Evaluation Of Therapy In Patients Research Articles

Implementation of fixed-dose combination therapy for secondary prevention of atherosclerotic cardiovascular disease among Syrian refugees in Lebanon: a qualitative evaluation

BackgroundWe report findings of a qualitative evaluation of fixed-dose combination therapy for patients with established atherosclerotic cardiovascular disease (ASCVD) attending Médecins Sans Frontières (MSF) clinics in Lebanon. Cardiovascular disease is a leading cause of death and disability worldwide, and humanitarian actors are increasingly faced with the challenge of providing care for chronic diseases such as ASCVD in settings where health systems are disrupted. Secondary prevention strategies, involving 3–5 medications, are known to be effective for patients at risk of heart attack or stroke, but supply and adherence are challenging in humanitarian settings. Fixed dose combination therapy, combining two or more medications in one tablet, may be a strategy to address this.MethodsThe evaluation was nested within a prospective mixed-methods study in which eligible ASCVD patients were followed for 1 year during (i) 6 months of usual care then (ii) 6 months of fixed dose combination (FDC) therapy. After 1 year, we conducted in-depth interviews with a purposive sample of patients, MSF staff and external stakeholders. Interviews focused on acceptability and sustainability of the fixed dose therapy intervention. Interview data were analysed thematically, informed by thea Theoretical Framework of Acceptability. Additional attention was paid to non-typical cases in order to test and strengthen analysis.ResultsPatients and health care providers were positive about the FDC intervention. For patients, acceptability was related to ease of treatment and trust in MSF staff, while, for staff, it was related to perceived improvements in adherence, having a good understanding of the medication and its use, and fitting well with their priorities for patient’s wellbeing. External stakeholders were less familiar with FDC therapy. While external clinicals expressed concerns about treatment inflexibility, non-clinician stakeholder interviews suggested that cost-effectiveness would have a major influence on FDC therapy acceptability. Sustainability was tied to the future role of MSF care provision and coherence with the local health system.ConclusionsFor patients and clinic staff, FDC was an acceptable treatment approach for secondary prevention of ASCVD disease in two MSF clinics in Lebanon. Sustainability is more complex and calls for better alignment of care with public systems.

Evaluation of Hyperbaric Oxygen Therapy for Patients with Autism Spectrum Disorders at Early Childhood Stage

Evaluation of Hyperbaric Oxygen Therapy for Patients with Autism Spectrum Disorders at Early Childhood Stage

Short-term Efficacy Evaluation of Emergency Interventional Therapy for Patients with Acute Myocardial Infarction

Short-term Efficacy Evaluation of Emergency Interventional Therapy for Patients with Acute Myocardial Infarction

Analyse des Versorgungsmodells „Portal“ – Untersuchung der Ergebnisqualität der IVOM-Therapie im Hinblick auf Latenzzeiten bei exsudativer AMD

For many maculopathies, the management of intravitreal injection (IVOM) presents a logistical challenge. To ensure contemporary and timely treatment, patients have to organise their rides to the surgery, and the clinic has to provide enough short term resources. The objective of this study is an evaluation of the IVOM therapy for patients with exudative AMD according to four quality indicators a) latency time within the treatment and monitoring cycle, b) the treatment and monitoring frequency, c) the adherence and d) the medical outcome. For more than seven years, patients with exudative AMD have been treated by many ophthalmologists using a networked portal system. Therefore, conservative doctors and surgical eye centres exchange treatment-relevant data. In total there are documented 2283 eyes of 1850 patients. We evaluate these electronic medical records retrospectively according to the mentioned quality indicators. This evaluation results in a latency time from OCT monitoring and the start of a new IVOM series of 8.1 working days. Within the first two treatment years, we achieve 10.5 injections and 8.2 monitoring visits in average. After two years, 72.9% of the cases were still in treatment or monitoring. We observed stabilisation of mean visual accuracy of about 0.05 logMAR. To improve the visual acuity, it is essential to achieve consistent therapy over a long period of time, especially in the case of treatment-relevant exudative AMD. The evaluation of our treatment system demonstrated that the PRN-scheme can be implemented by a cooperatively organised IVOM therapy. It is possible to achieve rapid retreatment and good adherence over many treatment years. For treatment-relevant exudative AMD it is essential for the improvement of the visual accuracy to implement consistent therapy over a long period of time. The evaluation of our treatment system demonstrates that the PRN scheme can be implemented in a cooperatively organised IVOM therapy. It is possible to achieve rapid retreatment and good patients' adherence over many treatment years.

Оценка антиангинальной эффективности ивабрадина у больных ишемической болезнью сердца, осложненной сердечной недостаточностью

Results of the multicenter open observational program NACHALO (evaluation of therapy in patients with combined coronary artery disease and heart failure as part of daily clinical practice), in which 569 doctors in 58 regions of the Russian Federation participated, were presented. The program included 2751 patients with ischemic heart disease, stable angina complicated by heart failure at the age from 25 to 94 years (mean age 62.6 ± 9.3 years). The follow-up period was 3 months, during which two visits were carried out--after 4 weeks and a final visit--12 weeks after the initiation of therapy. Despite treatment, angina attacks (mean 6.7 6.1 per week), increased blood pressure (average 145.1 ± 20.9/87.2 ± 1.8 mm Hg) and heart rate (average 85.8 ± 9.5 beats/min) were noted in patients before the inclusion in the program. The addition of ivabradine therapy resulted in a significant (p < 0.00001) reduction in heart rate to 73.2 ± 8.7 (at visit 1) and down to 65.2 ± 6.1 beats/min (at visit 2), the number of angina attacks per week to 3.8 (at visit 1) and 1.9 (at visit 2). There were significant (p < 0.00001) positive dynamics of the clinical wellness and the severity of symptoms in patients. Adverse effects that, according to doctors, were associated with the agent, were observed in only 0.15% of cases. Thus, in real clinical practice inhibitor of the if channels ivabradine has been shown to be highly effective in treatment of stable angina in patients with coronary artery disease complicated by heart failure.

Left ventricular hypertrophy and arrhythmogenesis.

Left ventricular hypertrophy (LVH) poses an independent risk of increased morbidity and mortality, including atrial arrhythmias, ventricular arrhythmias, and sudden cardiac death. The most common causes of LVH are hypertension and valvular heart disease. Electrocardiography and echocardiography are the first steps in the diagnosis and evaluation of therapy in patients with LVH. Cardiac MRI is the gold standard in diagnosis and assessment of response to therapy. Management of LVH should be based on etiology, evidence, and guideline adherence. Timely and optimal management of the underlying cause of LVH results in improvement (regression) of LVH and its related complications.

Economic evaluation of therapies for patients suffering from relapsed-refractory multiple myeloma in Greece

BackgroundMultiple myeloma is a hematologic malignancy that incurs a substantial economic burden in care management. Since most patients with multiple myeloma eventually relapse or become refractory to current therapies (rrMM), the aim of this study was to assess the cost-effectiveness of the combination of lenalidomide–dexamethasone, relative to bortezomib alone, in patients suffering from rrMM in Greece.MethodsAn international discrete event simulation model was locally adapted to estimate differences in overall survival and treatment costs associated with the two alternative treatment options. The efficacy data utilized came from three international trials (MM-009, MM-010, APEX). Quality of life data were extracted from the published literature. Data on resource use and prices came from relevant local sources and referred to 2012. The perspective of the analysis was that of public providers. Total costs for monitoring and administration of therapy to patients, management of adverse events, and cost of medication were captured. A 3.5% discount rate was used for costs and health outcomes. A Monte Carlo simulation was used to estimate probabilistic results with 95% uncertainty intervals (UI) and a cost-effectiveness acceptability curve.ResultsThe mean number of quality-adjusted life years (QALYs) was 3.01 (95% UI 2.81–3.20) and 2.22 (95% UI 2.02–2.41) for lenalidomide–dexamethasone and bortezomib, respectively, giving an incremental gain of 0.79 (95% UI 0.49–1.06) QALYs in favor of lenalidomide–dexamethasone. The mean cost of therapy per patient was estimated at €80;77,670 (95% UI €80;76,509–€80;78,900) and €80;48,928 (95% UI €80;48,300–€80;49,556) for lenalidomide–dexamethasone and bortezomib, respectively. The incremental cost per life year gained with lenalidomide–dexamethasone was estimated at €80;29,415 (95% UI €80;23,484–€80;37,583) and the incremental cost per QALY gained at €80;38,268 (95% UI €80;27,001–€80;58,065). The probability of lenalidomide–dexamethasone being a cost-effective therapy option at a threshold three times the per capita income (€80;60,000 per QALY) was higher than 95%. The results remained constant, without altering the conclusions, under several hypothetical scenarios.ConclusionThe combination of lenalidomide and dexamethasone may represent a cost-effective choice relative to bortezomib monotherapy for patients in Greece with previously treated multiple myeloma.

Evaluation of quetiapine therapy in patients with generalized anxiety disorder

Evaluation of quetiapine therapy in patients with generalized anxiety disorder

A Proposal for Improving Evidence Generation in Nephrology

The existing framework for the evaluation and reimbursement of new drugs and other treatments in nephrology does not appear to be providing the optimal incentives to advance science and improve outcomes for patients with end-stage renal disease. This article examines reasons for this malalignment and how the field of nephrology is affected, then proceeds to show that alternative evaluation paradigms are being developed by the health technology assessment community. These alternative evaluative frameworks are complementary to traditional evidence-based medicine and comparative evaluative research and may be worthy of adaptation by those interested in seeing more pivotal kidney research (both quantity and quality) and more efficient evaluation of new therapies for patients with chronic kidney failure treated using long-term dialysis therapy.

Net clinical benefit: Functional endpoints in brain tumor clinical trials

Primary brain tumors are associated with a poor prognosis and recognized impact on physical and neurologic function. In an effort to improve poor prognosis, novel therapeutic approaches have been pursued. The impact of therapy on function has not been fully evaluated in the past, with clinical trials focused on traditional survival endpoints. Therapies to date have been associated with incremental improvements in survival that may not have been associated with improvement in functional status. Methods for evaluating this impact include health-related quality of life symptom burden and evaluation of neurocognitive function. Each approach has associated benefits and limitations based on the type of treatment and the potential impact on functional status. An essential component of trial design evaluating functional endpoints is the development of clear hypotheses, specific aims, and predefined metrics of functional change related to each measure. This paper reviews these three approaches and discusses their potential use in evaluation of therapies for patients with primary brain tumors.

Pain therapy in multiple myeloma — clinical experience from an observational study

Abstract Aim: The aim of the present study was the documentation and evaluation of analgesic therapy in patients with multiple myeloma. Method: As part of a chemotherapy optimisation study, the patients' pain therapy was documented. The severity of pain was recorded using a visual analogue scale (VAS) from 0 (neither pain nor impairment) to 10 (greatest imaginable pain, and very severe impairment). Follow-up examinations took place after 3 days, 1 month and 3 months. Results: 123 patients (60.9%) of 202 patients with multiple myeloma stage III, were treated with analgesics because of severe pain. The average duration of documentation was 11.6 months. One hundred patients received analgesics orally or transdermally, and 32 of these patients received oral controlled-release hydromorphone (Palladon® retard). The remaining patients received analgesic treatment with bisphosponates i.v. and non-medication measures. Four patients (n = 19) were treated with a transdermal system and 8 patients who received a diffe...

Triglycerides and remnant particles as risk factors for coronary artery disease

Coronary artery disease (CAD) is the largest cause of morbidity and mortality in the world. A relationship between CAD and elevated levels of low-density lipoprotein cholesterol has been established. However, risk assessment limited to low-density lipoprotein fails to identify a significant portion of patients at risk for CAD. Remnant lipoproteins, derived from very low-density lipoprotein and chylomicrons, have been considered atherogenic. Recently, a simple and reliable immunoaffinity separation method for the isolation of remnant-like particles (RLP) has been developed. It has been shown that RLP cholesterol levels are significantly correlated with CAD, and thus cellular mechanisms have been determined by which RLP cholesterol causes progression of atherosclerosis. Measurement of RLP cholesterol is useful for the assessment of risk and the evaluation of therapy in patients at risk for CAD.

Evaluation of stem cell therapy in patients with acute myocardium infarction using radionuclide methods

Evaluation of stem cell therapy in patients with acute myocardium infarction using radionuclide methods

RAPID GASTRIC EMPTYING

Purpose: Although delayed gastric emptying for solids is classically used to diagnose gastroparesis, a number of patients with unexplained upper GI symptomatic have normal gastric emptying at 4 hours. Our objective was to determine if these patients might have rapid gastric emptying at 1 or 2 hours. Methods: Normal gastric emptying at 1, 2, and 4 hours at the 5th, 10th, and 25th percentiles from prior work (Am J Gastroenterol 95: 1456–1462,2000) was compared with 14 patients presenting with medically refractory symptoms of gastropathy: nausea, vomiting, abdominal pain, bloating/distension, anorexia/early satiety, referred for possible Gastric Electrical Stimulator (GES) placement. The normal control and patient data were examined for the best fit of predictive values for abnormalities and were compared by t-tests. Results: The data for Controls and Patients is included in the table below. 1 hour gastric emptying of 11 of 14 of our Patients was less than the Control 10th percentile, whereas 5 of 14 were less than the 10th percentile at 2 hours. Mean gastric emptying at 1 and 2 hours was significantly less than control values.TableConclusions: The 10th percentile with retention of 37% or less at 1 hour appears to provide maximal usefulness to identify rapid gastric emptying of solids with a sensitivity 79%. Establishing normal values for rapid gastric emptying has profound clinical usefulness, particularly when applied to evaluation of therapies for patients presenting with the symptoms of gastroparesis. These rapid gastric emptying parameters may help monitor the clinical status of patients with gastropathy before and after therapies such as GES.

Evaluation of β-bloker therapy in patients with dilated cardiomyopathy (DCM) —study by 123I-MIBG myocardial SPECT—

Evaluation of β-bloker therapy in patients with dilated cardiomyopathy (DCM) —study by 123I-MIBG myocardial SPECT—

Positron emission tomography with L‐methyl‐11 C‐methionine in the monitoring of therapy response in muscle‐invasive transitional cell carcinoma of the urinary bladder

To investigate whether positron emission tomography (PET) with L-methyl-11C-methionine as a tracer could be used for diagnostic purposes and for evaluation of therapy in patients with varying stages of urinary bladder cancer treated with chemotherapy. PET was employed in 44 separate examinations involving 29 patients (24 men and five women with a median age of 68 years [mean 66, range 47-78]) with localized or metastatic transitional cell carcinoma of the urinary bladder. In four patients PET examinations were performed prior to the commencement of chemotherapy, and after one course and after three courses. The diagnostic accuracy of PET was poor. The technique did not monitor the therapeutic effect of neoadjuvant chemotherapy, producing results that correlated with therapy outcome. PET identified those patients who responded less successfully to therapy. PET with L-methyl-11C-methionine demonstrates alterations in tumour metabolism long before visible changes appear on computed tomography or magnetic resonance imaging. Further work is required to develop more specific tracers.

Acute effects of dobutamine on myocardial oxygen consumption and cardiac efficiency measured using carbon-11 acetate kinetics in patients with dilated cardiomyopathy

Objectives. The aim of this study was to use positron emission tomography (PET)-derived carbon (C)-11 acetate kinetics to determine the effects of dobutamine on oxidative metabolism and its effects on myocardial efficiency in a group of patients with dilated cardiomyopathy.Background. Dobutamine is known to improve myocardial function but may do so at the expense of myocardial oxygen consumption, which could be a potential deleterious effect. Carbon-11 aceate kinetics correlate with myocardial oxygen consumption as shown in animal models. Combining these scintigraphic measurements of oxygen consumption with estimates of cardiac work results in a work-metabolic index, which reflects cardiac efficiency.Methods. Eight patients with nonischemic dilated cardiomyopathy underwent dynamic PET imaging, echocardiography and hemodynamic measurements. Seven of these patients were also studied while receiving dobutamine. Direct measurements of myocardial oxygen consumption using coronary sinus catheterization were obtained with eight of the PET studies to validate C-11 acetate in patients with cardiomyopathy.Results. The mean (± SD) C-11 clearance rate significantly increased with dobutamine from 0.105 ± 0.027 to 0.155 ±0.023 min−1(p = 0.001). Directly measured myocardial oxygen consumption had a linear relation to the mean C-11 clearance rate (r = 0.8, p = 0.018). Dobutamine was noted to significantly reduce systemic vascular resistance as well as the severity of mitral regurgitation. The work-metabolic index determined using hemodynamic variables and PET data increased from 2 ± 0.7 × 104to 2.6 ± 0.6 × 104(p = 0.04). Efficiency, estimated by employing the oxygen consumption to k2relation, also increased from 13 ± 4.5% to 16.9 ± 6.4% (p = 0.04).Conclusions. Despite an increase in myocardial oxygen consumption, dobutamine led to an increase in work-metabolic index in patients with dilated nonischemic cardiomyopathy. Dobutamine reduced systemic vascular resistance and mitral regurgitation, suggesting that in this group of patients, it had important vasodilatory action in addition to its inotropic effects. The use of the C-11 acetate PET for determining myocardial oxygen consumption and estimating efficiency could potentially complement existing clinical measures of ventricular performance and may allow improved and objective evaluation of therapy in patients with heart failure.

Sensitivity of eye movement registration and visual evoked potentials in evaluation of therapy in patients with multiple sclerosis

A major problem in the evaluation of multiple sclerosis (MS) treatment protocols is the lack of an objective and reliable marker of disease activity. In 24 MS patients who were treated with high doses of intravenous methylprednisolone because of an acute relapse or progressive disease the clinical improvement (as measured by the Kurtzke expanded disability status scale) was compared with two paraclinical parameters, i.e. visual evoked potentials (VEP) and the registration of saccadic and smooth pursuit eye movements. After treatment a significant clinical improvement was found in 50% of the patients. The registration of eye movements revealed a significant improvement in 83% of the patients, the VEP in 21%. It is demonstrated that especially the registration of eye movements can have an important application as an objective and sensitive method in the assessment of neurological functions during MS treatment protocols.

A tool for the physical therapy evaluation of patients with hip fractures in the extended care setting

A tool for the physical therapy evaluation of patients with hip fractures in the extended care setting

The value of right atrial emptying rate in predicting reduction in pulmonary artery pressure in patients with chronic obstructive pulmonary disease.

We used an improved noninvasive radionuclide method, recently developed by us, to evaluate changes in pulmonary artery pressure induced by sublingual nifedipine in patients with chronic obstructive pulmonary disease and pulmonary hypertension. The new method enhances the predictive power of right ventricular ejection fraction by using the right atrial emptying rate as an index of reduced right ventricular compliance. The results were compared to those of invasively measured pulmonary arterial pressure. In the 21 patients studied 20 mg of nifedipine sublingually reduced pulmonary arterial pressure by 13.35% from 36.95 +/- 13.95/12.71 +/- 6.24 (mean 20.79 +/- 8.19) mmHg to 32.67 +/- 12.17/10.9 +/- 6.2 (mean 18.16 +/- 7.3) mmHg (p less than 0.05 for all pressures). Cardiac index increased and the pulmonary and systemic resistances decreased. The percent changes in right atrial emptying rate showed an excellent correlation with the percent change in pulmonary pressure. An increase of 12% or more in right atrial emptying rate predicted in all patients a reduction in pulmonary arterial pressure of at least 8%, the specificity and positive predictive accuracy being 100%. The sensitivity and the predictive accuracy of a negative test were 93% and 80%, respectively. The new method is useful for long-term evaluation of drug therapy in patients with pulmonary hypertension.