Quality of reporting and risk of bias of randomized clinical trials published in Spanish and Latin American journals

Abstract Revascularization endodontic procedures commonly require multiple treatment sessions. However, single visit procedures may be advantageous from the clinical and patient management standpoints. The purpose of this review was to evaluate the outcomes of single-visit revascularization endodontic procedures for the management of immature permanent teeth with non-vital pulp. Two electronic databases (Scopus and PubMed) were searched, from their inception to July 2018, for studies that assessed clinical and/or radiographic and/or histologic outcomes of single-visit revascularization endodontic procedures performed in immature permanent teeth with non-vital pulp. Case reports, animal studies and clinical trials were included. The quality of case reports was appraised by Joanna Briggs Institute Critical Appraisal Checklist for Case Reports. The quality of randomized clinical trials was assessed by the revised Cochrane risk of bias tool for randomized trials. The risk of bias for animal studies was assessed using SYRCLE’s risk of bias tool. Tabulation followed by narrative synthesis was used to draw conclusions. Seven studies satisfied the selection criteria. Five were classified as case reports, one as a randomized clinical trial and one as animal study. The latter presented with a high risk of bias, whilst the remaining showed a low risk. The evidence supporting the potential use of single-visit revascularization endodontic procedures is scarce. Successful single-visit revascularization endodontic procedures commonly include the use of high concentrations of sodium hypochlorite and EDTA combined with the use of agitation systems. Further clinical trials with long term follow up are needed to confirm the results of the current review.

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Intervention Therapies to Reduce Pain-Related Fear in Fibromyalgia Syndrome: A Systematic Review of Randomized Clinical Trials

Pain Medicine ◽

10.1093/pm/pnaa331 ◽

2020 ◽

Author(s):

Javier Martinez-Calderon ◽

Mar Flores-Cortes ◽

Jose Miguel Morales-Asencio ◽

Alejandro Luque-Suarez

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Randomized Clinical Trials ◽

Risk Of Bias ◽

Cochrane Library ◽

Secondary Outcome ◽

Full Detail ◽

Eligibility Criteria ◽

Fear Avoidance Beliefs

Abstract Objective This systematic review aimed to evaluate the effectiveness of different interventions at reducing pain-related fear in people with fibromyalgia and to analyze whether the included trials reported their interventions in full detail. Design Systematic review. Setting No restrictions. Methods The Cochrane Library, CINAHL, EMBASE, PsycINFO, PubMed, and Scopus were searched from their inception to April 2020, along with manual searches and a gray literature search. Randomized clinical trials were included if they assessed pain-related fear constructs as the primary or secondary outcome in adults with fibromyalgia. Two reviewers independently performed the study selection, data extraction, risk-of-bias assessment, Template for Intervention Description and Replication (TIDieR) checklist assessment, and grading the quality of evidence. Results Twelve randomized clinical trials satisfied the eligibility criteria, including 11 cohorts with a total sample of 1,441 participants. Exercise, multicomponent, and psychological interventions were more effective than controls were in reducing kinesiophobia. However, there were no differences in decreasing kinesiophobia when self-management and electrotherapy were used. There were also no differences between groups with regard to the rest of the interventions and pain-related constructs (fear-avoidance beliefs, fear of pain, and pain-related anxiety). However, a serious risk of bias and a very serious risk of imprecision were detected across the included trials. This caused the overall certainty of the judged evidence to be low and very low. Additionally, the included trials reported insufficient details to allow the full replication of their interventions. Conclusions This systematic review shows that there are promising interventions, such as exercise, multicomponent, and psychological therapies, that may decrease one specific type of fear in people with fibromyalgia, i.e., kinesiophobia. However, because of the low–very low certainty of the evidence found, a call for action is needed to improve the quality of randomized clinical trials, which will lead to more definitive information about the clinical efficacy of interventions in this field.

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Assessment of the quality of reporting of randomized clinical trials in paediatric dentistry: A comparative systematic review

Journal of Taibah University Medical Sciences ◽

10.1016/j.jtumed.2019.12.006 ◽

2020 ◽

Vol 15 (1) ◽

pp. 1-7 ◽

Cited By ~ 1

Author(s):

Abeer Alnamankany ◽

Paul Ashley

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Randomized Clinical Trials ◽

Paediatric Dentistry ◽

Quality Of Reporting

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Quality of reporting of randomized clinical trials in implant dentistry. A systematic review on critical aspects in design, outcome assessment and clinical relevance

Journal Of Clinical Periodontology ◽

10.1111/j.1600-051x.2011.01839.x ◽

2012 ◽

Vol 39 ◽

pp. 81-107 ◽

Cited By ~ 39

Author(s):

Francesco Cairo ◽

Ignacio Sanz ◽

Paula Matesanz ◽

Michele Nieri ◽

Umberto Pagliaro

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Outcome Assessment ◽

Clinical Relevance ◽

Randomized Clinical Trials ◽

Quality Of Reporting ◽

Implant Dentistry ◽

Critical Aspects

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A multiyear systematic survey of the quality of reporting for randomised trials in dentistry, neurology and geriatrics published in journals of Spain and Latin America

BMC Medical Research Methodology ◽

10.1186/s12874-021-01337-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Vivienne C. Bachelet ◽

María S. Navarrete ◽

Constanza Barrera-Riquelme ◽

Víctor A. Carrasco ◽

Matías Dallaserra ◽

...

Keyword(s):

Clinical Trials ◽

Latin America ◽

Latin American ◽

Randomised Clinical Trials ◽

Secondary Outcome ◽

Secondary Outcome Measure ◽

Quality Of Reporting ◽

Systematic Survey ◽

The Impact

Abstract Background The Iberoamerican Cochrane Network is currently developing an extensive project to identify Spanish-language journals that publish original clinical research in Spain and Latin America. The project is called BADERI (Database of Iberoamerican Essays and Journal) and feeds the research articles, mainly randomised clinical trials (RCTs), into CENTRAL (Cochrane Collaboration Central Register of Controlled Trials). This study aims to assess the quality of reporting of RCTs published in Spanish and Latin American journals for three clinical fields and assess changes over time. Methods We did a systematic survey with time trend analysis of RCTs for dentistry, geriatrics, and neurology. These fields were chosen for pragmatic reasons as they had not yet been completed in BADERI. After screening RCTs from 1990 to 2018 for randomised or quasi-randomised clinical trials, we extracted data for 23 CONSORT items. The primary outcome was the total score of the 23 predefined CONSORT 2010 items for each RCT (score range from 0 to 34). The secondary outcome measure was the score for each one of these 23 items. Results A total of 392 articles from 1990 to 2018 were included as follows: dentistry (282), neurology (80), and geriatrics (30). We found that the overall compliance score for the CONSORT items included in this study for all 392 RCTs analysed was 12.6 on a scale with a maximum score of 34. With time, the quality of reporting improved slightly for all RCTs. None of the articles achieved the complete individual CONSORT item compliance score. The lowest overall compliance percentage was for item 10 (Randomisation implementation) and item 24 (Protocol registration), with a dismal 1% compliance across all included RCTs, regardless of country. Conclusions CONSORT compliance is very poor in the 392 analysed RCTs. The impact of the CONSORT statement on improving the completeness of RCT reporting in Latin America and Spain is not clear. Iberoamerican journals should become more involved in endorsing and enforcing adherence to the CONSORT guidelines.

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Quality of Reporting of Randomized Clinical Trials in Tai Chi Interventions—A Systematic Review

Evidence-based Complementary and Alternative Medicine ◽

10.1093/ecam/nep022 ◽

2011 ◽

Vol 2011 ◽

pp. 1-10 ◽

Cited By ~ 9

Author(s):

Jing-Yi Li ◽

Yuan-Fen Zhang ◽

Gordon S. Smith ◽

Chuan-Jiang Xue ◽

Yan-Nan Luo ◽

...

Keyword(s):

Clinical Trials ◽

Tai Chi ◽

Randomized Clinical Trials ◽

Reporting Quality ◽

Evidence Base ◽

Substantial Improvement ◽

Allocation Concealment ◽

Quality Of Reporting ◽

Study Results

Objectives. To evaluate the reporting quality of published randomized clinical trials (RCTs) in the Tai Chi literature following the publication of the CONSORT guidelines in 2001.Data Sources. The OVID MEDLINE and PUBMED databases.Review Methods. To survey the general characteristics of Tai Chi RCTs in the literature, we included any report if (i) it was an original report of the trial; (ii) its design was RCT; (iii) one of the treatments being tested was Tai Chi; and (iv) it was in English. In addition, we assessed the reporting quality of RCTs that were published between 2002 and 2007, using a modified CONSORT checklist of 40 items. The adequate description of Tai Chi interventions in these trials was examined against a 10-item checklist adapted from previous reviews.Results. The search yielded 31 Tai Chi RCTs published from 2002 to 2007 and only 11 for 1992–2001. Among trials published during 2002–2007, the most adequately reported criteria were related to background, participant eligibility and interpretation of the study results. Nonetheless, the most poorly reported items were associated with randomization allocation concealment, implementation of randomization and the definitions of period of recruitment and follow-up. In addition, only 23% of RCTs provided adequate details of Tai Chi intervention used in the trials.Conclusion. The findings in this review indicated that the reporting quality of Tai Chi intervention trials is sub-optimal. Substantial improvement is required to meet the CONSORT guidelines and allow assessment of the quality of evidence. We believe that not only investigators, but also journal editors, reviewers and funding agencies need to follow the CONSORT guidelines to improve the standards of research and strengthen the evidence base for Tai Chi and for complementary and alternative medicine.

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Effect of Foot Reflexology on Constipation: A Systematic Review and Meta-Analysis

Shiraz E-Medical Journal ◽

10.5812/semj.100585 ◽

2020 ◽

Vol 22 (1) ◽

Author(s):

Zahra Anjoman Azari ◽

Mojgan Mirghafourvand ◽

Ciara Hughes ◽

Shiva Havizari

Keyword(s):

Clinical Trials ◽

Fixed Effects ◽

Primary Outcome ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Risk Of Bias ◽

Gastrointestinal Disorders ◽

P Value ◽

Prevalent Symptom

Context: Constipation is a prevalent symptom of gastrointestinal disorders, which has an annoying impact on health and quality of life. On the other hand, reflexology is a popular type of complementary and alternative medicine in medical practices. Objectives: The present study aimed to assess the effect of foot reflexology on constipation symptoms. Methods: Nine databases were systematically searched to detect relevant Randomized Clinical Trials. The current used the Cochrane Risk of Bias tool to evaluate the methodological quality of the included articles. The primary outcome was the improvement of constipation symptoms. The Standardized Mean Difference (SMD) was measured, and random effects were reported instead of the fixed effects due to the high heterogeneity. Results: Out of the 693 articles retrieved from the databases and eight additional records identified through other sources, 496 titles, 48 abstracts, and 16 full-texts were reviewed, and 11 articles were included in this study, out of which nine articles entered the meta-analysis. The findings of the meta-analysis indicated that foot reflexology had a significant effect on the constipation score (SMD: -0.82; 95% CI: -1.47 to -0.17; P value = 0.0001; I2 = 93%) Conclusions: Foot reflexology can effectively improve constipation symptoms; however, clinical trials with better designs are recommended.

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