Assessing the quality of randomization methods in randomized control trials

Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 100570
Author(s):  
Deborah Lai ◽  
Daniel Wang ◽  
Matthew McGillivray ◽  
Shadi Baajour ◽  
Ali S Raja ◽  
...  
Author(s):  
Nancy P. Kropf ◽  
Sherry M. Cummings

Chapter 6, “Problem-Solving Therapy: Evidence-Based Practice,” details the research evidence concerning the effectiveness of problem-solving therapy (PST) for use with older adults. Only meta-analyses or randomized control trials (RCT) were included in this review. One meta-analysis and fifteen randomized control trials were identified that investigated PST outcomes on older adult depression, health-related quality of life, and coping. Outcomes of these studies determined that this therapy is effective in reducing anxiety and depression, and increasing problem-solving abilities in both community-based and in-home settings. Additionally, consistent support was found for the efficacy of telephone and video-phone PST, suggesting that these alternate means of administration may help overcome barriers to the receipt of mental health services experienced by homebound elders.


2021 ◽  
Author(s):  
Dawit Getachew Assefa ◽  
Gizachew Yismaw ◽  
Eyasu Makonnen

Abstract Background: The efficacies of artemisinin based combinations have been excellent in Africa, but little or no attention has been given to their safety. The aim of this review was to synthesize available evidence on the safety of dihydroartemisinin-piperaquine (DHA-PQ) compared to artemether-lumefantrine (AL) for the treatment of uncomplicated P.falciparum malaria among children in Africa.Method: A systematic literature search was done to identify relevant articles from online databases PubMed/ MEDLINE, Embase, and Cochrane Center for Clinical Trial database (CENTRAL) for retrieving randomized control trials comparing safety of DHA-PQ and AL for treatment of uncomplicated P.falciparum malaria among children in Africa. The search was performed from August 2020 to 30 April 2021. Using Rev-Man software (V5.4.1), the extracted data from eligible studies were pooled as risk ratio (RR) with 95% confidence interval (CI).Result: In this review, 18 studies were included, which involved 10,498 participants were included. Compared to AL, DHA-PQ was associated with a slightly higher frequency of early vomiting (RR 2.26, 95% CI 1.46 to 3.50; participants = 7796; studies = 10; I2 = 0%, high quality of evidence), cough (RR 1.06, 95% CI 1.01 to 1.11; participants = 8013; studies = 13; I2 = 0%, high quality of evidence), and diarrhea (RR 1.16, 95% CI 1.03 to 1.31; participants = 6841; studies = 11; I2 = 8%, high quality of evidence) were more frequent in DHA-PQ treatment arm. Conclusion: From this review, it can be concluded that early vomiting, diarrhea, and cough were significantly more frequent in patients who were treated with the DHA-PQ than that of AL, and both drugs are well tolerated. More studies comparing AL with DHA-PQ are needed to determine the comparative safety of these drugs.


2019 ◽  
Vol 4 (2) ◽  

Background: Multiple sclerosis (MS) presents with many symptoms, including urinary incontinence (UI) that physical therapy can play very important role, which is widely prevent, but the physical therapy management for UI in MS population lacks consensus. We analyzed the current evidence for effectiveness of physical therapy to decrease UI and improve quality of life (QOL) in population with MS. Purpose: To systematically review the literature and present the best available evidence for the efficacy and effectiveness of physical therapy intervention in treating the urinary incontinence for MS population and improve QOL. Data Source: Pub Med, Cochrane library, BMJ Group, BioMed Central, Wiley online library, Cumulative Index to Nursing and Allied Health Literature, and PEDro. Study Selection: 5 randomized, control trials (RCTs) and one clinical trial published in English from 2006- May 2019. Data Extraction: Any study concentrated on surgical or pharmaceutical treatment interventions, focused on bowel incontinence or were not within the physical therapy scope of practice. Data Synthesis: The study focuses on physical therapy intervention for MS patients with UI and randomized control study. Limitation of the Study: The reviewed study is limited to 6 randomized control trials. Conclusion: There is significant evidence that physical therapy interventions in MS patients with urinary incontinence are very effective and had significant change in reducing UI and increasing QOL.


2021 ◽  
Author(s):  
Dawit Getachew Assefa ◽  
Gizachew Yesmaw ◽  
Eyasu Makonnen

Abstract Background: The efficacies of artemisinin based combinations have been excellent in Africa, but little or no attention has been given to their safety. The aim of this review was to synthesize available evidence on the safety of dihydroartemisinin-piperaquine (DHA-PQ) compared to artemether-lumefantrine (AL) for the treatment of uncomplicated P.falciparum malaria among children in Africa.Method: A systematic literature search was done to identify relevant articles from online databases PubMed/ MEDLINE, Embase, and Cochrane Center for Clinical Trial database (CENTRAL) for retrieving randomized control trials comparing safety of DHA-PQ and AL for treatment of uncomplicated P.falciparum malaria among children in Africa. The search was performed from August 2020 to 30 April 2021. Using Rev-Man software (V5.4.1), the extracted data from eligible studies were pooled as risk ratio (RR) with 95% confidence interval (CI).Result: In this review, 18 studies were included, which involved 10,498 participants were included. Compared to AL, DHA-PQ was associated with a slightly higher frequency of early vomiting (RR 2.26, 95% CI 1.46 to 3.50; participants = 7796; studies = 10; I2 = 0%, high quality of evidence), cough (RR 1.06, 95% CI 1.01 to 1.11; participants = 8013; studies = 13; I2 = 0%, high quality of evidence), and diarrhea (RR 1.16, 95% CI 1.03 to 1.31; participants = 6841; studies = 11; I2 = 8%, high quality of evidence) were more frequent in DHA-PQ treatment arm.Conclusion: From this review, it can be concluded that early vomiting, diarrhea, and cough were significantly more frequent in patients who were treated with the DHA-PQ than that of AL, and both drugs are well tolerated. More studies comparing AL with DHA-PQ are needed to determine the comparative safety of these drugs.


2020 ◽  
Author(s):  
Pamela Gonzalez Mendez ◽  
Ranganatha Sitaram ◽  
Jeffrey A. Stanley ◽  
Julio Rodino Clement

ABSTRACT BACKGROUND: Depressive disorders are a group of neuropsychiatric disorders that cause significant distress and impairment in social, occupational, and other important areas of functioning. In the last decade, Brain-Computer Interfaces based-neurofeedback training appears as an innovative therapy for this condition and other neuropsychiatric disorders, allowing to volitionally self-regulate brain activity and behavior. Up to date, non-invasive neurofeedback training have been built on different techniques, including EEG, NIRS and fMRI. OBJECTIVES: This systematic review aims to evaluate the clinical application of fMRI neurofeedback training and its efficacy on treating depressive disorders. As a secondary objective, we intend to extract additional information on the neurofeedback training technique, in order to provide recommendations for future research. METHODS AND ANALYSIS: The systematic review complies with the PRISMA guidelines and it was submitted to PROSPERO registration. We will only include randomized control trials assessing participants with a depressive disorder. The intervention of interest is real-time fMRI neurofeedback training, the comparison of interest will be placebo neurofeedback, another active non-neurofeedback control or no treatment. The primary outcome will be effects on behavior (symptomatology/disease severity reduction). The secondary outcomes will assess quality of life, acceptability and adverse effects. Finally, we will evaluate other outcomes regarding brain MRI metrics (BOLD activation/connectivity), cognitive tasks performance, and physiology measures. At least two reviewers will independently select studies, extract data and assess the risk of bias. If methodologically possible, for primary and secondary outcomes, a meta-analysis will be performed and the data will be presented in summary tables of results using the GRADE approach. STRENGTH AND LIMITATIONS: As the number of studies on neurofeedback is increasing every year, and better quality of evidence is available, this systematic review, will include only randomized control trials. To our knowledge, this is the first systematic review assessing randomized control trials on fMRI neurofeedback training as a neurorehabilitation approach on depressive disorders. The main limitation of this systematic review might arise from the low number of extant RCTs.


2021 ◽  
Author(s):  
Dawit Getachew Assefa ◽  
Gizachew Yesmaw ◽  
Eyasu Makonnen

Abstract Background: Emergence of Plasmodium falciparum resistance to artemisinin and its derivatives poses a threat to global effort in controlling malaria. Resistance has already emerged to most antimalarial drugs in common use. On the other hand, significant number of the developing world in genral and African population in particular is sufferring from malaria of whom many are children.The aim of this review was, therefore, to compare the efficacy and safety of dihydroartemisinin-piperaquine and artemether-lumefantrine for treatment of uncomplicated P.falciparum malaria in African children.Method: A computerized systematic search method was used to search for articles from online databases PubMed/ MEDLINE, Embase, and Cochrane Center for Clinical Trial database (CENTRAL) for retrieving randomized control trials comparing efficacy and safety of DHA-PQ and AL for treatment of uncomplicated P.falciparum malaria in African children. The search was performed from August 2020 to 30 April 2021. Using Rev-Man software (V5.4), R-studio, and Comprehensive Meta-analysis software, the extracted data from eligible studies were pooled as risk ratio (RR) with 95% confidence interval (CI).Result: In this review, 25 studies which involved a total of 13,198 participants were included. PCR unadjusted treatment failure in children aged between 6 months and 15 years was significantly lower in DHA-PQ treatment arm on day 28 than that of AL (RR 0.14, 95% CI 0.08 to 0.26; participants = 1302; studies = 4; I2 = 0%, high quality of evidence). Consistently, the PCR adjusted treatment failure was significantly lower with DHA-PQ treatment group on day 28 (RR 0.45, 95% CI 0.29 to 0.68; participants = 8508; studies = 16; I2 = 51%, high quality of evidence) and on day 42 (RR 0.60, 95% CI 0.47 to 0.78; participants = 5959; studies = 17; I2 = 0%, high quality of evidence). However, the efficacy was ≥95% in both treatment groups on day 28. On days 28 and 42, a significant increase in serum hemoglobin level from the baseline was also observed in DHA-PQ treatment arm (SMD 0.15, 95% CI 0.05 to 0.26; participants = 2715; studies = 4; I2 = 32%, high quality of evidence) and (MD 0.35, 95% CI 0.12 to 0.59; participants = 1434; studies = 3; I2 = 35%, high quality of evidence), respectively. Compared to AL, DHA-PQ was associated with a slightly higher frequency of early vomiting (RR 2.26, 95% CI 1.46 to 3.50; participants = 7796; studies = 10; I2 = 0%, high quality of evidence), vomiting (RR 1.02, 95% CI 0.87 to 1.19; participants = 8789; studies = 13; I2 = 20%, high quality of evidence), cough (RR 1.06, 95% CI 1.01 to 1.11; participants = 8013; studies = 13; I2 = 0%, high quality of evidence), and diarrhea (RR 1.16, 95% CI 1.03 to 1.31; participants = 6841; studies = 11; I2 = 8%, high quality of evidence) were more frequent in DHA-PQ treatment arm.Conclusion: From this review, it can be concluded that DHA-PQ reduces new infection and recrudescence with significant impact on hemoglobin recovery more than AL, and both drugs are well tolerated. DHA-PQ may, therefore be recommended as a first line treatment for uncomplicated P.falciparum malaria in Africa, while use of AL continues.


2021 ◽  
Author(s):  
Cathrine Skov Schacksen ◽  
Nanna Celina Henneberg ◽  
Janusiya Anajan Muthulingam ◽  
Yuh Morimoto ◽  
Ryuichi Sawa ◽  
...  

BACKGROUND Heart failure is one of the world’s most frequently diagnosed cardiovascular diseases. An important element of heart failure management is cardiac rehabilitation, which aims to improve patients’ recovery, functional capacity, psychosocial well-being, and health-related quality of life. Patients in cardiac rehabilitation may lack sufficient motivation or feel that the rehabilitation process does not meet their individual needs. One solution to these challenges is the use of telerehabilitation. Although telerehabilitation has been available for several years, it is only in recent years that it has been utilized in heart failure studies. Especially within the past five years, we now have several studies focusing on the effectiveness of telerehabilitation for heart failure management, and the studies show varying results. Based on these studies, this paper provides a review and assessment of the general effectiveness of telerehabilitation as applied to heart failure management. OBJECTIVE The aim of this scoping review is to assess the effects of telerehabilitation in the management of heart failure by systematically reviewing the available scientific literature within the period from January 1st 2015 to December 31st 2020. METHODS The literature search was performed using PubMed and EMBASE. After duplicates were removed, 77 articles were screened and reviewed, of which 12 articles were included in this review. As measures of the effectiveness of telerehabilitation, the following outcomes were used: patient’s quality of life, physical capacity, depression/anxiety, and adherence to the intervention. RESULTS In reviewing the effects of telerehabilitation for heart failure patients, it was found that, 4 out of 6 randomized control trials, the single prospective study, and 4 out of 5 reviews reported increased quality of life for patients. For physical capacity, 4 randomized control trials and 3 systematic reviews revealed increased physical capacity. Depression or depressive symptoms was reported as reduced in 1 of the 6 randomized control trials and in 2 of the 5 reviews. Anxiety or anxiety-related symptoms was only reported as reduced in only 1 review. High adherence to the telerehabilitation program was reported in 4 randomized control trials and 4 reviews. It should be mentioned that some of the reviewed articles described the same studies although they used different outcome measures. CONCLUSIONS Telerehabilitation is still a relatively new approach to heart failure patients. It was found that there is a tendency toward improvement in patients’ quality of life and physical capacity. The outcome measures of depression, anxiety and adherence to the intervention were found to be positive. More research is needed to determine more precise and robust effects on the respective outcomes in telerehabilitation.


2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Emily Shockley ◽  
Aliya Amin ◽  
Dennis Savaiano

Background/Objective: Six out of ten deaths in the United States are caused by chronic diseases. There are multiple approaches to prevention and/or early detection of chronic diseases through screenings, nutrition, physical activity, and more. Unfortunately, a large portion of the US population have low rates of preventative care. Community health coalitions have the potential to improve preventative health outcomes by partnering with key members of communities to design programs that best fit community needs. In this systematic review, we examine evidence that community health coalitions can improve preventative health outcomes. Methods: PubMed, WebofScience, CINAHL, and PsycINFO were searched for (outcome OR health outcome) AND (prevention) AND (diabetes OR hypertension OR cancer OR prenatal) AND (community-based participatory research OR community coalition OR coalition OR health coalition). After screening 490 articles, 30 full-text, peer-reviewed, English articles meeting inclusion criteria of health coalition, prevention, health outcomes reported, and conducted in the United States were reviewed. Results: 27 of the 30 studies showed community health coalitions having a positive impact. Roughly half of the articles were randomized control trials. Community members and academia were represented in 80% and 77%, respectively, of the coalitions described, while other representations included faith-based organizations, health care, public health, industry, and education. Diabetes and cancer represented 74% of the targeted preventions addressed. 90% of the interventions focused on educating the community, and 33% focused on increasing health screening rates. 60% utilized trained community members to deliver interventions. 60% reported health measurements, 33% reported screening rates, and 30% reported knowledge and awareness. Conclusion, Impact, & Implications: While the evidence suggests community health coalitions are effective in improving preventative health outcomes, the quality of the studies remain low. There is a need for increased rigor of study design and assessment in order to determine the true efficacy of community health coalitions. The majority of the randomized-control trials in this review were rated as low-quality, highlighting the difficulty of designing a randomized, controlled study in a community. Inadequate funding, lack of rigorous design, or ethical challenges can limit the quality of the assessment. Further, although prenatal care was included as a search term, there were no coalitions found that addressed this type of preventative care. This points to a future need for the creation of or increased publications from prenatal health coalitions.  


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