scholarly journals Experimental pilot study after surgery on a food supplement for athletes to protect articular knee cartilage. A functional and biochemical study

2021 ◽  
Vol 38 (3) ◽  
pp. 168-172
Author(s):  
J Alfaro-Adrián ◽  
M Araña Ciordia ◽  
M Barajas Vélez
Keyword(s):  
Quality Of Life ◽  
Biochemical Study ◽  
Small Sample Size ◽  
Arthroscopic Surgery ◽  
Food Supplement ◽  
Small Sample ◽  
Ligamentous Injury ◽  
Sports Activity ◽  
Double Blind

This double-blind experimental study evaluates the efficacy of chondroprotective supplementation (Carticure Plus®, 5000 mg Collagen – Bioactive Peptides, 1500 mg Glucosamine Hydrochloride, 1200 mg Chondroitin Sulfate, 1.1 mg Copper, 80 mg Vitamin C, 2 mg Manganese) in patients with meniscal and ligament pathology who have required arthroscopic surgery. 12 patients with ligamentous injury and 12 patients with meniscopathy were selected, who underwent the measurement of different inflammatory markers using ELISA, collagen 2A and hyaluronic acid, in addition to evaluating pain as well as functionality and quality of life through VAS (Visual Analogue Scale), WOMAC (Western Ontario McMaster Universities Osteoarthritis Index) and KOOS (Knee Injury and Osteoarthritis Outcome Score). Statistically significant differences of clinical improvement were observed in favor of Carticure Plus®, with an improvement in the functional capacity of the WOMAC scale, 76% Carticure Plus® vs 53% placebo, for all patients and with a clear improvement in the first month in meniscal injury, in improvement of the activities of daily life (KOOS), Carticure Plus® 31% vs placebo -1%, sports activity, (Carticure Plus® 41% vs placebo 13,2%) and sports and recreational activities (KOOS) (Carticure Plus® 128% vs Placebo 10,4%). On the other hand, in ligamentous injury an improvement in quality of life (KOOS) Carticure Plus® 75% vs Placebo -8,8% and pain (KOOS) Carticure Plus® 49,6% vs Placebo 0,3% was observed in the first month compared to the baseline. In the patient group, pain (KOOS) Carticure Plus® 31,4% vs Placebo 1,3% and activities of daily living (KOOS) Carticure Plus® 43,9% vs Placebo 27,1% in the third month from baseline, are associated with an improvement due to Carticure Plus® when compared to the placebo group. Despite the small sample size, it is remarkable the fact that statistically significant differences have been found, the efficacy of Carticure Plus® could be assumed.

scholarly journals Randomized Controlled Trial of Strain-Specific Probiotic Formulation (Renadyl) in Dialysis Patients

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Ranganathan Natarajan ◽  
Bohdan Pechenyak ◽  
Usha Vyas ◽  
Pari Ranganathan ◽  
Alan Weinberg ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Statistical Power ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Venous Blood ◽  
Small Sample ◽  
Uremic Toxin ◽  
Double Blind

Background. Primary goal of this randomized, double-blind, placebo-controlled crossover study of Renadyl in end-stage renal disease patients was to assess the safety and efficacy of Renadyl measured through improvement in quality of life or reduction in levels of known uremic toxins. Secondary goal was to investigate the effects on several biomarkers of inflammation and oxidative stress.Methods. Two 2-month treatment periods separated by 2-month washout and crossover, with physical examinations, venous blood testing, and quality of life questionnaires completed at each visit. Data were analyzed with SAS V9.2.Results. 22 subjects (79%) completed the study. Observed trends were as follows (none reaching statistical significance): decline in WBC count(-0.51×109/L,P=0.057)and reductions in levels of C-reactive protein(-8.61 mg/L,P=0.071)and total indoxyl glucuronide(-0.11 mg%,P=0.058). No statistically significant changes were observed in other uremic toxin levels or measures of QOL.Conclusions. Renadyl appeared to be safe to administer to ESRD patients on hemodialysis. Stability in QOL assessment is an encouraging result for a patient cohort in such advanced stage of kidney disease. Efficacy could not be confirmed definitively, primarily due to small sample size and low statistical power—further studies are warranted.

scholarly journals Effects of galantamine and galantamine combined with nimodipine on cognitive speed and quality of life in mixed dementia: a 24-week, randomized, placebo-controlled exploratory trial (the REMIX study)

2014 ◽  
Vol 72 (6) ◽  
pp. 411-417 ◽  
Author(s):  
Paulo Caramelli ◽  
Jerson Laks ◽  
André Luis Fernandes Palmini ◽  
Ricardo Nitrini ◽  
Márcia Lorena Fagundes Chaves ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Sex Education ◽  
Small Sample Size ◽  
Drug Dose ◽  
Small Sample ◽  
Mixed Dementia ◽  
Double Blind ◽  
Cognitive Benefits ◽  
Cognitive Speed

The effects of galantamine (GAL) on quality of life (QoL) and cognitive speed, as well its effects combined with nimodipine (NIM) in Alzheimer disease (AD) with cerebrovascular disease (mixed dementia), have not been explored. Method : Double-blind, placebo-controlled, multicenter Brazilian trial, studying the effects of GAL/NIM vs. GAL/placebo (PLA) in mild to moderate mixed dementia. Patients were randomized to receive GAL/NIM or GAL/PLA for 24 weeks. Primary efficacy measures were changes on a computerized neuropsychological battery (CNTB) and QoL Scale in Alzheimer's Disease (QoL-AD) from baseline to week 24. Results : Twenty-one patients received at least one drug dose (9 GAL/NIM and 12 GAL/PLA). Groups were matched for age, sex, education, cognitive and QoL scores at baseline. No significant differences were observed between groups on primary or secondary measures. QoL and cognitive performance showed significant improvement (p<0.05) from baseline when all GAL-treated patients were analyzed. Adverse events were predominantly mild to moderate. Conclusion : GAL treatment improved QoL in mixed dementia, in addition to its previously known cognitive benefits. The combination GAL/NIM was not advantageous. However, the small sample size precludes any definitive conclusions. Trial registered at ClinicalTrials.gov: NCT00814658

An initial validation of a new quality of life measure for adults with intellectual disability: The Mini-MANS-LD

2018 ◽  
Vol 24 (2) ◽  
pp. 177-193
Author(s):  
Roman Raczka ◽  
Kate Theodore ◽  
Janice Williams
Keyword(s):  
Quality Of Life ◽  
Intellectual Disability ◽  
Small Sample Size ◽  
Initial Study ◽  
Small Sample ◽  
Self Report ◽  
Life Measure ◽  
Acceptable Internal Consistency ◽  
Report Measure

There is an appropriate increasing focus on the need to ensure the voices of people with intellectual disability are captured as part of assessing individuals’ quality of life; however, there remains a lack of a consensus on ways to achieve this. This article describes the development of a self-report measure of quality of life for people with intellectual disability, the ‘Mini-MANS-LD’, based on the concepts of Maslow’s hierarchy of needs. Following use with 33 individuals with intellectual disability, the Mini-MANS-LD was found to have acceptable psychometric properties, including moderate congruent validity and acceptable internal consistency. Administrators’ feedback suggested good acceptability and feasibility, and the measure was relatively quick to administer, easy to use and acceptable to service users. Despite a small sample size, this initial study suggests that the Mini-MANS-LD may present a conceptually relevant, feasible and acceptable self-report measure of quality of life for people with intellectual disability.

scholarly journals Experience of Using an App in HIV Patients Older Than 60 Years: Pilot Program (Preprint)

2018 ◽  
Author(s):  
Julián Olalla ◽  
Jose María García de Lomas ◽  
Efrén Márquez ◽  
Francisco Jesús González ◽  
Alfonso Del Arco ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Hiv Infection ◽  
New Technologies ◽  
Small Sample Size ◽  
Mobile App ◽  
Small Sample ◽  
Control Group

BACKGROUND New technologies can promote knowledge of HIV infection among patients suffering from this disease. Older patients with HIV infection represent an increasingly large group that could benefit from the use of specific apps. OBJECTIVE The aim of the study was to observe the acceptability and use of a mobile app on HIV infection in patients at least 60 years old and offer them the possibility of anonymously establishing contact with their peers. METHODS A series of clinical and psychosocial parameters were studied in 30 HIV-infected patients of over 60 years. The patients must be at least 60 years old, with a follow-up in the outpatient clinic for at least 1 year and without pathologies that limit his or her life expectancy to less than a year. They must know how to read and write. To be part of the group assigned to the app, they had to have their own smartphone and confirm that they were connected to the internet from that device. Overall, 15 of them were randomized to use an app and 15 were in the control group. All tests were repeated after 6 months. RESULTS The median age of patients was 66.5 years. Among them, 29 patients had an undetectable viral load at baseline. The median number of comorbid diseases was 2. Overall, 11 of them lived with their partners and 19 lived alone. They spent an average of 5 hours a day sitting down, and 56% (17/30) of them referred high physical activity. They scored 4 out of 5 for general quality of life perception. Moreover, 80% (24/30) presented high adherence to their treatment, and the average number of concomitant medications was 5. In the 6-min walking test, they covered a distance of 400 meters, and 3 of them desaturated during the test. The 15 patients made frequent use of the app, with 2407 sessions and an average of 7 min and 56 seconds time of use with a total of 13,143 screen views. During the 6 months of the trial, 3 non-AIDS events took place. There were no significant modifications to body mass index, blood pressure measurements, lipid profile, or immuno-virology information data. There were no differences in the questionnaire scores for perception of quality of life, confessed physical activity, or antiretroviral treatment (ART) and non-ART treatment adherence. CONCLUSIONS Significant differences between studied parameters were not objectified in these patients, possibly because this trial has significant limitations, such as a small sample size and only a brief follow-up period. However, patients did use the app frequently, making this a possible intervention to be proposed in future subsequent studies.

Comparison of Quality of Life across Adolescents with Cancer, Sickle Cell Disease and Hemophilia.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 5176-5176
Author(s):  
Mukta Sharma ◽  
Kristin Stegenga ◽  
Gerald Woods
Keyword(s):  
Quality Of Life ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Small Sample Size ◽  
Well Being ◽  
Small Sample ◽  
The Other ◽  
Oncology Group ◽  
Cell Disease

Abstract The purpose of this study is to assess Quality of Life (AQoL) of adolescents with cancer and compare it to adolescents with other hematological disorders who receive medical care from the Hematology/Oncology Clinic at Children’s Mercy Hospitals and Clinics (CMHC). Children with cancer are surviving longer due to improved medical care, and cancer is recently being recognized as a chronic illness. The other two disease conditions we are comparing the QoL of adolescents with cancer are - sickle cell disease (SCD) and hemophilia. Literature shows evidence that for each disease condition, patients have lower QoL compared to their healthy counter-parts, but there is a void in area of research comparing QoL of adolescents with cancer to other blood diseases like hemophilia and SCD. This project was funded by Children’s Mercy Cancer Center Board. Methods - Subjects between ages of 11 to 17 years with diagnosis of cancer, sickle cell disease or hemophilia that are followed at CMHC were eligible to participate. We mailed out AQoL questionnaires to 100 oncology, 100 sickle cell, and 52 hemophilia adolescents who were identified from database. Data was collected using a Likert-scaled instrument with 25 questions under four major sub-domains - Physical, emotional, social and functional well being. The AQOL scores for each domain represented an average of the Likert scale items with a theoretical minimum of 0 and a theoretical maximum of 4. We defined a difference of 0.5 or greater on any subdomain as having clinical relevance. Results 41 oncology, 29 SCD and 17 hemophilia responses were received back. Demographic data were self-disclosed to describe the sample population. Overall AQoL scores ranged from 0.0 to 4.0 for Phys, 1.0 to 4.0 for Soc, 0.4 to 4.0 for Emotional, and 1.4 to 4.0 for Functional subdomain. For all four measures, the scores were skewed right (clustered towards the upper limit with a long tail extending to the lower values). Only the Physical subdomain showed a borderline effect (p=0.056) with the Hemophilia group showing a larger mean than the other two groups. The remaining subdomains did not exhibit differences large enough to be clinically or statistically significant. Although there were small difference in the Oncology group with gender on the Physical and Emotional scale, these difference were not statistical significant. The differences on the Social and Functional well being scale were very small and within the range of clinical indifference, even after allowing for sampling error. There were no statistical or clinical differences in the Sickle Cell group between boys and girls, but this may be due to the small sample size in this group. No comparison with gender was possible in the hemophilia group. There were no statistical differences in the oncology group between those on or off treatment, but this may also be due to the small sizes in these groups. Conclusion With a few exceptions, the QOL subdomains showed no statistically significant or clinically significant differences between the three disease groups or between the boys and girls within each disease groups. This may be due, in part, to the small sample size of this study. There were two trends with achieved borderline significance: hemophilia patients showed higher AQOL scores on the physical and emotional subdomains.

MO815BEYOND SURVIVAL: COMPARISON OF HEMODIALYSIS AND CONSERVATIVE MANAGEMENT IN ELDERLY AND FRAIL STAGE 5 CHRONIC KIDNEY DISEASE PATIENTS

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Inês Sala ◽  
João Oliveira ◽  
Joana Freitas ◽  
Joana Tavares ◽  
Josefina Santos Lascasas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Kidney Disease ◽  
Survival Rate ◽  
Kidney Disease ◽  
Conservative Management ◽  
Small Sample Size ◽  
Small Sample ◽  
Clinical Frailty Scale ◽  
One Year

Abstract Background and Aims With the geriatric population increasing, the patients reaching stage 5 chronic kidney disease (CKD) are older, frailer and have multiple comorbidities. Technological advances in renal replacement therapy (RRT) and easier access to dialysis resulted in an expansion on geriatric dialysis population. Conservative management (CM) is an option that should be considered in this population, where is crucial to balance the survival and quality of life. Beside mortality, with this study we aim to evaluated patient-outcomes (hospitalization, falls and functional capacity) in older and frailer stage 5 CKD patients receiving hemodialysis (HD) and in CM. Method We conducted a single center retrospective study in older (≥ 75years), frailer (Clinical Frailty Scale – CFS ≥ 5) and with multiple comorbidities (modified Charlson comorbidity index – mCCI ≥ 5 and) stage 5 CKD patients, admitted in our Nephrology department between January 1, 2014 to December 31, 2020. The eGFR was calculated through Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) at the time of decision or at the time of starting HD. The comorbidities were stratified using the mCCI and frailty was assessed with CFS at the time of decision in CM group (CMG) and at the start of HD (HDG). We evaluated hospitalizations, falls, CFS one-year later and survival in each group. Survival analysis was performed using the Kaplan–Meier method and was calculated at the beginning of RRT or eGFR ≤ 15ml/min/1.73m2 in CMG. Differences between the two groups were tested with Mann-Whitney U method. Results A total of 76 patients with indication to start RRT were included: 61.8% (n=47) initiated HD and 38.2% (n=29) were in CM. The reasons for CM decision were deterioration of clinical condition (n=11), expected survival less than 6 months (n=8), patient option (n=5) and cognitive impairment (n=5). Clinical characteristics are presented in Table 1. The CMG was older [median, IQR: 88 (85.5-90.5) vs 80 (77.0 – 83.0), p &lt; 0.001] and had a lower BMI [23.44 (21.08 - 25.08) vs 26.23 (23.26 – 29.20), p=0.006]. Both groups did not differ significantly in terms of sex, CKD etiology, comorbidity or frailty. A total of 66 patients died at the end of the study [CMG 100% (n= 29) vs 78.7% HDG (n=37)]. The overall survival has higher on the HDG compared to the CMG with a median survival rate of 503 days (Fig 1). One-year survival rate was 53.5% in HDG vs 24% CMG (p &lt;0.001). The median (IQR) of number of hospitalizations per patient was greater in the HDG [4 (1.5-6.5) vs 3 (0.5-5.5) CMG]. In HDG 17% patients had at least one fall vs 3.4% in CMG. In both groups there was a general deterioration associated to a higher CFS at one-year follow up (p=0.003 HD group vs p=0.015 CMG). Conclusion In our study, hemodialysis was associated to improved survival in older and frailer stage 5 CKD patients compared to CM. However, this group had more hospitalizations, falls and poor functional status. These outcomes have a crucial impact on quality of life in this population and should be consider at the time of treatment decision. One of the limitations of our study was small sample size in both groups. In the future, we consider that is important to perform multicenter studies focused on patients-outcomes. We also think that it’s important to understand the patient and family perspective in terms of quality of life and symptom burden associated to each treatment option.

scholarly journals Technology Acceptance and Quality of Life among Older People Using a TUI Application

2019 ◽  
Vol 16 (23) ◽  
pp. 4706 ◽  
Author(s):  
Way Kiat Bong ◽  
Astrid Bergland ◽  
Weiqin Chen
Keyword(s):  
Quality Of Life ◽  
Older People ◽  
Technology Acceptance ◽  
User Interfaces ◽  
Small Sample Size ◽  
Small Sample ◽  
Tangible User Interfaces ◽  
Structured Interviews ◽  
Digital World

Good quality of life is important for healthy ageing. Studies have shown that although information and communication technology can improve older people’s quality of life, their technology acceptance level is rather low. Tangible user interfaces (TUIs) enable people to interact with the digital world through everyday physical objects, thus offering more intuitive digital environments for older people. In this study, we employ a TUI prototype to investigate the relationship between older people’s technology acceptance and quality of life, the changes in these outcome measures after using TUI, and the associations between them. The TUI prototype, Tangible Cup was used by 20 older participants over a period of three months. Data were collected using the technology acceptance model (TAM) questionnaire, the older people’s quality of life (OPQOL) questionnaire and semi-structured interviews. The results showed some positive changes in technology acceptance after the use of Tangible Cup. However, no change in the quality of life was found. While statistically significant correlations between the change in technology acceptance and the change in quality of life were observed, limitations such as small sample size and participants not accurately representing the target population should be noted. Thus, further research is needed to better understand the associations between the change in technology acceptance and the change in quality of life.

scholarly journals Impact of anxiety-depressive symptoms on outpatients’ quality of life: Preliminary results from an Italian observational study

2017 ◽  
Vol 41 (S1) ◽  
pp. S319-S319
Author(s):  
S. Tassi ◽  
G. Rioli ◽  
G. Mattei ◽  
S. Ferrari ◽  
G.M. Galeazzi
Keyword(s):  
Quality Of Life ◽  
Depressive Symptoms ◽  
Short Form ◽  
Small Sample Size ◽  
Depression Scale ◽  
Small Sample ◽  
Anxiety Symptoms ◽  
Literature Study ◽  
Cross Sectional

IntroductionSeveral studies have shown an association between the Short-Form 36 (SF36) scores and anxiety-depressive symptoms, suggesting that depression in particular could reduce Quality of Life (QoL) to the same, and even greater, extent than chronic non-communicable diseases, such as diabetes and hypertension.AimsTo explore the relationship among QoL and anxiety, depressive and anxiety-depressive symptoms in an outpatient sample.MethodsCross-sectional study. Inclusion criteria: outpatients aged ≥40 years, without history for cancer, attending colonoscopy after positive faecal occult blood test. Collected data: blood pressure, blood glucose, lipid profile. Psychometric test: Hospital Anxiety and Depression Scale (HADS). QoL was assessed with SF36. Statistics performed with STATA13.Results54 patients enrolled (27 females). Sixteen patients (30.2%) were positive for anxiety symptoms, ten (18.9%) for depressive symptoms and five (9.4%) for anxiety-depressive symptoms. The perceived QoL was precarious in twelve subjects (22.2%): eight (15.9%) had low score (≤ 42) at “Mental Component Summary” (MCS) subscale, three (5.7%) at the “Mental Health” item and one patient (1.9%) at the “Vitality” one. At the multiple regression analysis, depressive (OR = 28.63; P = 0.01) and anxiety-depressive symptoms (OR = 11.16; P = 0.02) were associated with MCS.ConclusionsThe association emerging from the present study between depressive/anxiety symptoms and the MCS component of SF36 is consistent with available literature. Study design and small sample size do not allow to generalize results, that need further studies to be confirmed.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Evaluation of a Fatigue Self-Management Program for People with Multiple Sclerosis

2016 ◽  
Vol 18 (3) ◽  
pp. 116-121 ◽  
Author(s):  
Hilda Mulligan ◽  
Amanda Wilkinson ◽  
Amelia Barclay ◽  
Hayley Whiting ◽  
Christelle Heynike ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Self Efficacy ◽  
Short Form ◽  
Small Sample Size ◽  
Management Program ◽  
Small Sample ◽  
Self Report ◽  
Self Management

Background: Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The program “Minimise Fatigue, Maximise Life: Creating Balance with Multiple Sclerosis” (MFML) was created in New Zealand because of the lack of a fatigue management program for people with MS in that country. This program aims to empower individuals with MS to manage their own symptoms of fatigue. The objective of this study was to evaluate the MFML fatigue self-management program. Methods: Self-report questionnaires were used to measure impact of fatigue (5-item Modified Fatigue Impact Scale), self-efficacy (MS Self-efficacy Scale), and quality of life (12-item Short Form Health Status Survey [SF-12]) 1 month before (T1), at commencement of (T2) (to investigate the stability of questionnaire scores before the intervention), and at the end of (T3) the 6-week group-based program. Increased self-efficacy and quality of life scores and a decrease in reported impact of fatigue were the anticipated primary outcomes, with participants acting as their own controls. Results: Twenty-five women (aged 37–63 years) participated. Stability of scores for all the questionnaires was evidenced between T1 and T2. After the intervention (T3), scores showed a significant improvement in self-efficacy and impact of fatigue, with large effect sizes, but no change in either the physical or mental component summary of the SF-12. Conclusions: Despite the small sample size, this study showed an organized approach to the management of fatigue for people living with MS, and its outcomes demonstrated benefits for participants.

Exploring the Benefits of Transformations in Health Utility Mapping

2020 ◽  
Vol 40 (2) ◽  
pp. 183-197
Author(s):  
Nicholas Mitsakakis ◽  
Karen E. Bremner ◽  
George Tomlinson ◽  
Murray Krahn
Keyword(s):  
Quality Of Life ◽  
Linear Regression ◽  
Simulation Study ◽  
Small Sample Size ◽  
Real Data ◽  
Health Utility ◽  
Small Sample ◽  
Health Utilities ◽  
Utility Values

Background. Quality-of-life research and cost-effectiveness analyses frequently require data on health utility, a global measure of health-related quality of life. When utilities are unavailable, researchers have “mapped” descriptive instruments to utility instruments, using samples of responses to both instruments. Health utilities have an idiosyncratic distribution, with upper bound and probability mass at 1, left skewness, and kurtosis. Estimation of mean utility values conditional on covariates is of interest, particularly in health utility mapping applications. Traditional linear regression may be unsuitable because fundamental assumptions are violated. Complex statistical methods come with deficiencies that may outweigh their benefits. Aim. To investigate the benefits of transforming the health utility response variable before fitting a linear regression model. Methods. We compared log, logit, arcsin, and Box-Cox transformations with an untransformed model, using several measures of model accuracy. We made our evaluation by designing and conducting a simulation study and reanalyzing data from 2 published studies, which “mapped” a psychometric descriptive instrument to a utility instrument. Results. In the simulation study, log transformation with smearing estimator had in most cases the lowest bias but one of the highest variances, especially for estimating low utility values under small sample size. The untransformed model was outperformed by the transformed models. Findings were inconclusive for the analysis of real data, where arcsin gave the lowest error for one of the data sets, while the untransformed model had the best performance for the other. Conclusions. We identified the benefits of transformations and offered suggestions for future modeling of health utilities. However, the benefits were moderate and no single transformation appeared to be universally optimal, suggesting that selection requires examination on a case-by-case basis.

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