scholarly journals Identifying Items to Assess Methodological Quality in Physical Therapy Trials: A Factor Analysis

2014 ◽  
Vol 94 (9) ◽  
pp. 1272-1284 ◽  
Author(s):  
Susan Armijo-Olivo ◽  
Greta G. Cummings ◽  
Jorge Fuentes ◽  
Humam Saltaji ◽  
Christine Ha ◽  
...  

Background Numerous tools and individual items have been proposed to assess the methodological quality of randomized controlled trials (RCTs). The frequency of use of these items varies according to health area, which suggests a lack of agreement regarding their relevance to trial quality or risk of bias. Objective The objectives of this study were: (1) to identify the underlying component structure of items and (2) to determine relevant items to evaluate the quality and risk of bias of trials in physical therapy by using an exploratory factor analysis (EFA). Design A methodological research design was used, and an EFA was performed. Methods Randomized controlled trials used for this study were randomly selected from searches of the Cochrane Database of Systematic Reviews. Two reviewers used 45 items gathered from 7 different quality tools to assess the methodological quality of the RCTs. An exploratory factor analysis was conducted using the principal axis factoring (PAF) method followed by varimax rotation. Results Principal axis factoring identified 34 items loaded on 9 common factors: (1) selection bias; (2) performance and detection bias; (3) eligibility, intervention details, and description of outcome measures; (4) psychometric properties of the main outcome; (5) contamination and adherence to treatment; (6) attrition bias; (7) data analysis; (8) sample size; and (9) control and placebo adequacy. Limitation Because of the exploratory nature of the results, a confirmatory factor analysis is needed to validate this model. Conclusions To the authors' knowledge, this is the first factor analysis to explore the underlying component items used to evaluate the methodological quality or risk of bias of RCTs in physical therapy. The items and factors represent a starting point for evaluating the methodological quality and risk of bias in physical therapy trials. Empirical evidence of the association among these items with treatment effects and a confirmatory factor analysis of these results are needed to validate these items.

2013 ◽  
Vol 41 (02) ◽  
pp. 231-252 ◽  
Author(s):  
Johannah L. Shergis ◽  
Anthony L. Zhang ◽  
Wenyu Zhou ◽  
Charlie C. Xue

Panax ginseng is one of the most frequently used herbs in the world. Numerous trials have evaluated its clinical benefits. However, the quality of these studies has not been comprehensively and systematically assessed. We reviewed randomized controlled trials (RCTs) of Panax ginseng to evaluate their quality and risk of bias. We searched four English databases, without publication date restriction. Two reviewers extracted details about the studies' methodological quality, guided by the Consolidated Standards of Reporting Trials (CONSORT) checklist and its extension for herbal interventions. Risk of bias was determined using the Cochrane Risk of Bias tool. Of 475 potentially relevant studies, 58 met our inclusion criteria. In these 58 studies, 48.3% of the suggested CONSORT checklist items and 35.9% of the extended herbal items were reported. The quality of RCTs published after the CONSORT checklist improved. Until 1995 (before CONSORT) (n = 4), 32.8% of the items were reported in studies. From 1996–2006 (CONSORT published and revised) (n = 30), 46.1% were reported, and from 2007 (n = 24), 53.5% were reported (p = 0.005). After the CONSORT extension for herbal interventions was published in 2006, RCT quality also improved, although not significantly. Until 2005 (n = 34), 35.2% of the extended herbal items were reported in studies; and from 2006 onwards (n = 24), 37.3% were reported (p = 0.64). Most studies classified risk of bias as "unclear". Overall, the quality of Panax ginseng RCT methodology has improved since the CONSORT checklist was introduced. However, more can be done to improve the methodological quality of, and reporting in, RCTs.


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.


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.


Author(s):  
Susan Armijo-Olivo ◽  
Michele Patrini ◽  
Ana Izabela S de Oliveira-Souza ◽  
Liz Dennett ◽  
Chiara Arienti ◽  
...  

2013 ◽  
Vol 258 (2) ◽  
pp. 199-207 ◽  
Author(s):  
Usama Ahmed Ali ◽  
Pieter C. van der Sluis ◽  
Yama Issa ◽  
Ibrahim Abou Habaga ◽  
Hein G. Gooszen ◽  
...  

2015 ◽  
Vol 101 (1) ◽  
pp. e1.66-e1
Author(s):  
Rym Boulkedid ◽  
Armiya Yousouf Abdou ◽  
Emilie Desselas ◽  
Marlène Monegat ◽  
Corinne Alberti ◽  
...  

BackgroundApproximately 15 to 30% of children and adolescents suffer from daily pain persistent over more than 3 months and there is evidence supporting that the prevalence of chronic pain is steadily increasing in this population. Chronic pain is known to have a negative impact on children's development and social behaviour, leading often to severe psychological distress and physical disability. We reviewed medical literature to assess the characteristics and quality of randomized controlled trials (RCTs) on pharmacological and non-pharmacological therapies in chronic and recurrent pain in the paediatric population.MethodsWe performed a systematic search of PubMed, Embase and the Cochrane Library up to March 2014. Bibliographies of relevant articles were also hand-searched. We included all RCTs that involved children and adolescents (age 0 to 18 years) and evaluated the use of a pharmacological agent or a non-pharmacological approach in the context of chronic or recurrent pain. The latter was defined as pain persisting for more than 3 months. Methodological quality was evaluated using the Cochrane Risk of Bias Tool. Two reviewers independently assessed studies for inclusion and evaluated methodological quality.ResultsA total of 52 randomized controlled trials were selected and included in the analysis. The majority were conducted in single hospital institutions, with no information on study funding. Median sample size was 45 (34–57) participants. Almost 50% of the RCTs included both adults and children with a median age at inclusion of 13 years. Non-pharmacological approaches were more commonly tested whereas evaluation of pharmacological agents concerned less than 30% of RCTs. Abdominal pain and headache were the most common types of chronic pain experienced among trial participants. Overall, the methodological quality was poor and did not parallel the number of RCTs that increased over the years. The risk of bias was high or unclear in 70% of the trials.ConclusionsThis is the first systematic review of RCTs conducted to evaluate pharmacological and non-pharmacological therapies in chronic and recurrent pain in children and adolescents. Although, management of pain in adults has significantly improved over the years due to the evaluation of numerous analgesic therapies, our results highlight the existing knowledge gap with regards to children and adolescents. Therapeutic strategies, in particular pharmacological agents, applied to relieve chronic or recurrent pain in children and adolescents are not evaluated through high quality RCTs. The need to improve analgesic therapy in children and adolescents with chronic pain is still unmet. We discuss possible research constraints and challenges related to this fact as well as adequate methodologies to circumvent them.


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