Treatment Phase Of Patients Research Articles

Determining the Incidental Pathologic Findings (IPFs) on panoramic radiographs before orthodontic treatments: A retrospective study

Background/Aim: Panoramic radiography is an imaging method that displays teeth, jaws and surrounding structures in two dimensions and is frequently used in the follow-up and treatment phase of patients. This study aims to determine the frequency of incidental findings (IPFs) in panoramic radiographs taken before orthodontic treatment. Material and Methods: In this retrospective study; A total of 330 patients (170 women, 160 men) aged between 7 and 49 years were included. IPFs were grouped into dental anomalies, radiopacities and radiolucent areas in the jaws, impacted teeth, and other anomalies in the jaws. Data were compared according to gender and age groups (6-12 years, 13-49 years). Results: Dental anomalies were detected in 90.6% of the panoramic radiographs examined. No statistically significant relationships were found between gender and dental abnormalities (p>0.05). The incidence of idiopathic osteosclerosis is 3.6%, and all of these people are men; It has been determined that people with sclerosing osteitis are mostly men and alveolar radiopacities are mostly not seen in women. It has been observed that patients are mostly between the ages of 6-12 in the absence of any dental anomalies. It has been determined that people with sclerosing osteitis are mostly between the ages of 13-49 and patients aged 13-49 mostly have alveolar radiopacities. It has been determined that patients with possible periapical or residual cyst and possible dentigerous cyst are mostly between the ages of 13-49, and patients aged 13-49 are mostly seen in radiolucent areas in the jaw bones. As a result of the analysis, a statistically significant relationship was found between age groups and IPFs (p<0.05). Conclusions: According to the results of this study, a high rate of dental anomalies were detected by evaluating panoramic radiographs before orthodontic treatment. Age and gender changes play a role in the presence of Incidental Pathologic Findings.

Early Time Courses of Recurrent Thromboembolism and Bleeding during Apixaban or Dalteparin Therapy for Patients with Cancer

Introduction The CARAVAGGIO trial was a multinational, randomised, investigator initiated, open-label with blind outcome assessment, noninferiority trial which demonstrated noninferiority of apixaban to dalteparin for treatment of cancer related venous thromboembolism (VTE) without an increased risk of major bleeding. In patients with acute VTE, the rates of recurrence and major bleeding are highest during the first weeks of anticoagulation (1). We sought to evaluate the efficacy and safety of apixaban during the initial high-risk phase of treatment in patients with cancer associated VTE. Specifically, we performed a pre-specified sub-analysis of the time courses of recurrence and bleeding, with the aim to determine the incidence after 7, 30 and 90 days of treatment with apixaban compared with dalteparin. Methods The study design and methods of the CARAVAGGIO trial (CARAVAGGIO; NCT03045406; https://clinicaltrials.gov/ct2/show/NCT03045406) have been described (2). Briefly, CARAVAGGIO compared the efficacy and safety of apixaban with dalteparin in consenting patients who had active cancer and a newly diagnosed symptomatic or incidental proximal lower-limb deep-vein thrombosis (DVT) or pulmonary embolism (PE). Eligible patients were randomly assigned to receive monotherapy with either apixaban or dalteparin for 6 months. The primary efficacy outcome was the incidence of objectively confirmed VTE. The primary safety outcome was major and clinically relevant non-major (CRNM) bleeding. Results The CARAVAGGIO study enrolled 1170 patients from 119 centres in eleven countries from April 2017 through June 2019); 1155 patients were included in the modified intention-to-treat analysis. The demographic and clinical characteristics of the patients were similar in the two treatment groups. Of the 78 recurrent VTE events 11 (14.1%) occurred in the first 7 days, 35 (44.8%) in the first 30 days and 63 (80.7%) in the first 90 days. Recurrent events occurred in 6 (1.0%) in the apixaban group and 5 (0.9%) in the dalteparin group (RR 1.21; 95% CI 0.37-3.93) by day 7, 15 (2.6%) in the apixaban group and 20 (3.5%) in the dalteparin group (RR 0.75; 95% CI 0.39-1.46) by day 30, and in 27 (4.7%) in the apixaban group and 36 (6.2%) in the dalteparin group (RR 0.75; 95% CI 0.46-1.23) by day 90. By 6 months, recurrent events occurred in 32 (5.6%) in the apixaban group and 46 (7.9%) in the dalteparin group (RR 0.70; 95% CI 0.45-1.08). (Table 1). During the six months of treatment, major and CRNM bleeding occurred in 70 patients who received apixaban (12.2%) and in 56 patients who received dalteparin (9.7%) (RR 1.26; 95% CI 0.90-1.75). Of the total 126 bleeding events, 24 (19.0%) occurred during the first 7 days; 58 (46.0%) during the first 30 days, and 89 (70.6%) during the first 90 days. Bleeding events occurred in 14 (2.4%) in the apixaban group and 10 (1.7%) in the dalteparin group (RR 1.40; 95% CI 0.63-3.14) by day 7, 30 (5.2%) in the apixaban group and 28 (4.8%) in the dalteparin group (RR 1.08; 95% CI 0.65-1.78) by day 30, and in 46 (8.0%) in the apixaban group and 43 (7.4%) in the dalteparin group (RR 1.07; 95% CI 0.72-1.60) by day 90. The Kaplan-Meier plot of time to recurrent VTE and major and CRNM bleeding is shown in figure 1. Conclusion The results of this sub-analysis of the CARAVAGGIO trial demonstrate no difference of oral apixaban to subcutaneous dalteparin at all time points. Specifically, there was no increase in recurrent VTE or bleeding events at 7 days, 30 days, 90 days and 6 months. This supports early initiation of oral anticoagulation. Oral versus subcutaneous anticoagulation has the advantage of ease of administration and outpatient delivery which may improve patients’ quality of life - an important consideration in patients with cancer. Reference 1. Raskob GE, Gallus AS, Sanders P, Thompson JR, Agnelli G, Buller HR, et al. Early time courses of recurrent thromboembolism and bleeding during apixaban or enoxaparin/warfarin therapy. A sub-analysis of the AMPLIFY trial. Thrombosis and haemostasis. 2016;115(4):809-16. 2. Agnelli G, Becattini C, Meyer G, Muñoz A, Huisman MV, Connors JM, et al. Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer. New England Journal of Medicine. 2020;382(17):1599-607. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Nursing support for symptoms in patients with cancer and caregiver burdens: a scoping review protocol

IntroductionTerminally ill patients with cancer experience a variety of symptoms, and their families experience certain caregiver burdens. Most studies on this topic have focused on the symptoms experienced by patients...

Evaluation of MCV/RDW Ratio and Correlations With Ferritin in Telogen Effluvium Patients.

IntroductionTelogen effluvium is one of the chronic diseases that affect the quality of life (QoL) in women. Genetic factors, vitamin deficiencies, hormonal and environmental conditions take roles in the etiology of hair loss.ObjectivesThe study aimed to evaluate the RDW(Red cell distribution witdh)/MCV(Mean corpuscular volume) ratio and its correlation with ferritin in Telogen Effluvium patients and to reveal their potential role in the etiopathogenesis of Telogen effluvium.MethodsWe retrospectively evaluated the medical data of 250 patients who were admitted to the dermatology outpatient clinic between September 2020 and December 2020 with a diagnosis of telogen effluvium. The control group was created retrospectively from the medical records of 250 healthy individuals. HB(Hemoglobin), HCT(Hematocrit), MPV(mean platelet volume), MCV, RDW, ferritin, and MCV/RDW ratio of both groups were compared and evaluated statistically.ResultsAll telogen effluvium patients were women in terms of gender. The mean age of the patient group was 33.11 ± 9.66 years and the mean age of the control group was 34.98 ± 12.37 years. The ratio of MCV/RDW, MPV, MCV, and ferritin is lower in the group with telogen effluvium compared to the control group and a statistically significant difference was found (P < 0.05).ConclusionsIron deficiency anemia is thought of as a factor in female patients with telogen effluvium. Although the data shows the correction of iron deficiency is insufficient telogen effluvium, we proposed that laboratory tests should be routinely used in the diagnosis and treatment phase of patients who apply with the complaint of hair loss.

The Association of Monocyte Lymphocyte Ratio and IFN-γ/ IL-4 Ratio on Status of Sputum Conversion in Tuberculosis Patients with Post Intensive Phase

Background: Conversion status post-intensive phase of treatment in patients with tuberculosis(TB) is an important thing in determining the choice of the next treatment plan. Alternativeparameters need to be studied to determine the factors that contribute to this status. Potentialparameters thought to have a role are Monocyte Lymphocyte Ratio (MLR) as a hematologicalmarker and Interferon Gamma/Interleukin-4 (IFN-γ/IL-4) as a molecular marker of cytokines andchemokines. Objective: analyzed the association between MLR and IFN-γ/IL-4 ratio on status ofsputum conversion in TB patients with post-intensive phase. Method: The design of this study wascross-sectional with consecutive sampling, which was conducted in the period March to July 2021.The data used in this study included MLR, IFN-g /IL-4 ratio, and sputum smear conversion. Thestatistical tests used included chi-square, fisher’s exact test, and logistic regression with p &lt; 0.05.Result: Low MLR (98.2%) and high MLR (55.6%) scores, both had positive sputum conversion(OR = 44.8; CI 4.169 – 481.452; p = 0.001). Meanwhile, the positive sputum conversion showedlow IFN-γ/IL-4 ratio (97.8%) and high IFN-γ/IL-4 ratio (80%; OR = 11.25; CI 1.169 – 108.280; p =0.036). There was a significant association between low MLR and sputum conversion positive (OR= 27.103; CI 2.289 – 320.883; p = 0.009). Meanwhile, IFN-γ/IL-4 ratio and sputum conversion didnot have a significant association (OR = 5.248; CI 0.414 – 66,454; p = 0.201). Conclusion: there isa significant association between MLR, IFN-γ/IL-4 ratio, and the combination of MLR and IFN-γ/IL-4 ratio on sputum conversion in TB patients with post-intensive phase.

Abstract P4-11-27: A multimodal and personalized digital companion to help survivors of breast cancer (BC) manage side effects of adjuvant endocrine therapy (ET): A qualitative exploration

Abstract Background: Mobile health (mHealth) applications (app) and remote monitoring demonstrated tangible value in terms of improving dose delivery, quality of life and mitigating the severity of acute treatment-related side effects, both in the metastatic setting and during the active phase of treatment in patients (pts) with early-stage solid tumors. However, the value of mHealth in ‘after primary treatment’ survivorship phase is less studied. Most BC pts have hormone receptor-positive disease and are eligible for adjuvant ET for 5-10 years. ET is associated with multiple side effects that negatively impact quality of life and treatment adherence. A prior survey among French survivors suggested that pts are willing to use digital companion app to help them in the after-cancer experience. In this setting, we developed a digital companion for survivors of BC receiving ET. Objectives: In this study, we explored acceptability, representations, levers, and barriers to a multimodal mHealth intervention among BC pts treated with ET. Methods: This was a qualitative study based on 3 focus groups (FG) with survivors of BC receiving adjuvant ET. The multimodal mHealth intervention had the following features: measure (symptom reporting), understand, and appease (information on interventions to relieve the symptom). FG were conducted via videoconference, lasted approximately 60-90 min, were recorded and transcribed for analysis. A content, thematic analysis was performed. All participants provided oral informed consent and socio-demographic information. Results: 17 BC survivors from diverse professional and socio-economic background participated. Mean age was 48.5 years (range: 32-61). There was a consensus regarding the acceptability and perception of usefulness of an app during treatment with adjuvant ET. A feeling of loneliness during this period was also expressed. Emergent themes cited included: a) positive representations i) satisfaction with the educational support with language and the level of information of the app judged as appropriate and reliable; ii) hope in the role of the app as a companion to alleviate the loneliness; iii) vehicle to enhance family interaction; iv) tool to boost engagement towards their treatment. b) concerns associated with i) fear of human contact replacement ii) fear of loss of interest over time, particularly in the setting of a 5-10 year journey. Pts were pro-active in providing feedback regarding innovative features that could be integrated: i) including interest on the use of biosensors (step counting, nutritional tracking); ii) to receive personalized encouragement messages and iii) updated information regarding scientific advances related to the treatment of early breast cancer. Most participants found the app to be aesthetically pleasing and easy to use. Conclusions: Findings from this qualitative study are promising regarding the acceptability and perception of usefulness of a personalized app for the mitigation of ET side effects in the adjuvant setting. It highlights the need of personalized educational material, but also maintenance of ‘bi-directional’ communication with health professionals. Optimization of the tool is ongoing and updated FG results will be presented. This tool will be tested in a randomized controlled trial starting in Q1/2022, which will evaluate its effectiveness. Quotes from participantsThemes emergedParticipants’ quotes from focus groupsSatisfaction with educational support‘’Today we find everything on the internet, bad and good things, we cannot know what is true and what is fake. (⋯) If an app can give us reliable information, good, summarized information, this would be great!’’Satisfaction with educational support; Hope in the role of the app to alleviate loneliness“I didn’t even know we had so many side-effects linked to endocrine therapy. Now I understand that it’s true, it’s not something from my head. It’s related to the treatment and it’s really nice to have this support.”Alleviation of loneliness‘’I often feel lonely, sometimes is difficult to have contact with the doctor.’’, ‘’We feel lonely, even our family cannot understand.’’Alleviation of loneliness‘’We need to exchange with people that lived the same situation.’’, “We go to forums, chats, Instagram⋯”, ‘’We realize that we are not alone, that we are not the only ones with the symptoms.’’Fear of human contact replacement‘’It is a good addition, but it will never replace the relationship that we have with our doctor.’’Fear of loss of interest over time‘’It is a good app to start endocrine therapy⋯ How to make the app interesting and useful during several years of treatment?’’ Citation Format: Elise Martin, Antonio Di Meglio, Pietro Lapidari, Daniele Presti, Davide Soldato, Léna Degousee, Marion Aupomerol, Barbara Pistilli, Léonor Fasse, Diane Boinon, Florian Scotte, Gwenn Menvielle, Agnès Dumas, Céline Lazorthes, Jonathan Benhamou, Matthieu Pozza, Raphaëlle Martin-Neuville, Nicolas Helleringer, Jeanne Eelkema, Fabrice Andre, Ines Vaz-Luis, Maria Alice Franzoi. A multimodal and personalized digital companion to help survivors of breast cancer (BC) manage side effects of adjuvant endocrine therapy (ET): A qualitative exploration [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-11-27.

Clinical, laboratory and radiological associations with extending of the intensive phase of treatment in patients with first diagnosed infiltrative pulmonary tuberculosis

Despite the availability of medical services, timely detection of pulmonary tuberculosis, before the appearance of destructive changes, is often difficult. The management of patients with an infiltrative form in a hospital setting does not always guarantee the same positive effect and sometimes requires prolongation of therapy. The effectiveness of therapy can be associated with various factors and is of interest to study. The aim of this work was to study the effectiveness of standard therapy in patients with first diagnosed infiltrative pulmonary tuberculosis, clinical laboratory and radiological associations with prolongation of the intensive phase of treatment. Materials and methods. The study involved 109 men from 18 to 53 years old with first diagnosed infiltrative pulmonary tuberculosis with preserved MBT sensitivity to 1-st line anti-tuberculosis drugs. Patients were examined before and after 60 doses of the intensive phase of treatment, after which two groups were formed. Group 1 included patients with pronounced positive clinical and radiological dynamics, who entered the continuation phase of therapy. Group 2 included patients with insufficient clinical and radiological dynamics, for whom the intensive phase of treatment was extended to 90 doses. Results. Weak dynamics in patients who needed prolongation of treatment was associated with the characteristics of the initial data of patients in this group compared with similar indicators in Group 1. These were a reliably higher frequency of symptoms of intoxication and coughing, a reliably greater number of patients excreting mycobacterium tuberculosis in large quantities in sputum, with reliably high blood concentrations of haptoglobin and ceruloplasmin levels. Conclusions. Patients requiring prolongation of the intensive phase of treatment are characterized by an initially higher prevalence of infiltrative changes in the lungs, a small number of lung lesions limited to 2 segments, the presence of destructive changes in 100 % of cases, and a significant increase in the factors of the systemic inflammatory response

Analysis of the intermediate results of the INVENT-1 clinical trial: open-label, randomized, multicenter study

Background. Attempts to treat tuberculosis (TB) with the help of intravenous drugs have been made since the early XX century. However, XXI century medicine recommends treating TB with pills, and invasive anti-TB drugs (ATBD) are rarely used. International expert groups recommend intravenous administration only for critically ill patients or for patients with absorption disorders. Meanwhile, the advantages of intravenous ATBD include direct monitoring of treatment, accurate dosing for each patient, fewer side effects, and avoidance of taking a large number of tablets.&#x0D; Objective. To evaluate the efficacy, safety, and tolerability of intravenous and oral administration of ATBD in the intensive phase of treatment in patients with advanced destructive pulmonary TB with bacterial excretion.&#x0D; Materials and methods. The study involved 318 patients from 9 clinical centres. The total duration of the study was 18 months. Intravenous and oral administration of isoniazid, rifampicin and ethambutol were compared. The intensive phase of the study lasted 2 months, the maintenance phase lasted 4 months. Inclusion criteria were the following: age 18-65 years, diagnosis of pulmonary TB, at least one positive test result for TB mycobacteria, radiological confirmation of lung destruction and advance TB process, in women – negative urine test for pregnancy, informed consent, negative GenXpert MTB/RIF analysis, and verbal consent to abstain from alcohol during the study.&#x0D; Results and discussion. Due to the resistance to 1st line drugs 14 people were excluded from the study, due to the lack of data on culture – 16 people, for other reasons – 7 people. In the infusion treatment group, 52.63 % had disseminated TB, and 47.37 % had infiltrative TB. In the group of tablet treatment disseminated TB occurred in 35.2 % of patients, infiltrative – in 61.8 %, miliary – in 3 %. At 4th visit, the efficacy of abacillation in both treatment groups was comparable: 34.2 % in the infusion group and 35.26 % in the oral treatment group. But as of the 6th visit, the share of abacillation in the infusion group was 57.42 %, and in the oral treatment group – 46.96 %. Analysis of the time needed to achieve a negative result on mycobacterium TB also revealed the benefits of infusions. Thus, up to the 3rd visit this parameter was reached by 15.78 % of the infusion group patients, and by 13.76 % of oral therapy group patients. The total proportion of patients with a negative test for mycobacterium TB and clinical improvement in the infusion group was 60 %, and in the oral therapy group – 52.90 %. In infiltrative TB, 27.8 % of the infusion group and only 9.5 % of the tablet therapy group reached abacillation by the 3rd visit. In disseminated TB, abacillation was achieved up to 3rd visit in 5 % of the infusion group and 8.3 % of the tablet treatment group, however, the total numbers at the end of the study were 45 and 25 %, respectively.&#x0D; Conclusions. 1. Monitoring the patient’s treatment is a cornerstone of TB therapy. 2. There is a tendency to the greater effectiveness of TB treatment using intravenous ATBD in the intensive phase of therapy. 3. It is necessary to analyze the long-term results of treatment and the impact of both treatment regimens on the recurrence of the process.

The Dynamics of Clinical and Laboratory Data in Patients with Firstly Diagnosed Pulmonary Tuberculosis and Alcohol Consumption, and the Possibility of Predicting the Effectiveness of Treatment

The objective: the study of dynamics of clinical and laboratory data after an intensive phase of treatment in patients with firstly diagnosed pulmonary tuberculosis (FDTB) who consume alcohol, and the development of a method for predicting the effectiveness of treatment.Materials and methods. A total of 109 men with FDTB aged 20 to 50 years were examined. Depending on the level of alcohol consumption, 3 groups of patients were formed. Patients of each group are divided into two subgroups depending on the treatment regimen.Results. An analysis of the dynamics of immuno-inflammatory indicators showed the greatest response to antioxidant therapy data of phagocytic and enzymatic activity of neutrophils and endogenous intoxication (p&lt;0.05). Assessment of the oxidative status indicators dynamics demonstrated the most significant effect of antioxidant in groups 1st and 2nd. The dynamics of a decrease in all indicators of oxidative stress in these groups was higher in patients receiving additional antioxidant therapy (p&lt;0.01). In group 3, the positive effect was less pronounced: an increase in blood levels of GPx and a decrease in diene conjugates and NO2 (p≤0.05) were determined. Models have been developed to predict the level of positive dynamics in the treatment of patients depending on the therapy received.Conclusions. The administration of antioxidants had the most significant positive effect on the dynamics of the levels of phagocytosis completeness, enzyme activity of neutrophils, medium molecular weight peptides and CRP and indicators of oxidative stress with the best effect in patients who drink alcohol at low and health-threatening levels. The initial alcohol consumpyion, phagocytic index and blood lymphocytes affect the positive effect of treatment according to the standard scheme of anti-tuberculosis therapy; when antioxidants are added to the standard scheme, the initial indicators of the alcohol consumption level and phagocytic number affect.

Сравнительный анализ результатов реконструктивно- пластического этапа лечения у пациентов с глубоким послеоперационным стерномедиастинитом

Сравнительный анализ результатов реконструктивно- пластического этапа лечения у пациентов с глубоким послеоперационным стерномедиастинитом

Evolving rifampicin and isoniazid mono-resistance in a high multidrug-resistant and extensively drug-resistant tuberculosis region: a retrospective data analysis

ObjectivesSouth Africa ranks among the highest drug-resistant tuberculosis (DR-TB) burdened countries in the world. This study assessed the changes in resistance levels in culture confirmed Mycobacterium tuberculosis (MTB) in the...

The control of clinical pneumonia in calves

In feedlot, the respiratory disease is the most common problems. The use of an appropriate antibiotic in the treatment of respiratory disease is an important consideration to the feedlot owner and his veterinarian. The aim of this study was to investigate the effects of penicillin in treatment of calves pneumonia. In this study, forty calves of 3-6 months of age with an average weight of 60 to 100 kg with pneumonia were clinically examined. Understudied calves were distributed in two groups, in control group for treatment penicillin was used, and the other group was kept as control. During the treatment phase of patients with pneumonia in control and experimental group, sterile swabs was taken from the lower part of the urt of infected patients, and simultaneous with antibiotic therapy, the taken sterile swabs were undergoes bacteriological examination and types of bacteria was characterized. Statistical results indicated that the treatment with penicillin decrease clinical signs significantly in comparison to control one (p<0.05). The results indicated that the penicillin procaine injection powder (3 million iu) might be effective in the treatment of pneumonia in calves with the effective range.

Which self-management strategies do health care professionals recommend to their cancer patients? An experimental investigation of patient age and treatment phase.

This vignette based study aimed to examine recommendations of health care professionals (HCPs) in promoting self-management strategies to cancer patients. Nine-hundred-forty-two physicians and nurses were asked to (1) indicate if they would recommend self-management strategies to a vignette cancer patient, and (2) to specify those in an open format. Vignettes included a manipulation of patient age (60 vs. 75years) and treatment phase (currently treated versus treatment completed). Six categories emerged through coding a total of 2303 recommendations: physical activity (71.8%), nutrition (64.3%), psychological support (36.7%), medical support (29.2%), conscious living (17.2%) and naturopathy (12.3%). While psychological support was particularly recommended during treatment, physical activity was more frequently recommended after completion of treatment. Results suggest that HCPs recommend a variety of self-management strategies besides standard medical treatment. Patient's treatment phase and age seem to partly influence recommendation behavior, potentially indicating insecurities regarding acute treatment situations and age-related stereotypes.

Continuation phase intravenous ketamine in adults with treatment-resistant depression

BackgroundLittle is known about the antidepressive effects of repeated intravenous ketamine infusions beyond the acute phase of treatment in patients with refractory depression. MethodsTwelve subjects with treatment-resistant non-psychotic unipolar or bipolar major depression and suicidal ideation were given repeated (up to 6) thrice-weekly acute-phase intravenous infusions of ketamine (0.5mg/kg, administered over 100min). Those who remitted during acute-phase treatment received continuation-phase treatment that consisted of 4 weekly ketamine infusions, followed by 4 weeks of post-continuation phase follow-up (during which no further ketamine infusions were administered). Clinical measures were assessed at baseline, at 24h following each infusion, at the last acute-phase observation, and during continuation and post-continuation follow-up (acute phase remitters only). ResultsOf the 12 enrollees, 5 (41.7%) remitted and 7 (58.3%) responded to ketamine treatment during the acute-phase. All five subjects who remitted during the acute-phase experienced further depressive symptom improvement during continuation-phase treatment. Four subjects lost remission status during the post-continuation phase, but all were still classified as positive treatment responders at the end of the post-continuation phase. Adverse effects were generally mild and transient during acute- and continuation-phase treatment; however, one subject developed behavioral outbursts and suicide threats during follow-up while hospitalized, and one subject died by suicide several weeks after the end of follow-up. LimitationsThis was an uncontrolled feasibility study with a small sample size. ConclusionsThe continuation-phase administration of ketamine at weekly intervals to patients with treatment-resistant depression who remitted during acute-phase ketamine treatment can extend the duration of depressive symptom remission. The antidepressive effect of ketamine persisted for several weeks after the end of continuation-phase treatment. Our results highlight the need for close monitoring of subjects who are at high baseline risk for suicide but do not respond clinically to ketamine. ClinicalTrials.gov identifierNCT02094898.

Adrenal Suppression in Pediatric Patients during Treatment for Acute Lymphoblastic Leukemia

Background: Hypothalamic-pituitary-adrenal (HPA) axis suppression is a form of adrenal insufficiency that can be found following the use of corticosteroids. Individuals with adrenal insufficiency may have non-specific symptoms or even no regular symptoms, however if presented with a physiologic stress such as infection, injury, or surgery, they are at risk of adrenal crisis. Adrenal crisis typically manifests with hypoglycemia, hypotension and critical illness; this condition is associated with significant morbidity and even mortality. Children being treated for leukemia are at increased risk of infection and may require surgical procedures, thus putting them at risk of adrenal crisis in the context of adrenal suppression.It is known that adrenal suppression exists in the short term after the induction phase of treatment in patients with acute lymphoblastic leukemia (ALL), but the prevalence and duration of suppression is still not fully understood. In addition, adrenal suppression has not been specifically evaluated during the maintenance phase of therapy. During maintenance there may be ongoing adrenal suppression from steroid use in induction, or new suppression from steroid use for maintenance therapy itself. There does not yet exist an accepted protocol to monitor for adrenal insufficiency in ALL. Knowing the prevalence and duration of adrenal suppression in maintenance will enable care teams to better recognize and manage the condition, potentially preventing significant morbidity and mortality.Methods: All cases of ALL treated at the Children's Hospital of Eastern Ontario from 2000 to 2014 were retrospectively reviewed for adrenal suppression. Patient characteristics, clinical features, laboratory data, treatment protocol utilized, adverse events and outcomes were examined.Results: 176 patients were diagnosed with new ALL at The Children's Hospital of Eastern Ontario between 2000 and 2014. Prompted by clinical suspicion, 24 had testing done to investigate for adrenal suppression during this time period. 9 of those patients had cortisol levels indicative of adrenal suppression and required further management for the same. Adrenal suppression was identified in early phases of treatment for ALL. Adrenal suppression was also identified in patients during the maintenance phase of treatment. Many more patients had symptoms that could be attributed to adrenal suppression, but never had cortisol levels tested.Conclusion: Adrenal suppression is found in children being treated for ALL, including during the maintenance phase of therapy. Adrenal suppression may have been present in greater numbers of children, but no routine testing protocol exists to identify these patients. Identifying and reviewing cases of adrenal suppression in children during treatment for ALL, including the maintenance phase, gives a better understanding of the risk of HPA axis suppression in this population. This study also provides background data for the development of a prospective study to further look at adrenal suppression in the maintenance phase of ALL. These studies will guide development of a testing protocol to better identify and manage adrenal suppression, thereby reducing its morbidity and mortality, in children being treated for ALL. DisclosuresNo relevant conflicts of interest to declare.

Clinical use of rivaroxaban: pharmacokinetic and pharmacodynamic rationale for dosing regimens in different indications.

Target-specific oral anticoagulants have become increasingly available as alternatives to traditional agents for the management of a number of thromboembolic disorders. To date, the direct Factor Xa inhibitor rivaroxaban is the most widely approved of the new agents. The dosing of rivaroxaban varies and adheres to specific schedules in each of the clinical settings in which it has been investigated. These regimens were devised based on the results of phase II dose-finding studies and/or pharmacokinetic modeling, and were demonstrated to be successful in randomized, phase III studies. In most cases, the pharmacodynamic profile of rivaroxaban permits once-daily dosing. A once-daily dose is indicated for the prevention of venous thromboembolism (VTE) in patients undergoing hip or knee replacement surgery, the long-term prevention of stroke in patients with non-valvular atrial fibrillation, and the long-term secondary prevention of recurrent VTE. Twice-daily dosing is required in the acute phase of treatment in patients with VTE and in the combination of rivaroxaban with standard single or dual antiplatelet therapy for secondary prevention after acute coronary syndrome events. This article reviews the empirical and clinical rationale supporting the dose regimens of rivaroxaban in each clinical setting.

Patient satisfaction on tuberculosis treatment service and adherence to treatment in public health facilities of Sidama zone, South Ethiopia

BackgroundPatient compliance is a key factor in treatment success. Satisfied patients are more likely to utilize health services, comply with medical treatment, and continue with the health care providers. Yet, the national tuberculosis control program failed to address some of these aspects in order to achieve the national targets. Hence, this study attempted to investigate patient satisfaction and adherence to tuberculosis treatment in Sidama zone of south Ethiopia.MethodsA facility based cross sectional study was conducted using quantitative method of data collection from March to April 2011. A sample of 531 respondents on anti TB treatment from 11 health centers and 1 hospital were included in the study. The sample size to each facility was allocated using probability proportional to size allocation, and study participants for the interview were selected by systematic random sampling. A Pre tested, interviewer administered questionnaire was used to collect the data. Collected data was edited, coded and entered to Epi data version 3.1 and exported to SPSS version 16. Confirmatory factor analysis was done to identify factors that explain most of the variance observed in most of the manifested variables. Bivariate and Multivariate analysis were computed to analyze the data.ResultThe study revealed 90% of the study participants were satisfied with TB treatment service. However, 26% of respondents had poor adherence to their TB treatment. Patient perceived on professional care, time spent with health care provider, accessibility, technical competency, convenience (cleanliness) and consultation and relational empathy were independent predictors of overall patient satisfaction (P < 0.05). In addition to this, perceived waiting time was significantly associated with patient satisfaction (Beta = 0.262). In multivariate analysis occupational status, area of residence, perceived time spent with health care provider, perceived accessibility, perceived waiting time, perceived professional care and over all patient satisfaction were significantly associated with adherence to TB treatment (P < 0.05). Moreover, patient waiting time at reception room (Adjusted OR = 1.022, 95% CI 1.009, 1.0035) and Patient treatment phase (Adjusted OR = 0.295, 95% CI 0.172, 0.507) were independent predictor of adherence to TB treatment.ConclusionThe finding of this study showed that patients’ perceptions on health care provider interaction had a significant influence on patient satisfaction and adherence to TB treatment. Moreover, absence of drugs and long waiting time had a negative outcome on patient adherence. Therefore, the problem needs an urgent attention from programme managers and health care providers to intervene the challenges.

The Use of Anti–Interleukin-12/23 Agents and Major Adverse Cardiovascular Events

Question: Is the use of anti–interleukin (IL)-12 and IL-23 agents to treat chronic plaque psoriasis associated with an increase in major adverse cardiovascular events? Objective: To evaluate a possible association between biologic therapies for CPP [chronic plaque psoriasis] and MACEs [major adverse cardiovascular events] via metaanalysis. Data Sources: Randomized controlled trials (RCTs) of anti–IL-12/23 (ustekinumab and briakinumab) agents and anti–tumor necrosis factor (TNF) agents (adalimumab, etanercept, and infliximab) used in treating CPP were reviewed using the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and Ovid MEDLINE from database inception to May 2011. The results of registered nonpublished completed studies were procured through abstract publications or poster presentations. Study Selection: Randomized, placebo-controlled, doubleblind, monotherapy studies (with safety outcome data for MACE) of IL-12/23 antibodies and anti–TNFagents in adults. Studies of psoriatic arthritis were excluded. Data Extraction: Two investigators independently searched data while 6 investigators reviewed the abstracted data. Results: A total of 22 RCTs comprising 10 183 patients met the predefined inclusion criteria. The primary outcome measure was MACE, a composite end point of myocardial infarction, cerebrovascular accident, or cardiovascular death during the placebo-controlled phase of treatment in patients receiving at least 1 dose of study agent or placebo. Absolute risk differences were used as an effect measure. There was no evidence of statistical heterogeneity across the studies using the I statistic (I=0), allowing for combination of trial results using the MantelHaenszel fixed-effects method. During the placebocontrolled phases of the anti–IL-12/23 studies, 10 of 3179 patients receiving anti–IL-12/23 therapies experienced MACEs compared with zero events in 1474 patients receiving placebo (Mantel-Haenszel risk difference, 0.012 events/person-year; 95% confidence interval [CI], −0.001 to 0.026; P=.12). In the anti–TNFtrials, only 1 of 3858 patients receiving anti–TNFagents experienced a MACE compared with 1 of 1812 patients receiving placebo (Mantel-Haenszel risk difference, −0.0005 events/personyear; 95% CI, −0.010 to 0.009; P=.94). Authors’ Conclusions: Compared with placebo, there was no significant difference in the rate of MACEs observed in patients receiving anti–IL-12/IL-23 antibodies or anti– TNFtreatments. This study may have been underpowered to identify a significant difference.

Association Between Biologic Therapies for Chronic Plaque Psoriasis and Cardiovascular Events

Ustekinumab and briakinumab, monoclonal antibodies to the shared p40 subunit of interleukin (IL)-12 and IL-23, have shown efficacy in treating chronic plaque psoriasis (CPP). Preliminary reports of major adverse cardiovascular events (MACEs) in psoriasis patients receiving anti-IL-12/23 agents have prompted concern. To evaluate a possible association between biologic therapies for CPP and MACEs via meta-analysis. Randomized controlled trials (RCTs) of anti-IL-12/23 (ustekinumab and briakinumab) agents and anti-tumor necrosis factor α (TNF-α) agents (adalimumab, etanercept, and infliximab) used in treating CPP were reviewed using the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and Ovid MEDLINE from database inception to May 2011. The results of registered nonpublished completed studies were procured through abstract publications or poster presentations. Randomized, placebo-controlled, double-blind, monotherapy studies (with safety outcome data for MACE) of IL-12/23 antibodies and anti-TNF-α agents in adults. Studies of psoriatic arthritis were excluded. Two investigators independently searched data while 6 investigators reviewed the abstracted data. A total of 22 RCTs comprising 10 183 patients met the predefined inclusion criteria. The primary outcome measure was MACE, a composite end point of myocardial infarction, cerebrovascular accident, or cardiovascular death during the placebo-controlled phase of treatment in patients receiving at least 1 dose of study agent or placebo. Absolute risk differences were used as an effect measure. There was no evidence of statistical heterogeneity across the studies using the I(2) statistic (I(2) = 0), allowing for combination of trial results using the Mantel-Haenszel fixed-effects method. During the placebo-controlled phases of the anti-IL-12/23 studies, 10 of 3179 patients receiving anti-IL-12/23 therapies experienced MACEs compared with zero events in 1474 patients receiving placebo (Mantel-Haenszel risk difference, 0.012 events/person-year; 95% confidence interval [CI], -0.001 to 0.026; P =.12). In the anti-TNF-α trials, only 1 of 3858 patients receiving anti-TNF-α agents experienced a MACE compared with 1 of 1812 patients receiving placebo (Mantel-Haenszel risk difference, -0.0005 events/person-year; 95% CI, -0.010 to 0.009; P = .94). Compared with placebo, there was no significant difference in the rate of MACEs observed in patients receiving anti-IL-12/IL-23 antibodies or anti-TNF-α treatments. This study may have been underpowered to identify a significant difference.

Mycobacterial Clearance from Sputum Is Delayed during the First Phase of Treatment in Patients with Diabetes

Although type 2 diabetes (DM) is a recognized risk factor for development of tuberculosis (TB), the impact on treatment is unclear. Among the few published reports, some suggest that mycobacterial clearance during treatment is delayed in TB patients with DM. Using survival analysis on data from 469 culture-positive TB patients retrospectively identified in south Texas, we found DM to be an independent risk factor for a 5-day delay in mycobacterial clearance within the first 60 days of treatment.