scholarly journals Analysis of the Registration Information on Interventions of Acupuncture and Moxibustion Trials in the International Clinical Trials Registry Platform

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Yali Liu ◽  
Wenjie Chen ◽  
Yingxin Tan ◽  
Xingyue Yang ◽  
Jia Liu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sham Acupuncture ◽  
World Health ◽  
Control Group ◽  
Duration Of Treatment ◽  
Acupuncture And Moxibustion ◽  
Health Organization ◽  
Number Of Treatment ◽  
Clinical Trials Registry

Purpose. To analyze and compare the clinical registration information about acupuncture and moxibustion for intervention characteristics. Methods. Clinical trials from the International Clinical Trials Registry Platform of the World Health Organization in acupuncture and moxibustion were comprehensively collected from 2013 to 2015; data were independently screened and extracted by two retrievers, and relevant data involving either basic descriptions or intervention characteristics were analyzed. Results. 425 acupuncture and moxibustion registered clinical trials were included; 88.00% (374/425) were designed as controlled studies, among which 38.59% (164/425) had sham acupuncture as the control group. The most common diseases were pain-related at approximately 19.29% (82/425) of trials. Reports on the intervention information in these acupuncture and moxibustion clinical studies were not sufficiently presented; these reports included the reporting of names of points (39.8%), the method of needle stimulation (32.5%), needle type (29.6%), needle retention time (34.1%), the number of treatment sessions (22.4%), and the frequency and duration of treatment sessions (38.1%). Conclusion. The registration information for the clinical trials of acupuncture and moxibustion was quite low according to this investigational study. Steps should be taken to improve the quality of acupuncture and moxibustion registration information.

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.

Reflections on FDA and WHO recommendations concerning clinical trials

1989 ◽  
Vol 4 (2) ◽  
pp. 117-122 ◽  
Author(s):  
J.-F. Dreyfus ◽  
D. Cremniter ◽  
J.D. Guelfi
Keyword(s):  
Clinical Trials ◽  
Drug Users ◽  
Objective Evaluation ◽  
World Health ◽  
Measuring Instruments ◽  
New Techniques ◽  
The Usa ◽  
The One ◽  
Health Organization

SummaryWe are still confronted by numerous different nosographic models and problems concerning the objective evaluation of patients progress during treatment. It is interesting to consider the consequences of this situation in psychiatry which still involves a relative diversity of practical methods used in clinical trials. The recommendations of the USA Food and Drug Administration, on the one hand, constitute a highly structured and precise reference. The World Health Organization, on the other hand, promulgates general recommendations resulting from a compromise designed to satisfy the greatest number of clinicians.Despite the apparently diverse principles and the different practical methods they propose, both those sets of recommendations have been useful in inspiring clinicians to reflect upon these different methodological approaches. The qualities of the inclusion criteria used in the study of patients and the sensitivity of the different measuring instruments have allowed psychotropic drug users as well as producers to recognize the need for a certain rigour in clinical trials.The FDA and WHO guidelines have certainly improved the quality of clinical trials in psychopharmacology. However, they also represent a source of resistance to innovation.A series of consensus meetings to first reconcile US and European points of view and later to include new techniques in the recognized sets of methods would therefore be helpful.

Pelatihan Regulasi Emosi untuk Meningkatkan Kualitas Hidup Caregiver Skizofrenia

2021 ◽  
Vol 5 (1) ◽  
pp. 39-51
Author(s):  
Anisa Fitriani ◽  
Fuad Nashori ◽  
Indahria Sulistyarini
Keyword(s):  
Quality Of Life ◽  
World Health Organization ◽  
World Health ◽  
Control Group ◽  
Control Group Design ◽  
Purposive Sampling ◽  
Group Design ◽  
Health Organization

Penelitian ini bertujuan untuk mengetahui pengaruh pelatihan regulasi emosi untuk meningkatkan kualitas hidup caregiver skizofrenia. Metode yang digunakan adalah kuasi eksperimen dengan pretest-posttest control group design dan teknik pengambilan sampel menggunakan purposive sampling. Subjek terdiri atas dua puluh caregiver laki-laki dan perempuan berusia 47-63 tahun yang dibagi dalam kelompok eksperimen dan kontrol. Metode pengumpulan data menggunakan wawancara, observasi, dan pengukuran kualtias hidup dengan skala World Health Organization of Quality of Life-BREF. Data dianalisis menggunakan anava campuran untuk mengetahui perbedaan kualitas hidup kelompok eksperimen dan kontrol saat prates, paskates, dan tindak lanjut. Hasil penelitian menunjukkan adanya peningkatan yang sangat signifikan pada skor kualitas hidup kelompok eksperimen setelah diberi pelatihan regulasi emosi. Skor kualitas hidup mengalami peningkatan kembali saat pengukuran tindak lanjut, sedangkan pada kelompok kontrol tidak terdapat peningkatan yang signifikan. Hasil tersebut menunjukkan bahwa pelatihan regulasi emosi efektif dalam meningkatkan kualitas hidup caregiver skizofrenia.

scholarly journals Attribution of non-ClinicalTrials.gov registries among WHO International Clinical Trials Registry Platform-registered trials from 2014 to 2018: A protocol for a meta-epidemiological study

2018 ◽  
Author(s):  
Masahiro Banno ◽  
Yasushi Tsujimoto ◽  
Yuki Kataoka
Keyword(s):  
Clinical Trials ◽  
Epidemiological Study ◽  
Medical Information ◽  
University Hospital ◽  
World Health ◽  
Study Phase ◽  
Target Sample Size ◽  
Registration Number ◽  
Health Organization ◽  
Clinical Trials Registry

Background. The attribution of non-ClinicalTrials.gov registries among registered trials of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) had increased until 2013. However, the attribution after 2013 is unknown. Moreover, no study has investigated the usage of non-ClinicalTrials.gov registries after 2015 or compared the characteristics of trials under non-ClinicalTrials.gov and ClinicalTrials.gov registries. Methods. This will be a meta-epidemiological study. It will include all trials registered on the ICTRP from January 1, 2014, to December 31, 2018. First, we will describe the total attribution of non-ClinicalTrials.gov registries among the ICTRP-registered trials for each year and each registry worldwide. Second, we will compare the recruitment status, target sample size, study type, study design, countries, prospective registration, funding, and study phase of the trials on ClinicalTrials.gov and other registries from 2014 to 2018. Third, we will report on the distribution of primary registries of trials from the top five countries in order of the quantity of registered trials on the ICTRP. Ethics & Dissemination. Ethics approval is not required for this study. This protocol has been registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). The findings will be published in a peer-reviewed journal and may be presented at conferences. Trial Registration Number. UMIN000034401

scholarly journals Quality of Life and Migraine Disability among Female Migraine Patients in a Tertiary Hospital in Malaysia

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Munvar Miya Shaik ◽  
Norul Badriah Hassan ◽  
Huay Lin Tan ◽  
Siew Hua Gan
Keyword(s):  
Quality Of Life ◽  
Psychological Health ◽  
Tertiary Hospital ◽  
Poor Quality ◽  
World Health ◽  
Control Group ◽  
Healthy Controls ◽  
Pain Scores ◽  
Health Organization

Background. Disability caused by migraine may be one of the main causes of burden contributing to poor quality of life (QOL) among migraine patients. Thus, this study aimed to measure QOL among migraine sufferers in comparison with healthy controls.Methods. Female diagnosed migraine patients (n= 100) and healthy controls (n=100) completed the Malay version of the World Health Organization QOL Brief (WHOQOL-BREF) questionnaire. Only migraine patients completed the Malay version of the Migraine Disability Assessment questionnaire.Results. Females with migraines had significantly lower total WHOQOL-BREF scores (84.3) than did healthy controls (91.9,P<0.001). Similarly, physical health (23.4 versus 27.7,P<0.001) and psychological health scores (21.7 versus 23.2,P< 0.001) were significantly lower than those for healthy controls. Seventy-three percent of patients experienced severe disability, with significantly higher number of days with headaches (13.8 days/3 months,P< 0.001) and pain scores (7.4,P< 0.013). Furthermore, migraine patients with lower total QOL scores had 1.2 times higher odds of having disability than patients with higher total QOL scores.Conclusions. The present study showed that migraine sufferers experienced significantly lower QOL than the control group from a similar population. Disability was severe and frequent and was associated with lower QOL among the migraine patients.

scholarly journals Impact of schistosomiasis on quality of life and productivity of workers

2002 ◽  
Vol 8 (2-3) ◽  
pp. 354-362
Author(s):  
M. I. Kamel
Keyword(s):  
Quality Of Life ◽  
World Health ◽  
Control Group ◽  
Hours Of Work ◽  
Productivity Indicators ◽  
Health Organization ◽  
General Physical ◽  
Textile Factory ◽  
The Impact

The effect of schistosomiasis on quality of life [QOL] and productivity of workers was examined. In a textile factory in Alexandria, Egypt, personal, occupational and sociodemographic data were collected from 172 workers with schistosomiasis and 172 workers without schistosomiasis. Several indicators of productivity and the World Health Organization QOL brief were used to determine the impact of schistosomiasis. The disease affected the general, physical and independence, psychological and spiritual, and social domains of QOL. Although the productivity score of workers with schistosomiasis did not differ significantly from the control group, they had significantly lower additional hours of work and lower total incentives/month. A significant relationship was found between severity of schistosomiasis and QOL domains and productivity indicators.

scholarly journals Exclusion of Pregnant Women from Clinical Trials during the Coronavirus Disease 2019 Pandemic: A Review of International Registries

2020 ◽  
Vol 37 (08) ◽  
pp. 792-799 ◽  
Author(s):  
Devin D. Smith ◽  
Jessica L. Pippen ◽  
Adebayo A. Adesomo ◽  
Kara M. Rood ◽  
Mark B. Landon ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pregnant Women ◽  
World Health ◽  
Eligibility Criteria ◽  
Current State ◽  
Key Points ◽  
State Of Research ◽  
Novel Coronavirus ◽  
Health Organization ◽  
Clinical Trials Registry

Objective Pregnant women have been historically excluded from clinical trials for nonobstetric conditions, even during prior epidemics. The objective of this review is to describe the current state of research for pregnant women during the coronavirus disease 2019 (COVID-19) pandemic. Study Design We conducted a search of international trial registries for trials relating to the novel coronavirus. The eligibility criteria for each trial were reviewed for inclusion/exclusion of pregnant women. Relevant data were extracted and descriptive statistics were calculated for individual and combined data. The total number of trials from each registry were compared, as well as the proportions of pregnancy-related trials within each. Results Among 621,370 trials in the World Health Organization International Clinical Trials Registry, 927 (0.15%) were COVID-19 related. Of those, the majority (52%) explicitly excluded pregnancy or failed to address pregnancy at all (46%) and only 16 (1.7%) were pregnancy specific. When categorized by region, 688 (74.2%) of COVID-19 trials were in Asia, followed by 128 (13.8%) in Europe, and 66 (7.2%) in North America. Of the COVID-19 trials which included pregnant women, only three were randomized-controlled drug trials. Conclusion Approximately 1.7% of current COVID-19 research is pregnancy related and the majority of trials either explicitly exclude or fail to address pregnancy. Only three interventional trials worldwide involved pregnant women. The knowledge gap concerning the safety and efficacy of interventions for COVID-19 created by the exclusion of pregnant women may ultimately harm them. While “ethical” concerns about fetal exposure are often cited, it is in fact unethical to habitually exclude pregnant women from research. Key Points

scholarly journals Effectiveness of Educational Combination of Marital Relation on Reducing Conflict Marital and Improvement of the Quality of Life for Women

2016 ◽  
Vol 10 (12) ◽  
pp. 107
Author(s):  
Mozhgan Rafiee ◽  
Hossein Davoodi
Keyword(s):  
Quality Of Life ◽  
Marital Conflict ◽  
World Health ◽  
Control Group ◽  
Life Questionnaire ◽  
Statistical Population ◽  
Marital Conflicts ◽  
Statistical Sample ◽  
Health Organization

This study was carried out with the objective of evaluating the effect of combined Effectiveness of 1 And 2 Educational Combination Relation Marital Skills (Speaking and listening to each other) and (moving forward together) On Reducing Marital Conflict And Improving The Quality of Life For Women of Mahmudabad city. The statistical population of the research were 80 housewives under the support of Welfare Organization of Mahmoud Abad city who had records in 2014-15 among whom 20 individuals were randomly selected as statistical sample using available sampling. 10 individuals were randomly assigned to the experimental group and 10 individuals were assigned to the control group. Research tools were marital conflicts’ questionnaire with 42 items (Barati & Snaie, 1996) and quality of life questionnaire with 26 questions (WHOQ-REFB) of the world Health Organization. The results of the study showed that integrated teaching of 1 and 2 marital communication skills (taking and listening to each other) and (moving forward together) has had no effect on reduction of marital conflicts and improvement of quality of life of woman.

scholarly journals Medical and surgical interventions for the treatment of urinary stones in children: A Cochrane Review

2019 ◽  
Vol 13 (12) ◽  
Author(s):  
Lenka Barreto ◽  
Jae Hung Jung ◽  
Ameera Abdelrahim ◽  
Munir Ahmed ◽  
Guy P.C. Dawkins ◽  
...  
Keyword(s):  
Cochrane Review ◽  
Stone Disease ◽  
Risk Of Bias ◽  
World Health ◽  
Urinary Stones ◽  
Controlled Trials ◽  
Surgical Interventions ◽  
Health Organization ◽  
Clinical Trials Registry

Introduction: We performed systematic review to assess the effects of different medical and surgical management of urinary stones in children. Methods: We performed a comprehensive search using multiple databases (MEDLINE, EMBASE, Cochrane Register of Controlled Trials), trials registries (World Health Organization International Clinical Trials Registry Platform Search Portal and ClinicalTrials.gov), and abstract proceedings of major urological and paediatric urology meetings, with no restrictions on the language of publication or publication status, up until December 2017. We included all randomized controlled trials (RCTs) and quasi-RCTs. Two review authors independently assessed the eligibility of studies for inclusion, extracted data, and assessed risk of bias in accordance with the Cochrane ‘Risk of bias’ tool. We performed statistical analyses using a random-effects model and assessed the quality of the evidence according to GRADE. Results: We included 14 studies with a total of 978 randomized participants in our review, informing seven comparisons with shock wave lithotripsy, percutaneous nephrolithotripsy, ureterorenoscopy (regardless of the type of lithotripsy), open stone surgery, and medical expulsive therapy. There was very low quality of evidence in the most comparisons with regards to the effectiveness and adverse events for the treatment of paediatric upper renal tract stone disease. Conclusions: Based on mostly very low-quality evidence for most comparisons and outcomes, we are uncertain about the effect of nearly all medical and surgical interventions to treat stone disease in children. There is a critical need for better quality trials assessing patient-important outcomes in children with stone disease to inform future guidelines on the management of this condition.

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