Satisfaction with Pharmacotherapy for Approved and Off-Label Indications—A Delphi Study

2005 ◽  
Vol 39 (4) ◽  
pp. 649-654 ◽  
Author(s):  
Mitja Kos ◽  
Albert I Wertheimer ◽  
Ales Mrhar
Keyword(s):  
Drug Therapy ◽  
Delphi Study ◽  
Delphi Technique ◽  
Control Group ◽  
Supporting Evidence ◽  
Statistical Association ◽  
Off Label ◽  
Drug Regulatory Agency ◽  
Compulsory Health Insurance ◽  
Pediatric Illnesses

BACKGROUND: Prescribing for non-approved uses is widespread in the treatment of AIDS, cancer, and pediatric illnesses, but it is by no means limited to these areas. Few studies have been performed evaluating reasons for off-label prescribing. OBJECTIVE: To explore the satisfaction with drug therapy as one of the potential reasons for off-label uses by testing a hypothesis that the satisfaction with drug therapy for off-label indications is lower than for approved indications. METHODS: The study compared the satisfaction with drug therapy for known off-label indications with a control group of approved indications. Twenty-four of the first 50 single-ingredient drugs, according to their share in the drug cost budget of the Slovenian Compulsory Health Insurance, had 86 different off-label indications eligible for inclusion. A control group of 86 approved indications was randomly selected from the list of all possible approved indications for the same 24 drugs. A 2–round Delphi technique, involving an expert panel of physicians who are members of the drug regulatory agency, was used to evaluate the satisfaction with drug therapy for selected indications. RESULTS: After the second round of the Delphi study, the median scores of satisfaction with drug therapy for approved and off-label indications were 7.00 and 6.50, respectively (p = 0.001). CONCLUSIONS: The study shows that the satisfaction with available drug therapy for off-label indications is lower than for approved indications. The statistical association, biologic plausibility, and coherence with existing information, as well as the temporality of the association, provide supporting evidence that low satisfaction with drug therapy is one of the incentives for off-label use.

Clinical efficacy of osteopathic correction in the complex treatment of patients with unoperated open-angle glaucoma

2020 ◽  
pp. 97-105
Author(s):  
E. N. Simakova ◽  
O. V. Stenkova
Keyword(s):  
Intraocular Pressure ◽  
Drug Therapy ◽  
Primary Open Angle Glaucoma ◽  
Open Angle Glaucoma ◽  
Randomized Study ◽  
Main Group ◽  
Control Group ◽  
Open Angle ◽  
Complex Treatment ◽  
Hypotensive Drug

Introduction. Glaucoma is one of the most significant eye diseases. It is often diagnosed, not always amenable to therapy, and can lead to a complete loss of visual functions. In recent years, the method of osteopathic correction has become widespread as one of the effective methods of treatment and rehabilitation of patients with pathologies of various body systems. In the pathogenesis of glaucoma, it is customary to distinguish a dystrophic concept, which considers primary open-angle glaucoma as a result of dystrophic changes in the connective tissue, as well as in the endothelial lining of the trabeculae and Schlemm′s canal, especially destructive changes in mitochondria and the alteration of their functional activity. A vascular concept is also distinguished. According to this concept, the central link in the pathogenesis of glaucoma is circulatory disorder in the ciliary vessels, ocular artery, and major vessels of the head and neck, it can be assumed that osteopathic correction in the treatment of patients with open-angle glaucoma will be pathogenetically substantiated and will have a positive effect on intraocular pressure and trophicity of the optic nerve. The goal of research — to study the influence of in osteopathic correction on the nature of unoperated glaucoma (stage IIA) and to substantiate the possibility of using osteopathic correction in the complex treatment of patients with this pathology.Materials and methods. A prospective controlled randomized study was conducted at 52 city polyclinics, branch 3, Moscow, from January 2018 to January 2019. 40 patients (70 eyes) aged 50 to 75 years with primary open-angle glaucoma IIA stage were examined. At this stage of the disease, patients most often seek medical care and the issue of conservative management is primarily considered. All patients were divided into two groups of 20 people: the main group and the control group. The treatment in the main group included hypotensive drug therapy and osteopathic correction. Patients of the control group received only drug therapy. All patients underwent ophthalmic (visometry, tonometry, perimetry) and osteopathic examination twice: before the treatment and after 3 months.Results. For patients with primary open-angle IIA non-operated glaucoma, regional (most often regions of the head, neck, dura mater) and local (abdominal diaphragm, iliac bones, hip and knee joints) somatic dysfunctions were the most typical. In the main group a statistically significant decrease in the frequency and severity of dysfunctions at all levels was stated. Also, in patients receiving osteopathic correction, a significant decrease in the level of intraocular pressure and perimetric indices was noted. In patients of the control group, no reliable changes in these indicators were obtained.Conclusion. The results obtained indicate that osteopathic correction is clinically effective in the complex treatment of patients with primary open-angle II A glaucoma.

S275 – Nasal Morphology and Nasal Patency in Leprosy Patients

2008 ◽  
Vol 139 (2_suppl) ◽  
pp. P167-P167
Author(s):  
Maria Teresa Torres Larrosa ◽  
Luis Jorge Peréz Peréz ◽  
Juan-Jose Artazkoz-del Toro
Keyword(s):  
Drug Therapy ◽  
Therapy Group ◽  
Control Group ◽  
Nasal Patency ◽  
Multidrug Therapy ◽  
Airway Patency ◽  
Expiratory Resistance ◽  
Leprosy Patients ◽  
The Right ◽  
The Impact

Objectives 1) To assess the impact of multi-drug leprosy therapy on the development of nasal deformities and nasal airway patency. 2) Evaluate the nasal morphology and nasal patency in leprosy patients treated with the multidrug therapy in comparison with patients treated with 1 drug therapy and a group of healthy volunteers. Methods In an overall group of 84 patients studied, 38 were treated with a therapy based on a single drug, and 22 were treated with multi-drug therapy, while 24 subjects formed a control group. We used anterior rhinoscopy to analised the morphology of the nose. We meassured the nasal inspiratory and expiratory resistance of the right and left nostrils and total nasal inspiratory and expiratory resistance at a transnasal pressure of 150 Pa. by using active anterior rhinomanometry. The statistical analysis was carried out using the Varianza analisys. Results The nasal structures in the 1-drug therapy group underwent bone and cartilaginous resorption with an increase in nasal resistances. We found significant statistical differences between the resistance values obtained in this group and the control group (p<0,05). In the multidrug therapy group, the morphology of the nose remains as in healthy patients. No significant statistical differences were found between the resistance values obtained in the multidrug therapy patients and the control group (P>0,05). Conclusions The multidrug therapy prevents developing nasal deformities and maintains a normal nasal airflow.

Strengthening the pharmacological potential of drug therapy in treatment of patients with chronic pancreatitis by using therapeutic physical factors

2020 ◽  
pp. 8-14
Author(s):  
R. M. Mallaeva ◽  
A. N. Makhinko ◽  
M. B. Uzdenov
Keyword(s):  
Quality Of Life ◽  
Chronic Pancreatitis ◽  
Drug Therapy ◽  
Clinical Manifestations ◽  
Medical Rehabilitation ◽  
Control Group ◽  
Physical Factors ◽  
Standard Drug ◽  
Pharmacological Potential

The purpose of the study is to improve rehabilitation treatment of patients with chronic pancreatitis (CP) at inpatient stage by strengthening pharmacological potential of drug therapy due to inclusion of therapeutic physical factors (TPF) in therapeutic programs. Materials and methods. 159 patients with acute CP were observed. By simple randomization, 4 groups were formed: the control group (MG, 39 people) received standard drug therapy; 1st comparison group (GC1; 38 people) additionally received TPF; GC2 (40 people) in addition to treatment in GC1 had drinking mineral water «Slavyanovskaya»; in main group (42 people) in addition to the treatment in GC2 got preformed peloidotherapy on the cervical-collar zone. All the patients underwent the evaluation of clinical score and quality of life before and after medical rehabilitation. Results. In MG, clinical symptomatology leveling was by 78,2% (p<0,01), in GC1 — by 71,5% (p<0,01), GC2 — by 62,3% (p<0,01), CG — by 57,2% (p<0,01) on average immediately after the treatment, which was in a clear correlation with indicators of quality of life. In the long term (in 6 and 12 months), the advantage of combination therapy was noted with the same validity, the preservation of the achieved positive result was mostly noted in the MG: after 6 months the improvement in physical health compared to the initial values was noted by 34,4% (p<0,01), after 12 months — by 24,0% (p<0,05); mental — by 32,3% (p<0,01) and 22,5% (p<0,05), respectively. In both comparison groups, positive dynamics was 10–12% lower, and in the control group, after 6 months, there was only a tendency to improve quality of life indicators. Conclusion. The inclusion of TPF in the programs of the inpatient stage of medical rehabilitation of patients with chronic pancreatitis by strengthening the pharmacological potential of drug therapy contributes to the leveling of clinical manifestations (abdominal pain, dyspepsia and diarrhea), the result of which is an improvement in the quality of life of this category of patients.

The effect of hirudotherapy on cerebral circulatory homeostasis in patients with genital endometriosis

2020 ◽  
pp. 58-66
Author(s):  
Ya. I. Uraeva ◽  
I. I. Ivanova ◽  
N. N. Lazarenko ◽  
E. V. Filatova ◽  
I. A. Pankova ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Drug Therapy ◽  
Cerebral Circulation ◽  
The State ◽  
Control Group ◽  
Complex Treatment ◽  
Statistical Regression ◽  
Treatment Results ◽  
Standard Drug ◽  
Before And After

The results of the treatment of women (n = 94) suffering from genital endometriosis are presented. The first (control, n = 30) group of women received standard drug therapy; the second (main, n = 64) group of women additionally had hirudotherapy procedures using medical leeches. The course of treatment consisted of 10–12 procedures. The state of cerebral circulation was assessed according to the rheoencephalography data before and after the treatment, as well as after 1, 3, 6, and 9 months. As a result, in patients in the 2-nd (main) group receiving complex treatment, the state of cerebral circulation improved signifi cantly. Moreover, according to the statistical regression analysis, it was possible to predict its further decrease by two periods ahead, compared with the treatment results in patients in the 1-st (control) group.

scholarly journals Evaluation Criteria for Interactive E-Books for Open and Distance Learning

2015 ◽  
Vol 16 (5) ◽  
Author(s):  
Aras BOZKURT ◽  
Mujgan BOZKAYA
Keyword(s):  
Mixed Method ◽  
Delphi Study ◽  
Delphi Technique ◽  
Qualitative Data ◽  
Evaluation Criteria ◽  
Heuristic Inquiry ◽  
Mixed Method Study ◽  
Final Phase ◽  
Open And Distance Learning ◽  
Research Questions

<p>The aim of this mixed method study is to identify evaluation criteria for interactive e-books. To find answers for the research questions of the study, both quantitative and qualitative data were collected through a four-round Delphi study with a panel consisting of 30 experts. After that, a total of 20 interactive e-books were examined with heuristic inquiry methodology. In the final phase, the results of the Delphi technique and the heuristic inquiry results were integrated. As a result, four themes, 15 dimensions, and 37 criteria were developed for interactive e-books. Lastly, the results and their implications are discussed in this paper and suggestions for further research are presented.</p>

scholarly journals Bone mineral density in children with long-term antiepileptic therapy

2013 ◽  
Vol 141 (5-6) ◽  
pp. 329-332 ◽  
Author(s):  
Milena Dimic ◽  
Aleksandar Dimic ◽  
Zoran Milosevic ◽  
Jelena Vojinovic
Keyword(s):  
Bone Mineral Density ◽  
Vitamin D ◽  
Drug Therapy ◽  
Antiepileptic Drug ◽  
Bone Mineral ◽  
Control Group ◽  
Mineral Density ◽  
Antiepileptic Therapy ◽  
Epileptic Children ◽  
Antiepileptic Drug Therapy

Introduction. Vitamin D active metabolites deficit that is altered by negative calcium and phosphorus balance is a potential complication during long?term antiepileptic drug therapy. Objective. The aim of this study was to examine lumbar bone mineral density (BMD) in epileptic children receiving antiepileptic drug therapy longer than one year. methods. The examined sample consisted of 34 epileptic children, 18 male and 16 female, aged 6?12 (9.77?2.01) years, treated with carbamazepine, valproate, phenobarbital, lamotrigine or their combination without vitamin D supplementation. The lumbar spine BMD (L1?L4) was estimated by a Lunar densitometer and obtained results were compared with results of 35 matched population of healthy children from the control group. results. Lumbar BMD Z?score was significantly lower in female patients treated with antiepileptic therapy compared with those in the control group (?1.048?1.35 vs. ?0.399?0.518; p=0.03). Bone mineral density Z?score decrease of both gender groups receiving antiepileptic polytherapy was significantly lower compared to the control group (?1.153?0.938 vs. ?0.043?0.815; p=0.007). Therapy duration had no influence on the lumbar BMD level decrease either in boys (rxy=0.33; p=0.174) or in girls (rxy=0.02; p=0.935) treated with antiepileptic therapy. Conclusion. Our results have indicated that antiepileptic drug therapy usage longer than one year can have adverse affects on the lumbar spine BMD (L1?L4) in epileptic children, and that prophylactic vitamin D supplementation is also necessary in these patients.

scholarly journals A Retrospective Study Evaluating the Effectiveness of an Asthma Clinical Pathway in Pediatric Inpatient Practice

2008 ◽  
Vol 13 (4) ◽  
pp. 233-241
Author(s):  
Elisa Edwards ◽  
Kristie Fox
Keyword(s):  
Drug Therapy ◽  
Hospital Stay ◽  
Clinical Pathway ◽  
Length Of Hospital Stay ◽  
Control Group ◽  
Readmission Rates ◽  
Asthma Education ◽  
Children's Hospital ◽  
Children’S Hospital ◽  
Pediatric Inpatient

OBJECTIVE To determine if the asthma clinical pathway implemented at Wolfson Children's Hospital reduces the length of hospital stay. To determine if pathway use affected the use of asthma education, the use of appropriate discharge medications based on asthma classification, and readmission rates. METHODS A list of patients aged 2 to 18 years discharged from Wolfson Children's Hospital between September 1, 2004 and August 31, 2006 with the diagnosis of asthma was generated. Medical records of eligible patients were reviewed for demographic information, asthma pathway use, duration of hospital stay in days, readmission rates, receipt of asthma education, and medications prescribed upon discharge. Patients placed on the asthma clinical pathway were compared to a control group with asthma who were matched based on age and discharge date. Length of stay was averaged for each group. Asthma education, discharge medications, and readmission rates were compared between the two groups. RESULTS Forty-three patients placed on the asthma clinical pathway were compared to a 43 patients in the control group that were matched for age and discharge date. Use of the asthma clinical pathway reduced hospital stay by 0.372 days (P = .0373). Receipt of asthma education (P = .3864), the use of appropriate drug therapy prescribed upon discharge (P = .1398), and readmission rates (P = .5486) were unaffected by pathway use. CONCLUSIONS The asthma clinical pathway used at Wolfson Children's Hospital reduces length of hospital stay, but has no bearing on receipt of asthma education, use of appropriate drug therapy upon discharge, or readmission rates.

scholarly journals Pengaruh pemberian obat anti tuberkulosis dengan vitamin D terhadap perubahan BTA pada penderita tuberkulosis paru di Kabupaten Pidie

2021 ◽  
Vol 2 (1) ◽  
pp. 25
Author(s):  
Rina Maulidar ◽  
Nurjannah Nurjannah ◽  
Aulina Adamy ◽  
Iskandar Iskandar
Keyword(s):  
Vitamin D ◽  
Drug Therapy ◽  
Intervention Group ◽  
Control Group ◽  
Significance Level ◽  
The World ◽  
Post Test ◽  
And Control ◽  
Global Health Problem ◽  
Test Control

Background: Tuberculosis (TB) is a global health problem, Indonesia had the second rank of the case in the world after India which is the fourth cause of death. Giving vitamin D together with anti-tuberculosis drugs can increase healing proses because vitamin D (anti-microbial immunomodulators) kills Mycobacterium tuberculosis.Objectives: This study aims to measure the effect of giving anti-tuberculosis drugs with vitamin D on changes in AFB in patients with pulmonary tuberculosis.Methods: This study was used a quasi-experiment design, pre-test and post-test control group was doing at 25th March – 25th July 2019. This research has been conducted in Pidie Regency. The intervention group (17 samples with tuberculosis drugs) was given Softgels vitamin D 5000 IU for 4 months, while the control group was only anti-tuberculosis drug therapy. The data were analyzed statistically using the Wilcoxon and Mann Whitney tests at a significance level of 95%.Results: Before the intervention, the BTA status of both the intervention and control group was similar (p= 0.061). After the intervention, there was a decrease in AFB interactions (p= 0.000). There was a decrease in the contribution of AFB in the control group before with after intervention (p= 0.000). There are those who support (p= 0.033) giving vitamin D the acceleration of pulmonary tuberculosis treatment. Conclusion: It is better to administer vitamin D to the successful treatment of pulmonary TB in patients undergoing anti-tuberculosis drug therapy.

scholarly journals 4CPS-156 A rare case and an effective drug therapy: off-label use of tacrolimus in a paediatric dysimmune disease

2018 ◽  
Author(s):  
L Cingolani ◽  
S Gatti ◽  
MA Berardi ◽  
G Ortenzi ◽  
M Vallorani ◽  
...  
Keyword(s):  
Drug Therapy ◽  
Rare Case ◽  
Effective Drug ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Using the Delphi Technique to Explore Complex Concepts in Speech-Language Pathology: An Illustrative Example From Children's Social Communication

2017 ◽  
Vol 26 (4) ◽  
pp. 1225-1235 ◽  
Author(s):  
Kristen Izaryk ◽  
Elizabeth Skarakis-Doyle
Keyword(s):  
Social Communication ◽  
Delphi Study ◽  
Delphi Technique ◽  
Complex Problem ◽  
Consensus Building ◽  
Speech Language Pathology ◽  
Speech Language Pathologists ◽  
Starting Point ◽  
Language Pathology ◽  
Key Features

PurposeIn recent years, there has been an increasing interest in expanding the research approaches that speech-language pathologists utilize, particularly for addressing complex questions. Consensus-building techniques can be useful for addressing such questions. The Delphi technique is a consensus-building process involving structured communication among members of an expert panel via independent responses to iterative rounds of questionnaires. The purpose of this research note is to describe and demonstrate the Delphi technique using an application to a complex problem in speech-language pathology, that is, the bases of social communication and pragmatics.MethodThe Delphi technique was described and illustrated via the following study: 10 expert speech-language pathologists participated in a 3-round Delphi study. Participants were asked to list the key features of social communication and pragmatics in Round 1. Questions for Rounds 2 and 3 were developed on the basis of the participants' responses to previous rounds.ResultsThe Delphi technique was useful in bringing participants to consensus on the key features of social communication and pragmatics and offered a starting point for the continued exploration of this complex problem.ConclusionA discussion of the benefits and limitations of the technique is included, highlighting the utility of the technique to the field of speech-language pathology.

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