This study is an analysis of a pilot COPD clinical audit that evaluated adherence to guidelines for patients with COPD in a stable disease phase during a routine visit in specialized secondary care ...outpatient clinics in order to identify the variables associated with the decision to step-up or step-down pharmacological treatment.
This study was a pilot clinical audit performed at hospital outpatient respiratory clinics in the region of Andalusia, Spain (eight provinces with over eight million inhabitants), in which 20% of centers in the area (catchment population 3,143,086 inhabitants) were invited to participate. Treatment changes were evaluated in terms of the number of prescribed medications and were classified as step-up, step-down, or no change. Three backward stepwise binominal multivariate logistic regression analyses were conducted to evaluate variables associated with stepping up, stepping down, and inhaled corticosteroids discontinuation.
The present analysis evaluated 565 clinical records (91%) of the complete audit. Of those records, 366 (64.8%) cases saw no change in pharmacological treatment, while 99 patients (17.5%) had an increase in the number of drugs, 55 (9.7%) had a decrease in the number of drugs, and 45 (8.0%) noted a change to other medication for a similar therapeutic scheme. Exacerbations were the main factor in stepping up treatment, as were the symptoms themselves. In contrast, rather than symptoms, doctors used forced expiratory volume in 1 second and previous treatment with long-term antibiotics or inhaled corticosteroids as the key determinants to stepping down treatment.
The majority of doctors did not change the prescription. When changes were made, a number of related factors were noted. Future trials must evaluate whether these therapeutic changes impact clinically relevant outcomes at follow-up.
Clinical practice in chronic obstructive pulmonary disease (COPD) can be influenced by weather variability throughout the year. To explore the hypothesis of seasonal variability in clinical practice, ...the present study analyzes the results of the 2013-2014 Andalusian COPD audit with regard to changes in clinical practice according to the different seasons.
The Andalusian COPD audit was a pilot clinical project conducted from October 2013 to September 2014 in outpatient respiratory clinics of hospitals in Andalusia, Spain (8 provinces with more than 8 million inhabitants) with retrospective data gathering. For the present analysis, astronomical seasons in the Northern Hemisphere were used as reference. Bivariate associations between the different COPD guidelines and the clinical practice changes over the seasons were explored by using binomial multivariate logistic regression analysis with age, sex, Charlson comorbidity index, type of hospital, and COPD severity by forced expiratory volume in 1 second as covariates, and were expressed as odds ratio (OR) with 95% confidence intervals (CIs).
The Andalusian COPD audit included 621 clinical records from 9 hospitals. After adjusting for covariates, only inhaler device satisfaction evaluation was found to significantly differ according to the seasons with an increase in winter (OR, 3.460; 95% CI, 1.469-8.151), spring (OR, 4.215; 95% CI, 1.814-9.793), and summer (OR, 3.371; 95% CI, 1.391-8.169) compared to that in autumn. The rest of the observed differences were not significant after adjusting for covariates. However, compliance with evaluating inhaler satisfaction was low.
The various aspects of clinical practice for COPD care were found to be quite homogeneous throughout the year for the variables evaluated. Inhaler satisfaction evaluation, however, presented some significant variation during the year. Inhaler device satisfaction should be evaluated during all clinical visits throughout the year for improved COPD management.
In order to investigate the effect that a variation of the chemical nature of the structure directing agent may have in the products of synthesis, the cation 1-benzyl-1-methylpyrrolidinium (BMPIRROL) ...and several fluorinated derivatives of this cation have been employed as structure directing agents in the synthesis of pure silica molecular sieves in fluoride medium. It has been found that the hydrogen-bearing cation strongly directs the formation of pure silica zeolite beta, highly crystalline and stable at long crystallization time. On the contrary, employing the same synthesis conditions and molar compositions, only the 1-orthofluorobenzyl-1-methylpyrrolidinium (
o-FBMPIRROL) directs the crystallization of this phase while the 1-metafluorobenzyl-1-methylpyrrolidinium (
m-FBMPIRROL) and the 1-parafluorobenzyl-1-methylpyrrolidinium (
p-FBMPIRROL) direct the formation of the ZSM-12 zeolite. The fluorinated derivatives are more unstable than their hydrogen-bearing counterpart since the co-crystallization of the small pore octadecasil structure was observed for the three fluorinated derivatives. Nevertheless, the results show that the presence of fluorine in the organic molecule and its position in the aromatic ring has a marked effect in the crystallization pathway.
This article investigates the efficiency of the university education using two linked databases (Saber Pro and Saber 11) from the Colombian Institute for Evaluation of Education (ICFES) corresponding ...to 2014. We use a non-parametric frontier approach that combines the “order m” technique with the concept of a meta-frontier to disaggregate students’ total efficiency in generic skills in quantitative reasoning, critical reading, and written communication, into the parts attributable to the students themselves and the university. The analysis is performed by academic programme and by education sector (public vs. private). Results indicate that most of the inefficiency of students in the assessment of generic skills in higher education is attributable to the students themselves and a significant number of students could improve their performance in the assessment in each of the academic programmes if they performed
as efficiently as those located on the frontier. Furthermore, the inefficiency share of students varies between academic programmes and university sectors, with students in the private sector more inefficient than those in the public sector in some and less inefficient in others. This research constitutes the first application of the technique of “order m” with the approach of the meta-frontier for the analysis of educational efficiency using data at the student and university levels.
Abstract Introduction Bisphosphonate-related osteonecrosis of the jaws (BRONJ) is a pathologic condition of increasing frequency, with a poorly understood pathophysiology and which can be difficult ...to manage. The aim of this study was to find a reproducible experimental model that directly relates chronic bisphosphonate administration with the development of osteonecrosis with or without tooth extraction, with no other drug involved. Material and methods Twenty male Wistar rats were divided into 4 groups ( n = 5/group). Animals were injected over 9 weeks with zoledronic acid (0.1 mg/kg). In groups 1 and 2 three times a week intraperitoneally, and in group 3 once a week intravenously. A control group (group 4) received intraperitoneal injections of saline solution three times a week. After 8 weeks of treatment, 3 right upper jaw molars were extracted in groups 1, 3 and 4 and all rats were sacrificed 1 week later. The maxillae were histologically analyzed for presence of osteonecrosis foci, number of osteoclasts, vascularity, bone resorption status and presence of abscess. Radiographic examination was performed with a plain radiograph of each hemi-head. Results We found that group 1 (dental extractions and highest cumulative dose of zoledronic acid) had the highest incidence of osteonecrosis (80%), absence of bone resorption (100%) and lowest number of osteoclasts (mean 7.9/field at 40×). Zoledronic acid-treated groups showed variable degrees of osteosclerosis and trabecular disorganization on X-ray study. Conclusions We offer a new animal model of BRONJ after zoledronic acid administration and dental extractions, achieving bone changes similar or superior to previous studies, highlighting the dental extraction as an important trigger factor.
Abstract
Background
Ileocolonoscopy and Rutgeerts endoscopic score remains the gold standard to evaluate post-operative recurrence (POR) in Crohn's disease (CD) patients. Intestinal ultrasound (IUS) ...is proposed as a non-invasive alternative to ileocolonoscopy for the diagnosis of POR, with a sensitivity of 94% and specificity of 84%. There are several IUS scores that evaluate CD disease activity such as SUS-CD (validated), IBUS-SAS and Simple US Score, which have not yet been studied in the diagnosis of POR. The aim of this study is to assess whether IUS parameters and ultrasound scores correlate with endoscopy in the diagnosis of POR.
Methods
A unicentric retrospective study was performed. There were included patients with CD with both an ileocolonoscopy and intestinal ultrasound performed for the detection of POR, the time between tests was less than 6 months and there was no therapeutic change between tests. Endoscopic POR was evaluated with Rutgeers score (RS), considering POR RS ≥i2b. In IUS, were used: Simple US Score, SUS-CD and IBUS-SAS.
Results
103 patients were included, baseline characteristics are in Table 1. 30 patients (29.1%) had no endoscopic POR, 22 (21.4%) had RS i2a, 12 (11.6%) RS i2b and 39 (37.9%) had severe POR (RS i3-i4). The mean wall thickness measured by IUS in patients without endoscopic POR was 2.7 mm (SD +/- 1.3) versus 5.0 (SD +/- 1.7) in patients with RS ≥i2b (p 0.001). Hyperemia (Limberg >1) was present in 60 patients (82.2%) with RS ≥i2a vs in 4 patients (13.3%) without endoscopic POR (p 0.001). Both hyperemia and wall thickness had a sensitivity of 89.0% and specificity of 76.7% in the diagnosis of POR.
The mean values for IUS scores were: Simple US Score 5.5 (SD +/- 3.1), SUS-CD 2.1 (SD +/- 1.8) and IBUS-SAS 32.9 (SD +/- 26.3). There were positive correlation for IUS scores (Simple US Score r 0.68, SUS-CD r 0.68 and IBUS-SAS r 0.67) with RS (p <0.0001). For the Simple US Score an area under the ROC curve (AUC) of 84.13% (95% CI 76.81 – 91.45) was obtained, with a score ≥3, the sensitivity (S) was 82.19% and specificity (E) 80.0%. IBUS-SAS presented an AUC of 84.93% (95% CI 77.98 - 91.87), a result ≥15 granted a S 82.19% and E 80.0%. The SUS-CD index had an AUC of 83.38% (95% CI 75.55 - 91.20), a result ≥1 presented S 82.19% and E 80.0%.
Conclusion
In our experience, IUS scores (IBUS-SAS, SUS-CD and Simple US Score) show a high sensitivity and specificity in the diagnosis of POR. The three scores had AUC greater than 80%, IBUS-SAS showed slightly higher AUC results.
Abstract
Background
Vedolizumab is a humanized monoclonal antibody directed against α4β7 integrin used in inflammatory bowel disease (IBS) patients1. The usual dosage of Vedolizumab is 300 mg ...intravenously (iv). Recently the subcutaneous (sc) formulation (108 mg every 2 weeks) has been approved, which provides more independence for the patient, avoiding visits to the hospital and possible inconveniences associated with it2.
Methods
The aim of the study is to evaluate the clinical and biochemical response of IBS patients treated with vedolizumab, 16 weeks after transitioning from iv to sc. An observational, prospective, single-center cohort study was performed. Patients with IBS and maintenance treatment with vedolizumab, stable for at least 4 months, were offered to switch to sc formulation. At the same time of treatment administration a blood test was performed, with vedolizumab levels and fecal calprotectin. Clinical index as Harvey-Bradshaw Index (HBI)/Simple Clinical Colitis Activity Index (SCCAI) and questionaries (IBDQ-9 and TSQM) were performed on each visit.
Results
43 patients were included, 12 of them (27.9%) chose to transition to sc formulation. Baseline characteristics of both groups are shown in Table 1. 34 (79.1%) patients were prescribed vedolizumab due to previous biologic failure, 7 (16.3%) in first line due to comorbidities and 2 (4.7%) because of adverse effects in prior treatment.
All included patients remained in remission during follow-up. At week 16 (w16), no significant differences were found in calprotectin levels in patients on iv treatment (mean 146.6 ± SD 45.9) vs sc (159.26 ± 53.9) (p 0.9). Vedolizumab serum levels at w16 were higher in the sc group (22364.3 ± 5141.6) vs. iv (11425.9 ± 1514.2), with statistically significant differences (p 0.009). At w16, 9 (75%) of the patients in the SC group were highly satisfied with the medication and 11 (91.7%) considered it easy to administer. 1 patient (8.3%) in the sc group returned to iv treatment. 4 patients (12.9%) in iv and 2 (16.6%) in sc treatment presented mild adverse effects. The 2 cases (100%) of the sc group the adverse event was local inflammation at the injection site.
Conclusion
In our experience, vedolizumab sc is a safe and convenient alternative to iv administration. Vedolizumab serum levels in patients who transitioned to sc were higher than iv formulation.
1. Smith, Michael A et al. "Vedolizumab: an α4β7 integrin inhibitor for inflammatory bowel diseases." The Annals of pharmacotherapy vol. 48,12 (2014): 1629-35.
2. Vermeire, Séverine et al. "Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn's Disease: Results From the VISIBLE 2 Randomised Trial." Journal of Crohn's & colitis vol. 16,1 (2022): 27-38.
Abstract
Background
The role of ustekinumab (UST) and vedolizumab (VDZ) in articular extra-intestinal manifestations of IBD remains unclear and most existing studies are retrospective. The aim of ...this study is to analyze the incidence of new onset or worsening of a preexisting IBD-associated arthropathy in patients treated with UST and VDZ.
Methods
An observational prospective study in a tertiary care University hospital was conducted. IBD patients undergoing treatment with VDZ or UST with previous spondyloarthritis (SpA) or new onset arthropathy were included. Articular manifestations were evaluated by a rheumathologist within 72 hours. IBD and rheumatological related variables were assessed at baseline and after 6 months, including demographics, clinical, biochemical, endoscopic and ultrasound data.
Results
201 patients were on treatment with UST and VDZ. Of these, 80 were referred to rheumatology for previous SpA or symptoms onset. 56 (70%) with VDZ and 24 (30%) with UST. 24 (30%) of them were classified as SpA: 22 (92%) had a previous diagnosis and 2 (8%) debuted during treatment with VDZ or UST. The remaining 56 (70%) were diagnosed with other rheumatological pathologies. Type of arthritis was: peripheral arthritis, 11 (46.4%); axial, 7 (29%) and mixed, 6 (25%).
Most patients had received 1 or 2 biological therapies (73%), 90% of them were anti-TNF experienced. 48% of patients received UST or VDZ in monotherapy, without disease-modifying antirheumatic drugs (DMARDs).
The most frequent type of arthritis in patients with previous SpA was peripheral (50% peripheral only and 18% mixed). Joint activity remained stable or even improved in these patients. Only 2 (9%) had axial disease flare-up, one with UST and one with VDZ. Both patients had moderate intestinal activity (C-reactive protein; CRP > 2.5 mg/dl and faecal calprotectin; FC > 600 ug/g). Treatment was not discontinued in any case.SpA debuted in 2 patients with mixed arthritis on treatment with VDZ. Both patients also had poor IBD control (CRP > 3.5 mg/dl and CF > 600 ug/g). A change of biologic therapy was performed in addition to adjusting treatment with concomitant DMARDs.
Conclusion
In our experience, treatment with UST and VDZ did not worsen joint pathology in patients with SpA. Most of them remained stable or improved. Patients with joint flare-ups also had poor control of bowel activity, which could be the main cause of worsening SpA.
Abstract
Background
Given the low immunogenicity of ustekinumab (UST), it has been suggested that it is not necessary to add an immunomodulator (IMM). However, there is little scientific evidence on ...whether the efficacy of combined UST+IMM treatment may be greater than in monotherapy, due to the concomitant action of both drugs. The aim of the study was to evaluate the survival of UST treatment with and without concomitant IMM.
Methods
Patients with stable follow-up at Hospital Universitario La Paz (Madrid), with Crohn’s disease (CD) and previous or current treatment with UST, since May 2016, were retrospectively included.
Results
A total of 137 patients were included. Table 1 shows the baseline characteristics.
In 98 patients (71.53%) UST indication was induction of remission; in 22 (16.06%) post-surgical recurrence treatment; in 5 (3.65%) it was prescribed as post-surgical recurrence prophylaxis; and in the remaining 12 (8.76%) the indication was for other reasons.
At the time of analysis, 91 (66.42%) patients were still on active treatment and 46 (33.58%) had discontinued treatment (of which 9 due to primary failure, 27 due to secondary loss of response, 9 due to adverse events, 1 due to remission).
89 patients (64.96%) did not receive concomitant IMM. Whilst, 48 (35.04%) received concomitant treatment with an IMM. The mean time of IMM treatment was 9.16 years (SD 6.76).
UST treatment had a mean duration of 2.19 years (SD 1.35) in patients receiving concomitant IMM; while it was of 1.67 years (SD 1.02) in those who did not receive concomitant IMM; being this statistically significant (p=0.0124) (Figure 1).
When performing a multivariate analysis by linear regression, the only variables that negatively influenced UST survival were age at diagnosis (Coef. -0.36; p=0.028), perianal disease (Coef. -0.29; p=0.198) and location rather than L1 (Coef. 0.2; p=0.072). However, concomitant IMM use had a positive influence (Coef. 0.45; p=0.032).
Conclusion
In our experience, the survival of ustekinumab is greater in combined treatment with immunosuppressant, being also the only independent variable associated with a greater durability of the drug.
This article investigates the efficiency of the university education using two linked databases (Saber Pro and Saber 11) from the Colombian Institute for Evaluation of Education (ICFES) corresponding ...to 2014. We use a non-parametric frontier approach that combines the "order m" technique with the concept of a meta-frontier to disaggregate students' total efficiency in generic skills in quantitative reasoning, critical reading, and written communication, into the parts attributable to the students themselves and the university. The analysis is performed by academic programme and by education sector (public vs. private). Results indicate that most of the inefficiency of students in the assessment of generic skills in higher education is attributable to the students themselves and a significant number of students could improve their performance in the assessment in each of the academic programmes if they performed as efficiently as those located on the frontier. Furthermore, the inefficiency share of students varies between academic programmes and university sectors, with students in the private sector more inefficient than those in the public sector in some and less inefficient in others. This research constitutes the first application of the technique of "order m" with the approach of the meta-frontier for the analysis of educational efficiency using data at the student and university levels.
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