Standards Of Reporting Trials Research Articles

Effects of phrenic nerve magnetic stimulation on respiratory function in stroke patients: study protocol for a randomised controlled trial.

Respiratory dysfunction is a notable complication in stroke patients, in which the diaphragm, as the primary respiratory muscle, directly influences lung function. Repetitive peripheral magnetic stimulation (rPMS) is a new, non-invasive approach that is used to treat brain and nerve problems. Few studies have examined the effect of magnetic stimulation on the phrenic nerve, breathing and diaphragm in stroke patients. This study aims to assess the effect of magnetic phrenic nerve stimulation on respiratory muscle function and lung function in adults with stroke. The results of this study may provide a promising approach to managing respiratory dysfunction in stroke patients. This randomised controlled trial is designed to compare the effectiveness of bilateral magnetic phrenic nerve stimulation (rPMS) and conventional rehabilitation training in enhancing respiratory muscle strength, lung function indicators, diaphragmatic excursion and diaphragm thickness in patients with respiratory muscle weakness. Thirty patients admitted to the First Hospital of Fujian Medical University will be included in this study. Participants in the intervention group will undergo daily bilateral magnetic phrenic nerve stimulation for 2 weeks. Stimulation will be administered at a frequency of 25 Hz, with a pulse duration of 1.1 s and an inter-pulse interval of 5.9 s, for 5 days each week. Primary outcome measures will be assessed at baseline and after 2 weeks (end of the intervention) to evaluate the efficacy of rPMS compared with conventional rehabilitation techniques. Before commencing the study, all participants will receive a comprehensive explanation of the study procedures, including the assessments. They will also be provided informed consent forms for review, completion and signing. This study was approved by the Ethics Committee for Research at the First Affiliated Hospital of Fujian Medical University (No.: MRCTA, ECFAH of FMU [2021]641, dated 10 November 2023) (Appendix Ⅰ & Ⅱ). The trial protocol will strictly adhere to the Uniform Standards for Reporting of Trials (CONSORT) statement. The trial has been registered with the Chinese Clinical Trial Registry.Dissemination of individual findings for each participant will be available at the end of the study. The findings will be disseminated to different interest groups, participants or other patients with respiratory dysfunction through journal papers and/or conference presentations. The results of the primary trial will be submitted for publication in a peer-reviewed journal. ChiCTR2300075669, registered on 12 September 2023.

Quality reporting of randomized controlled trials on SGLT2 inhibitors for heart failure: a comprehensive assessment

Randomised controlled trials (RCTs) provide clinicians with the best evidence of the effectiveness of an intervention, and complete and transparent trial reports help to critically assess and use trial results. The objective of our study was to assess the quality of reporting in RCTs of sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for heart failure (HF) and identify factors associated with improved reporting quality. Two researchers conducted a comprehensive search in four databases (PubMed, Web of Science, EMBASE, and Cochrane). The quality of each report was assessed using a 25-point Overall Quality Score (OQS) based on the guidelines provided in the 2010 Consolidated Standards for Reporting of Trials (CONSORT) statement. We included a total of 58 relevant RCTs. The median OQS in the 2010 CONSORT statement was 15 (range 7.5–24). The missing items were primarily found in the 'Methods' and 'Results' sections of the 2010 CONSORT statement. Multivariate regression modeling revealed that a more recent publication year, high impact factor, and large sample size were significant predictors of OQS improvement. The findings suggest that the overall quality of reported RCTs of SGLT2 inhibitors in HF is unsatisfactory, which reduces their potential usefulness.

Benefits of equine therapies on the cognitive of children with Autism Spectrum Disorder: systematic review and meta-analysis

Autistic Spectrum Disorder (ASD) is a neurodevelopmental disorder whose main characteristics are changes in cognitive areas and social deficit. The aim of this study was to describe the benefits of equine activities and therapies in the cognitive areas of children with ASD/autism. This is a systematic review with meta-analysis of scientific articles indexed in the following online databases: BVS Salud, Periódicos CAPES, PubMed, Science.Gov and SCIELO, in addition to the website of the National Association of Riding Therapy (ANDE), Brazil, and the REDALYC platform, for inclusion of additional studies. As per Preferred Reporting Items for Systematic Reviews and Meta-analysis and assessed for quality by Consolidated Standards for Reporting of Trials - CONSORT checklist. There were 29 articles eligible for analysis, totaling 591 participants. The methods used in the interventions and evaluations differed between the articles, but it was possible to identify benefits of horse-assisted activities and therapies in the cognitive areas of children with ASD and autism, especially with regard to social and emotional cognitive, as well as, in reducing irritability, hyperactivity and aggressiveness. Therefore, this systematic review confirms the benefits of horse-assisted activities and therapies in the cognitive areas of children with ASD and autism with intellectual deficit.

ACURATE: A Guide for Reporting Sham Controls in Trials Using Acupuncture

ACURATE: A Guide for Reporting Sham Controls in Trials Using Acupuncture

ACURATE: A guide for reporting sham controls in trials using acupuncture

This paper presents the Acupuncture Controls gUideline for Reporting humAn Trials and Experiments (ACURATE) checklist, an extension of The Consolidated Standards for Reporting of Trials (CONSORT) and to be used along with STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) when both real and sham acupuncture needles are used in the study. This checklist focuses on a clear depiction of sham needling procedures to enhance replicability and enable a precise appraisal. We encourage researchers to use ACURATE in trials and reviews involving sham acupuncture to assist reporting of sham acupuncture procedures and the related components.

Reporting quality of RCTs of acupuncture for vascular dementia

To evaluate the reporting quality of randomized controlled trials (RCTs) of acupuncture for vascular dementia. The RCTs of acupuncture for vascular dementia were systematically retrieved from the Cochrane Library, PubMed, EMbase, CNKI, SinoMed, VIP and Wanfang databases from the date of establishment to October 31, 2018. The reporting quality of RCT was evaluated based on the internationally-recognized Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). A total of 33 RCTs were included. According to the CONSORT statement, 12 items had a reporting rate of 0%, including important changes to methods after trial commencement, sample size, blind method, trial registry, etc.; 5 items had a reporting rate of below 10%, including trial design, type of randomization, random allocation sequence, randomization implementation and participant flow. The reporting rate was 36.36% for baseline data and 57.58% for randomization sequence generation. According to the STRICTA statement, the reporting rate was 21.21% for description of acupuncture depth, 60.61% for description of acupuncture response, 27.27% for description of additional intervention details and 0% for qualification of acupuncturists, respectively. At present, the reporting quality of RCTs of acupuncture for vascular dementia is generally low. In the future, the RCTs of acupuncture for vascular dementia should be normatively reported according to the CONSORT statement and STRICTA statement.

Reporting quality of randomized controlled trials of acupuncture for cancer pain

Based on the internationally-recognized Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA), the reported quality of randomized controlled trials (RCTs) of acupuncture for cancer pain during last 10 years were evaluated. The RCTs of acupuncture for cancer pain were searched by computer. The English databases included PubMed and EMbase while the Chinese databases included CNKI, Wanfang, VIP and SinoMed. The publication date of the literature was from March 2009 to March 2019. As a result, 22 Chinese RCTs and 13 English RCTs were included. According to the CONSORT statement, among the Chinese studies, 1 RCT reported primary and secondary outcomes, 8 RCTs reported randomization, none of RCTs reported allocation concealment and blind method, and 4 RCTs reported baseline data; among the English studies, 8 RCTs reported primary and secondary outcomes, 8 RCTs reported randomization, 6 RCTs reported described allocation concealment, 7 RCTs reported blind method, and 13 RCTs reported baseline data. According to the STRICTA statement, among the Chinese studies, 17 RCTs reported the name of acupoints, 6 RCTs reported depth of insertion, 17 RCTs reported acupuncture response sought, and none of RCTs reported the qualifications of acupuncturists; among the English studies, 12 RCTs reported the name of acupoints, 7 RCTs reported depth of insertion, 8 RCTs reported acupuncture response sought, and 7 RCTs reported the qualifications of acupuncturists. The Chinese RCTs have more detailed description of acupuncture intervention and theory, but not enough attention is paid to methodological description such as randomization, blindness, data analysis. On the other hand, the English RCTs have better description of methodology, but the description of theory and details of acupuncture is relatively weak. It is concluded that more efforts were needed to further improve the clinical trial design according to the CONSORT statement and STRICTA statement to improve the quality of clinical evidence.

Assessment of the Quality of Randomized Clinical Trials Published by Iranian Researchers in Persian Internal Journals in 2014

Introduction: A randomized clinical trial is known as the best and most effective way to assess the effects of interventions if it is properly planned and implemented. The purpose of this study was to evaluate the quality of clinical trials published in Persian internal journals by Iranian researchers. Method: In this cross-sectional study, all the clinical trials published by Iranian researchers in the Iranian Journals in 2014, were evaluated according to entry criteria and finally 587 included articles were reviewed and their quality was evaluated by using Consolidated Standards of Reporting Trials (CONSORT) checklist. Results: The results revealed that the mean±SD adherence to the CONSORT checklist’s item in our included articles was 59.61±24.99. The lowest adherence to the items was seen for random allocation (76.1%), description of the sampling method (70.1%) and presenting RCT code registration (60.4%), respectively. The highest adherence was observed for title suitability (96%), appropriate presentation time and place of study (84.2%), a suitable expression of study participants (82.8%) and time duration of the study (82.3%). Conclusion: The adherence to the various items of CONSORT checklist in Iranian Persian language journals was not in satisfactory status. In this regard, the CONSORT checklist needs to be carefully followed for conducting and reporting RCTs by Iranian researchers.

Literature quality analysis of RCTs regarding acupuncture for chronic neck pain

The internationally-accepted Consolidated Standards for Reporting of Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) were applied to evaluate the literature quality of randomized controlled trials (RCTs) regarding acupuncture for chronic neck pain in past 10 years. The literature of RCTs regarding acupuncture for chronic neck pain was searched by computer; the English literature was searched in PubMed and EMbase, while the Chinese literature was searched in CNKI, Wanfang database, VIP database and China Biomedical Literature Database. The literature published from January 2008 to January 2018 was searched. As a result, 29 Chinese articles and 10 English articles were included. According to CONSORT, among Chinese articles, 28 articles (96.6%) described baseline data, 23 articles (79.3%) described randomization, 0 articles (0.0%) described allocation concealment, 3 articles (10.3%) described blind method; among English articles, 6 articles (60.0%) described baseline data, 8 articles (80.0%) described randomization, 8 articles (80.0%) described allocation concealment, and 7 articles (70.0%) described blind method. According to STRICTA, among Chinese articles, 8 articles (27.6%) described needle instrument selection, 18 articles (62.1%) described needle depth, 24 articles (82.8%) described needling sensation, and 0 articles (0.0%) described acupuncturist' qualifications; among English articles, 5 articles (50.0%) described needle instrument selection, 8 articles (80.0%) described needle depth, 3 articles (30.0%) described needling sensation, and 4 articles (40.0%) described acupuncturist' qualifications. In conclusion, the reporting of acupuncture details in Chinese literature is superior to that in English literature, while the reporting of trial design in English literature is slightly superior to that in Chinese literature. Moreover, both Chinese and English literature need to further improve clinical trial design to improve the reporting quality of clinical evidence based on CONSORT and STRICTA.

Assessing the quality of reports about randomized controlled trials of scalp acupuncture treatment for vascular dementia

BackgroundThis study aimed to evaluate the quality of reports about randomized controlled trials (RCTs) of scalp acupuncture (SA) for the treatment of vascular dementia (VD).MethodA systematic search of reports published through to December 2015 was performed in eight databases. The quality of RCTs that used SA as an intervention for VD was evaluated based on the 2010 Consolidated Standards for Reporting of Trials (CONSORT) and 2010 Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Thirteen items from the CONSORT guideline were scored to give an overall quality score (OQS, range 0–13), and a combined key methodological index score (MIS) (range 0–5) of five key methodological items was measured. The OQS of 17 items from the STRICTA guideline (range 0–17) was also measured.ResultsIn total, 26 reports were evaluated. The median OQS based on the CONSORT guideline was 8 (minimum 5, maximum 11), and “trial design,” “sample size,” “ancillary analyses,” and “harms” had a positive rate of less than 10%. The median MIS was 2 (minimum 0, maximum 5), with “allocation concealment and implementation,” “blinding,” and “intent-to-treat analysis” having a positive rate of less than 15%. The median OQS based on the STRICTA guideline was 12 (minimum 8, maximum 14), with “extent to which treatment was varied (1c),” “number of needle insertions per subject per session (2a),” and “setting and context of treatment (4b)” having a positive rate of less than 10%.ConclusionsThe overall quality of reports on RCTs of SA treatment for VD was moderate to low. The quality of methodological items was markedly lower than that of other items. The CONSORT and STRICTA guidelines should be used more frequently to standardize the quality of RCT reports of SA treatment for VD.

Comparison of the efficacy of once- and twice-daily colchicine dosage in pediatric patients with familial Mediterranean fever--a randomized controlled noninferiority trial.

BackgroundIn this study, we examined the efficacy and safety of a once-daily dosage schema of colchicine compared with a twice-daily dosage schema in pediatric patients with familial Mediterranean fever (FMF).MethodsIn this 24-week, multicenter, randomized controlled noninferiority trial, pediatric patients newly diagnosed with FMF carrying a homozygous or compound heterozygous mutation and not receiving any treatment were included. Patients were randomly assigned using a block randomization method to receive treatment with a once- or twice-daily dosage. Clinical and laboratory characteristics and medication side effects were recorded and compared between groups. The study was carried out in compliance with Good Clinical Practice and the Consolidated Standards for Reporting of Trials (CONSORT) statement.ResultsA total of 92 patients were selected, and 79 patients completed the study. There were 42 patients in the once-daily dosage group and 37 in the twice-daily dosage group. The results indicated that the once-daily dosage was not inferior to the twice-daily dosage regarding decrease in attack frequency and duration as well as improvement in clinical findings and Mor severity scores. Alterations in laboratory findings indicating inflammation, such as erythrocyte sedimentation rate, C-reactive protein, and serum amyloid A, were similar in both groups. The rates of drug side effects were similar between the once- and twice-daily dosage groups, implying comparable safety of colchicine, with the exception of diarrhea, which was slightly higher in the once-daily dosage group.ConclusionsUsing colchicine with either a once- or twice-daily dosage provides similar clinical and laboratory improvements. Considering both efficacy and safety, colchicine can be prescribed with a once-daily dosage.Trial Registration IDClinicalTrials.gov identifier NCT02602028. Registered 5 November 2015.

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

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. 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. 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. 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.

Endorsement of CONSORT by Chinese medical journals: a survey of "instruction to authors".

To determine the extent to which Chinese medical (CM) journals incorporate Consolidated Standards for Reporting of Trials (CONSORT) into their "instruction to authors". We reviewed the latest "instruction to authors" of the CM journals in China which indexed by MEDLINE in 2010 or Excerpta Medica Database (EMBASE) in 2012 and extracted all information of CONSORT, International Committee of Medical Journal Editors (ICMJE), other reporting guidelines or clinical trial registration. By reading the instructions to authors and reviewing recent studies published in those journals, those that do not publish clinical trials were excluded. We also contacted each of journals by telephone on contributor's status to ask them whether mentioned CONSORT in their instructions and incorporated it into their editorial and peer-review process. Full-text papers of randomized controlled trials (RCTs, from January 2011 to March 2012) published in the journals which mentioned "CONSORT" in their instructions for authors were downloaded. Seven CM journals were included. Three of these journals mentioned CONSORT in its instructions. By telephone survey, all journals gave responses and all respondents knew CONSORT statement. Three of 7 journals required authors to comply with the CONSORT statement and provide the CONSORT checklist and a flow chart of the trial. The rest 4 journals recommended authors of RCTs to refer to the CONSORT statement. From January 2011 to March 2012, a total of 50 RCTs were obtained from the 3 journals endorsing the CONSORT statement; 17 (17/50, 34%) contained a flow diagram in their manuscript, and none of those RCTs had mentioned the trial registration information. The endorsement of CONSORT by CM journals' "instruction to authors" was not satisfactory. The spread of CONSORT endorsement should be wider in instructing the performance of CM clinical trials in the future. Chinese journals should introduce CONSORT to their authors and require authors to comply with CONSORT when they submit their research.

Insufficient Reporting on Race and Ethnicity in Randomized Trials for Patients With Rheumatoid Arthritis: Comment on the Article by Simsek et al

describing the incomplete reporting of recruitment infor-mation for rheumatoid arthritis (RA) patients in clinicaltrials of biologic agents (1). We agree with the authors’assessment that the inadequacy of information on the re-cruitment process limits the reader’s ability to assess theexternal validity of the findings.We would also like to highlight other important limita-tions in the reporting of clinical trial results of biologicagents in RA that compromise the generalizability of thefindings to individual patients. Whereas participant ageand sex are uniformly reported, information concerningrace and ethnicity is inconsistently reported despiteemerging evidence of disparities in outcomes among mi-nority patients (2). To support this observation, we per-formed a systematic review of 76 published clinical trialsof biologic agents from 1999 to 2012 and found that 29(38%) of the 76 trials reported on the proportion of pa-tientswhowerewhiteversusnonwhite,andonly11(14%)of the 76 trials reported on race or ethnic subgroups. Sim-ilar trends have been observed in other reviews of clinicaltrials from the general medical literature (3).It should be further emphasized that reporting of otherpatient characteristics reflecting socioeconomic status,such as employment status and household income, wouldbe helpful to improve the interpretability of results (4).These indices were previously found to significantly im-pact patient outcomes in several diseases, including RA(5). Exclusion of these types of data points may hinder aclinician’s ability to determine whether the findings of aparticular study are applicable to individual patients.As pointed out by Simsek and Yazici, consensus state-ments such as the Consolidated Standards of ReportingTrials offer guidance regarding the reporting of results,although the original guidelines do not specifically ad-dress the reporting of race and ethnicity (6). We believethat increased reporting of patient demographic informa-tion, particularly race and ethnicity, could shed light onthe reasons for the disparities in outcomes seen in minor-ity patients in clinical practice (7). This increased report-ing will also improve the interpretability of results fromtrials of biologic agents in RA to specific patient popula-tionsandclarifythegeneralizabilityoftheseresultsforourincreasingly diverse patient population.Jeffrey Potter, MDTanya Spruill, PhDJeffrey D. Greenberg, MD, MPH

Assessment of the quality of clinical therapeutic research published in Chinese Journal of Pediatrics

To evaluate the methodological qualities of clinical therapeutic research papers published in Chinese Journal of Pediatrics and find out the weaknesses and defects in the literature of clinical therapeutic research in China. The clinical therapeutic research articles from Chinese Journal of Pediatrics, which were published in the years 1999, 2000, 2001, 2009, 2010 and 2011, were analyzed manually, after dividing into randomized controlled trials (RCT) and non-randomized controlled trials. The methodological quality of RCT articles were evaluated by Consolidated Standards for Reporting of Trials (CONSORT) and Jadad scale, while non-RCT reports were assessed by specific evaluation standard criteria and analytical table. And the group A (1999 - 2001) and group B (2009 - 2011) of the quality documents were compared and analyzed. Seventeen RCTs were included. Based on the items in the CONSORT statement, the reporting quality of sample size determination, demographic baseline, random principle, blinding, lost to follow-up were all lower than 50%. Fourteen (82.4%) in the 17 RCTs mentioned 'eligibility criteria for participants', 11 (64.7%) RCTs mentioned 'details of the interventions', 15 (88.2%) RCTs mentioned 'adverse effects'. Compared with RCT reports in the year of 1999, 2000 and 2001, the methodological qualities of those in 2009, 2010 and 2011 were not improved. In the 17 RCTs, the total score achieved based on the Jadad scale, only 11.8% (2 out of 17) were high-quality trials (≥ 3 points). Analysis of the 28 non-RCTs, which were included and assessed by evaluation criteria and evaluation table, also showed some disadvantages on some key items. The methodological quality of clinical therapeutic research reports should be consistent with the standards of international evaluation, pediatric clinicians should improve know ledge in clinical epidemiology, clinical trial methodology, and improve the quality of research reports.

Randomized trials, systematic reviews, meta-analyses: basic criteria in the world of scientific evidence

Under ordinary circumstances choosing the best treatment for each individual patient is a challenging issue. This choice should be based on three main aspects: the patients' psychopathological status, the clinical experience and the best scientific knowledge available regarding efficacy and safety of each treatment. The approach that integrates these three aspects is known as Evidence Based Medicine (EBM). The aim of this report is to present the main methodological features of what constitutes an evidence base, in order to assist mental health professionals in the compelling world of scientific evidence. We describe randomized controlled trials as a tool for evaluating the efficacy and tolerability of treatments, systematic reviews of randomized trials, and meta-analysis, a statistical technique that allows to calculate a weighted pooled estimate of treatment efficacy and tolerability. Finally we will describe two standardized tools for assessing quality of evidence, the CONSORT (Consolidated Standards for Reporting of Trials) statement and the GRADE (Grading of Recommendations Assessment, Development and Evaluation).

Assessing the quality of reports about randomized controlled trials of acupuncture treatment on mild cognitive impairment.

ObjectiveTo evaluate the reports' qualities which are about randomized controlled trials (RCTs) of acupuncture treatment on Mild Cognitive Impairment (MIC).MethodsNine databases including the Cochrane Central Register of Controlled Trials (CENTRAL,2010), PUBMED (1984-5/2010), EMbase (1984-5/2010), MEDLINE (1984-5/2010), CINAL (1984-5/2010), China National Knowledge Infrastructure (CNKI, 1980-5/2010), China Biomedicine Database disc (CBMdisc, 1980-5/2010), VIP (a full text issues database of China, 1989-5/2010) were searched systematically. Hand search for further references was conducted. Language was limited to Chinese and English. We identified 14 RCTs that used acupuncture as an intervention and assessed the quality of these reports against the Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA).ResultsIn regard to the items in the CONSORT statement, 13(92.86%) RCTs described baseline demographic and clinical characteristics in each group. 7 (50.0%) mentioned the method of generating the random sequence, only 2 (14.3%) RCTs had adequate allocation concealment. No RCTs used blinding. RCTs reported the sample size calculation. In regard to the items in STRICTA, 10 (71.43%) mentioned the depths of insertion, 6 (42.86%) reported acupuncture response, 11 (78.57%) mentioned the technique of acupuncture, 12 (85.71%) recorded the time, and only 3 (21.43%) RCTs reported the numbers of needles inserted. No RCTs reported the background of the acupuncture practitioners and professional title of practitioners.ConclusionThe reporting quality of RCTs of acupuncture for mild cognitive impairment was moderate to low. The CONSORT statement and STRICTA should be used to standardize the reporting of RCTs of acupuncture in future.

Standards for reporting randomized controlled trials in neurosurgery

The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials. The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist. In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39-44) compared with those published in neurosurgical journals (mean 26.4, range 17-38; p < 0.0001). Jadad scores were also significantly higher for the major medical journals (mean 3.42, range 2-5) than neurosurgical journals (mean 2.45, range 1-5; p = 0.05). Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could improve the methodology and reporting of RCTs in neurosurgery.

Quality reporting of endoscopic diagnostic studies in gastrointestinal journals: where do we stand on the use of the STARD and CONSORT statements?

Many papers have been published in the field of diagnostic endoscopy in the last few years. However, there are no reports on their quality. The aim of this study was to evaluate quality in recently published endoscopic articles. The study reviewed published articles on diagnostic endoscopy from 1998 to 2008. Quality was assessed and independently quantified by two observers using the STARD (STandards for the Reporting of Diagnostic accuracy studies) and CONSORT (Consolidated Standards for Reporting of Trials) statements. The interobserver proportion of agreement and kappa coefficient were estimated. A total of 120 articles comprising 10 randomized controlled trials and 110 diagnostic accuracy studies were evaluated. Most studies related to colonic polyp detection (30 %) or evaluation of Barrett's esophagus (29 %). Chromoscopy (45 %), fluorescence (21 %), and narrow-band imaging (14 %) were the technologies most often evaluated. The mean number of items (i. e. standard requirements) fulfilled by the randomized controlled trials was 15.7 +/- 2.2 out of 22 while for the diagnostic accuracy studies it was 12.2 +/- 3.6 out of 25. Reporting of study results was complete in 90 % of the randomized controlled trials, but only 65 % of the diagnostic accuracy studies presented a cross-table of results. The global proportion of agreement between observers was 97 % in randomized controlled trials and 95 % in diagnostic accuracy studies. Recent publications in diagnostic endoscopy achieve only medium quality according to the available statements. It seems that it would be useful for authors, reviewers, and editors to be familiar with and apply these statements. The development of a specific checklist for diagnostic endoscopy publications might be helpful toward achieving better quality reporting in the future.

Quality of Randomized Controlled Trials in Acupuncture Treatment of Hepatitis B Virus Infection–A Systematic Review

The purpose of this work was to evaluate the quality of randomized controlled trials (RCTs) with acupuncture treatment for hepatitis B virus (HBV) infection. A systematic review of the literature for clinical trials was performed up to September 2008. RCTs assessing acupuncture point stimulation for patients with HBV infection were considered for inclusion. The search identified 70 relevant trials meeting the inclusion. The quality of each trial was assessed using the revised Consolidated Standards for Reporting of Trials (CONSORT) statement, facilitating critical appraisal and interpretation of RCTs by providing guidance to authors; the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) recommendations, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies; and the Jadad scale, widely used in different settings to assess methodological quality. All trials were reported "randomization", but only 2 mentioned the methods. None reported allocation concealment, a method used to keep clinicians and participants unaware of upcoming assignments. None reported blinding. 3 studies described the number of withdrawals/dropouts, while none used the analysis of "intention to treat". The reported items of the STRICTA recommendations were assigned for 65% (13 out of 20). Only 2 studies had a high quality Jadad score. The results from our work show that the quality was low caused by their methodological flaws and inadequate reports. Further rigorous clinical trials for HBV infection would be necessary to evaluate the efficacy of acupuncture.