Effects of an ergonomic program on the quality of life and work performance of university staff with physical disabilities: A clinical trial with three-month follow-up

2019 ◽  
Vol 12 (1) ◽  
pp. 58-64
Author(s):  
Maria Ángela Ramalho-Pires de Almeida ◽  
Gracia Maria Ábalos-Medina ◽  
Carmen Villaverde-Gutiérrez ◽  
Neide Maria Gomes-de Lucena ◽  
Alecsandra Ferreira-Tomaz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Work Performance ◽  
Physical Disabilities ◽  
University Staff ◽  
Ergonomic Program

Evaluating the impact of a trial in breast cancer tumor markers: A value of research analysis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16524-e16524
Author(s):  
Rahber Thariani ◽  
David K Blough ◽  
William Barlow ◽  
Norah Lynn Henry ◽  
Julie Gralow ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Tumor Marker ◽  
Tumor Markers ◽  
Societal Value ◽  
Cancer Tumor ◽  
The Impact

e16524 Background: Despite not being recommended by clinical guidelines, the tumor markers carcinoembryonic antigen (CEA), cancer antigen (CA)15-3, and CA 27.29 are used by some clinicians to screen for increased risk of breast cancer recurrence. Although additional research may be warranted to evaluate the benefits and risks of breast cancer tumor marker tests, clinical trials would likely need to involve thousands of women and would take many years to complete. We conducted an analysis to assess the societal value of a prospective randomized clinical trial (RCT) for breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors Methods: We used value of information techniques to assess the benefits of reducing uncertainty of using breast cancer tumor markers. We developed a decision-analytic model of biomarker testing in addition to standard surveillance at follow-up appointments every 3-6 months for five years. Expected value of sample information (EVSI) was assessed over a range of trial sizes and assumptions. Results: The overall value of research for an RCT involving 9,000 women was $166 million (EVSI). The value of improved information characterizing the survival impact of tumor markers was $81 million, quality-of-life $38 million, and test performance $95 million. Conclusions: Our analysis indicates that substantial societal value may be gained by conducting a clinical trial evaluating the use of breast cancer tumor markers. The most important aspects of the trial in our analysis were information gained on survival improvements as well as quality-of-life parameters associated with testing and test sensitivity and specificity. Our analysis indicates that smaller randomized trials, as well as adding quality of life instruments to existing trials, retrospective, and observational trials can also generate valuable and relevant information.

scholarly journals Impact of oral rehabilitation on the quality of life of partially dentate elders in a randomised controlled clinical trial: 2 year follow-up

PLoS ONE ◽  
2018 ◽  
Vol 13 (10) ◽  
pp. e0203349 ◽  
Author(s):  
Gerald McKenna ◽  
Patrick Finbarr Allen ◽  
Martina Hayes ◽  
Cristiane DaMata ◽  
Ciaran Moore ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Oral Rehabilitation ◽  
Randomised Controlled Clinical Trial ◽  
Randomised Controlled ◽  
Partially Dentate

scholarly journals Efficacy and safety of two Ayurvedic dosage forms for Allergic rhinitis: Study protocol for an open-label randomized controlled trial

2019 ◽  
Author(s):  
JM Dahanayake ◽  
Pathirage Kamal Perera ◽  
P Galappaththy ◽  
D Samaranayake
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Allergic Rhinitis ◽  
Dosage Forms ◽  
Open Label ◽  
Randomized Controlled ◽  
Nasal Symptoms ◽  
Freeze Dried

Abstract Background Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system in Sri Lanka. The aim of this study is to find out whether the use of two preparations (decoction and its freeze dried powder) over a period of 4 weeks is able to cure the symptoms of allergic rhinitis. Study design This is a three arm open label non-inferiority randomized controlled clinical trial in patients with AR. The study duration is 28 days oral administration of the two Ayurvedic dosage forms (Decoction and freeze dried) and the antihistamine loratidine into the 3 arms allocated randomly. After a 1 week run-in period, eligible subjects are randomly assigned to the TMD12 decoction group, TMD12 freeze dried group and the antihistamine group. Total Nasal symptom Score (TNSS) of the patients are used as the primary efficacy outcome. TNSS is recorded and compared in all 3 arms prior to visit 1, at the end of 28 days, end of the first month of follow up and second month of follow up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and Health Related Quality of Life questionnaire are used as secondary end points. Discussion This clinical trial will be able to provide supportive evidence based scientific data on classical Ayurvedic dosage forms and the new dosage forms developed as freeze dried powder in the treatment of allergic rhinitis. Also by this trial, it is expected to develop capacity to scientifically evaluate Ayurvedic treatments that may help patients having conditions such as allergic rhinitis.

scholarly journals A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial (Preprint)

2017 ◽  
Author(s):  
Mariam Aguas ◽  
Javier del Hoyo ◽  
Raquel Faubel ◽  
Diana Mu�oz ◽  
David Dom�nguez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Disease Activity ◽  
Remote Monitoring ◽  
Web Based ◽  
Randomized Controlled ◽  
Inflammatory Bowel ◽  
Web Platform

BACKGROUND Telemedicine has been successfully used to provide inflammatory bowel disease (IBD) patients with health care services remotely via the implementation of information and communications technology, which uses safe and feasible apps that have been well accepted by patients in remission. However, the design of telemedicine apps in this setting involves difficulties that hinder the adherence of patients to the follow-up plans and the efficacy of these systems to improve disease activity and quality of life. OBJECTIVE This study aimed to evaluate the development of a Web platform, Telemonitoring of Crohn Disease and Ulcerative Colitis (TECCU), for remote monitoring of patients with complex IBD and the design of a clinical trial involving IBD patients who received standard care (G_Control), nurse-assisted telephone care (G_NT), or care based on distance monitoring (G_TECCU). METHODS We describe the development of a remote monitoring system and the difficulties encountered in designing the platform. A 3-arm randomized controlled trial was designed to evaluate the effectiveness of this Web platform in disease management compared with G_NT and G_Control. RESULTS According to the schedules established for the medical treatment initiated (corticosteroids, immunosuppressants, or biological agents), a total of 63 patients (21 patients from each group) answered periodic questionnaires regarding disease activity, quality of life, therapeutic adherence, adverse effects, satisfaction, work productivity, and social activities. Blood and stool analyses (fecal calprotectin) were performed periodically. On the basis of the results of these tests in G_TECCU, alerts were generated in a Web platform with adapted action plans, including changes in medication and frequency of follow-up. The main issues found were the development of an easy-to-use Web platform, the selection of validated clinical scores and objective biomarkers for remote monitoring, and the design of a clinical trial to compare the 3 main follow-up methods evaluated to date in IBD. CONCLUSIONS The development of a Web-based remote management program for safe and adequate control of IBD proved challenging. The results of this clinical trial will advance knowledge regarding the effectiveness of TECCU Web platform for improvement of disease activity, quality of life, and use of health care resources in complex IBD patients. CLINICALTRIAL ClinicalTrials.gov NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (Archived by WebCite at http://www.webcitation.org/6y4DQdmt8) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/9639

scholarly journals Effect of Intradermal Thumbtack Needle for Functional Constipation: Study Protocol for a Real- World Clinical Trial

2021 ◽  
Author(s):  
WenQian Zhao ◽  
Ying Xu ◽  
Jingjing Liao ◽  
Ji Li ◽  
Li Wang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Real World ◽  
Functional Constipation ◽  
Assessment Tools ◽  
Life Questionnaire ◽  
Self Rating ◽  
Bowel Movements

Abstract Background: Many high-quality clinical trials have proved the efficacy of acupuncture in the improving frequency of spontaneous bowel movements, stool characteristics, and et cetera of Functional Constipation (FC) [1]. However, the high requirement of time make many patients unable to attend, this clinical trial will demonstrate the efficacy of intradermal thumbtack needle in ameliorate spontaneous bowel movement of FC.Methods: This multi-center real world clinical trial is performed involving 482 FC patients. All patients are randomly allocated into 2 group, which are group A to receive intradermal thumbtack needle twice a week for 4 weeks (intervention group n=241) or group B to take oral administration of mosapride 3 times a day for 4 weeks (control group n=241). This trial includes a 4-week treatment period and a 4-week follow-up period. The primary outcome is the number of completely spontaneous defecation per week, we use Weekly CSBMs analyze the frequency of spontaneous defecation per week during treatment and follow-up period to compared with the baseline. The secondary outcomes include FC patients’ stool consistence, gastrointestinal or anorectal symptoms, quality of life, anxiety and depression levels during treatment and follow-up period and efficacy expectations. The relevant assessment tools include: Bristol tool Form Scale (BSFS), Cleveland Constipation Score (CCS), Patient Assessment of Constipation Quality of Life Questionnaire(PAC－QOL), Self-rating Anxiety Scale (SAS) , Self-rating Depression Scale (SDS) and Efficacy Expectancy Scale. At the end, the scales filled by patients and researchers will be entered by data administrator, all the outcome assessments will be performed by independent outcome assessors and will be analyzed by professional statisticians with SPSS 25.0 software.Discussion: We hypothesize that intradermal needle is better than or equal to positive drugs in the improving frequency of spontaneous bowel movements, stool characteristics，and et cetera of FC patients . The results of this trial will provide us with a clinical basis for the application of intradermal needles in the treatment of FC.Trial registration: Chinese Clinical Trial Registry, ChinCTR2100043684.Registered on 26 February 2021.

Effects of dry needling on function, hypertonia and quality of life in chronic stroke: a randomized clinical trial

2021 ◽  
pp. 096452842110563
Author(s):  
Sandra Calvo ◽  
Natalia Brandín-de la Cruz ◽  
Carolina Jiménez-Sánchez ◽  
Elisabeth Bravo-Esteban ◽  
Pablo Herrero
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Upper Extremity ◽  
Chronic Stroke ◽  
Control Group ◽  
Sensorimotor Function ◽  
Single Session ◽  
Dry Needling

Background: Persons with stroke commonly have impairments associated with a reduction in functionality. Motor impairments are the most prevalent, causing an impact on activities of daily life. Objective: The aim of this study was to evaluate the effect of a session of dry needling (DN) applied to the upper extremity muscles on the sensorimotor function, hypertonia, and quality of life of persons with chronic stroke. Methods: A randomized, sham-controlled clinical trial was performed. Participants were randomly assigned into an intervention group that received a single session DN in the biceps brachii, brachialis, flexor digitorum superficialis and profundus, extensor digitorum, adductor pollicis and triceps brachii muscles, or into a control group that received the same treatment but with a sham DN intervention. Treatment outcomes included the Fugl–Meyer Assessment Scale for the upper extremity, the Modified Modified Ashworth Scale, and the EuroQol-5D questionnaire. Measurements were carried out before, immediately after, and 14 days after intervention. Results: Twenty-three persons participated in the study. Significant differences between groups were observed after the intervention in the total wrist–hand motor score (p = 0.023) and sensorimotor score (p = 0.022), for hypertonia in the elbow extensors both after treatment (p = 0.002) and at follow-up (p = 0.018), and in quality of life at follow-up (p = 0.030). Conclusions: A single session of DN improved total wrist–hand motor function and total sensorimotor function in persons with chronic stroke immediately after treatment, as well as quality of life 2 weeks after treatment. Trial registration number: NCT03546517 (ClinicalTrials.gov)

scholarly journals A Randomized Clinical Trial Preventive Outreach Targeting Dental Caries and Oral-Health-Related Quality of Life for Refugee Children

2021 ◽  
Vol 18 (4) ◽  
pp. 1686
Author(s):  
Murad Alrashdi ◽  
Maria Jose Cervantes Mendez ◽  
Moshtagh R. Farokhi
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Oral Health ◽  
Dental Caries ◽  
Refugee Children ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

Objective: The study assessed a preventive outreach educational intervention targeting improvements in dental caries and oral-health-related quality of life in the children of refugee families by comparing pre- and postintervention outcomes. Methods: This randomized controlled clinical trial assessed the outcomes at baseline and three times over six months using the WHO oral health assessment form (DMFT/dmft) and the parent version of the Michigan Oral-Health-Related Quality of Life scale. Children and at least one of their parents/caretakers were educated on oral health topics in two one-hour sessions. Results: Of the 66 enrolled families, 52 (72%) completed the six-month follow-up. DMFT/dmft scores increased significantly in both the control and intervention groups (p < 0.05); differences in the changes in the DMFT/dmft and MOHRQoL-P scores from baseline to the three- and six-month follow-up visits between groups were not significant (p > 0.05). Conclusions: Oral health education programs targeting a diverse group of refugee children and their parents/caregivers single-handedly did not reduce the increased number of caries lesions or improve oral-health-related quality of life.

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