scholarly journals AB0766 ACCURACY OF PATIENT REPORTED OUTCOME REPORTING IN RANDOMIZED CONTROLLED TRIALS IN PSORIATIC ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1681.2-1681
Author(s):  
B. Frade-Sosa ◽  
A. Kerschbaumer ◽  
P. Studenic ◽  
E. Chwala ◽  
J. S. Smolen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Randomized Controlled Trials ◽  
Well Being ◽  
Controlled Trials ◽  
Research Support ◽  
Randomized Controlled ◽  
Patient Reported

Background:Patient-reported outcomes (PROs) allow incorporating the patient’s perspective and health related quality of life (HRQoL) into shared decision making when choosing the optimal treatment strategy in patients suffering from psoriatic arthritis (PsA). PsA is a chronic inflammatory disease with heterogeneous manifestations with a range of symptoms, co-morbidities and reduced quality of life. International working groups (1) emphasized to integrate these outcomes as endpoints in clinical trials and as part of the core set of measures.Objectives:To evaluate the quality of PRO reporting in randomized clinical trials in PsA.Methods:We conducted a systematic literature review (PROSPERO ID 160930) searching PUBMED, MEDLINE and the Cochrane Library for publications (in English language) on randomized controlled trials investigating biological or targeted synthetic disease modifying drugs in adult PsA patients that included some PROs to evaluate the response to treatment. Two of the authors (BFS, AK) screened, selected and extracted the data of the trials that fulfilled inclusion criteria. Statistics were descriptive.Results:Of 1392 articles in total 880 were screened (512 duplicates); 92 were selected for detailed analysis with 48 finally analysed. 87% were primary publications were some patient-outcome measure were reported. The Health Assessment Questionnaire Disability Index (HAQ-DI) was reported in all RCTs (100%), while 70% of trials reported on the Short Form (36) Health Survey (SF36). Fatigue (FACIT-F) was reported in 29% of trials with different rates of articles published before and after the OMERACT working group recommendations (27% vs 50%) (1). Data on burden of psoriasis through the Dermatology Life Quality Index in 45%. Other PRO measurements to assess potentially affected health domains such as sleep disturbance, psychological disorders or well-being at work were reported only rarely.Conclusion:Our SLR shows that all trials report data on HAQ-DI. However, important domains as also emphasized by the OMERACT working group (1) are not routinely reported. Especially fatigue, included in 2016 as part of the OMERACT “Inner core” of the PsA Core Domain Set is only reported in about one quarter of studies, although 50% of studies published after 2016 report on fatigue. Data on emotional well-being, psychological status, productivity losses, and sleep disturbance remain rarely reported in PsA randomized controlled trials.References:[1]Orbai A, de Wit M, Mease P, et al International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. Annals of the Rheumatic Diseases 2017;76:673-680.Acknowledgments:Acknowledgements: The author BFS had received an economic grant from the Spanish Society of Rheumatology (FER KERN-PHARMA Scholarships for Short stays: Plan for the promotion of research) and the Catalan Society of Rheumatology (BequesNovartis de formació per estades a l’estranger) for the research stay in Vienna (Austria).Disclosure of Interests:Beatriz Frade-Sosa Grant/research support from: FER KERN-PHARMA Scholarships for Short stays: Plan for the promotion of research. BequesNovartis de formació per estades a l’estranger, Andreas Kerschbaumer Paid instructor for: Celgene, Speakers bureau: Andreas Kerschbaumer has received lecture fees from Bristol-Myers Squibb, Gilead, Merck Sharp and Dohme and Pfizer., Paul Studenic Grant/research support from: Abbvie, Eva Chwala: None declared, Josef S. Smolen Grant/research support from: AbbVie, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, Roche – grant/research support, Consultant of: AbbVie, Amgen Inc., AstraZeneca, Astro, Celgene Corporation, Celtrion, Eli Lilly, Glaxo, ILTOO, Janssen, Medimmune, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Samsung, Sanofi, UCB – consultant, Speakers bureau: AbbVie, Amgen Inc., AstraZeneca, Astro, Celgene Corporation, Celtrion, Eli Lilly, Glaxo, ILTOO, Janssen, Medimmune, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Samsung, Sanofi, UCB – speaker, Daniel Aletaha Grant/research support from: AbbVie, Novartis, Roche, Consultant of: AbbVie, Amgen, Celgene, Lilly, Medac, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi Genzyme, Speakers bureau: AbbVie, Celgene, Lilly, Merck, Novartis, Pfizer, Sanofi Genzyme, UCB

scholarly journals The Effect of Yoga Interventions on Cancer-Related Fatigue and Quality of Life for Women with Breast Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 19 ◽  
pp. 153473542095988
Author(s):  
Meagan O’Neill ◽  
Dominic Samaroo ◽  
Christian Lopez ◽  
George Tomlinson ◽  
Daniel Santa Mina ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Well Being ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Cancer Related Fatigue

Background: Women with breast cancer (BC) are living longer with debilitating side effects such as cancer-related fatigue (CRF) that affect overall well-being. Yoga promotes health, well-being and may be beneficial in reducing CRF. Although there have been previous systematic reviews and meta-analyses, the effects of yoga on CRF and quality of life (QOL) remain unclear, particularly in comparison with other types of physical activity (PA). Our objective is to carry out a systematic review and meta-analysis of the effects of yoga on CRF and QOL in women with BC. Methods: Electronic databases were searched (MEDLINE, Embase Classic+Embase and EMB Reviews, Cochrane Central CT) from inception to May 2018. Randomized controlled trials were included if they were full text, in English, included a yoga intervention, a comparator (including non-PA usual care or alternate PA intervention), and reported on CRF or QOL. Effects of yoga were pooled using standardized mean difference (SMD) via a random effects model. Results: Of the 2468 records retrieved, 24 trials were included; 18 studies compared yoga to a non-PA comparator and 6 to a PA comparator. Yoga demonstrated statistically significant improvements in CRF over non-PA (SMD −0.30 [−0.51; −0.08]) but not PA (SMD −0.17 [−0.50; 0.17]) comparators. Additionally, yoga demonstrated statistically significant improvements in QOL over non-PA (SMD −0.27 [−0.46; −0.07]) but not PA (SMD 0.04 [−0.22; +0.31]) comparators. Discussion: This meta-analysis found that yoga provides small to medium improvements in CRF and QOL compared to non-PA, but not in comparison to other PA interventions.

scholarly journals The effects of life review interventions on spiritual well-being, psychological distress, and quality of life in patients with terminal or advanced cancer: A systematic review and meta-analysis of randomized controlled trials

2017 ◽  
Vol 31 (10) ◽  
pp. 883-894 ◽  
Author(s):  
Chong-Wen Wang ◽  
Amy YM Chow ◽  
Cecilia LW Chan
Keyword(s):  
Quality Of Life ◽  
Confidence Interval ◽  
Randomized Controlled Trials ◽  
Well Being ◽  
Life Review ◽  
Mean Difference ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Standardized Mean Difference

Background: Life review interventions have been used to alleviate psycho-spiritual distress in people near the end of life. However, their effectiveness remains inconclusive. Aim: To evaluate the effects of therapeutic life review on spiritual well-being, psychological distress, and quality of life in patients with terminal or advanced cancer. Design: A systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology. Data sources: Five databases were searched from their respective inception through February 2017 for relevant randomized controlled trials. The effects of therapeutic life review were pooled across the trials. Standardized mean differences were calculated for the pooled effects. Heterogeneity was assessed using the I2 test. Study quality was assessed using the Cochrane criteria. Results: Eight randomized controlled trials met the inclusion criteria. The pooled results suggested a desirable effect of therapeutic life review on the meaning of life domain of spiritual well-being (standardized mean difference = 0.33; 95% confidence interval, 0.12 to 0.53), general distress (standardized mean difference = −0.32; 95% confidence interval, −0.55 to −0.09), and overall quality of life (standardized mean difference = 0.35; 95% confidence interval, 0.15 to 0.56) when compared to usual care only. Of the three outcomes examined, only the pooled effect on overall quality of life remained statistically significant at follow-ups up to 3 months after the intervention (standardized mean difference = 0.82; 95% confidence interval, 0.47 to 1.18). Conclusions: Therapeutic life review is potentially beneficial for people near the end of life. However, the results should be interpreted with caution due to the limited number of randomized controlled trials and associated methodological weaknesses. Further rigorously designed randomized controlled trials are warranted.

scholarly journals EXPRESS: The benefit of exercise-based rehabilitation programmes in patients with pulmonary hypertension: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
pp. 204589402110078
Author(s):  
Lu Yan ◽  
Wence Shi ◽  
Zhi-hong Liu ◽  
Qin Luo ◽  
Zhihui Zhao ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Hypertension ◽  
Randomized Controlled Trials ◽  
Exercise Capacity ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Mean ◽  
Quality Evidence

Background: Several studies have suggested that exercise capacity and quality of life are reduced in patients with pulmonary hypertension (PH), and exercise-based rehabilitation can improve exercise capacity and quality of life in patients with PH. The aim of this study is to assess the efficacy and safety of exercise-based rehabilitation in patients with PH through a meta-analysis of randomized controlled trials. Methods: We searched PubMed, Embase, Medline, and the Cochrane Central Register of Controlled Trials up to November 2018. All randomized controlled trials (RCTs) comparing exercise capacity and quality of life between patients undergoing exercise-based rehabilitation and those undergoing non-exercise training were included. Data were extracted separately and independently by two investigators, and discrepancies were arbitrated by the third investigator. We used the random-effects model to analyze the results, the GRADE to assess the risk of bias in the included studies, and I ² statistic to estimate the degree of heterogeneity. Results: Nine RCTs are included, however, only seven RCTs were able to extract data. Including inpatients and outpatients, the total number of participants was 234, most of whom were diagnosed as pulmonary artery hypertension (PAH). The study duration ranged from 3 to15 weeks. The mean six-minute walk distance after exercise training was 51.94 metres higher than control (27.65 to 76.23 metres, n=234, 7 RCTs, low quality evidence), the mean peak oxygen uptake  was 2.96 ml/kg/minute higher (2.49 to 3.43 ml/kg/minute, n=179, 4 RCTs, low-quality evidence) than in the control group . Concluded: Our finding suggest that an exercise-based training program positively influences exercise capacity in patients with PH.

The effectiveness of functional electrical stimulation of the legs in patients with heart failure: A systematic review and meta-analysis of randomized controlled trials

2021 ◽  
pp. 026921552110569
Author(s):  
Hsun-Yi Wang ◽  
Yu-Hsuan Chen ◽  
Yi-Chun Kuan ◽  
Shih-Wei Huang ◽  
Li-Fong Lin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Electrical Stimulation ◽  
Confidence Interval ◽  
Randomized Controlled Trials ◽  
Functional Electrical Stimulation ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Patients With Heart Failure

Objective To investigate the effectiveness of functional electrical stimulation of the legs in patients with heart failure. Methods Data were obtained from PubMed, Cochrane Library, and Embase databases until August 12, 2021. We included randomized controlled trials that evaluated the effects of functional electrical stimulation applied to the legs of patients with heart failure, namely changes in cardiopulmonary function, muscle strength, and quality of life. Results In total, 14 randomized controlled trials (consisting of 518 patients) were included in our article. Pooled estimates demonstrated that functional electrical stimulation significantly improved peak oxygen consumption (peak VO2; standardized mean difference = 0.33, 95% confidence interval = 0.07–0.59, eight randomized controlled trials, n = 321), 6-min walking distance (mean difference = 48.03 m, 95% confidence interval = 28.50–67.57 m, 10 randomized controlled trials, n = 380), and Minnesota Living with Heart Failure Questionnaire quality of life score (mean difference =  − 8.23, 95% confidence interval =  − 12.64 to − 3.83, nine randomized controlled trials, n = 383). Muscle strength of lower extremities was not significantly improved in the functional electrical stimulation group compared with that in the control group (standardized mean difference = 0.26, 95% confidence interval =  − 0.18 to 0.71, five randomized controlled trials, n = 218). Furthermore, the subgroup analysis revealed that functional electrical stimulation significantly improved peak VO2, 6-min walking distance, and Minnesota Living with Heart Failure Questionnaire quality of life score in the heart failure with reduced ejection fraction and heart failure with preserved ejection fraction subgroups. Conclusion Functional electrical stimulation can effectively improve the cardiopulmonary function and quality of life in patients with heart failure. However, functional electrical stimulation did not significantly improve muscle strength in the legs.

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