scholarly journals Randomized Controlled Trials of Acupuncture (1997–2007): An Assessment of Reporting Quality with a CONSORT- and STRICTA-Based Instrument

2011 ◽  
Vol 2011 ◽  
pp. 1-25 ◽  
Author(s):  
Richard Hammerschlag ◽  
Ryan Milley ◽  
Agatha Colbert ◽  
Jeffrey Weih ◽  
Beth Yohalem-Ilsley ◽  
...  
Keyword(s):  
English Language ◽  
Assessment Tool ◽  
Geographical Origin ◽  
Reporting Quality ◽  
Inclusion Criteria ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
Practitioner Training ◽  
Acupuncture Research

The present study describes the development of a comprehensive quality of reporting assessment tool and its application to acupuncture RCTs from 1997–2007. This Oregon CONSORT STRICTA Instrument (OCSI) is based on the revised CONSORT guidelines as modified by the STRICTA recommendations for acupuncture trials. Each of the resulting 27 OCSI items were applied to English language prospective RCTs that compared acupuncture, using manual and/or electro-stimulation, to no treatment, a sham procedure, or usual biomedical care. The 333 RCTs that met inclusion criteria were dispersed among 27 countries and 141 journals. Mean quality of reporting score for all articles was 63.0% (SD 16.5). Mean OCSI scores revealed a 30.9% improvement over the ten-year period (P<.001). Our findings suggest that to enhance quality of reporting, authors should better attend to seven specific OCSI items in three categories: practitioner training, adverse events, and aspects of randomization and blinding (n=5). The broad diversity in geographical origin, publication site and quality of reporting, viewed in light of the considerable room for improvement in mean OCSI scores, emphasizes the importance of making STRICTA as well as CONSORT more widely known to journals and to the acupuncture research community.

scholarly journals Assessing the reporting quality of randomized-controlled clinical trials involving novel oral anticoagulants in patients with atrial fibrillation based on the CONSORT statement

2017 ◽  
Vol 4 (4) ◽  
pp. 147
Author(s):  
Alexandra D. Arvanitaki ◽  
Polyxeni Mantzouratou ◽  
Elias Zintzaras
Keyword(s):  
Atrial Fibrillation ◽  
English Language ◽  
Treatment Effectiveness ◽  
Oral Anticoagulants ◽  
Reporting Quality ◽  
Consort Statement ◽  
Efficacy And Safety ◽  
Quality Of Reporting ◽  
Randomized Controlled

<p class="abstract"><strong>Background:</strong> Inadequate reporting of the published randomized controlled trials (RCTs) may restrict the generalizability of treatment effectiveness and tolerability of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF). The main objective of this study was to assess the reporting quality of RCTs for efficacy and safety of NOACs vs. warfarin in patients with AF based on the consolidated standards of reporting trials (CONSORT) statement.</p><p class="abstract"><strong>Methods:</strong> Pubmed was searched for relevant english-language RCTs. Eligible articles included pivotal RCTs and articles reporting results from sub-populations or post-hoc secondary analysis of the pivotal trials (non-pivotal trials). Eligible articles were assessed according to 37-item/sub-item checklist of CONSORT statement 2010. The assessment was overall and according to trial’s type, NOAC treatment and impact factor (IF) of journals.</p><p class="abstract"><strong>Results:</strong> Search identified 92 articles eligible for evaluation. Half of CONSORT items were reported by more than 90% of the articles and 25% of items were reported in all articles. The majority of pivotal studies (94%) answered &gt;75% of CONSORT items, while only half of non-pivotal studies had similar compliance (p&lt;0.01). NOACs showed similar pattern in reporting quality (p&gt;0.05), while IF had a significant effect in quality (p&lt;0.01).  </p><p><strong>Conclusions:</strong> RCTs for efficacy and safety of NOACs vs. warfarin in AF patients found to be well reported. Though, the quality of reporting is affected by type of trial and journals’ IF.</p>

scholarly journals Randomized controlled trials and neurosurgery: the ideal fit or should alternative methodologies be considered?

2016 ◽  
Vol 124 (2) ◽  
pp. 558-568 ◽  
Author(s):  
Alireza Mansouri ◽  
Benjamin Cooper ◽  
Samuel M. Shin ◽  
Douglas Kondziolka
Keyword(s):  
Randomized Controlled Trials ◽  
Sample Size ◽  
English Language ◽  
Sample Size Calculation ◽  
Median Number ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
Mesh Terms

OBJECT Randomized-controlled trials (RCTs) are advocated to provide high-level medical evidence. However, in neurosurgery, there are barriers to conducting RCTs. The authors of this study sought to analyze the quality of neurosurgical RCTs since 2000 to determine the adequacy of their design and reporting. METHODS A search of the MEDLINE and EMBASE databases (2000–2014) was conducted. The medical subject heading (MeSH) terms used in the search included: “neurosurgery” OR “neurosurgical procedure,” “brain neoplasms,” “infarction” and “decompression,” “carotid stenosis,” “cerebral hemorrhage,” and “spinal fusion.” These studies were limited to RCTs, in humans, and in the English language. The Consolidated Standards for Reporting of Trials (CONSORT) and Jadad scales were used to assess the quality of RCT design and reporting. The standardized median times cited (median citations divided by years since publication) were used to assess impact. A pragmatic-explanatory continuum indicator summary-based scale was used to assess the design of the studies as primarily pragmatic or explanatory. RESULTS Sixty-one articles were identified, and the following subspecialties were the most common: vascular (23, 37%), followed by functional neurosurgery and neurooncology (both 13, 21%). The following nations were the primary leaders in RCTs: US (25 studies, 41%), Germany (8 studies, 13%), and the United Kingdom (7 studies, 11%). Median sample size was 100 (interquartile range [IQR] 41.5–279). The majority of the studies (40, 66%) had pragmatic objectives. The median number of times cited overall was 69 (IQR 20.5–193). The combined median CONSORT score was 36 (IQR 27.5–39). Blinding was most deficiently reported. Other areas with a relatively low quality of reporting were sample size calculation (34.2% of surgical, 38.5% of drug, and 20% of device studies), allocation concealment (28.9% of surgical, 23.1% of drug, and 50% of device studies), and protocol implementation (18.4% of surgical, 23% of drug, and 20% of device studies). The quality of reporting did not correlate with the study impact. All studies had a median Jadad score ≤ 3. Thirty-three pragmatic studies (83%) and 5 explanatory studies (25%) met the design objectives. All pragmatic studies based on drug and device trials met their objectives, while 74% of pragmatic surgical trials met their objectives. CONCLUSIONS The prevalence of neurosurgical RCTs is low. The quality of RCT design and reporting in neurosurgery is also low. Many study designs are not compatible with stated objectives. Pragmatic studies were more likely to meet design objectives. Given the role of RCTs as one of the highest levels of evidence, it is critical to improve on their methodology and reporting.

scholarly journals Paediatric cohort studies on lower respiratory diseases and their reporting quality: systematic review of the year 2018

2020 ◽  
Vol 56 (5) ◽  
pp. 2000168
Author(s):  
Cristina Ardura-Garcia ◽  
Rebeca Mozun ◽  
Eva S.L. Pedersen ◽  
Maria Otth ◽  
Maria Christina Mallet ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cohort Studies ◽  
Reporting Quality ◽  
Inclusion Criteria ◽  
Birth Cohorts ◽  
Joint Effort ◽  
Quality Of Reporting ◽  
Respiratory Problems ◽  
Paediatric Cohort

The paediatric respiratory research community uses cohort studies extensively. However, the landscape of these studies and their quality of reporting has not been assessed.We performed a systematic review of publications on cohort studies reporting on paediatric lower respiratory problems published in 2018. We searched MEDLINE and Embase and extracted data on study and journal characteristics. We assessed the number of items of the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) checklist that a random sample (100 papers) reported. We analysed factors associated with the STROBE score and with the most poorly reported items, using Poisson and logistic regression.Of the 21 319 records identified, 369 full-text articles met our inclusion criteria. Most papers studied asthma aetiology through birth cohorts and were based in Europe or North America. The reporting quality was insufficient: 15% reported the 22 STROBE items; median (interquartile range) score 18 (16–21). The most poorly reported items were sources of bias, sample size, statistical methods, descriptive results and generalisability. None of the study or journal factors were associated with the STROBE score.We need a joint effort of editors, reviewers and authors to improve the reporting quality of paediatric cohort studies on respiratory problems.

scholarly journals Deficiencies in the reporting quality of RCTs in neurosurgery: How can we do better?

2015 ◽  
Vol 42 (S1) ◽  
pp. S12-S12
Author(s):  
A Mansouri ◽  
B Cooper ◽  
S Shin ◽  
D Kondziolka
Keyword(s):  
Sample Size Calculation ◽  
Reporting Quality ◽  
Allocation Concealment ◽  
High Yield ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
Study Designs ◽  
Design Factors

Background: Deficiencies in design and reporting of randomized controlled trials (RCTs) limit their validity. The quality of recent RCTs in neurosurgery was analyzed to assess adequacy of design and reporting. Methods: A high-yield search of the MEDLINE and EMBASE databases (2000-present) was conducted. The CONSORT and Jadad scales were used to assess the quality of design/reporting. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman’s test was used to assess correlations. Regression analysis was used to assess associations. Results: Sixty-one articles were identified. Vascular was the most common sub-specialty (37%). The median CONSORT and Jadad scores were 36 (IQR 27.5-39) and 3 (IQR 2-3). Blinding, sample size calculation and allocation concealment were most deficiently reported. The quality of reporting did not correlate with the study impact. The majority of studies (83%) had pragmatic objectives; while pragmatic studies had compatible design factors, trials with explanatory objectives were less successful. Conclusions: The prevalence and quality of neurosurgical RCTs is low. Many study designs are not compatible with stated objectives. Given the role of RCTs as one of the highest levels of evidence, it is critical to improve on their methodology and reporting. Alternative methodologies merit discussion.

EVALUATION OF RANDOMIZED CONTROLLED TRIALS ON COMPLEMENTARY AND ALTERNATIVE MEDICINE

2000 ◽  
Vol 16 (1) ◽  
pp. 13-21 ◽  
Author(s):  
Bernard S. Bloom ◽  
Aurélia Retbi ◽  
Sandrine Dahan ◽  
Egon Jonsson
Keyword(s):  
Alternative Medicine ◽  
Randomized Controlled Trials ◽  
Complementary And Alternative Medicine ◽  
English Language ◽  
Ordinary Least Squares ◽  
Controlled Trials ◽  
Inclusion Criteria ◽  
Randomized Controlled ◽  
Complementary And Alternative

Objectives: Use of complementary and alternative medicine (CAM) is growing in all Western countries. The goal of this study was to evaluate quality of randomized controlled trials (RCTs) of CAM interventions for specific diagnoses to inform clinical decision making.Methods: MEDLINE and related databases were searched for CAM RCTs. Visual review was done of bibliographies, meta-analyses, and CAM journals. Inclusion criteria for review and scoring were blinded RCT, specified diagnosis and intervention, complete study published between January 1, 1966 and July 31, 1998 in an English-language, peer-reviewed journal. Two reviewers independently scored each study.Results: More than 5,000 trials were found, but only 258 met all study inclusion criteria. The main cause for rejection (> 90%) was that the study was not an RCT or had no blinding. Mean score across 95 diagnosis/intervention categories was 44.7 (S.D. ± 14.3) on a 100-point scale. Ordinary least-squares regression found date of publication, biostatistician as author or consultant, published in one of five widely read English-language medical journals and diagnosis/intervention category of hypertension/relaxation as significant predictors of higher scores.Conclusions: The overall quality of evidence for CAM RCTs is poor but improving slowly over time, about the same as that of biomedicine. Thus, most services are provided without good evidence of benefit.

scholarly journals Static Magnetic Field Therapy: A Critical Review of Treatment Parameters

2009 ◽  
Vol 6 (2) ◽  
pp. 133-139 ◽  
Author(s):  
Agatha P. Colbert ◽  
Helané Wahbeh ◽  
Noelle Harling ◽  
Erin Connelly ◽  
Heather C. Schiffke ◽  
...  
Keyword(s):  
Magnetic Field ◽  
Static Magnetic Field ◽  
Animal Studies ◽  
English Language ◽  
Reporting Quality ◽  
Clinical Indication ◽  
Acupuncture Points ◽  
Target Tissue ◽  
Quality Of Reporting

Static magnetic field (SMF) therapy, applied via a permanent magnet attached to the skin, is used by people worldwide for self-care. Despite a lack of established SMF dosage and treatment regimens, multiple studies are conducted to evaluate SMF therapy effectiveness. Our objectives in conducting this review are to: (i) summarize SMF research conducted in humans; (ii) critically evaluate reporting quality of SMF dosages and treatment parameters and (iii) propose a set of criteria for reporting SMF treatment parameters in future clinical trials. We searched 27 electronic databases and reference lists. Only English language human studies were included. Excluded were studies of electromagnetic fields, transcranial magnetic stimulation, magnets placed on acupuncture points, animal studies, abstracts, posters and editorials. Data were extracted on clinical indication, study design and 10 essential SMF parameters. Three reviewers assessed quality of reporting and calculated a quality assessment score for each of the 10 treatment parameters. Fifty-six studies were reviewed, 42 conducted in patient populations and 14 in healthy volunteers. The SMF treatment parameters most often and most completely described were site of application, magnet support device and frequency and duration of application. Least often and least completely described were characteristics of the SMF: magnet dimensions, measured field strength and estimated distance of the magnet from the target tissue. Thirty-four (61%) of studies failed to provide enough detail about SMF dosage to permit protocol replication by other investigators. Our findings highlight the need to optimize SMF dosing parameters for individual clinical conditions before proceeding to a full-scale clinical trial.

scholarly journals Reporting quality of randomized, controlled trials evaluating immunotherapy in lung cancer

2021 ◽  
Author(s):  
Jun Du ◽  
Yundi Zhang ◽  
Yiting Dong ◽  
Jianchun Duan ◽  
Hua Bai ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Randomized Controlled Trials ◽  
Reporting Quality ◽  
Controlled Trials ◽  
Randomized Controlled

Tools to assess the Risk of bias and Reporting Quality of Randomized Controlled Trials in Rehabilitation

2021 ◽  
Author(s):  
Susan Armijo-Olivo ◽  
Michele Patrini ◽  
Ana Izabela S de Oliveira-Souza ◽  
Liz Dennett ◽  
Chiara Arienti ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Reporting Quality ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomized Controlled

scholarly journals Promoting Diet and Physical Activity in Nurses

2016 ◽  
Vol 31 (1) ◽  
pp. 19-27 ◽  
Author(s):  
Luciana Torquati ◽  
Toby Pavey ◽  
Tracy Kolbe-Alexander ◽  
Michael Leveritt
Keyword(s):  
Physical Activity ◽  
English Language ◽  
Data Extraction ◽  
Student Nurses ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Data Synthesis ◽  
Diet And Physical Activity ◽  
Data Source

Objective. To systematically review the effectiveness of intervention studies promoting diet and physical activity (PA) in nurses. Data Source. English language manuscripts published between 1970 and 2014 in PubMed, Scopus, CINAHL, and EMBASE, as well as those accessed with the PICO tool, were reviewed. Study Inclusion and Exclusion Criteria. Inclusion criteria comprised (1) nurses/student nurses working in a health care setting and (2) interventions where PA and/or diet behaviors were the primary outcome. Exclusion criteria were (1) non–peer-reviewed articles or conference abstracts and (2) interventions focused on treatment of chronic conditions or lifestyle factors other than PA or diet in nurses. Data Extraction. Seventy-one full texts were retrieved and assessed for inclusion by two reviewers. Data were extracted by one reviewer and checked for accuracy by a second reviewer. Data Synthesis. Extracted data were synthesized in a tabular format and narrative summary. Results. Nine (n = 737 nurses) studies met the inclusion criteria. Quality of the studies was low to moderate. Four studies reported an increase in self-reported PA through structured exercise and goal setting. Dietary outcomes were generally positive, but were only measured in three studies with some limitations in the assessment methods. Two studies reported improved body composition without significant changes in diet or PA. Conclusions. Outcomes of interventions to change nurses’ PA and diet behavior are promising, but inconsistent. Additional and higher quality interventions that include objective and validated outcome measures and appropriate process evaluation are required.

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