medina, Catalina; Barquera, Simón

2018-01-01

To describe the prevalence, awareness and proportion of adults with an adequate control of hypertension. Blood pressure was measured at 8 352 adults who participated in the Ensanut MC 2016. The adults who reported having diagnosis of hypertension or had systolic blood pressure values (TAS) ≥140mmHg or diastolic blood pressure (TAD) ≥90mmHg were classified as hypertensive. Hypertension was considered controlled when blood pressure was TAS <140mmHg and TAD <90mmHg. The prevalence of hypertension was 25.5%. Of these, 40.0% were unaware of having high blood pressure. Of the hypertensive adults who had previous diagnosis of hypertension and receiving drug treatment (79.3%), 45.6% had blood pressure under control. A high percentage of adults are unaware of having hypertension and nearly half have inadequate control. The relevance of current programmes for diagnosing hypertension should be assessed, as well as the effectiveness of their control strategies.

Cement burns: retrospective study of 18 cases and review of the literature.

PubMed

Poupon, M; Caye, N; Duteille, F; Pannier, M

2005-11-01

Cement is increasingly used in the construction industry, but the occurrence of cement burns is rarely reported. This retrospective study concerns patients treated for cement burns in our unit between 1997 and 2002. Eighteen patients 18-64 years of age, treated previously in our unit for cement burns, were interviewed by telephone for evaluation. The mean time since treatment was 39 months. Burns were predominantly seen on the lower limbs, and a third occurred during an accident on the job. All deep burns were excised, and 16 patients received grafts. Mean hospital stay was 10 days, and mean sick leave 2 months. Our study indicated that all patients were poorly informed about cement-related risks. Surgical treatment of full-thickness cement burns at diagnosis enables rapid healing with a minimum of sequelae and reduces the high socioeconomic costs resulting from these lesions. This study indicates once again the need to improve preventive measures; which are very often inadequate because of lack of awareness of risks.

Clinical review: Humidifiers during non-invasive ventilation - key topics and practical implications

PubMed Central

2012-01-01

Inadequate gas conditioning during non-invasive ventilation (NIV) can impair the anatomy and function of nasal mucosa. The resulting symptoms may have a negative effect on patients' adherence to ventilatory treatment, especially for chronic use. Several parameters, mostly technical aspects of NIV, contribute to inefficient gas conditioning. Factors affecting airway humidity during NIV include inspiratory flow, inspiratory oxygen fraction, leaks, type of ventilator, interface used to deliver NIV, temperature and pressure of inhaled gas, and type of humidifier. The correct application of a humidification system may avoid the effects of NIV-induced drying of the airway. This brief review analyses the consequences of airway dryness in patients receiving NIV and the technical tools necessary to guarantee adequate gas conditioning during ventilatory treatment. Open questions remain about the timing of gas conditioning for acute or chronic settings, the choice and type of humidification device, the interaction between the humidifier and the underlying disease, and the effects of individual humidification systems on delivered humidity. PMID:22316078

Communication about chronic critical illness.

PubMed

Nelson, Judith E; Mercado, Alice F; Camhi, Sharon L; Tandon, Nidhi; Wallenstein, Sylvan; August, Gary I; Morrison, R Sean

2007-12-10

Despite poor outcomes, life-sustaining treatments including mechanical ventilation are continued for a large and growing population of patients with chronic critical illness. This may be owing in part to a lack of understanding resulting from inadequate communication between clinicians and patients and families. Our objective was to investigate the informational needs of patients with chronic critical illness and their families and the extent to which these needs are met. In this prospective observational study conducted at 5 adult intensive care units in a large, university-affiliated hospital in New York, New York, 100 patients with chronic critical illness (within 3-7 days of elective tracheotomy for prolonged mechanical ventilation) or surrogates for incapacitated patients were surveyed using an 18-item questionnaire addressing communication about chronic critical illness. Main outcome measures included ratings of importance and reports of whether information was received about questionnaire items. Among 125 consecutive, eligible patients, 100 (80%) were enrolled; questionnaire respondents included 2 patients and 98 surrogates. For all items, more than 78% of respondents rated the information as important for decision making (>98% for 16 of 18 items). Respondents reported receiving no information for a mean (SD) of 9.0 (3.3) of 18 items, with 95% of respondents reporting not receiving information for approximately one-quarter of the items. Of the subjects rating the item as important, 77 of 96 (80%) and 69 of 74 (93%) reported receiving no information about expected functional status at hospital discharge and prognosis for 1-year survival, respectively. Many patients and their families may lack important information for decision making about continuation of treatment in the chronic phase of critical illness. Strategies for effective communication in this clinical context should be investigated and implemented.

Communication About Chronic Critical Illness

PubMed Central

Nelson, Judith E.; Mercado, Alice F.; Camhi, Sharon L.; Tandon, Nidhi; Wallenstein, Sylvan; August, Gary I.; Morrison, R. Sean

2008-01-01

Background Despite poor outcomes, life-sustaining treatments including mechanical ventilation are continued for a large and growing population of patients with chronic critical illness. This may be owing in part to a lack of understanding resulting from inadequate communication between clinicians and patients and families. Our objective was to investigate the informational needs of patients with chronic critical illness and their families and the extent to which these needs are met. Methods In this prospective observational study conducted at 5 adult intensive care units in a large, university-affiliated hospital in New York, New York, 100 patients with chronic critical illness (within 3–7 days of elective tracheotomy for prolonged mechanical ventilation) or surrogates for incapacitated patients were surveyed using an 18-item questionnaire addressing communication about chronic critical illness. Main outcome measures included ratings of importance and reports of whether information was received about questionnaire items. Results Among 125 consecutive, eligible patients, 100 (80%) were enrolled; questionnaire respondents included 2 patients and 98 surrogates. For all items, more than 78% of respondents rated the information as important for decision making (>98% for 16 of 18 items). Respondents reported receiving no information for a mean (SD) of 9.0 (3.3) of 18 items, with 95% of respondents reporting not receiving information for approximately one-quarter of the items. Of the subjects rating the item as important, 77 of 96 (80%) and 69 of 74 (93%) reported receiving no information about expected functional status at hospital discharge and prognosis for 1-year survival, respectively. Conclusions Many patients and their families may lack important information for decision making about continuation of treatment in the chronic phase of critical illness. Strategies for effective communication in this clinical context should be investigated and implemented. PMID:18071175

Tennessee health plan tobacco cessation coverage.

PubMed

Kolade, Folasade M

2014-01-01

To evaluate the smoking cessation coverage available from public and private Tennessee health plans. Cross-sectional study. The sampling frame for private plans was a register of licensed plans obtained from the Tennessee Commerce Department. Government websites and reports provided TennCare data. Data were abstracted from plan manuals and formularies for benefit year 2012. Classification of coverage included comprehensive-all seven recommended medications plus individual and group counseling; moderate-at least two forms of nicotine replacement therapy (NRT) plus bupropion and varenicline and one form of counseling; inadequate-at least one treatment, or none-no medications or counseling, or coverage only for pregnant women. Of nine private plans, one provided comprehensive coverage; two, moderate coverage; four, inadequate coverage, as did TennCare; and two plans provided no coverage. Over 362,800 smokers had inadequate access to cessation treatments under TennCare, while 119,094 smokers had inadequate or no cessation coverage under private plans. In 2012, Tennessee fell short of Healthy People goals for total managed care and comprehensive TennCare coverage of smoking cessation. If Tennessee mandates that all health plans provide full coverage, 481,900 smokers may immediately be in a better position to quit. © 2013 Wiley Periodicals, Inc.

Treatment of Rheumatoid Arthritis with Biologic DMARDS (Rituximab and Etanercept)

PubMed Central

Gashi, Afrim A.; Rexhepi, Sylejman; Berisha, Idriz; Kryeziu, Avni; Ismaili, Jehona; Krasniqi, Gezim

2014-01-01

ABSTRACT Goal: To determine efficacy and safety of treatment with Rituximab and Etanercept plus Methotrexate in patients with active Rheumatoid Arthritis (RA), who had an inadequate response to nonbiologic DMARDS therapies and to explore the pharmacogenetics and pharmacodynamics of Rituximab and Etanercept in our populations. Study was done at Rheumatology Clinic of University Clinical Centre in Prishtina during 2009-2011 years. Methods: We evaluated primary efficacy and safety at 24 weeks in patients enrolled in the study of long term efficacy of Rituximab and Etanercept. Patients with active Rheumatoid Arthritis and an inadequate response to 1 or more non biologic DMARDS were randomized to receive intravenous Rituximab (1 course consisting of 2 infusions of 1.000 mg each –one group, and Etanercept 25 mg twice weekly –second group, but both groups with background MTX. The primary efficacy end point was a response on the ACR 20%, improvement criteria at 24 weeks, Secondary end points were responses on the ACR 50 and ACR 70, improvement criteria, the DAS 28, and EULAR response criteria at 24 weeks. Results: During our investigations we treated 20 patients, 15 females and 5 males, in the treated group with RTX and 13 patients 8 females and 5 males in the treated group with ETN. Patients of group 1 and group 2 were of ages 37-69 years old and 19-69 years old (average 47-44) Most of the patients belong in 2nd and 3 rd functional stage according to Steinbrocker. All ACR response parameters were significantly improved in RTX treated patients who also had clinically meaningful improvement in fatigue, disability and quality of life. Patients showed a trend less progression in radiographic end points. Most adverse events occurred with the first RTX infusion and were mild to moderate severity. Conclusion: At 24 weeks, a single course of RTX and ETN provided significant and clinically meaningful improvements in disease activity in patients with active, longstanding RA who had an inadequate response to 1 or more nonbiologic DMARDS. PMID:24783914

Vildagliptin versus insulin in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea: results from a randomized, 24 week study.

PubMed

Forst, Thomas; Koch, Cornelia; Dworak, Markus

2015-06-01

There is limited evidence to guide the selection of second-line anti-hyperglycemic agents in patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with sulfonylurea monotherapy and are intolerant to metformin. We compared the efficacy and safety of vildagliptin 50 mg qd and Neutral Protamine Hagedorn (NPH) insulin qd in such patients. This was a 24 week, multicenter, randomized, open-label study. The co-primary endpoints were (i) proportion of patients achieving HbA1c <7.0% without any confirmed hypoglycemic events (HEs) or weight gain ≥3% (composite endpoint); (ii) rate of confirmed HEs. Treatment satisfaction was assessed using the TSQM-9 questionnaire at study end. A total of 162 patients were randomly assigned to vildagliptin (n = 83) and NPH insulin (n = 79). Similar proportion of patients achieved the composite endpoint in vildagliptin versus NPH insulin group (35.4% versus 34.2%; OR 0.985; 95% CI 0.507, 1.915; p = 0.96). After 24 weeks, 48.8% of patients in the vildagliptin group and 60.8% in the NPH insulin group achieved HbA1c <7.0%; 13.4% in the vildagliptin group and 29.1% in the insulin group had at least one confirmed HE; while 11.0% in the vildagliptin group and 22.8% in the insulin group experienced weight gain. The rate of confirmed HEs was significantly lower in patients receiving vildagliptin versus NPH insulin (1.3 versus 5.1 events per year). The TSQM-9 score for 'convenience' at week 24 increased significantly more with vildagliptin than with NPH insulin. Addition of vildagliptin and NPH insulin resulted in a similar number of patients reaching HbA1c target without HEs or weight gain in T2DM patients inadequately controlled with sulfonylurea. The addition of vildagliptin to sulfonylurea could be considered as a treatment option prior to intensification with insulin, with the advantages of a lower HE rate and greater patient convenience. Study results are limited by a higher drop-out rate in the vildagliptin arm.

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

PubMed

Bell, Susan P; Schnipper, Jeffrey L; Goggins, Kathryn; Bian, Aihua; Shintani, Ayumi; Roumie, Christianne L; Dalal, Anuj K; Jacobson, Terry A; Rask, Kimberly J; Vaccarino, Viola; Gandhi, Tejal K; Labonville, Stephanie A; Johnson, Daniel; Neal, Erin B; Kripalani, Sunil

2016-05-01

Reduction in 30-day readmission rates following hospitalization for acute coronary syndrome (ACS) and acute decompensated heart failure (ADHF) is a national goal. The aim of this study was to determine the effect of a tailored, pharmacist-delivered, health literacy intervention on unplanned health care utilization, including hospital readmission or emergency room (ER) visit, following discharge. Randomized, controlled trial with concealed allocation and blinded outcome assessors Two tertiary care academic medical centers Adults hospitalized with a diagnosis of ACS and/or ADHF. Pharmacist-assisted medication reconciliation, inpatient pharmacist counseling, low-literacy adherence aids, and individualized telephone follow-up after discharge The primary outcome was time to first unplanned health care event, defined as hospital readmission or an ER visit within 30 days of discharge. Pre-specified analyses were conducted to evaluate the effects of the intervention by academic site, health literacy status (inadequate versus adequate), and cognition (impaired versus not impaired). Adjusted hazard ratios (aHR) and 95% confidence intervals (CI) are reported. A total of 851 participants enrolled in the study at Vanderbilt University Hospital (VUH) and Brigham and Women's Hospital (BWH). The primary analysis showed no statistically significant effect on time to first unplanned hospital readmission or ER visit among patients who received interventions compared to controls (aHR = 1.04, 95% CI 0.78-1.39). There was an interaction of treatment effect by site (p = 0.04 for interaction); VUH aHR = 0.77, 95% CI 0.51-1.15; BWH aHR = 1.44 (95% CI 0.95-2.12). The intervention reduced early unplanned health care utilization among patients with inadequate health literacy (aHR 0.41, 95% CI 0.17-1.00). There was no difference in treatment effect by patient cognition. A tailored, pharmacist-delivered health literacy-sensitive intervention did not reduce post-discharge unplanned health care utilization overall. The intervention was effective among patients with inadequate health literacy, suggesting that targeted practice of pharmacist intervention in this population may be advantageous.

Evaluation of adjuvant carboplatin chemotherapy in the management of surgically excised anal sac apocrine gland adenocarcinoma in dogs.

PubMed

Wouda, R M; Borrego, J; Keuler, N S; Stein, T

2016-03-01

There is no widely accepted standard of care for canine anal sac apocrine gland adenocarcinoma (ASAGAC). Surgery alone is inadequate in many cases, but the benefit of adjuvant chemotherapy is not well established. The primary objective of this retrospective study was to evaluate the role of carboplatin chemotherapy in the post-operative management of ASAGAC. Seventy-four dogs with naturally occurring ASAGAC underwent surgery. Forty-four dogs received adjuvant carboplatin and 30 did not. Median overall survival (OS) was 703 days. Median time to progression (TTP) was 384 days. Only primary tumour size and lymph node metastasis at diagnosis significantly impacted the outcome. Differences in OS and TTP, between the dogs that received adjuvant carboplatin and those that did not, failed to reach statistical significance. Treatment of progressive disease, whilst not limited to chemotherapy, significantly prolonged the survival. This study shows that adjuvant carboplatin chemotherapy is well tolerated and may have a role in the management of dogs with ASAGAC. © 2013 John Wiley & Sons Ltd.

Efficacy and tolerability of vildagliptin as add-on therapy to metformin in Chinese patients with type 2 diabetes mellitus.

PubMed

Pan, C; Xing, X; Han, P; Zheng, S; Ma, J; Liu, J; Lv, X; Lu, J; Bader, G

2012-08-01

To investigate the efficacy and tolerability of vildagliptin as add-on therapy to metformin in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. This was a 24-week, randomized, double-blind, placebo-controlled study. Patients with T2DM (N = 438) with haemoglobin A1c (HbA1c) of 7.0-10.0% and fasting plasma glucose (FPG) <15 mmol/l (<270 mg/dl) were randomized (1 : 1 : 1) to vildagliptin 50 mg bid, vildagliptin 50 mg qd or placebo in addition to metformin. The treatment groups were well balanced at baseline [mean HbA1c, 8.0%, FPG, 8.8 mmol/l (158 mg/dl); body mass index, 25.5 kg/m(2) ]. The adjusted mean change (AMΔ) in HbA1c at endpoint was -1.05 ± 0.08%, -0.92 ± 0.08% and -0.54 ± 0.08% in patients receiving vildagliptin 50 mg bid, 50 mg qd and placebo, respectively. The between-treatment difference (vildagliptin 50 mg bid-placebo) was -0.51 ± 0.11%, p < 0.001. A greater proportion of vildagliptin-treated patients met at least one responder criterion (82.1 and 70.7%) compared to placebo-treated patients (60.4%). The AMΔ at endpoint for FPG with vildagliptin 50 mg bid, -0.95 mmol/l (-17.1 mg/dl); 50 mg qd, -0.84 mmol/l (-15.1 mg/dl) was significantly different compared with the placebo -0.26 mmol/l (-4.68 mg/dl) (p ≤ 0.001). Adverse events (AEs) were reported as 34.2, 36.5 and 37.5% for patients receiving vildagliptin 50 mg bid, 50 mg qd or placebo, respectively. Two patients in the vildagliptin 50 mg qd and one in the placebo group reported serious AEs, which were not considered to be related to the study drug; one incidence of hypoglycaemic event was reported in the vildagliptin 50 mg bid group. Vildagliptin as add-on therapy to metformin improved glycaemic control and was well tolerated in Chinese patients who were inadequately controlled by metformin only. © 2012 Blackwell Publishing Ltd.

Clinical characteristics and patient-reported outcomes in patients with inadequately controlled rheumatoid arthritis despite ongoing treatment.

PubMed

Taylor, Peter C; Alten, Rieke; Gomez-Reino, Juan J; Caporali, Roberto; Bertin, Philippe; Sullivan, Emma; Wood, Robert; Piercy, James; Vasilescu, Radu; Spurden, Dean; Alvir, Jose; Tarallo, Miriam

2018-01-01

Despite the wide array of treatments available for rheumatoid arthritis (RA), some patients continue to report unmet clinical needs. We investigated the extent of inadequate disease control in patients with RA. Data were drawn from the Adelphi 2014 RA Disease-Specific Program in France, Germany, Italy, Spain and the UK. Rheumatologists provided patient demographics, comorbidities, satisfaction with RA control and other clinical details. Patients reported their level of satisfaction and completed the EuroQoL 5-Dimensions Health Questionnaire and Work Productivity and Activity Impairment Questionnaire. Patients had been on their current therapy ≥3 months and had 28-joint disease activity scores (DAS28) reported. Adequately controlled (DAS28 ≤3.2) and inadequately controlled (DAS28 >3.2) patient cohorts were compared using univariate tests. Of 1147 patients, 74% were women, the mean age was 52 years and the mean time since RA diagnosis was 7 years. Twenty-seven percent of patients had inadequately controlled RA, whereas 73% had adequately controlled RA. Inadequately controlled patients were more affected clinically versus adequately controlled patients; 69% vs 13% had moderate/severe RA, the current level of pain was 4.6 vs 2.3, and 67% vs 41% experienced flares, respectively (all p<0.0001). Inadequately controlled patients had higher rates of depression (16% vs 5%; p<0.0001), worse health state, greater work and activity impairment, and lower satisfaction rates among the patients and their physicians than the adequately controlled cohort. RA was insufficiently controlled in over a quarter of patients despite their current therapy and this had a negative impact on the patients.

Time of HIV Diagnosis and Engagement in Prenatal Care Impact Virologic Outcomes of Pregnant Women with HIV.

PubMed

Momplaisir, Florence M; Brady, Kathleen A; Fekete, Thomas; Thompson, Dana R; Diez Roux, Ana; Yehia, Baligh R

2015-01-01

HIV suppression at parturition is beneficial for maternal, fetal and public health. To eliminate mother-to-child transmission of HIV, an understanding of missed opportunities for antiretroviral therapy (ART) use during pregnancy and HIV suppression at delivery is required. We performed a retrospective analysis of 836 mother-to-child pairs involving 656 HIV-infected women in Philadelphia, 2005-2013. Multivariable regression examined associations between patient (age, race/ethnicity, insurance status, drug use) and clinical factors such as adequacy of prenatal care measured by the Kessner index which classifies prenatal care as inadequate, intermediate, or adequate prenatal care; timing of HIV diagnosis; and the outcomes: receipt of ART during pregnancy and viral suppression at delivery. Overall, 25% of the sample was diagnosed with HIV during pregnancy; 39%, 38%, and 23% were adequately, intermediately, and inadequately engaged in prenatal care. Eight-five percent of mother-to-child pairs received ART during pregnancy but only 52% achieved suppression at delivery. Adjusting for patient factors, pairs diagnosed with HIV during pregnancy were less likely to receive ART (AOR 0.39, 95% CI 0.25-0.61) and achieve viral suppression (AOR 0.70, 95% CI 0.49-1.00) than those diagnosed before pregnancy. Similarly, women with inadequate prenatal care were less likely to receive ART (AOR 0.06, 95% CI 0.03-0.11) and achieve viral suppression (AOR 0.31, 95% CI 0.20-0.47) than those with adequate prenatal care. Targeted interventions to diagnose HIV prior to pregnancy and engage HIV-infected women in prenatal care have the potential to improve HIV related outcomes in the perinatal period.

Efficacy and safety of pioglitazone added to alogliptin in Japanese patients with type 2 diabetes mellitus: a multicentre, randomized, double-blind, parallel-group, comparative study.

PubMed

Kaku, K; Katou, M; Igeta, M; Ohira, T; Sano, H

2015-12-01

A phase IV, multicentre, randomized, double-blind, parallel-group, comparative study was conducted in Japanese subjects with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control, despite treatment with alogliptin in addition to diet and/or exercise therapy. Subjects with glycated haemoglobin (HbA1c) concentrations of 6.9-10.5% were randomized to receive 16 weeks' double-blind treatment with pioglitazone 15 mg, 30 mg once daily or placebo added to alogliptin 25 mg once daily. The primary endpoint was the change in HbA1c from baseline at the end of treatment period (week 16). Both pioglitazone 15 and 30 mg combination therapy resulted in a significantly greater reduction in HbA1c than alogliptin monotherapy [-0.80 and -0.90% vs 0.00% (the least squares mean using analysis of covariance model); p < 0.0001, respectively]. The overall incidence rates of treatment-emergent adverse events were similar among the treatment groups. Pioglitazone/alogliptin combination therapy was effective and generally well tolerated in Japanese subjects with T2DM and is considered to be useful in clinical settings. © 2015 John Wiley & Sons Ltd.

Prevalence and types of preanalytical error in hematology laboratory of a tertiary care hospital in South India.

PubMed

Arul, Pitchaikaran; Pushparaj, Magesh; Pandian, Kanmani; Chennimalai, Lingasamy; Rajendran, Karthika; Selvaraj, Eniya; Masilamani, Suresh

2018-01-01

An important component of laboratory medicine is preanalytical phase. Since laboratory report plays a major role in patient management, more importance should be given to the quality of laboratory tests. The present study was undertaken to find the prevalence and types of preanalytical errors at a tertiary care hospital in South India. In this cross-sectional study, a total of 118,732 samples ([62,474 outpatient department [OPD] and 56,258 inpatient department [IPD]) were received in hematology laboratory. These samples were analyzed for preanalytical errors such as misidentification, incorrect vials, inadequate samples, clotted samples, diluted samples, and hemolyzed samples. The overall prevalence of preanalytical errors found was 513 samples, which is 0.43% of the total number of samples received. The most common preanalytical error observed was inadequate samples followed by clotted samples. Overall frequencies (both OPD and IPD) of preanalytical errors such as misidentification, incorrect vials, inadequate samples, clotted samples, diluted samples, and hemolyzed samples were 0.02%, 0.05%, 0.2%, 0.12%, 0.02%, and 0.03%, respectively. The present study concluded that incorrect phlebotomy techniques due to lack of awareness is the main reason for preanalytical errors. This can be avoided by proper communication and coordination between laboratory and wards, proper training and continuing medical education programs for laboratory and paramedical staffs, and knowledge of the intervening factors that can influence laboratory results.

Influence of Maternal Health Literacy on Child Participation in Social Welfare Programs: The Philadelphia Experience

PubMed Central

Mohamad, Zeinab; Cnaan, Avital; Kavanagh, Jane; Shea, Judy A.

2010-01-01

We examined the influence of maternal health literacy on child participation in social welfare programs. In this cohort, 20% of the mothers had inadequate or marginal health literacy. Initially, more than 50% of the families participated in Temporary Assistance for Needy Families (TANF), the Food Stamp Program, and Special Supplemental Nutrition Program for Women, Infants, and Children, whereas fewer than 15% received child care subsidies or public housing. In multivariate regression, TANF participation was more than twice as common among children whose mothers had adequate health literacy compared with children whose mothers had inadequate health literacy. PMID:20634468

The control of dyslipidemia in outpatient clinics in Greece (OLYMPIC) Study.

PubMed

Diamantopoulos, E J; Athyros, V G; Yfanti, G K; Migdalis, E N; Elisaf, M; Vardas, P E; Manolis, A S; Karamitsos, D T; Ganotakis, E S; Hatseras, D

2005-01-01

The objective of this study was to determine the proportion of Greek patients referred to outpatient clinics for dyslipidemia who achieved the low-density lipoprotein cholesterol (LDL-C) goal defined by the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) guidelines, using lifestyle changes, lipid-lowering drug treatment (LLDT), or both. Adult patients with dyslipidemia, who had been receiving a hypolipidemic diet and/or LLDT for at least 3 months were assessed in a multicenter study performed at 66 sites across Greece. Patients were followed up for an additional 3-month treatment period. Lipid levels were recorded at baseline and at the end of the study. The primary endpoint was the proportion of patients achieving their individual LDL-C target at the end of the study, according to their coronary heart disease (CHD) risk status or its equivalents, as defined by the NCEP-ATP III guidelines. Multivariate logistic models were used to identify determinants of undertreatment. The study included 2,660 adults (20-75 years) from 7 regions of Greece. Of the evaluable sample (n = 2,211; men 51%; mean age 62 +/-9 years) 81% were receiving LLDT (96% with statins and 3% with fibrates), 44% had a history of CHD, 61% arterial hypertension, 36% diabetes, and 26% a family history of premature CHD. Overall, 6% were at low CHD risk, 30% at medium CHD risk, and 63% at high CHD risk. At the end of the study, 26% of all patients and 30% of those receiving LLDT achieved the NCEP-specified LDL-C target levels. The percentage of patients at LDL-C goal according to CHD risk status was: low risk 67% (95% CI = 59-75), medium risk 29% (95% CI = 26-33), and high risk 20% (95% CI = 18-22). Statins proved to be more effective than fibrates (p <0.0001). Atorvastatin-treated subjects (n = 1,222, mean dose 19 mg/day) attained the LDL-C target (31% of the cases) at a higher rate than those receiving other LLDT (n = 574, 26% at target, p <0.01) or not receiving drug treatment (n = 415, 8%, p <0.001). This outcome was more evident in the high-CHD risk group (n = 1,402, 26% with atorvastatin vs 16% with other LLDT and 3% not receiving LLDT attained the LDL-C goal, ANOVA, p <0.001). The majority of dyslipidemic patients receiving LLDT, mainly those with high-CHD risk, are not achieving the NCEP LDL-C target. This is mainly explained by inadequate dose titration to ensure target goals are met. Promoting healthy lifestyle and appropriate LLDT (potent statins with sufficient dose titration) must be implemented to ensure that patients attain LDL-C treatment goals and thus benefit from the reduction in individual CHD risk.

Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial.

PubMed

Burmester, Gerd R; Kremer, Joel M; Van den Bosch, Filip; Kivitz, Alan; Bessette, Louis; Li, Yihan; Zhou, Yijie; Othman, Ahmed A; Pangan, Aileen L; Camp, Heidi S

2018-06-12

Upadacitinib is a selective inhibitor of Janus kinase 1 and was efficacious in phase 2 studies in patients with moderate-to-severe rheumatoid arthritis. We aimed to assess the efficacy of upadacitinib in patients with inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). This study is a double-blind, placebo-controlled trial at 150 sites in 35 countries. We enrolled patients aged 18 years or older with active rheumatoid arthritis for 3 months or longer, who had received csDMARDs for at least 3 months with a stable dose for at least 4 weeks before study entry, and had an inadequate response to at least one of the following csDMARDs: methotrexate, sulfasalazine, or leflunomide. Using interactive response technology, we randomly assigned patients receiving stable background csDMARDs (2:2:1:1) to receive a once-daily extended-release formulation of upadacitinib 15 mg or 30 mg, or placebo, for 12 weeks. Patients, investigators, and the funder were masked to allocation. After 12 weeks, patients taking placebo received 15 mg or 30 mg of upadacitinib once daily, according to the prespecified randomisation assignment. The primary endpoints were the proportion of patients at week 12 who achieved 20% improvement in American College of Rheumatology criteria (ACR20), and a 28-joint disease activity score using C-reactive protein (DAS28[CRP]) of 3·2 or less. We did efficacy analyses in the full analysis set of all randomly assigned patients who received at least one dose of study drug, and used non-responder imputation for assessment of the primary outcomes. This study is registered with ClinicalTrials.gov, number NCT02675426. Between Dec 17, 2015, and Dec 22, 2016, 1083 patients were assessed for eligibility, of whom 661 were recruited and randomly assigned to receive upadacitinib 15 mg (n=221), upadacitinib 30 mg (n=219), or placebo (n=221). All patients received at least one dose of study drug, and 618 (93%) completed 12 weeks of treatment. At week 12, ACR20 was achieved by 141 (64%; 95% CI 58-70) of 221 patients receiving upadacitinib 15 mg and 145 (66%; 60-73) of 219 patients receiving upadacitinib 30 mg, compared with 79 (36%; 29-42) of 221 patients receiving placebo (p<0·0001 for each dose vs placebo). DAS28(CRP) of 3·2 or less was met by 107 (48%; 95% CI 42-55) patients receiving upadacitinib 15 mg and 105 (48%; 41-55) patients receiving upadacitinib 30 mg, compared with 38 (17%; 12-22) patients receiving placebo (p<0·0001 for each dose vs placebo). Adverse events were reported in 125 (57%) of 221 patients receiving upadacitinib 15 mg, 118 (54%) of 219 patients receiving upadacitinib 30 mg, and 108 (49%) of 221 patients receiving placebo. The most frequently reported adverse events (≥5% of patients in any group) were nausea (16 [7%] of 221 in the upadacitinib 15 mg group; three [1%] of 219 in the upadacitinib 30 mg group; and seven [3%] of 221 in the placebo group), nasopharyngitis (12 [5%]; 13 [6%]; and nine [4%]), upper respiratory tract infection (12 [5%]; 12 [5%]; and nine [4%]), and headache (nine [4%]; seven [3%]; and 12 [5%]). More infections were reported for upadacitinib (64 [29%] of 221 patients receiving 15 mg and 69 [32%] of 219 patients receiving 30 mg) versus placebo (47 [21%] of 221 patients). There were three herpes zoster infections (one [<1%] in the placebo group, one [<1%] in the upadacitinib 15 mg group, and one [<1%] in the upadacitinib 30 mg group) and one primary varicella zoster virus infection (one [<1%] in the upadacitinib 30 mg group), two malignancies (both in the upadacitinib 30 mg group), one adjudicated major adverse cardiovascular event (in the upadacitinib 30 mg group), and five serious infections (one [<1%] in the placebo group, one [<1%] in the upadacitinib 15 mg group, three [1%] in the upadacitinib 30 mg group). No deaths were reported during the trial. Patients with moderately to severely active rheumatoid arthritis who received upadacitinib (15 mg or 30 mg) in combination with csDMARDs showed significant improvements in clinical signs and symptoms. AbbVie Inc. Copyright © 2018 Elsevier Ltd. All rights reserved.

The treatment of epilepsy in developing countries: where do we go from here?

PubMed Central

Scott, R. A.; Lhatoo, S. D.; Sander, J. W.

2001-01-01

Epilepsy is the most common serious neurological disorder and is one of the world's most prevalent noncommunicable diseases. As the understanding of its physical and social burden has increased it has moved higher up the world health agenda. Over four-fifths of the 50 million people with epilepsy are thought to be in developing countries; much of this condition results from preventable causes. Around 90% of people with epilepsy in developing countries are not receiving appropriate treatment. Consequently, people with epilepsy continue to be stigmatized and have a lower quality of life than people with other chronic illnesses. However, bridging the treatment gap and reducing the burden of epilepsy is not straightforward and faces many constraints. Cultural attitudes, a lack of prioritization, poor health system infrastructure, and inadequate supplies of antiepileptic drugs all conspire to hinder appropriate treatment. Nevertheless, there have been successful attempts to provide treatment, which have shown the importance of community-based approaches and also indicate that provision for sustained intervention over the long term is necessary in any treatment programme. Approaches being adopted in the demonstration projects of the Global Campaign Against Epilepsy--implemented by the International League Against Epilepsy, the International Bureau for Epilepsy, and the World Health Organization--may provide further advances. Much remains to be done but it is hoped that current efforts will lead to better treatment of people with epilepsy in developing countries. PMID:11357214

Professional Development Recognizing Technology Integration Modeled after the TPACK Framework

ERIC Educational Resources Information Center

McCusker, Laura

2017-01-01

Public school teachers within a Pennsylvania intermediate unit are receiving inadequate job-embedded professional development that recognizes knowledge of content, pedagogy, and technology integration, as outlined by Mishra and Koehler's Technological Pedagogical Content Knowledge (TPACK) framework (2006). A school environment where teachers are…

[Errors in medical care rendered by military treatment and prevention institutions (according to the data of forensic medical expertise].

PubMed

Kolkutin, V V; Fetisov, V A

2003-12-01

The authors discuss one of the important aspects of military medicolegal laboratory activities connected with the quality control of medical care rendered in the military treatment-and-prophylactic institutions in the nineties of the XX century. The example of medical care defects (MCD) permitted to reveal their nature, causes and sites of origin at pre-hospital (PHS) and hospital (HS) stages. Despite some decrease in the total number of MCD revealed HS defects prevail (more than 75%); the organizational defects at PHS and diagnostic defects at HS are predominant. The main MCD causes are inadequate qualification of medical workers, defects in organization of treatment-and-diagnostic process and inadequate examination of patients.

Risk Factors for premature birth in a hospital 1

PubMed Central

Ahumada-Barrios, Margarita E.; Alvarado, German F.

2016-01-01

Abstract Objective: to determine the risk factors for premature birth. Methods: retrospective case-control study of 600 pregnant women assisted in a hospital, with 298 pregnant women in the case group (who gave birth prematurely <37 weeks) and 302 pregnant women who gave birth to a full-term newborn in the control group. Stata software version 12.2 was used. The Chi-square test was used in bivariate analysis and logistic regression was used in multivariate analysis, from which Odds Ratios (OR) and Confidence Intervals (CI) of 95% were derived. Results: risk factors associated with premature birth were current twin pregnancy (adjusted OR= 2.4; p= 0.02), inadequate prenatal care (< 6 controls) (adjusted OR= 3.2; p <0.001), absent prenatal care (adjusted OR= 3.0; p <0.001), history of premature birth (adjusted OR= 3.7; p <0.001) and preeclampsia (adjusted OR= 1.9; p= 0.005). Conclusion: history of premature birth, preeclampsia, not receiving prenatal care and receiving inadequate prenatal care were risk factors for premature birth. PMID:27463110

Training School Psychologists to Conduct Evidence-Based Treatments for Depression

ERIC Educational Resources Information Center

Stark, Kevin D.; Arora, Prerna; Funk, Catherine L.

2011-01-01

Cognitive behavioral therapy is an effective approach to the treatment of depressive disorders within schools, due to its demonstrated efficacy, as well as its availability in manualized treatment form. When implemented by therapists with inadequate training, the treatment is often stilted, less engaging for participants, and aimlessly guided…

Opinions about Treatment Modalities among Patients Involuntarily Committed to a Forensic Psychiatric Hospital in Finland

ERIC Educational Resources Information Center

Repo-Tiihonen, Eila; Vuorio, Osmo; Koivisto, Hanna; Paavola, Paula; Hakola, Panu

2004-01-01

Patient satisfaction studies concerning various treatment modalities are few among involuntary forensic psychiatric treatment. They indicate general satisfaction with medication, interactive treatment and occupational therapy but dissatisfaction with lack of privacy, insufficiently explained rules and inadequately explained reasons of seclusion.…

Lack of access to chemotherapy for colon cancer: multiplicative disadvantage of being extremely poor, inadequately insured and African American.

PubMed

Gorey, Kevin M; Haji-Jama, Sundus; Bartfay, Emma; Luginaah, Isaac N; Wright, Frances C; Kanjeekal, Sindu M

2014-03-22

Despite evidence of chemotherapy's ability to cure or comfort those with colon cancer, nearly half of such Americans do not receive it. African Americans (AA) seem particularly disadvantaged. An ethnicity by poverty by health insurance interaction was hypothesized such that the multiplicative disadvantage of being extremely poor and inadequately insured is worse for AAs than for non-Hispanic white Americans (NHWA). California registry data were analyzed for 459 AAs and 3,001 NHWAs diagnosed with stage II to IV colon cancer between 1996 and 2000 and followed until 2011. Socioeconomic data from the 2000 census categorized neighborhoods: extremely poor (≥ 30% of households poor), middle (5-29% poor) and low poverty (< 5% poor). Participants were randomly selected from these poverty strata. Primary health insurers were Medicaid, Medicare, private or none. Chemotherapy rates were age and stage-adjusted and comparisons used standardized rate ratios (RR). Logistic and Cox regressions, respectively, modeled chemotherapy receipt and long term survival. A significant 3-way ethnicity by poverty by health insurance interaction effect on chemotherapy receipt was observed. Among those who did not live in extremely poor neighborhoods and were adequately insured privately or by Medicare, chemotherapy rates did not differ significantly between AAs (37.7%) and NHWAs (39.5%). Among those who lived in extremely poor neighborhoods and were inadequately insured by Medicaid or uninsured, AAs (14.6%) were nearly 60% less likely to receive chemotherapy than were NHWAs (25.5%, RR = 0.41). When the 3-way interaction effect as well as the main effects of poverty, health insurance and chemotherapy was accounted for, survival rates of AAs and NHWAs were the same. The multiplicative barrier to colon cancer care that results from being extremely poor and inadequately insured is worse for AAs than it is for NHWAs. AAs are more prevalently poor, inadequately insured, and have fewer assets so they are probably less able to absorb the indirect and direct, but uncovered, costs of colon cancer care. Policy makers ought to be cognizant of these factors as they implement the Affordable Care Act and consider future health care reforms.

Protection of Tempered Aluminum Alloy in Contact with the Environment

NASA Astrophysics Data System (ADS)

Araoyinbo, A. O.; Salleh, M. A. A. Mohd; Rahmat, A.; Azmi, A. I.; Rahim, W. M. F. Wan Abd; Perju, M. C.; Jin, T. S.

2018-06-01

In many service applications an increasing temperature or inadequate protections often give rise to localized forms of corrosion in an initially free and unprotected system. This research understudy the corrosion chemistry, the effect of chromium as the inhibitor, Vickers hardness test, and weight loss on tempered aluminium alloy 7075 in corrosive mediums. The tempers of the aluminium alloy used are T6 and T73 where obtained by solution heat treatment at 470°C and quenched before immersion test in acidic (pH3), and slightly alkaline (pH7.5) solutions. The results obtained were characterized by conventional weight loss process and morphology observation with a microscope. The surface morphology shows exfoliation form of corrosion and the weight loss analysis shows the as received sample experience more weight loss when compared with the other heat treated samples.

Adjuvant chemotherapy for rectal cancer: Is it needed?

PubMed Central

Milinis, Kristijonas; Thornton, Michael; Montazeri, Amir; Rooney, Paul S

2015-01-01

Adjuvant chemotherapy has become a standard treatment of advanced rectal cancer in the West. The benefits of adjuvant chemotherapy after surgery alone have been well established. However, controversy surrounds the use adjuvant chemotherapy in patients who received preoperative chemoradiotherapy, despite it being recommended by a number of international guidelines. Results of recent multicentre randomised control trials showed no benefit of adjuvant chemotherapy in terms of survival and rates of distant metastases. However, concerns exist regarding the quality of the studies including inadequate staging modalities, out-dated chemotherapeutic regimens and surgical approaches and small sample sizes. It has become evident that not all the patients respond to adjuvant chemotherapy and more personalised approach should be employed when considering the benefits of adjuvant chemotherapy. The present review discusses the strengths and weaknesses of the current evidence-base and suggests improvements for future studies. PMID:26677436

Literacy Training in Penal Institutions.

ERIC Educational Resources Information Center

Gold, Patricia Cohen

Most presently existing literacy training programs for inmates in America's prisons are inadequate. Before program planners and developers can remedy this situation, they must be able to obtain accurate information on the numbers of illiterate inmates and the numbers of inmates currently receiving literacy instruction in America's prisons. The…

Prevalence, Outcomes, and Management of Enteral Tube Feeding Intolerance: A Retrospective Cohort Study in a Tertiary Center.

PubMed

Wang, Kailun; McIlroy, Kerry; Plank, Lindsay D; Petrov, Max S; Windsor, John A

2017-08-01

Enteral tube feeding (ETF) is the most common form of artificial feeding in hospitalized patients, and the development of intolerance (ETFI) is the most common complication. This study aimed to determine the prevalence of ETFI, the clinical consequences, and the current management approach to ETFI in hospitalized adult patients. Adult patients receiving ETF were identified from a prospective database in the Nutrition Services at Auckland City Hospital. Further information was obtained by the review of clinical records for a 12-month period, up to December 2014. The prevalence of ETFI was 33% among 754 patients. ETFI more frequently occurred in the intensive care unit ( P < .05). Patients with ETFI were less likely to reach their feeding goal rate ( P < .01). Multivariate analysis showed that younger age, certain specialties, and acute mesenteric ischemia were independent predictors of ETFI ( P < .05). The management of ETFI was highly variable. Medication was the most common treatment, while changes in the feeding protocol such as reducing infusion rate and stopping and changing the route of ETF were also frequently attempted. ETFI is a frequent problem in adult hospitalized patients receiving ETF, and it is associated with poor clinical outcomes such as inadequate nutrition and complications of feeding. While the pathophysiology is poorly understood, there also appears to be no standard evidence-based treatment. Studies investigating the mechanisms and optimized management are therefore indicated.

SAFETY AND TOXICITY OF AN ACCELERATED COARSELY FRACTIONATED RADIATION PROTOCOL FOR TREATMENT OF APPENDICULAR OSTEOSARCOMA IN 14 DOGS: 10 GY × 2 FRACTIONS.

PubMed

Pagano, Candace; Boudreaux, Bonnie; Shiomitsu, Keijiro

2016-09-01

Coarsely fractionated radiation is commonly used as a method for pain control in dogs with appendicular osteosarcoma, however there is little published information on optimal protocols. The aim of this retrospective, descriptive study was to report safety and toxicity findings in a sample of dogs with appendicular osteosarcoma that had been treated with a radiation scheme of 10 Gy delivered over two consecutive days for a total of 20 Gy. Dogs were included in the study if they had osteosarcoma that was treated with the aforementioned protocol. Dogs were excluded if treated with the same protocol for any other bone tumor besides osteosarcoma or inadequate follow-up. Thirteen of the 14 patients received adjuvant therapy with pamidronate and a nonsteroidal anti-inflammatory. Nine dogs received adjuvant chemotherapy with carboplatin after radiation was complete. Within a median of 14 days, 92.8% of dogs subjectively had improved pain control. Median duration of response (DOR) was 80 days (range 20-365). The majority of patients developed VRTOG grade one toxicity, primarily alopecia. Five dogs (35.7%) developed pathologic fracture postradiation treatment. Timing of fracture was variable ranging from 24 to 250 days. This radiation protocol was well tolerated, with minimal toxicity, subjectively improved survival time, and had the benefit of being completed in two consecutive days. © 2016 American College of Veterinary Radiology.

Fire-eater's lung complicated by an infectious abscess requiring surgical treatment.

PubMed

Harlander, Matevz; Tercelj, Marjeta; Sok, Mihael; Rott, Tomaz

2010-02-01

We describe a case of fire-eater's pneumonia that was complicated by an infectious lung abscess with substantial haemoptysis. Conservative treatment was inadequate. Surgical resection was necessary and proved to be successful.

Patient complaints about hospital services: applying a complaint taxonomy to analyse and respond to complaints.

PubMed

Harrison, Reema; Walton, Merrilyn; Healy, Judith; Smith-Merry, Jennifer; Hobbs, Coletta

2016-04-01

To explore the applicability of a patient complaint taxonomy to data on serious complaint cases. Qualitative descriptive study. Complaints made to the New South Wales (NSW) Health Care Complaints Commission, Australia between 2005 and 2010. All 138 cases of serious complaints by patients about public hospitals and other health facilities investigated in the 5-year period. A thematic analysis of the complaints was conducted to identify particular complaint issues and the Reader et al. (Patient complaints in healthcare systems: a systematic review and coding taxonomy. BMJ Qual Saf 2014;23:678-89.) patient complaint taxonomy was then used to classify these issues into categories and sub-categories. The 138 investigated cases revealed 223 complaint issues. Complaint issues were distributed into the three domains of the patient complaint taxonomy: clinical, management and relationships. Complaint issue most commonly related to delayed diagnosis, misdiagnosis, medication errors, inadequate examinations, inadequate/nil treatment and quality of care including nursing care. The types of complaints from patients about their healthcare investigated by the NSW Commission were similar to those received by other patient complaint entities in Australia and worldwide. The application of a standard taxonomy to large numbers of complaints cases from different sources would enable the creation of aggregated data. Such data would have better statistical capacity to identify common safety and quality healthcare problems and so point to important areas for improvement. Some conceptual challenges in devising and using a taxonomy must be addressed, such as inherent problems in ensuring coding consistency, and giving greater weight to patient concerns about their treatment. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Tocilizumab in patients with active rheumatoid arthritis and inadequate responses to DMARDs and/or TNF inhibitors: a large, open-label study close to clinical practice

PubMed Central

Bykerk, Vivian P; Östör, Andrew J K; Alvaro-Gracia, José; Pavelka, Karel; Ivorra, José Andrés Román; Graninger, Winfried; Bensen, William; Nurmohamed, Michael T; Krause, Andreas; Bernasconi, Corrado; Stancati, Andrea; Sibilia, Jean

2012-01-01

Objective To evaluate the safety and efficacy of tocilizumab in clinical practice in patients with rheumatoid arthritis (RA) with inadequate responses (IR) to disease-modifying antirheumatic drugs (DMARDs) or both DMARDs and tumour necrosis factor α inhibitors (TNFis). Methods Patients—categorised as TNFi-naive, TNFi-previous (washout) or TNFi-recent (no washout) —received open-label tocilizumab (8 mg/kg) every 4 weeks ± DMARDs for 24 weeks. Adverse events (AEs) and treatment discontinuations were monitored. Efficacy end points included American College of Rheumatology (ACR) responses, 28-joint disease activity score (DAS28) and European League Against Rheumatism responses. Results Overall, 1681 (976 TNF-naive, 298 TNFi-previous and 407 TNFi-recent) patients were treated; 5.1% discontinued treatment because of AEs. The AE rate was numerically higher in TNFi-recent (652.6/100 patient-years (PY)) and TNFi-previous (653.6/100PY) than in TNFi-naive (551.1/100PY) patients. Serious AE rates were 18.0/100PY, 28.0/100PY and 18.6/100PY; serious infection rates were 6.0/100PY, 6.8/100PY and 4.2/100PY, respectively. At week 4, 36.5% of patients achieved ACR20 response and 14.9% DAS28 remission (<2.6); at week 24, 66.9%, 46.6%, 26.4% and 56.8% achieved ACR20/ACR50/ACR70 responses and DAS28 remission, respectively. Overall, 61.6% (TNFi-naive), 48.5% (TNFi-previous) and 50.4% (TNFi-recent) patients achieved DAS28 remission. Conclusions In patients with RA who were DMARD-IR/TNFi-IR, tocilizumab ± DMARDs provided rapid and sustained efficacy without unexpected safety concerns. PMID:22615456

Efficacy and Tolerability of Travoprost 0.004%/Timolol 0.5% Fixed-Dose Combination for the Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Inadequately Controlled with Beta-Blocker Monotherapy.

PubMed

Lerner, Simon Fabian; Park, Ki Ho; Hubatsch, Douglas A; Erichev, Valeriy; Paczka, Jose A; Roberts, Timothy V

2017-01-01

Objective . To evaluate the efficacy and tolerability of travoprost 0.004%/timolol 0.5% fixed-dose combination (TTFC) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) inadequately controlled on beta-blocker monotherapy. Methods . In this phase IV, open-label study, 156 patients on beta-blocker monotherapy with mean intraocular pressure (IOP) between 18 and 32 mmHg were randomized (no washout period) to receive TTFC for 8 weeks (TTFC group) or to continue beta-blocker monotherapy for 4 weeks followed by TTFC for the remaining 4 weeks (beta-blocker group). Results . The mean IOP (±standard deviation) at baseline in the TTFC and beta-blocker groups was 22.5 ± 2.5 mmHg and 22.2 ± 2.3 mmHg, respectively, and at weeks 4 and 8, was 16.7 ± 3.1 mmHg and 16.1 ± 3.1 mmHg, respectively, in TTFC group and 21.1 ± 3.1 mmHg and 16.1 ± 2.8 mmHg, respectively, in the beta-blocker group. There was a significant least squares mean difference between TTFC and beta-blocker in 8 a.m. IOP at week 4 (-4.6 mmHg; one-sided 95% confidence interval [-inf, -3.9]; p < 0.0001 [primary endpoint]); the upper bound of the 95% confidence interval was within the prespecified limit (<0). Both treatments were well tolerated. Conclusion . Superior IOP control was achieved with TTFC in patients with OAG or OHT previously uncontrolled with beta-blockers. No new safety findings were identified. This trial is registered with ClinicalTrials.gov NCT02003391.

Repaglinide/troglitazone combination therapy: improved glycemic control in type 2 diabetes.

PubMed

Raskin, P; Jovanovic, L; Berger, S; Schwartz, S; Woo, V; Ratner, R

2000-07-01

This multicenter open-label clinical trial compared the efficacy and safety of repaglinide/troglitazone combination therapy, repaglinide monotherapy, and troglitazone monotherapy in type 2 diabetes that had been inadequately controlled by sulfonylureas, acarbose, or metformin alone. Patients with type 2 diabetes (n = 256) who had inadequate glycemic control (HbA1c > or =7.0%) during previous monotherapy were randomly assigned to receive repaglinide (0.5-4.0 mg at meals), troglitazone (200-600 mg once daily), or a combination of repaglinide (1-4 mg at meals) and troglitazone (200-600 mg once daily). After a 4-6 week washout period, the trial assessed 22 weeks of treatment: 3 weeks (weeks 0-2) of forced titration, 11 weeks of fixed-dose treatment (weeks 3-13), and 8 weeks (weeks 14-21) of titration to maximum dose. Changes in HbA1c and fasting plasma glucose (FPG) values were measured. The combination therapy showed a significant reduction in mean HbA1c values (-1.7%) that was greater than with either type of monotherapy Repaglinide monotherapy resulted in a reduction of HbA1c values that was significantly greater than troglitazone (-0.8 vs. -0.4%) (P < 0.05). Combination therapy was more effective in reducing FPG values (-80 mg/dl) than either repaglinide (-43 mg/dl) or troglitazone (-46 mg/dl) monotherapies. Adverse events were similar in all groups. Combination therapy with repaglinide and troglitazone leads to better glycemic control than monotherapy with either agent alone. Repaglinide monotherapy was more effective in lowering HbA1c levels than troglitazone monotherapy Repaglinide/troglitazone combination therapy was effective and did not show unexpected adverse events.

Hypothyroidism: etiology, diagnosis, and management.

PubMed

Almandoz, Jaime P; Gharib, Hossein

2012-03-01

Hypothyroidism is the result of inadequate production of thyroid hormone or inadequate action of thyroid hormone in target tissues. Primary hypothyroidism is the principal manifestation of hypothyroidism, but other causes include central deficiency of thyrotropin-releasing hormone or thyroid-stimulating hormone (TSH), or consumptive hypothyroidism from excessive inactivation of thyroid hormone. Subclinical hypothyroidism is present when there is elevated TSH but a normal free thyroxine level. Treatment involves oral administration of exogenous synthetic thyroid hormone. This review presents an update on the etiology and types of hypothyroidism, including subclinical disease; drugs and thyroid function; and diagnosis and treatment of hypothyroidism. Copyright © 2012 Elsevier Inc. All rights reserved.

Periapical Status and Quality of Root Canal Fillings in a Moroccan Subpopulation

PubMed Central

El Merini, Hafsa; Lamzawaq, Amine; Hamza, Mouna

2017-01-01

Aim The aim of the study was to assess the prevalence of apical periodontitis (AP) and quality of root canal fillings in an adult Moroccan subpopulation. Methods In the study 508 patients were included, attending the Conservative Dentistry Clinic at the Faculty of Dentistry of Casablanca. 508 panoramic and 709 periapical radiographs were observed. The periapical status of all teeth (with the exception of third molars) was examined according to Ørstavik's periapical index. The statistical analysis was performed with the software Epi Info Version 6.04dfr, April 2001. Results A total of 12719 teeth were examined. 45.3% of patients had apical periodontitis. 4.2% of teeth were treated endodontically and 70.4% of these treatments were inadequate. 91,5% with inadequate endodontic treatment presented apical periodontitis, while only 8,2% with adequate endodontic treatment had apical periodontitis. The lower molars and the upper premolars were the most affected teeth. The presence of apical periodontitis was correlated significantly with insufficient root canal fillings (p < 0.05). Conclusions The present study found a high prevalence of apical periodontitis in this Moroccan population. Inadequate root canal fillings were associated with an increased prevalence of apical periodontitis. PMID:28713425

'Before reaching the last mile'- Knowledge, attitude, practice and perceived barriers related to tuberculosis directly observed therapy among ASHA workers in Central India: A mixed method study.

PubMed

Singh, Akash Ranjan; Pakhare, Abhijit; Kokane, Arun M; Shewade, Hemant Deepak; Chauhan, Ashish; Singh, Abhishek; Gangwar, Arti; Thakur, Prahlad Singh

2017-12-01

Community-based direct observed treatment (DOT) providers are an important bridge for the national tuberculosis programme in India to reach the unreached. The present study has explored the knowledge, attitude, practice and barriers perceived by the community-based DOT providers. Mixed-methods study design was used among 41 community-based DOT providers (Accredited Social Health Activist (ASHAs)) working in 67 villages from a primary health center in Raisen district of Madhya Pradesh, India. The cross-sectional quantitative component assessed the knowledge and practices and three focus-group discussions explored the attitude and perceived barriers related to DOT provision. 'Adequate knowledge' and 'satisfactory practice' related to DOT provision was seen in 14 (34%) and 13 (32%) ASHAs respectively. Only two (5%) received any amount of honorarium for completion of DOT in last 3years. The focus-group discussions revealed unfavourable attitude; inadequate training and supervision, non-payment of honorarium, issues related to assured services after referral and patient related factors as the barriers to satisfactory practice of DOT. Study revealed inadequate knowledge and unsatisfactory practice related to DOT provision among ASHAs. Innovations addressing the perceived barriers to improve practice of DOT provision by ASHAs are urgently required. Copyright © 2017 Ministry of Health, Saudi Arabia. Published by Elsevier Ltd. All rights reserved.

Epidemiology and prognosis of candidaemia in elderly patients.

PubMed

Ramos-Martínez, Antonio; Vicente-López, Natalia; Sánchez-Romero, Isabel; Padilla, Belén; Merino-Amador, Paloma; Garnacho-Montero, José; Ruiz-Camps, Isabel; Montejo, Miguel; Salavert, Miguel; Mensa, José; Cuenca-Estrella, Manuel

2017-12-01

The aim of the study was to analyse the epidemiology and prognosis of candidaemia in elderly patients. We performed a comparison of clinical presentation of candidaemia according to age and a study of hazard factors within a prospective programme performed in 29 hospitals. One hundred and seventy-six episodes occurred in elderly patients (>75 years), 227 episodes in middle-aged patients (61-75 years) and 232 episodes in younger patients (16-60 years). Central venous catheter, parenteral nutrition, neutropenia, immunosuppressive therapy and candidaemia caused by Candida parapsilosis were less frequent in elderly patients. These patients received inadequate antifungal therapy (57.3%) more frequently than middle-aged and younger patients (40.5% P < .001). Mortality during the first week (20%) and 30 days (42%) was higher in elderly patients. The variables independently associated with mortality in elderly patients during the first 7 days were acute renal failure (OR: 2.64), Pitt score (OR: 1.57) and appropriate antifungal therapy (OR: 0.132). Primary candidaemia (OR: 2.93), acute renal failure (OR: 3.68), Pitt score (OR: 1.38), appropriate antifungal therapy (OR: 0.3) and early removal of the central catheter (OR: 0.47) were independently associated with 30-day mortality.In conclussion, inadequate antifungal treatment is frequently prescribed to elderly patients with candidaemia and is related with early and late mortality. © 2017 Blackwell Verlag GmbH.

Mental illness and homicide--prevention of recidivism.

PubMed

Talevska, Valentina; Stefanovski, Branko

2011-12-01

We hypothesized that the integration of forensic psychiatrists and the forensic system into the general stream of mental health should lead to better reintegration of forensic patients into the society. The aims of the study were to explore the link between violence, murder, psychiatric disorders and other variables, and to suggest a mode of prevention of criminal recidivism. This investigation provided a more reflective profile of mentally ill persons convicted of murder, hospitalized in Psychiatric Hospital in Demir Hisar in Macedonia between 2007 and 2009. Study results indicated the offender with severe mental illness incarcerated for murder in Demir Hisar Psychiatric Hospital to be predominantly suffering from a mood disorder, to be a male with secondary school education, and to have significant intimate and family relationships characterized by rage as a frequently mentioned motive for murder. On committing homicide, they frequently used firearm or sharp objects. The offenders lived in dysfunctional families, had extensive histories of substance abuse and criminal activity before their murder conviction, and received inadequate treatment for their mental disorder and substance abuse. We suggest that the offenders (murderers) continue their treatment in mental health forensic services upon completing their obligatory treatment at a psychiatric hospital.

[Improvement of oral health care in geriatric care by training of nurses and nursing assistants for the elderly].

PubMed

Jordan, R; Sirsch, E; Gesch, D; Zimmer, S; Bartholomeyczik, S

2012-04-01

Because oral health among residents of German nursing homes is inadequate, this intervention study evaluated the effects of dental training for nurses and nursing assistants (RN and RA) in homes for the elderly on their assessment of oral health in residents and, as a consequence, on the status of residents' oral health. 53 residents and the RNs and RAs from three homes for the elderly participated in this study. The nursing staff received training in dental health care. As primary outcome, the competence in performing the Brief Oral Health Examination (BOHSE) was measured at baseline date and four months after training. Additional outcome measures were dental and denture hygiene in residents, functional status of dentures, and treatment needs. Dental training was shown to improve the nursing staff's competences in oral health assessment in tendency. Residents' oral hygiene improved significantly, whereas no relevant effects on hygiene and functional status of dentures were registered. The need for dental treatment turned out to be considerable at both measurements. Modifications in test tools with identification of dental treatment needs seem to be indicated in order to improve cooperation between nursing staff and dentists in homes for the elderly.

The rural-to-urban migrant population in China: gloomy prospects for tuberculosis control.

PubMed

Tobe, Ruoyan Gai; Xu, Lingzhong; Song, Peipei; Huang, Yong

2011-12-01

The migrant population is a population with a high risk of tuberculosis (TB) infection and transmission. Globally, migration is likely to have a significant impact on TB epidemiology, particularly in countries that receive substantial numbers of migrants from countries with a high infection burden. China, a country with the world's second highest TB burden, faces a considerable increase in the number of rural-to-urban migrants. This population has a significant impact on urban TB epidemics and is specifically targeted by national guidelines for TB control. TB control among the migrant population has had relatively poor outcomes. Barriers to detection and treatment have both financial and non-financial aspects, such as the "migratory" nature of the migrant population, their marginalized working and living environment, poor financial status, little awareness of TB, inadequate referral to TB dispensaries, and potential social stigma in the workplace. Currently, the free TB treatment policy has limited ability to relieve the financial burden on most migrant TB patients as would allow optimal outcomes of TB detection and treatment. Universal health insurance coverage and fostering of personnel in community-based primary health care for the rural-to- urban migrant population represent two pillars of successful TB control.

Plasma HIV-1 RNA viral load rebound among people who inject drugs receiving antiretroviral therapy (ART) in a Canadian setting: an ethno-epidemiological study.

PubMed

Small, Will; Milloy, M J; McNeil, Ryan; Maher, Lisa; Kerr, Thomas

2016-01-01

People who inject drugs (PWID) living with HIV often experience sub-optimal antiretroviral therapy (ART) treatment outcomes, including HIV plasma viral load (PVL) rebound. While previous studies have identified risk factors for PVL rebound among PWID, no study has examined the perspectives of PWID who have experienced PVL rebound episodes. We conducted an ethno-epidemiological study to investigate the circumstances surrounding the emergence of rebound episodes among PWID in Vancouver, BC, Canada. Comprehensive clinical records linked to a community-based prospective observational cohort of HIV-positive drug users were used to identify PWID who had recently experienced viral rebound. In-depth qualitative interviews with 16 male and 11 female participants explored participant perspectives regarding the emergence of viral rebound. A timeline depicting each participant's HIV viral load and adherence to ART was used to elicit discussion of circumstances surrounding viral rebound. Viral rebound episodes were shaped by interplay between various individual, social, and environmental factors that disrupted routines facilitating adherence. Structural-environmental influences resulting in non-adherence included housing transitions, changes in drug use patterns and intense drug scene involvement, and inadequate care for co-morbid health conditions. Social-environmental influences on ART adherence included poor interactions between care providers and patients producing non-adherence, and understandings of HIV treatment that fostered intentional treatment discontinuation. This study describes key pathways which led to rebound episodes among PWID receiving ART and illustrates how environmental forces may increase vulnerability for non-adherence leading to treatment failure. Our findings have potential to help inform interventions and supports that address social-structural forces that foster non-adherence among PWID.

2015 Space Human Factors Engineering Standing Review Panel

NASA Technical Reports Server (NTRS)

Steinberg, Susan

2015-01-01

The 2015 Space Human Factors Engineering (SHFE) Standing Review Panel (from here on referred to as the SRP) met for a site visit in Houston, TX on December 2 - 3, 2015. The SRP reviewed the updated research plans for the Risk of Inadequate Design of Human and Automation/Robotic Integration (HARI Risk), the Risk of Inadequate Human-Computer Interaction (HCI Risk), and the Risk of Inadequate Mission, Process and Task Design (MPTask Risk). The SRP also received a status update on the Risk of Incompatible Vehicle/Habitat Design (Hab Risk) and the Risk of Performance Errors Due to Training Deficiencies (Train Risk). The SRP is pleased with the progress and responsiveness of the SHFE team. The presentations were much improved this year. The SRP is also pleased with the human-centered design approach. Below are some of the more extensive comments from the SRP. We have also made comments in each section concerning gaps/tasks in each. The comments below reflect more significant changes that impact more than just one particular section.

Development and validation of a new instrument for testing functional health literacy in Japanese adults.

PubMed

Nakagami, Katsuyuki; Yamauchi, Toyoaki; Noguchi, Hiroyuki; Maeda, Tohru; Nakagami, Tomoko

2014-06-01

This study aimed to develop a reliable and valid measure of functional health literacy in a Japanese clinical setting. Test development consisted of three phases: generation of an item pool, consultation with experts to assess content validity, and comparison with external criteria (the Japanese Health Knowledge Test) to assess criterion validity. A trial version of the test was administered to 535 Japanese outpatients. Internal consistency reliability, calculated by Cronbach's alpha, was 0.81, and concurrent validity was moderate. Receiver Operating Characteristics and Item Response Theory were used to classify patients as having adequate, marginal, or inadequate functional health literacy. Both inadequate and marginal functional health literacy were associated with older age, lower income, lower educational attainment, and poor health knowledge. The time required to complete the test was 10-15 min. This test should enable health workers to better identify patients with inadequate health literacy. © 2013 Wiley Publishing Asia Pty Ltd.

Economic burden of inadequate symptom control among US commercially insured patients with irritable bowel syndrome with diarrhea.

PubMed

Buono, Jessica L; Mathur, Kush; Averitt, Amelia J; Andrae, David A

2017-04-01

To assess healthcare resource use and costs among irritable bowel syndrome (IBS) with diarrhea (IBS-D) patients with and without evidence of inadequate symptom control on current prescription therapies and estimate incremental all-cause costs associated with inadequate symptom control. IBS-D patients aged ≥18 years with ≥1 medical claim for IBS (ICD-9-CM 564.1x) and either ≥2 claims for diarrhea (ICD-9-CM 787.91, 564.5x), ≥1 claim for diarrhea plus ≥1 claim for abdominal pain (ICD-9-CM 789.0x), or ≥1 claim for diarrhea plus ≥1 pharmacy claim for a symptom-related prescription within 1 year of an IBS diagnosis were identified from the Truven Health MarketScan database. Inadequate symptom control, resource use, and costs were assessed up to 1 year following the index date. Inadequate symptom control included any of the following: (1) switch or (2) addition of new symptom-related therapy; (3) IBS-D-related inpatient or emergency room (ER) admission; (4) IBS-D-related medical procedure; (5) diagnosis of condition indicating treatment failure; or (6) use of a more aggressive prescription. Generalized linear models assessed incremental costs of inadequate symptom control. Of 20,624 IBS-D patients (mean age = 48.5 years; 77.8% female), 66.4% had evidence of inadequate symptom control. Compared to those without inadequate symptom control, patients with evidence of inadequate symptom control had significantly more hospitalizations (12.0% vs 6.0%), ER visits (37.1% vs 22.6%), use of outpatient services (73.0% vs 60.7%), physician office visits (mean 11.0 vs 8.1), and prescription fills (mean 40.0 vs 26.7) annually (all p < .01). Incremental costs associated with inadequate symptom control were $3,065 (2013 US dollars), and were driven by medical service costs ($2,391; 78%). Study included US commercially insured patients only and inferred IBS-D status and inadequate symptom control from claims. Inadequate symptom control associated with available IBS-D therapies represents a significant economic burden for both payers and IBS-D patients.

Help Your Child Learn To Write Well.

ERIC Educational Resources Information Center

Office of Educational Research and Improvement (ED), Washington, DC.

Addressing parents, this pamphlet describes ways to help children learn to write well and thereby excel in school, enjoy self-expression, and become more self-reliant. Writing is discussed as a practical, job-related, stimulating, social, and therapeutic activity that receives inadequate attention in many schools. It is emphasized that writing is…

29 CFR 1954.20 - Complaints about State program administration.

Code of Federal Regulations, 2010 CFR

2010-07-01

... pattern of delays in processing cases, of inadequate workplace inspections, or the granting of variances... investigation should be made, he shall cause such investigation, including any workplace inspection, to be made... complaints received on the same or similar issues and whether the complaints relate to safety and health...

Genomics of mineral nutrient biofortification: calcium, iron and zinc

USDA-ARS?s Scientific Manuscript database

Dietary deficiencies affect nearly half of the people on the planet, who simply do not receive sufficient nutrition from the food they buy or grow. Inadequate calcium, iron, and zinc consumption create short and long term health problems, which in turn can magnify and stagnate national development. ...

22 CFR 226.25 - Revision of budget and program plans.

Code of Federal Regulations, 2012 CFR

2012-04-01

... section. (c) For nonconstruction awards, recipients shall request prior approvals from the USAID Agreement... recipient does not receive an award or if the award is less than anticipated and inadequate to cover such... construction awards, recipients shall request prior written approval promptly from the USAID Agreement Officer...

22 CFR 145.25 - Revision of budget and program plans.

Code of Federal Regulations, 2012 CFR

2012-04-01

.... (c) For nonconstruction awards, recipients shall request prior approvals from the Department for one... reason the recipient does not receive an award or if the award is less than anticipated and inadequate to... awards, recipients shall request prior written approval promptly from the Grants Officer for budget...

22 CFR 145.25 - Revision of budget and program plans.

Code of Federal Regulations, 2013 CFR

2013-04-01

.... (c) For nonconstruction awards, recipients shall request prior approvals from the Department for one... reason the recipient does not receive an award or if the award is less than anticipated and inadequate to... awards, recipients shall request prior written approval promptly from the Grants Officer for budget...

22 CFR 145.25 - Revision of budget and program plans.

Code of Federal Regulations, 2011 CFR

2011-04-01

.... (c) For nonconstruction awards, recipients shall request prior approvals from the Department for one... reason the recipient does not receive an award or if the award is less than anticipated and inadequate to... awards, recipients shall request prior written approval promptly from the Grants Officer for budget...

22 CFR 226.25 - Revision of budget and program plans.

Code of Federal Regulations, 2013 CFR

2013-04-01

... section. (c) For nonconstruction awards, recipients shall request prior approvals from the USAID Agreement... recipient does not receive an award or if the award is less than anticipated and inadequate to cover such... construction awards, recipients shall request prior written approval promptly from the USAID Agreement Officer...

22 CFR 226.25 - Revision of budget and program plans.

Code of Federal Regulations, 2014 CFR

2014-04-01

... section. (c) For nonconstruction awards, recipients shall request prior approvals from the USAID Agreement... recipient does not receive an award or if the award is less than anticipated and inadequate to cover such... construction awards, recipients shall request prior written approval promptly from the USAID Agreement Officer...

22 CFR 226.25 - Revision of budget and program plans.

Code of Federal Regulations, 2011 CFR

2011-04-01

... section. (c) For nonconstruction awards, recipients shall request prior approvals from the USAID Agreement... recipient does not receive an award or if the award is less than anticipated and inadequate to cover such... construction awards, recipients shall request prior written approval promptly from the USAID Agreement Officer...

22 CFR 145.25 - Revision of budget and program plans.

Code of Federal Regulations, 2014 CFR

2014-04-01

.... (c) For nonconstruction awards, recipients shall request prior approvals from the Department for one... reason the recipient does not receive an award or if the award is less than anticipated and inadequate to... awards, recipients shall request prior written approval promptly from the Grants Officer for budget...

Building Successful Partnerships in Health Literacy

ERIC Educational Resources Information Center

McIntyre, Sue; Dale, Helen; Gabler, Carol

2010-01-01

Health literacy, the ability to obtain and understand information and services to make good health decisions, has received much attention recently. Literacy is a stronger predictor of health status than age, income, race, ethnicity, employment status, or educational level. Inadequate health literacy costs the United States an estimated $100-$236…

Visible Voices: Literacy Identity and the Invisible Homeless

ERIC Educational Resources Information Center

Juchniewicz, Melissa M.

2012-01-01

Despite calls for increased awareness of and sensitivity to diverse students and their in- and out-of-school literacies, the "invisible homeless"--those who often decline to self-identify--receive inadequate scholarly attention. They are often individuals who fear the stigma associated with homelessness as they navigate workplace, academic, and…

Reforming Mental Health Services for Seriously Emotionally Disturbed Youth: Rhetoric, Practice, and Research.

ERIC Educational Resources Information Center

Saxe, Leonard; And Others

Children with serious emotional disorders receive inadequate and inappropriate services, rather than the comprehensive and coordinated system of care needed. To develop the knowledge needed to provide adequate and appropriate services, an alliance is needed among advocates, practitioners, and researchers. The Mental Health Services Program for…

Pediatric Traumatic Brain Injury. Special Topic Report #3.

ERIC Educational Resources Information Center

Waaland, Pamela K.; Cockrell, Janice L.

This brief report summarizes what is known about pediatric traumatic brain injury, including the following: risk factors (e.g., males especially those ages 5 to 25, youth with preexisting problems including previous head injury victims, and children receiving inadequate supervision); life after injury; physical and neurological consequences (e.g.,…

Issues in Rural Palliative Care: Views from the Countryside

ERIC Educational Resources Information Center

Robinson, Carole A.; Pesut, Barbara; Bottorff, Joan L.

2010-01-01

Context: Growing concern exists among health professionals over the dilemma of providing necessary health care for Canada's aging population. Hospice palliative services are an essential need in both urban and rural settings. Rural communities, in particular, are vulnerable to receiving inadequate services due to their geographic isolation.…

On CALL: One Approach to Improving Services for Students with Low-Incidence Disabilities

ERIC Educational Resources Information Center

Bradley-Johnson, Sharon; Johnson, C. Merle; Drevon, Daniel D.

2015-01-01

Students with low-incidence disabilities frequently receive less than optimal psychoeducational services because the specialized tests and instructional materials required to meet their idiosyncratic needs often are unavailable due to budget constraints, inadequate training of school personnel, and the difficulty school personnel have keeping…

Placebo-controlled, double-blind trial of intravenous ribavirin for the treatment of hantavirus cardiopulmonary syndrome in North America.

PubMed

Mertz, Gregory J; Miedzinski, Lil; Goade, Diane; Pavia, Andrew T; Hjelle, Brian; Hansbarger, Christine O; Levy, Howard; Koster, Frederick T; Baum, Kenneth; Lindemulder, Adeline; Wang, Wenquan; Riser, Laura; Fernandez, Humberto; Whitley, Richard J

2004-11-01

BACKGROUND. Ribavirin is active in vitro against hantaviruses, but the findings of an open trial of the use of intravenous ribavirin for the treatment of hantavirus cardiopulmonary syndrome (HCPS) were inconclusive. Subjects with suspected HCPS in the prodrome or cardiopulmonary phase but without shock were eligible for randomization to receive either intravenous ribavirin (33 mg/kg [

Many Patients with Cancer Need Better Treatments for Pain

Cancer.gov

Inadequate pain treatment in patients with cancer remains a significant problem and appears to be more frequent among minorities, according to a new study published online April 16, 2012, in the Journal of Clinical Oncology.

Psychotrauma and effective treatment of post-traumatic stress disorder in soldiers and peacekeepers

PubMed Central

Vitzthum, Karin; Mache, Stefanie; Joachim, Ricarda; Quarcoo, David; Groneberg, David A

2009-01-01

Psychotrauma occurs as a result to a traumatic event, which may involve witnessing someone's actual death or personally experiencing serious physical injury, assault, rape and sexual abuse, being held as a hostage, or a threat to physical or psychological integrity. Post-traumatic stress disorder (PTSD) is an anxiety disorder and was defined in the past as railway spine, traumatic war neurosis, stress syndrome, shell shock, battle fatigue, combat fatigue, or post-traumatic stress syndrome (PTSS). If untreated, post-traumatic stress disorder can impair relationships of those affected and strain their families and society. Deployed soldiers are especially at a high risk to be affected by PTSD but often receive inadequate treatment. Reviews to date have focused only on a single type of treatment or groups of soldiers from only one country. The aim of the current review was to evaluate characteristics of therapeutic methods used internationally to treat male soldiers' PTSD after peacekeeping operations in South Eastern Europe and the Gulf wars. This systematic literature review returned results pertaining to the symptoms, diagnosis, timing and effectiveness of treatment. Sample groups and controls were relatively small and, therefore, the results lack generalizability. Further research is needed to understand the influence and unique psychological requirements of each specific military operation on the internationally deployed soldiers. PMID:19643016

Screening and treatment of obesity in school health care - the gap between clinical guidelines and reality.

PubMed

Häkkänen, Paula; Ketola, Eeva; Laatikainen, Tiina

2018-05-06

School health care offers a natural setting for childhood obesity interventions. Earlier studies reveal inadequate screening and treatment in primary care. However, longitudinal studies in unselected populations are lacking. We aimed to examine how school nurses and physicians identified obesity, diagnosed it and offered interventions over primary school. We compared the results with Finnish recommendations. From our cohort of 2000 primary school sixth graders (aged 12-14), 172 were obese at least once during primary school. We manually collected retrospective electronic health record (EHR) data of these 'ever-obese' children. Of the ever-obese children, 96% attended annual nurse assessments more than twice. School physicians met 53% of the ever-obese children at health checks at first grade and 93% at fifth grade. Of overweight-related extra visits to school nurses, 94% took place without parents. Parents were present in 48% of extra school physician visits. Only 29% of the 157 who became obese during the first five school grades received an obesity diagnosis. However, school physicians mentioned weight problems in EHR for 90% of the children and, similarly, school nurses for 99%. The majority received a treatment plan at least once. For 78%, at least one plan was made with the parents. Still, 28% missed nutrition plans, 31% exercise plans and 90% lacked recorded weight development targets. The gap between clinical guidelines and reality in school health care could be narrowed by improving diagnosing and parent collaboration. Obstacles in parent involvement and work methods in school health care need further study. © 2018 Nordic College of Caring Science.

Two Phase III randomised double-blind studies of fixed-dose TC-5214 (dexmecamylamine) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to prior antidepressant therapy.

PubMed

Möller, Hans-Jürgen; Demyttenaere, Koen; Olausson, Bengt; Szamosi, Johan; Wilson, Ellis; Hosford, David; Dunbar, Geoffrey; Tummala, Raj; Eriksson, Hans

2015-10-01

To evaluate the neuronal nicotinic channel modulator TC-5214 (dexmecamylamine) as adjunct therapy in patients with major depressive disorder (MDD) and inadequate response to prior antidepressant treatment. Study 004 (D4130C00004) and Study 005 (D4130C00005) comprised an 8-week open-label antidepressant (SSRI/SNRI) treatment period followed by an 8-week randomised, active treatment with twice-daily TC-5214 (0.5, 2 or 4 mg in Study 004; 0.1, 1 or 4 mg in Study 005) or placebo, adjunct to ongoing SSRI/SNRI. Primary efficacy endpoint was change in MADRS total score from randomisation (Week 8) to treatment end (Week 16). Secondary endpoints included MADRS response and remission, and changes in SDS and HAM-D-17-item scores. Safety and tolerability were monitored throughout. Studies 004 and 005 randomised 640 and 696 patients, respectively, to TC-5214 or placebo. No statistically significant improvements in MADRS total score or any secondary endpoints were seen with TC-5214 versus placebo in either study at treatment end. The most commonly reported adverse events (> 10%) with TC-5214 were constipation, dizziness and dry mouth. TC-5214 adjunct to antidepressant was generally well tolerated. However, the studies were not supportive of an antidepressant effect for TC-5214 in patients with MDD and inadequate response to prior antidepressant therapy.

Association between prenatal care utilization and risk of preterm birth among Chinese women.

PubMed

Zhang, Bin; Yang, Rong; Liang, Sheng-Wen; Wang, Jing; Chang, Jen Jen; Hu, Ke; Dong, Guang-Hui; Hu, Rong-Hua; Flick, Louise H; Zhang, Yi-Ming; Zhang, Dan; Li, Qing-Jie; Zheng, Tong-Zhang; Xu, Shun-Qing; Yang, Shao-Ping; Qian, Zheng-Min

2017-08-01

It is recognized that prenatal care plays an important role in reducing adverse birth. Chinese pregnant women with medical condition were required to seek additional health care based on the recommended at least 5 times health care visits. This study was to estimate the association between prenatal care utilization (PCU) and preterm birth (PTB), and to investigate if medical conditions during pregnancy modified the association. This population-based case control study sampled women with PTB as cases; one control for each case was randomly selected from women with term births. The Electronic Perinatal Health Care Information System (EPHCIS) and a questionnaire were used for data collection. The PCU was measured by a renewed Prenatal Care Utilization (APNCU) index. Logistic regression models were used to estimate odds ratios (OR) and the 95% confidence interval (95% CI). Totally, 2393 women with PTBs and 4263 women with term births were collected. In this study, 695 (10.5%) women experienced inadequate prenatal care, and 5131 (77.1%) received adequate plus prenatal care. Inadequate PCU was associated with PTB (adjusted OR: 1.41, 95% CI: 1.32-1.84); the similar positive association was found between adequate plus PCU and PTB. Among women with medical conditions, these associations still existed; but among women without medical conditions, the association between inadequate PCU and PTB disappeared. Our data suggests that women receiving inappropriate PCU are at an increased risk of having PTB, but it does depend on whether the woman has a medical condition during pregnancy.

Effect of a single session of muscle-biased therapy on pain sensitivity: a systematic review and meta-analysis of randomized controlled trials

PubMed Central

Gay, Charles W; Alappattu, Meryl J; Coronado, Rogelio A; Horn, Maggie E; Bishop, Mark D

2013-01-01

Background Muscle-biased therapies (MBT) are commonly used to treat pain, yet several reviews suggest evidence for the clinical effectiveness of these therapies is lacking. Inadequate treatment parameters have been suggested to account for inconsistent effects across studies. Pain sensitivity may serve as an intermediate physiologic endpoint helping to establish optimal MBT treatment parameters. The purpose of this review was to summarize the current literature investigating the short-term effect of a single dose of MBT on pain sensitivity in both healthy and clinical populations, with particular attention to specific MBT parameters of intensity and duration. Methods A systematic search for articles meeting our prespecified criteria was conducted using Cumulative Index to Nursing and Allied Health Literature (CINAHL) and MEDLINE from the inception of each database until July 2012, in accordance with guidelines from the Preferred Reporting Items for Systematic reviews and Meta-Analysis. Relevant characteristics from studies included type, intensity, and duration of MBT and whether short-term changes in pain sensitivity and clinical pain were noted with MBT application. Study results were pooled using a random-effects model to estimate the overall effect size of a single dose of MBT on pain sensitivity as well as the effect of MBT, dependent on comparison group and population type. Results Reports from 24 randomized controlled trials (23 articles) were included, representing 36 MBT treatment arms and 29 comparative groups, where 10 groups received active agents, 11 received sham/inert treatments, and eight received no treatment. MBT demonstrated a favorable and consistent ability to modulate pain sensitivity. Short-term modulation of pain sensitivity was associated with short-term beneficial effects on clinical pain. Intensity of MBT, but not duration, was linked with change in pain sensitivity. A meta-analysis was conducted on 17 studies that assessed the effect of MBT on pressure pain thresholds. The results suggest that MBT had a favorable effect on pressure pain thresholds when compared with no-treatment and sham/inert groups, and effects comparable with those of other active treatments. Conclusion The evidence supports the use of pain sensitivity measures by future research to help elucidate optimal therapeutic parameters for MBT as an intermediate physiologic marker. PMID:23403507

Psychometric properties of the Spanish version of the Cocaine Selective Severity Assessment to evaluate cocaine withdrawal in treatment-seeking individuals.

PubMed

Pérez de los Cobos, José; Trujols, Joan; Siñol, Núria; Vasconcelos e Rego, Lisiane; Iraurgi, Ioseba; Batlle, Francesca

2014-09-01

Reliable and valid assessment of cocaine withdrawal is relevant for treating cocaine-dependent patients. This study examined the psychometric properties of the Spanish version of the Cocaine Selective Severity Assessment (CSSA), an instrument that measures cocaine withdrawal. Participants were 170 cocaine-dependent inpatients receiving detoxification treatment. Principal component analysis revealed a 4-factor structure for CSSA that included the following components: 'Cocaine Craving and Psychological Distress', 'Lethargy', 'Carbohydrate Craving and Irritability', and 'Somatic Depressive Symptoms'. These 4 components accounted for 56.0% of total variance. Internal reliability for these components ranged from unacceptable to good (Chronbach's alpha: 0.87, 0.65, 0.55, and 0.22, respectively). All components except Somatic Depressive Symptoms presented concurrent validity with cocaine use. In summary, while some properties of the Spanish version of the CSSA are satisfactory, such as interpretability of factor structure and test-retest reliability, other properties, such as internal reliability and concurrent validity of some factors, are inadequate. Copyright © 2014 Elsevier Inc. All rights reserved.

Nigerian medical students' opinions about the undergraduate curriculum in psychiatry.

PubMed

James, Bawo; Omoaregba, Joyce; Okogbenin, Esther; Buhari, Olubunmi; Obindo, Taiwo; Okonoda, Mayowa

2013-05-01

The number of psychiatrists in Nigeria is inadequate to meet the treatment needs for neuropsychiatric disorders. Developing mental health competency in the future Nigerian physician workforce is one approach to filling the treatment gap. The authors aimed to assess medical students' attitudes to this training and its relevance to their future practice and to assess whether they are getting adequate or relevant training. A cross-sectional, questionnaire-based survey was undertaken among a sample (N=375) of 5th- and 6th-year students across four medical schools in Nigeria. Over one-tenth (12%) chose psychiatry as a future career choice. Most expressed positive attitudes toward psychiatry and its relevance to their future careers. A majority were enthusiastic about receiving training in psychiatry in primary-care settings and welcomed a curriculum that emphasized the learning and management of common psychiatric disorders seen in general practice. Medical students surveyed would welcome an undergraduate curriculum that integrates the learning of psychiatry with other specialties and skills-training relevant for primary care. Efforts to modify the current curriculum in psychiatry in Nigerian medical schools should be encouraged.

Effects of adolescence-onset hypogonadism on metabolism, bone mineral density and quality of life in adulthood.

PubMed

Tam, Friederike I W; Huebner, Angela; Hofbauer, Lorenz C; Rohayem, Julia

2015-09-01

In a cross-sectional study of 54 patients with adolescence-onset hypogonadism (33 females, 21 males; age range: 19-40 years), medical care, quality of life, and health status were assessed. Most patients had received adequate medical care with short cumulative periods of interruption of hormone replacement. The prevalence of the metabolic syndrome was 27% in females and 19% in males. In comparison to the general population, females had both a lower bone mineral density (dual-energy X-ray absorptiometry, Z-score=-0.8, p<0.001) and a higher prevalence of obesity (age 19-29 years: study population 35%, general population 4%). The body fat percentage (dual-energy X-ray absorptiometry) was significantly elevated (age 19-29 years: females Z-score=+1.8, p<0.001, males Z-score=+2.4, p=0.001). Quality of life (SF-36) was normal. Despite adequate treatment, patients with early-onset hypogonadism are prone to develop signs and symptoms consistent with inadequate hormone replacement. A successful transition from pediatric to adult medicine seems important to optimize treatment outcomes.

Contemporary management of patients with high-risk non-muscle-invasive bladder cancer who fail intravesical BCG therapy.

PubMed

Yates, D R; Rouprêt, M

2011-08-01

It is advocated that patients with high-risk non-muscle-invasive bladder cancer (NMIBC) receive an adjuvant course of intravesical Bacille Calmette-Guerin (BCG) as first-line treatment. However, a substantial proportion of patients will 'fail' BCG, either early with persistent (refractory) disease or recur late after a long disease-free interval (relapsing). Guideline recommendation in the 'refractory' setting is radical cystectomy, but there are situations when extirpative surgery is not feasible due to competing co-morbidity, a patient's desire for bladder preservation or reluctance to undergo surgery. In this review, we discuss the contemporary management of NMIBC in patients who have failed prior BCG and are not suitable for radical surgery and highlight the potential options available. These options can be categorised as immunotherapy, chemotherapy, device-assisted therapy and combination therapy. However, the current data are still inadequate to formulate definitive recommendations, and data from ongoing trials and maturing studies will give us an insight into whether there is a realistic efficacious second-line treatment for patients who fail intravesical BCG but are not candidates for definitive surgery.

Need for symptomatic management in advanced multiple sclerosis.

PubMed

Rønning, O M; Tornes, K D

2017-05-01

A majority of patients with advanced multiple sclerosis (MS) need symptomatic treatment. Many MS-related symptoms may not be recognized and thus are not treated. We conducted a study to estimate the prevalence of inadequate symptomatic treatment of patients with advanced MS. Patients with advanced MS admitted to a specialist MS rehabilitation clinic were included in this study. Severity was assessed using the Expanded Disability Status Scale (EDSS). The information we collected included age of onset, initial course, time to sustained disability, pharmacological treatment, degree of spasticity, pain and bladder dysfunction, and unmet needs of symptomatic treatment. In total, we assessed demographic and clinical characteristics in 129 patients with a mean age of 56 years and a median EDSS of 7.5. The proportion with inadequate symptom treatment was regarding spasticity 46%, pain 28%, and bladder dysfunction 23%. This study showed that a large proportion of patients with advanced MS had lack of symptomatic treatment. These patients probably underuse neurological specialist services. Better symptomatic treatment could contribute to improving quality of life of people with MS. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Transmission of Extensively Drug-Resistant Tuberculosis in South Africa

PubMed Central

Shah, N. Sarita; Auld, Sara C.; Brust, James C.M.; Mathema, Barun; Ismail, Nazir; Moodley, Pravi; Mlisana, Koleka; Allana, Salim; Campbell, Angela; Mthiyane, Thuli; Morris, Natashia; Mpangase, Primrose; van der Meulen, Hermina; Omar, Shaheed V.; Brown, Tyler S.; Narechania, Apurva; Shaskina, Elena; Kapwata, Thandi; Kreiswirth, Barry; Gandhi, Neel R.

2017-01-01

BACKGROUND Drug-resistant tuberculosis threatens recent gains in the treatment of tuberculosis and human immunodeficiency virus (HIV) infection worldwide. A widespread epidemic of extensively drug-resistant (XDR) tuberculosis is occurring in South Africa, where cases have increased substantially since 2002. The factors driving this rapid increase have not been fully elucidated, but such knowledge is needed to guide public health interventions. METHODS We conducted a prospective study involving 404 participants in KwaZulu-Natal Province, South Africa, with a diagnosis of XDR tuberculosis between 2011 and 2014. Interviews and medical-record reviews were used to elicit information on the participants’ history of tuberculosis and HIV infection, hospitalizations, and social networks. Mycobacterium tuberculosis isolates underwent insertion sequence (IS)6110 restriction-fragment– length polymorphism analysis, targeted gene sequencing, and whole-genome sequencing. We used clinical and genotypic case definitions to calculate the proportion of cases of XDR tuberculosis that were due to inadequate treatment of multidrug-resistant (MDR) tuberculosis (i.e., acquired resistance) versus those that were due to transmission (i.e., transmitted resistance). We used social-network analysis to identify community and hospital locations of transmission. RESULTS Of the 404 participants, 311 (77%) had HIV infection; the median CD4+ count was 340 cells per cubic millimeter (interquartile range, 117 to 431). A total of 280 participants (69%) had never received treatment for MDR tuberculosis. Genotypic analysis in 386 participants revealed that 323 (84%) belonged to 1 of 31 clusters. Clusters ranged from 2 to 14 participants, except for 1 large cluster of 212 participants (55%) with a LAM4/KZN strain. Person-to-person or hospital-based epidemiologic links were identified in 123 of 404 participants (30%). CONCLUSIONS The majority of cases of XDR tuberculosis in KwaZulu-Natal, South Africa, an area with a high tuberculosis burden, were probably due to transmission rather than to inadequate treatment of MDR tuberculosis. These data suggest that control of the epidemic of drug-resistant tuberculosis requires an increased focus on interrupting transmission. (Funded by the National Institute of Allergy and Infectious Diseases and others.) PMID:28099825

Parent perspectives on information about late effects of childhood cancer treatment and their role in initial treatment decision making.

PubMed

Greenzang, Katie A; Dauti, Angela; Mack, Jennifer W

2018-06-01

Though most childhood cancer survivors experience late effects of treatment, we know little about parent preferences for late effects information during therapy, or how parents weigh late effects when making treatment decisions. Our objective was to explore how parents of children with cancer consider late effects in initial treatment decision making and during active cancer treatment. Semistructured interviews were conducted with 12 parents of children with cancer who were actively receiving treatment at Dana-Farber/Boston Children's Cancer and Blood Disorders Center. Interviews were audio-recorded, transcribed verbatim, and qualitatively analyzed using thematic analysis. Ten of 12 parents reported that they had to decide between two or more treatment options for their child's cancer. Of those, 50% (5/10) considered late effects to be an important factor in their decision making. Most parents wanted early and detailed information about their child's risk of late effects to make treatment decisions and to feel prepared for the future. However, a few parents felt too overwhelmed to focus on late effects at diagnosis. While many recalled extensive late effects information in informed consent discussions, some parents felt these issues were minimally addressed. Parents desire detailed information about late effects to make informed treatment decisions and prepare for the future. Despite the role of late effects in treatment decision making, some parents feel that late effects are either inadequately addressed or too overwhelming to process at diagnosis. Parents may benefit from early assessment of their information needs and a return to these issues over time. © 2018 Wiley Periodicals, Inc.

Maternal syphilis and accomplishing sexual partner treatment: still a huge gap.

PubMed

Dallé, Jessica; Baumgarten, Vanessa Z; Ramos, Mauro C; Jimenez, Mirela F; Acosta, Lisiane; Bumaguin, Daniela B; Antonello, Vicente S

2017-08-01

Congenital syphilis (CS) is a preventable epidemic disease for which control is hindered by socioeconomic and health system issues. Inadequately treated maternal syphilis (MaS) commonly has serious adverse obstetric outcomes. This study - which is a cross-sectional study in a Brazilian large urban public Mother and Child hospital, making use of secondary data - evaluated the occurrence of treatment of sexual partners (SP) among women with MaS. The results showed that 771 MaS cases were identified from 2007 to 2014. No information on SP treatment was available in 570 (73.9%) cases. Of the 201 cases presenting information, 25 (12.4%) SP were treated. Out of 164 women having six or more prenatal visits, 25 (15.2%) SP received treatment. Data analyzed biennially have shown a growing trend of cases without collected information, ranging from 27.2% in 2007-2008 to 87.5% in 2013-2014. No linear trend in proportions of treated SP (maximum 7.4% SP treated) was found. Thus, in this study, it has been concluded that the proportion of SP adequately treated was consistently low, and the quality of information deteriorated during the studied period. Prenatal care per se, as provided, was not effective in delivering adequate treatment of SP. Creative integrated services with SP active participation are greatly needed if CS is to be controlled.

3M syndrome: a report of four cases in two families.

PubMed

Güven, Ayla; Cebeci, Ayşe Nurcan

2011-01-01

3M syndrome is a rare entity characterized by severe growth retardation, dysmorphic features and skeletal changes as its major components. It is differentiated from other types of dwarfism by its clinical features and by the typical slender long bones and foreshortened vertebral bodies that can be visualized radiographically. 3M syndrome has an autosomal recessive mode of inheritance. An early diagnosis is important for genetic counseling. In this report, we present four children (3 males, 1 female) from two families who were aged between 4(11/12) and 10(11/12) years and had clinical findings of 3M syndrome. One of these patients had received growth hormone (GH) treatment which was discontinued due to an inadequate height gain. Physicians should be aware of this entity in the differential diagnosis of children with severe short stature and mild skeletal changes.

"Ready to shoot and do shoot": black working-class self-defense and community politics in Harlem, New York, during the 1920s.

PubMed

King, Shannon

2011-01-01

Throughout the first three decades of the twentieth century, black people in New York City encountered white violence, especially police brutality in Manhattan. The black community used various strategies to curtail white mob violence and police brutality, one of which was self-defense. This article examines blacks’ response to violence, specifically the debate concerning police brutality and self-defense in Harlem during the 1920s. While historians have examined race riots, blacks’ everyday encounters with police violence in the North have received inadequate treatment. By approaching everyday violence and black responses—self-defense, legal redress, and journalists’ remonstrations—as a process of political development, this article argues that the systematic violence perpetrated by the police both mobilized and politicized blacks individually and collectively to defend their community, but also contributed to a community consciousness that established police brutality as a legitimate issue for black protest.

National Poisons Information Services: report and comment 1980.

PubMed Central

Volans, G N; Mitchell, G M; Proudfoot, A T; Shanks, R G; Woodcock, J A

1981-01-01

The National Poisons Information Services (NPIS) covering the United Kingdom and the Republic of Ireland currently receive over 40,000 telephone inquiries a year. Over the years there has been little change in the proportion of inquiries related to each of the main categories of poisons (drugs, household, chemical, agricultural, animals, and plants). More detailed analysis, however, shows pronounced changes in the inquiries relating to specific types of poisoning, particularly with drugs. By monitoring these trends and assessing the risks of toxicity, the NPIS has an important role in informing the medical profession of the need for preventive measures and for improved methods of treatment. At present, the NPIS cannot make full use of the available data due to inadequate staffing and lack of computer facilities. It is argued that for a modest increase in funding a much more comprehensive service could be provided. PMID:6786585

3M Syndrome: A Report of Four Cases in Two Families

PubMed Central

Cebeci, Ayşe Nurcan

2011-01-01

3M syndrome is a rare entity characterized by severe growth retardation, dysmorphic features and skeletal changes as its major components. It is differentiated from other types of dwarfism by its clinical features and by the typical slender long bones and foreshortened vertebral bodies that can be visualized radiographically. 3M syndrome has an autosomal recessive mode of inheritance. An early diagnosis is important for genetic counseling. In this report, we present four children (3 males, 1 female) from two families who were aged between 411/12 and 1011/12 years and had clinical findings of 3M syndrome. One of these patients had received growth hormone (GH) treatment which was discontinued due to an inadequate height gain. Physicians should be aware of this entity in the differential diagnosis of children with severe short stature and mild skeletal changes. Conflict of interest:None declared. PMID:21911330

Linagliptin as add-on to empagliflozin and metformin in patients with type 2 diabetes: Two 24-week randomized, double-blind, double-dummy, parallel-group trials.

PubMed

Tinahones, Francisco J; Gallwitz, Baptist; Nordaby, Matias; Götz, Sophia; Maldonado-Lutomirsky, Mario; Woerle, Hans J; Broedl, Uli C

2017-02-01

To evaluate the efficacy and safety of linagliptin vs placebo as add-on to empagliflozin and metformin in patients with type 2 diabetes. Patients with inadequate glycaemic control despite stable-dose metformin received open-label empagliflozin 10 mg (study 1) or 25 mg (study 2) as add-on therapy for 16 weeks. Subsequently, those with HbA1c ≥7.0 and ≤10.5% (>53 and ≤91 mmol/mol) (N = 482) were randomized to 24 weeks' double-blind, double-dummy treatment with linagliptin 5 mg or placebo in study 1, or to linagliptin 5 mg or placebo in study 2; all patients continued treatment with metformin and empagliflozin 10 mg (study 1) or metformin and empagliflozin 25 mg (study 2). The primary endpoint was change from baseline (defined as the last value before first intake of randomized, double-blind treatment) in HbA1c at week 24. At week 24, HbA1c (mean baseline 7.82-8.04 [62-64 mmol/mol]) was significantly reduced with linagliptin vs placebo; adjusted mean (SE) differences in change from baseline in HbA1c with linagliptin vs placebo were -.32% (.10) (-3.59 [1.08] mmol/mol) ( P = .001) for patients on empagliflozin 10 mg and metformin, and -0.47% (0.10) (-5.15 [1.04] mmol/mol) ( P < 0.001) for patients on empagliflozin 25 mg and metformin. Adverse events were reported in more patients receiving placebo than in those receiving linagliptin: 55.5% vs 48.4% in study 1 and 58.9% vs 52.7% in study 2. Linagliptin as add-on to empagliflozin and metformin for 24 weeks improved glycaemic control vs placebo, and was well tolerated. © 2016 John Wiley & Sons Ltd.

Recommendations for optimizing methotrexate treatment for patients with rheumatoid arthritis

PubMed Central

Bello, Alfonso E; Perkins, Elizabeth L; Jay, Randy; Efthimiou, Petros

2017-01-01

Methotrexate (MTX) remains the cornerstone therapy for patients with rheumatoid arthritis (RA), with well-established safety and efficacy profiles and support in international guidelines. Clinical and radiologic results indicate benefits of MTX monotherapy and combination with other agents, yet patients may not receive optimal dosing, duration, or route of administration to maximize their response to this drug. This review highlights best practices for MTX use in RA patients. First, to improve the response to oral MTX, a high initial dose should be administered followed by rapid titration. Importantly, this approach does not appear to compromise safety or tolerability for patients. Treatment with oral MTX, with appropriate dose titration, then should be continued for at least 6 months (as long as the patient experiences some response to treatment within 3 months) to achieve an accurate assessment of treatment efficacy. If oral MTX treatment fails due to intolerability or inadequate response, the patient may be “rescued” by switching to subcutaneous delivery of MTX. Consideration should also be given to starting with subcutaneous MTX given its favorable bioavailability and pharmacodynamic profile over oral delivery. Either initiation of subcutaneous MTX therapy or switching from oral to subcutaneous administration improves persistence with treatment. Upon transition from oral to subcutaneous delivery, MTX dosage should be maintained, rather than increased, and titration should be performed as needed. Similarly, if another RA treatment is necessary to control the disease, the MTX dosage and route of administration should be maintained, with titration as needed. PMID:28435338

Fibromyalgia syndrome: prevalence, pharmacological and non-pharmacological interventions in outpatient health care. An analysis of statutory health insurance data.

PubMed

Sauer, Kristin; Kemper, Claudia; Glaeske, Gerd

2011-01-01

Fibromyalgia syndrome (FMS) is a chronic pain condition impacting on quality of life, causing physical and psychological impairment resulting in limited participation in professional and social life. The objective of this study was to assess the prevalence, recommended pharmacological and non-pharmacological interventions of FMS, patients' characteristics and to compare findings to current research. About 1.6 Mio patients of a German statutory health insurance company (GEK) in 2007 were analyzed for: (a) the prevalence of FMS (ICD-10: M79.7); (b) and comorbid depression (ICD-10: F32/33); (c) the recommended pharmacological and non-pharmacological intervention rates; (d) and characteristics of patients associated with being prescribed recommended interventions. The (a) standardized prevalence of FMS in 2007 was 0.05% in men and 0.4% in women. (b) 51.9% of the patients with prevalent FMS had a comorbid depression in 2007 (88.2% female). (c) 66% of FMS patients received the recommended pharmacological treatment, 59% physical therapy, 6.1% cognitive-behavioural therapy and 3.4% a combination of these (multi-component therapy, MCT). (d) One year increase in age was associated with a 3% decrease in the predicted odds of receiving MCT (95%, CI 0.95-0.99). The current data indicate an FMS-prevalence that differs from epidemiological surveys and screenings, probably due to methodological differences. Especially females with comorbid depression are affected. The likelihood of receiving MCT is not associated with gender, but with younger age. Yet, the findings seem to indicate insufficient and inadequate treatment, but FMS warrants more research. Copyright © 2010 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

Health Issues Facing Black Women.

ERIC Educational Resources Information Center

Reid, Inez Smith

Black women in the United States experience a high incidence of serious health problems and, as a group, receive insufficient and inadequate medical care. The death rate for black women suffering from breast cancer has increased substantially since 1950. Also of great concern is the high incidence of cervical cancer in low income black women…

How Are Kentucky's Children Stacking Up? A County by County Analysis.

ERIC Educational Resources Information Center

Chandler, Betsy

In a county by county analysis, this report assesses the quality of life for Kentucky's children. Researchers developed a child quotient (CQ) based on 18 indicators: per capita income, children in poverty, women receiving inadequate prenatal care, infant deaths, teens giving birth, substandard dwellings, children in foster care, per-pupil…

Survivors' Narratives of the Impact of Parental Suicide

ERIC Educational Resources Information Center

Ratnarajah, Dorothy; Schofield, Margot J.

2008-01-01

The impact of parental suicide on surviving children and their family system has received inadequate research attention. Using a qualitative narrative methodology with thematic analysis, we explored the short-term and lifelong impact of parental suicide among 10 adults who, as children or adolescents, had lost a parent through suicide. The suicide…

Hopes & Hurdles: California Foster Youth and College Financial Aid

ERIC Educational Resources Information Center

Cochrane, Deborah Frankle; Szabo-Kubitz, Laura

2009-01-01

This report examines why former foster youth in California are not receiving the aid they are likely eligible for, from inadequate or poorly targeted information about college costs and financial aid to structural obstacles within the aid process and programs. While many of this report's findings and recommendations are specific to foster youth,…

43 CFR 12.925 - Revision of budget and program plans.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., recipients shall request prior approvals from Federal awarding agencies for one or more of the following... prior approval of the Federal awarding agency. All pre-award costs are incurred at the recipient's risk... the recipient does not receive an award or if the award is less than anticipated and inadequate to...

7 CFR 3019.25 - Revision of budget and program plans.

Code of Federal Regulations, 2014 CFR

2014-01-01

... awards, recipients shall request prior approvals from Federal awarding agencies for one or more of the... prior approval of the Federal awarding agency. All pre-award costs are incurred at the recipient's risk... the recipient does not receive an award or if the award is less than anticipated and inadequate to...

7 CFR 3019.25 - Revision of budget and program plans.

Code of Federal Regulations, 2011 CFR

2011-01-01

... awards, recipients shall request prior approvals from Federal awarding agencies for one or more of the... prior approval of the Federal awarding agency. All pre-award costs are incurred at the recipient's risk... the recipient does not receive an award or if the award is less than anticipated and inadequate to...

49 CFR 19.25 - Revision of budget and program plans.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., recipients shall request prior approvals from Federal awarding agencies for one or more of the following... prior approval of the Federal awarding agency. All pre-award costs are incurred at the recipient's risk... the recipient does not receive an award or if the award is less than anticipated and inadequate to...

45 CFR 74.25 - Revision of budget and program plans.

Code of Federal Regulations, 2013 CFR

2013-10-01

... items. (c) For nonconstruction awards, recipients shall obtain prior approvals from the HHS awarding... approval of the HHS awarding agency. However, all pre-award costs are incurred at the recipient's risk: the... does not receive an award or if the award to the recipient is less than anticipated and inadequate to...

49 CFR 19.25 - Revision of budget and program plans.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., recipients shall request prior approvals from Federal awarding agencies for one or more of the following... prior approval of the Federal awarding agency. All pre-award costs are incurred at the recipient's risk... the recipient does not receive an award or if the award is less than anticipated and inadequate to...

43 CFR 12.925 - Revision of budget and program plans.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., recipients shall request prior approvals from Federal awarding agencies for one or more of the following... prior approval of the Federal awarding agency. All pre-award costs are incurred at the recipient's risk... the recipient does not receive an award or if the award is less than anticipated and inadequate to...

7 CFR 3019.25 - Revision of budget and program plans.

Code of Federal Regulations, 2013 CFR

2013-01-01

... awards, recipients shall request prior approvals from Federal awarding agencies for one or more of the... prior approval of the Federal awarding agency. All pre-award costs are incurred at the recipient's risk... the recipient does not receive an award or if the award is less than anticipated and inadequate to...

43 CFR 12.925 - Revision of budget and program plans.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., recipients shall request prior approvals from Federal awarding agencies for one or more of the following... prior approval of the Federal awarding agency. All pre-award costs are incurred at the recipient's risk... the recipient does not receive an award or if the award is less than anticipated and inadequate to...

45 CFR 74.25 - Revision of budget and program plans.

Code of Federal Regulations, 2012 CFR

2012-10-01

... items. (c) For nonconstruction awards, recipients shall obtain prior approvals from the HHS awarding... approval of the HHS awarding agency. However, all pre-award costs are incurred at the recipient's risk: the... does not receive an award or if the award to the recipient is less than anticipated and inadequate to...

7 CFR 3019.25 - Revision of budget and program plans.

Code of Federal Regulations, 2010 CFR

2010-01-01

... awards, recipients shall request prior approvals from Federal awarding agencies for one or more of the... prior approval of the Federal awarding agency. All pre-award costs are incurred at the recipient's risk... the recipient does not receive an award or if the award is less than anticipated and inadequate to...

49 CFR 19.25 - Revision of budget and program plans.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., recipients shall request prior approvals from Federal awarding agencies for one or more of the following... prior approval of the Federal awarding agency. All pre-award costs are incurred at the recipient's risk... the recipient does not receive an award or if the award is less than anticipated and inadequate to...

43 CFR 12.925 - Revision of budget and program plans.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., recipients shall request prior approvals from Federal awarding agencies for one or more of the following... prior approval of the Federal awarding agency. All pre-award costs are incurred at the recipient's risk... the recipient does not receive an award or if the award is less than anticipated and inadequate to...

49 CFR 19.25 - Revision of budget and program plans.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., recipients shall request prior approvals from Federal awarding agencies for one or more of the following... prior approval of the Federal awarding agency. All pre-award costs are incurred at the recipient's risk... the recipient does not receive an award or if the award is less than anticipated and inadequate to...

45 CFR 74.25 - Revision of budget and program plans.

Code of Federal Regulations, 2011 CFR

2011-10-01

... items. (c) For nonconstruction awards, recipients shall obtain prior approvals from the HHS awarding... approval of the HHS awarding agency. However, all pre-award costs are incurred at the recipient's risk: the... does not receive an award or if the award to the recipient is less than anticipated and inadequate to...

49 CFR 19.25 - Revision of budget and program plans.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., recipients shall request prior approvals from Federal awarding agencies for one or more of the following... prior approval of the Federal awarding agency. All pre-award costs are incurred at the recipient's risk... the recipient does not receive an award or if the award is less than anticipated and inadequate to...

7 CFR 3019.25 - Revision of budget and program plans.

Code of Federal Regulations, 2012 CFR

2012-01-01

... awards, recipients shall request prior approvals from Federal awarding agencies for one or more of the... prior approval of the Federal awarding agency. All pre-award costs are incurred at the recipient's risk... the recipient does not receive an award or if the award is less than anticipated and inadequate to...

45 CFR 74.25 - Revision of budget and program plans.

Code of Federal Regulations, 2014 CFR

2014-10-01

... items. (c) For nonconstruction awards, recipients shall obtain prior approvals from the HHS awarding... approval of the HHS awarding agency. However, all pre-award costs are incurred at the recipient's risk: the... does not receive an award or if the award to the recipient is less than anticipated and inadequate to...

Finding Possibility in Pitfalls: The Role of Permeable Methods Pedagogy in Preservice Teacher Learning

ERIC Educational Resources Information Center

Hebard, Heather

2016-01-01

Background/context: Tensions between university-based teacher preparation courses and field placements have long been identified as an obstacle to novices' uptake of promising instructional practices. This tension is particularly salient for writing instruction, which continues to receive inadequate attention in K-12 classrooms. More scholarship…

Confronting the Achievement Gap

ERIC Educational Resources Information Center

Gardner, David

2007-01-01

This article talks about the large achievement gap between children of color and their white peers. The reasons for the achievement gap are varied. First, many urban minorities come from a background of poverty. One of the detrimental effects of growing up in poverty is receiving inadequate nourishment at a time when bodies and brains are rapidly…

Training Needs of Purchasing and Supply Management Personnel in Hong Kong

ERIC Educational Resources Information Center

Lau, Antonio K. W.

2010-01-01

Purpose: The importance of purchasing and supply management (PSM) for business performance has received considerable attention in recent years. However, research on PSM training and education is inadequate. This paper aims to present initial findings from PSM practitioners about current PSM training and education needs in Hong Kong.…

Developmental Status and Social-Emotional Functioning of Young Children Experiencing Homelessness

ERIC Educational Resources Information Center

Haskett, Mary E.; Armstrong, Jenna Montgomery; Tisdale, Jennifer

2016-01-01

The developmental status and social-emotional functioning of young children who are homeless has received inadequate attention in spite of high rates of homelessness among families with young children and the potentially negative impact of homelessness and associated stressors on children's well-being. The aim of this study was to gain…

Predictors of Satisfaction with First Intercourse: A New Perspective for Sexuality Education.

ERIC Educational Resources Information Center

Thomsen, Debora L.; Chang, I. Joyce

This study sought to identify predictors of satisfaction with first sexual intercourse. A survey of 292 undergraduates at a large rural midwestern university revealed that the majority of respondents received inadequate sex education. Most of their school sex education covered reproduction and disease prevention, to the exclusion of human sexual…

Ticking Time Bomb: U. of South Florida Responds to a Threat of Terrorism.

ERIC Educational Resources Information Center

Fender, Rickard C.

1996-01-01

The University of South Florida's emergency plans were found inadequate when its campus newspaper received a letter threatening extensive destruction. A group of 31 representatives of 20 areas of the institution created 11 subplans for an emergency preparedness center, personnel, events and activities, faculty/student relations, communications,…

Clinical Practice Guideline for Vitamin D

NASA Technical Reports Server (NTRS)

Tarver, William J.

2013-01-01

Vitamin D and its metabolites have clinical significance because they play a critical function in calcium homeostasis and bone metabolism. Although not all of the pathologic mechanisms have been adequately described, vitamin D insufficiency and deficiency, as measured by low levels of 25-OH vitamin D, are associated with a variety of clinical conditions including osteoporosis, falls and fractures in the elderly, decreased immune function, bone pain, and possibly colon cancer and cardiovascular health.2 Apart from inadequate dietary intake, patients may present with low levels of vitamin D if they receive inadequate sunlight. The astronaut population is potentially vulnerable to low levels of vitamin D for several reasons. Firstly, they may train for long periods in Star City, Russia, which by virtue of its northern latitude receives less sunlight in winter months. Secondly, astronauts are deprived of sunlight while aboard the International Space Station (ISS). In addition, ISS crew members are exposed to microgravity for prolonged durations and are likely to develop low bone mineral density despite the use of countermeasures. Therefore, closely monitoring and maintaining adequate vitamin D levels is important for the astronaut corps.

Preload assessment and optimization in critically ill patients.

PubMed

Voga, Gorazd

2010-01-01

Preload assessment and optimization is the basic hemodynamic intervention in critically ill. Beside clinical assessment, non-invasive or invasive assessment by measurement of various pressure or volume hemodynamic variables, are helpful for estimation of preload and fluid responsiveness. The use of dynamic variables is useful in particular subgroup of critically ill patients. In patients with inadequate preload, fluid responsiveness and inadequate flow, treatment with crystalloids or colloids is mandatory. When rapid hemodynamic response is necessary colloids are preferred.

Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial.

PubMed

Ludvik, Bernhard; Frías, Juan P; Tinahones, Francisco J; Wainstein, Julio; Jiang, Honghua; Robertson, Kenneth E; García-Pérez, Luis-Emilio; Woodward, D Bradley; Milicevic, Zvonko

2018-05-01

Glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose co-transporter-2 (SGLT2) inhibitors improve glycaemic control and reduce bodyweight in patients with type 2 diabetes through different mechanisms. We assessed the safety and efficacy of the addition of the once-weekly GLP-1 receptor agonist dulaglutide to the ongoing treatment regimen in patients whose diabetes is inadequately controlled with SGLT2 inhibitors, with or without metformin. AWARD-10 was a phase 3b, double-blind, parallel-arm, placebo-controlled, 24-week study done at 40 clinical sites in Austria, Czech Republic, Germany, Hungary, Israel, Mexico, Spain, and the USA. Eligible adult patients (≥18 years) with inadequately controlled type 2 diabetes (HbA 1c concentration ≥7·0% [53 mmol/mol] and ≤9·5% [80 mmol/mol]), a BMI of 45 kg/m 2 or less, and taking stable doses (>3 months) of an SGLT2 inhibitor (with or without metformin) were randomly assigned (1:1:1) via an interactive web-response system to subcutaneous injections of either dulaglutide 1·5 mg, dulaglutide 0·75 mg, or placebo once per week for 24 weeks. Patients and investigators were masked to dulaglutide and placebo assignment, and those assessing outcomes were masked to study drug assignment. The primary objective was to test for the superiority of dulaglutide (1·5 mg or 0·75 mg) versus placebo for change in HbA 1c concentration from baseline at 24 weeks. All analyses were done in the intention-to-treat population, defined as all randomly assigned patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT02597049. Between Dec 7, 2015, and Feb 3, 2017, 424 patients were randomly assigned to dulaglutide 1·5 mg (n=142), dulaglutide 0·75 mg (n=142), and placebo (n=140). One patient in the dulaglutide 0·75 mg group was excluded from the analysis because they did not receive any dose of the study drug. The reduction in HbA 1c concentration at 24 weeks was larger in patients receiving dulaglutide (least squares mean [LSM] for dulaglutide 1·5 mg -1·34% [SE 0·06] or -14·7 mmol/mol [0·6]; dulaglutide 0·75 mg -1·21% [0·06] or -13·2 mmol/mol [0·6]) than in patients receiving placebo (-0·54% [0·06] or -5·9 mmol/mol [0·6]; p<0·0001 for both groups vs placebo). The LSM differences were -0·79% (95% CI -0·97 to -0·61) or -8·6 mmol/mol (-10·6 to -6·7) for dulaglutide 1·5 mg and -0·66% (-0·84 to -0·49) or -7·2 mmol/mol (-9·2 to -5·4) for dulaglutide 0·75 mg (p<0·0001 for both). Serious adverse events were reported for five (4%) patients in the dulaglutide 1·5 mg group, three (2%) patients in the dulaglutide 0·75 mg group, and five (4%) patients in the placebo group. Treatment-emergent adverse events were more common in patients treated with dulaglutide than in patients who received placebo, mainly because of an increased incidence of gastrointestinal adverse events. Nausea (21 [15%] patients in the dulaglutide 1·5 mg group vs seven [5%] in the dulaglutide 0·75 mg group vs five [4%] in the placebo group), diarrhoea (eight [6%] vs 14 [10%] vs four [3%]), and vomiting (five [4%] vs four [3%] vs one [1%]) were more common with dulaglutide than with placebo. One episode of severe hypoglycaemia was reported in the dulaglutide 0·75 mg group. Two (1%) patients receiving dulaglutide 1·5 mg died, but these deaths were not considered to be related to study drug; no deaths occurred in the other groups. Dulaglutide as add-on treatment to SGLT2 inhibitors (with or without metformin) resulted in significant and clinically relevant improvements in glycaemic control, with acceptable tolerability that is consistent with the established safety profile of dulaglutide. Eli Lilly and Company. Copyright © 2018 Elsevier Ltd. All rights reserved.

[A prognostic model for assessment of outcome of root canal treatment in teeth with pulpitis or apical periodontitis].

PubMed

Zhang, M M; Zheng, Y D; Liang, Y H

2018-02-18

To present a prognostic model for evaluating the outcome of root canal treatment in teeth with pulpitis or apical periodontitis 2 years after treatment. The implementation of this study was based on a retrospective study on the 2-year outcome of root canal treatment. A cohort of 360 teeth, which received treatment and review, were chosen to build up the total sample size. In the study, 143 teeth with vital pulp and 217 teeth with apical periodontitis were included. About 67% of the samples were selected randomly to derive a training date set for modeling, and the others were used as validating date set for testing. Logistic regression models were used to produce the prognostic models. The dependent variable was defined as absence of periapical lesion or reduction of periapical lesion. The predictability of the models was evaluated by the area under the receiver-operating characteristic (ROC) curve (AUC). Four predictors were included in model one (absence of apical lesion): pre-operative periapical radiolucency, canal curvature, density and apical extent of root fillings. The AUC was 0.802 (95%CI: 0.744-0.859). And the AUC of the testing date was 0.688. Only the density and apical extent of root fillings were included to present model two (reduction of apical lesion). The AUC of training dates and testing dates were 0.734 (95%CI: 0.612-0.856) and 0.681, respectively. As predicted by model one, the probability of absence of periapical lesion 2 years after endodontic treatment was 90% in pulpitis teeth with sever root-canal curvature and adequate root canal fillings, but 51% in teeth with apical periodontitis. When using prognostic model two for prediction, in teeth with apical periodontitis, the probability of detecting lesion reduction with adequate or inadequate root fillings was 95% and 39% 2 years after treatment. The pre-operative periapical status, canal curvature and quality of root canal treatment could be used to predict the 2-year outcome of root canal treatment.

Diagnosis of latent tuberculosis and prevention of reactivation in rheumatic patients receiving biologic therapy: international recommendations.

PubMed

Iannone, Florenzo; Cantini, Fabrizio; Lapadula, Giovanni

2014-05-01

To review the official international recommendations on the management of latent tuberculosis infection (LTBI) in patients with rheumatic diseases undergoing biologic therapy. A systematic search of all clinical practice recommendations on the diagnosis and treatment of LTBI in rheumatic patients eligible for starting biologic drugs published between January 2002 and March 2013. For the diagnosis of LTBI, based on positivity of tuberculin skin test (TST), interferon-γ release assay (IGRA) is also available. Most recommendations advise using both TST and IGRA, especially in case of Bacillus Calmette-Guérin vaccination, to screen patients before commencing biologic drugs. There is a general consensus that evaluation of the global risk of TB infection is a crucial point and that patients with LTBI must receive chemoprophylaxis prior to biologic therapy. However, recommendations on the need for rescreening for activation of LTBI or new TB infection while patients are being treated are inadequate. Nevertheless, the main concern is poor compliance with TB recommendations of rheumatologists in clinical practice, which seems to be the main cause of the occurrence of active TB in rheumatic patients receiving biologic therapy. Notwithstanding some differences, mainly related to regional TB incidence, international recommendations strongly suggest careful screening for LTBI before starting biologic therapy. However, the critical point is implementing dissemination and awareness of the recommendations among rheumatologists to improve adherence in real life.

Long-term efficacy and safety of ertugliflozin monotherapy in patients with inadequately controlled T2DM despite diet and exercise: VERTIS MONO extension study.

PubMed

Aronson, Ronnie; Frias, Juan; Goldman, Allison; Darekar, Amanda; Lauring, Brett; Terra, Steven G

2018-06-01

This phase III, multicentre, randomized study (ClinicalTrials.gov; NCT01958671) evaluated the efficacy and safety of ertugliflozin monotherapy in adults with inadequately controlled type 2 diabetes (glycated haemoglobin [HbA1c], 7.0% to 10.5% [53-91 mmol/mol]) despite diet and exercise. The 52-week study comprised a 26-week, double-blind, placebo-controlled period (Phase A) during which 461 participants received placebo, ertugliflozin 5 mg/d or ertugliflozin 15 mg/d. This was followed by a 26-week active-controlled period (Phase B) during which participants in the placebo group who had not received glycaemic rescue therapy had blinded metformin added. Results to Week 52 are reported. Because of the use of metformin in Phase B, no statistical comparisons of efficacy were made between the ertugliflozin and placebo/metformin groups at Week 52. The mean (standard error) change from baseline to Week 52 in HbA1c was -0.9% (0.1) and -1.0% (0.1) in the ertugliflozin 5 and 15 mg groups, respectively. The proportions of participants with HbA1c <7.0% at Week 52 were 25.6% and 28.5%, respectively. Ertugliflozin reduced fasting plasma glucose, body weight and systolic blood pressure (SBP). The incidence of genital mycotic infections (GMIs) in females was significantly higher in both ertugliflozin groups (5 mg, 26.9%; 15 mg, 29.0%) vs the placebo/metformin group (9.9%), and in males was significantly higher in the 15 mg group (7.8%) vs the placebo/metformin group (1.2%). Ertugliflozin was not associated with increased incidence of urinary tract infections, symptomatic hypoglycaemia or hypovolaemia adverse events compared with placebo/metformin. Ertugliflozin treatment over 52 weeks improved glycaemic control and reduced body weight and SBP, but increased GMIs. © 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs

PubMed Central

Charles-Schoeman, Christina; Burmester, Gerd; Nash, Peter; Zerbini, Cristiano A F; Soma, Koshika; Kwok, Kenneth; Hendrikx, Thijs; Bananis, Eustratios; Fleischmann, Roy

2016-01-01

Objectives Biological disease-modifying antirheumatic drugs (bDMARDs) have shown diminished clinical response following an inadequate response (IR) to ≥1 previous bDMARD. Here, tofacitinib was compared with placebo in patients with an IR to conventional synthetic DMARDs (csDMARDs; bDMARD-naive) and in patients with an IR to bDMARDs (bDMARD-IR). Methods Data were taken from phase II and phase III studies of tofacitinib in patients with rheumatoid arthritis (RA). Patients received tofacitinib 5 or 10 mg twice daily, or placebo, as monotherapy or with background methotrexate or other csDMARDs. Efficacy endpoints and incidence rates of adverse events (AEs) of special interest were assessed. Results 2812 bDMARD-naive and 705 bDMARD-IR patients were analysed. Baseline demographics and disease characteristics were generally similar between treatment groups within subpopulations. Across subpopulations, improvements in efficacy parameters at month 3 were generally significantly greater for both tofacitinib doses versus placebo. Clinical response was numerically greater with bDMARD-naive versus bDMARD-IR patients (overlapping 95% CIs). Rates of safety events of special interest were generally similar between tofacitinib doses and subpopulations; however, patients receiving glucocorticoids had more serious AEs, discontinuations due to AEs, serious infection events and herpes zoster. Numerically greater clinical responses and incidence rates of AEs of special interest were generally reported for tofacitinib 10 mg twice daily versus tofacitinib 5 mg twice daily (overlapping 95% CIs). Conclusions Tofacitinib demonstrated efficacy in both bDMARD-naive and bDMARD-IR patients with RA. Clinical response to tofacitinib was generally numerically greater in bDMARD-naive than bDMARD-IR patients. The safety profile appeared similar between subpopulations. Trial registration numbers (NCT00413660, NCT0050446, NCT00603512, NCT00687193, NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385). PMID:26275429

Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs.

PubMed

Charles-Schoeman, Christina; Burmester, Gerd; Nash, Peter; Zerbini, Cristiano A F; Soma, Koshika; Kwok, Kenneth; Hendrikx, Thijs; Bananis, Eustratios; Fleischmann, Roy

2016-07-01

Biological disease-modifying antirheumatic drugs (bDMARDs) have shown diminished clinical response following an inadequate response (IR) to ≥1 previous bDMARD. Here, tofacitinib was compared with placebo in patients with an IR to conventional synthetic DMARDs (csDMARDs; bDMARD-naive) and in patients with an IR to bDMARDs (bDMARD-IR). Data were taken from phase II and phase III studies of tofacitinib in patients with rheumatoid arthritis (RA). Patients received tofacitinib 5 or 10 mg twice daily, or placebo, as monotherapy or with background methotrexate or other csDMARDs. Efficacy endpoints and incidence rates of adverse events (AEs) of special interest were assessed. 2812 bDMARD-naive and 705 bDMARD-IR patients were analysed. Baseline demographics and disease characteristics were generally similar between treatment groups within subpopulations. Across subpopulations, improvements in efficacy parameters at month 3 were generally significantly greater for both tofacitinib doses versus placebo. Clinical response was numerically greater with bDMARD-naive versus bDMARD-IR patients (overlapping 95% CIs). Rates of safety events of special interest were generally similar between tofacitinib doses and subpopulations; however, patients receiving glucocorticoids had more serious AEs, discontinuations due to AEs, serious infection events and herpes zoster. Numerically greater clinical responses and incidence rates of AEs of special interest were generally reported for tofacitinib 10 mg twice daily versus tofacitinib 5 mg twice daily (overlapping 95% CIs). Tofacitinib demonstrated efficacy in both bDMARD-naive and bDMARD-IR patients with RA. Clinical response to tofacitinib was generally numerically greater in bDMARD-naive than bDMARD-IR patients. The safety profile appeared similar between subpopulations. (NCT00413660, NCT00550446, NCT00603512, NCT00687193, NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385). 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/

Impact of Inadequate Empirical Therapy on the Mortality of Patients with Bloodstream Infections: a Propensity Score-Based Analysis

PubMed Central

Retamar, Pilar; Portillo, María M.; López-Prieto, María Dolores; Rodríguez-López, Fernando; de Cueto, Marina; García, María V.; Gómez, María J.; del Arco, Alfonso; Muñoz, Angel; Sánchez-Porto, Antonio; Torres-Tortosa, Manuel; Martín-Aspas, Andrés; Arroyo, Ascensión; García-Figueras, Carolina; Acosta, Federico; Corzo, Juan E.; León-Ruiz, Laura; Escobar-Lara, Trinidad

2012-01-01

The impact of the adequacy of empirical therapy on outcome for patients with bloodstream infections (BSI) is key for determining whether adequate empirical coverage should be prioritized over other, more conservative approaches. Recent systematic reviews outlined the need for new studies in the field, using improved methodologies. We assessed the impact of inadequate empirical treatment on the mortality of patients with BSI in the present-day context, incorporating recent methodological recommendations. A prospective multicenter cohort including all BSI episodes in adult patients was performed in 15 hospitals in Andalucía, Spain, over a 2-month period in 2006 to 2007. The main outcome variables were 14- and 30-day mortality. Adjusted analyses were performed by multivariate analysis and propensity score-based matching. Eight hundred one episodes were included. Inadequate empirical therapy was administered in 199 (24.8%) episodes; mortality at days 14 and 30 was 18.55% and 22.6%, respectively. After controlling for age, Charlson index, Pitt score, neutropenia, source, etiology, and presentation with severe sepsis or shock, inadequate empirical treatment was associated with increased mortality at days 14 and 30 (odds ratios [ORs], 2.12 and 1.56; 95% confidence intervals [95% CI], 1.34 to 3.34 and 1.01 to 2.40, respectively). The adjusted ORs after a propensity score-based matched analysis were 3.03 and 1.70 (95% CI, 1.60 to 5.74 and 0.98 to 2.98, respectively). In conclusion, inadequate empirical therapy is independently associated with increased mortality in patients with BSI. Programs to improve the quality of empirical therapy in patients with suspicion of BSI and optimization of definitive therapy should be implemented. PMID:22005999

Evaluation of buprenorphine dosage adequacy in opioid receptor agonist substitution therapy for heroin dependence: first use of the BUprenorphine-naloxone Dosage Adequacy eVAluation (BUDAVA) questionnaire.

PubMed

D'Amore, Antonio; Romano, Filomena; Biancolillo, Vincenzo; Lauro, Guglielmo; Armenante, Ciro; Pizzirusso, Anna; Del Tufo, Salvatore; Ruoppolo, Ciro; Auriemma, Francesco; Cassese, Francesco; Oliva, Patrizia; Amato, Patrizia

2012-07-01

The dosing of opioid receptor agonist medications adequately and on an individual basis is crucial in the pharmacotherapy of opioid dependence. Clinical tools that are able to measure dose appropriateness are sorely needed. The recently developed and validated Opiate Dosage Adequacy Scale (ODAS) comprehensively evaluates the main outcomes relevant for methadone dose optimization, namely relapse, cross-tolerance, objective and subjective withdrawal symptoms, craving and overdose. Based on the ODAS, we developed a new assessment tool (BUprenorphine-naloxone Dosage Adequacy eVAluation [BUDAVA]) for evaluating dosage adequacy in patients in treatment with buprenorphine-naloxone. The main goal of this observational study was to explore whether the BUDAVA questionnaire could be used to assess buprenorphine-based, long-term substitution therapy for heroin addiction. The study included heroin-dependent patients who had been in treatment with buprenorphine-naloxone for at least 3 months. Patients (n = 196) were recruited from 11 drug abuse treatment centres in Italy. Dosage adequacy was assessed with the BUDAVA questionnaire. Patients classified as inadequately treated had their dosage modified. After 1 week, they were again administered the questionnaire to assess the adequacy of the new dosage. The buprenorphine-naloxone dosage was found to be inadequate in 61 of the 196 patients. In 13 patients, the treatment scored as inadequate only in the subjective withdrawal symptoms item of the questionnaire and therefore no dosage adjustment was made in the 2 weeks that have characterized this work. The remaining 48 inadequately treated patients had their dosage modified (42 dose increases and six dose decreases). After 1 week on the modified dosage, in 24 of these patients the new regimen was found by the assessment with the questionnaire to be adequate. These preliminary results suggest that the BUDAVA questionnaire may be useful for guiding buprenorphine-naloxone maintenance dose adjustments in heroin-dependent patients.

Brief Report: Secukinumab Provides Significant and Sustained Inhibition of Joint Structural Damage in a Phase III Study of Active Psoriatic Arthritis

PubMed Central

Landewé, Robert B.; Mease, Philip J.; McInnes, Iain B.; Conaghan, Philip G.; Pricop, Luminita; Ligozio, Greg; Richards, Hanno B.; Mpofu, Shephard

2016-01-01

Objective To assess whether secukinumab treatment in patients with active psoriatic arthritis (PsA) is associated with sustained inhibition of radiographic progression. Methods In this phase III, double‐blind, placebo‐controlled study, 606 patients with PsA were randomized to receive intravenous (IV) secukinumab at a dose of 10 mg/kg (weeks 0, 2, 4) followed by subcutaneous secukinumab at a dose of 150 mg or 75 mg (the IV→150 mg and IV→75 mg groups, respectively) or placebo. Patients were stratified according to prior anti–tumor necrosis factor (anti‐TNF) exposure (71% were anti‐TNF naive). At week 16, placebo‐treated patients who had at least a 20% reduction in the tender and swollen joint counts (responders) continued to receive placebo until week 24; nonresponders were re‐randomized to receive secukinumab at a dose of 150 mg or 75 mg. The modified total Sharp/van der Heijde score (SHS) was determined at baseline, week 16 or 24, and week 52. Results In the overall population, radiographic progression was inhibited through 52 weeks; efficacy was demonstrated for both erosion and joint space narrowing scores and in patients who switched from placebo to secukinumab at week 24. Subgroup analyses showed that secukinumab reduced radiographic progression at week 24, regardless of previous anti‐TNF treatment. Among anti‐TNF–naive patients, the mean changes from baseline to week 24 in the modified total SHS were 0.05 in the pooled secukinumab group and 0.57 in the placebo group; among patients with an inadequate response or intolerance to anti‐TNF treatment, the mean changes were 0.16 and 0.58, respectively. Anti‐TNF–naive patients showed negligible progression through week 52. Inhibition of structural damage was observed through week 52 irrespective of concomitant methotrexate use. A high proportion of patients receiving secukinumab showed no progression (change in SHS of ≤ 0.5) from baseline to week 24 (82.3% of the IV→150 mg group and 92.3% of the IV→75 mg group) and from week 24 to week 52 (85.7% of the IV→150 mg group and 85.8% of the IV→75 mg group). Conclusion Secukinumab inhibited radiographic progression over 52 weeks of treatment in patients with active PsA. PMID:27014997

Perioperative intravenous fluid prescribing: a multi-centre audit.

PubMed

Harris, Benjamin; Schopflin, Christian; Khaghani, Clare; Edwards, Mark

2015-01-01

Excessive or inadequate intravenous fluid given in the perioperative period can affect outcomes. A number of guidelines exist but these can conflict with the entrenched practice, evidence base and prescriber knowledge. We conducted a multi-centre audit of intraoperative and postoperative intravenous fluid therapy to investigate fluid administration practice and frequency of postoperative electrolyte disturbances. A retrospective audit was done in five hospitals of adult patients undergoing elective major abdominal, gastrointestinal tract or orthopaedic surgery. The type, volume and quantity of fluid and electrolytes administered during surgery and in 3 days postoperatively was calculated, and electrolyte disturbances were studied using clinical records. Data from four hundred thirty-one patients in five hospitals covering 1157 intravenous fluid days were collected. Balanced crystalloid solutions were almost universally used in the operating theatre and were also the most common fluid administered postoperatively, followed by hypotonic dextrose-saline solutions and 0.9 % sodium chloride. For three common uncomplicated elective operations, the volume of fluid administered intraoperatively demonstrated considerable variability. Over half of the patients received no postoperative fluid on day 1, and even more were commenced on free oral fluids immediately postoperatively or on day 1. Postoperative quantities of sodium exceeded the recommended amounts for maintenance in half of the patients who continued to receive intravenous fluids. Potassium administration in those receiving intravenous fluids was almost universally inadequate. Hypokalaemia and hyponatraemia were the common findings. We documented the current clinical practice and confirmed that early free oral fluids and cessation of any intravenous fluids is common postoperatively in keeping with the aims of enhanced recovery after surgery programmes. Excessive sodium and water and inadequate potassium in those given intravenous fluids postoperatively is common and needs to be investigated. The variation in intraoperative fluid volume administration for three common procedures is considerable and in keeping with other international studies. Future trials of fluid therapy should include the intraoperative and postoperative phases.

Cost and mortality prediction using polymerase chain reaction pathogen detection in sepsis: evidence from three observational trials

PubMed Central

2010-01-01

Introduction Delays in adequate antimicrobial treatment contribute to high cost and mortality in sepsis. Polymerase chain reaction (PCR) assays are used alongside conventional cultures to accelerate the identification of microorganisms. We analyze the impact on medical outcomes and healthcare costs if improved adequacy of antimicrobial therapy is achieved by providing immediate coverage after positive PCR reports. Methods A mathematical prediction model describes the impact of PCR-based rapid adjustment of antimicrobial treatment. The model is applied to predict cost and medical outcomes for 221 sepsis episodes of 189 post-surgical and intensive care unit (ICU) sepsis patients with available PCR data from a prospective, observational trial of a multiplex PCR assay in five hospitals. While this trial demonstrated reduction of inadequate treatment days, data on outcomes associated with reduced inadequate initial antimicrobial treatment had to be obtained from two other, bigger, studies which involved 1,147 (thereof 316 inadequately treated) medical or surgical ICU patients. Our results are reported with the (5% to 95%) percentile ranges from Monte Carlo simulation in which the input parameters were randomly and independently varied according to their statistical characterization in the three underlying studies. The model allows predictions also for different patient groups or PCR assays. Results A total of 13.1% of PCR tests enabled earlier adequate treatment. We predict that cost for PCR testing (300 €/test) can be fully recovered for patients above 717 € (605 € to 1,710 €) daily treatment cost. A 2.6% (2.0 to 3.2%) absolute reduction of mortality is expected. Cost per incremental survivor calculates to 11,477 € (9,321 € to 14,977 €) and incremental cost-effectiveness ratio to 3,107 € (2,523 € to 4,055 €) per quality-adjusted life-year. Generally, for ICU patients with >25% incidence of inadequate empiric antimicrobial treatment, and at least 15% with a positive blood culture, PCR represents a cost-neutral adjunct method. Conclusions Rapid PCR identification of microorganisms has the potential to become a cost-effective component for managing sepsis. The prediction model tested with data from three observational trials should be utilized as a framework to deepen insights when integrating more complementary data associated with utilization of molecular assays in the management of sepsis. PMID:20950442

Comparative efficacy and safety of tocilizumab, rituximab, abatacept and tofacitinib in patients with active rheumatoid arthritis that inadequately responds to tumor necrosis factor inhibitors: a Bayesian network meta-analysis of randomized controlled trials.

PubMed

Lee, Young Ho; Bae, Sang-Cheol

2016-11-01

This study aimed to assess the relative efficacy and safety of biologics and tofacitinib in patients with rheumatoid arthritis (RA) showing an inadequate response to tumor necrosis factor (TNF) inhibitors. We performed a Bayesian network meta-analysis to combine the direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of tocilizumab, rituximab, abatacept and tofacitinib in patients with RA that inadequately responds to TNF inhibitors. Four RCTs including 1796 patients met the inclusion criteria. The tocilizumab 8 mg group showed a significantly higher American College of Rheumatology 20% (ACR20) response rate than the abatacept and tofacitinib groups. Ranking probability based on surface under the cumulative ranking curve (SUCRA) indicated that tocilizumab 8 mg had the highest probability of being the best treatment for achieving the ACR20 response rate (SUCRA = 0.9863), followed by rituximab (SUCRA = 0.6623), abatacept (SUCRA = 0.5428), tocilizumab 4 mg (SUCRA = 0.4956), tofacitinib 10 mg (SUCRA = 0.4715), tofacitinib 5 mg (SUCRA = 0.3415) and placebo (SUCRA = 0). In contrast, the safety based on the number of withdrawals due to adverse events did not differ significantly among the treatment options. Tocilizumab 8 mg was the second-line non-TNF biologic with the highest performance regarding an early good response based on ACR20 response rate and acceptable safety profile, followed by rituximab, abatacept and tofacitinib in patients with RA and an inadequate response to anti-TNF therapy, and none of these treatments were associated with a significant risk of withdrawal due to adverse events. © 2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

A Cost-Utility Analysis of Lisdexamfetamine Versus Atomoxetine in the Treatment of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder and Inadequate Response to Methylphenidate.

PubMed

Zimovetz, Evelina A; Beard, Stephen M; Hodgkins, Paul; Bischof, Matthias; Mauskopf, Josephine A; Setyawan, Juliana

2016-10-01

An economic analysis from the perspective of the UK National Health Service (NHS) evaluated the cost effectiveness of lisdexamfetamine dimesylate (LDX) compared with atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder who have had an inadequate response to methylphenidate. A 1-year decision-analytic model was constructed, with the health outcomes "response", "nonresponse", and "unable to tolerate". Clinical data were taken from a head-to-head, randomized controlled trial in inadequate responders to methylphenidate. Response to treatment was defined as a score of 1 (very much improved) or 2 (much improved) on the Clinical Global Impression-Improvement subscale. Tolerability was assessed by discontinuation rates owing to adverse events. Utility weights were identified via a systematic literature review. Healthcare resource use estimates were obtained via a survey of clinicians. Daily drug costs were derived from British National Formulary 2012 costs and mean doses reported in the trial. One-way and probabilistic sensitivity analyses (PSAs) were performed. The comparison of LDX with atomoxetine resulted in an estimate of an incremental cost-effectiveness ratio of £1802 per quality-adjusted life-year (QALY). The result was robust in a wide range of sensitivity analyses; results were most sensitive to changes in drug costs and efficacy. In the PSA, assuming a maximum willingness to pay of £20,000 per QALY, LDX versus atomoxetine had an 86 % probability of being cost effective. In 38 % of PSA runs, LDX was more effective and less costly than atomoxetine. From the perspective of the UK NHS, LDX provides a cost-effective treatment option for children and adolescents who are inadequate responders to methylphenidate.

Secondary prevention after acute myocardial infarction: drug adherence, treatment goals, and predictors of health lifestyle habits. The BLITZ-4 Registry.

PubMed

Urbinati, Stefano; Olivari, Zoran; Gonzini, Lucio; Savonitto, Stefano; Farina, Rosario; Del Pinto, Maurizio; Valbusa, Alberto; Fantini, Giuseppe; Mazzoni, Alessandra; Maggioni, Aldo P

2015-12-01

To describe drug adherence and treatment goals, and to identify the independent predictors of smoking persistence and unsatisfactory lifestyle habits six months after an acute myocardial infarction (AMI). 11,706 patients with AMI (30% female, mean age 68 years) were enrolled in 163 large-volume coronary care units (CCUs). At six months, drug adherence was ≥90%, while blood pressure (BP) <140/90 mmHg, low density lipoprotein (LDL) <100 mg/dl (in patients on statins), HbA1c <7% (in treated diabetics), and smoking persistence were observed in 74%, 76%, 45%, and 27% of patients, respectively. Inadequate fish intake decreased from 73% to 55%, inadequate intake of fruit and vegetables from 32% to 23%, and insufficient exercise in eligible patients from 74% to 59% (p < 0.0001). At multivariable analysis, a post-discharge cardiac visit and referral to cardiac rehabilitation at follow-up were independently associated with a lower risk of insufficient physical exercise (odds ratio (OR) 0.71 and 0.70, respectively) and persistent smoking (OR 0.68 and 0.60), whereas only referral to cardiac rehabilitation was associated with a lower risk of inadequate fish and fruit/vegetable intake (OR 0.70 and 0.65). Six months after an AMI, despite a high adherence to drug treatments, BP, LDL, and diabetic goals are inadequately achieved. Subjects with healthy lifestyles improved after discharge, but the rate of those with regular exercise habits and adequate fish intake could be further improved. Access to post-discharge cardiac visit and referral to cardiac rehabilitation were associated with better adherence to healthy lifestyles. Knowledge of the variables associated with specific lifestyle changes may help in tailoring secondary prevention programmes. © The European Society of Cardiology 2014.

Tofacitinib in Rheumatoid Arthritis: Lack of Early Change in Disease Activity Predicts a Low Probability of Achieving Low Disease Activity at Month 6.

PubMed

Van Vollenhoven, Ronald F; Lee, Eun Bong; Fallon, Lara; Zwillich, Samuel H; Wilkinson, Bethanie; Chapman, Douglass; Demasi, Ryan; Keystone, Edward

2018-04-26

Optimal targeted treatment in rheumatoid arthritis requires early identification of failure to respond. This post-hoc analysis explored the relationship between early disease activity changes and achievement of low disease activity (LDA) and remission targets with tofacitinib. Data were from two randomized, double-blind, Phase 3 studies. In ORAL Start (NCT01039688), methotrexate (MTX)-naïve patients received tofacitinib 5 or 10 mg BID, or MTX, for 24 months. In placebo-controlled ORAL Standard (NCT00853385), MTX-inadequate responder (MTX-IR) patients received tofacitinib 5 or 10 mg BID or adalimumab 40 mg Q2W, with MTX, for 12 months. Probabilities of achieving LDA (CDAI ≤10; DAS28-4[ESR] ≤3.2) at months 6 and 12 were calculated, given failure to achieve threshold improvement from baseline (change in CDAI ≥6; DAS28-4[ESR] ≥1.2) at month 1 or 3. In ORAL Start, 7.2% and 5.4% of patients receiving tofacitinib 5 and 10 mg BID, respectively, failed to improve CDAI ≥6 at month 3; of those who failed, 3.8% and 28.6%, respectively, achieved month 6 CDAI-defined LDA. In ORAL Standard, 18.8% and 17.5% of patients receiving tofacitinib 5 and 10 mg BID, respectively, failed to improve CDAI ≥6 at month 3; of those who failed, 0% and 2.9%, respectively, achieved month 6 CDAI-defined LDA. Findings were similar when considering month 1 improvements or DAS28-4(ESR) thresholds. In MTX-IR patients, lack of response to tofacitinib after 1 or 3 months predicted low probability of achieving LDA at month 6. Lack of early response may be considered when deciding whether to continue treatment with tofacitinib. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

The experience of adverse childhood experiences and dental care in childhood.

PubMed

Crouch, Elizabeth; Radcliff, Elizabeth; Nelson, Joni; Strompolis, Melissa; Martin, Amy

2018-06-06

Routine preventive dental care is important to overall child health and well-being. However, the experience of adversity in childhood may prevent children from getting adequate preventive care. This study seeks to explore how the prevalence of adverse childhood experiences (ACEs) and the role of a protective adult may be associated with dental care utilization in childhood. Data from the 2016 South Carolina Behavioral Risk Factor Surveillance System (SC BRFSS), which interviews adults eighteen year of age and older, were used in this study. Dental care utilization in childhood was measured as the adult retrospectively reported frequency of dental care in childhood: at least once every 2 years (adequate dental care) or less often than every 2 years (inadequate dental care). ACEs were determined by asking about each of respondent's childhood exposure to eleven childhood experiences, including divorce, parental incarceration, domestic violence, drug and alcohol abuse, mental illness and emotional, physical or sexual abuse. The presence of a protective adult in childhood included respondents who had an adult who made them feel safe and protected during childhood. Descriptive and bivariate statistics explored differences in the adequacy of child dental care by ACE exposure, the presence of a protective adult and selected demographic characteristics. Multivariate regression models were used to examine the impact of counts and types of ACEs and the presence of a protective adult with inadequate childhood dental care. The unweighted study sample included 7079 respondents ageing from 18 to 79 years of age Sampling weights were used for all analyses. Among all respondents, 71.7% reported receiving adequate dental care during childhood; 28.3% responded that they received inadequate dental care. Adjusting for sociodemographic characteristics, respondents who experienced four or more ACEs had a higher likelihood of inadequate dental care than respondents who reported no ACEs (aOR 2.79; 95% CI 2.77-2.82). The odds of reporting inadequate dental care were lower among those grew up with an adult who made them feel safe and protected (aOR 0.38; 95% CI 0.37-0.39). The presence of protective factors may mitigate the effects of ACEs on paediatric dental care. This research contributes to the literature through the further identification of the role of dentists in identifying signs of abuse and neglect. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Antibiotic treatment and mortality in patients with Listeria monocytogenes meningitis or bacteraemia.

PubMed

Thønnings, S; Knudsen, J D; Schønheyder, H C; Søgaard, M; Arpi, M; Gradel, K O; Østergaard, C

2016-08-01

Invasive Listeria monocytogenes infections carry a high mortality despite antibiotic treatment. The rareness of the infection makes it difficult to improve antibiotic treatment through randomized clinical trials. This observational study investigated clinical features and outcome of invasive L. monocytogenes infections including the efficacy of empiric and definitive antibiotic therapies. Demographic, clinical and biochemical findings, antibiotic treatment and 30-day mortality for all episodes of L. monocytogenes bacteraemia and/or meningitis were collected by retrospective medical record review in the North Denmark Region and the Capital Region of Denmark (17 hospitals) from 1997 to 2012. Risk factors for 30-day all-cause mortality were assessed by logistic regression. The study comprised 229 patients (median age: 71 years), 172 patients had bacteraemia, 24 patients had meningitis and 33 patients had both. Significant risk factors for 30-day mortality were septic shock (OR 3.0, 95% CI 1.4-6.4), altered mental state (OR 3.6, 95% CI 1.7-7.6) and inadequate empiric antibiotic therapy (OR 3.8, 95% CI 1.8-8.1). Cephalosporins accounted for 90% of inadequately treated cases. Adequate definitive antibiotic treatment was administered to 195 patients who survived the early period (benzylpenicillin 72, aminopenicillin 84, meropenem 28, sulfamethoxazole/trimethoprim 6, and piperacillin/tazobactam 5). Definitive antibiotic treatment with benzylpenicillin or aminopenicillin resulted in a lower 30-day mortality in an adjusted analysis compared with meropenem (OR 0.3; 95% CI 0.1-0.8). In conclusion, inadequate empiric antibiotic therapy and definitive therapy with meropenem were both associated with significantly higher 30-day mortality. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Pitfalls in communication that lead to nonbeneficial emergency surgery in elderly patients with serious illness: description of the problem and elements of a solution.

PubMed

Cooper, Zara; Courtwright, Andrew; Karlage, Ami; Gawande, Atul; Block, Susan

2014-12-01

To provide a description of communication breakdowns and to identify interventions to improve surgical decision making for elderly patients with serious illness and acute, life-threatening surgical conditions. Communication between surgeons, patients, and surrogates about goals of treatment plays an important and understudied role in determining the surgical interventions elderly patients with serious illness receive. Communication breakdowns may lead to nonbeneficial procedures in acute events near the end of life. We review the available literature on factors that lead to communication challenges and nonbeneficial surgery at the end of life. We use this review to identify solutions for navigating surgical decision making for seriously ill elderly patients with acute surgical conditions. Surgeon, patient, surrogate, and systemic factors-including time constraints, inadequate provider communication skills and training, uncertainty about prognosis, patient and surrogate anxiety and fear of inaction, and limitations in advance care planning-contribute to communication challenges and nonbeneficial surgery at the end of life. Surgeons could accomplish more effective communication with seriously ill elderly patients if they had a structured, standardized approach to exploring patients' preferences and to integrating those preferences into surgical decisions in the acute setting. Improved communication among surgeons, patients, and surrogates is necessary to ensure that patients receive the care that they want and to avoid nonbeneficial treatment. Further research is needed to learn how to best structure these conversations in the emergency surgical setting.

Efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus: a 24-week multicentre, randomized, double-blind, placebo-controlled phase III trial.

PubMed

Hong, S; Park, C-Y; Han, K A; Chung, C H; Ku, B J; Jang, H C; Ahn, C W; Lee, M-K; Moon, M K; Son, H S; Lee, C B; Cho, Y-W; Park, S-W

2016-05-01

We assessed the 24-week efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus (T2DM) that was inadequately controlled with diet and exercise. The present study was designed as a multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study. Patients (n = 142) were randomized 2 : 1 into two different treatment groups as follows: 99 received teneligliptin (20 mg) and 43 received placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. Teneligliptin significantly reduced the HbA1c level from baseline compared with placebo after 24 weeks. At week 24, the differences between changes in HbA1c and fasting plasma glucose (FBG) in the teneligliptin and placebo groups were -0.94% [least-squares (LS) mean -1.22, -0.65] and -1.21 mmol/l (-1.72, -0.70), respectively (all p < 0.001). The incidence of hypoglycaemia and adverse events were not significantly different between the two groups. This phase III, randomized, placebo-controlled study provides evidence of the safety and efficacy of 24 weeks of treatment with teneligliptin as a monotherapy in Korean patients with T2DM. © 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Medical tests: women's reported and preferred decision‐making roles and preferences for information on benefits, side‐effects and false results

PubMed Central

Davey, Heather M.; Barratt, Alexandra L.; Davey, Elizabeth; Butow, Phyllis N.; Redman, Sally; Houssami, Nehmat; Salkeld, Glenn P.

2002-01-01

Abstract Objective  To determine women's preferences for and reported experience with medical test decision‐making. Design  Computer‐assisted telephone survey. Setting and participants  Six hundred and fifty‐two women resident in households randomly selected from the New South Wales electronic white pages. Main outcome measures  Reported and preferred test and treatment (for comparison) decision‐making, satisfaction with and anxiety about information on false results and side‐effects; and effect of anxiety on desire for such information. Results  Overall most women preferred to share test (94.6%) and treatment (91.2%) decision‐making equally with their doctor, or to take a more active role, with only 5.4–8.9% reporting they wanted the doctor to make these decisions on their behalf. This pattern was consistent across all age groups. In general, women reported experiencing a decision‐making role that was consistent with their preference. Women who had a usual doctor were more likely to report experiencing an active role in decision‐making. More women reported receiving as much information as they wanted about the benefits of tests and treatment than about the side‐effects of tests and treatment. Most women wanted information about the possibility of false test results (91.5%) and test side‐effects (95.6%), but many reported the doctor never provided this information (false results = 40.0% and side‐effects = 31.3%). A substantial proportion said this information would make them anxious (false results = 56.6% and side‐effects = 43.1%), but reported they wanted the information anyway (false results = 77.6% and side‐effects = 88.1%). Conclusions  Women prefer an active role in test and treatment decision‐making. Many women reported receiving inadequate information. If so, this may jeopardize informed decision‐making. PMID:12460222

Long-term outcome for Down syndrome patients with hematopoietic disorders.

PubMed

Li, Meng-Ju; Lee, Ni-Chung; Yang, Yung-Li; Yen, Hsiu-Ju; Chang, Hsiu-Hao; Chien, Yin-Hsiu; Lu, Meng-Yao; Jou, Shiann-Tarng; Lin, Kai-Hsin; Hwu, Wuh-Liang; Lin, Dong-Tsamn

2016-02-01

Although Down syndrome (DS) patients have a higher risk of developing transient myeloproliferative disorder (TMD) and acute leukemia, very little data is available on long-term outcome in Taiwanese patients. The current study was designed to determine the clinical characteristics and treatment outcome of DS patients with TMD or acute leukemia (AL). In 25 consecutive DS patients with TMD or AL enrolled from 1990 to 2012, clinical manifestations and treatment protocols were investigated and GATA1 (GATA binding protein 1) mutations were identified. Among 16 DS-acute myeloid leukemia (DS-AML) patients, clinical outcomes were compared between survivors and nonsurvivors. Most of our DS patients had TMD (32%), acute megakaryoblastic leukemia (24%), or acute erythromegakaryoblastic leukemia (16%). The median follow-up time was 22.5 months (1-230 months). The age was younger and the hemoglobin (Hb) level and platelet count were higher in TMD patients than in leukemia patients. Among DS-AML patients, the Hb level was higher in survivors than nonsurvivors (8.8 ± 2.7 g/dL vs. 5.8 ± 2.4 g/dL; p = 0.044) and the age was older in relapsed patients than in nonrelapsed patients (43.8 ± 18 months old vs. 21.6 ± 8.6 months old; p = 0.025). The 3-year overall survival (OS) rate was 44%, higher in patients receiving appropriate chemotherapy than in those receiving inadequate treatment (63.6% vs. 0%, p = 0.001), and higher in those diagnosed with TMD or AL after 2008 than before 2008 (33.3% vs. 75%; p = 0.119). Outcome in DS-AML patients is optimal if appropriate treatment is provided. With modification of the treatment strategy in 2008, OS increased in Taiwan. Copyright © 2015. Published by Elsevier B.V.

Impulsive Personality Traits and Alcohol Use: Does Sleeping Help with Thinking?

PubMed Central

Miller, Mary Beth; DiBello, Angelo M.; Lust, Sarah A.; Meisel, Matthew K.; Carey, Kate B.

2016-01-01

Objective Both impulsivity and sleep disturbance have been associated with heavy alcohol use among young adults; yet studies to date have not examined their interactive effects. The current study aimed to determine if adequate sleep moderates the association between impulsive personality traits and alcohol use among young adults. Method College students (N = 568) who had been mandated to alcohol treatment following violation of campus alcohol policy provided information regarding alcohol use and related consequences, impulsive personality traits (measured using the UPPS Impulsive Behavior Scale), and perception of sleep adequacy as part of a larger intervention trial. Results Higher urgency, lower premeditation, and higher sensation-seeking predicted greater levels of alcohol consumption, while higher urgency predicted more alcohol-related consequences. As hypothesized, there was a significant interaction between premeditation and sleep adequacy in the prediction of drinks per week; in contrast to hypotheses, however, premeditation was associated with drinking only among those reporting adequate (rather than inadequate) sleep. Specifically, the tendency to premeditate was associated with less drinking among those who reported adequate sleep and was not associated with drinking among those reporting inadequate sleep. Conclusion Sensation-seeking and urgency are associated with greater alcohol involvement among young adults, regardless of sleep adequacy. Conversely, the ability to plan ahead and anticipate the consequences of one’s behaviors (premeditation) is only protective against heavy drinking among individuals receiving adequate sleep. With replication, these findings may inform alcohol prevention and intervention efforts. PMID:28094998

Impulsive personality traits and alcohol use: Does sleeping help with thinking?

PubMed

Miller, Mary Beth; DiBello, Angelo M; Lust, Sarah A; Meisel, Matthew K; Carey, Kate B

2017-02-01

Both impulsivity and sleep disturbance have been associated with heavy alcohol use among young adults; yet studies to date have not examined their interactive effects. The current study aimed to determine if adequate sleep moderates the association between impulsive personality traits and alcohol use among young adults. College students (N = 568) who had been mandated to alcohol treatment following violation of campus alcohol policy provided information regarding alcohol use and related consequences, impulsive personality traits (measured using the UPPS Impulsive Behavior Scale), and perception of sleep adequacy as part of a larger intervention trial. Higher urgency, lower premeditation, and higher sensation-seeking predicted greater levels of alcohol consumption, while higher urgency predicted more alcohol-related consequences. As hypothesized, there was a significant interaction between premeditation and sleep adequacy in the prediction of drinks per week; in contrast to hypotheses, however, premeditation was associated with drinking only among those reporting adequate (rather than inadequate) sleep. Specifically, the tendency to premeditate was associated with less drinking among those who reported adequate sleep and was not associated with drinking among those reporting inadequate sleep. Sensation-seeking and urgency are associated with greater alcohol involvement among young adults, regardless of sleep adequacy. Conversely, the ability to plan ahead and anticipate the consequences of one's behaviors (premeditation) is only protective against heavy drinking among individuals receiving adequate sleep. With replication, these findings may inform alcohol prevention and intervention efforts. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Assessment of technical equipment supply in healthcare institutions: example of Almaty.

PubMed

Kurakbayev, Kuralbai K; Issayev, Daniyar S; Koshimbekov, Murat K; Kumar, Ainur B

2014-09-01

The share of healthcare-related expenditure in the Gross Domestic Product of Kazakhstan is relatively small, and it is strategically important to restructure budgetary expenses in favor of healthcare with simultaneous redistribution of resources in accordance with changing demands and prioritization of high-quality medical care. The aim of this study was to analyze resource provision to healthcare organizations in Kazakhstan and its structure and level assessment. The study is based on a comparative assessment of technical and technological equipment of medical institutions in Almaty, Kazakhstan. We analyzed the scope and structure of the financial component of the resource base in Almaty. We carried out information processing and analysis methods, content analysis, mathematical treatment, as well as conducted case studies. Also, we held opinion poll among medical staff (specialists, managerial staff) (n = 300) P for trend < 0.001 and patients (n = 210) P for trend < 0.001. About 18.8% of patients do not receive medical care because of defects of the equipment, whereas 19.9% of patients claim that the reason of refusal of the provision of medical services is an equipment overload. Most of the respondents referred to on poor technical equipment, mismatch with the world standards of performance and competitiveness. Lack of advanced medical technology, inadequate financing, insufficient supply of domestic medical equipment, and inadequate procurement by tender were also noted. The obtained data point to the need for optimization and upgrading medical equipment at various levels of healthcare.

Assessment of technical equipment supply in healthcare institutions: example of Almaty

PubMed Central

Kurakbayev, Kuralbai K.; Issayev, Daniyar S.; Koshimbekov, Murat K.; Kumar, Ainur B.

2014-01-01

Background: The share of healthcare-related expenditure in the Gross Domestic Product of Kazakhstan is relatively small, and it is strategically important to restructure budgetary expenses in favor of healthcare with simultaneous redistribution of resources in accordance with changing demands and prioritization of high-quality medical care. The aim of this study was to analyze resource provision to healthcare organizations in Kazakhstan and its structure and level assessment. Materials and Methods: The study is based on a comparative assessment of technical and technological equipment of medical institutions in Almaty, Kazakhstan. We analyzed the scope and structure of the financial component of the resource base in Almaty. We carried out information processing and analysis methods, content analysis, mathematical treatment, as well as conducted case studies. Also, we held opinion poll among medical staff (specialists, managerial staff) (n = 300) P for trend < 0.001 and patients (n = 210) P for trend < 0.001. Results: About 18.8% of patients do not receive medical care because of defects of the equipment, whereas 19.9% of patients claim that the reason of refusal of the provision of medical services is an equipment overload. Conclusion: Most of the respondents referred to on poor technical equipment, mismatch with the world standards of performance and competitiveness. Lack of advanced medical technology, inadequate financing, insufficient supply of domestic medical equipment, and inadequate procurement by tender were also noted. The obtained data point to the need for optimization and upgrading medical equipment at various levels of healthcare. PMID:25535494

Prenatal health care beyond the obstetrics service: Utilization and predictors of unscheduled care

PubMed Central

Magriples, Urania; Kershaw, Trace S.; Rising, Sharon Schindler; Massey, Zohar; Ickovics, Jeannette R.

2008-01-01

OBJECTIVE The objective of the study was to describe the patient characteristics of prenatal care utilization within and outside of routine obstetric care, and the clinical and psychosocial factors that predict care utilization. STUDY DESIGN Four hundred twenty pregnant women enrolled in a randomized controlled trial receiving prenatal care in a university-affiliated clinic. All hospital encounters were obtained by review of computerized databases. The Kotelchuck index (KI) was computed, and the characteristics of inadequate, adequate, or excessive prenatal care were described. Demographic and psychosocial predictors of unscheduled visits were evaluated. RESULTS A total of 50.5% of women were adequate users by KI, with 19% being inadequate. An average of 5 additional unscheduled encounters occurred (standard deviation 4.2; range, 0−26). Almost 75% of participants made an unscheduled obstetric visit, with 38% making 2 or more unscheduled visits. Overweight/obese, younger women, high symptom distress, and excessive and inadequate prenatal users were more likely to utilize the labor floor before delivery. CONCLUSION Unscheduled care is common during pregnancy. PMID:18166312

14 CFR § 1260.125 - Revision of budget and program plans.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., A-110 and A-122 to allow recipients to do the following: (1) Incur pre-award costs 90 calendar days... reason the recipient does not receive an award or if the award is less than anticipated and inadequate to... construction awards, recipients shall request prior written approval promptly from NASA for budget revisions...

10 CFR 603.830 - Pre-award costs.

Code of Federal Regulations, 2010 CFR

2010-01-01

... at the recipient's risk (e.g., DOE is not obligated to reimburse the costs if, for any reason, the recipient does not receive an award, or if the award is less than anticipated and inadequate to cover the... 10 Energy 4 2010-01-01 2010-01-01 false Pre-award costs. 603.830 Section 603.830 Energy DEPARTMENT...

10 CFR 603.830 - Pre-award costs.

Code of Federal Regulations, 2013 CFR

2013-01-01

... at the recipient's risk (e.g., DOE is not obligated to reimburse the costs if, for any reason, the recipient does not receive an award, or if the award is less than anticipated and inadequate to cover the... 10 Energy 4 2013-01-01 2013-01-01 false Pre-award costs. 603.830 Section 603.830 Energy DEPARTMENT...

10 CFR 603.830 - Pre-award costs.

Code of Federal Regulations, 2012 CFR

2012-01-01

... at the recipient's risk (e.g., DOE is not obligated to reimburse the costs if, for any reason, the recipient does not receive an award, or if the award is less than anticipated and inadequate to cover the... 10 Energy 4 2012-01-01 2012-01-01 false Pre-award costs. 603.830 Section 603.830 Energy DEPARTMENT...

10 CFR 603.830 - Pre-award costs.

Code of Federal Regulations, 2014 CFR

2014-01-01

... at the recipient's risk (e.g., DOE is not obligated to reimburse the costs if, for any reason, the recipient does not receive an award, or if the award is less than anticipated and inadequate to cover the... 10 Energy 4 2014-01-01 2014-01-01 false Pre-award costs. 603.830 Section 603.830 Energy DEPARTMENT...

10 CFR 603.830 - Pre-award costs.

Code of Federal Regulations, 2011 CFR

2011-01-01

... at the recipient's risk (e.g., DOE is not obligated to reimburse the costs if, for any reason, the recipient does not receive an award, or if the award is less than anticipated and inadequate to cover the... 10 Energy 4 2011-01-01 2011-01-01 false Pre-award costs. 603.830 Section 603.830 Energy DEPARTMENT...

Roots of Federal ELL Case Run Deep

ERIC Educational Resources Information Center

Zehr, Mary Ann

2009-01-01

The U.S. Supreme Court will hear oral arguments later this month from a class action Miriam Flores, 42-year-old Mexican-born homemaker, joined on behalf of her first child in 1996. The lawsuit, Flores v. State of Arizona, contends that programs for English-language learners in Nogales are deficient and receive inadequate funding from the state.…

HIV-Related Knowledge and Attitudes among First Year Medical Students in Mumbai, India Adolescents

ERIC Educational Resources Information Center

Samant, Yogindra; Mankeshwar, Ranjit; Sankhe, Lalit; Parker, David L.

2006-01-01

Background: The total number of people with HIV (Human Immunodeficiency Virus) infection in India is estimated to be 10% of all global cases. People living with HIV in India often experience discrimination while receiving health care due to inadequate knowledge and fear among health care professionals. Data presented in this paper represents the…

Towards a Theory of Diagnosis in Second and Foreign Language Assessment: Insights from Professional Practice across Diverse Fields

ERIC Educational Resources Information Center

Alderson, J. Charles; Brunfaut, Tineke; Harding, Luke

2015-01-01

Diagnostic language assessment has received increased research interest in recent years, with particular attention on methods through which diagnostic information can be gleaned from standardized proficiency tests. However, diagnostic procedures in the broader sense have been inadequately theorized to date, with the result that there is still…

Intravenous parecoxib and continuous femoral block for postoperative analgesia after total knee arthroplasty. A randomized, double-blind, prospective trial.

PubMed

Sarridou, Despoina G; Chalmouki, Georgia; Braoudaki, Maria; Koutsoupaki, Anna; Mela, Argiro; Vadalouka, Athina

2015-01-01

Up until now, the optimal strategy for postoperative pain management after total knee arthroplasty (TKA) remains to be elucidated. The current investigation aimed to examine the analgesic efficacy and the opioid sparing effects of intravenous parecoxib in combination with continuous femoral blockade. Randomized, double-blind, prospective trial. University hospital in the United Kingdom. In total, 90 patients underwent TKA under subarachnoid anesthesia and received continuous femoral block initially as a bolus with 20 mL of ropivacaine 0.75%. Infusion of 0.2% on 10 mL/h followed. Patients were randomized into 2 groups. Group D and Group P received parecoxib and placebo, respectively at 12 hour time intervals. Visual analog scale (VAS) pain scores were obtained at different time intervals including 4, 8, 12, 24 and 36 hours. The pain scores were measured with patients in a resting position. Morphine could also be administered with a patient controlled analgesia (PCA) pump if the specified analgesia was deemed inadequate (VAS > 5). None of the patients were withdrawn from the study. Parecoxib provided greater relief than placebo following TKA. The VAS pain scores measured at rest were statistically significantly lower in parecoxib-treated patients compared to the placebo group (P = 0.007) at 4 (P = 0.044), 12 (P = 0.001), and 24 hours (P = 0.012), postoperatively. Patients receiving parecoxib consumed less morphine at all time intervals than patients receiving placebo, with borderline statistical significance (P = 0.054). In each time period, all patients receiving continuous femoral block irrespectively of the treatment group, required low morphine doses. Current protocol did not answer question as to functional recovery. According to our findings intravenous parecoxib in combination with continuous femoral block provided superior analgesic efficacy and opioid sparing effects in patients undergoing TKA.

Continuous spinal anaesthesia versus single dosing. A comparative study.

PubMed

De Andrés, J A; Febré, E; Bellver, J; Bolinches, R

1995-03-01

Continuous and single dose spinal anaesthesia were compared in a prospective randomized fashion in 108 patients undergoing orthopaedic surgery. Continuous spinal anaesthesia was via a 20 gauge polyamide multiperforated catheter introduced through an 18 gauge Tuohy needle. Single-dose spinal anaesthesia was performed with a 24 guage x 103 mm Sprotte spinal needle. The mean local anaesthetic dose for the continuous technique was 38.4 (SD 16.5) mg as hyperbaric lignocaine 5%, and for the single-dose spinal anaesthesia 10.8 (SD 2.2) mg as hyperbaric bupivacaine 0.5%. Segmental levels reached with the initial dose did not differ significantly between the two groups. Mean time required to perform continuous spinal anaesthesia was 6.7 (SD 3.9) min, which was longer than for single dose 4.9 (SD 2.8) min (P < 0.05). The onset time and efficacy of anaesthesia, and the duration of the operation were similar in the two groups. Analgesia was inadequate in six patients who received continuous spinal anaesthesia (11%) and one patient who received single dose (2%) (P = 0.18). Hypotension was more frequent in those receiving single doses (P < 0.05). Caudal rotation of the outlet needle orifice to advance the catheter correlated with inadequate analgesia (P < 0.01, r = 0.38). There were no significant differences in the incidence of post-operative complications.

Parents' willingness to pay for biologic treatments in juvenile idiopathic arthritis.

PubMed

Burnett, Heather F; Ungar, Wendy J; Regier, Dean A; Feldman, Brian M; Miller, Fiona A

2014-12-01

Biologic therapies are considered the standard of care for children with the most severe forms of juvenile idiopathic arthritis (JIA). Inconsistent and inadequate drug coverage, however, prevents many children from receiving timely and equitable access to the best treatment. The objective of this study was to evaluate parents' willingness to pay (WTP) for biologic and nonbiologic disease-modifying antirheumatic drugs (DMARDs) used to treat JIA. Utility weights from a discrete choice experiment were used to estimate the WTP for treatment characteristics including child-reported pain, participation in daily activities, side effects, days missed from school, drug treatment, and cost. Conditional logit regression was used to estimate utilities for each attribute level, and expected compensating variation was used to estimate the WTP. Bootstrapping was used to generate 95% confidence intervals for all WTP estimates. Parents had the highest marginal WTP for improved participation in daily activities and pain relief followed by the elimination of side effects of treatment. Parents were willing to pay $2080 (95% confidence interval $698-$4065) more for biologic DMARDs than for nonbiologic DMARDs if the biologic DMARD was more effective. Parents' WTP indicates their preference for treatments that reduce pain and improve daily functioning without side effects by estimating the monetary equivalent of utility for drug treatments in JIA. In addition to evidence of safety and efficacy, assessments of parents' preferences provide a broader perspective to decision makers by helping them understand the aspects of drug treatments in JIA that are most valued by families. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

RESPITE: switching to riociguat in pulmonary arterial hypertension patients with inadequate response to phosphodiesterase-5 inhibitors.

PubMed

Hoeper, Marius M; Simonneau, Gérald; Corris, Paul A; Ghofrani, Hossein-Ardeschir; Klinger, James R; Langleben, David; Naeije, Robert; Jansa, Pavel; Rosenkranz, Stephan; Scelsi, Laura; Grünig, Ekkehard; Vizza, Carmine Dario; Chang, MiKyung; Colorado, Pablo; Meier, Christian; Busse, Dennis; Benza, Raymond L

2017-09-01

A proportion of pulmonary arterial hypertension (PAH) patients do not reach treatment goals with phosphodiesterase-5 inhibitors (PDE5i). RESPITE investigated the safety, feasibility and benefit of switching from PDE5i to riociguat in these patients.RESPITE was a 24-week, open-label, multicentre, uncontrolled study. Patients in World Health Organization (WHO) functional class (FC) III, with 6-min walking distance (6MWD) 165-440 m, cardiac index <3.0 L·min -1 ·m -2 and pulmonary vascular resistance >400 dyn·s·cm -5 underwent a 1-3 day PDE5i treatment-free period before receiving riociguat adjusted up to 2.5 mg maximum t.i.d Exploratory end-points included change in 6MWD, WHO FC, N -terminal prohormone of brain natriuretic peptide (NT-proBNP) and safety.Of 61 patients enrolled, 51 (84%) completed RESPITE. 50 (82%) were receiving concomitant endothelin receptor antagonists. At week 24, mean±sd 6MWD had increased by 31±63 m, NT-proBNP decreased by 347±1235 pg·mL -1 and WHO FC improved in 28 patients (54%). 32 patients (52%) experienced study drug-related adverse events and 10 (16%) experienced serious adverse events (2 (3%) study drug-related, none during the PDE5i treatment-free period). Six patients (10%) experienced clinical worsening, including death in two (not study drug-related).In conclusion, selected patients with PAH may benefit from switching from PDE5i to riociguat, but this strategy needs to be further studied. Copyright ©ERS 2017.

NCRI phase II study of CHOP in combination with ofatumumab in induction and maintenance in newly diagnosed Richter syndrome.

PubMed

Eyre, Toby A; Clifford, Ruth; Bloor, Adrian; Boyle, Lucy; Roberts, Corran; Cabes, Maite; Collins, Graham P; Devereux, Stephen; Follows, George; Fox, Christopher P; Gribben, John; Hillmen, Peter; Hatton, Chris S; Littlewood, Tim J; McCarthy, Helen; Murray, Jim; Pettitt, Andrew R; Soilleux, Elizabeth; Stamatopoulos, Basile; Love, Sharon B; Wotherspoon, Andrew; Schuh, Anna

2016-10-01

Richter syndrome (RS) is associated with chemotherapy resistance and a poor historical median overall survival (OS) of 8-10 months. We conducted a phase II trial of standard CHOP-21 (cyclophosphamide, doxorubicin, vincristine, prednisolone every 21 d) with ofatumumab induction (Cycle 1: 300 mg day 1, 1000 mg day 8, 1000 mg day 15; Cycles 2-6: 1000 mg day 1) (CHOP-O) followed by 12 months ofatumumab maintenance (1000 mg given 8-weekly for up to six cycles). Forty-three patients were recruited of whom 37 were evaluable. Seventy-three per cent were aged >60 years. Over half of the patients received a fludarabine and cyclophosphamide-based regimen as prior CLL treatment. The overall response rate was 46% (complete response 27%, partial response 19%) at six cycles. The median progression-free survival was 6·2 months (95% confidence interval [CI] 4·9-14·0 months) and median OS was 11·4 months (95% CI 6·4-25·6 months). Treatment-naïve and TP53-intact patients had improved outcomes. Fifteen episodes of neutropenic fever and 46 non-neutropenic infections were observed. There were no treatment-related deaths. Seven patients received platinum-containing salvage at progression, with only one patient obtaining an adequate response to proceed to allogeneic transplantation. CHOP-O with ofatumumab maintenance provides minimal benefit beyond CHOP plus rutuximab. Standard immunochemotherapy for RS remains wholly inadequate for unselected RS. Multinational trials incorporating novel agents are urgently needed. © 2016 John Wiley & Sons Ltd.

A comparison between pre-operative carprofen and a long-acting sufentanil formulation for analgesia after ovariohysterectomy in dogs.

PubMed

Slingsby, Louisa S; Murison, Pamela J; Goossens, Lieve; Engelen, Marc; Waterman-Pearson, Avril E

2006-09-01

To assess the analgesic efficacy and adverse effects of a novel, long-acting sufentanil preparation in dogs undergoing ovariohysterectomy (OHE). Blinded, positively controlled, randomized field trial with four parallel treatment groups. Eighty client owned dogs undergoing elective OHE randomly allocated into four treatment groups (each n = 20). Three groups received intramuscular (IM) sufentanil (at 10, 15 and 25 microg kg(-1), respectively) and the control group received subcutaneous (SC) carprofen 4 mg kg(-1) SC plus acepromazine 0.05 mg kg(-1) IM as pre-anaesthetic medication. OHE was performed under thiopental/halothane anaesthesia. Visual Analogue Scale (VAS) scores for pain and sedation were awarded and mechanical nociceptive thresholds were measured at the wound and hock before surgery and up to 24 hours after tracheal extubation. Serum cortisol was measured before surgery, during surgery and up to 24 hours after tracheal extubation. Animals with inadequate post-operative analgesia were given rescue medication. In the carprofen group, VAS pain scores were significantly higher, wound tenderness was greater and requirement for rescue analgesia was more than in the sufentanil-treated groups. Sufentanil produced dose dependent analgesia and sedation. All treatment groups showed similar patterns of change for cortisol concentrations. Use of the sufentanil preparation was associated with a relatively high incidence of adverse events. The long-acting preparation of sufentanil provided excellent post-operative analgesia that was significantly better than that provided by carprofen. However, use of this formulation, in the anaesthetic technique used in the study, resulted in a relatively high incidence of adverse effects. Full mu (MOP) opioid agonists provide significantly better post-operative analgesia than nonsteroidal anti-inflammatory drugs after moderately painful surgery. However, the widely recognized adverse effects of opioids may preclude the use of these agents.

Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease in Patients Naïve to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy.

PubMed

Sands, Bruce E; Sandborn, William J; Van Assche, Gert; Lukas, Milan; Xu, Jing; James, Alexandra; Abhyankar, Brihad; Lasch, Karen

2017-01-01

Vedolizumab is a gut-selective α4β7 integrin antagonist for the treatment of moderately to severely active Crohn's disease (CD). Aims of this study were to characterize the efficacy and safety of vedolizumab induction and maintenance therapy in patients who were naïve to tumor necrosis factor-alpha (TNF-α) antagonist therapy (TNF-naïve) or who had discontinued TNF-α antagonist therapy because of inadequate response (i.e., primary nonresponse), loss of response, or intolerance (collectively classified as the TNF-failure population). Post hoc analyses of the efficacy data for 516 TNF-naïve and 960 TNF-failure patients from the GEMINI 2 and GEMINI 3 trials were evaluated at weeks 6, 10, and 52 and included clinical remission (CD Activity Index [CDAI] score ≤150), enhanced clinical response (≥100-point decrease from baseline in CDAI score), durable clinical remission (remission at ≥80% of visits), and corticosteroid-free remission. Adverse events were summarized for the TNF-naïve and TNF-failure subgroups by treatment received. Among patients who responded to vedolizumab induction at week 6, 48.9% of TNF-naïve and 27.7% of TNF-failure patients were in remission with vedolizumab at week 52 (versus 26.8% and 12.8% with placebo). Clinical efficacy was similar between the different types of TNF-α antagonist failure or the number of prior TNF-α antagonists failed. Safety profiles were similar in both subpopulations. Vedolizumab had increased efficacy over placebo in CD patients irrespective of TNF-α antagonist treatment history. Overall, rates of response and remission were numerically higher in patients receiving vedolizumab as a first biologic than in patients who had experienced TNF failure.

Community perceptions and practices of treatment seeking for childhood pneumonia: a mixed methods study in a rural district, Ghana.

PubMed

Abbey, Mercy; Chinbuah, Margaret A; Gyapong, Margaret; Bartholomew, L Kay; van den Borne, Bart

2016-08-22

The World Health Organization recommends community case management of malaria and pneumonia for reduction of under-five mortality in developing countries. Caregivers' perception and understanding of the illness influences the care a sick child receives. Studies in Ghana and elsewhere have routinely shown adequate recognition of malaria by caregivers. Similarly, evidence from Asia and some African countries have shown adequate knowledge on pneumonia. However, in Ghana, little has been documented about community awareness, knowledge, perceptions and management of childhood pneumonia particularly in the Dangme West district. Therefore this formative study was conducted to determine community perceptions of pneumonia for the purpose of informing the design and implementation of context specific health communication strategies to promote early and appropriate care seeking behaviour for childhood pneumonia. A mixed method approach was adopted. Data were obtained from structured interviews (N = 501) and eight focus group discussions made up of 56 caregivers of under-fives and eight community Key Informants. Descriptive and inference statistics were used for the quantitative data and grounded theory to guide the analysis of the qualitative data. Two-thirds of the respondents had never heard the name pneumonia. Most respondents did not know about the signs and symptoms of pneumonia. For the few who have heard about pneumonia, causes were largely attributed to coming into contact with cold temperature in various forms. Management practices mostly were self-treatment with home remedies and allopathic care. The low awareness and inadequate recognition of pneumonia implies that affected children may not receive prompt and appropriate treatment as their caregivers may misdiagnose the illness. Adequate measures need to be taken to create the needed awareness to improve care seeking behaviour.

Cervical cancer screening: Safety, acceptability, and feasibility of a single-visit approach in Bulawayo, Zimbabwe.

PubMed

Fallala, Muriel S; Mash, Robert

2015-05-05

Cervical cancer is the commonest cancer amongst African women, and yet preventative services are often inadequate. The purpose of the study was to assess the safety, acceptability and feasibility of visual inspection with acetic acid and cervicography (VIAC) followed by cryotherapy or a loop electrical excision procedure (LEEP) at a single visit for prevention of cancer of the cervix. The United Bulawayo Hospital, Zimbabwe. The study was descriptive, using retrospective data extracted from electronic medical records of women attending the VIAC clinic. Over 24 months 4641 women visited the clinic and were screened for cervical cancer using VIAC. Cryotherapy or LEEP was offered immediately to those that screened positive. Treated women were followed up at three months and one year. The rate of positive results on VIAC testing was 10.8%. Of those who were eligible, 17.0% received immediate cryotherapy, 44.1% received immediate LEEP, 1.9% delayed treatment, and 37.0% were referred to a gynaecologist. No major complications were recorded after cryotherapy or LEEP. Amongst those treated 99.5% expressed satisfaction with their experience. Only 3.2% of those treated at the clinic had a positive result on VIAC one year later. The service was shown to be feasible to sustain over time with the necessary consumables. There were no service-related treatment postponements and the clinic staff and facility were able to meet the demand for the service. A single-visit approach using VIAC, followed by cryotherapy or LEEP, proved to be safe, acceptable and feasible in an urban African setting in Bulawayo, Zimbabwe. Outcomes a year later suggested that treatment had been effective.

The impact of pharmacist's counseling on pediatric patients' caregiver's knowledge on epilepsy and its treatment in a tertiary hospital.

PubMed

Chen, Chunliang; Lee, Dorothy Sze Huay; Hie, Szu Liang

2013-10-01

Epilepsy is a chronic condition requiring compliance to long treatment regimes. Knowledge on epilepsy can affect compliance to treatment. Pediatric epileptic patients need caregivers for their care; however, prior research showed that caregivers had inadequate knowledge in epilepsy. In view of this, outpatient pharmacist epilepsy service was set up in collaboration with neurologists to bridge knowledge gaps. To determine if caregiver education provided by outpatient pharmacists is associated with improved knowledge in epilepsy and its management. Pediatric outpatient clinic at a pediatric and women's health hospital. A cross-sectional pre- to post-intervention study using scores of caregiver knowledge of epilepsy as the primary outcome was conducted. The intervention was one counseling session by pharmacists. A knowledge questionnaire (A) was administered to the caregiver to obtain baseline information before the session and readministered by telephone (C) 2 weeks post-session. Additionally, a perception questionnaire (B) was administered immediately after the session. Knowledge scores pre and post pharmacist counseling. Twenty-seven completed questionnaire sets (A, B and C) were collected from 55 caregivers who received the intervention (response rate = 49 %) between September 2010 and May 2011. Average post-counseling knowledge scores was significantly higher than pre-counseling scores (14.7 vs. 10.4, p = 0.000) (score range -21 to 21). Caregivers' confidence to administer antiepileptic drugs to the child increased significantly from 3.60 to 3.94 post-counseling (p = 0.002, score range 0-5). Mean total satisfaction score was 36.00 (score range 5-40). A specialized counseling session given by pharmacists increased caregiver's knowledge about epilepsy and medication adherence. The session was well received by caregivers. Pharmacists should continue to be involved in the care of epileptic patients.

Long-term treatment with rituximab in severe juvenile idiopathic arthritis-associated uveitis.

PubMed

Miserocchi, Elisabetta; Modorati, Giulio; Berchicci, Luigi; Pontikaki, Irene; Meroni, Pierluigi; Gerloni, Valeria

2016-06-01

To evaluate retrospectively the long-term efficacy of rituximab in patients with severe juvenile idiopathic arthritis (JIA)-associated uveitis. Eight patients (15 eyes) with severe and longstanding JIA uveitis, who had an inadequate response in controlling uveitis to one or more biologic agents including tumour necrosis factor blockers and abatacept, received rituximab therapy. Rituximab was given at a dose of 1000 mg per infusion on days 1 and 15 and then every 6 months. Clinical responses to treatment, including decrease in uveitis activity, visual acuity changes, reduction of concomitant local and systemic corticosteroid and/or immunosuppressants, and occurrence of adverse events, were assessed. Eight patients with a mean±SD age of 22.8±5.5 years were treated. The mean ocular disease duration was 17.7 years; the mean±SD follow-up time on rituximab was 44.75±4.9 months; and the mean number of rituximab infusions received was 8.75 (range 6-12). All patients achieved complete control of uveitis, but in two patients rituximab was discontinued due to inefficacy in treating arthritis. The decrease in uveitis activity was evident 4-5 months after the first infusion. Systemic corticosteroids and immunosuppressants used in association with rituximab were discontinued in five patients at the end of follow-up. None of the patients experienced visual worsening during the follow-up. No drug-related complications were encountered. Rituximab may be a promising effective treatment option for refractory uveitis associated with JIA leading to long-term quiescence of uveitis, particularly for patients who have not previously responded to other biologic therapies. 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/

Barriers to access and uptake of antiretroviral therapy among HIV-positive men who have sex with men in Hanoi, Vietnam: from HIV testing to treatment.

PubMed

Bui, Hao T M; Le, Giang M; Mai, Anh Q; Zablotska-Manos, Iryna; Maher, Lisa

2017-08-01

Little is known about the experiences of Vietnamese men who have sex with men in accessing HIV testing and treatment. We aimed to explore barriers to access and uptake of antiretroviral therapy (ART) among HIV-positive men who have sex with men in Hanoi. During 2015, we conducted qualitative interviews with 35 participants recruited using snowball sampling based on previous research and social networks. Key individual impediments to ART uptake included inadequate preparation for a positive diagnosis and the dual stigmatisation of homosexuality and HIV and its consequences, leading to fear of disclosure of HIV status. Health system barriers included lack of clarity and consistency about how to register for and access ART, failure to protect patient confidentiality and a reticence by providers to discuss sexual identity and same-sex issues. Results suggest fundamental problems in the way HIV testing is currently delivered in Hanoi, including a lack of client-centred counselling, peer support and clear referral pathways. Overcoming these barriers will require educating men who have sex with men about the benefits of routine testing, improving access to quality diagnostic services and building a safe, confidential treatment environment for HIV-positive men to access, receive and remain in care.

Improved wound management at lower cost: a sensible goal for Australia.

PubMed

Norman, Rosana E; Gibb, Michelle; Dyer, Anthony; Prentice, Jennifer; Yelland, Stephen; Cheng, Qinglu; Lazzarini, Peter A; Carville, Keryln; Innes-Walker, Karen; Finlayson, Kathleen; Edwards, Helen; Burn, Edward; Graves, Nicholas

2016-06-01

Chronic wounds cost the Australian health system at least US$2·85 billion per year. Wound care services in Australia involve a complex mix of treatment options, health care sectors and funding mechanisms. It is clear that implementation of evidence-based wound care coincides with large health improvements and cost savings, yet the majority of Australians with chronic wounds do not receive evidence-based treatment. High initial treatment costs, inadequate reimbursement, poor financial incentives to invest in optimal care and limitations in clinical skills are major barriers to the adoption of evidence-based wound care. Enhanced education and appropriate financial incentives in primary care will improve uptake of evidence-based practice. Secondary-level wound specialty clinics to fill referral gaps in the community, boosted by appropriate credentialing, will improve access to specialist care. In order to secure funding for better services in a competitive environment, evidence of cost-effectiveness is required. Future effort to generate evidence on the cost-effectiveness of wound management interventions should provide evidence that decision makers find easy to interpret. If this happens, and it will require a large effort of health services research, it could be used to inform future policy and decision-making activities, reduce health care costs and improve patient outcomes. © 2015 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Radiation therapy in the management of patients with mesothelioma

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gordon, W. Jr.; Antman, K.H.; Greenberger, J.S.

The results of radiation therapy in the management of 27 patients with malignant mesothelioma were reviewed. Eight patients were treated with a curative intent combining attempted surgical excision of tumor (thoracic in 6 and peritoneal in 2), aggressive radiation therapy, and combination chemotherapy using an adriamycin-containing regimen. One patient achieved a 2-year disease-free inteval followed by recurrence of tumor above the thoracic irradiation field. This patient was retreated with localized irradiation and is disease-free after 5 years of initial diagnosis. One patient has persistent abdominal disease at 18 months; the other 6 patients suffered local recurrence within 8-13 months ofmore » initiation of treatment. Radiation therapy was used in 19 other patients who received 29 courses for palliation of dyspnea, superior vena cava syndrome, dysphagia, or neurological symptoms of brain metastasis. A palliation index was used to determine the effectiveness of irradiation and revealed that relief of symptoms was complete or substantial in 5 treatment courses, moderately effective in 6 courses and inadequate in 18 treatment courses. Adequate palliation strongly correlated with a dose at or above 4,000 rad in 4 weeks. The management of patients with mesothelioma requires new and innovative approaches to increase the effectiveness of radiation therapy and minimize the significant potential combined toxicity of pulmonary irradiation and adriamycin.« less

Ipragliflozin Add-on Therapy to a GLP-1 Receptor Agonist in Japanese Patients with Type 2 Diabetes (AGATE): A 52-Week Open-Label Study.

PubMed

Ishihara, Hisamitsu; Yamaguchi, Susumu; Nakao, Ikko; Sakatani, Taishi

2018-06-20

Few data are available regarding ipragliflozin treatment in combination with glucagon-like peptide-1 (GLP-1) receptor agonists. The aim of this study was to evaluate the efficacy and safety of ipragliflozin in combination with GLP-1 receptor agonists in Japanese patients with inadequately controlled type 2 diabetes mellitus (T2DM). This multicenter study (consisting of three periods: a 4-week washout period, a 6-week observation period, and a 52-week open-label treatment period) included patients aged ≥ 20 years who received a stable dose/regimen of a GLP-1 receptor agonist either solely or in combination therapy with a sulfonylurea for ≥ 6 weeks, with glycosylated hemoglobin (HbA1c) of ≥ 7.5% and a fasting plasma glucose (FPG) of ≥ 126 mg/dL. Ipragliflozin treatment was given at a fixed dose of 50 mg/day for 20 weeks, followed by 50 or 100 mg/day for 32 weeks. Changes from baseline in glycemic control and other parameters were examined; safety was also assessed. The mean changes in HbA1c and body weight from baseline to end of treatment were - 0.92% and - 2.69 kg, respectively, in all ipragliflozin-treated patients (n = 103). Overall, sustained reductions from baseline were observed for HbA1c, FPG, self-monitored blood glucose, and body weight during the 52-week treatment. The dose increase of ipragliflozin to 100 mg/day resulted in better glycemic control and weight reduction for patients in whom the 50-mg dose was insufficient. Overall, 46.6% (48/103) of patients experienced drug-related adverse events. The most common drug-related treatment-emergent adverse events were pollakiuria (9.7%), hypoglycemia (8.7%), constipation (6.8%), and thirst (5.8%). Combined therapy with ipragliflozin and GLP-1 receptor agonists/sulfonylureas was significantly efficacious in reducing glycemic parameters in patients with T2DM with inadequate glycemic control, and no major safety concerns were identified. The results from this study suggest that ipragliflozin can be recommended as a well-tolerated and effective add-on therapy to a GLP-1 receptor agonist for the treatment of T2DM. ClinicalTrials.gov (identifier: NCT02291874). Astellas Pharma Inc., Tokyo, Japan.

Benchmarking the quality of schizophrenia pharmacotherapy: a comparison of the Department of Veterans Affairs and the private sector.

PubMed

Leslie, Douglas L; Rosenheck, Robert A

2003-09-01

Comparing quality of care between large health care systems is important for health systems management. This study used measures of the quality of pharmacotherapy for patients with schizophrenia and compared these measures across a sample of patients from the Department of Veterans Affairs (VA) and the private sector. A random sample of all patients diagnosed with schizophrenia in the VA during fiscal year (FY) 2000 was identified using administrative data. In the private sector, a sample of patients diagnosed with schizophrenia in 2000 was identified using MEDSTAT's MarketScan database. For both groups, use of antipsychotic medications was studied and measures of the quality of pharmacotherapy were constructed, including whether patients were prescribed any antipsychotic medication, one of the newer atypical antipsychotics, and whether dosing adhered to established treatment recommendations. These measures were compared across the two groups using logistic regression models, controlling for age, gender, and comorbid diagnoses. Most patients with a diagnosis of schizophrenia (82% in the VA and 73% in the private sector) received an antipsychotic medication, usually one of the newer atypical drugs. Patients in the VA were more likely to be dosed above treatment recommendations, and less likely to be dosed below treatment recommendations. Overall, differences in proportion schizophrenia patients dosed according to recommendations were not statistically different across the two systems (60% in the VA, 58% in the private sector). Differences between the two systems were mixed, with the VA outperforming the private sector with respect to some measures and doing worse on others. Although the VA and the private sector were comparable with respect to the quality measures used in this study, there is room for improvement in both systems. Treatment recommendations are based on the best available clinical evidence of effectiveness and safety. Quality of care might be improved with better adherence to these recommendations. Relatively low rates of adherence to treatment recommendations may be due to lack of awareness of these recommendations among prescribing physicians, or a belief that the recommendations are inadequate. To the extent that low rates of adherence to treatment recommendations are caused by a lack of awareness among physicians, policies should be developed to disseminate this information and encourage the appropriate use of these medications. Further research is needed to understand physician prescribing decisions for these medications. To the extent that physicians feel treatment recommendations for these drugs are inadequate, further research is needed to refine the recommendations.

Oregon's Coordinated Care Organizations and Their Effect on Prenatal Care Utilization Among Medicaid Enrollees.

PubMed

Oakley, Lisa P; Harvey, S Marie; Yoon, Jangho; Luck, Jeff

2017-09-01

Introduction Previous studies indicate that inadequate prenatal care is more common among women covered by Medicaid compared with private insurance. Increasing the proportion of pregnant women who receive early and adequate prenatal care is a Healthy People 2020 goal. We examined the impact of the implementation of Oregon's accountable care organizations, Coordinated Care Organizations (CCOs), for Medicaid enrollees, on prenatal care utilization among Oregon women of reproductive age enrolled in Medicaid. Methods Using Medicaid eligibility data linked to unique birth records for 2011-2013, we used a pre-posttest treatment-control design that compared prenatal care utilization for women on Medicaid before and after CCO implementation to women never enrolled in Medicaid. Additional stratified analyses were conducted to explore differences in the effect of CCO implementation based on rurality, race, and ethnicity. Results After CCO implementation, mothers on Medicaid had a 13% increase in the odds of receiving first trimester care (OR 1.13, CI 1.04, 1.23). Non-Hispanic (OR 1.20, CI 1.09, 1.32), White (OR 1.20, CI 1.08, 1.33) and Asian (OR 2.03, CI 1.26, 3.27) women on Medicaid were more likely to receive initial prenatal care in the first trimester after CCO implementation and only Medicaid women in urban areas were more likely (OR 1.14, CI 1.05, 1.25) to initiate prenatal care in the first trimester. Conclusion Following Oregon's implementation of an innovative Medicaid coordinated care model, we found that women on Medicaid experienced a significant increase in receiving timely prenatal care.

Inadequate Diagnosis and Treatment of Malaria Among Travelers Returning from Africa During the Ebola Epidemic--United States, 2014-2015.

PubMed

Tan, Kathrine R; Cullen, Karen A; Koumans, Emilia H; Arguin, Paul M

2016-01-22

Among 1,683 persons in the United States who developed malaria following international travel during 2012, more than half acquired disease in one of 16 countries in West Africa. Since March 2014, West Africa has experienced the world's largest epidemic of Ebola virus disease (Ebola), primarily affecting Guinea, Sierra Leone, and Liberia; in 2014, approximately 20,000 Ebola cases were reported. Both Ebola and malaria are often characterized by fever and malaise and can be clinically indistinguishable, especially early in the course of disease. Immediate laboratory testing is critical for diagnosis of both Ebola and malaria, so that appropriate lifesaving treatment can be initiated. CDC recommends prompt malaria testing of patients with fever and history of travel to an area that is endemic for malaria, using blood smear microscopy, with results available within a few hours. Empiric treatment of malaria is not recommended by CDC. Reverse transcription-polymerase chain reaction (RT-PCR) testing is recommended to diagnose Ebola. During the Ebola outbreak in West Africa, CDC received reports of delayed laboratory testing for malaria in travelers returning to the United States because of infection control concerns related to Ebola. CDC reviewed documented calls to its malaria consultation service and selected three patient cases to present as examples of deficiencies in the evaluation and treatment of malaria among travelers returning from Africa during the Ebola epidemic.

Bone health status of postmenopausal Chinese women.

PubMed

Lo, Sue S T

2015-12-01

To evaluate the prevalence of osteoporosis in treatment-naïve postmenopausal women, their treatment adherence, and the risk factors for osteoporosis. Cross-sectional study of bone density reports, a self-administered health checklist, and computerised consultation records. Primary care sexual and reproductive health service in Hong Kong. Postmenopausal Chinese women who had never received osteoporosis treatment or hormone replacement therapy. Each woman completed a checklist of risk factors for osteoporosis, menopause age, history of hormone replacement therapy, and osteoporosis treatment prior to undergoing bone mineral density measurement at the postero-anterior lumbar spine and left femur. The consultation records of those with osteoporosis were reviewed to determine their treatment adherence. T-score at the spine and hip, presence or absence of risk factors for osteoporosis, and treatment adherence. Between January 2008 and December 2011, 1507 densitometries were performed for eligible women; 51.6% of whom were diagnosed with osteopenia and 25.7% with osteoporosis. The mean age of women with normal bone mineral density, osteopenia, and osteoporosis was 57.0, 58.0, and 59.7 years, respectively. Approximately half of them had an inadequate dietary calcium intake, performed insufficient weight-bearing exercise, or had too little sun exposure. Logistic regression analysis revealed that age, body mass index of <18.5 kg/m(2), parental history of osteoporosis or hip fracture, and duration of menopause were significant risk factors for osteoporosis. Among those with osteoporosis, 42.9% refused treatment, 30.7% complied with treatment, and 26.3% discontinued treatment or defaulted from follow-up. Those who refused treatment were significantly older. Osteoporosis is prevalent in postmenopausal women. Only 50% adopted primary prevention strategies. Almost 70% refused treatment or stopped prematurely.

Response to inadequate dialysis in chronic peritoneal dialysis patients. Results from the 2000 Centers for Medicare and Medicaid (CMS) ESRD Peritoneal Dialysis Clinical Performance Measures (PD-CPM) Project.

PubMed

Rocco, Michael V; Frankenfield, Diane L; Prowant, Barbara; Frederick, Pamela; Flanigan, Michael J

2003-04-01

It is not known if patient prescriptions are being changed if patients are receiving an inadequate dose of peritoneal dialysis. Data from the 2000 Centers for Medicare and Medicaid were used to obtain data on dialysis adequacy and dialysis prescriptions. A total of 359 of 1,268 (28%) adult peritoneal dialysis patients had a total weekly Kt/V urea (twKt/V) less than 2.0 and 436 of 1,245 (35%) patients had a total weekly creatinine clearance (twCrCl) less than 60 L/wk/1.73 m2, defined as "inadequate dialysis." Among chronic ambulatory peritoneal dialysis (CAPD) patients, 81 of 188 (43%) patients had inadequate dialysis and a change in the peritoneal dialysis prescription within 6 months of the initial adequacy value. Among cycler patients, 106 of 197 (54%) patients had inadequate dialysis and a change in the prescription. Thirty-six of 46 (78%) CAPD patients and 48 of 56 (86%) cycler patients had an improvement in twKt/V after the prescription was revised. Thirty-two of 42 (76%) CAPD patients and 45 of 57 (79%) cycler patients had an improvement in twCrCl after the prescription was changed. For these patients, twKt/V increased from 1.6 +/- 0.3 to 2.1 +/- 0.5, with an increase in the peritoneal Kt/V urea from 1.5 +/- 0.3 to 1.9 +/- 0.4. Similarly, twCrCl increased from 46.3 +/- 7.5 to 59.1 +/- 10.6 L/wk/1.73 m2 with an increase in the peritoneal CrCl dose from 42.0 +/- 9.1 to 52.7 +/- 9.9 L/wk/1.73 m2. About half of peritoneal dialysis patients with inadequate dialysis did not have a prescription change and could benefit from modifications in their dialysis prescription.

Potential of photodynamic therapy in treatment of fungal infections of the mouth. Design and characterisation of a mucoadhesive patch containing toluidine blue O.

PubMed

Donnelly, Ryan F; McCarron, Paul A; Tunney, Michael M; David Woolfson, A

2007-01-03

Mucocutaneous oropharyngeal candidiasis is predominately caused by Candida albicans. The overall incidence of oral candidiasis in young adults has increased dramatically with the spread of HIV/AIDS. Conventional treatments have been shown to have a fungistatic rather than a fungicidal effect, resulting in an inadequate treatment outcome for patients. In addition, increasing resistance of C. albicans to antifungal agents has made effective treatment more difficult. Accordingly, interest has arisen in development of new prophylaxis/treatment regimens. One such alternative treatment is photodynamic antimicrobial chemotherapy (PACT), in which a combination of a photosensitising drug and visible light cause selective destruction of microbial cells. Due to the highly coloured nature of photosensitisers and the potential for staining of teeth, lips and buccal mucosa, administration of photosensitisers to humans as a liquid mouthwash is undesirable. Targeted delivery of the photosensitiser directly to the site of infection should be the aim. The current study, therefore, reports on a mucoadhesive patch containing toluidine blue O (TBO), as a potential delivery system for use in PACT of oropharyngeal candidiasis. Patches prepared from aqueous blends of poly(methyl vinyl ether/maleic anhydride) and tripropyleneglycol methyl ether possessed suitable properties for use as mucoadhesive drug delivery systems and were capable of resisting dissolution when immersed in artificial saliva. When releasing directly into an aqueous sink, patches containing 50 and 100mg TBO cm(-2) both generated receiver compartment concentrations exceeding the concentration (2.0-5.0 mg ml(-1)) required to produce high levels of kill (>90%) of both planktonic and biofilm-grown C. albicans upon illumination. However, the concentrations of TBO in the receiver compartments separated from patches by membranes intended to mimic biofilm structures were an order of magnitude below those inducing high levels of kill, even after 6h release. Therefore, short application times of TBO-containing mucoadhesive patches should allow treatment of recently-acquired oropharyngeal candidiasis, caused solely by planktonic cells. Longer patch application times may be required for persistent disease where biofilms are implicated.

Services for Men Who Batter: Implications for Programs and Policies.

ERIC Educational Resources Information Center

Feazell, Carann Simpson; And Others

1984-01-01

Analyzed data on services offered to battering males in a survey of 90 agencies. Found that most agencies are young, inadequately funded, and provide diverse services independent of each other, and that batterers exhibit characteristics that need specific treatment. Described a developing model for successful treatment. (JAC)

Screening for Adolescent Idiopathic Scoliosis: US Preventive Services Task Force Recommendation Statement.

PubMed

Grossman, David C; Curry, Susan J; Owens, Douglas K; Barry, Michael J; Davidson, Karina W; Doubeni, Chyke A; Epling, John W; Kemper, Alex R; Krist, Alex H; Kurth, Ann E; Landefeld, C Seth; Mangione, Carol M; Phipps, Maureen G; Silverstein, Michael; Simon, Melissa A; Tseng, Chien-Wen

2018-01-09

Adolescent idiopathic scoliosis, a lateral curvature of the spine of unknown cause with a Cobb angle of at least 10°, occurs in children and adolescents aged 10 to 18 years. Idiopathic scoliosis is the most common form and usually worsens during adolescence before skeletal maturity. Severe spinal curvature may be associated with adverse long-term health outcomes (eg, pulmonary disorders, disability, back pain, psychological effects, cosmetic issues, and reduced quality of life). Early identification and effective treatment of mild scoliosis could slow or stop curvature progression before skeletal maturity, thereby improving long-term outcomes in adulthood. To update the 2004 US Preventive Services Task Force (USPSTF) recommendation on screening for idiopathic scoliosis in asymptomatic adolescents. The USPSTF reviewed the evidence on the benefits and harms of screening for and treatment of adolescent idiopathic scoliosis. The USPSTF found no direct evidence on screening for adolescent idiopathic scoliosis and health outcomes and no evidence on the harms of screening. The USPSTF found inadequate evidence on treatment with exercise and surgery. It found adequate evidence that treatment with bracing may slow curvature progression in adolescents with mild or moderate curvature severity (Cobb angle <40° to 50°); however, evidence on the association between reduction in spinal curvature in adolescence and long-term health outcomes in adulthood is inadequate. The USPSTF found inadequate evidence on the harms of treatment. Therefore, the USPSTF concludes that the current evidence is insufficient and that the balance of benefits and harms of screening for adolescent idiopathic scoliosis cannot be determined. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for adolescent idiopathic scoliosis in children and adolescents aged 10 to 18 years. (I statement).

The effects of vortioxetine on cognitive dysfunction in patients with inadequate response to current antidepressants in major depressive disorder: A short-term, randomized, double-blind, exploratory study versus escitalopram.

PubMed

Vieta, Eduard; Sluth, Lasse B; Olsen, Christina K

2018-02-01

Major Depressive Disorder (MDD) is a heterogeneous disease characterized by emotional, physical and cognitive symptoms. This study explored the effects of vortioxetine versus escitalopram on outcomes of cognition, functioning and mood symptoms in depressed patients with inadequate response to current antidepressant treatment. In this parallel-group, active-comparator study, adult patients (18-65 years, N = 101) with MDD, with inadequate response to current antidepressant monotherapy, were randomized 1:1 to 8 weeks' double-blind treatment with flexible doses (10-20mg/day) of either vortioxetine or escitalopram. Primary and key secondary efficacy measures were the Digit Symbol Substitution Test (DSST), analyzed using a mixed model for repeated measurements, and the University of San Diego Performance-based Skills Assessment - Brief (UPSA-B), analyzed using analysis of covariance (last observation carried forward method). At week 8, DSST and UPSA-B performance had improved in both treatment groups, with no statistically significant treatment differences. Numerical improvements across measures of cognition, functioning and mood symptoms generally favored vortioxetine. Most adverse events were mild or moderate, with nausea being the most common adverse event. This was an exploratory study with small sample sizes implying limited statistical power. Although this explorative study did not meet primary endpoints, the results confirm vortioxetine in doses of 10-20mg/day as an efficacious and well-tolerated antidepressant switch treatment. The overall direction of numerical effect sizes across cognition endpoints support previous findings that vortioxetine specifically benefits cognitive function in MDD. Copyright © 2017 H Lundbeck A/S. Published by Elsevier B.V. All rights reserved.

Parent-Implemented Procedural Modification of Escape Extinction in the Treatment of Food Selectivity in a Young Child with Autism

ERIC Educational Resources Information Center

Tarbox, Jonathan; Schiff, Averil; Najdowski, Adel C.

2010-01-01

Fool selectivity is characterized by the consumption of an inadequate variety of foods. The effectiveness of behavioral treatment procedures, particularly nonremoval of the spoon, is well validated by research. The role of parents in the treatment of feeding disorders and the feasibility of behavioral procedures for parent implementation in the…

A pilot study on the application of the current European guidelines for the management of acute coronary syndrome without elevation of ST segment (NSTEMI) in the Emergency Department setting in the Italian region Lazio.

PubMed

Valli, Gabriele; De Marco, Francesca; Spina, Maria Teresa; Valeriano, Valentina; Rosa, Antonello; Minerva, Valentina; Mirante, Enrico; Ruggieri, Maria Pia; Pugliese, Francesco Rocco

2014-12-01

In 2011 the European Society of Cardiology published the new guidelines for the treatment and management of acute coronary syndrome without elevation of the ST segment (NSTEMI). For the treatment of the syndrome, the use of P2Y12 inhibitors in addition to aspirin was strongly recommended (evidence IA). We studied the application of this recommendation in the setting of the emergency department in the vast and uneven area of the Italian region Lazio, three years after the release of these drugs in Italy. 121 consecutive patients (65% older than 65 years) affected by NSTEMI were recruited between May and July 2013. During the transition in the emergency department data was collected on patient's symptoms, syndrome severity and type & timing of treatments chosen. Adherence to the guidelines was evaluated considering the number of "good treated" patients: these being the patients that received at least 80% of the main five recommendations on percutaneous coronary intervention (PCI) timing, antiplatelet and anti-coagulant therapy suggested by the European Cardiology Task Force (ESC guidelines, 2011) for the very acute phase of NSTEMI. Patients were treated with: 1) 35% of cases with double antiplatelet therapy and anticoagulation (DAPT+AC), 2) 22% of cases with single antiplatelet and anticoagulation (SAPT+AC), 3) 6% of cases with a single antiplatelet therapy (SAPT), 4) 6% of cases with a double antiplatelet therapy (DAPT) and 5) 24% of cases did not receive any therapy. Data on PCI was available for 95 patients and, of these, only 82% of the patients underwent the procedure. The percentage of "good treated" patients were among of 20-40%, depending on PCI timing--as guidelines suggested--was considered as mandatory (20,5%) or as the extreme time limit (40%). Significant differences were found between patients treated in a central hospital with a hemodynamic laboratory active 24/24hr (HUB) and patients treated in the other hospital (SPOKE). HUBs showed a higher percent of "good treated" patients, a higher percentage of early invasive treated and a better adherence to recommended pharmacological therapy. A significant number of patients did not receive adequate treatment during the emergency department stay. The absence of hemodynamic services increases the risk of inadequate treatment.

A multicentre study investigating subcutaneous etonogestrel implants with injectable testosterone decanoate as a potential long-acting male contraceptive.

PubMed

Brady, B M; Amory, J K; Perheentupa, A; Zitzmann, M; Hay, C J; Apter, D; Anderson, R A; Bremner, W J; Pollanen, P; Nieschlag, E; Wu, F C W; Kersemaekers, W M

2006-01-01

The combination of etonogestrel implants with injectable testosterone decanoate was investigated as a potential male contraceptive. One hundred and thirty subjects were randomly assigned to three treatment groups, all receiving two etonogestrel rods (204 mg etonogestrel) and 400 mg testosterone decanoate either every 4 weeks (group I, n = 42), or every 6 weeks (group II, n = 51) or 600 mg testosterone decanoate every 6 weeks (group III, n = 37) for a treatment period of 48 weeks. One hundred and ten men completed 48 weeks of treatment. Sperm concentrations of <1 x 10(6)/ml were achieved in 90% (group I), 82% (group II) and 89% (group III) of subjects by week 24. Suppression was slower in group II, which also demonstrated more frequent escape from gonadotrophin suppression than groups I and III. Peak testosterone concentrations remained in the normal range throughout in all groups. Mean trough testosterone concentrations were initially subphysiological but increased into the normal range during treatment. Mean haemoglobin levels increased in group I, and a non-significant increase in weight and decline in high-density lipoprotein cholesterol was observed in all groups. Fourteen subjects discontinued treatment due to adverse events. Subcutaneous etonogestrel implants in combination with injectable testosterone decanoate resulted in profound suppression of spermatogenesis that could be maintained for up to 1 year. Efficacy of suppression was less in group II, probably due to inadequate testosterone dosage. This combination has potential as a long-acting male hormonal contraceptive.

Do diabetes group visits lead to lower medical care charges?

PubMed

Clancy, Dawn E; Dismuke, Clara E; Magruder, Kathryn Marley; Simpson, Kit N; Bradford, David

2008-01-01

To evaluate whether attending diabetes group visits (GVs) leads to lower medical care charges for inadequately insured patients with type 2 diabetes mellitus (DM). Randomized controlled clinical trial. Data were abstracted from financial records for 186 patients with uncontrolled type 2 DM randomized to receive care in GVs or usual care for 12 months. Mann-Whitney tests for differences of means for outpatient visits (primary and specialty care), emergency department (ED) visits, and inpatient stays were performed. Separate charge models were developed for primary and specialty outpatient visits. Because GV adherence is potentially dependent on unobserved patient characteristics, treatment effect models of outpatient charges and specialty care visits were estimated using maximum likelihood methods. Mann-Whitney test results indicated that GV patients had reduced ED and total charges but more outpatient charges than usual care patients. Ordinary least squares estimations confirmed that GVs increased outpatient visit charges; however, controlling for endogeneity by estimating a treatment effect model of outpatient visit charges showed that GVs statistically significantly reduced outpatient charges (P <.001). Estimation of a separate treatment effect model of specialty care visits confirmed that GV effects on outpatient visit charges occurred via a reduction in specialty care visits. After controlling for endogeneity via estimation of a treatment effect model, GVs statistically significantly reduced outpatient visit charges. Estimation of a separate treatment effect model of specialty care visits indicated that GVs likely substitute for more expensive specialty care visits.

Delta-9-tetrahydrocannabinol + cannabidiol. A reasonable option for some patients with multiple sclerosis.

PubMed

2014-06-01

Conventional drugs have only a limited impact on spasticity associated with multiple sclerosis and are rarely satisfactory. A solution for oral transmucosal delivery (spray) containing a mixture of cannabis extracts (2.7 mg of delta-9-tetrahydrocannabinol + 2.5 mg of cannabidiol per spray) has been granted marketing authorisation in France for patients who are inadequately relieved by standard treatments. Three double-blind, placebo-controlled trials in a total of about 300 patients tested this combination, in addition to ongoing treatment, for periods of 6 to 14 weeks. Individually, none of these trials showed any tangible anti-spastic efficacy, but two combined analyses showed "response rates" of about 35% with the mixture versus about 25% with placebo. In a trial with 572 patients, the 241 patients who "responded" after 4 weeks of treatment were randomised to either continue using the cannabis extract or receive placebo. Twelve weeks later, 75% of patients using the extract were still "responders", versus 51% of patients switched to placebo. The principal adverse effects of the cannabis extracts consist of neuropsychiatric disorders that resolve on treatment withdrawal. The potential for abuse increases with the dose and is tangible from 16 sprays per day. Pharmacokinetic interactions due to P-glycoprotein inhibition are likely. Treatment during pregnancy may lead to neonatal withdrawal symptoms. In practice, about 10% of patients in whom standard anti-spastic medications are unsatisfactory benefit from a specific effect of the cannabis extracts contained in this oral spray.

Supplanting Chinese Influence in Africa: The U.S. African Diaspora

DTIC Science & Technology

2011-03-14

dysfunctional governments, to weak economies. Other critical factors include: inadequate basic infrastructure, high unemployment , rapid population growth...increased unemployment in many sectors. At the same time, local merchants and manufacturers are unable to favorably compete against Chinese...establish a pre-automated program modeled after a franchise plan. Selected individuals or teams will receive intense training and subsequently will be

Preservice Teachers' Classroom Management Training: A Survey of Self-Reported Training Experiences, Content Coverage, and Preparedness

ERIC Educational Resources Information Center

Christofferson, Michael; Sullivan, Amanda L.

2015-01-01

Many teachers report that their preservice training in classroom management was inadequate or ineffective, but little is known about the types of training they receive. In this exploratory study, 157 preservice teachers from throughout the United States were surveyed about the training sources through which they obtained knowledge and skills in…

Inadequate Controls Over the DoD Service-Disabled Veteran-Owned Small Business Set-Aside Program Allow Ineligible Contractors to Receive Contracts

DTIC Science & Technology

2012-02-29

status, which we identified from the red flags generated during our review. Table 2. Awards to Contractors That Potentially Misstated Their SDVOSB...verification of the SDVOSB stutus is not required by the FAR. NA VAIR Response: C:oncur. While the contracti ng officer complied with aJI applicable

The Cascade Model of Teachers' Continuing Professional Development in Kenya: A Time for Change?

ERIC Educational Resources Information Center

Bett, Harry Kipkemoi

2016-01-01

Kenya is one of the countries whose teachers the UNESCO (2015) report cited as lacking curriculum support in the classroom. As is the case in many African countries, a large portion of teachers in Kenya enter the teaching profession when inadequately prepared, while those already in the field receive insufficient support in their professional…

Special Study: Inadequate Structural Assembly of Schoolbus Bodies. The Accidents at Decatur and Huntsville, Alabama.

ERIC Educational Resources Information Center

National Transportation Safety Board (DOT), Washington, DC. Bureau of Surface Transportation Safety.

This study reviews some examples of injuries received in two school bus accidents; explains how the design of joints and fastenings in the buses was involved in the injuries and in the structural strength of schoolbuses; and compares schoolbus construction with construction of other types of buses that employ more efficient and complete…

Psychosocial needs of older cancer patients: a pilot study abstract.

PubMed

Houldin, A D; Wasserbauer, N

1996-08-01

Approximately 50% of all cancers occur in persons aged 65 and over (American Cancer Society, 1994). However, the special psychological problems of these patients have been inadequately addressed (Massie & Holland, 1989). The psychosocial needs of older cancer patients were surveyed in this pilot study. Two-thirds of the older adults surveyed experienced concerns or problems. Almost 50% of the sample did not receive adequate assistance in dealing with their emotional needs and 69% did not receive sufficient spiritual support. Older cancer patients experience psychosocial distress and may benefit from professional assistance in dealing with these concerns.

Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise.

PubMed

Nauck, Michael A; Stewart, Murray W; Perkins, Christopher; Jones-Leone, Angela; Yang, Fred; Perry, Caroline; Reinhardt, Rickey R; Rendell, Marc

2016-02-01

Additional safe and effective therapies for type 2 diabetes are needed, especially ones that do not cause weight gain and have a low risk of hypoglycaemia. The present study evaluated albiglutide as monotherapy. In this placebo-controlled study, 309 patients (aged ≥ 18 years) with type 2 diabetes inadequately controlled by diet and exercise and who were not using a glucose-lowering agent (HbA1c 7.0-10.0% [53.00-85.79 mmol/mol], body mass index 20-45 kg/m(2), and fasting C-peptide ≥ 0.26 nmol/l) were randomised (1:1:1 on a fixed randomisation schedule using an interactive voice response system) to receive once-weekly albiglutide 30 mg (n = 102) or 50 mg (n = 102) or matching placebo (n = 105). The study treatments were blinded to both patients and study personnel. All study data were collected at individual patient clinic visits. The primary efficacy endpoint was change in HbA1c from baseline to week 52. The primary analysis was applied to the intent-to-treat population. Additional efficacy and safety endpoints were assessed. At week 52, both albiglutide 30 mg and 50 mg were superior to placebo in reducing HbA1c. The least-squares means treatment difference from placebo was -0.84% (95% CI -1.11%, -0.58%; p < 0.0001) with albiglutide 30 mg and -1.04% (-1.31%, -0.77%; p < 0.0001) with albiglutide 50 mg. Injection-site reactions were reported more frequently with albiglutide (30 mg: 17.8%; 50 mg: 22.2%) than with placebo (9.9%). Other commonly reported adverse events included nausea, diarrhoea, vomiting and hypoglycaemia; the incidences of these were generally similar across treatment groups. Albiglutide is safe and effective as monotherapy and significantly lowered HbA1c levels over 52 weeks, did not cause weight gain, and had good gastrointestinal tolerability and a low rate of hypoglycaemia compared with placebo. Trial registration ClinicalTrials.gov NCT00849017 Funding This study was sponsored by GlaxoSmithKline.

Person-centred psychopharmacotherapy: what is it? Each patient is a unique, responsive and responsible subject.

PubMed

Jakovljevic, Miro

2015-09-01

Modern psychopharmacotherapy is currently in contention both outside and within the field of psychiatry. Conventional psychopharmacology paradigms focusing just on a disease perspective, biological narrative and a "one fits all" treatment are often regarded as inadequate and disjunctive. A significant proportion of psychiatric patients achieve no improvement or only partial improvement in their symptoms, while many of them suffer adverse and even toxic effects of medications. Psychopharmacotherapy as a sole form of treatment may carry the wrong message that patients don't have to change their life style and don't have to learn any new skills, they just have to receive their medication on time because the only problem is in brain chemistry. Evidence-based psychopharmacotherapy and person-centered narrative psychopharmacotherapy are not competitors but a complementuary duality, as intimately connected as brain and soul. Narrative preserves individuality, distinctivenesss and therapeutic context, whereas quantitative methods and evidence-based guidelines offer a solid foundation for what is reliably and generally correct. The purpose of person-centered psychopharmacotherapy is to empower the patients to control their disease, to re-author their problematic life story, to obtain full personal recovery and to regain control over their life.

Oral choline supplementation for postoperative pain

PubMed Central

Sidhu, N.; Davies, S.; Nadarajah, A.; Rivera, J.; Whittington, R.; Mercier, R. J.; Virag, L.; Wang, S.; Flood, P.

2013-01-01

Background Activation of nicotinic receptors with nicotine has been shown to reduce post-surgical pain in clinical and preclinical studies. Choline is a selective agonist at α7-type nicotinic receptors that does not have addictive or sympathetic activating properties. It is anti-nociceptive in animal studies. We conducted a double-blind randomized trial of oral choline supplementation with lecithin to aid in the treatment of pain after gynaecological surgery. Methods Sixty women having open gynaecological surgery were randomly assigned to receive 20 g of lecithin before surgery or placebo. Plasma choline concentration and tumour necrosis factor (TNF) were measured. Pain report was the primary outcome measure. Results We achieved a small but statistically significant increase in choline after surgery with oral supplementation. Plasma TNF was not decreased and pain report was not different between groups at rest or with movement. There were no adverse effects of treatment. Conclusions Oral supplementation with lecithin during the perioperative period resulted in very slow absorption and thus only a small increase in plasma choline was achieved. This concentration was inadequate to reduce TNF as has been shown in other studies. The absence of an anti-inflammatory effect was likely related to our failure to demonstrate efficacy in pain reduction. PMID:23568851

Healthcare barriers and supports for American Indian women with cancer.

PubMed

Liddell, Jessica L; Burnette, Catherine E; Roh, Soonhee; Lee, Yeon-Shim

2018-05-18

Although American Indian (AI) women continue to experience cancer at higher rates and have not seen the same decline in cancer prevalence as the general U.S. population, little research examines how interactions with health care providers may influence and exacerbate these health disparities. The purpose of the study was to understand the experiences of AI women who receive cancer treatment, which is integral for eradication of AI cancer disparities among women. A qualitative descriptive methodology was used with a sample of 43 AI women with breast, cervical, colon, and other types of cancer from the Northern Plains region of South Dakota. Interviews were conducted from June 2014 to February 2015. Qualitative content analysis revealed that women experienced: (a) health concerns being ignored or overlooked; (b) lack of consistent and qualified providers; (c) inadequate healthcare infrastructure; (d) sub-optimal patient-healthcare provider relationships; (e) positive experiences with healthcare providers; and (f) pressure and misinformation about treatment. Results indicate the types of support AI women may need when accessing healthcare. Culturally informed trainings for healthcare professionals may be needed to provide high-quality and sensitive care for AI women who have cancer, and to support those providers already providing proper care.

[Management of anaphylaxis in Latin America: current situation].

PubMed

Cardona, Victoria; Álvarez-Perea, Alberto; Ansotegui, Ignacio J; Arias-Cruz, Alfredo; González-Díaz, Sandra Nora; Latour-Staffeld, Patricia; Ivancevich, Juan Carlos; Sánchez-Borges, Mario; Serrano, Carlos; Solé, Dirceu; Tanno, Luciana K

2017-01-01

Anaphylaxis is a systemic and severe allergic reaction, which can be fatal. The first-line treatment of choice, according to international guidelines, is intramuscular adrenaline. However, different studies show that the performance of health professionals managing anaphylaxis is often inadequate. To assess the current resources available in Latin American countries for the diagnosis and treatment of anaphylaxis. Online survey promoted by the Latin American Society of Allergy and Immunology to representatives of the national allergy societies of Latin American countries. Responses were received from 10 countries out of the 14 countries invited to participate. Only five of the countries have clinical practice guidelines in anaphylaxis. Adrenaline autoinjectors are available only in two countries, Argentina and Brazil, but are not subsidized by public health systems. In all countries, adrenaline is available in ampoules, which is the presentation usually prescribed to patients for self-administration. The use of adrenaline was estimated to be less than 50 % of cases in five countries, while antihistamines and corticosteroids are almost always used. The determination of serum tryptase is possible in some health centers, often private, in five of the countries surveyed. It is necessary to improve resources related to the diagnosis and management of anaphylaxis in Latin American countries.

Resolution of abnormal cardiac MRI T2 signal following immune suppression for cardiac sarcoidosis.

PubMed

Crouser, Elliott D; Ruden, Emily; Julian, Mark W; Raman, Subha V

2016-08-01

Cardiac MR (CMR) with late gadolinium enhancement is commonly used to detect cardiac damage in the setting of cardiac sarcoidosis. The addition of T2 mapping to CMR was recently shown to enhance cardiac sarcoidosis detection and correlates with increased cardiac arrhythmia risk. This study was conducted to determine if CMR T2 abnormalities and related arrhythmias are reversible following immune suppression therapy. A retrospective study of subjects with cardiac sarcoidosis with abnormal T2 signal on baseline CMR and a follow-up CMR study at least 4 months later was conducted at The Ohio State University from 2011 to 2015. Immune suppression treated participants had a significant reduction in peak myocardial T2 value (70.0±5.5 vs 59.2±6.1 ms, pretreatment vs post-treatment; p=0.017), and 83% of immune suppression treated subjects had objective improvement in cardiac arrhythmias. Two subjects who had received inadequate immune suppression treatment experienced progression of cardiac sarcoidosis. This report indicates that abnormal CMR T2 signal represents an acute inflammatory manifestation of cardiac sarcoidosis that is potentially reversible with adequate immune suppression therapy. Copyright © 2016 American Federation for Medical Research.

Systemic Sclerosis-Associated Pulmonary Arterial Hypertension

PubMed Central

Chaisson, Neal F.

2013-01-01

Pulmonary arterial hypertension (PAH) is the leading cause of death in systemic sclerosis (SSc) and affects up to 12% of all patients with SSc, with a 50% mortality rate within 3 years of PAH diagnosis. Compared with the idiopathic form of PAH (IPAH), patients with SSc-associated PAH (SSc-PAH) have a threefold increased risk of death and may receive a diagnosis late in the course of disease because of insidious onset and the high prevalence of cardiac, musculoskeletal, and pulmonary parenchymal comorbidities. Treatment with conventional forms of PAH therapy often yield poor results compared with IPAH cohorts; unfortunately, the exact reasons behind this remain poorly understood but likely include variations in the pathologic mechanisms, differences in cardiovascular response to increasing afterload, and inadequate strategies to detect and treat SSc-PAH early in its course. Current methods for screening and longitudinal evaluation of SSc-PAH, such as the 6-min walk test, transthoracic echocardiography, and MRI, each have notable advantages and disadvantages. We provide an up-to-date, focused review of SSc-PAH and how it differs from IPAH, including pathogenesis, appropriate screening for disease onset, and new approaches to treatment and longitudinal assessment of this disease. PMID:24081346

Health-Related Quality of Life in Heart Failure Patients With Varying Levels of Health Literacy Receiving Telemedicine and Standardized Education.

PubMed

Yehle, Karen S; Plake, Kimberly S; Nguyen, Patricia; Smith, Diane

2016-05-01

The purpose of this study was to examine the effect of telemonitoring plus education by home healthcare nurses on health-related quality of life in patients with heart failure who had varying health literacy levels. In this pretest/posttest treatment only study, 35 patients with a diagnosis of heart failure received home healthcare nurse visits, including education and telemonitoring. Heart failure education was provided by nurses at each home healthcare visit for approximately 15 to 20 minutes. All participants completed the Short-Form Test of Functional Health Literacy in Adults (S-TOFHLA) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) during the first week of home healthcare services. The MLHFQ was administered again at the completion of the covered home healthcare services period (1-3 visits per week for 10 weeks). Most participants were older adults (mean age 70.91±12.47) and had adequate health literacy (51.4%). Almost half of the participants were NYHA Class III (47.1%). All participants received individual heart failure education, but this did not result in statistically significant improvements in health-related quality-of-life scores. With telemonitoring and home healthcare nurse visits, quality-of-life scores improved by the conclusion of home healthcare services (clinically significant), but the change was not statistically significant. Individuals with marginal and inadequate health literacy ability were able to correctly use the telemonitoring devices.

Blood Glucagon Levels Predict the Hemoglobin A1c Response to Saxagliptin in Patients with Type 2 Diabetes Inadequately Controlled with Metformin.

PubMed

Liu, Hao; Hu, Yun; Li, Feng-Fei; Liu, Bing-Li; Su, Xiao-Fei; Ma, Jian-Hua

2016-12-01

Dipeptidyl peptidase-4 (DPP-4) inhibitors are widely used as second-option medications when metformin fails. Variance of the glycated hemoglobin (HbA1c) response to DPP-4 inhibitions in patients with type 2 diabetes mellitus (T2DM) has been observed, but the characteristics which predict the response to DPP-4 inhibitor therapy are unclear. The aim of this study was to investigate the characteristics of α- and β-cell functions which might predict the efficacy of saxagliptin and facilitate personalization of treatment. We studied 60 patients with T2DM who had inadequate glycemic control [HbA1c7.0-13.0% (53-119 mmol/mol)) with metformin alone. The patients were treated with saxagliptin (5 mg, daily) and metformin (1000-2000 mg as former) for 12 weeks. Oral glucose tolerance tests were carried out at baseline and endpoint to evaluate α- and β-cell functions, and blood C-peptide, insulin, glucagon levels were tested. Blood glucose, HbA1c and weight were also observed. Significant reduction of weight, HbA1c and glucagon was observed after 12-week treatment, while C-peptide, insulin and homeostasis model assessment-β increased (P < 0.05). Linear regression and receiver operating characteristic analysis showed that baseline HbA1c and 30 min-glucagon were correlated with the HbA1c response to saxagliptin, while the weight loss was correlated with gender, age and fasting-insulin level. Further analysis showed the 30 min-glucagon of 49.1 pmol/L was the optimal cutoff value to predict the efficacy of saxagliptin. Saxagliptin added to metformin significantly improved glycemic control and α- and β-cell function. Blood glucagon level was a good predicting factor for the HbA1c response to saxagliptin, and it will help appropriate patient selection. Chinese Clinical Trial Register identifier, ChiCTR-PPR-15007045.

Mandibular Fracture Patterns at a Medical Center in Central Taiwan: A 3-Year Epidemiological Review.

PubMed

Lin, Fu-Yu; Wu, Chao-I; Cheng, Hsu-Tang

2017-12-01

Mandibular fractures constitute a major portion of maxillofacial trauma and may lead to considerable functional and aesthetic sequelae if treatment is inadequate or delayed. An epidemiology study on mandibular fractures may guide the preventive efforts of the Taiwan public health care system. Therefore, a retrospective review was conducted at a medical center in central Taiwan to evaluate the current mandibular fracture epidemiology.The medical records and digitized radiographs of 198 patients who received treatment for mandibular fractures during a 3-year period (from October 2010 to September 2013) at a medical center in central Taiwan were reviewed to obtain demographic and injury data.The average age was 29.4 years (3-82 years). Patients aged 21 to 30 years sustained the most mandibular fractures (62 patients, 31.3%). The overall sex distribution (male to female) ratio was 1.8. Motor-vehicle accidents (MVAs) were the most common mechanism of injury (162 patients, 82%), and scooter and motorcycle riders wearing partial-coverage helmets constituted the majority of patients. A chart review identified 198 patients with 335 mandibular fractures; 113 patients (57.1%) had multiple mandibular fractures. The most common fracture sites were the symphysis and parasymphysis regions (38.9%), followed by the condyle (26.0%), angle (14.3%), body (14.3%), and ramus (6.6%).MVAs are the major cause of mandibular fractures in central Taiwan, and patients aged <30 years sustained the most mandibular fractures. Compared with previous studies, the present study has a higher percentage of women with mandibular fractures. In addition, inadequate mandibular protection by partial-coverage helmets may be a major reason for mandibular fractures most commonly localized in the symphysis and parasymphysis regions. The incidence and causes of mandibular fractures may reflect the trauma patterns within the community, thus facilitating the development of a preventive strategy for the socioeconomic and environmental background of central Taiwan. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON)

PubMed Central

Kremer, Joel M; Gaich, Carol L; DeLozier, Amy M; Schlichting, Douglas E; Xie, Li; Stoykov, Ivaylo; Rooney, Terence; Bird, Paul; Sánchez Bursón, Juan Miguel; Genovese, Mark C; Combe, Bernard

2017-01-01

Objectives To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs). Methods In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form-36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables. Results 527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI <0.5; p≤0.001), reductions in fatigue (FACIT-F ≥3.56; p≤0.05), improvements in PtGA (p≤0.001) and pain (p≤0.001) and reductions in duration of MJS (p<0.01). Conclusions Baricitinib improved most PROs through 24 weeks compared with placebo in this study of treatment-refractory patients with previously inadequate responses to bDMARDs, including at least one TNFi. PRO results aligned with clinical efficacy data for baricitinib. Trial registration number NCT01721044; Results. PMID:27799159

Hospital resource utilization and costs of inappropriate treatment of candidemia.

PubMed

Arnold, Heather M; Micek, Scott T; Shorr, Andrew F; Zilberberg, Marya D; Labelle, Andrew J; Kothari, Smita; Kollef, Marin H

2010-04-01

To evaluate the impact of inappropriate therapy--defined as delayed antifungal therapy beyond 24 hours from culture collection, inadequate antifungal dosage, or administration of an antifungal to which an isolate was considered resistant--on postculture hospital length of stay and costs, and to evaluate the relationship between modifiable risk factors, including failure to remove a central venous catheter, antifungal delay, and inadequate dosage, for an additive effect on hospital length of stay and costs. Single-center retrospective cohort study. 1250-bed academic medical center. One hundred sixty-seven consecutive adult patients admitted between January 2004 and May 2006 with culture-confirmed Candida bloodstream infections that occurred within 14 days of hospital admission and who received at least one dose of antifungal treatment. Patients were stratified according to appropriateness of antifungal therapy. Appropriate therapy was defined as initiation of an antifungal to which the isolated pathogen was sensitive in vitro within 24 hours of positive culture collection, in addition to receipt of an adequate dose as recommended by the Infectious Diseases Society of America and the antifungal package insert. Postculture length of stay was the primary outcome and hospital costs the secondary outcome. An evaluation of modifiable risk factors was performed separately. Data were analyzed for 167 patients (22 in the appropriate therapy group and 145 in the inappropriate therapy group). Postculture length of stay was shorter in the appropriate therapy group (mean 7 vs 10.4 days, p=0.037). This correlated with total hospital costs that were lower in the appropriate therapy group (mean $15,832 vs $33,021, p<0.001.) A graded increase in costs was noted with increasing number of modifiable risk factors (p=0.001). Inappropriate therapy for Candida bloodstream infection occurring within 14 days of hospitalization was associated with prolonged postculture length of stay and increased costs. A rise in costs, but not length of stay, was noted with increasing modifiable risk factors.

Long‐term safety and efficacy of canagliflozin as add‐on therapy to teneligliptin in Japanese patients with type 2 diabetes

PubMed Central

Kadowaki, Takashi; Inagaki, Nobuya; Kondo, Kazuoki; Nishimura, Kenichi; Kaneko, Genki; Maruyama, Nobuko; Nakanishi, Nobuhiro; Watanabe, Yumi; Gouda, Maki

2017-01-01

Aim To evaluate the long‐term safety and efficacy of canagliflozin as add‐on therapy in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control with teneligliptin monotherapy. Methods This open‐label 52‐week study was conducted in Japan. Patients received canagliflozin 100 mg added to teneligliptin 20 mg orally once daily for 52 weeks. The safety endpoint was the incidence of adverse events (AEs). The efficacy endpoints included changes in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG) and body weight from baseline to week 52 (with last observation carried forward). Results Overall, 153 patients entered the treatment period and 142 completed the study. The overall incidence rates of AEs and drug‐related AEs were 69.9% and 22.9%, respectively. Most AEs and drug‐related AEs were mild or moderate in severity. There were no previously undescribed safety signals. The mean changes in HbA1c, FPG and body weight were −0.99% (95% confidence interval [CI] −1.12 to −0.85), −38.6 mg/dL (95% CI −43.4 to −33.9) and −3.92% (95% CI −4.53 to −3.31), respectively. These effects were maintained for 52 weeks without attenuation. HbA1c and body weight were both decreased in 82.24% of patients at the end of the treatment period. Reductions in postprandial glucose were observed at weeks 24 and 52. Conclusions No new safety risks with this combination were identified, and sustained improvements in HbA1c, FPG and body weight were observed. The findings suggest that long‐term co‐administration of canagliflozin with teneligliptin is well tolerated and effective in Japanese patients with T2DM who have inadequate glycaemic control on teneligliptin alone. PMID:28608617

Value of ultrasonography as a marker of early response to abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results from the APPRAISE study

PubMed Central

D'Agostino, Maria-Antonietta; Wakefield, Richard J; Berner-Hammer, Hilde; Vittecoq, Olivier; Filippou, Georgios; Balint, Peter; Möller, Ingrid; Iagnocco, Annamaria; Naredo, Esperanza; Østergaard, Mikkel; Boers, Maarten; Gaillez, Corine; Van Holder, Karina; Le Bars, Manuela

2016-01-01

Objectives To study the responsiveness of a combined power Doppler and greyscale ultrasound (PDUS) score for assessing synovitis in biologic-naïve patients with rheumatoid arthritis (RA) starting abatacept plus methotrexate (MTX). Methods In this open-label, multicentre, single-arm study, patients with RA (MTX inadequate responders) received intravenous abatacept (∼10 mg/kg) plus MTX for 24 weeks. A composite PDUS synovitis score, developed by the Outcome Measures in Rheumatology–European League Against Rheumatism (OMERACT–EULAR)-Ultrasound Task Force, was used to evaluate individual joints. The maximal score of each joint was added into a Global OMERACT–EULAR Synovitis Score (GLOESS) for bilateral metacarpophalangeal joints (MCPs) 2–5 (primary objective). The value of GLOESS containing other joint sets was explored, along with clinical efficacy. Results Eighty-nine patients completed the 24-week treatment period. The earliest PDUS sign of improvement in synovitis was at week 1 (mean change in GLOESS (MCPs 2–5): −0.7 (95% CIs −1.2 to −0.1)), with continuous improvement to week 24. Early improvement was observed in the component scores (power Doppler signal at week 1, synovial hyperplasia at week 2, joint effusion at week 4). Comparable changes were observed for 22 paired joints and minimal joint subsets. Mean Disease Activity Score 28 (C reactive protein) was significantly reduced from weeks 1 to 24, reaching clinical meaningful improvement (change ≥1.2) at week 8. Conclusions In this first international prospective study, the composite PDUS score is responsive to abatacept. GLOESS demonstrated the rapid onset of action of abatacept, regardless of the number of joints examined. Ultrasound is an objective tool to monitor patients with RA under treatment. Trial registration number NCT00767325. PMID:26590174

The effects of chamomile extract on sleep quality among elderly people: A clinical trial.

PubMed

Adib-Hajbaghery, Mohsen; Mousavi, Seyedeh Nesa

2017-12-01

The prevalence of insomnia increases with age. Chamomile is among the medicinal plants which are used as tranquilizer. Yet, there is inadequate experimental and clinical evidence regarding its hypnotic effects. This study sought to evaluate the effects of chamomile extract on sleep quality among elderly people. A single-blind randomized controlled trial was performed. A convenient sample of sixty elderly people who aged sixty or more and lived in Kahrizak day care nursing home, Karaj, Iran, were randomly allocated to a control and a treatment group. The treatment group received chamomile extract capsules (200mg) twice a day for 28 consecutive days while the control group received wheat flour capsules (200mg) in the same manner. Using the Pittsburgh Sleep Quality Index, sleep quality was assessed immediately before, two weeks after beginning, immediately after the completion, and two weeks after the completion of the intervention. The data were analyzed via the independent-sample t, Chi-square, and Fisher's exact tests as well as the repeated measures analysis of variance. The means of age in the control and the treatment groups were 70.73±6.44 and 69.36±4.99, respectively. Except for the habitual sleep efficiency component of the Sleep Quality Index, the study groups did not differ significantly from each other at baseline regarding the scores of the other components of the index. Moreover, at baseline, sleep quality in both groups was low, with no statistically significant between-group difference (P=0.639). However, after the intervention, sleep quality in the treatment group was significantly better than the control group (P<0.05). The use of chamomile extract can significantly improve sleep quality among elderly people. Thus, it can be used as a safe modality for promoting elderly people's sleep. Copyright © 2017 Elsevier Ltd. All rights reserved.

Rating maternal and neonatal health services in developing countries.

PubMed Central

Bulatao, Rodolfo A.; Ross, John A.

2002-01-01

OBJECTIVE: To assess maternal and neonatal health services in 49 developing countries. METHODS: The services were rated on a scale of 0 to 100 by 10 - 25 experts in each country. The ratings covered emergency and routine services, including family planning, at health centres and district hospitals, access to these services for both rural and urban women, the likelihood that women would receive particular forms of antenatal and delivery care, and supporting elements of programmes such as policy, resources, monitoring, health promotion and training. FINDINGS: The average rating was only 56, but countries varied widely, especially in access to services in rural areas. Comparatively good ratings were reported for immunization services, aspects of antenatal care and counselling on breast feeding. Ratings were particularly weak for emergency obstetric care in rural areas, safe abortion and HIV counselling. CONCLUSION: Maternal health programme effort in developing countries is seriously deficient, particularly in rural areas. Rural women are disadvantaged in many respects, but especially regarding the treatment of emergency obstetric conditions. Both rural and urban women receive inadequate HIV counselling and testing and have quite limited access to safe abortion. Improving services requires moving beyond policy reform to strengthening implementation of services and to better staff training and health promotion. Increased financing is only part of the solution. PMID:12378290

Health facility-based data on women receiving sulphadoxine-pyrimethamine during pregnancy in Tanzania: lessons to learn from a cross-sectional survey in Mkuranga and Mufindi districts and other national survey reports

PubMed Central

2014-01-01

Background A study of health facility (HF) data on women receiving sulphadoxine-pyrimethamine (SP) for intermittent preventive treatment of malaria during pregnancy (IPTp) was carried out at antenatal care clinics in Mkuranga and Mufindi districts. Methods A review of health management information system (HMIS) registers, interviews with health-care workers (HWs) and district and national level malaria control program managers corroborated by inter-temporal assessment through observations at HF levels. Statistical data were analyzed in Excel and interpreted in triangulation with qualitative data from interviews and observations. Results Data indicated that IPTp doses administered to women were inadequate and partly inconsistent. HMIS registers lacked space for IPT records, forcing HWs to manipulate their record-keeping. The proportion/number of IPTp recipients in related to the supply of SP for free delivery, to women’s attendance behaviours, showed variation by quarter and year of reporting. Conclusion It is impossible to achieve rational health service planning when the HMIS is weak. Whilst it is acknowledged that the HMIS is already overloaded, concerted measures are urgently needed to accommodate data on new interventions and other vertical programs if malaria programs are to achieve their goals. PMID:24433529

Nigerian Medical Students' Opinions about the Undergraduate Curriculum in Psychiatry

ERIC Educational Resources Information Center

James, Bawo; Omoaregba, Joyce; Okogbenin, Esther; Buhari, Olubunmi; Obindo, Taiwo; Okonoda, Mayowa

2013-01-01

Objective: The number of psychiatrists in Nigeria is inadequate to meet the treatment needs for neuropsychiatric disorders. Developing mental health competency in the future Nigerian physician workforce is one approach to filling the treatment gap. The authors aimed to assess medical students' attitudes to this training and its relevance to their…

Prevalence and pattern of epilepsy treatment in different socioeconomic classes in Brazil.

PubMed

Noronha, Ana L A; Borges, Moacir A; Marques, Lucia H N; Zanetta, Dirce M T; Fernandes, Paula T; de Boer, Hanneke; Espíndola, Javier; Miranda, Claudio T; Prilipko, Leonid; Bell, Gail S; Sander, Josemir W; Li, Li M

2007-05-01

The worldwide prevalence of epilepsy is variable, estimated at 10//1,000 people, and access to treatment is also variable. Many people go untreated, particularly in resource-poor countries. To estimate the prevalence of epilepsy and the proportion of people not receiving adequate treatment in different socioeconomic classes in Brazil, a resource-poor country. A door-to-door survey was conducted to assess the prevalence and treatment gap of epilepsy in three areas of two towns in Southeast Brazil with a total population of 96,300 people. A validated screening questionnaire for epilepsy (sensitivity 95.8%, specificity 97.8%) was used. A neurologist further ascertained positive cases. A validated instrument for socioeconomic classification was used. Lifetime prevalence was 9.2/1,000 people [95% CI 8.4-10.0] and the prevalence of active epilepsy was 5.4/1,000 people. This was higher in the more deprived social classes (7.5/1,000 compared with 1.6/1,000 in the less deprived). Prevalence was also higher in elderly people (8.5/1,000). Thirty-eight percent of patients with active epilepsy had inadequate treatment (19% on no medication); the figures were similar in the different socioeconomic groups. The prevalence of epilepsy in Brazil is similar to other resource-poor countries, and the treatment gap is high. Epilepsy is more prevalent among less wealthy people and in elderly people. There is an urgent need for education in Brazil to inform people that epilepsy is a treatable, as well as preventable, condition.

Learn about Small Wastewater Systems

EPA Pesticide Factsheets

Many small and rural communities, including those in Indian Country and along the U.S.-Mexico border, struggle with aging or inadequate wastewater treatment systems, or do not have access to basic wastewater services.

Experiences of caregivers of infants who have been on bubble continuous positive airway pressure at Queen Elizabeth Central Hospital, Malawi: A descriptive qualitative study.

PubMed

Gondwe, Mtisunge Joshua; Gombachika, Belinda; Majamanda, Maureen D

2017-03-01

An innovative, low-cost bubble continuous positive airway pressure (bCPAP) device has recently been introduced in Malawi for the treatment of respiratory distress in infants. While this novel bCPAP system has been shown to be safe and effective in reducing infant mortality, caregivers' experiences have not been investigated. The purpose of this study was to explore experiences of parents and guardians of infants who had been on bCPAP at Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi. This was a descriptive phenomenological study that was carried out at the Chatinkha nursery unit and the paediatric nursery ward at QECH, from January to February 2015. Purposive sampling was used to select participants for in-depth interviews. Data saturation was reached with 12 caregivers. Data were analysed using Colaizzi's framework. Caregivers received inadequate, inconsistent, and sporadic information about bCPAP. Student nurses and doctors were best able to answer caregivers' questions and concerns. When their infants were on bCPAP, caregivers felt anxious and fearful. However, upon implementation of bCPAP treatment for their children, the caregivers were satisfied with it. The main sources of psychological stress were limited parent-child interaction and the constraints of prescribed visiting hours. Family, friends, and caregiver involvement in the care of infants provided some psychological comfort. The results show gaps in the information and psychological support that mothers of infants on bCPAP receive in hospital. We recommend that psychological support be given to the mothers of infants on bCPAP at QECH.

Low-volume bowel preparation is inferior to standard 4 1 polyethylene glycol.

PubMed

Haapamäki, Markku M; Lindström, Monica; Sandzén, Birger

2011-03-01

Four liters or more of orally taken polyethylene glycol solution (PEG) has proved to be an effective large-bowel cleansing method prior to colonoscopy. The problem has been the large volume of fluid and its taste, which is unacceptable to some examinees. We aimed to investigate the effectiveness of 2 l PEG combined with senna compared with 4 l PEG for bowel preparation. The design was a single-center, prospective, randomized, investigator-blinded study with parallel assignment, in the setting of the Endoscopy Unit of Umeå University Hospital. Outpatients (n = 490) scheduled for colonoscopy were enrolled. The standard-volume arm received 4 l PEG, and the low-volume arm received 36 mg senna glycosides in tablets and 2 l PEG. The cleansing result (primary endpoint) was assessed by the endoscopist using the Ottawa score. The patients rated the subjective grade of ease of taking the bowel preparation. Analysis was on an intention-to-treat basis. There were significantly more cases with poor or inadequate bowel cleansing after the low-volume alternative with senna and 2 l PEG (22/203) compared with after 4 l PEG (8/196, p = 0.027). The low-volume alternative was better tolerated by the examinees: 119/231 rated the treatment as easy to take compared with 88/238 in the 4 l PEG arm (p = 0.001). 4 l PEG treatment is better than 36 mg senna and 2 l PEG as routine colonic cleansing before colonoscopy because of fewer failures.

Warfarin or aspirin in embolism prevention in patients with mitral valvulopathy and atrial fibrillation.

PubMed

Lavitola, Paulo de Lara; Sampaio, Roney Orismar; Oliveira, Walter Amorim de; Bôer, Berta Napchan; Tarasoutchi, Flavio; Spina, Guilherme Sobreira; Grinberg, Max

2010-12-01

Atrial fibrillation (AF) associated to rheumatic mitral valve disease (RMVD) increases the incidence of thromboembolism (TE), with warfarin being the standard therapy, in spite of difficulties in treatment adherence and therapeutic control. To compare the effectiveness of Aspirin vs Warfarin in TE prevention in patients with AF and RMVD. A total of 229 patients (pts) with AF and RMVD were followed in a prospective and randomized study. The first group consisted of 110 pts receiving Aspirin - 200 mg/day (Group Aspirin - GA) and the second group consisted of 119 pts receiving Warfarin at individually-adjusted doses (Group Warfarin - GW). There were 15 embolic events in GA and 24 in GW (p = 0.187), of which 21 presented INR < 2.0. Thus, after excluding patients with inadequate INR, there was a higher number of embolic events in GA than in GW (15 vs 3) (p < 0.0061). The GW showed lower treatment adherence (p = 0.001). Neither group presented episodes of major bleeding. Small bleeding episodes were more frequent in the GW (p < 0.01). Increased serum levels of cholesterol and triglycerides constituted a risk factor for a higher number of thromboembolic events in the studied population, with no difference between the groups. In patients presenting RMVD with AF for less than a year and no previous embolism, Aspirin is little effective in preventing TE. Patients with lower-risk mitral valvulopathy (mitral regurgitation and mitral biological prosthesis), especially in cases presenting contraindication to or low adherence to Warfarin, Aspirin use can present some benefit in TE prevention.

Vitamin D and Depression: Where is all the Sunshine?

PubMed Central

Penckofer, Sue; Kouba, Joanne; Byrn, Mary; Ferrans, Carol Estwing

2010-01-01

Depression in its own right is a disabling condition impairing all aspects of human function. In persons with a chronic medical disease, depression often makes the management of chronic illness more difficult. Recently, vitamin D has been reported in the scientific and lay press as an important factor that may have significant health benefits in the prevention and the treatment of many chronic illnesses. Most individuals in this country have insufficient levels of vitamin D. This is also true for persons with depression as well as other mental disorders. Whether this is due to insufficient dietary intake, lifestyle (e.g., little outdoor exposure to sunshine), or other factors is addressed in this paper. In addition, groups at risk and suggested treatment for inadequate vitamin D levels are addressed. Effective detection and treatment of inadequate vitamin D levels in persons with depression and other mental disorders may be an easy and cost-effective therapy which could improve patients’ long-term health outcomes as well as their quality of life. PMID:20450340

[INERTIA study: Clinical inertia in non-insulinized patients on oral hypoglycemic treatment. A study in Spanish primary and specialty care settings].

PubMed

González-Clemente, José Miguel; Font, Beatriu; Lahoz, Raquel; Llauradó, Gemma; Gambús, Gemma

2014-06-06

To study clinical inertia in the management of oral hypoglycemic agents (OHA) in non-insulin treated patients with type 2 diabetes mellitus (T2DM) in Spain. Epidemiological, cross-sectional, retrospective (2 years), multicenter study. Clinical inertia was measured as the total number of patients without OHA treatment intensification divided by the total number of patients with inadequate HbA1c values (≥7%), multiplied by 100. Total clinical inertia (TCI) was the absence of OHA treatment intensification in all visits with a HbA1c≥7% values in the previous 2 years; partial clinical inertia (PCI) occurred when this absence only occurred in some of these visits. We assessed OHA treatment compliance with the Morisky-Green test. We included 2,971 patients, 1,416 adequately controlled (HbA1c<7%) and 1,555 inadequately controlled (HbA1c≥7%). PCI prevalence was 52.5%(95% confidence interval [95% CI] 52.4-52.6%) while TCI prevalence was 12.8% (95% CI 12.2-13.8%). PCI was lower in patients adequately controlled as compared with those inadequately controlled (31.4% vs. 71.8%; P<.001). PCI was associated with sedentary lifestyle, hypertension and higher prevalence of micro and macrovascular complications. Only 38.0% of patients were compliant with the OHA treatment, being this percentage even lower in subjects with ICP. Two variables were independently associated with ICP: female sex (odds ratio [OR] 1.43; 95% CI 1.09-1.86%) and a shorter duration of DM2 (OR 0.98; 95% CI 0.95-0.99). One out of 2 patients with T2DM and treated with OHA without insulin suffer from PCI. Only 4 out of 10 patients are compliant with OHA treatment. Female sex and a shorter duration of T2DM are independently associated with PCI. Copyright © 2012 Elsevier España, S.L. All rights reserved.

Adapting Japanese Lesson Study to Enhance the Teaching and Learning of Geometry and Spatial Reasoning in Early Years Classrooms: A Case Study

ERIC Educational Resources Information Center

Moss, Joan; Hawes, Zachary; Naqvi, Sarah; Caswell, Beverly

2015-01-01

Increased efforts are needed to meet the demand for high quality mathematics in early years classrooms. Despite the foundational role of geometry and spatial reasoning for later mathematics success, the strand receives inadequate instructional time and is limited to concepts of static geometry. Moreover, early years teachers typically lack both…

Effects of Weightlessness on Vestibular Development of Quail

NASA Technical Reports Server (NTRS)

Fritzsch, Bernd; Bruce, Laura L.

1999-01-01

The data confirm previous findings that quail embryos can, under proper circumstances, develop until hatching in microgravity. There were no gross abnormalities in the few ears of the late embryos (we received 3 ears at E14.5 and 4 ears at E16.5). Due to inadequate numbers of samples returned and their fully insufficient fixation, no conclusions could be reached that warrant any publications.

Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis.

PubMed

Strand, Vibeke; van Vollenhoven, Ronald F; Lee, Eun Bong; Fleischmann, Roy; Zwillich, Samuel H; Gruben, David; Koncz, Tamas; Wilkinson, Bethanie; Wallenstein, Gene

2016-06-01

To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX. In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks or placebo. PROs included HAQ-Disability Index, Patient Global Assessment of Arthritis, Patient Assessment of Arthritis Pain, health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) and sleep (Medical Outcomes Study-Sleep). At month 3, tofacitinib 10 mg BID treatment resulted in significant changes from baseline vs placebo across all PROs, sustained to month 12, with the highest number of patients reporting improvements ⩾minimum clinically important differences vs placebo (P < 0.05). Changes from baseline at month 3 with tofacitinib 5 mg BID and adalimumab were similar and statistically significant vs placebo across most PROs, excluding SF-36 Mental Component Score and Social Functioning, Role Emotional, and Mental Health domains, with significantly more patients reporting improvements ⩾minimum clinically important differences. Numbers Needed to Treat were lowest for tofacitinib 10 mg BID and similar between tofacitinib 5 mg BID and adalimumab. Patients with moderate to severe RA and inadequate responses to MTX reported improvements across a broad range of PROs with tofacitinib 5 and 10 mg BID and adalimumab that were significantly superior to placebo. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis

PubMed Central

Strand, Vibeke; van Vollenhoven, Ronald F.; Lee, Eun Bong; Fleischmann, Roy; Zwillich, Samuel H.; Gruben, David; Koncz, Tamas; Wilkinson, Bethanie

2016-01-01

Objective. To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX. Methods. In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks or placebo. PROs included HAQ-Disability Index, Patient Global Assessment of Arthritis, Patient Assessment of Arthritis Pain, health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) and sleep (Medical Outcomes Study-Sleep). Results. At month 3, tofacitinib 10 mg BID treatment resulted in significant changes from baseline vs placebo across all PROs, sustained to month 12, with the highest number of patients reporting improvements ⩾minimum clinically important differences vs placebo (P < 0.05). Changes from baseline at month 3 with tofacitinib 5 mg BID and adalimumab were similar and statistically significant vs placebo across most PROs, excluding SF-36 Mental Component Score and Social Functioning, Role Emotional, and Mental Health domains, with significantly more patients reporting improvements ⩾minimum clinically important differences. Numbers Needed to Treat were lowest for tofacitinib 10 mg BID and similar between tofacitinib 5 mg BID and adalimumab. Conclusion. Patients with moderate to severe RA and inadequate responses to MTX reported improvements across a broad range of PROs with tofacitinib 5 and 10 mg BID and adalimumab that were significantly superior to placebo. PMID:26929445

Molecular imaging of RNA interference therapy targeting PHD2 for treatment of myocardial ischemia.

PubMed

Huang, Mei; Wu, Joseph C

2011-01-01

Coronary artery disease is the number one cause of morbidity and mortality in the Western world. It typically occurs when heart muscle receives inadequate blood supply due to rupture of atherosclerotic plaques. During ischemia, up-regulation of hypoxia inducible factor-1 alpha (HIF-1α) transcriptional factor can activate several downstream angiogenic genes. However, HIF-1α is naturally degraded by prolyl hydroxylase-2 (PHD2) protein. Recently, we cloned the mouse PHD2 gene by comparing the homolog gene in human and rat. The best candidate shRNA sequence for inhibiting PHD2 was inserted behind H1 promoter, followed by a separate hypoxia response element (HRE)-incorporated promoter driving a firefly luciferase (Fluc) reporter gene. This construct allowed us to monitor gene expression noninvasively and was used to test the hypothesis that inhibition of PHD2 by short hairpin RNA interference (shRNA) can lead to significant improvement in angiogenesis and contractility as revealed by in vitro and in vivo experiments.

Medication adherence and its associated factors among diabetic patients at Zewditu Memorial Hospital, Addis Ababa, Ethiopia.

PubMed

Ali, Muhammed; Alemu, Tigestu; Sada, Oumer

2017-12-04

Diabetes is a global problem with devastating human, social and economic impact. Anti-diabetic medications play a major role in the glycemic control of patients with diabetes. However, inadequate adherence compromises safety and treatment effectiveness, leading to increased mortality and morbidity. The aim of this study was to assess adherence to anti-diabetic medications and associated factors among patient with diabetes mellitus receiving care at Zewditu Memorial Hospital. Among the total of 146 diabetic patients (mean age 46.5 ± 14.7), the level of adherence to anti diabetic medication was 54.8% (80) whilst 45.2% (66) of the participants were non adherent. Multiple logistic regression showed that knowledge of medication (AOR = 4.905, 95% CI 1.64-14.62, medication availability (AOR = 0.175, 95% CI 0.031-0.987) and education level (AOR = 13.65, 95% CI 1.45-128.456) were reasons for non-adherence.

[Online information service: the library support for evidence-based practice].

PubMed

Markulin, Helena; Petrak, Jelka

2014-01-01

It frequently happens that physicians do not have adequate skills or enough time for searching and evaluating evidence needed in their everyday practice. Medical librarian can serve as a mediator in enabling physicians to utilize the potential offered by contemporary evidence-based medicine. The Central Medical Library (CML) at University of Zagreb, School of Medicine, designed a web-based information service aimed at the promotion of evidence-based practice in the Croatian medical community. The users can ask for a help in finding information on their clinical problems. A responsible librarian will analyse the problem, search information resources and evaluate the evidence. The answer is returned to the user by an e-mail. In the 2008-2012 period 166 questions from 12 clinical fields were received and most of them (36.1%) came from internal medicine doctors. The share of treatment-related questions was 70.5%. In the setting of underdeveloped ICT infrastructure and inadequate EBM resources availability, such information service can help in transfer of scientific evidence into the everyday clinical practice.

Molecular Imaging of RNA Interference Therapy Targeting PHD2 for Treatment of Myocardial Ischemia

PubMed Central

Huang, Mei; Wu, Joseph C.

2011-01-01

Summary Coronary artery disease is the number one cause of morbidity and mortality in the Western world. It typically occurs when heart muscle receives inadequate blood supply due to rupture of atherosclerotic plaques. During ischemia, up-regulation of hypoxia inducible factor-1 alpha (HIF-1α) transcriptional factor can activate several downstream angiogenic genes. However, HIF-1α is naturally degraded by prolyl hydroxylase-2 (PHD2) protein. Recently, we cloned the mouse PHD2 gene by comparing the homolog gene in human and rat. The best candidate shRNA sequence for inhibiting PHD2 was inserted behind H1 promoter, followed by a separate hypoxia response element (HRE)-incorporated promoter driving a firefly luciferase (Fluc) reporter gene. This construct allowed us to monitor gene expression noninvasively and was used to test the hypothesis that inhibition of PHD2 by short hairpin RNA interference (shRNA) can lead to significant improvement in angiogenesis and contractility as revealed by in vitro and in vivo experiments. PMID:21194030

Barriers to and facilitators of HIV-positive patients' adherence to antiretroviral treatment regimens.

PubMed

Roberts, K J

2000-03-01

HIV-positive patients must strictly adhere to antiretroviral regimens for the medications to work properly. Little, however, is known about the obstacles that patients face in adhering to the regimens or what, if anything, helps patients to adhere. The goals of the project were to describe, from HIV-positive patients' own perspectives, the barriers they face in adhering to antiretroviral regimens and the strategies they use to maximize their adherence. Five main barriers (forgetfulness, social/physical environment, complexity of the regimens, medication side effects, and inadequate patient knowledge) to adherence and six main facilitators (mechanical devices, "making a commitment," "routinizing," health beliefs, social support, and professional support) emerged from the data. Patients may overcome some of these barriers by receiving better health education about the need for adherence, professional and lay support for their efforts, and mechanical devices such as alarm clocks and medi-sets. Other barriers, however, such as the complexity of the medications, highlight the need for simplified antiretroviral regimens.

Brief Report: Secukinumab Provides Significant and Sustained Inhibition of Joint Structural Damage in a Phase III Study of Active Psoriatic Arthritis.

PubMed

van der Heijde, Désirée; Landewé, Robert B; Mease, Philip J; McInnes, Iain B; Conaghan, Philip G; Pricop, Luminita; Ligozio, Greg; Richards, Hanno B; Mpofu, Shephard

2016-08-01

To assess whether secukinumab treatment in patients with active psoriatic arthritis (PsA) is associated with sustained inhibition of radiographic progression. In this phase III, double-blind, placebo-controlled study, 606 patients with PsA were randomized to receive intravenous (IV) secukinumab at a dose of 10 mg/kg (weeks 0, 2, 4) followed by subcutaneous secukinumab at a dose of 150 mg or 75 mg (the IV→150 mg and IV→75 mg groups, respectively) or placebo. Patients were stratified according to prior anti-tumor necrosis factor (anti-TNF) exposure (71% were anti-TNF naive). At week 16, placebo-treated patients who had at least a 20% reduction in the tender and swollen joint counts (responders) continued to receive placebo until week 24; nonresponders were re-randomized to receive secukinumab at a dose of 150 mg or 75 mg. The modified total Sharp/van der Heijde score (SHS) was determined at baseline, week 16 or 24, and week 52. In the overall population, radiographic progression was inhibited through 52 weeks; efficacy was demonstrated for both erosion and joint space narrowing scores and in patients who switched from placebo to secukinumab at week 24. Subgroup analyses showed that secukinumab reduced radiographic progression at week 24, regardless of previous anti-TNF treatment. Among anti-TNF-naive patients, the mean changes from baseline to week 24 in the modified total SHS were 0.05 in the pooled secukinumab group and 0.57 in the placebo group; among patients with an inadequate response or intolerance to anti-TNF treatment, the mean changes were 0.16 and 0.58, respectively. Anti-TNF-naive patients showed negligible progression through week 52. Inhibition of structural damage was observed through week 52 irrespective of concomitant methotrexate use. A high proportion of patients receiving secukinumab showed no progression (change in SHS of ≤ 0.5) from baseline to week 24 (82.3% of the IV→150 mg group and 92.3% of the IV→75 mg group) and from week 24 to week 52 (85.7% of the IV→150 mg group and 85.8% of the IV→75 mg group). Secukinumab inhibited radiographic progression over 52 weeks of treatment in patients with active PsA. © 2016 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.

Impact of [18F]fluorodeoxyglucose PET-CT staging on treatment planning in radiotherapy incorporating elective nodal irradiation for non-small-cell lung cancer: a prospective study.

PubMed

Kolodziejczyk, Milena; Kepka, Lucyna; Dziuk, Miroslaw; Zawadzka, Anna; Szalus, Norbert; Gizewska, Agnieszka; Bujko, Krzysztof

2011-07-15

To evaluate prospectively how positron emission tomography (PET) information changes treatment plans for non-small-cell lung cancer (NSCLC) patients receiving or not receiving elective nodal irradiation (ENI). One hundred consecutive patients referred for curative radiotherapy were included in the study. Treatment plans were carried out with CT data sets only. For stage III patients, mediastinal ENI was planned. Then, patients underwent PET-CT for diagnostic/planning purposes. PET/CT was fused with the CT data for final planning. New targets were delineated. For stage III patients with minimal N disease (N0-N1, single N2), the ENI was omitted in the new plans. Patients were treated according to the PET-based volumes and plans. The gross tumor volume (GTV)/planning tumor volume (PTV) and doses for critical structures were compared for both data sets. The doses for areas of potential geographical misses derived with the CT data set alone were compared in patients with and without initially planned ENI. In the 75 patients for whom the decision about curative radiotherapy was maintained after PET/CT, there would have been 20 cases (27%) with potential geographical misses by using the CT data set alone. Among them, 13 patients would receive ENI; of those patients, only 2 patients had the PET-based PTV covered by 90% isodose by using the plans based on CT alone, and the mean of the minimum dose within the missed GTV was 55% of the prescribed dose, while for 7 patients without ENI, it was 10% (p = 0.006). The lung, heart, and esophageal doses were significantly lower for plans with ENI omission than for plans with ENI use based on CT alone. PET/CT should be incorporated in the planning of radiotherapy for NSCLC, even in the setting of ENI. However, if PET/CT is unavailable, ENI may to some extent compensate for an inadequate dose coverage resulting from diagnostic uncertainties. Copyright © 2011 Elsevier Inc. All rights reserved.

Prospective randomized trial of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC) versus paclitaxel and FAC (TFAC) in patients with operable breast cancer: impact of taxane chemotherapy on locoregional control.

PubMed

Albert, Jeffrey M; Buzdar, Aman U; Guzman, Reina; Allen, Pamela K; Strom, Eric A; Perkins, George H; Woodward, Wendy A; Hoffman, Karen E; Tereffe, Welela; Hunt, Kelly K; Buchholz, Thomas A; Oh, Julia L

2011-07-01

A previous randomized trial (CALGB 9344/Intergroup 0148) compared four cycles of adjuvant doxorubicin/cyclophosphamide (AC) to four cycles of AC plus four cycles of paclitaxel (AC + T) and demonstrated that the addition of paclitaxel improved locoregional control (LRC) in patients with node-positive breast cancer. However, it could not be determined whether it was the paclitaxel or the increased duration of chemotherapy that led to this improvement. The present study aimed to analyze whether the addition of paclitaxel to a doxorubicin-based regimen improves LRC in a cohort of patients who all received eight total cycles of chemotherapy. Five hundred eleven women with operable breast cancer were randomized on a single-institution prospective trial to receive 5-fluorouracil, doxorubicin, cyclophosphamide (FAC) × 8 cycles (n = 252) or FAC × 4 cycles plus paclitaxel × 4 cycles (TFAC) (n = 259). Rates of LRC and overall survival (OS) were analyzed. Median follow-up was 124 months (range 5-167 months). The 10-year LRC rate was 92.6 versus 93.1% in the FAC versus TFAC arms, respectively (P = 0.26). The LRC between treatment arms did not differ when analyzed by locoregional treatment group: breast conservation therapy (BCT), mastectomy alone (M), and mastectomy + radiation (M + RT). The 10-year LRC rates were 95.1% (FAC) versus 91.2% (TFAC) after BCT (P = 0.98), 89.5% (FAC) versus 93.4% (TFAC) after M (P = 0.24), and 94.7% (FAC) versus 96.5% (TFAC) after M + RT (P = 0.59). Additionally, there was no difference in OS between the treatment arms, with 10-year OS rates of 78.4% (FAC) versus 81.7% (TFAC) (P = 0.93). The addition of paclitaxel to a doxorubicin-based regimen had no impact on LRC, regardless of the type of local therapy received. Historically inferior LRC with AC chemotherapy alone versus AC + T may have been due to an inadequate duration of systemic therapy and not due to the absence of paclitaxel.

Outcomes and secondary prevention strategies for male hip fractures.

PubMed

Riley, Rebecca L; Carnes, Molly L; Gudmundsson, Adalsteinn; Elliott, Mary E

2002-01-01

To assess clinical outcomes and determine whether osteoporosis assessment and secondary prevention strategies were performed for male veterans hospitalized for hip fractures. Retrospective chart review for male veterans hospitalized for hip fracture from January 1993 through July 1999. The Veterans Affairs Medical Center, Madison, WI. Medical charts were available for 46 of 53 male patients admitted for hip fracture during the study period. Three subjects were excluded because hip fracture was associated with high-impact trauma. Mean age of the 43 study patients was 72 years (range 43-91 y), and mean length of hospitalization was 16 days (median 11 d, range 3-108 d). Thirty-two (82%) of 39 veterans whose disposition was documented were discharged to a nursing home. Eleven (26%) of 43 men died within 12 months after fracture. Twelve (28%) had fractured previously. Four (10%) subsequently had another fracture. Three of 9 patients with documented ambulation status were ambulatory at 1 year. Three patients received a bone mass measurement within a prespecified time interval of 6 months subsequent to fracture. No patient's records included a diagnosis of osteoporosis either before or within 6 months after fracture. One-third of the patients had documentation of calcium or multivitamin supplementation at discharge. One patient was receiving calcitonin at the time of fracture and continued to receive it afterward. No other patient was prescribed antiresorptive therapy by the time of hospital discharge. Male veterans with hip fractures received inadequate evaluation and treatment for osteoporosis, although a substantial portion had documentation of recurrent fractures. Education of clinicians and creation of algorithms for management of established osteoporosis may improve outcomes for these individuals.

Design and Weighting Methods for a Nationally Representative Sample of HIV-infected Adults Receiving Medical Care in the United States-Medical Monitoring Project

PubMed Central

Iachan, Ronaldo; H. Johnson, Christopher; L. Harding, Richard; Kyle, Tonja; Saavedra, Pedro; L. Frazier, Emma; Beer, Linda; L. Mattson, Christine; Skarbinski, Jacek

2016-01-01

Background: Health surveys of the general US population are inadequate for monitoring human immunodeficiency virus (HIV) infection because the relatively low prevalence of the disease (<0.5%) leads to small subpopulation sample sizes. Objective: To collect a nationally and locally representative probability sample of HIV-infected adults receiving medical care to monitor clinical and behavioral outcomes, supplementing the data in the National HIV Surveillance System. This paper describes the sample design and weighting methods for the Medical Monitoring Project (MMP) and provides estimates of the size and characteristics of this population. Methods: To develop a method for obtaining valid, representative estimates of the in-care population, we implemented a cross-sectional, three-stage design that sampled 23 jurisdictions, then 691 facilities, then 9,344 HIV patients receiving medical care, using probability-proportional-to-size methods. The data weighting process followed standard methods, accounting for the probabilities of selection at each stage and adjusting for nonresponse and multiplicity. Nonresponse adjustments accounted for differing response at both facility and patient levels. Multiplicity adjustments accounted for visits to more than one HIV care facility. Results: MMP used a multistage stratified probability sampling design that was approximately self-weighting in each of the 23 project areas and nationally. The probability sample represents the estimated 421,186 HIV-infected adults receiving medical care during January through April 2009. Methods were efficient (i.e., induced small, unequal weighting effects and small standard errors for a range of weighted estimates). Conclusion: The information collected through MMP allows monitoring trends in clinical and behavioral outcomes and informs resource allocation for treatment and prevention activities. PMID:27651851

Seladelpar (MBX-8025), a selective PPAR-δ agonist, in patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid: a double-blind, randomised, placebo-controlled, phase 2, proof-of-concept study.

PubMed

Jones, David; Boudes, Pol F; Swain, Mark G; Bowlus, Christopher L; Galambos, Michael R; Bacon, Bruce R; Doerffel, Yvonne; Gitlin, Norman; Gordon, Stuart C; Odin, Joseph A; Sheridan, David; Wörns, Markus-Alexander; Clark, Virginia; Corless, Linsey; Hartmann, Heinz; Jonas, Mark E; Kremer, Andreas E; Mells, George F; Buggisch, Peter; Freilich, Bradley L; Levy, Cynthia; Vierling, John M; Bernstein, David E; Hartleb, Marek; Janczewska, Ewa; Rochling, Fedja; Shah, Hemant; Shiffman, Mitchell L; Smith, John H; Choi, Yun-Jung; Steinberg, Alexandra; Varga, Monika; Chera, Harinder; Martin, Robert; McWherter, Charles A; Hirschfield, Gideon M

2017-10-01

Many patients with primary biliary cholangitis have an inadequate response to first-line therapy with ursodeoxycholic acid. Seladelpar is a potent, selective agonist for the peroxisome proliferator-activated receptor-delta (PPAR-δ), which is implicated in bile acid homoeostasis. This first-in-class study evaluated the anti-cholestatic effects and safety of seladelpar in patients with an inadequate response to ursodeoxycholic acid. The study was a 12-week, double-blind, placebo-controlled, phase 2 trial of patients with alkaline phosphatase of at least 1·67 times the upper limit of normal (ULN) despite treatment with ursodeoxycholic acid. Patients, recruited at 29 sites in North America and Europe, were randomly assigned to placebo, seladelpar 50 mg/day, or seladelpar 200 mg/day while ursodeoxycholic acid was continued. Randomisation was done centrally (1:1:1) by a computerised system using an interactive voice-web response system with a block size of three. Randomisation was stratified by region (North America and Europe). The primary outcome was the percentage change from baseline in alkaline phosphatase over 12 weeks, analysed in the modified intention-to-treat (ITT) population (any randomised patient who received at least one dose of medication and had at least one post-baseline alkaline phosphatase evaluation). This study is registered with ClinicalTrials.gov (NCT02609048) and the EU Clinical Trials Registry (EudraCT2015-002698-39). Between Nov 4, 2015, and May 26, 2016, 70 patients were screened at 29 sites in North America and Europe. During recruitment, three patients treated with seladelpar developed fully reversible, asymptomatic grade 3 alanine aminotransferase increases (one on 50 mg, two on 200 mg), ranging from just over five to 20 times the ULN; as a result, the study was terminated after 41 patients were randomly assigned. The modified ITT population consisted of 12 patients in the placebo group, 13 in the seladelpar 50 mg group, and 10 in the seladelpar 200 mg group. Mean changes from baseline in alkaline phosphatase were -2% (SD 16) in the placebo group, -53% (14) in the seladelpar 50 mg group, and -63% (8) in the seladelpar 200 mg group. Changes in both seladelpar groups versus placebo were significant (p<0·0001 for both groups vs placebo), with no significant difference between the two seladelpar groups (p=0·1729). All five patients who received seladelpar for 12 weeks had normal alkaline phosphatase values at the end of treatment, based on a central laboratory ULN for alkaline phosphatase of 116 U/L. The most frequently reported adverse events were pruritus (16%; one patient on placebo, four on seladelpar 50 mg, and one on seladelpar 200 mg), nausea (13%; one patient on placebo, three on seladelpar 50 mg, and one on seladelpar 200 mg), diarrhoea (10%; two patients on placebo, one on seladelpar 50 mg, and one on seladelpar 200 mg), dyspepsia (8%; two patients on seladelpar 50 mg and one on seladelpar 200 mg), muscle spasms (8%; three patients on seladelpar 200 mg), myalgia (8%; one patient on placebo and two on seladelpar 200 mg), and dizziness (8%; one patient on placebo and two on seladelpar 50 mg). Seladelpar normalised alkaline phosphatase levels in patients who completed 12 weeks of treatment. However, treatment was associated with grade 3 increases in aminotransferases and the study was stopped early. The effects of seladelpar should be explored at lower doses. CymaBay Therapeutics. Copyright © 2017 Elsevier Ltd. All rights reserved.

Ante natal care (ANC) utilization, dietary practices and nutritional outcomes in pregnant and recently delivered women in urban slums of Delhi, India: an exploratory cross-sectional study.

PubMed

Ghosh-Jerath, Suparna; Devasenapathy, Niveditha; Singh, Archna; Shankar, Anuraj; Zodpey, Sanjay

2015-03-20

Antenatal Care (ANC) is one of the crucial factors in ensuring healthy outcomes in women and newborns. Nutrition education and counselling is an integral part of ANC that influences maternal and child health outcomes. A cross sectional study was conducted in Pregnant Women (PW) and mothers who had delivered in the past three months; Recently Delivered Women (RDW) in urban slums of North-east district of Delhi, India, to explore ANC utilization, dietary practices and nutritional outcomes. A household survey was conducted in three urban slums to identify PW and RDW. Socio-economic and demographic profile, various components of ANC received including nutrition counselling, dietary intake and nutritional outcomes based on anthropometric indices and anaemia status were assessed. Socio-demographic characteristics, nutrient intake and nutritional status were compared between those who availed ANC versus those who did not using logistic regression. Descriptive summary for services and counselling received; dietary and nutrient intake during ANC were presented. Almost 80% (274 out of 344) women received some form of ANC but the package was inadequate. Determinants for non-utilization of ANC were poverty, literacy, migration, duration of stay in the locality and high parity. Counselling on nutrition was reported by a fourth of the population. Nutrient intake showed suboptimal consumption of protein and micronutrients like iron, calcium, vitamin A, vitamin C, thiamine, riboflavin niacin, zinc and vitamin B12 by more than half of women. A high prevalence of anaemia among PW (85%) and RDW (97.1%) was observed. There was no difference in micronutrient intake and anaemia prevalence among women who received ANC versus who did not. Pregnant women living in urban poor settlements have poor nutritional status. This may be improved by strengthening the nutrition counselling component of ANC which was inadequate in the ANC package received. Empowering community based health workers in providing effective nutrition counselling should be explored given the overburdened public health system.

Effectiveness of community-based support for pregnant women living with HIV: a cohort study in South Africa.

PubMed

Fatti, Geoffrey; Shaikh, Najma; Eley, Brian; Grimwood, Ashraf

2016-01-01

Antiretroviral treatment (ART) initiation in HIV-infected pregnant women in sub-Saharan Africa (SSA) remains inadequate, and there is a severe shortage of professional healthcare workers in the region. The effectiveness of community support programmes for HIV-infected pregnant women and their infants in SSA is unclear. This study compared initiation of maternal antiretrovirals and infant outcomes amongst HIV-infected pregnant women and their infants who received and did not receive community-based support (CBS) in a high HIV-prevalence setting in South Africa. A cohort study, including HIV-infected pregnant women and their infants, was conducted at three sentinel surveillance facilities between January 2009 and June 2012, utilising enhanced routine clinical data. Through home visits, CBS workers encouraged uptake of interventions in the ART cascade, provided HIV-related education, ART initiation counselling and psychosocial support. Outcomes were compared using Kaplan-Meier analyses and multivariable Cox and log-binomial regression. Amongst 1105 mother-infant pairs included, 264 (23.9%) received CBS. Amongst women eligible to start ART antenatally, women who received CBS had a reduced risk of not initiating antenatal ART, 5.4% vs. 30.3%; adjusted risk ratio (aRR) = 0.18 (95% CI: 0.08-0.44; P < .0001). Women who received CBS initiated antenatal ART with less delay after the first antenatal visit, median 26 days vs. 39 days; adjusted hazard ratio (aHR) = 1.57 (95% CI: 1.15-2.14; P = .004). Amongst women who initiated antenatal zidovudine (ZDV) to prevent vertical transmission, women who received CBS initiated ZDV with less delay, aHR = 1.52 (95% CI: 1.18-2.01; P = .001). Women who received CBS had a lower risk of stillbirth, 1.5% vs. 5.4%; aRR = 0.24 (95% CI: 0.07-1.00; P = .050). Pregnant women living with HIV who received CBS had improved antenatal triple ART initiation in eligible women, women initiated ART and ZDV with shorter delays, and had a lower risk of stillbirth. CBS is an intervention that shows promise in improving maternal and infant health in high HIV-prevalence settings.

IL-6 receptor inhibition modulates type III collagen and C-reactive protein degradation in rheumatoid arthritis patients with an inadequate response to anti-tumour necrosis factor therapy: analysis of connective tissue turnover in the tocilizumab RADIATE.

PubMed

Juhl, Pernille; Thudium, Christian S; Gudmann, Natasja S; Karsdal, Morten A; Bay-Jensen, Anne-Christine; Siebuhr, Anne Sofie

2018-01-31

The objective of this study was to examine the tissue degradation in response to anti-IL6 receptor treatment in rheumatoid arthritis (RA) patients which are anti-TNF-α inadequate responders. RADIATE was a randomised, double-blinded, placebo-controlled, parallel-group, phase III trial. RA patients with previous inadequate response to anti-TNFα therapy (n=299) were randomly assigned to tocilizumab 4 or 8 mg/kg with methotrexate (10-25 mg weekly) or placebo with methotrexate. Type III collagen degradation (C3M) and CRP degradation (CRPM) were analysed in serum samples at baseline and 16 weeks. Treatment with 4 and 8 mg/kg tocilizumab significantly decreased C3M (p=0.0001 and p=0.0007) and CRPM (p<0.0001) levels after 16 weeks. Changes in C3M and CRPM levels after 16 weeks correlated well with the changes in disease activity score 28 (DAS28). Change in CRPM levels furthermore correlated moderately with the change in patient pain (VAS) (rpartial of 0.20) and Health assessment questionnaire disability index (HAQ-DI) (rpartial of 0.24). Changes in biomarker levels above median change led to an odds ratio of 1.95 (C3M) and 3.00 (CRPM) for achieving the American College of Rheumatology 20% improvement criteria (ACR20). This study shows that a decrease in inflammation leads to a decrease in excessive extracellular matrix degradation. It furthermore supports earlier shown evidence that tocilizumab works in the treatment of RA patients, although there is a clear need for identifying and selecting patients who are more likely to respond to treatment.

Biobehavioral pain profile in individuals with chronic spine pain.

PubMed

Matteliano, Deborah; Scherer, Yvonne Krall; Chang, Yu-Ping

2014-03-01

Pain in the spine is the most frequently described pain problem in primary care, afflicting at least 54 million Americans. When spinal pain becomes chronic, the prognosis for recovery is poor, often leading to disability and reduced quality of life. Clinical treatment is inadequate, often focusing on physical pathology alone. To improve treatment outcomes for chronic pain as recommended by current guidelines, the Biobehavioral Pain Profile (BPP), which includes six pain response subscales, was developed to guide cognitive behavioral therapy (CBT). The purpose of this study was to describe the BPP in 100 individuals with chronic spine pain and examine the associations between the BPP and important clinical outcomes, including chronic pain, disability, and quality of life. Participants reported a high level of pain, a low quality of life, and a high level of disability despite receiving treatment with opioids. Scores on BPP subscales including evaluating loss of control, past and current experience, physiologic responsivity, and thoughts of disease progression were elevated, indicating a need for CBT. Five of the six BPP subscales had a significant association with quality of life, chronic pain, and disability with the thought of disease progression being a strong factor for most of the clinical outcome variables. By identifying BPP, clinicians can provide appropriate treatments to improve individuals' quality of life and prevent further disability. Further study using the BPP to guide CBT is needed. Copyright © 2014 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Family Support Network for Adolescent Cannabis Users, Cannabis Youth Treatment (CYT) Series, Volume 3.

ERIC Educational Resources Information Center

Hamilton, Nancy L.; Brantley, Laura Bunch; Tims, Frank M.; Angelovich, Nancy; McDougall, Barbara

Substance-abusing adolescents experiencing inadequate family structure and functioning will be at a serious disadvantage with regard to recovery. The family support network (FSN) intervention seeks to extend the focus of treatment beyond the world of the adolescent by engaging the family, a major system in his or her life. Designed to increase…

Family Members and Friends Who Help Beneficiaries Make Health Decisions

PubMed Central

Sofaer, Shoshanna; Kreling, Barbara; Kenney, Erin; Swift, Elaine K.; Dewart, Tracey

2001-01-01

People enrolled in Medicare often turn to family members and friends for help in making health decisions, including Medicare health plan choices. To learn how family members and friends participate in decisionmaking, what information they currently use, and what information they would like, we held eight focus groups in San Diego and Baltimore. Although responses were different in the two markets, participants in both cities reported receiving inadequate information and indicated they were largely unaware of available CMS-supported information. Beneficiaries want easy-to-use print materials targeted to their needs and opportunities to participate in seminars and receive personal counseling. PMID:12500366

Evidence of improved fluid management in patients receiving haemodialysis following a self-affirmation theory-based intervention: A randomised controlled trial.

PubMed

Wileman, Vari; Chilcot, Joseph; Armitage, Christopher J; Farrington, Ken; Wellsted, David M; Norton, Sam; Davenport, Andrew; Franklin, Gail; Da Silva Gane, Maria; Horne, Robert; Almond, Mike

2016-01-01

Haemodialysis patients are at risk of serious health complications; yet, treatment non-adherence remains high. Warnings about health risks associated with non-adherence may trigger defensive reactions. We studied whether an intervention based on self-affirmation theory reduced resistance to health-risk information and improved fluid treatment adherence. In a cluster randomised controlled trial, 91 patients either self-affirmed or completed a matched control task before reading about the health-risks associated with inadequate fluid control. Patients' perceptions of the health-risk information, intention and self-efficacy to control fluid were assessed immediately after presentation of health-risk information. Interdialytic weight gain (IDWG), excess fluid removed during haemodialysis, is a clinical measure of fluid treatment adherence. IDWG data were collected up to 12 months post-intervention. Self-affirmed patients had significantly reduced IDWG levels over 12 months. However, contrary to predictions derived from self-affirmation theory, self-affirmed participants and controls did not differ in their evaluation of the health-risk information, intention to control fluid or self-efficacy. A low-cost, high-reach health intervention based on self-affirmation theory was shown to reduce IDWG over a 12-month period, but the mechanism by which this apparent behaviour change occurred is uncertain. Further work is still required to identify mediators of the observed effects.

Double-blind, placebo-controlled pilot study of adjunctive quetiapine SR in the treatment of PMS/PMDD.

PubMed

Jackson, Christine; Pearson, Brenda; Girdler, Susan; Johnson, Jacqueline; Hamer, Robert M; Killenberg, Susan; Meltzer-Brody, Samantha

2015-11-01

Premenstrual dysphoric disorder (PMDD), a more severe form of premenstrual syndrome (PMS), afflicts 5-8% of reproductive age women and results in significant functional impairment. We conducted a double-blind, placebo-controlled trial of adjunctive quetiapine in patients with PMS/PMDD who had inadequate response to selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor therapy for their symptoms. A PMS/PMDD diagnosis was confirmed by 2-month prospective diagnostic assessment of PMS/PMDD using the Prospective Record of the Impact and Severity of Premenstrual Symptoms (PRISM) calendar. Women were randomized equally to receive quetiapine sustained-release (SR) or placebo (25-mg starting dose) during the luteal phase for 3 months. Outcome variables included the Hamilton Depression and Anxiety Scales, Clinical Global Impression Scale, and PRISM. Twenty women were enrolled in the treatment phase. Although the study was underpowered, greater reductions in luteal phase mood ratings were observed in the quetiapine group on the 17-item Hamilton Depression Rating Scale, Clinical Global Impression improvement rating, and PRISM daily score. The quetiapine group showed most improvement in symptoms of mood lability, anxiety, and irritability. This small double-blind study suggests that adjunctive treatment with quetiapine SR may be a useful addition to selective serotonin reuptake inhibitor therapy in women with PMS/PMDD by reducing symptoms and improving quality of life. Copyright © 2015 John Wiley & Sons, Ltd.

Functional connectivity analysis of resting-state fMRI networks in nicotine dependent patients

NASA Astrophysics Data System (ADS)

Smith, Aria; Ehtemami, Anahid; Fratte, Daniel; Meyer-Baese, Anke; Zavala-Romero, Olmo; Goudriaan, Anna E.; Schmaal, Lianne; Schulte, Mieke H. J.

2016-03-01

Brain imaging studies identified brain networks that play a key role in nicotine dependence-related behavior. Functional connectivity of the brain is dynamic; it changes over time due to different causes such as learning, or quitting a habit. Functional connectivity analysis is useful in discovering and comparing patterns between functional magnetic resonance imaging (fMRI) scans of patients' brains. In the resting state, the patient is asked to remain calm and not do any task to minimize the contribution of external stimuli. The study of resting-state fMRI networks have shown functionally connected brain regions that have a high level of activity during this state. In this project, we are interested in the relationship between these functionally connected brain regions to identify nicotine dependent patients, who underwent a smoking cessation treatment. Our approach is on the comparison of the set of connections between the fMRI scans before and after treatment. We applied support vector machines, a machine learning technique, to classify patients based on receiving the treatment or the placebo. Using the functional connectivity (CONN) toolbox, we were able to form a correlation matrix based on the functional connectivity between different regions of the brain. The experimental results show that there is inadequate predictive information to classify nicotine dependent patients using the SVM classifier. We propose other classification methods be explored to better classify the nicotine dependent patients.

National survey of China's oncologists' knowledge, attitudes, and clinical practice patterns on complementary and alternative medicine.

PubMed

Yang, Geliang; Lee, Richard; Zhang, Huiqing; Gu, Wei; Yang, Peiying; Ling, Changquan

2017-02-21

It is common for cancer patients to use complementary and alternative medicine (CAM). This study was designed to explore China's oncologists' knowledge, attitudes and clinical practices regarding CAM use by their patients. An online survey was conducted of China's oncologists. Among 11,270 participants who completed the online survey, 6,007 (53.3%) were identified as oncologists. Most were men (75.2%), with a mean age of 33.4 (standard deviation: 6.5) years. The 6,007 oncologists discussed with 36.5% of their patients about CAM. Most of them (75.6%) did not want to initiate discussions due to lack of knowledge on CAM. Oncologists estimated that 40.0% of their patients used CAM treatments. Oncologists reported that 28.7% of their patients underwent anticancer therapy with the concurrent use of CAM. Four out of five of the responding oncologists self-reported inadequate knowledge and only 22.0% reported receiving professional education on CAM. Nearly half (44.9%) of the oncologists believed CAM treatment was effective for symptoms and treatment of cancer. Physician factors associated with initiating discussions with patients about CAM use included sex, age (≥ 33 years), medical license for traditional Chinese medicine, enough knowledge and professional education experience. China's oncologists infrequently discussed with their patients about CAM due to lack of knowledge. Most of the oncologists did not encourage CAM use.

Monitoring of KRAS-mutated ctDNA to discriminate pseudo-progression from true progression during anti-PD-1 treatment of lung adenocarcinoma

PubMed Central

Guibert, Nicolas; Mazieres, Julien; Delaunay, Myriam; Casanova, Anne; Farella, Magali; Keller, Laura; Favre, Gilles; Pradines, Anne

2017-01-01

Objectives Pseudo-progression is a rare but worrying situation for both clinicians and patients during immunotherapy. Dedicated ir-RECIST criteria have been established to improve this situation. However, this can be sometimes considered inadequate and patients experiencing true progression may then receive inefficient treatments. Additional reliable tools to discriminate pseudo from true progression are thus needed. So far, no biomarker has been identified to distinguish pseudo from true progression. We hypothesize that biomarkers associated with the molecular characteristics of the tumor may be of interest. To avoid a tumor re-biopsy, circulating markers appear to be a less invasive and reproducible procedure. As ctDNA kinetics correlate with the response to treatment in KRAS-mutated adenocarcinoma, we anticipated that this analysis could be of interest. Materials and methods We monitored the level of KRAS-mutated ctDNA by digital droplet PCR in serial plasma samples from two patients who had experienced pseudo-progression and compared the variations with those from of a patient that had true progression. Results ctDNA showed rapid and dramatic decreases in pseudo-progressive patients, whereas it was strongly increased in the progressive patient. Conclusions ddPCR of ctDNA may thus be an additional tool to discriminate pseudo-progression from true progression for tumors that harbor an oncogenic addiction. PMID:28445137

Enhancing Human Milk Production With Domperidone in Mothers of Preterm Infants.

PubMed

Asztalos, Elizabeth V; Campbell-Yeo, Marsha; da Silva, Orlando P; Ito, Shinya; Kiss, Alex; Knoppert, David

2017-02-01

Mothers of preterm infants often are at risk of expressing an inadequate amount of milk for their infants and the use of galactogogues is often considered. Domperidone is a widely used galactogogue with little information available to guide clinicians regarding initiation, timing, and duration of treatment. Research aim: The primary objective of this study was to determine whether administration of domperidone within the first 21 days after delivery would lead to a higher proportion of mothers achieving a 50% increase in the volume of milk at the end of 14 days of treatment compared with mothers receiving placebo. Eligible mothers were randomized to one of two treatment arms: Group A-domperidone 10 mg orally three times daily for 28 days; or Group B-placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days. A total of 90 mothers of infants ≤ 29 weeks gestation were randomized. Mean milk volumes at entry were similar for both groups. More mothers achieved a 50% increase in milk volume after 14 days in Group A (77.8%) compared with Group B (57.8%), odds ratio = 2.56, 95% confidence interval [1.02, 6.25], p = .04. A greater number of mothers experienced a 50% or more increase in human milk volume, but the absolute increase in milk volume was modest.

Misdiagnosis trends in patients with hereditary angioedema from the real-world clinical setting.

PubMed

Zanichelli, Andrea; Longhurst, Hilary J; Maurer, Marcus; Bouillet, Laurence; Aberer, Werner; Fabien, Vincent; Andresen, Irmgard; Caballero, Teresa

2016-10-01

Hereditary angioedema due to C1 inhibitor deficiency (C1-INH-HAE) causes swelling in the skin and upper airways and pain in the abdomen because of mucosal swelling. C1-INH-HAE is frequently misdiagnosed, leading to delays in diagnosis, inadequate treatment, and unnecessary procedures. To evaluate the history of misdiagnosis in patients participating in the Icatibant Outcome Survey (IOS). The IOS is an observational study in which safety and effectiveness of icatibant have been evaluated since 2009. As part of the IOS, patients record any misdiagnoses received before being diagnosed as having C1-INH-HAE. In January 2016, a total of 418 of 633 IOS patients with C1-INH-HAE type I or II had provided misdiagnosis data. Of these, 185 of 418 (44.3%) received 1 or more prior misdiagnoses. The most common misdiagnoses were allergic angioedema (103 of 185) and appendicitis (50 of 185). A variety of other misdiagnoses were reported, including a substantial number of gastrointestinal disorders (excluding appendicitis). Misdiagnosis rates were similar between males (41.1%) and females (46.5%) and between C1-INH-HAE type I (43.7%) and type II (51.6%). Patients with family members diagnosed as having C1-INH-HAE were significantly less likely to be misdiagnosed than patients without a family history (140 of 366 [41.7%] vs 38 of 58 [65.5%], respectively; P = .001). Patients with a prior misdiagnosis had longer median delay to C1-INH-HAE diagnosis (13.3 years) than patients without (1.7 years; P < .001). From this large database, approximately 50% of patients with C1-INH-HAE type I or II have previously had their conditions misdiagnosed, most commonly as allergic angioedema or appendicitis. Misdiagnosis results in marked delays in receiving the correct diagnosis, during which time patients cannot access effective, lifesaving treatment. ClinicalTrials.gov: NCT01034969. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Validation of self-reported health literacy questions among diverse English and Spanish-speaking populations.

PubMed

Sarkar, Urmimala; Schillinger, Dean; López, Andrea; Sudore, Rebecca

2011-03-01

Limited health literacy (HL) contributes to poor health outcomes and disparities, and direct measurement is often time-intensive. Self-reported HL questions have not been validated among Spanish-speaking and diverse English-speaking populations. To evaluate three self-reported questions: 1 "How confident are you filling out medical forms?"; 2 "How often do you have problems learning about your medical condition because of difficulty understanding written information?"; and 3 "How often do you have someone help you read hospital materials?" Answers were based on a 5-point Likert scale. This was a validation study nested within a trial of diabetes self-management support in the San Francisco Department of Public Health. English and Spanish-speaking adults with type 2 diabetes receiving primary care. Using the Test of Functional Health Literacy in Adults (s-TOFHLA) in English and Spanish as the reference, we classified HL as inadequate, marginal, or adequate. We calculated the C-index and test characteristics of the three questions and summative scale compared to the s-TOFHLA and assessed variations in performance by language, race/ethnicity, age, and education. Of 296 participants, 48% were Spanish-speaking; 9% were White, non-Hispanic; 47% had inadequate HL and 12% had marginal HL. Overall, 57% reported being confident with forms "somewhat" or less. The "confident with forms" question performed best for detecting inadequate (C-index = 0.82, (0.77-0.87)) and inadequate plus marginal HL (C index = 0.81, (0.76-0.86); p<0.01 for differences from other questions), and performed comparably to the summative scale. The "confident with forms" question and scale also performed best across language, race/ethnicity, educational attainment, and age. A single self-reported HL question about confidence with forms and a summative scale of three questions discriminated between Spanish and English speakers with adequate HL and those with inadequate and/or inadequate plus marginal HL. The "confident with forms" question or the summative scale may be useful for estimating HL in clinical research involving Spanish-speaking and English-speaking, chronically-ill, diverse populations.

Challenges in implementing uncomplicated malaria treatment in children: a health facility survey in rural Malawi.

PubMed

Kabaghe, Alinune N; Phiri, Mphatso D; Phiri, Kamija S; van Vugt, Michèle

2017-10-18

Prompt and effective malaria treatment are key in reducing transmission, disease severity and mortality. With the current scale-up of artemisinin-based combination therapy (ACT) coverage, there is need to focus on challenges affecting implementation of the intervention. Routine indicators focus on utilization and coverage, neglecting implementation quality. A health system in rural Malawi was assessed for uncomplicated malaria treatment implementation in children. A cross-sectional health facility survey was conducted in six health centres around the Majete Wildlife Reserve in Chikwawa district using a health system effectiveness approach to assess uncomplicated malaria treatment implementation. Interviews with health facility personnel and exit interviews with guardians of 120 children under 5 years were conducted. Health workers appropriately prescribed an ACT and did not prescribe an ACT to 73% (95% CI 63-84%) of malaria rapid diagnostic test (RDT) positive and 98% (95% CI 96-100%) RDT negative children, respectively. However, 24% (95% CI 13-37%) of children receiving artemisinin-lumefantrine had an inappropriate dose by weight. Health facility findings included inadequate number of personnel (average: 2.1 health workers per 10,000 population), anti-malarial drug stock-outs or not supplied, and inconsistent health information records. Guardians of 59% (95% CI 51-69%) of children presented within 24 h of onset of child's symptoms. The survey presents an approach for assessing treatment effectiveness, highlighting bottlenecks which coverage indicators are incapable of detecting, and which may reduce quality and effectiveness of malaria treatment. Health service provider practices in prescribing and dosing anti-malarial drugs, due to drug stock-outs or high patient load, risk development of drug resistance, treatment failure and exposure to adverse effects.

Cost-effectiveness of prucalopride in the treatment of chronic constipation in the Netherlands

PubMed Central

Nuijten, Mark J. C.; Dubois, Dominique J.; Joseph, Alain; Annemans, Lieven

2015-01-01

Objective: To assess the cost-effectiveness of prucalopride vs. continued laxative treatment for chronic constipation in patients in the Netherlands in whom laxatives have failed to provide adequate relief. Methods: A Markov model was developed to estimate the cost-effectiveness of prucalopride in patients with chronic constipation receiving standard laxative treatment from the perspective of Dutch payers in 2011. Data sources included published prucalopride clinical trials, published Dutch price/tariff lists, and national population statistics. The model simulated the clinical and economic outcomes associated with prucalopride vs. standard treatment and had a cycle length of 1 month and a follow-up time of 1 year. Response to treatment was defined as the proportion of patients who achieved “normal bowel function”. One-way and probabilistic sensitivity analyses were conducted to test the robustness of the base case. Results: In the base case analysis, the cost of prucalopride relative to continued laxative treatment was € 9015 per quality-adjusted life-year (QALY). Extensive sensitivity analyses and scenario analyses confirmed that the base case cost-effectiveness estimate was robust. One-way sensitivity analyses showed that the model was most sensitive in response to prucalopride; incremental cost-effectiveness ratios ranged from € 6475 to 15,380 per QALY. Probabilistic sensitivity analyses indicated that there is a greater than 80% probability that prucalopride would be cost-effective compared with continued standard treatment, assuming a willingness-to-pay threshold of € 20,000 per QALY from a Dutch societal perspective. A scenario analysis was performed for women only, which resulted in a cost-effectiveness ratio of € 7773 per QALY. Conclusion: Prucalopride was cost-effective in a Dutch patient population, as well as in a women-only subgroup, who had chronic constipation and who obtained inadequate relief from laxatives. PMID:25926794

Policy Pathways to Address Provider Workforce Barriers to Buprenorphine Treatment.

PubMed

Haffajee, Rebecca L; Bohnert, Amy S B; Lagisetty, Pooja A

2018-06-01

At least 2.3 million people in the U.S. have an opioid use disorder, less than 40% of whom receive evidence-based treatment. Buprenorphine used as part of medication-assisted treatment has high potential to address this gap because of its approval for use in non-specialty outpatient settings, effectiveness at promoting abstinence, and cost effectiveness. However, less than 4% of licensed physicians are approved to prescribe buprenorphine for opioid use disorder, and approximately 47% of counties lack a buprenorphine-waivered physician. Existing policies contribute to workforce barriers to buprenorphine provision and access. Providers are reticent to prescribe buprenorphine because of workforce barriers, such as (1) insufficient training and education on opioid use disorder treatment, (2) lack of institutional and clinician peer support, (3) poor care coordination, (4) provider stigma, (5) inadequate reimbursement from private and public insurers, and (6) regulatory hurdles to obtain the waiver needed to prescribe buprenorphine in non-addiction specialty treatment settings. Policy pathways to addressing these provider workforce barriers going forward include providing free and easy-to-access education for providers about opioid use disorders and medication-assisted treatment, eliminating buprenorphine waiver requirements for those licensed to prescribe controlled substances, enforcing insurance parity requirements, requiring coverage of evidence-based medication-assisted treatment as essential health benefits, and providing financial incentives for care coordination across healthcare professional types-including behavioral health counselors and other non-physicians in specialty and non-specialty settings. This article is part of a supplement entitled The Behavioral Health Workforce: Planning, Practice, and Preparation, which is sponsored by the Substance Abuse and Mental Health Services Administration and the Health Resources and Services Administration of the U.S. Department of Health and Human Services. Copyright © 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Real-life efficacy and safety of vildagliptin compared with sulfonylureas as add-on to metformin in patients with type 2 diabetes mellitus in Germany.

PubMed

Göke, R; Gruenberger, J B; Bader, G; Dworak, M

2014-05-01

Metformin is an established first-line treatment for type 2 diabetes mellitus (T2DM) patients, but intensification of oral anti-diabetes therapy is usually required over time. A large observational study of 45,868 T2DM patients in 27 countries (EDGE) was conducted to compare the effectiveness and safety of vildagliptin as add-on therapy to another oral anti-diabetes drug (OAD) vs other dual OAD combinations. This report presents results from a post-hoc analysis of patients in Germany who received vildagliptin or a sulfonylurea (SU) in combination with metformin. Patients inadequately controlled with monotherapy became eligible only after the add-on treatment was finalized. Patients included were assigned to receive either vildagliptin or another OAD (SUs, thiazolidinediones, glinides, α-glucosidase inhibitors, or metformin; DPP-4 inhibitors or glucagon-like peptide-1 [GLP-1] mimetics/analogs were excluded). The primary end-point was the proportion of patients achieving a reduction in HbA1c >0.3% without peripheral edema, hypoglycemia, discontinuation due to gastrointestinal event, or weight gain ≥5%. Of 8887 patients enrolled in Germany, 6439 received vildagliptin and 971 received SUs as add-on to metformin. The primary end-point was reached in 34.9% and 29.6% of patients in the vildagliptin and SU groups, respectively, with an unadjusted odds ratio of 1.27 (95% CI = 1.09, 1.47; p = 0.001). HbA1c decreased in both cohorts from baseline (-0.7% with vildagliptin vs -0.5% with SUs), with a mean between-group difference of -0.2% (95% CI = -0.22, -0.09). The number of hypoglycemic events was 4-fold higher in the SU group than in the vildagliptin group (vildagliptin = 0.11%; SU = 0.41%). In a real-life setting, vildagliptin was associated with a numerically greater reduction in HbA1c, less hypoglycemia, and more patients reaching target HbA1c without hypoglycemia or weight gain compared with SUs. Open-label design and under reporting of adverse events are limitations of this post hoc analysis.

Sarcoma of the prostate: a single institutional review.

PubMed

Janet, Nguyen L; May, Abdel-Wahab; Akins, Robin S

2009-02-01

We report the management and outcome of prostate sarcoma at 1 institution and analyze factors that may determine prognosis. The medical records of 10 patients with prostate sarcoma were reviewed to identify symptoms at presentation, diagnostic procedures, and staging methods. Histology, grade, tumor size, stage, and treatment modality were analyzed. Overall survival was assessed. Five patients had rhabdomyosarcoma (RMS) and five had other subtypes, including two with carcinosarcoma, two with high-grade sarcoma not-otherwise-specified, and one with leiyomyosarcoma. Eight patients presented with locally advanced disease and two with metastatic disease.The two metastatic patients received chemotherapy, and one also had hormonal ablation therapy. Of the eight with local disease, two had neoadjuvant chemotherapy and surgery, one had surgery alone, one had surgery and postoperative radiation, one had radiation alone, and three had chemoradiation.Chemotherapy consisted of vincristine, adriamycin, and cyclophosphomide for rhabdomyosarcoma and of cisplatin, adriamycin, and ifosphamide for the other subtypes. Radiation dose ranged from 40 Gy to 55.8 Gy.The median survival follow-up of the study is 46.5 months. The median survival for the rhabdomyosarcoma subgroup and nonrhabdomyosarcoma subroup is 142 months and 24 months, respectively. There were three deaths, of which two had metastatic disease at presentation and one later developed distant metastases after having surgery alone. One patient developed a local recurrence 47 months after chemoradiation and was successfully salvaged with surgery. In terms of tumor-related factors, the histologic subtype of prostate sarcoma appears to have prognostic significance. The overall survival for adults with non-RMS histologies is poor with a median survival of only 2 years. Pediatric patients with RMS faired much better with a median survival of over 10 years. We did not find any difference in outcome with regard to grade or tumor size. The presence of metastatic disease at diagnosis, however, is a poor predictor of outcome.In terms of treatment-related factors, surgery alone is inadequate treatment. One patient treated with surgery alone developed distant metastases 38 months later, then received chemotherapy and hormonal therapy, and died at 58 months. Patients who received combined modality treatment appear to fare better.Finally, these patients need long term follow-up. One patient developed a local recurrence 47 months after chemoradiation. This patient was successfully salvaged with surgery and is currently alive at 170 months.

The effectiveness and cost-effectiveness of community-based support for adolescents receiving antiretroviral treatment: an operational research study in South Africa.

PubMed

Fatti, Geoffrey; Jackson, Debra; Goga, Ameena E; Shaikh, Najma; Eley, Brian; Nachega, Jean B; Grimwood, Ashraf

2018-02-01

Adolescents and youth receiving antiretroviral treatment (ART) in sub-Saharan Africa have high attrition and inadequate ART outcomes, and evaluations of interventions improving ART outcomes amongst adolescents are very limited. Sustainable Development Goal (SDG) target 3c is to substantially increase the health workforce in developing countries. We measured the effectiveness and cost-effectiveness of community-based support (CBS) provided by lay health workers for adolescents and youth receiving ART in South Africa. A retrospective cohort study including adolescents and youth who initiated ART at 47 facilities. Previously unemployed CBS-workers provided home-based ART-related education, psychosocial support, symptom screening for opportunistic infections and support to access government grants. Outcomes were compared between participants who received CBS plus standard clinic-based care versus participants who received standard care only. Cumulative incidences of all-cause mortality and loss to follow-up (LTFU), adherence measured using medication possession ratios (MPRs), CD4 count slope, and virological suppression were analysed using multivariable Cox, competing-risks regression, generalized estimating equations and mixed-effects models over five years of ART. An expenditure approach was used to determine the incremental cost of CBS to usual care from a provider perspective. Incremental cost-effectiveness ratios were calculated as annual cost per patient-loss (through death or LTFU) averted. Amongst 6706 participants included, 2100 (31.3%) received CBS. Participants who received CBS had reduced mortality, adjusted hazard ratio (aHR) = 0.52 (95% CI: 0.37 to 0.73; p < 0.0001). Cumulative LTFU was 40% lower amongst participants receiving CBS (29.9%) compared to participants without CBS (38.9%), aHR = 0.60 (95% CI: 0.51 to 0.71); p < 0.0001). The effectiveness of CBS in reducing attrition ranged from 42.2% after one year to 35.9% after five years. Virological suppression was similar after three years, but after five years 18.8% CBS participants versus 37.2% non-CBS participants failed to achieve viral suppression, adjusted odds ratio = 0.24 (95% CI: 0.06 to 1.03). There were no significant differences in MPR or CD4 slope. The cost of CBS was US$49.5/patient/year. The incremental cost per patient-loss averted was US$600 and US$776 after one and two years, respectively. CBS for adolescents and youth receiving ART was associated with substantially reduced patient attrition, and is a low-cost intervention with reasonable cost-effectiveness that can aid progress towards several health, economic and equality-related SDG targets. © 2018 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.

Burden of disease from inadequate water, sanitation and hygiene in low- and middle-income settings: a retrospective analysis of data from 145 countries

PubMed Central

Prüss-Ustün, Annette; Bartram, Jamie; Clasen, Thomas; Colford, John M; Cumming, Oliver; Curtis, Valerie; Bonjour, Sophie; Dangour, Alan D; De France, Jennifer; Fewtrell, Lorna; Freeman, Matthew C; Gordon, Bruce; Hunter, Paul R; Johnston, Richard B; Mathers, Colin; Mäusezahl, Daniel; Medlicott, Kate; Neira, Maria; Stocks, Meredith; Wolf, Jennyfer; Cairncross, Sandy

2014-01-01

Objective To estimate the burden of diarrhoeal diseases from exposure to inadequate water, sanitation and hand hygiene in low- and middle-income settings and provide an overview of the impact on other diseases. Methods For estimating the impact of water, sanitation and hygiene on diarrhoea, we selected exposure levels with both sufficient global exposure data and a matching exposure-risk relationship. Global exposure data were estimated for the year 2012, and risk estimates were taken from the most recent systematic analyses. We estimated attributable deaths and disability-adjusted life years (DALYs) by country, age and sex for inadequate water, sanitation and hand hygiene separately, and as a cluster of risk factors. Uncertainty estimates were computed on the basis of uncertainty surrounding exposure estimates and relative risks. Results In 2012, 502 000 diarrhoea deaths were estimated to be caused by inadequate drinking water and 280 000 deaths by inadequate sanitation. The most likely estimate of disease burden from inadequate hand hygiene amounts to 297 000 deaths. In total, 842 000 diarrhoea deaths are estimated to be caused by this cluster of risk factors, which amounts to 1.5% of the total disease burden and 58% of diarrhoeal diseases. In children under 5 years old, 361 000 deaths could be prevented, representing 5.5% of deaths in that age group. Conclusions This estimate confirms the importance of improving water and sanitation in low- and middle-income settings for the prevention of diarrhoeal disease burden. It also underscores the need for better data on exposure and risk reductions that can be achieved with provision of reliable piped water, community sewage with treatment and hand hygiene. PMID:24779548

Burden of disease from inadequate water, sanitation and hygiene in low- and middle-income settings: a retrospective analysis of data from 145 countries.

PubMed

Prüss-Ustün, Annette; Bartram, Jamie; Clasen, Thomas; Colford, John M; Cumming, Oliver; Curtis, Valerie; Bonjour, Sophie; Dangour, Alan D; De France, Jennifer; Fewtrell, Lorna; Freeman, Matthew C; Gordon, Bruce; Hunter, Paul R; Johnston, Richard B; Mathers, Colin; Mäusezahl, Daniel; Medlicott, Kate; Neira, Maria; Stocks, Meredith; Wolf, Jennyfer; Cairncross, Sandy

2014-08-01

To estimate the burden of diarrhoeal diseases from exposure to inadequate water, sanitation and hand hygiene in low- and middle-income settings and provide an overview of the impact on other diseases. For estimating the impact of water, sanitation and hygiene on diarrhoea, we selected exposure levels with both sufficient global exposure data and a matching exposure-risk relationship. Global exposure data were estimated for the year 2012, and risk estimates were taken from the most recent systematic analyses. We estimated attributable deaths and disability-adjusted life years (DALYs) by country, age and sex for inadequate water, sanitation and hand hygiene separately, and as a cluster of risk factors. Uncertainty estimates were computed on the basis of uncertainty surrounding exposure estimates and relative risks. In 2012, 502,000 diarrhoea deaths were estimated to be caused by inadequate drinking water and 280,000 deaths by inadequate sanitation. The most likely estimate of disease burden from inadequate hand hygiene amounts to 297,000 deaths. In total, 842,000 diarrhoea deaths are estimated to be caused by this cluster of risk factors, which amounts to 1.5% of the total disease burden and 58% of diarrhoeal diseases. In children under 5 years old, 361,000 deaths could be prevented, representing 5.5% of deaths in that age group. This estimate confirms the importance of improving water and sanitation in low- and middle-income settings for the prevention of diarrhoeal disease burden. It also underscores the need for better data on exposure and risk reductions that can be achieved with provision of reliable piped water, community sewage with treatment and hand hygiene. © 2014 The Authors. Tropical Medicine and International Health published by John Wiley & Sons Ltd.

Transitioning from adequate to inadequate sleep duration associated with higher smoking rate and greater nicotine dependence in a population sample

PubMed Central

Patterson, Freda; Grandner, Michael A.; Lozano, Alicia; Satti, Aditi; Ma, Grace

2017-01-01

Introduction Inadequate sleep (≤6 and ≥9 h) is more prevalent in smokers than non-smokers but the extent to which sleep duration in smokers relates to smoking behaviors and cessation outcomes, is not yet clear. To begin to address this knowledge gap, we investigated the extent to which sleep duration predicted smoking behaviors and quitting intention in a population sample. Methods Data from current smokers who completed the baseline (N=635) and 5-year follow-up (N=477) assessment in the United Kingdom Biobank cohort study were analyzed. Multivariable regression models using smoking behavior outcomes (cigarettes per day, time to first cigarette, difficulty not smoking for a day, quitting intention) and sleep duration (adequate (7–8 h) versus inadequate (≤6 and ≥9 h) as the predictor were generated. All models adjusted for age, sex, race, and education. Results Worsening sleep duration (adequate to inadequate) predicted a more than three-fold higher odds in increased cigarettes per day (OR =3.18; 95% CI =1.25–8.06), a more than three-fold increased odds of not smoking for the day remaining difficult (OR =3.90; 95% CI =1.27–12.01), and a > 8-fold increased odds of higher nicotine dependence (OR= 8.98; 95% CI =2.81–28.66). Improving sleep duration (i.e., inadequate to adequate sleep) did not predict reduced cigarette consumption or nicotine dependence in this population sample. Conclusion Transitioning from adequate to inadequate sleep duration may be a risk factor for developing a more “hard-core” smoking profile. The extent to which achieving healthy sleep may promote, or optimize smoking cessation treatment response, warrants investigation. PMID:28950118

Implementation of Human Trafficking Education and Treatment Algorithm in the Emergency Department.

PubMed

Egyud, Amber; Stephens, Kimberly; Swanson-Bierman, Brenda; DiCuccio, Marge; Whiteman, Kimberly

2017-11-01

Health care professionals have not been successful in recognizing or rescuing victims of human trafficking. The purpose of this project was to implement a screening system and treatment algorithm in the emergency department to improve the identification and rescue of victims of human trafficking. The lack of recognition by health care professionals is related to inadequate education and training tools and confusion with other forms of violence such as trauma and sexual assault. A multidisciplinary team was formed to assess the evidence related to human trafficking and make recommendations for practice. After receiving education, staff completed a survey about knowledge gained from the training. An algorithm for identification and treatment of sex trafficking victims was implemented and included a 2-pronged identification approach: (1) medical red flags created by a risk-assessment tool embedded in the electronic health record and (2) a silent notification process. Outcome measures were the number of victims who were identified either by the medical red flags or by silent notification and were offered and accepted intervention. Survey results indicated that 75% of participants reported that the education improved their competence level. The results demonstrated that an education and treatment algorithm may be an effective strategy to improve recognition. One patient was identified as an actual victim of human trafficking; the remaining patients reported other forms of abuse. Education and a treatment algorithm were effective strategies to improve recognition and rescue of human trafficking victims and increase identification of other forms of abuse. Copyright © 2017 Emergency Nurses Association. Published by Elsevier Inc. All rights reserved.

Comparison of patients undergoing switching versus augmentation of antipsychotic medications during treatment for schizophrenia.

PubMed

Ascher-Svanum, Haya; Brnabic, Alan Jm; Lawson, Anthony H; Kinon, Bruce J; Stauffer, Virginia L; Feldman, Peter D; Kelin, Katarina

2012-01-01

It is often difficult to determine whether a patient may best benefit by augmenting their current medication or switching them to another. This post-hoc analysis compares patients' clinical and functional profiles at the time their antipsychotic medications were either switched or augmented. Adult outpatients receiving oral antipsychotic treatment for schizophrenia were assessed during a 12-month international observational study. Clinical and functional measures were assessed at the time of first treatment switch/augmentation (0-14 days prior) and compared between Switched and Augmented patient groups. Due to low numbers of patients providing such data, interpretations are based on effect sizes. Data at the time of change were available for 87 patients: 53 Switched and 34 Augmented. Inadequate response was the primary reason for treatment change in both groups, whereas lack of adherence was more prevalent in the Switched group (26.4% vs 8.8%). Changes in clinical severity from study initiation to medication change were similar, as indicated by Clinical Global Impressions-Severity scores. However, physical and mental component scores of the 12-item Short-Form Health Survey improved in the Augmented group, but worsened in the Switched group. These findings suggest that the patient's worsening or lack of meaningful improvement prompts clinicians to switch antipsychotic medications, whereas when patients show some improvement, clinicians may be more likely to try bolstering the improvements through augmentation. Current findings are consistent with physicians' stated reasons for switching versus augmenting antipsychotics in the treatment of schizophrenia. Confirmation of these findings requires further research.

Hydroxyurea Use in Young Children With Sickle Cell Anemia in New York State.

PubMed

Anders, David G; Tang, Fei; Ledneva, Tatania; Caggana, Michele; Green, Nancy S; Wang, Ying; Sturman, Lawrence S

2016-07-01

This study examined hydroxyurea usage in young children with sickle cell anemia within New York State (NYS). The cohort was 273 children with sickle cell anemia born in NYS in 2006-2009 and enrolled essentially continuously in Medicaid for the first 4 years of life. Medicaid data were used to examine hydroxyurea usage in this group by age at first prescription fill, persistence, region, treatment institution, and year. Log-binomial regression models were used to estimate the likelihood of receiving hydroxyurea treatment. Data from birth through 2014 for all members of the study group were assembled and analyzed in 2015. About 25% of the cohort had at least one filled hydroxyurea prescription by their fifth birthday, and nearly 40% by the end of the study period. The mean proportion of days covered for the first year of therapy was 56.3%. Adherence was also assessed by calculating medication possession ratios for individual treatment periods. Slightly more than one third of treated children showed 80% coverage by these measures. There was a consistent, but not statistically significant, trend toward younger age at first fill. Significant regional and treatment center differences in initiation of hydroxyurea use, but not in persistence after initiation, were noted among NYS centers. Subsequent to clinical studies demonstrating safety, current NYS-wide use of hydroxyurea in young children with sickle cell anemia appears to be widespread and increasing. However, practice differences between treatment centers and inadequate adherence may limit the full disease-modifying effects of hydroxyurea. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Refeeding syndrome in a small-for-dates micro-preemie receiving early parenteral nutrition.

PubMed

Mizumoto, Hiroshi; Mikami, Masamitsu; Oda, Hirotsugu; Hata, Daisuke

2012-10-01

This report describes a small-for-date extremely low birth weight infant who manifested bradycardic events, respiratory failure, and hemolytic jaundice during her first week of life. These complications were attributed to severe hypophosphatemia and hypokalemia. Inadequate supply and refeeding syndrome triggered by early aggressive parenteral nutrition were responsible for electrolyte abnormalities. © 2012 The Authors. Pediatrics International © 2012 Japan Pediatric Society.

Copper, iron, and selenium dietary deficiencies negatively impact skeletal integrity: A review.

PubMed

Medeiros, Denis M

2016-06-01

Nutrients have been known to have a significant role in maintaining the health of the skeleton, both bone and cartilage. The nutrients that have received the majority of the attention are Vitamin D and calcium. However, limited attention has been directed toward three trace elements that may have mechanistic impact upon the skeletal tissues and could compromise skeletal health resulting from inadequate intakes of copper, iron, and selenium. The role of copper and selenium has been known, but the role of iron has only received recent attention. Copper deficiency is thought to impact bone health by a decrease in lysyl oxidase, a copper-containing enzyme, which facilitates collagen fibril crosslinking. Iron deficiency impact upon bone has only recently been discovered but the exact mechanism on how the deficient states enhance bone pathology is speculative. Selenium deficiency has an impact on cartilage thereby having an indirect impact on bone. However, several studies suggest that a mycotoxin when consumed by humans is the culprit in some cartilage disorders and the presence of selenium could attenuate the pathology. This review summarizes the current knowledge base with respect to skeletal integrity when each of these three trace elements are inadequate in diets of both animals and humans. © 2016 by the Society for Experimental Biology and Medicine.

Infant feeding intentions among first time pregnant women in urban Melbourne, Australia.

PubMed

York, Elissa; Hoban, Elizabeth

2013-07-01

to identify first time pregnant women's infant feeding intentions for the first 2 years of life. a qualitative phenomenological approach was used, with semi-structured interviews as the primary method of data collection. two of Eastern Health's antenatal clinics in the outer east region of Melbourne, Australia. seven first time pregnant women from an Eastern Health antenatal clinic. women's infant feeding intention for the first 2 years of life. all the participants intend to breast feed their infant for around 6 months. Women rely heavily on information about infant feeding options from friends, books and the internet, as the information provided by health professionals was found to be inadequate, acquired late in the pregnancy and difficult to access. the information women receive from midwives at antenatal appointments and parenting classes about infant feeding options is inadequate, as women are not satisfied with the timing, amount and usefulness of the information they receive. in order to see an increase in the rate of breast feeding it is imperative to create supportive environments for women to breast feed, and for midwives and health professionals to provide information and continued support for women in both the pre- and postnatal period. Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.

Military and VA general dentistry training: a national resource.

PubMed

Atchison, Kathryn A; Bachand, William; Buchanan, C Richard; Lefever, Karen H; Lin, Sylvia; Engelhardt, Rita

2002-06-01

In 1999, HRSA contracted with the UCLA School of Dentistry to evaluate the postgraduate general dentistry (PDG) training programs. The purpose of this article is to compare the program characteristics of the PGD training programs sponsored by the Armed Services (military) and VA. Surveys mailed to sixty-six VA and forty-two military program directors in fall 2000 sought information regarding the infrastructure of the program, the program emphasis, resident preparation prior to entering the program, and a description of patients served and types of services provided. Of the eighty-one returned surveys (75 percent response rate), thirty were received from military program directors and fifty-one were received from VA program directors. AEGDs reported treating a higher proportion of children patients and GPRs more medically intensive, disadvantaged and HIV/AIDS patients. Over half of the directors reported increases in curriculum emphasis in implantology. The program directors reported a high level of inadequate preparation among incoming dental residents. Having a higher ratio of residents to total number of faculty predicted inadequate preparation (p=.022) although the model was weak. Although HRSA doesn't financially support federally sponsored programs, their goal of improved dental training to care for medically compromised individuals is facilitated through these programs, thus making military and VA general dentistry programs a national resource.

Detectable Changes in The Blood Transcriptome Are Present after Two Weeks of Antituberculosis Therapy

PubMed Central

Bloom, Chloe I.; Graham, Christine M.; Berry, Matthew P. R.; Wilkinson, Katalin A.; Oni, Tolu; Rozakeas, Fotini; Xu, Zhaohui; Rossello-Urgell, Jose; Chaussabel, Damien; Banchereau, Jacques; Pascual, Virginia; Lipman, Marc; Wilkinson, Robert J.; O’Garra, Anne

2012-01-01

Rationale Globally there are approximately 9 million new active tuberculosis cases and 1.4 million deaths annually. Effective antituberculosis treatment monitoring is difficult as there are no existing biomarkers of poor adherence or inadequate treatment earlier than 2 months after treatment initiation. Inadequate treatment leads to worsening disease, disease transmission and drug resistance. Objectives To determine if blood transcriptional signatures change in response to antituberculosis treatment and could act as early biomarkers of a successful response. Methods Blood transcriptional profiles of untreated active tuberculosis patients in South Africa were analysed before, during (2 weeks and 2 months), at the end of (6 months) and after (12 months) antituberculosis treatment, and compared to individuals with latent tuberculosis. An active-tuberculosis transcriptional signature and a specific treatment-response transcriptional signature were derived. The specific treatment response transcriptional signature was tested in two independent cohorts. Two quantitative scoring algorithms were applied to measure the changes in the transcriptional response. The most significantly represented pathways were determined using Ingenuity Pathway Analysis. Results An active tuberculosis 664-transcript signature and a treatment specific 320-transcript signature significantly diminished after 2 weeks of treatment in all cohorts, and continued to diminish until 6 months. The transcriptional response to treatment could be individually measured in each patient. Conclusions Significant changes in the transcriptional signatures measured by blood tests were readily detectable just 2 weeks after treatment initiation. These findings suggest that blood transcriptional signatures could be used as early surrogate biomarkers of successful treatment response. PMID:23056259

A randomized, double-blind study of the efficacy and tolerability of extended-release quetiapine fumarate (quetiapine XR) monotherapy in patients with major depressive disorder

PubMed Central

Wang, Gang; McIntyre, Alexander; Earley, Willie R; Raines, Shane R; Eriksson, Hans

2014-01-01

Objectives To evaluate the efficacy and tolerability of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with major depressive disorder (MDD). Patients and methods This was a 10-week (8-week active treatment/2-week post-treatment) randomized, double-blind, placebo- and active-controlled study (D1448C00004). Patients received quetiapine XR 150 mg/day, escitalopram 10 mg/day, or placebo; patients with an inadequate response (<20% improvement in Montgomery–Åsberg Depression Rating Scale [MADRS] total score) at week two received double-dose treatment. The primary end point was week eight change from randomization in MADRS total score. Secondary end points included MADRS response (≥50% improvement) and remission (score ≤8); Hamilton Rating Scale for Depression total and item 1; Hamilton Rating Scale for Anxiety total, psychic, and somatic; Clinical Global Impressions – Severity of Illness total; Pittsburgh Sleep Quality Index (PSQI) global; and Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form percentage maximum total scores. Tolerability was assessed throughout. Results A total of 471 patients was randomized. No significant improvements in MADRS total score were observed at week eight (last observation carried forward) with either active treatment (quetiapine XR, −17.21 [P=0.174]; escitalopram, −16.73 [P=0.346]) versus placebo (−15.61). There were no significant differences in secondary end points versus placebo, with the exception of week-eight change in PSQI global score (quetiapine XR, −4.96 [P<0.01] versus placebo, −3.37). Mixed-model repeated-measures analysis of observed-case data suggested that the primary analysis may not be robust. Most commonly reported adverse events included dry mouth, somnolence, and dizziness for quetiapine XR, and headache and nausea for escitalopram. Conclusion In this study, neither quetiapine XR (150/300 mg/day) nor escitalopram (10/20 mg/day) showed significant separation from placebo. Both compounds have been shown previously to be effective in the treatment of MDD; possible reasons for this failed study are discussed. Quetiapine XR was generally well tolerated, with a profile similar to that reported previously. PMID:24511235

Impact of the quality of coronal restoration and root canal filling on the periapical health in adult syrian subpopulation

PubMed Central

Alafif, Hisham

2014-01-01

Background: The purpose of this study was to determine the status of periapical tissues of endodontically treated teeth according to coronal restorations and root canal fillings separately and in concomitant in adult Syrian subpopulation. Methods: 784 endodontically treated teeth from two hundred randomly selected Syrian adult patients were radiographically evaluated. According to predetermined criteria, the quality of coronal restorations and root canal filling of each tooth was scored as adequate or inadequate. The status of periapical tissues was also classified as healthy or diseased. Results were analyzed using Chi-squared test. Results: Adequate coronal restorations were determined in 58.54% of cases which was accompanied with less periapical pathosis than that in teeth with inadequate restorations (P < 0.01). 14% of teeth were restored by posts which showed no significant impact on the periapical tissues health. 18.5% of endodontic treatments were evaluated as adequate with less number of periapical radiolucencies than that of inadequate root canal fillings (P < 0.01). Absence of periapical pathosis was 96.6% in cases with both adequate coronal restorations and root canals fillings. The rate was 88.5% in cases with only adequate root canals fillings, and about 70% in cases with only adequate coronal restorations. When the treatment was inadequate in both coronal and root canals fillings, success rate was only observed in 48.8%. Conclusion: The most important factor with regard to the periradicular tissue health is the quality of root canal filling without neglecting the influence of coronal restoration (regardless of its type). There is a high prevalence rate of periapical pathosis in Syrian subpopulation due to poor dental practice. PMID:25565729

Identifying Patients Who Need a Change in Depression Treatment and Implementing That Change.

PubMed

Papakostas, George I

2016-08-01

For patients whose depression is difficult to treat or treatment-resistant, physicians must make an educated choice to switch, augment, or combine therapies to help patients adequately respond after initial treatment selections fail. Uncover some of the complexities of this challenging diagnosis by following the case of Robert, a 55-year-old accountant whose inadequate response to treatment by his primary care doctor has prompted a referral to a specialist. © Copyright 2016 Physicians Postgraduate Press, Inc.

Keratomalacia

MedlinePlus

... affected, resulting in an inadequate tear film and dry eyes. People with extreme eye dryness can develop foamy ... keratomalacia is based on the presence of a dry or ulcerated cornea in an undernourished person. ... eye drops or ointments Treatment of vitamin A deficiency ...

Basis for selecting optimum antibiotic regimens for secondary peritonitis.

PubMed

Maseda, Emilio; Gimenez, Maria-Jose; Gilsanz, Fernando; Aguilar, Lorenzo

2016-01-01

Adequate management of severely ill patients with secondary peritonitis requires supportive therapy of organ dysfunction, source control of infection and antimicrobial therapy. Since secondary peritonitis is polymicrobial, appropriate empiric therapy requires combination therapy in order to achieve the needed coverage for both common and more unusual organisms. This article reviews etiological agents, resistance mechanisms and their prevalence, how and when to cover them and guidelines for treatment in the literature. Local surveillances are the basis for the selection of compounds in antibiotic regimens, which should be further adapted to the increasing number of patients with risk factors for resistance (clinical setting, comorbidities, previous antibiotic treatments, previous colonization, severity…). Inadequate antimicrobial regimens are strongly associated with unfavorable outcomes. Awareness of resistance epidemiology and of clinical consequences of inadequate therapy against resistant bacteria is crucial for clinicians treating secondary peritonitis, with delicate balance between optimization of empirical therapy (improving outcomes) and antimicrobial overuse (increasing resistance emergence).

Foreign body urethra misdiagnosed as stricture leading to inadequate management and prolonged treatment duration: a lesson to learn.

PubMed

Sharma, Deepanshu; Pandey, Siddharth; Garg, Gaurav; Sankhwar, Satyanarayan

2018-05-26

Misdiagnosis of a urethral foreign body (FB) as urethral stricture leads to inadequate management and prolonged treatment duration. A 55-year-old male patient was referred with complaints of difficulty in voiding and poor urinary stream for 2 months. He initially presented at a primary healthcare centre and was misdiagnosed as urethral stricture and was scheduled for urethroplasty. Surprisingly, intraoperative cystourethroscopy performed by us revealed that the urethra had been obstructed by an FB. The FB was gently pushed into the bladder and retrieved. The postoperative course was uneventful. The present case represents a rare occurrence of polyembolokoilamania or insertion of a FB into any bodily orifice for sexual gratification. © BMJ Publishing Group Ltd (unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Health promotion financing with Mongolia's social health insurance.

PubMed

Bayarsaikhan, Dorjsuren; Nakamura, Keiko

2015-03-01

Health promotion is receiving more attention in Mongolia. A survey is undertaken to examine health promotion in terms of health-related information, education, counseling, screening, preventive and medical checkups. Almost all (97.5%) of the subjects feel that access to reliable and systematically organized health-related information is important. About 60% of the subjects expressed that the amount of currently available information is inadequate. There are several factors that limit the implementation of public health programs. These include inadequate focus on promoting health at individual level, lack of funds, and limited incentives to promote health. This article examined social health insurance as an option to address these issues. Three hypothetical benefits package options expanded to health promotion were developed and simulated by a computerized tool. The simulations show that all 3 options are financially sustainable at the existing level of contribution if Mongolia will gain near universal health insurance coverage and improve revenue collection practices. © 2009 APJPH.

Maladaptively high and low openness: the case for experiential permeability.

PubMed

Piedmont, Ralph L; Sherman, Martin F; Sherman, Nancy C

2012-12-01

The domain of Openness within the Five-Factor Model (FFM) has received inconsistent support as a source for maladaptive personality functioning, at least when the latter is confined to the disorders of personality included within the American Psychiatric Association's (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR; APA, ). However, an advantage of the FFM relative to the DSM-IV-TR is that the former was developed to provide a reasonably comprehensive description of general personality structure. Rather than suggest that the FFM is inadequate because the DSM-IV-TR lacks much representation of Openness, it might be just as reasonable to suggest that the DSM-IV-TR is inadequate because it lacks an adequate representation of maladaptive variants of both high and low Openness. This article discusses the development and validation of a measure of these maladaptive variants, the Experiential Permeability Inventory. © 2012 The Authors. Journal of Personality © 2012, Wiley Periodicals, Inc.

Monitoring patients with continuous-flow ventricular assist devices outside of the intensive care unit: novel challenges to bedside nursing.

PubMed

O'Shea, Genevieve; Teuteberg, Jeffrey J; Severyn, Donald A

2013-03-01

Ventricular assist devices provide therapeutic options for patients with severe heart failure who have exhausted available medical therapies. With restoration of organ perfusion with ventricular assist devices, the heart failure resolves and quality of life and functional status improve. The current generation of continuous-flow devices present novel challenges to the clinical assessment of patients by substantially reducing or nearly eliminating any palpable pulse. Patients therefore generally have inadequate arterial pulsatility for most noninvasive monitoring devices such as pulse oximeters or automated blood pressure cuffs to work accurately. This article describes the function of continuous-flow devices and how this function affects common monitoring options, as well as how to clinically assess recipients of continuous-flow devices to promptly identify those whose condition may be deteriorating or who may be receiving inadequate perfusion.

Health promotion financing with Mongolia's social health insurance.

PubMed

Bayarsaikhan, Dorjsuren; Nakamura, Keiko

2009-10-01

Health promotion is receiving more attention in Mongolia. A survey is undertaken to examine health promotion in terms of health-related information, education, counseling, screening, and preventive and medical checkups. Almost all (97.5%) the participants feel that access to reliable and systematically organized health-related information is important. About 60% of the participants said that the amount of currently available information is inadequate. There are several factors that limit the implementation of public health programs. These include inadequate focus on promoting health at the individual level, lack of funds, and limited incentives to promote health. This article examines social health insurance as an option to address these issues. Three hypothetical benefits package options expanded to health promotion were developed and simulated by a computerized tool. The simulations show that all 3 options are financially sustainable at the existing level of contribution if Mongolia will gain near universal health insurance coverage and improve revenue collection practices.

Empowerment and use of antenatal care among women in Ghana: a cross-sectional study.

PubMed

Sipsma, Heather; Ofori-Atta, Angela; Canavan, Maureen; Udry, Christopher; Bradley, Elizabeth

2014-11-01

Empowerment among women in the context of a romantic relationship may affect the use of reproductive healthcare services; however, current literature examining this association is limited and inconsistent. We therefore aimed to examine the relationship between several measures of empowerment and use of inadequate antenatal care among women in Ghana. We conducted a cross-sectional study using data from a nationally representative cohort of women in Ghana. Our analytic sample was limited to non-pregnant women who had been pregnant and involved in a relationship within the last 12 months. We used multivariable logistic regression to assess the associations between empowerment and inadequate use of antenatal care and interaction terms to assess moderation by education. Approximately 26% of women received inadequate antenatal care. Multivariable analysis indicated that having experienced physical abuse in the past year was directly associated with inadequate use of antenatal care (OR = 5.12; 95% CI = 1.35, 19.43) after adjusting for socio-demographic characteristics. This effect was particularly pronounced among women with no formal education and was non-significant among women with at least some formal education (P-value for interaction <0.001). Results suggest that improving use of reproductive health care services will require reducing partner abuse and enhancing empowerment among women in Ghana and other low-income countries, particularly among those with no formal education. Furthermore, the involvement of male partners will be critical for improving reproductive health outcomes, and increasing education among girls in these settings is likely a strong approach for improving reproductive health and buffering effects of low empowerment among women.

Effects of grazing management treatment on grassland plant communities and prairie grouse habitat

Treesearch

Llewellyn L. Manske; William T. Barker; Mario E. Biondini

1988-01-01

Seasonlong grazing treatments show no benefit to grass basal cover and visual obstruction is not adequate. Pastures with one grazing period in mid season show no positive change in grass basal cover but have better visual obstruction than seasonlong. Deferred grazing decreases basal cover of warm season grasses and visual obstruction reduced to inadequate levels the...

Under-treatment of cancer pain.

PubMed

Fairchild, Alysa

2010-03-01

Cancer pain remains inadequately treated, despite internationally accepted management guidelines and a myriad of treatment options. Risk factors for undertreatment are reviewed, along with possible explanations. Recent studies documenting the scope of the problem as well as investigating solutions are discussed with clinical-practice recommendations outlined. Women over 65 years of age representative of a cultural minority, with earlier stage disease, cared for at home, and with high-school education or less are at highest risk of having uncontrolled cancer pain. Optimal treatment is impeded by patients' maladaptive beliefs, nonadherence, underreporting or miscommunication with caregivers; from a healthcare provider perspective, it may be due to inadequate assessment, documentation, knowledge, and communication. Emerging data support the vital influence of lay caregivers on appropriate pain management. Although home-education programs may decrease pain and improve quality of life, there are also less intensive approaches deliverable by individuals to holistically address pain. Prospective study of barriers to both delivery and receipt of adequate pain management is needed, as the majority of published literature is based on survey studies. Treatment must be individualized based on clinical circumstances and patient wishes, with the goal of maximizing function and quality of life.

Assessment of the quality of reporting observational studies in the pediatric dental literature.

PubMed

Butani, Yogita; Hartz, Arthur; Levy, Steven; Watkins, Catherine; Kanellis, Michael; Nowak, Arthur

2006-01-01

The purpose of this assessment was to evaluate reporting of observational studies in the pediatric dental literature. This assessment included the following steps: (1) developing a model for reporting information in clinical dentistry studies; (2) identifying treatment comparisons in pediatric dentistry that were evaluated by at least 5 observational studies; (3) abstracting from these studies any data indicated by applying the reporting model; and (4) comparing available data elements to the desired data elements in the reporting model. The reporting model included data elements related to: (1) patients; (2) providers; (3) treatment details; and (4) study design. Two treatment comparisons in pediatric dentistry were identified with 5 or more observational studies: (1) stainless steel crowns vs amalgams (10 studies); and (2) composite restorations vs amalgam (5 studies). Results from studies comparing the same treatments varied substantially. Data elements from the reporting model that could have explained some of the variation were often reported inadequately or not at all. Reporting of observational studies in the pediatric dental literature may be inadequate for an informed interpretation of the results. Models similar to that used in this study could be used for developing standards for the conduct and reporting of observational studies in pediatric dentistry.

Relationship between prenatal care and maternal complications in women with preeclampsia: implications for continuity and discontinuity of prenatal care.

PubMed

Liu, Ching-Ming; Chang, Shuenn-Dyh; Cheng, Po-Jen

2012-12-01

Prenatal care is associated with better pregnancy outcome and may be a patient safety issue. However, no studies have investigated the types and quality of prenatal care provided in northern Taiwan. This retrospective study assessed whether the hospital-based continuous prenatal care model at tertiary hospitals reduced the risk of perinatal morbidity and maternal complications in pre-eclampsia patients. Of 385 pre-eclampsia patients recruited from among 23,665 deliveries, 198 were classified as patients with little or no prenatal care who received traditional, individualized, and physician-based discontinuous prenatal care (community-based model), and 187 were classified as control patients who received tertiary hospital-based continuous prenatal care. The effects on perinatal outcome were significantly different between the two groups. The cases in the hospital-based care group were less likely to be associated with preterm delivery, low birth weight, very low birth weight, and intrauterine growth restriction. After adjustment of confounding factors, the factors associated with pregnant women who received little or no prenatal care by individualized physician groups were diastolic blood pressure ≥ 105 mmHg, serum aspartate transaminase level ≥ 150 IU/L, and low-birth-weight deliveries. This study also demonstrated the dose-response effect of inadequate, intermediate, adequate, and intensive prenatal care status on fetal birth weight and gestational periods (weeks to delivery). The types of prenatal care may be associated with different pregnancy outcomes and neonatal morbidity. Factors associated with inadequate prenatal care may be predictors of pregnancy outcome in pregnant women with pre-eclampsia. Copyright © 2012. Published by Elsevier B.V.

Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study.

PubMed

Deodhar, Atul; Gottlieb, Alice B; Boehncke, Wolf-Henning; Dong, Bin; Wang, Yuhua; Zhuang, Yanli; Barchuk, William; Xu, Xie L; Hsia, Elizabeth C

2018-06-02

Guselkumab, a human monoclonal antibody that binds to the p19 subunit of interleukin 23, has been approved for the treatment of moderate-to-severe psoriasis. Psoriatic arthritis is a common comorbidity of psoriasis with an umet need for novel treatments. We assessed the efficacy and safety of guselkumab in patients with active psoriatic arthritis. We did a randomised, double-blind, placebo-controlled, phase 2a trial at 34 rheumatology and dermatology practices in Canada, Germany, Poland, Romania, Russia, Spain, and the USA. Eligible participants were aged 18 years or older with active psoriatic arthritis and plaque psoriasis affecting at least 3% of their body surface area, with three or more of 66 tender joints and three or more of 68 swollen joints, who had an inadequate response or intolerance to standard treatments. We randomly assigned patients (2:1) via a central interactive web-response system using computer-generated permuted blocks with a block size of six, stratified by previous anti-tumour necrosis factor-α use, to receive subcutaneous guselkumab 100 mg or placebo at week 0, week 4, and every 8 weeks thereafter for 24 weeks. Patients, investigators, and site staff were masked to treatment assignment until final database lock at week 56. At week 16, patients with less than 5% improvement in swollen and tender joint counts were eligible for early escape to ustekinumab. At week 24, the remaining placebo-treated patients crossed over to receive guselkumab 100 mg at weeks 24, 28, 36, and 44 and guselkumab-treated patients received a placebo injection at week 24, followed by guselkumab injections at weeks 28, 36, and 44. The primary endpoint was the proportion of patients with at least 20% improvement at week 24 in signs and symptoms of psoriatic arthritis according to American College of Rheumatology criteria (ACR20) in the modified intention-to-treat population (ie, all randomly assigned patients who received at least one dose of study treatment). Safety analyses included patients according to the study drug received. This study is registered with ClinicalTrials.gov, number NCT02319759. Between March 27, 2015, and Jan 17, 2017, we randomly assigned 149 patients to treatment: 100 to guselkumab and 49 to placebo. 17 (35%) of 49 patients in the placebo group and ten (10%) of 100 patients in the guselkumab group were eligible for early escape to ustekinumab at week 16. 29 (59%) of 49 patients in the placebo group crossed over and received guselkumab at week 24. Three (6%) of 49 patients in the placebo group, one (3%) of 29 patients who crossed over from placebo to guselkumab, and six (6%) of 100 patients in the guselkumab group discontinued study treatment before week 44. 58 (58%) of 100 patients in the guselkumab group and nine (18%) of 49 patients in the placebo group achieved an ACR20 response at week 24 (percentage difference 39·7% [95% CI 25·3-54·1]; p<0·0001). Between week 0 and week 24, 36 (36%) of 100 guselkumab-treated patients and 16 (33%) of 49 placebo-treated patients had at least one adverse event. The most frequent adverse event was infection in both groups (16 [16%] of 100 patients in the guselkumab group vs ten [20%] of 49 patients in the placebo group). The prevalence of adverse events between week 0 and week 56 in guselkumab-treated patients (51 [40%] of 129) indicated no disproportional increase with longer guselkumab exposure. No deaths occurred. Guselkumab, a novel anti-interleukin 23p19 antibody, significantly improved signs and symptoms of active psoriatic arthritis and was well tolerated during 44 weeks of treatment. The results of this study support further development of guselkumab as a novel and comprehensive treatment in psoriatic arthritis. Janssen Research & Development. Copyright © 2018 Elsevier Ltd. All rights reserved.

Protocol for the ENCODE trial: evaluating a novel online depression intervention for persons with epilepsy.

PubMed

Meyer, Björn; Weiss, Mario; Holtkamp, Martin; Arnold, Stephan; Brückner, Katja; Schröder, Johanna; Scheibe, Franziska; Nestoriuc, Yvonne

2017-02-07

Depression is common among persons with epilepsy (PwE), affecting roughly one in three individuals, and its presence is associated with personal suffering, impaired quality of life, and worse prognosis. Despite the availability of effective treatments, depression is often overlooked and treated inadequately in PwE, in part because of assumed concerns over drug interactions or proconvulsant effects of antidepressants. Internet-administered psychological interventions might complement antidepressant medication or psychotherapy, and preliminary evidence suggests that they can be effective. However, no trial has yet examined whether an Internet intervention designed to meet the needs of PwE can achieve sustained reductions in depression and related symptoms, such as anxiety, when offered as adjunct to treatment as usual. This randomized controlled trial will include 200 participants with epilepsy and a current depressive disorder, along with currently at least moderately elevated depression (Patient Health Questionnaire (PHQ-9) sum score of at least 10). Patients will be recruited via epilepsy treatment centers and other sources, including Internet forums, newspaper articles, flyers, posters, and media articles or advertisements, in German-speaking countries. Main inclusion criteria are: self-reported diagnosis of epilepsy and a depressive disorder, as assessed with a phone-administered structured diagnostic interview, none or stable antidepressant medication, no current psychotherapy, no other major psychiatric disorder, no acute suicidality. Participants will be randomly assigned to either (1) a care-as-usual/waitlist (CAU/WL) control group, in which they receive CAU and are given access to the Internet intervention after 3 months (that is, a CAU/WL control group), or (2) a treatment group that may also use CAU and in addition immediately receives six-month access to the novel, Internet-administered intervention. The primary outcome measure is the PHQ-9, collected at three months post-baseline; secondary measures include self-reported anxiety, work and social adjustment, epilepsy symptoms (including seizure frequency and severity), medication adherence, potential negative treatment effects and health-related quality of life. Measurements are collected online at pre-treatment (T0), three months (T1), six months (T2), and nine months (T3). Results of this trial are expected to extend the body of knowledge with regard to effective and efficient treatment options for PwE who experience elevated depression and anxiety. ClinicalTrials.gov: NCT02791724 . Registered 01 June 2016.

Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study

PubMed Central

2012-01-01

Background Treatment options for patients suffering from progressive forms of multiple sclerosis (MS) remain inadequate. Mast cells actively participate in the pathogenesis of MS, in part because they release large amounts of various mediators that sustain the inflammatory network. Masitinib, a selective oral tyrosine kinase inhibitor, effectively inhibits the survival, migration and activity of mast cells. This exploratory study assessed the safety and clinical benefit of masitinib in the treatment of primary progressive MS (PPMS) or relapse-free secondary progressive MS (rfSPMS). Methods Multicenter, randomized, placebo-controlled, proof-of-concept trial. Masitinib was administered orally at 3 to 6 mg/kg/day for at least 12 months, with dose adjustment permitted in event of insufficient response with no toxicity. The primary response endpoint was the change relative to baseline in the multiple sclerosis functional composite score (MSFC). Clinical response was defined as an increase in MSFC score relative to baseline of > 100%. Results Thirty-five patients were randomized to receive masitinib (N = 27) or placebo (N = 8). Masitinib was relatively well tolerated with the most common adverse events being asthenia, rash, nausea, edema, and diarrhea. The overall frequency of adverse events was similar to the placebo group, however, a higher incidence of severe and serious events was associated with masitinib treatment. Masitinib appeared to have a positive effect on MS-related impairment for PPMS and rfSPMS patients, as evidenced by an improvement in MSFC scores relative to baseline, compared with a worsening MSFC score in patients receiving placebo; +103% ± 189 versus -60% ± 190 at month-12, respectively. This positive, albeit non-statistically significant response was observed as early as month-3 and sustained through to month-18, with similar trends seen in the PPMS and rfSPMS subpopulations. A total of 7/22 (32%) assessable masitinib patients reported clinical response following 12 months of treatment (according to the modified intent-to-treat population, observed cases) compared with none in the placebo group. The Expanded Disability Status Scale remained stable for both treatment groups. Conclusion These data suggest that masitinib is of therapeutic benefit to PPMS and rfSPMS patients and could therefore represent an innovative avenue of treatment for this disease. This exploratory trial provides evidence that may support a larger placebo-controlled investigation. PMID:22691628

Tofacitinib: A Review in Rheumatoid Arthritis.

PubMed

Dhillon, Sohita

2017-12-01

Tofacitinib (Xeljanz ® ) is a potent, selective JAK inhibitor that preferentially inhibits Janus kinase (JAK) 1 and JAK3. In the EU, oral tofacitinib 5 mg twice daily is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant of, one or more DMARDs. Several clinical studies of ≤ 24 months' duration showed that tofacitinib monotherapy (as first- or second-line treatment) and combination therapy with a conventional synthetic DMARD (csDMARD; as second- or third-line treatment) was effective in reducing signs and symptoms of disease and improving health-related quality of life (HR-QOL), with benefits sustained during long-term therapy (≤ 96 months). Tofacitinib monotherapy inhibited progression of structural damage in methotrexate-naïve patients during ≤ 24 months' treatment, with beneficial effects also seen in patients receiving tofacitinib plus methotrexate as second-line therapy for 12 months. Tofacitinib was generally well tolerated during ≤ 114 months' treatment, with most adverse events of mild or moderate severity. The tolerability profile of tofacitinib was generally similar to that of biological DMARDs (bDMARDs), with infections and infestations the most common adverse events (AEs) in tofacitinib recipients. However, the incidence of herpes zoster (HZ) was higher with tofacitinib than in the general RA population, although infections were clinically manageable. When added to background methotrexate, tofacitinib was noninferior to adalimumab in terms of efficacy, and both combination therapies had generally similar tolerability profiles. Although additional comparative studies are needed to more definitively position tofacitinib relative to bDMARDs and other targeted synthetic DMARDs, current evidence indicates that oral tofacitinib is a useful option for the treatment of patients with RA.

Effectiveness and Safety of Transdermal Buprenorphine Versus Sustained-release Tramadol in Patients With Moderate to Severe Musculoskeletal Pain: An 8-Week, Randomized, Double-Blind, Double-Dummy, Multicenter, Active-controlled, Noninferiority Study.

PubMed

Leng, Xiaomei; Li, Zhanguo; Lv, Houshan; Zheng, Yi; Liu, Yi; Dai, Kerong; Yao, Chen; Yan, Xiaoyan; Zeng, Xiaofeng

2015-07-01

The aim of this noninferiority study was to investigate clinical effectiveness and safety of buprenorphine transdermal system (BTDS) in patients with moderate to severe musculoskeletal pain inadequately controlled with nonsteroidal anti-inflammatory drugs, compared with sustained-release tramadol tablets. Eligible patients were randomized (1:1) to receive low-dose 7-day BTDS (5, 10, and 20 μg/h, maximum dosage of 20 μg/h) or sustained-release tramadol tablets (100 mg, maximum dosage of 400 mg/d) over an 8-week double-blind treatment period (3-week titration, 5-week maintenance). The primary endpoint was the difference in the visual analogue scale (VAS) pain scores from baseline to treatment completion. Noninferiority was assumed if the treatment difference on the VAS scale was within ±1.5 cm, this threshold indicating a clinically meaningful result. ClinicalTrials.gov identifier: NCT01476774. Two hundred eighty patients were randomized to BTDS (n=141) or to tramadol (n=139). Both treatments were associated with a significant reduction in pain by the end of the treatment. The least squares mean difference of the change from baseline in VAS scores between the BTDS and tramadol groups were 0.45 (95% confidence interval, -0.02 to 0.91), which was within the ±1.5 cm predefined threshold, indicating that the effectiveness of BTDS was not inferior to the effectiveness of sustained-release tramadol tablets. The incidence of adverse events was comparable between the 2 treatment groups. Our results suggest that BTDS is a good therapeutic option for patients experiencing chronic musculoskeletal pain of moderate to severe intensity that is insufficiently controlled by nonsteroidal anti-inflammatory drugs.

Fear of Birth Defects Is a Major Barrier to Soil-Transmitted Helminth Treatment (STH) for Pregnant Women in the Philippines

PubMed Central

Totañes, Francis Isidore G.; Macatangay, Bernard J. C.; Belizario, Vicente Y.

2014-01-01

The World Health Organization recommends anthelminthic treatment for pregnant women after the first trimester in soil-transmitted helminth (STH) endemic regions to prevent adverse maternal-fetal consequences. Although studies have shown the high prevalence of infection in the Philippines, no research has evaluated deworming practices. We hypothesized that pregnant women are not receiving deworming treatment and we aimed to identify barriers to World Health Organization guideline implementation. We conducted key informant interviews with local Department of Health (DOH) administrators, focus group discussions with nurses, midwives, and health care workers, and knowledge, attitudes, and practices surveys with women of reproductive age to elicit perspectives about deworming during pregnancy. Key informant interviews revealed that healthcare workers were not deworming pregnant women due to inadequate drug supply, infrastructure and personnel as well as fear of teratogenicity. Focus group discussions showed that healthcare workers similarly had not implemented guidelines due to infrastructure challenges and concerns for fetal malformations. The majority of local women believed that STH treatment causes side effects (74.8%) as well as maternal harm (67.3%) and fetal harm (77.9%). Women who were willing to take anthelminthics while pregnant had significantly greater knowledge as demonstrated by higher Treatment Scores (mean rank 146.92 versus 103.1, z = −4.40, p<0.001) and higher Birth Defect Scores (mean rank 128.09 versus 108.65, z = −2.43, p = 0.015). This study concludes that World Health Organization guidelines are not being implemented in the Philippines. Infrastructure, specific protocols, and education for providers and patients regarding anthelminthic treatment are necessary for the successful prevention of STH morbidity and mortality among pregnant women. PMID:24586245

[Assessment of medical waste management in a Palestinian hospital].

PubMed

Al-Khatib, I A; Khatib, R A

2006-01-01

We studied medical waste management in a Palestinian hospital in the West Bank and the role of municipality in this management. In general, "good management practices" were inadequate; there was insufficient separation between hazardous and non-hazardous wastes, an absence of necessary rules and regulations for the collection of wastes from the hospital wards and the on-site transport to a temporary storage location inside and outside the hospital and inadequate waste treatment and disposal of hospital wastes along with municipal garbage. Moreover, training of personnel was lacking and protective equipment and measures for staff were not available. No special landfills for hazardous wastes were found within the municipality.

Lost in the crowd: prison mental health care, overcrowding, and the courts.

PubMed

Appelbaum, Paul S

2011-10-01

Skyrocketing inmate populations have put considerable pressure on prison mental health services. In California, prison populations have exceeded 200% of capacity, and litigation to rectify constitutionally inadequate care has been under way for more than two decades. After the failure of other remedies, a federal court ordered the state to reduce its inmate population to 137.5% of capacity in two years. The U.S. Supreme Court upheld the order, although it signaled that California could obtain more time to comply. Other states now are on notice that the justices will not permit grossly inadequate treatment conditions to continue indefinitely.

Renovating existing space to meet special needs for outpatient paediatric oncology.

PubMed

Rhodes, D A

1999-01-01

Many existing hospital buildings are inadequate to meet needs caused by a tremendous shift from inpatient to outpatient care. Expensive diagnostic and treatment facilities must still be shared by inpatients and outpatients, which in many cases makes renovations to existing facilities on site more appealing than new free-standing facilities; However, care must be taken in the planning and design to make sure that existing hospital operations can be maintained throughout this work. St. Jude Children's Research Hospital in Memphis, an internationally acclaimed institution devoted to the research and treatment of catastrophic illnesses in children has experienced a large growth in its outpatients' care due mainly to changes in treatment modalities and the development of more effective cures. The result has been an extreme overcrowding and unpleasant experiences for patient and family due to awkward patient flow and work processes attempting to respond to the inadequate facility conditions. This paper will not only review the planning issues, but will discuss the renovation which will require several phases in order to minimise disruption to the ongoing activities.

Incomplete surgery, local immunostimulation, and recurrence of some tumour types in dogs and cats.

PubMed

Misdorp, W

1987-07-01

Histologically confirmed inadequate treatment resulted in a lower than expected recurrence percentage in dogs with haemangiopericytoma (38%) and mastocytoma (30%). Clinical suspicion of inadequate tumour treatment did not always correlate with the histologically assessed inadequacy, nor with the appearance of local recurrence. Local recurrence did not seem to be correlated with histological grade of malignancy and tumour size. Local injection of C. parvum vaccine did not result in a lower percentage of local recurrence or longer recurrence-free intervals in any of the three tumour groups (canine haemangiopericytoma, canine mastocytoma, feline mammary carcinoma). Nor was palliative local adjuvant injection of Cp successful in dogs and cats with soft tissue sarcomas or in dogs with gingival melanoma. Re-operation of locally recurrent tumour was successful in some dogs with haemangiopericytoma, in a few with mastocytoma, but not in cats with mammary carcinoma. A trend toward histological progression of recurrences and metastases, when compared with the primary tumours, was not evident. The possible reasons for the relatively low recurrence rate of some tumour types and for the failure of Cp-treatment are discussed.

The development of chronic pain: physiological CHANGE necessitates a multidisciplinary approach to treatment

PubMed Central

Ahlbeck, Karsten; Aldington, Dominic; Alon, Eli; Coluzzi, Flaminia; Dahan, Albert; Huygen, Frank; Kocot-Kępska, Magdalena; Mangas, Ana Cristina; Mavrocordatos, Philippe; Morlion, Bart; Müller-Schwefe, Gerhard; Nicolaou, Andrew; Pérez Hernández, Concepción; Sichère, Patrick; Schäfer, Michael; Varrassi, Giustino

2013-01-01

Chronic pain is currently under-diagnosed and under-treated, partly because doctors’ training in pain management is often inadequate. This situation looks certain to become worse with the rapidly increasing elderly population unless there is a wider adoption of best pain management practice. This paper reviews current knowledge of the development of chronic pain and the multidisciplinary team approach to pain therapy. The individual topics covered include nociceptive and neuropathic pain, peripheral sensitization, central sensitization, the definition and diagnosis of chronic pain, the biopsychosocial model of pain and the multidisciplinary approach to pain management. This last section includes an example of the implementation of a multidisciplinary approach in Belgium and describes the various benefits it offers; for example, the early multidimensional diagnosis of chronic pain and rapid initiation of evidence-based therapy based on an individual treatment plan. The patient also receives continuity of care, while pain relief is accompanied by improvements in physical functioning, quality of life and emotional stress. Other benefits include decreases in catastrophizing, self-reported patient disability, and depression. Improved training in pain management is clearly needed, starting with the undergraduate medical curriculum, and this review is intended to encourage further study by those who manage patients with chronic pain. PMID:23786498

Ruxolitinib for the treatment of inadequately controlled polycythemia vera without splenomegaly: 80-week follow-up from the RESPONSE-2 trial.

PubMed

Griesshammer, Martin; Saydam, Guray; Palandri, Francesca; Benevolo, Giulia; Egyed, Miklos; Callum, Jeannie; Devos, Timothy; Sivgin, Serdar; Guglielmelli, Paola; Bensasson, Caroline; Khan, Mahmudul; Ronco, Julian Perez; Passamonti, Francesco

2018-05-27

RESPONSE-2 is a phase 3 study comparing the efficacy and safety of ruxolitinib with the best available therapy (BAT) in hydroxyurea-resistant/hydroxyurea-intolerant polycythemia vera (PV) patients without palpable splenomegaly. This analysis evaluated the durability of the efficacy and safety of ruxolitinib after patients completed the visit at week 80 or discontinued the study. Endpoints included proportion of patients achieving hematocrit control (< 45%), proportion of patients achieving complete hematologic remission (CHR) at week 28, and the durability of hematocrit control and CHR. At the time of analysis, 93% (69/74) of patients randomized to ruxolitinib were receiving ruxolitinib; while in the BAT arm, 77% (58/75) of patients crossed over to ruxolitinib after week 28. No patient remained on BAT by week 80. Among patients who achieved a hematocrit response at week 28, the probability of maintaining response up to week 80 was 78% in the ruxolitinib arm. At week 80, durable CHR was achieved in 18 patients (24%) in the ruxolitinib arm versus 2 patients (3%) in the BAT arm. The safety profile of ruxolitinib was consistent with previous reports. These data support that ruxolitinib treatment should be considered also as a standard of care for hydroxyurea-resistant/hydroxyurea-intolerant PV patients without palpable splenomegaly.

Potent Antiarthritic Properties of Phloretin in Murine Collagen-Induced Arthritis.

PubMed

Wang, Shun-Ping; Lin, Shih-Chao; Li, Shiming; Chao, Ya-Hsuan; Hwang, Guang-Yuh; Lin, Chi-Chen

2016-01-01

In the exploration of potential therapeutic agents for rheumatoid arthritis (RA), DBA/1J mice are used as the RA model of collagen-induced arthritis (CIA). Phloretin, a flavonoid compound extracted from Prunus mandshurica , has been found to exhibit anti-inflammatory activity, making it a potential candidate for treatment of RA. The objective of this study was to evaluate the therapeutic effects of phloretin on CIA mice. CIA mice were dosed daily with phloretin at either 50 or 100 mg/kg among two treatment groups. CIA treated mice showed mitigation of clinical symptoms of RA in addition to reduced inflammation of hind-limbs compared to mice who did not receive phloretin. Histological analysis showed that phloretin suppressed the severity of RA and effectively mitigated joint inflammation and cartilage- and bone-destruction via reducing proinflammatory cytokine productions (TNF- α , IL-6, IL-1 β , and IL-17). This was at least partially mediated by causing inadequate splenocyte activation and proliferation. Moreover, phloretin-treated CIA mice showed decreased oxidative stress and diminished levels of malondialdehyde (MDA) and hydrogen peroxide (H 2 O 2 ) in paw tissues as well as reduced productivity of anti-collagen antibodies in serum. We have concluded that phloretin could be a potent and effective antiarthritis agent, demonstrating anti-inflammatory, antioxidative, and immunomodulatory effects in CIA mice.

Estimated Under-Five Deaths Associated with Poor-Quality Antimalarials in Sub-Saharan Africa

PubMed Central

Renschler, John P.; Walters, Kelsey M.; Newton, Paul N.; Laxminarayan, Ramanan

2015-01-01

Many antimalarials sold in sub-Saharan Africa are poor-quality (falsified, substandard, or degraded), and the burden of disease caused by this problem is inadequately quantified. In this article, we estimate the number of under-five deaths caused by ineffective treatment of malaria associated with consumption of poor-quality antimalarials in 39 sub-Saharan countries. Using Latin hypercube sampling our estimates were calculated as the product of the number of private sector antimalarials consumed by malaria-positive children in 2013; the proportion of private sector antimalarials consumed that were of poor-quality; and the case fatality rate (CFR) of under-five malaria-positive children who did not receive appropriate treatment. An estimated 122,350 (interquartile range [IQR]: 91,577–154,736) under-five malaria deaths were associated with consumption of poor-quality antimalarials, representing 3.75% (IQR: 2.81–4.75%) of all under-five deaths in our sample of 39 countries. There is considerable uncertainty surrounding our results because of gaps in data on case fatality rates and prevalence of poor-quality antimalarials. Our analysis highlights the need for further investigation into the distribution of poor-quality antimalarials and the need for stronger surveillance and regulatory efforts to prevent the sale of poor-quality antimalarials. PMID:25897068

How I use hydroxyurea to treat young patients with sickle cell anemia

PubMed Central

2010-01-01

Hydroxyurea has many characteristics of an ideal drug for sickle cell anemia (SCA) and provides therapeutic benefit through multiple mechanisms of action. Over the past 25 years, substantial experience has accumulated regarding its safety and efficacy for patients with SCA. Early proof-of-principle studies were followed by prospective phase 1/2 trials demonstrating efficacy in affected adults, then adolescents and children, and more recently infants and toddlers. The phase 3 National Heart, Lung and Blood Institute–sponsored Multicenter Study of Hydroxyurea trial proved clinical efficacy for preventing acute vaso-occlusive events in severely affected adults. Based on this cumulative experience, hydroxyurea has emerged as an important therapeutic option for children and adolescents with recurrent vaso-occlusive events; recent evidence documents sustained long-term benefits with prevention or reversal of chronic organ damage. Despite abundant evidence for its efficacy, however, hydroxyurea has not yet translated into effective therapy for SCA. Because many healthcare providers have inadequate knowledge about hydroxyurea, patients and families are not offered treatment or decline because of unrealistic fears. Limited support for hydroxyurea by lay organizations and inconsistent medical delivery systems also contribute to underuse. Although questions remain regarding its long-term risks and benefits, current evidence suggests that many young patients with SCA should receive hydroxyurea treatment. PMID:20223921

Ethically problematic treatment decisions: a physician survey.

PubMed

Saarni, Samuli I; Parmanne, Piitu; Halila, Ritva

2008-02-01

Experiencing ethical problems requires both ethically problematic situations and ethical sensitivity. Ethically problematic treatment decisions are distressing and might reflect health care quality problems. Whether all physicians actually experience ethical problems, what these problems are and how they vary according to physician age, gender and work sector are largely unknown. A mail survey of all non-retired physicians licensed in Finland (n = 17,172, response rate 75.6%). The proportion of physicians reporting having made ethically problematic treatment decisions decreased in linear fashion from 60% at ages below 30 years to 21% at ages over 63 years. The only problem that did not decrease in frequency with age was having withdrawn necessary treatments. Women and primary care physicians reported problematic decisions most often, although gender differences were small. Primary care physicians most often reported having performed too many investigations or having pressured patients, whereas hospital physicians emphasized having withdrawn necessary treatments. Performing unnecessary treatments or investigations was explained by pressure from patients or relatives, and performing too few treatments or investigations was explained by inadequate resources. In general, young physicians felt pressured to do too much, whereas older physicians felt they could not do enough due to inadequate resources. Older physicians might be less exposed to ethically problematic situations, be more able to handle them or have lower ethical sensitivity. Young physicians could benefit from support in resisting pressure to perform unnecessary treatments, whereas older physicians might benefit from training in recognizing ethical issues.

Fund my treatment!: A call for ethics-focused social science research into the use of crowdfunding for medical care.

PubMed

Snyder, Jeremy; Mathers, Annalise; Crooks, Valorie A

2016-11-01

Crowdfunding involves raising money from large groups of individuals, often through the use of websites dedicated to this purpose. Crowdfunding campaigns aimed at raising money to pay for expenses related to receiving medical treatment are receiving increased media attention and there is evidence that medical crowdfunding websites are heavily used. Nonetheless, virtually no scholarly attention has been paid to these medical crowdfunding campaigns and there is no systematic evidence about how widely they are used and for what reasons, and what effects they have on the provision of medical care and individuals' relationships to their health systems. Ethical concerns have been raised in relation to these campaigns, focusing on issues for campaigners and donors such as exposure to fraudulent campaigns, loss of privacy, and fairness in how medical crowdfunding funds are distributed. Medical crowdfunding websites themselves have not been systematically studied, despite their significant influence on how these campaigns are developed and promoted. In this paper, we identify three very broad and pressing ethical questions regarding medical crowdfunding for social scientists to address and offer some preliminary insights into key issues informing future answers to each: Who benefits the most from medical crowdfunding and how does medical crowdfunding affect access to medical care; How does medical crowdfunding affect our understanding of the causes of inadequate access to medical care; and How are campaigner and donor privacy affected by website design? Our observations indicate the need for increased scholarly attention to the ethical and practical effects of medical crowdfunding for campaigners, recipients, donors, and the health system as a whole. Copyright © 2016 Elsevier Ltd. All rights reserved.

Maternal diet quality and nutrient intake in the gestational period: results from the delta healthy sprouts comparative impact trial.

PubMed

Tussing-Humphreys, Lisa M; Thomson, Jessica L; Goodman, Melissa H; Olender, Sarah

2016-01-01

A woman's diet while pregnant can play an important role in her reproductive health as well as the health of her unborn child. Diet quality and nutrient intake amongst pregnant women residing in the rural Lower Mississippi Delta (LMD) region of the United States is inadequate. The Delta Healthy Sprouts Project was designed to test the comparative impact of two home visiting programs on weight status, dietary intake, and health behaviors of women and their infants residing in the LMD region. This paper reports results pertaining to maternal diet quality and nutrient intake in the gestational period. The experimental arm (PATE) received monthly home visits beginning in the second trimester using the Parents as Teachers curriculum enhanced with a nutrition and lifestyle behavior curriculum. The control arm (PAT) received monthly home visits using the Parents as Teachers curriculum only. Maternal diet was assessed via 24-h dietary recall at gestational months (GM) 4 (baseline), 6, and 8. Diet quality was computed using the Healthy Eating Index-2010 (HEI-2010). Gestational period retention rates for PAT and PATE arms were 77 % (33/43) and 67 % (26/39), respectively. Significant effects were not found for time, treatment, or time by treatment for the HEI-2010 total or component scores, macro- or micronutrient intake or percentage of women meeting recommended nutrient intakes. Perhaps due to low participant enrollment and higher than expected rates of drop out and noncompliance, we were not able to demonstrate that the enhanced nutrition and lifestyle curriculum (PATE) intervention had a significant effect on diet quality or nutrient intake during pregnancy in this cohort of rural, Southern, primarily African American women. clinicaltrials.gov, NCT01746394. Registered 5 December 2012.

Simultaneous Control of PTH and Ca×P Is Sustained over Three Years of Treatment with Cinacalcet HCl

PubMed Central

Evenepoel, Pieter; Curzi, Mario P.; González, Maria Teresa; Husserl, Fred E.; Kopyt, Nelson; Sterling, Lulu Ren; Mix, Chris; Wong, Gordon

2009-01-01

Background & objectives: Chronic kidney disease (CKD) is commonly complicated by secondary hyperparathyroidism (SHPT), leading to increased risk of morbidity and mortality. SHPT is a progressive disease often requiring long-term therapy to control parathyroid hormone (PTH) and mineral imbalances. Vitamin D sterols and phosphate binders, used as traditional therapies to lower PTH and phosphorus, may provide inadequate long-term control for many dialysis patients. Cinacalcet, by simultaneously lowering PTH, calcium, phosphorus, and calcium-phosphorus levels, may maintain PTH and mineral balance in these individuals. However, as with traditional therapies, long-term data are limited. Design, setting, participants, & measurement: Dialysis subjects from at least one of five lead-in studies (double-blind placebo-controlled, including one extension trial) completing up to 52 wk of either cinacalcet or placebo were eligible for this open-label extension study, including an 8-wk dose titration (initiated at 30 mg/d), followed by 24-wk maintenance and up to 132 wk of follow-up. Final efficacy analysis was at week 180. Results: Three hundred thirty-four of 589 enrolled subjects received cinacalcet from the beginning of the lead-in study. Weekly median PTH values were ≤300 pg/ml (weeks 16 through 180) and median Ca×P values were ≤55 mg2/dl2 (weeks 4 through 180). Similar results were exhibited in the 255 subjects who initially received placebo. Among the patients exposed to cinacalcet from the beginning of the lead-in study, 3% of subjects exhibited treatment-related serious adverse events. Conclusions: Cinacalcet effectively maintained PTH, Ca and P reductions in dialysis subjects for up to 180 wk. PMID:19696213

Incidence, characteristics and management of pain in one operational area of medical emergency teams.

PubMed

Kosiński, Sylweriusz; Bryja, Magdalena; Wojtaszowicz, Rafał; Górka, Andrzej

2014-01-01

Experience of pain associated with both chronic as well as acute medical conditions is a main cause for call for ambulance. The aim of this study was to establish both frequency and characteristics of pain reported by patients treated in pre-hospital environment in a single operational area. The supplementary goal was an analysis of methods of pain alleviation applied by medical personnel in the above described scenario. The written documentation of 6 months of year 2009 provided by doctor-manned as well as paramedic-only ambulances operating in Tatra county, Małopolska, Poland was analyzed. Medical personnel inquired about pain experienced in 57.4% of cases, 10-point numerical rating scale was used in 22.3% of patients. Pain was reported by 43.8% of patients, the most frequent reasons of experienced pain were trauma and cardiovascular diseases. In almost half of the cases pain was referred to the areas of chest and abdomen. Non-traumatic pain was reported by 47.7% of patients, post-traumatic in 41.3% of cases, 11% of subjects reported ischemic chest pain. 42.3% of pain-reporting patients received some form of analgesia, yet only 3% of subjects in this group received opiates. Personnel of paramedic-only ambulances tended to use pain intensity scale more often (P < 0.01), yet administered pain alleviating drugs noticeably less often than the doctor-manned teams (P < 0.01). The use of pain alleviating drugs, opiates especially, was inadequate in proportion to frequency and intensity of pain reported by patients. General, nation-wide standards of pain measurement and treatment in pre-hospital rescue are suggested as a means to improve the efficacy of pain reduction treatment.

One-year efficacy and safety of saxagliptin add-on in patients receiving dapagliflozin and metformin.

PubMed

Matthaei, S; Aggarwal, N; Garcia-Hernandez, P; Iqbal, N; Chen, H; Johnsson, E; Chin, A; Hansen, L

2016-11-01

Greater reductions in glycated haemoglobin (HbA1c) with saxagliptin, a dipeptidyl peptidase-4 inhibitor, versus placebo add-on in patients with type 2 diabetes who had inadequate glycaemic control with dapagliflozin 10 mg/d plus metformin were demonstrated after 24 weeks of treatment. Results over 52 weeks of treatment were assessed in this analysis. Patients (mean baseline HbA1c 7.9%) receiving open-label dapagliflozin 10 mg/d plus metformin were randomized to double-blind saxagliptin 5 mg/d or placebo add-on. The adjusted mean change from baseline to week 52 in HbA1c was greater with saxagliptin than with placebo add-on -0.38% vs 0.05%; difference -0.42% (95% confidence interval -0.64, -0.20)]. More patients achieved the HbA1c target of <7% with saxagliptin than with placebo add-on (29% vs 13%), and fewer patients were rescued or discontinued the study for lack of glycaemic control with saxagliptin than with placebo add-on (19% vs 28%). Reductions from baseline in body weight (≤1.5 kg) occurred in both groups. Similar proportions of patients reported ≥1 adverse event with saxagliptin (58.2%) and placebo add-on (58.0%); no new safety signals were detected. Hypoglycaemia was infrequent in both treatment groups (≤2.5%), with no major episodes. The rate of urinary tract infections was similar in the saxagliptin and placebo add-on groups (7.8% vs 7.4%). The incidence of genital infections was 3.3% with saxagliptin versus 6.2% with placebo add-on. Triple therapy with saxagliptin add-on to dapagliflozin plus metformin for 52 weeks resulted in sustained improvements in glycaemic control without an increase in body weight or increased risk of hypoglycaemia. © 2016 John Wiley & Sons Ltd.

Risk of radiation-induced malignancy with heterotopic ossification prophylaxis: a case-control analysis.

PubMed

Sheybani, Arshin; TenNapel, Mindi J; Lack, William D; Clerkin, Patrick; Hyer, Daniel E; Sun, Wenqing; Jacobson, Geraldine M

2014-07-01

To determine the risk of radiation-induced malignancy after prophylactic treatment for heterotopic ossification (HO). A matched case-control study was conducted within a population-based cohort of 3489 patients treated either for acetabular fractures with acetabular open reduction internal fixation or who underwent total hip arthroplasty from 1990 to 2009. Record-linkage techniques identified patients who were diagnosed with a malignancy from our state health registry. Patients with a prior history of malignancy were excluded from the cohort. For each documented case of cancer, 2 controls were selected by stratified random sampling from the cohort that did not develop a malignancy. Matching factors were sex, age at time of hip treatment, and duration of follow-up. A total of 243 patients were diagnosed with a malignancy after hip treatment. Five patients were excluded owing to inadequate follow-up time in the corresponding control cohort. A cohort of 238 cases (control, 476 patients) was included. Mean follow-up was 10 years, 12 years in the control group. In the cancer cohort, 4% of patients had radiation therapy (RT), compared with 7% in the control group. Of the 9 patients diagnosed with cancer after RT, none occurred within the field. The mean latency period was 5.9 years in the patients who received RT and 6.6 years in the patients who did not. Median (range) age at time of cancer diagnosis in patients who received RT was 62 (43-75) years, compared with 70 (32-92) years in the non-RT patients. An ad hoc analysis was subsequently performed in all 2749 patients who were not matched and found neither an increased incidence of malignancy nor a difference in distribution of type of malignancy. We were unable to demonstrate an increased risk of malignancy in patients who were treated with RT for HO prophylaxis compared with those who were not. Copyright © 2014 Elsevier Inc. All rights reserved.

Influence of diabetes on liver injury induced by antitubercular drugs and on silymarin hepatoprotection in rats.

PubMed

Srivastava, R K; Sharma, S; Verma, S; Arora, B; Lal, H

2008-12-01

Isoniazid, rifampicin and pyrazinamide during short-course chemotherapy for tuberculosis can result in liver injury. The coexistence of tuberculosis and diabetes is common in patients who receive inadequate treatment. The risk of hepatotoxicity from many toxicants is increased in diabetic rats. Silymarin provides protection against liver injury caused by many hepatotoxicants, including antitubercular drugs (ATDs). In the wake of increased severity of ATD-induced hepatotoxicity in diabetes we report here the results of a study on the influence of diabetes on silymarin hepatoprotection in rats. Rats with diabetes induced via intraperitoneally injected streptozotocin (50 mg/kg), nondiabetic rats and insulin-treated diabetic rats received isoniazid (7.5 mg/kg/day), rifampicin (10 mg/kg/day) and pyrazinamide (35 mg/kg/day) orally (p.o.) with or without silymarin (100 mg/kg/day p.o.) treatment for 45 days. Compared to nondiabetic rats, liver function tests and histological changes of liver revealed exaggerated liver injury in diabetic rats caused by ATDs which was evident by 5- to 8-fold increases in serum levels of marker enzymes (aspartate and alanine aminotransferase, alkaline phosphatase and gamma-glutamyltranspeptidase) and 1- to 2-fold increases in bilirubin accompanied by a 2-fold decrease in total serum proteins, intense fatty and inflammatory infiltrations, necrosis and fibrosis. Coadministration of silymarin provided protection against ATD hepatotoxicity in all animals. However, insulin-treated diabetic animals showed greater silymarin-induced hepatoprotection against ATD-induced liver injury, which was characterized by near normal levels of marker enzymes, an increase in total proteins and normal hepatic structure. These results thus indicate that diabetes exaggerates ATD-induced liver injury and attenuates silymarin-induced hepatoprotection. However, insulin treatment for diabetes offers greater silymarin-induced hepatoprotection against ATD-induced liver injury. Copyright (c) 2008 Prous Science, S.A.U. or its licensors. All rights reserved.

Risk of Radiation-Induced Malignancy With Heterotopic Ossification Prophylaxis: A Case–Control Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sheybani, Arshin, E-mail: arshin-sheybani@uiowa.edu; TenNapel, Mindi J.; Lack, William D.

2014-07-01

Purpose: To determine the risk of radiation-induced malignancy after prophylactic treatment for heterotopic ossification (HO). Methods and Materials: A matched case–control study was conducted within a population-based cohort of 3489 patients treated either for acetabular fractures with acetabular open reduction internal fixation or who underwent total hip arthroplasty from 1990 to 2009. Record-linkage techniques identified patients who were diagnosed with a malignancy from our state health registry. Patients with a prior history of malignancy were excluded from the cohort. For each documented case of cancer, 2 controls were selected by stratified random sampling from the cohort that did not developmore » a malignancy. Matching factors were sex, age at time of hip treatment, and duration of follow-up. Results: A total of 243 patients were diagnosed with a malignancy after hip treatment. Five patients were excluded owing to inadequate follow-up time in the corresponding control cohort. A cohort of 238 cases (control, 476 patients) was included. Mean follow-up was 10 years, 12 years in the control group. In the cancer cohort, 4% of patients had radiation therapy (RT), compared with 7% in the control group. Of the 9 patients diagnosed with cancer after RT, none occurred within the field. The mean latency period was 5.9 years in the patients who received RT and 6.6 years in the patients who did not. Median (range) age at time of cancer diagnosis in patients who received RT was 62 (43-75) years, compared with 70 (32-92) years in the non-RT patients. An ad hoc analysis was subsequently performed in all 2749 patients who were not matched and found neither an increased incidence of malignancy nor a difference in distribution of type of malignancy. Conclusion: We were unable to demonstrate an increased risk of malignancy in patients who were treated with RT for HO prophylaxis compared with those who were not.« less

The prevalence of medical error related to end-of-life communication in Canadian hospitals: results of a multicentre observational study.

PubMed

Heyland, Daren K; Ilan, Roy; Jiang, Xuran; You, John J; Dodek, Peter

2016-09-01

In the hospital setting, inadequate engagement between healthcare professionals and seriously ill patients and their families regarding end-of-life decisions is common. This problem may lead to medical orders for life-sustaining treatments that are inconsistent with patient preferences. The prevalence of this patient safety problem has not been previously described. Using data from a multi-institutional audit, we quantified the mismatch between patients' and family members' expressed preferences for care and orders for life-sustaining treatments. We recruited seriously ill, elderly medical patients and/or their family members to participate in this audit. We considered it a medical error if a patient preferred not to be resuscitated and there were orders to undergo resuscitation (overtreatment), or if a patient preferred resuscitation (cardiopulmonary resuscitation, CPR) and there were orders not to be resuscitated (undertreatment). From 16 hospitals in Canada, 808 patients and 631 family members were included in this study. When comparing expressed preferences and documented orders for use of CPR, 37% of patients experienced a medical error. Very few patients (8, 2%) expressed a preference for CPR and had CPR withheld in their documented medical orders (Undertreatment). Of patients who preferred not to have CPR, 174 (35%) had orders to receive it (Overtreatment). There was considerable variability in overtreatment rates across sites (range: 14-82%). Patients who were frail were less likely to be overtreated; patients who did not have a participating family member were more likely to be overtreated. Medical errors related to the use of life-sustaining treatments are very common in internal medicine wards. Many patients are at risk of receiving inappropriate end-of-life care. 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/

Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years.

PubMed

Lovell, Daniel J; Ruperto, Nicolino; Mouy, Richard; Paz, Eliana; Rubio-Pérez, Nadina; Silva, Clovis A; Abud-Mendoza, Carlos; Burgos-Vargas, Ruben; Gerloni, Valeria; Melo-Gomes, Jose A; Saad-Magalhaes, Claudia; Chavez-Corrales, J; Huemer, Christian; Kivitz, Alan; Blanco, Francisco J; Foeldvari, Ivan; Hofer, Michael; Huppertz, Hans-Iko; Job Deslandre, Chantal; Minden, Kirsten; Punaro, Marilynn; Block, Alan J; Giannini, Edward H; Martini, Alberto

2015-10-01

The efficacy and safety of abatacept in patients with juvenile idiopathic arthritis (JIA) who experienced an inadequate response to disease-modifying antirheumatic drugs were previously established in a phase III study that included a 4-month open-label lead-in period, a 6-month double-blind withdrawal period, and a long-term extension (LTE) phase. The aim of this study was to present the safety, efficacy, and patient-reported outcomes of abatacept treatment (10 mg/kg every 4 weeks) during the LTE phase, for up to 7 years of followup. Patients enrolled in the phase III trial could enter the open-label LTE phase if they had not achieved a response to treatment at month 4 or if they had received abatacept or placebo during the double-blind period. One hundred fifty-three (80.5%) of 190 patients entered the LTE phase, and 69 patients (36.3%) completed it. The overall incidence rate (events per 100 patient-years) of adverse events decreased during the LTE phase (433.61 events during the short-term phase [combined lead-in and double-blind periods] versus 132.39 events during the LTE phase). Similar results were observed for serious adverse events (6.82 versus 5.60), serious infections (1.13 versus 1.72), malignancies (1.12 versus 0), and autoimmune events (2.26 versus 1.18). American College of Rheumatology (ACR) Pediatric 30 (Pedi 30) responses, Pedi 70 responses, and clinically inactive disease status were maintained throughout the LTE phase in patients who continued to receive therapy. Improvements in the Child Health Questionnaire physical and psychosocial summary scores were maintained over time. Long-term abatacept treatment for up to 7 years was associated with consistent safety, sustained efficacy, and quality-of-life benefits in patients with JIA. © 2015 The Authors. Arthritis & Rheumatology is published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.

Long‐Term Safety, Efficacy, and Quality of Life in Patients With Juvenile Idiopathic Arthritis Treated With Intravenous Abatacept for Up to Seven Years

PubMed Central

Ruperto, Nicolino; Mouy, Richard; Paz, Eliana; Rubio‐Pérez, Nadina; Silva, Clovis A.; Abud‐Mendoza, Carlos; Burgos‐Vargas, Ruben; Gerloni, Valeria; Melo‐Gomes, Jose A.; Saad‐Magalhaes, Claudia; Chavez‐Corrales, J.; Huemer, Christian; Kivitz, Alan; Blanco, Francisco J.; Foeldvari, Ivan; Hofer, Michael; Huppertz, Hans‐Iko; Job Deslandre, Chantal; Minden, Kirsten; Punaro, Marilynn; Block, Alan J.; Giannini, Edward H.; Martini, Alberto

2015-01-01

Objective The efficacy and safety of abatacept in patients with juvenile idiopathic arthritis (JIA) who experienced an inadequate response to disease‐modifying antirheumatic drugs were previously established in a phase III study that included a 4‐month open‐label lead‐in period, a 6‐month double‐blind withdrawal period, and a long‐term extension (LTE) phase. The aim of this study was to present the safety, efficacy, and patient‐reported outcomes of abatacept treatment (10 mg/kg every 4 weeks) during the LTE phase, for up to 7 years of followup. Methods Patients enrolled in the phase III trial could enter the open‐label LTE phase if they had not achieved a response to treatment at month 4 or if they had received abatacept or placebo during the double‐blind period. Results One hundred fifty‐three (80.5%) of 190 patients entered the LTE phase, and 69 patients (36.3%) completed it. The overall incidence rate (events per 100 patient‐years) of adverse events decreased during the LTE phase (433.61 events during the short‐term phase [combined lead‐in and double‐blind periods] versus 132.39 events during the LTE phase). Similar results were observed for serious adverse events (6.82 versus 5.60), serious infections (1.13 versus 1.72), malignancies (1.12 versus 0), and autoimmune events (2.26 versus 1.18). American College of Rheumatology (ACR) Pediatric 30 (Pedi 30) responses, Pedi 70 responses, and clinically inactive disease status were maintained throughout the LTE phase in patients who continued to receive therapy. Improvements in the Child Health Questionnaire physical and psychosocial summary scores were maintained over time. Conclusion Long‐term abatacept treatment for up to 7 years was associated with consistent safety, sustained efficacy, and quality‐of‐life benefits in patients with JIA. PMID:26097215

An Economic Evaluation of Tofacitinib Treatment in Rheumatoid Arthritis: Modeling the Cost of Treatment Strategies in the United States.

PubMed

Claxton, Lindsay; Jenks, Michelle; Taylor, Matthew; Wallenstein, Gene; Mendelsohn, Alan M; Bourret, Jeffrey A; Singh, Amitabh; Moynagh, Dermot; Gerber, Robert A

2016-09-01

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Tofacitinib is approved in the United States for use in adults with moderately to severely active RA and an inadequate response or intolerance to methotrexate. To (a) evaluate, using an economic model, the treatment costs of an RA strategy including tofacitinib, compared with adalimumab, etanercept, certolizumab and tocilizumab biologic RA treatment strategies, which are commonly prescribed in the United States, and (b) assess the economic impact of monotherapy and combination therapy in patients who had an inadequate response to methotrexate therapy (MTX-IR analysis) and to combination therapy in patients who had an inadequate response to a tumor necrosis factor inhibitor (TNF-IR analysis). A transparent, Excel-based economic model with a decision-tree approach was developed to evaluate costs over a 1- and 2-year time horizon. The model compared tofacitinib 5 mg twice a day (BID) either as monotherapy or in combination with MTX with similarly labeled biologic therapies. Response to treatment was modeled as American College of Rheumatology (ACR) 20/50/70 response. ACR20 represented clinical response and determined whether patients continued therapy. ACR response rates at 6-month intervals were sourced from prescribing information and safety event rates from a published meta-analysis. Following an adverse event or a lack of response to treatment, it was assumed that 75% of patients switched to the next line of treatment (first to abatacept and then to rituximab). The perspective was that of a U.S. payer. Costs were reported in 2015 U.S. dollars and included drug wholesale acquisition costs, monitoring, drug administration, and treatment for minor and serious adverse events. The patient population eligible for treatment was based on the total number of members (i.e., RA and non-RA) in a payer organization; members with RA treated with biologic therapies were estimated using epidemiological data. Sensitivity analyses were conducted to explore the impact of varying key parameters, including treatment-switching probability, product rebate, major rates of adverse drug reaction, and ACR20 rates, on the model outcomes. Tofacitinib combination therapy after MTX failure was associated with the lowest cost per member per month (PMPM) over a 2-year time frame at $5.53, compared with $6.49 for adalimumab, $6.43 for etanercept, $5.95 for certolizumab, and $5.89 for tocilizumab. Similar savings were observed when all biologics were administered as monotherapy. Tofacitinib combination therapy was also associated with the lower PMPM cost compared with adalimumab combination therapy in the TNF-IR analysis. Tofacitinib was also among the lowest cost per ACR20 responder in each analysis. Sensitivity analyses demonstrated that tofacitinib would potentially be cost saving even in the least optimistic scenarios. This analysis suggests that tofacitinib 5 mg BID following MTX failure is a lower cost per patient treatment option when used either as monotherapy or combination therapy, compared with adalimumab, etanercept, certolizumab and tocilizumab biologic regimens. Tofacitinib + MTX in TNF-IR patients was also predicted to be a lower-cost treatment option compared with adalimumab+MTX and was associated with the lowest cost per ACR 20/50/70 responder. This study was funded by Pfizer, which determined the research topic and paid York Health Economics Consortium to develop the analysis and conduct the research. York Health Economics Consortium has received consultancy fees from Pfizer. Gerber, Wallenstein, Mendelsohn, Bourret, Singh, and Moynagh are employees and shareholders of Pfizer. Editorial support was funded by Pfizer and was provided by Claxton, Jenks, and Taylor, who are employees of York Health Economics Consortium. Study concept and design were contributed primarily by Taylor, Jenks, Gerber, and Singh, along with the other authors. Gerber, Moynagh, and Singh collected the data, assisted by Bouret and Mendelsohn; data interpretation was performed by Claxton, Gerber, Bouret, and Mendelsohn. The manuscript was written primarily by Claxton, with assistance from the other authors, and revised by Claxton, Gerber, Bouret, and Mendelsohn, with assistance from the other authors.

Textlinguistik und Schulunterricht. Am Beispiel der Behandlung der indirekten Rede im Englischen. (Text Linguistics and Instruction in the Schools: Example: The Treatment of Indirect Discourse in English).

ERIC Educational Resources Information Center

Kueper, Christoph

1979-01-01

Compares sentence grammar with text linguistics, giving a survey of the treatment of indirect discourse in school grammars, and finding them inadequate. Recommends rules derived from text linguistics in spite of their greater complexity, because they do not hold the student to mechanical recasting of sentences. (IFS/WGA)

Multiplicative disadvantage of being an unmarried and inadequately insured woman living in poverty with colon cancer: historical cohort exploration in California.

PubMed

Levitz, Naomi R; Haji-Jama, Sundus; Munro, Tonya; Gorey, Kevin M; Luginaah, Isaac N; Bartfay, Emma; Zou, Guangyong; Wright, Frances C; Kanjeekal, Sindu M; Hamm, Caroline; Balagurusamy, Madhan K; Holowaty, Eric J

2015-01-01

Many Americans diagnosed with colon cancer do not receive indicated chemotherapy. Certain unmarried women may be particularly disadvantaged. A 3-way interaction of the multiplicative disadvantages of being an unmarried and inadequately insured woman living in poverty was explored. California registry data were analyzed for 2,319 women diagnosed with stage II to IV colon cancer between 1996 and 2000 and followed until 2014. Socioeconomic data from the 2000 census classified neighborhoods as high poverty (≥30% of households poor), middle (5-29%) or low poverty (<5% poor). Primary health insurance was private, Medicare, Medicaid or none. Comparisons of chemotherapy rates used standardized rate ratios (RR). We respectively used logistic and Cox regression models to assess chemotherapy and survival. A statistically significant 3-way marital status by health insurance by poverty interaction effect on chemotherapy receipt was observed. Chemotherapy rates did not differ between unmarried (39.0%) and married (39.7%) women who lived in lower poverty neighborhoods and were privately insured. But unmarried women (27.3%) were 26% less likely to receive chemotherapy than were married women (37.1%, RR = 0.74, 95% CI 0.58, 0.95) who lived in high poverty neighborhoods and were publicly insured or uninsured. When this interaction and the main effects of health insurance, poverty and chemotherapy were accounted for, survival did not differ by marital status. The multiplicative barrier to colon cancer care that results from being inadequately insured and living in poverty is worse for unmarried than married women. Poverty is more prevalent among unmarried women and they have fewer assets so they are probably less able to absorb the indirect and direct, but uncovered, costs of colon cancer care. There seem to be structural inequities related to the institutions of marriage, work and health care that particularly disadvantage unmarried women that policy makers ought to be cognizant of as future reforms of the American health care system are considered.

The Women's EMPOWER Survey: Women's Knowledge and Awareness of Treatment Options for Vulvar and Vaginal Atrophy Remains Inadequate.

PubMed

Krychman, Michael; Graham, Shelli; Bernick, Brian; Mirkin, Sebastian; Kingsberg, Sheryl A

2017-03-01

Postmenopausal women's knowledge about vulvar and vaginal atrophy (VVA) and available treatment options has historically been inadequate. Recent direct-to-consumer marketing and educational efforts would have been expected to increase awareness and treatment options. To compare results of the Women's EMPOWER survey with other available VVA surveys to assess progress in women's understanding and approaches to treatment of VVA. The Women's EMPOWER survey, an internet-based survey of US women with VVA symptoms, assessed women's awareness of VVA and their behaviors and attitudes associated with symptom treatment. These survey results were compared with previously published results of the Revealing Vaginal Effects at Mid-Life (REVEAL), Women's Voices in Menopause (WVM), Vaginal Health: Insight, Views, & Attitudes (VIVA), Clarifying Vaginal Atrophy's Impact on Sex and Relationship (CLOSER), and Real Women's Views of Treatment Options for Menopausal Vaginal Changes (REVIVE) surveys. Results of the Women's EMPOWER survey were consistent with those of past VVA surveys and showed that postmenopausal women generally failed to recognize VVA and its chronic, progressive process and that they were reluctant to discuss vaginal or sexual symptoms with their health care professionals (HCPs). However, women indicated a strong desire for accurate medical information about VVA from their health care professionals and a willingness to learn if HCPs would initiate the conversation. Most women believed that vaginal symptoms are a normal part of aging and they just need to cope with the symptoms. In the United States, women were most concerned with safety-related issues, including increased risk of breast cancer, side effects, and systemic absorption. The Women's EMPOWER survey demonstrates and reinforces that even with multimedia marketing and educational strategies in the years after other major VVA surveys, minimal progress has been made toward increasing women's awareness of, knowledge about, or understanding of VVA. Based on these data, a focus on initiating discussions and education with postmenopausal women so that they better comprehend VVA as a chronic progressive medical condition (not just aging), the symptoms associated with VVA, and the benefit-risk profile regarding treatment options is warranted. Krychman M, Graham S, Bernick B, et al. The Women's EMPOWER Survey: Women's Knowledge and Awareness of Treatment Options for Vulvar and Vaginal Atrophy Remains Inadequate. J Sex Med 2017;14:425-433. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Treatment recommendations for DSM-5-defined mixed features.

PubMed

Rosenblat, Joshua D; McIntyre, Roger S

2017-04-01

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) mixed features specifier provides a less restrictive definition of mixed mood states, compared to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), including mood episodes that manifest with subthreshold symptoms of the opposite mood state. A limited number of studies have assessed the efficacy of treatments specifically for DSM-5-defined mixed features in mood disorders. As such, there is currently an inadequate amount of data to appropriately inform evidence-based treatment guidelines of DSM-5 defined mixed features. However, given the high prevalence and morbidity of mixed features, treatment recommendations based on the currently available evidence along with expert opinion may be of benefit. This article serves to provide these interim treatment recommendations while humbly acknowledging the limited amount of evidence currently available. Second-generation antipsychotics (SGAs) appear to have the greatest promise in the treatment of bipolar disorder (BD) with mixed features. Conventional mood stabilizing agents (ie, lithium and divalproex) may also be of benefit; however, they have been inadequately studied. In the treatment of major depressive disorder (MDD) with mixed features, the comparable efficacy of antidepressants versus other treatments, such as SGAs, remains unknown. As such, antidepressants remain first-line treatment of MDD with or without mixed features; however, there are significant safety concerns associated with antidepressant monotherapy when mixed features are present, which merits increased monitoring. Lurasidone is the only SGA monotherapy that has been shown to be efficacious specifically in the treatment of MDD with mixed features. Further research is needed to accurately determine the efficacy, safety, and tolerability of treatments specifically for mood episodes with mixed features to adequately inform future treatment guidelines.

Physician Reimbursement for Critical Care Services Integrating Palliative Care for Patients Who Are Critically Ill

PubMed Central

Nelson, Judith E.; Weissman, David E.; Hays, Ross M.; Mosenthal, Anne C.; Mulkerin, Colleen; Puntillo, Kathleen A.; Ray, Daniel E.; Bassett, Rick; Boss, Renee D.; Brasel, Karen J.; Campbell, Margaret L.; Cortez, Therese B.; Curtis, J. Randall

2012-01-01

Patients with advanced illness often spend time in an ICU, while nearly one-third of patients with advanced cancer who receive Medicare die in hospitals, often with failed ICU care. For most, death occurs following the withdrawal or withholding of life-sustaining treatments. The integration of palliative care is essential for high-quality critical care. Although palliative care specialists are becoming increasingly available, intensivists and other physicians are also expected to provide basic palliative care, including symptom treatment and communication about goals of care. Patients who are critically ill are often unable to make decisions about their care. In these situations, physicians must meet with family members or other surrogates to determine appropriate medical treatments. These meetings require clinical expertise to ensure that patient values are explored for medical decision making about therapeutic options, including palliative care. Meetings with families take time. Issues related to the disease process, prognosis, and treatment plan are complex, and decisions about the use or limitation of intensive care therapies have life-or-death implications. Inadequate reimbursement for physician services may be a barrier to the optimal delivery of high-quality palliative care, including effective communication. Appropriate documentation of time spent integrating palliative and critical care for patients who are critically ill can be consistent with the Current Procedural Terminology codes (99291 and 99292) for critical care services. The purpose of this article is to help intensivists and other providers understand the circumstances in which integration of palliative and critical care meets the definition of critical care services for billing purposes. PMID:22396564

A Critique of the Diagnostic Construct Schizophrenia

ERIC Educational Resources Information Center

Wong, Stephen E.

2014-01-01

This article examines problems in the clinical utility of the diagnosis of schizophrenia including reliance on questionable data, arbitrary criteria and categorization, inadequate precision for assessment and treatment evaluation, and omission of information on causal current and historical environmental factors. Some alternatives to the…

Health literacy and warfarin therapy at two anticoagulation clinics in Brazil

PubMed Central

Martins, Maria Auxiliadora Parreiras; Costa, Josiane Moreira; Mambrini, Juliana Vaz de Melo; Ribeiro, Antonio Luiz Pinho; Benjamin, Emelia J; Brant, Luisa Campos Caldeira; Paasche-Orlow, Michael K; Magnani, Jared W

2017-01-01

Objective Health literacy has been related to health-related conditions and health outcomes. Studies examining the association of health literacy and anticoagulation have had variable results. We sought to investigate the relations of health literacy and percentage of time in therapeutic range (TTR) in a vulnerable Brazilian cohort at two hospital-based anticoagulation clinics. Methods We measured health literacy with the Short Assessment of Health Literacy for Portuguese-speaking Adults (SAHLPA-18) in 2015–2016. We identified the demographic and clinical characteristics associated with health literacy and related health literacy to TTR. Results We enrolled 422 adults prescribed chronic warfarin therapy in our observational study (median age 62.1 years; 58.8% women; monthly income $200.00). The prevalence of inadequate health literacy (score 0–14 points) was 72.3% with a median score of 12 (quartiles, Q1=10; Q3=15) on the SAHLPA-18. The median TTR was 66.1%. In the multivariable logistic analysis, cognitive impairment and assistance with taking warfarin were associated with inadequate health literacy. Prosthetic heart valves and more school years were associated with adequate health literacy. Our analyses showed no significant relation between health literacy and TTR, analysing health literacy as a categorical (adjusted OR 1.05; 95% CI 0.65 to 1.70) or continuous variable (Spearman’s coefficient 0.02; p=0.70). Conclusions Inadequate health literacy was highly prevalent in this impoverished Brazilian cohort receiving anticoagulation with warfarin. However, we did not identify an association between health literacy and TTR. Future investigations may consider the systemic factors that contribute towards successful anticoagulation outcomes for vulnerable patient cohorts with inadequate health literacy. PMID:28258243

Health literacy and warfarin therapy at two anticoagulation clinics in Brazil.

PubMed

Martins, Maria Auxiliadora Parreiras; Costa, Josiane Moreira; Mambrini, Juliana Vaz de Melo; Ribeiro, Antonio Luiz Pinho; Benjamin, Emelia J; Brant, Luisa Campos Caldeira; Paasche-Orlow, Michael K; Magnani, Jared W

2017-07-01

Health literacy has been related to health-related conditions and health outcomes. Studies examining the association of health literacy and anticoagulation have had variable results. We sought to investigate the relations of health literacy and percentage of time in therapeutic range (TTR) in a vulnerable Brazilian cohort at two hospital-based anticoagulation clinics. We measured health literacy with the Short Assessment of Health Literacy for Portuguese-speaking Adults (SAHLPA-18) in 2015-2016. We identified the demographic and clinical characteristics associated with health literacy and related health literacy to TTR. We enrolled 422 adults prescribed chronic warfarin therapy in our observational study (median age 62.1 years; 58.8% women; monthly income $200.00). The prevalence of inadequate health literacy (score 0-14 points) was 72.3% with a median score of 12 (quartiles, Q1=10; Q3=15) on the SAHLPA-18. The median TTR was 66.1%. In the multivariable logistic analysis, cognitive impairment and assistance with taking warfarin were associated with inadequate health literacy. Prosthetic heart valves and more school years were associated with adequate health literacy. Our analyses showed no significant relation between health literacy and TTR, analysing health literacy as a categorical (adjusted OR 1.05; 95% CI 0.65 to 1.70) or continuous variable (Spearman's coefficient 0.02; p=0.70). Inadequate health literacy was highly prevalent in this impoverished Brazilian cohort receiving anticoagulation with warfarin. However, we did not identify an association between health literacy and TTR. Future investigations may consider the systemic factors that contribute towards successful anticoagulation outcomes for vulnerable patient cohorts with inadequate health literacy. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.