Methodological Quality of Randomized Controlled Trials of Spinal Manipulation and Mobilization in Tension-Type Headache, Migraine, and Cervicogenic Headache

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.

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Volume and methodological quality of randomized controlled trials in laparoscopic surgery: assessment over a 10-year period

The American Journal of Surgery ◽

10.1016/j.amjsurg.2015.04.022 ◽

2015 ◽

Vol 210 (5) ◽

pp. 922-929 ◽

Cited By ~ 6

Author(s):

Stavros A. Antoniou ◽

Alexandros Andreou ◽

George A. Antoniou ◽

Oliver O. Koch ◽

Gernot Köhler ◽

...

Keyword(s):

Laparoscopic Surgery ◽

Randomized Controlled Trials ◽

Methodological Quality ◽

Controlled Trials ◽

Randomized Controlled

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A systematic review of trends in the methodological quality of randomized controlled trials in various research fields

Journal of Clinical Epidemiology ◽

10.1016/j.jclinepi.2008.07.012 ◽

2009 ◽

Vol 62 (3) ◽

pp. 227-231.e9 ◽

Cited By ~ 35

Author(s):

Matthew E. Falagas ◽

Tatiana Grigori ◽

Eleni Ioannidou

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Methodological Quality ◽

Controlled Trials ◽

Randomized Controlled ◽

Research Fields

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Characteristic of Clinical Studies on Baduanjin during 2000–2019: A Comprehensive Review

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/4783915 ◽

2020 ◽

Vol 2020 ◽

pp. 1-9

Author(s):

Jing Zhou ◽

Yunyang Yu ◽

Biwei Cao ◽

Xiaoya Li ◽

Miao Wu ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Clinical Studies ◽

Methodological Quality ◽

Case Reports ◽

Case Series ◽

Small Sample ◽

Chronic Obstructive ◽

Controlled Trials ◽

Randomized Controlled

To date, a growing number of clinical studies have demonstrated the safety and health benefits from Baduanjin intervention. Based on this, our objective is to systematically retrieve and summarize the clinical studies on Baduanjin, with a view to providing more evidence-based evidence in support of the application of Baduanjin for healthcare, and to identify the shortcomings of existing research and provide feasibility suggest for further clinical research. Both four English language and four Chinese language electronic databases were used to search articles related to Baduanjin during 2000–2019. SPSS 22.0 software was used to analyze the data, and the risk of bias tool in the RevMan 5.3.5 software was used to evaluate the methodological quality of randomized controlled trials. A total of 810 publications were identified, including 43 (5.3%) systematic reviews, 614 (75.8%) randomized controlled trials, 66 (8.1%) nonrandomized controlled clinical studies, 84 (10.4%) case series, and 3 (0.4%) case reports. The top 10 diseases/conditions included diabetes, chronic obstructive pulmonary disease, hypertension, low back pain, neck pain, stroke, coronary heart disease, cognitive impairment, insomnia, and osteoporosis or osteopenia. The style of State General Administration of Sport of China in 2003 was the most commonly used version of Baduanjin, and Baduanjin was practiced with an average of 35 minutes, 1 or 2 times a day, 3–5 days per week, and a 18-week average duration. It is also worth noting that there were no serious adverse events related to Baduanjin intervention. Most studies were small sample size research, and the methodological quality of randomized controlled trials is generally low. The clinical studies of Baduanjin have a substantial quantity and evidence base. However, there are significant differences among different studies in the specific intervention measures such as style, intensity, duration, learning, and practice methods, which need to be further standardized and unified. Further high-quality designed and reporting studies are recommended to further validate the clinical benefits of Baduanjin.

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Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols

Journal of Clinical Epidemiology ◽

10.1016/j.jclinepi.2011.10.016 ◽

2012 ◽

Vol 65 (6) ◽

pp. 602-609 ◽

Cited By ~ 43

Author(s):

Rahul Mhaskar ◽

Benjamin Djulbegovic ◽

Anja Magazin ◽

Heloisa P. Soares ◽

Ambuj Kumar

Keyword(s):

Randomized Controlled Trials ◽

Methodological Quality ◽

Controlled Trials ◽

Randomized Controlled

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Journal impact factor and methodological quality of surgical randomized controlled trials: an empirical study

Langenbeck s Archives of Surgery ◽

10.1007/s00423-017-1593-6 ◽

2017 ◽

Vol 402 (7) ◽

pp. 1015-1022 ◽

Cited By ~ 4

Author(s):

Usama Ahmed Ali ◽

Beata M. M. Reiber ◽

Joren R. ten Hove ◽

Pieter C. van der Sluis ◽

Hein G. Gooszen ◽

...

Keyword(s):

Empirical Study ◽

Impact Factor ◽

Randomized Controlled Trials ◽

Journal Impact Factor ◽

Methodological Quality ◽

Controlled Trials ◽

Randomized Controlled ◽

Journal Impact

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An assessment of quality of randomized controlled trials in shoulder instability surgery using a modification of the clear CLEAR-NPT score

Shoulder & Elbow ◽

10.1177/1758573218754370 ◽

2018 ◽

Vol 10 (4) ◽

pp. 238-249

Author(s):

Hassanin Alkaduhimi ◽

Aimane Saarig ◽

Just A. van der Linde ◽

Nienke W. Willigenburg ◽

Derek F. P. van Deurzen ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Shoulder Instability ◽

Methodological Quality ◽

Relevant Literature ◽

Patient Characteristics ◽

Controlled Trials ◽

Care Providers ◽

Quality Of Reporting ◽

Randomized Controlled

Background The present study aimed to evaluate the methodological quality and determine the quality of reporting of randomized controlled trials (RCTs) that assess surgical treatment for shoulder instability. Methods A Cochrane, Pubmed, EMBASE and Trip database search was performed, including the relevant literature, regarding RCTs that report on shoulder instability published between January 1994 and January 2017. Methodological quality was assessed with a modification of the Checklist to Evaluate A Report of a Nonpharmacologic Trial (CLEAR-NPT). Points were assigned based on 18 items regarding patient characteristics, randomization, care provider characteristics, surgical details and blinding, with a total score ranging from 0 points to 18 points. Missing items were verified with the corresponding authors of the studies. Quality of reporting corresponds to the total scores including the items that were additionally provided by the authors. Results We included 22 studies. Of these, nine corresponding authors provided additional information. The average methodological quality was 16.9 points (11 studies) and the average quality of reporting was 9.5 points (22 studies). Items scoring worst included information regarding the surgeon’s experience, the patients’ level of activity, comorbidities, analyzing according to ‘intention-to-treat’ principles, and blinding of care providers, participants and assessors. Conclusions RCTs reporting on shoulder instability surgery are well performed but poorly reported.

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Scales to Assess the Quality of Randomized Controlled Trials: A Systematic Review

Physical Therapy ◽

10.2522/ptj.20070147 ◽

2008 ◽

Vol 88 (2) ◽

pp. 156-175 ◽

Cited By ~ 423

Author(s):

Susan Armijo Olivo ◽

Luciana Gazzi Macedo ◽

Inae Caroline Gadotti ◽

Jorge Fuentes ◽

Tasha Stanton ◽

...

Keyword(s):

Systematic Review ◽

Physical Therapy ◽

Randomized Controlled Trials ◽

Methodological Quality ◽

Health Care Research ◽

Controlled Trials ◽

Validity And Reliability ◽

Randomized Controlled ◽

Manual Search

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.

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