The methodological quality of randomized controlled trials in plastic surgery needs improvement: A systematic review

2013 ◽  
Vol 66 (4) ◽  
pp. 447-452 ◽  
Author(s):  
Riaz A. Agha ◽  
Christian F. Camm ◽  
Eric Edison ◽  
Dennis P. Orgill
2008 ◽  
Vol 88 (2) ◽  
pp. 156-175 ◽  
Author(s):  
Susan Armijo Olivo ◽  
Luciana Gazzi Macedo ◽  
Inae Caroline Gadotti ◽  
Jorge Fuentes ◽  
Tasha Stanton ◽  
...  

Background and PurposeThe methodological quality of randomized controlled trials (RCTs) is commonly evaluated in order to assess the risk of biased estimates of treatment effects. The purpose of this systematic review was to identify scales used to evaluate the methodological quality of RCTs in health care research and summarize the content, construction, development, and psychometric properties of these scales.MethodsExtensive electronic database searches, along with a manual search, were performed.ResultsOne hundred five relevant studies were identified. They accounted for 21 scales and their modifications. The majority of scales had not been rigorously developed or tested for validity and reliability. The Jadad Scale presented the best validity and reliability evidence; however, its validity for physical therapy trials has not been supported.Discussion and ConclusionMany scales are used to evaluate the methodological quality of RCTs, but most of these scales have not been adequately developed and have not been adequately tested for validity and reliability. A valid and reliable scale for the assessment of the methodological quality of physical therapy trials needs to be developed.


Author(s):  
Subhranil Saha ◽  
Malay Mundle ◽  
Shubhamoy Ghosh ◽  
Munmun Koley ◽  
Sk. Intaj Hossain

Background & Aim: Systematic reviews of high-quality randomized controlled trials are crucial to evidence-based medicine. The objective of this review is to test whether there is enough evidence of efficacy of homeopathy from conducted clinical trials in humans suffering from HIV/AIDS. Methods: The study design was criteria-based systematic review of cumulative research and assessment of the methodological quality of only 5 published clinical trials and one review article. Among the clinical outcome studies, 3 studies were of open-label, non-randomized, non-controlled format, 2 were randomized controlled trials and one was a set of replication study. The qualities of the trials were evaluated using a list of validated and pre-defined criteria of good methodology, and the outcomes of the trials were interpreted in relation to their quality. Main outcome measures were methodological qualities in terms of consideration of threats to external, internal, construct and statistical conclusion validity. Results: Trials were too few in number and were not of very high quality. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. The results of this review may be complicated by publication bias. Conclusions: At this moment, the evidences are not sufficient to draw definitive conclusions. So, further evaluation of homeopathy by well-performed controlled trials of high methodological quality is required.


2019 ◽  
Vol 42 (4) ◽  
pp. 434-440 ◽  
Author(s):  
Francesco Bortolotti ◽  
Livia Solidoro ◽  
Maria Lavinia Bartolucci ◽  
Serena Incerti Parenti ◽  
Corrado Paganelli ◽  
...  

Summary Background Surgically assisted rapid maxillary expansion (SARME) is a surgical technique developed to correct transverse discrepancies in skeletally mature patients. However, there is limited evidence concerning the immediate skeletal and dental changes obtained only due to SARME. Objective The aim of the present systematic review is to investigate the immediate skeletal and dental effects of SARME in adult patients with transverse maxillary hypoplasia. Search Methods An electronic search of the literature in MEDLINE, The Cochrane Library, Lilacs and Scopus databases was performed. Selection Criteria Only randomized controlled trials (RCTs) studies investigating the skeletal and dental effects of SARME procedures in adult patients were included. Data Collection and Analysis The included studies received a methodological quality scoring according to the revised Cochrane risk-of-bias tool for randomized trials. The quality of evidence was assessed by means of the Grading Recommendation Assessment, Development and Evaluation (GRADE) system. For each included study and for each analysed parameter, the difference in means and 95 per cent confidence interval was calculated between baseline and immediate post-expansion. A meta-analysis of original outcome data, if possible, was conducted. Results Nine articles were selected. The methodological quality ratings indicated that one study was at low risk of bias, seven presented some concerns and only one was at high risk of bias. In all the included studies, the SARME procedure resulted in a significant expansion of the maxillary transverse dimension. The meta-analysis compared skeletal and dental inter-molar width before and after treatment: the mean difference was of 3.3 mm (2.8–3.9) and 7.0 mm (6.1–7.8), respectively (P-value less than 0.001). The quality of evidence was low-moderate. Conclusions SARME is effective in obtaining a significant expansion of the maxillary transverse dimension. However, the immediate SARME effect is mainly a molar expansion rather than a pure bone transverse widening of the maxilla. Registration The review protocol was registered at PROSPERO database with the registration number CRD42018117967.


2018 ◽  
Author(s):  
David R Vago ◽  
Resh Gupta ◽  
Sara Lazar

One potential pathway by which mindfulness-based meditation improves health outcomes is through changes in cognitive functioning. A systematic review of randomized controlled trials of mindfulness-based interventions (MBIs) was conducted with a focus on assessing the state of the evidence for effects on cognitive processes and associated assays. Here, we comment on confounding issues surrounding the reporting of these and related findings, including 1) criteria that appropriately define an MBI; 2) limitations of assays used to measure cognition; and 3) methodological quality of MBI trials and reporting of findings. Because these issues contribute to potentially distorted interpretations of existing data, we offer constructive means for interpretation and recommendations for moving the field of mindfulness research forward regarding the effects on cognition.


2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Pierre Côté ◽  
Jan Hartvigsen ◽  
Iben Axén ◽  
Charlotte Leboeuf-Yde ◽  
Melissa Corso ◽  
...  

Abstract Background A small proportion of chiropractors, osteopaths, and other manual medicine providers use spinal manipulative therapy (SMT) to manage non-musculoskeletal disorders. However, the efficacy and effectiveness of these interventions to prevent or treat non-musculoskeletal disorders remain controversial. Objectives We convened a Global Summit of international scientists to conduct a systematic review of the literature to determine the efficacy and effectiveness of SMT for the primary, secondary and tertiary prevention of non-musculoskeletal disorders. Global summit The Global Summit took place on September 14–15, 2019 in Toronto, Canada. It was attended by 50 researchers from 8 countries and 28 observers from 18 chiropractic organizations. At the summit, participants critically appraised the literature and synthesized the evidence. Systematic review of the literature We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, the Cumulative Index to Nursing and Allied Health, and the Index to Chiropractic Literature from inception to May 15, 2019 using subject headings specific to each database and free text words relevant to manipulation/manual therapy, effectiveness, prevention, treatment, and non-musculoskeletal disorders. Eligible for review were randomized controlled trials published in English. The methodological quality of eligible studies was assessed independently by reviewers using the Scottish Intercollegiate Guidelines Network (SIGN) criteria for randomized controlled trials. We synthesized the evidence from articles with high or acceptable methodological quality according to the Synthesis without Meta-Analysis (SWiM) Guideline. The final risk of bias and evidence tables were reviewed by researchers who attended the Global Summit and 75% (38/50) had to approve the content to reach consensus. Results We retrieved 4997 citations, removed 1123 duplicates and screened 3874 citations. Of those, the eligibility of 32 articles was evaluated at the Global Summit and 16 articles were included in our systematic review. Our synthesis included six randomized controlled trials with acceptable or high methodological quality (reported in seven articles). These trials investigated the efficacy or effectiveness of SMT for the management of infantile colic, childhood asthma, hypertension, primary dysmenorrhea, and migraine. None of the trials evaluated the effectiveness of SMT in preventing the occurrence of non-musculoskeletal disorders. Consensus was reached on the content of all risk of bias and evidence tables. All randomized controlled trials with high or acceptable quality found that SMT was not superior to sham interventions for the treatment of these non-musculoskeletal disorders. Six of 50 participants (12%) in the Global Summit did not approve the final report. Conclusion Our systematic review included six randomized clinical trials (534 participants) of acceptable or high quality investigating the efficacy or effectiveness of SMT for the treatment of non-musculoskeletal disorders. We found no evidence of an effect of SMT for the management of non-musculoskeletal disorders including infantile colic, childhood asthma, hypertension, primary dysmenorrhea, and migraine. This finding challenges the validity of the theory that treating spinal dysfunctions with SMT has a physiological effect on organs and their function. Governments, payers, regulators, educators, and clinicians should consider this evidence when developing policies about the use and reimbursement of SMT for non-musculoskeletal disorders.


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