scholarly journals A novel method to interpret early phase trials shows how the narrowing of the coronary sinus concordantly improves symptoms, functional status and quality of life in refractory angina

Heart ◽  
2020 ◽  
Vol 107 (1) ◽  
pp. 41-46
Author(s):  
E Marc Jolicoeur ◽  
Stefan Verheye ◽  
Timothy D Henry ◽  
Lawrence Joseph ◽  
Serge Doucet ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Coronary Sinus ◽  
Early Phase ◽  
Exercise Duration ◽  
Control Group ◽  
Refractory Angina ◽  
Group Level ◽  
Early Phase Trials ◽  
Level Analysis

BackgroundReduction of the coronary sinus was shown to improve angina in patients unsuitable for revascularisation. We assessed whether a percutaneous device that reduces the diameter of the coronary sinus improved outcomes across multiple endpoints in a phase II trial.MethodsWe conducted a novel analysis performed as a post hoc efficacy analysis of the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) trial, which enrolled patients with Canadian Cardiovascular Society (CCS) class 3–4 refractory angina. We used four domains: symptoms (CCS Angina Scale), functionality (total exercise duration), ischaemia (imaging) and health-related quality of life. For all domains, we specified a meaningful threshold for change. The primary endpoint was defined as a probability of ≥80% that the reducer exceeded the meaningful threshold on two or more domains (group-level analysis) or that the average efficacy score in the reducer group exceeded the sham control group by at least two points (patient-level analysis).ResultsWe randomised 104 participants to either a device that narrows to coronary sinus (n=52) or a sham implantation (n=52). The reducer group met the prespecified criteria for concordance at the group level and demonstrated improvement in symptoms (0.59 CCS grade, 95% credible interval (CrI)=0.22 to 0.95), total exercise duration (+27.9%, 95% CrI=2.8% to 59.8%) and quality of life (stability +11.2 points, 95% CrI=3.3 to 19.1; perception +11.0, 95% CrI=3.3 to 18.7).ConclusionsThe reducer concordantly improved symptoms, functionality and quality of life compared with a sham intervention in patients with angina unsuitable for coronary revascularisation. Concordant analysis such as this one can help interpret early phase trials and guide the decision to pursue a clinical programme into a larger confirmatory trial.Trail registration numberClinicalTrials.gov identifier: NCT01205893.

scholarly journals ANALGESIC EFFECT OF BRYOPHYLLUM PINNATUM L AND CURCUMA XANTHORRIZA COMBINATION ON MICE'S INDUCED BY FORMALDEHYDE AS ARTHRALGIA AGENT

2021 ◽  
pp. 48-50
Author(s):  
Tuti Sri Suhesti ◽  
Hanif Nasiatul ◽  
Mustofa Mustofa
Keyword(s):  
Quality Of Life ◽  
Analgesic Effect ◽  
Early Phase ◽  
Late Phase ◽  
Ethanolic Extract ◽  
Control Group ◽  
Nociceptive Responses ◽  
Dose Combination ◽  
Bryophyllum Pinnatum

Arthralgia is pain in arthritis. Its prevalence is widespread and increasing every year and greatly affect quality of life. Bryophyllum pinnatum L (BP) leaves and Curcuma xanthorriza (CX) rhizomes potensially as antioxidant, analgesic and anti-inflammatory.In this study we examined the analgetic effects of both ethanolic BP and CX extract's combination on the analgetic score using formaldehyde induced.Male mice strain balb/c were divided into 7 groups (n=7), consists of control group (aquadest),aspirin group at a dose of 100mg/ mL,ethanolic extract group with various doses at 200mg/kg BB, p.o. Each group was induced by 0.05 ml Formaldehyde (2.5%) on day. Early phase nociceptive responses were measured in the first 5 minutes and late phase was measured at 15-30 minutes after formaldehyde induced.The analgetic score were determined on early phase and late phase,and then analyzed using ANOVA test.The results showed that the combination of BP and CX extract have analgesic activity in male mice's were induced by formaldehyde. Dose combination of BP and CX with a dose of 100:0 significantly showed optimum analgetic score.The results suggest that BP extract had analgetic activities that should be further examined and potentially candidate as exploited for arthralgia therapies

Implantation of a Coronary Sinus Reducer to Treat Refractory Angina in a 38-Year-Old with an Anomalous Left Coronary Artery and No Revascularization Options

Cardiology ◽  
2020 ◽  
Vol 145 (3) ◽  
pp. 126-129
Author(s):  
Kevin Cheng ◽  
Ranil de Silva
Keyword(s):  
Quality Of Life ◽  
Coronary Artery ◽  
Coronary Sinus ◽  
Left Coronary Artery ◽  
Multidisciplinary Teams ◽  
Refractory Angina ◽  
Anomalous Left Coronary Artery ◽  
Percutaneous Revascularization ◽  
Anomalous Left Coronary

A 38-year-old female with anomalous left coronary artery from the pulmonary artery presented with refractory angina (Canadian Cardiovascular Society [CCS] class 4). Having failed two previous internal mammary artery grafts to the left anterior descending artery and with no percutaneous revascularization options, she underwent coronary sinus reducer implantation, which improved her symptoms (CCS 0), quality of life, and corresponded to an improvement in ischemia on myocardial perfusion scanning. This case report describes an unusual case of refractory angina in the context of congenital heart disease, illustrates the benefit of this novel hourglass-shaped stent in improving ischemia, quality of life, depression and anxiety, and highlights the importance of managing these patients in multidisciplinary teams.

Cancer prevention

2018 ◽  
Author(s):  
Jim Cassidy ◽  
Donald Bissett ◽  
Roy A. J. Spence OBE ◽  
Miranda Payne ◽  
Gareth Morris-Stiff
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Cancer Therapy ◽  
Cancer Prevention ◽  
Early Phase ◽  
Early Phase Trials ◽  
Phases Of Development ◽  
Trail Design

Introduces the reader to importance of clinical trials in cancer therapy. Describes the phases of development and some of the “traditional” guidelines for such studies. Focuses particularly on early phase trials of novel compounds. Also describes endpoints used in such trials. Section on quality of life which highlights the growing importance of this aspect of trail design and interpretation

Results of osteopathic correction of patients with post-traumatic coccygodynia

2019 ◽  
pp. 19-27
Author(s):  
Yu. V. Antonova ◽  
A. M. Iskandarov ◽  
I. B. Mizonova
Keyword(s):  
Quality Of Life ◽  
Emotional State ◽  
Pain Syndrome ◽  
Control Group ◽  
Life Questionnaire ◽  
Treatment Area ◽  
Diffi Cult ◽  
Osteopathic Treatment ◽  
Post Traumatic

Introduction.Coccygodynia is a multidisciplinary disease which is diffi cult to treat. It seriously limits the ability to work and signifi cantly affects the quality of life of patients. The study of somatic dysfunctions in patients with coccygodynia and the analysis of the results of osteopathic treatment of such patients makes it possible to justify the necessity of osteopathic correction of coccygodynia.Goal of the study— to determine the structure of the leading somatic dysfunctions in patients with coccygodynia and to study the effectiveness of osteopathic treatment of this pathology.Materials and methods.The study involved 44 patients from 25 to 65 years old, randomly divided into two groups. The main group of 24 people (20 women and 4 men) received osteopathic treatment, in accordance with the identifi ed leading somatic dysfunctions. Patients of the control group (16 women and 4 men) were treated locally with soft manual techniques (the treatment area was limited by the pelvic region). In order to assess the results of the treatment, we examined the intensity of the pain syndrome and the psycho-emotional state of patients. The severity of the pain syndrome was assessed in accordance with the visual analogue scale (VAS). The psycho-emotional state (with physical and mental components) was assessed with the help of the SF-36 quality of life questionnaire.Results.Somatic dysfunctions typical for patients with coccygodynia have been identifi ed. Osteopathic treatment has proven to be more effective in comparison with local manual therapy of coccygodynia both in early periods and in 3 months after the end of the treatment course.Conclusion.Osteopathic treatment of post-traumatic coccygodynia is effective, and can be recommended for treatment of such patients.

COMPARISON OF THE QUALITY OF LIFE OF PATIENTS IN THE LOCALY ADVANCED BREAST CANCER FORMS AFTER SYSTEM AND INTRALYMPHATIC POLYCHEMOTHERAPY

2018 ◽  
Vol 4 ◽  
pp. 3-13
Author(s):  
Yuriy Dumanskiy ◽  
Oleksandr Bondar ◽  
Oleksandr Tkachenko ◽  
Evhenii Stoliachuk ◽  
Vasilii Ermakov
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Locally Advanced ◽  
Developed Countries ◽  
Control Group ◽  
Preoperative Treatment ◽  
Discrete Elements ◽  
Important Indicator ◽  
Significant Difference

In recent years, breast cancer (BC) is the most common cancer pathology and the most common cause of disability among women in developed countries. Finding the most effective ways of interaction between the patient and the doctor creates the preconditions for the necessary analysis of the treatment process from an objective and subjective point of view. Therefore, an important indicator to be taken into account is the quality of life of a patient. To compare the indicators of a comprehensive assessment of the quality of life of patients to the adverse locally advanced forms (LA) of breast cancer before and after systemic intravenous polychemotherapy (SPCTx) and selective endolymphatic polychemotherapy (ELPCTx) in neoadjuvant mode. The study was conducted on the basis of a random analysis of outpatient cards from 112 patients with LA BC T4A-DN0-3M0 who received a comprehensive antitumor treatment on the basis of the Donetsk regional antitumor center and the University Clinic of the Odessa National Medical University from 2000 to 2017, which was proposed a questionnaire at various stages of preoperative treatment. The first (control) group consisted of 65 patients (58 %) with inoperable forms of LA BC, which was performed in neoadjuvant mode by SPCTx. The second (study group) included 47 patients (42 %) with inoperable forms of LA BC, which was performed as a neoadjuvant course ELPCTx. According to the integral indicators of quality of life and quality of health between patients in the control and study groups, there was no statistically significant difference. In a detailed analysis of the indicators of symptomatic scales, the difference between the groups did not exceed the critical. Based on the results of a study conducted among patients receiving endolymphatic chemotherapy in a neoadjuvant mode, the subjective evaluations of treatment in absolute numbers have better reference values without statistical superiority. The study of the integrative indicator of quality of life and its discrete elements is an ergonomic and economical means of heuristic assessment of the health of patients in order to further develop more rational and convenient ways of solving urgent issues of modern oncology by increasing compliance and finding a compromise between the physician and the patient.

Effectiveness of mobile applications on healthy lifestyles aimed at diabetic patients: review of systematic reviews. (Preprint)

2019 ◽  
Author(s):  
Francisco Jesús Represas Carrera Sr ◽  
Ángel Alfredo Martínez Ques Sr ◽  
Ana Clavería Fontán Sr
Keyword(s):  
Quality Of Life ◽  
Diabetes Mellitus ◽  
Systematic Reviews ◽  
Mobile Applications ◽  
Control Group ◽  
Diabetic Patients ◽  
Healthy Lifestyles ◽  
Major Public Health Problem

BACKGROUND Diabetes mellitus is currently a major public health problem worldwide. It is traditionally approached in a clinical inpatient relationship between the patient and the healthcare professional. However, the rise of new technologies, particularly mobile applications, is revolutionizing the traditional healthcare model through the introduction of telehealthcare. OBJECTIVE (1) To assess the effects of mobile applications for improving healthy lifestyles on the quality of life and metabolic control of diabetes mellitus in adult patients. (2) To describe the characteristics of the mobile applications used, identify the healthy lifestyles they target, and describe any adverse effects their use may have. METHODS Review of systematic reviews and meta-analysis, following the guidelines of the Cochrane Collaboration and the Joanna Briggs Institute. We included studies that used any mobile application aimed at helping patients improve self-management of diabetes mellitus by focusing on healthy lifestyles. Studies needed to include a control group receiving regular care without the use of mobile devices. In May 2018, a search was conducted in Medline, Embase, Cochrane, LILACS, PsychINFO, Cinahl and Science Direct, updated in May 2019. The methodological quality of the studies was assessed using the Amstar-2 tool. RESULTS Seven systematic reviews of 798 articles were initially selected for analysis. The interventions had a duration of between 1 and 12 months. Mobile applications focused singly or simultaneously on different lifestyles aspects (diet, physical exercise, motivation, blood glucose levels, etc.). There are significant changes in HbA1c values, body weight and BMI, although in others, such as lipid profile, quality of life, or blood pressure, there is no clear improvement. CONCLUSIONS There is clear evidence that the use of mobile applications improves glycemic control in diabetic patients in the short term. There is a lack of evidence in its long-term benefits. It is thus necessary to carry out further studies to learn about the long-term effectiveness of mobile applications aimed at promoting the healthy lifestyles of diabetic patients. CLINICALTRIAL PROSPERO Register: CRD42019133685

scholarly journals The influence of the Kinesio Taping on selected ultrasonography measurements, and quality of life in patients with rotator cuff lesions

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Aneta Bac ◽  
Magdalena Wróbel ◽  
Katarzyna Ogrodzka-Ciechanowicz ◽  
Edyta Michalik ◽  
Anna Ścisłowska-Czarnecka
Keyword(s):  
Quality Of Life ◽  
Rotator Cuff ◽  
Statistical Significance ◽  
Control Group ◽  
Subacromial Space ◽  
Kinesio Taping ◽  
Significant Difference ◽  
Rotator Cuff Lesions ◽  
Significant Change

Abstract The assessment of the six-week influence of Kinesio Taping combined with a rehabilitation on selected ultrasonography measurements, the level of disability, and the quality of life in patients with rotator cuff lesions. 60 participants were randomly assigned into a taping group (KT combined with a six-week rehabilitating protocol) and a control group (only rehabilitation protocol). In all patients the following assessments were performed twice: USG, UEFI and NHP questionnaires. In the examination of the subacromial space and the subacromial bursa in the taping group, no statistical significance was observed. A statistically significant change in the thickness of the muscles was obtained only for the thickness of the infraspinatus in the taping group. A statistically significant change was obtained in the assessment of tendinopathy only for the supraspinatus muscle in both groups. Within both groups a statistically significant difference was observed in the average UEFI and NHP scores; however, the differences in the scores obtained between the groups were not statistically significant. The use of KT with a rehabilitation program did not yield statistically significantly better results in the improvement of selected shoulder region indicators, the function of the upper limb and the quality of life.

scholarly journals Quality of life in patients with narcolepsy: a WHOQOL-bref study

2008 ◽  
Vol 66 (2a) ◽  
pp. 163-167 ◽  
Author(s):  
Heloísa Rovere ◽  
Sueli Rossini ◽  
Rubens Reimão
Keyword(s):  
Quality Of Life ◽  
Patient Group ◽  
World Health ◽  
Control Group ◽  
World Health Organization Quality ◽  
Severe Impairment ◽  
Perception Of Quality ◽  
Social Domains ◽  
Health Organization

OBJECTIVE: To evaluate the perception of Quality of Life (QL) in Brazilian patients with narcolepsy. METHOD: 40 adult patients aged between 20 and 72 years (mean=41.55; SD=14.50); (28 F; 12M), with the diagnosis of chronic narcolepsy were followed up at the outpatient clinic (Patient Group). The Control Group was composed of 40 adults. The instrument utilized was the World Health Organization Quality of Life (WHOQOL-BREF). RESULTS: The two groups were homogeneous and no difference was found with regards to age, sex, and demographic characteristics. The perception of QL in physical, psychological and social domains showed lower scores in those patients with narcolepsy than in the control group (p<0.05). Concerning physical domain, all the aspects evaluated were significantly impaired, in patient group, including sleep satisfaction (p<0.001); energy for daily activities (p=0.039); capacity to perform activities (p=0.001); and capacity to work (p=0.001). CONCLUSION: The perception of QL showed severe impairment in patients with narcolepsy for physical, psychological and social domains.

scholarly journals Inquiry Based Stress Reduction (IBSR) Improves Overall Stuttering Experience among Adults Who Stutter: A Randomized Controlled Trial

2021 ◽  
Vol 10 (10) ◽  
pp. 2187
Author(s):  
Omrit Feldman ◽  
Eran Goldstien ◽  
Benjamin Rolnik ◽  
Ariel B. Ganz ◽  
Shahar Lev-Ari
Keyword(s):  
Quality Of Life ◽  
Stress Reduction ◽  
Satisfaction With Life ◽  
Psychological Flexibility ◽  
Well Being ◽  
The United States ◽  
Control Group ◽  
Randomized Controlled ◽  
Adults Who Stutter

Stuttering is a speech disorder that can cause disturbances in the timing and flow of speech. In addition to being a communication disorder, stuttering is often accompanied by a reduction in the quality of life and has impacts on social status, mental well-being, self-acceptance, and the chances of integration into the labor market. The Inquiry Based Stress Reduction (IBSR) program, developed in the United States by Byron Katie in 1986, is the clinical application of “The Work” method (Thework.com) and represents an emerging mindfulness and cognitive-reframing method. IBSR has been demonstrated to improve mental health and well-being in adults and may alleviate psychological and psychosocial symptoms of stuttering. The purpose of this trial was to examine the effect of a 12-week IBSR intervention on the overall stuttering experience and indicators of anxiety, psychological flexibility, and well-being among adults who stutter (AWS). This study was a randomized controlled clinical trial. Participants were randomized to IBSR (n = 28) and control (n = 28) groups. Validated questionnaires of overall stuttering experience (OASES-A), anxiety (STAI), psychological flexibility (PFQ), and satisfaction with life (SWLS) were completed before, after, and one month after the intervention. An intention-to-treat approach was implemented for analysis. Our results show that participants in the IBSR intervention group exhibited a greater improvement in their overall stuttering experience as compared to the control group, as well as in general information on stuttering awareness and perception, reactions to stuttering, communication in daily situations, and quality of life. In addition, we found a greater reduction in anxiety levels and an increase in satisfaction-with-life scores in the IBSR group. These results indicate that IBSR can improve the overall stuttering experience.

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