Consolidated Standards For Reporting Trials Research Articles

Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs)

BackgroundEvidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on replication to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential; however, SWAT publications are often the first to be abandoned in the face of other time pressures. Reporting guidance for embedded methodology trials does exist but is not widely used. We sought therefore to build on these guidelines to develop a straightforward, concise reporting standard, which remains adherent to the CONSORT guideline.MethodsAn iterative process was used to develop the guideline. This included initial meetings with key stakeholders, development of an initial guideline, pilot testing of draft guidelines, further iteration and pilot testing, and finalisation of the guideline.ResultsWe developed a reporting guideline applicable to randomised SWATs, including replications of previous evaluations. The guideline follows the Consolidated Standards for Reporting Trials (CONSORT) statement and provides example text to ensure ease and clarity of reporting across all domains.ConclusionsThe SWAT reporting guideline will aid authors, reviewers, and journal editors to produce and review clear, structured reports of randomised SWATs, whilst also adhering to the CONSORT guideline.Trial registrationEQUATOR Network – Guidelines Under Development (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#SWAT). Registered on 25 March 2021.

Review on Ethics in Research – Homoeopathic Perspective

AbstractEthics is a moral principle that governs a system. Research ethics may be defined as doing what is morally and legally right in research. Despite dealing with human beings, homoeopathy research deals with human clinical, pre-clinical (drug proving) trials, preclinical animal studies, veterinary studies and plant studies that demand varied ethical strategies. The importance of ethics in medical research is mandated to avoid adverse events before, during and after the trials. Ethics in medical practice and medical research is based on Nuremberg's Code and Declaration of Helsinki. The two major guidelines in the homoeopathic medical research publications are Reporting data on Homeopathic treatments (RedHot): A supplement to Consolidated Standards for Reporting Trials (CONSORT) for clinical trials and Reporting Experiments in Homeopathic Basic Research (REHBaR). This article discusses the evolution of ethics in medical research, principles of ethics, components to be considered pre-trial, during and post-trial. The evolution of strategies based on the principles of ethics in medical research is correlated.

Overall Reporting Descriptions of Acupuncture for Chronic Pain in Randomized Controlled Trials in English Journals.

BackgroundWhether the clinical effect of acupuncture in chronic pain is effective has always been a hot topic of research, which has a great relationship with the overall reporting descriptions of acupuncture, especially the sham acupuncture intervention. To confirm the effectiveness of acupuncture, more clinical studies are often required. Therefore, it is necessary to report high-quality and complete descriptions of acupuncture in clinical trials. This study aims to assess the overall reporting quality of acupuncture for chronic pain in randomized controlled trials (RCTs).MethodsThree databases from inception to March 2020 were searched, to assess the quality of acupuncture reports included the RCTs based on the pain-specific supplement to Consolidated Standards for Reporting Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. The quality of sham acupuncture descriptions was evaluated based on the Template for Intervention Description and Replication (TIDieR)-placebo checklist. Descriptive statistics and analysis of the results were carried out according to the percentage of each item.ResultsA total of 74 RCTs were included which met the inclusion criteria. Based on the pain-specific CONSORT, the reporting rates of “Statistical methods”, “Participant flow”, and “Blinding” were “52.70%”, “70.27%”, and “77.03%”, respectively. The weakest reported items in STRICTA were related to the depth of insertion (Item 2c, 54.05%) and the setting and context of treatment (Item 4b, 0.00%). Based on the TIDieR-placebo checklist, the reporting rates of “Item 12”, “Item 11”, “Item 13”, “Item 3”, and “Item 4” were “8.11%”, “10.81%”, “29.73%”, “ 44.59% ”, and “47.30%”, respectively.ConclusionAt present, the overall report quality of acupuncture treatment for chronic pain in English journals is acceptable, but the report rate in some aspects is still low. In the future, researchers should report RCTs of acupuncture following cleaner checklists and guidelines.

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

ObjectivesThis systematic review aimed to determine the improvement in quality of the reporting of randomized clinical trials (RCTs) in paediatric dentistry. The quality of reporting during the period 2014–2015 was compared with the quality of reporting during 1985–2006.MethodsThis systematic review compared the scientific quality of RCTs in paediatric dentistry published in five paediatric dentistry journals during the defined periods. The Consolidated Standards for Reporting Trials (CONSORT) checklist of 2010 was used to evaluate the quality of reporting. The inter-reviewers’ agreement was assessed by calculating the kappa score, and disagreements between reviewers were resolved by consequent discussion. The p values and percentages were used to test for significant differences between the two reviews (1985–2006 and 2014–2015).ResultsA total of 40 articles were included. Although the quality of reporting showed considerable heterogeneity, the overall quality of reporting by RCTs was satisfactory and had improved over the years.ConclusionsUsing CONSORT checklist, this study showed general improvement in the quality of reporting of RCTs published in pediatric dentistry journals in all article's sections.

Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) guidelines: a development protocol.

Randomized clinical trials are acknowledged as the most appropriate methodology for demonstrating the efficacy or effectiveness of one intervention as opposed to another and thus play a major role in clinical decision-making. However, it is recognized that despite the existence of various guidelines, for example, the Consolidated Standards for Reporting Trials (CONSORT) statement, the quality of manuscripts describing randomized trials is often suboptimal. The current project aims to develop and disseminate new guidelines, Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE), to improve the planning and reporting quality of randomized trials in the field of Endodontics. The project leads (VN, PD) designed a robust process to develop the PRIRATE guidelines. At first, a steering committee of eight members, including the project leads, was formed. Thereafter, a five-stage consensus process will be followed: initial steps, pre-meeting activities, face-to-face consensus meeting, post-meeting activities and post-publication activities. The steering committee will develop the first draft of the PRIRATE guidelines by identifying relevant and important items from various sources including the CONSORT guidelines and the Clinical and Laboratory Images in Publications (CLIP) principles. This will be followed by the establishment of a PRIRATE Delphi Group (PDG) consisting of 30 members. The individual items of the first draft of the PRIRATE guidelines developed by the steering committee will be evaluated and scored on a 9-point Likert scale by the PDG members. Items with a score of seven and above by more than 70% of PDG members will be included in the second draft of the guidelines, and the Delphi process will be repeated until each item fulfils the set conditions. After obtaining consensus from the PDG, the PRIRATE guidelines will be discussed by 20 selected individuals within a PRIRATE Face-to-face Consensus Meeting Group (PFCMG) to arrive at a final consensus. The final PRIRATE guidelines will be accompanied with an explanation and elaboration document developed by the steering committee and approved by six members, three from the PDG and three from the PFCMG. The PRIRATE guidelines will be published in journals and actively disseminated toeducational institutions, national and internationalacademic societies and presented at scientific meetings. The steering committee will periodically revise and update the PRIRATE guidelines based on feedback from stakeholders.

Medical treatment of urinary stones.

To identify the latest progression on medical treatment of urinary stones. Nonsteroidal anti-inflammatory drugs should be the preferred analgesic option for patients presenting to the emergency department with renal colic. A-blockers could be of patient benefit when used for distal ureteral stones more than 5 mm in size. However, the quality of the randomized controlled studies on medical expulsive therapy (MET) is still low based on the Consolidated Standards for Reporting Trials (CONSORT) criteria. MET should be used with caution in children and pregnant women. In patients with renal stones, the evaluation of the comorbidities of developing chronic Kidney Disease (CKD) or End Stage Renal Disease (ESRD) is mandatory. It is highly recommended to follow the European Association of Urology Urolithiasis Guidelines Panel Diagnostic and Therapeutic algorithms to prevent stone recurrence. Medical treatment of urinary stone disease should be supported by well designed higher level of evidence clinical research.

Clinical Outcomes After the Nonoperative Management of Lateral Patellar Dislocations: A Systematic Review.

Background:The first-line treatment for patellar dislocations is often nonoperative and consists of physical therapy and immobilization techniques, with various adjuncts employed. However, the outcomes of nonoperative therapy are poorly described, and there is a lack of quality evidence to define the optimal intervention.Purpose:To perform a comprehensive review of the literature and assess the quality of studies presenting patient outcomes from nonoperative interventions for patellar dislocations.Study Design:Systematic review; Level of evidence, 4.Methods:The MEDLINE, AMED, Embase, CINAHL, Cochrane Library, PEDro, and SPORTDiscus electronic databases were searched through July 2017 by 3 independent reviewers. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. Study quality was assessed using the CONSORT (Consolidated Standards for Reporting Trials) criteria for randomized controlled trials and the Newcastle-Ottawa Scale for cohort studies and case series.Results:A total of 25 studies met our inclusion criteria, including 12 randomized controlled trials, 7 cohort studies, and 6 case series, consisting of 1066 patients. Studies were grouped according to 4 broad categories of nonoperative interventions based on immobilization, weightbearing status, quadriceps exercise type, and alternative therapies. The most commonly used outcome measure was the Kujala score, and the pooled redislocation rate was 31%.Conclusion:This systematic review found that patient-reported outcomes consistently improved after all methods of treatment but did not return to normal. Redislocation rates were high and close to the redislocation rates reported in natural history studies. There is a lack of quality evidence to advocate the use of any particular nonoperative technique for the treatment of patellar dislocations.

Assessment of Reporting Quality in Randomised Controlled Trials of Acupuncture for Post-Stroke Rehabilitation Using the Consort Statement and Stricta Guidelines

To evaluate the completeness of reporting of randomised controlled trials (RCTs) of acupuncture for post-stroke rehabilitation in order to provide information to facilitate transparent and more complete reporting of acupuncture RCTs in this field. Multiple databases were searched from their inception through September 2015. Quality of reporting for included papers was assessed against a subset of criteria adapted from the Consolidated Standards for Reporting Trials (CONSORT) 2010 statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Each item was scored 1 if it was reported, or 0 if it was not clearly stated. Descriptive statistical analysis was performed. Cohen's κ-statistics were calculated to assess agreement between the two reviewers. A total of 87 RCTs were included in the full text. Based on CONSORT, good reporting was evident for items ''Randomised' in the title or abstract', 'Participants', 'Statistical methods', 'Recruitment', 'Baseline data', and 'Outcomes and estimation', with positive rates >80%. However, the quality of reporting for the items 'Trial design', 'Outcomes', 'Sample size', 'Allocation concealment', 'Implementation', 'Blinding', 'Flow chart', 'Intent-to-treat analysis', and 'Ancillary analyses' was very poor with positive rates <10%. Based on STRICTA, the items 'Number of needle insertions per subject per session', 'Responses sought', and 'Needle type' had poor reporting with positive rates <50%. Substantial agreement was observed for most items and good agreement was observed for some items. The reporting quality of RCTs in acupuncture for post-stroke rehabilitation is unsatisfactory and needs improvement.

Telerehabilitation Versus Traditional Care Following Total Hip Replacement: A Randomized Controlled Trial Protocol.

BackgroundTotal hip replacement (THR) is the gold standard treatment for severe hip osteoarthritis. Effectiveness of physical rehabilitation for THR patients following discharge from hospital is supported by evidence; however, barriers such as geographical location and transport can limit access to appropriate health care. One solution to this issue is using an alternative model of care using telerehabilitation technology to deliver rehabilitation programs directly into patients’ homes. A telerehabilitation model may also have potential health care cost savings for health care providers.ObjectiveThis study aims to determine if a telerehabilitation model of care delivered remotely is as effective as face-to-face rehabilitation in the THR population and cost effective for health care providers and patients.MethodsA total of 70 people undergoing THR will be recruited to participate in a randomized, single-blind, controlled noninferiority clinical trial. The trial will compare a technology-based THR rehabilitation program to in-person care. On discharge from hospital, participants randomized to the in-person group will receive usual care, defined as a paper home exercise program (HEP) targeting strengthening exercises for quadriceps, hip abductors, extensors, and flexors; they will be advised to perform their HEP 3 times per day. At 2, 4, and 6 weeks postoperatively, they will receive a 30-minute in-person physiotherapy session with a focus on gait retraining and reviewing and progressing their HEP. The telerehabilitation protocol will involve a program similar in content to the in-person rehabilitation program, except delivery will be directly into the homes of the participants via telerehabilitation technology on an iPad. Outcomes will be evaluated preoperatively, day of discharge from in-patient physiotherapy, 6 weeks and 6 months postoperatively. The primary outcome will be the quality of life subscale of the hip disability and osteoarthritis outcome score, measured at 6 weeks. Both intention-to-treat and per-protocol analyses as recommended in the extension of the Consolidated Standards for Reporting Trials (CONSORT) guideline for noninferiority trials will be performed.ResultsRecruitment commenced in September 2015 and is expected to be completed by June 2017. Data collection will be completed by December 2017. It is anticipated the results from this trial will be published by July 2018.ConclusionsPrevious research investigating telerehabilitation in postoperative orthopedic conditions has yielded promising results. If shown to be as effective as in-person care, telerehabilitation after THR could be helpful in addressing access issues in this population. Furthermore, it may help reduce the cost of health care provision by enabling patients to take a more independent approach to their rehabilitation.Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12615000824561; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364010 (Archived by WebCite at http://www.webcitation.org/6oWXweVfI)

Guidelines for reporting embedded recruitment trials.

BackgroundRecruitment to clinical trials is difficult with many trials failing to recruit to target and within time. Embedding trials of recruitment interventions within host trials may provide a successful way to improve this. There are no guidelines for reporting such embedded methodology trials. As part of the Medical Research Council funded Systematic Techniques for Assisting Recruitment to Trials (MRC START) programme designed to test interventions to improve recruitment to trials, we developed guidelines for reporting embedded trials.MethodsWe followed a three-phase guideline development process: (1) pre-meeting literature review to generate items for the reporting guidelines; (2) face-to-face consensus meetings to draft the reporting guidelines; and (3) post-meeting feedback review, and pilot testing, followed by finalisation of the reporting guidelines.ResultsWe developed a reporting checklist based on the Consolidated Standards for Reporting Trials (CONSORT) statement 2010. Embedded trials evaluating recruitment interventions should follow the CONSORT statement 2010 and report all items listed as essential. We used a number of examples to illustrate key issues that arise in embedded trials and how best to report them, including (a) how to deal with description of the host trial; (b) the importance of describing items that may differ in the host and embedded trials (such as the setting and the eligible population); and (c) the importance of identifying clearly the point at which the recruitment interventions were embedded in the host trial.ConclusionsImplementation of these guidelines will improve the quality of reports of embedded recruitment trials while advancing the science, design and conduct of embedded trials as a whole.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1126-y) contains supplementary material, which is available to authorized users.

Quality evaluation of randomized controlled trials reports of laparoscopy compared with open colorectal resection for colorectal cancer

Objectives: Previously, there were no data looking at the quality evaluation of randomized controlled trials (RCTs) on effect comparison of laparoscopic surgery and open surgery for colorectal cancer in China. Here, we evaluate the completeness and transparency of RCT reports in this field. Methods: The following databases were searched: Medline, EMbase, SCI Expanded, China National Knowledge Infrastructure, the Chinese Biological Medicine Database, VIP database and Wan Fang databases) to search RCT reports on the effect comparison of laparoscopic surgery and open surgery for colorectal cancer in China. Our study evaluated the reporting quality of RCTs based on 22 standards of Consolidated Standards for Reporting Trials (CONSORT) 2010 Statement. Two reviewers responded with ‘yes’ or ‘no’ to each standard to judge whether the authors had reported or had recorded concrete details of the reports accomplished in accordance with the requirement of each standard. Results: A total of 40 relevant RCTs were included in the final analysis. For the ‘Title and abstract’, only three articles (7.5%) could be identified directly from its title as the report of RCTs. For the ‘Methods’, only three articles (7.5%) applied the method of random allocation of sequences; only two articles (5%) mentioned the type of randomization or gave the description of the mechanism of allocation concealment; no article referred the concrete implementation of random method. Only one article (2.5%) applied the method of blinding or sample size calculation; no article had analysis about the metaphase of an experiment or an explanation of its interruption. For ‘results’, only one article (2.5%) described participant flow, primary and secondary outcomes with estimated effect size or ancillary analyses. Only 13 articles (32.5%) showed baseline demographic and clinical characteristics, 10 (25%) referred to intention-to-treat analysis, and 12 (30%) mentioned important harms or unintended effects. For the ‘discussion’, only eight articles (20%) gave the description of trials’ limitations and 13 (32.5%) presented the generalizability (external validity, applicability) of the trial findings. Conclusion: The quality of the RCT reports on effect comparison of laparoscopic surgery and open surgery for colorectal cancer in China is poor. The reporting of RCTs in this field should be standardized, according to the specifications of the CONSORT 2010.

Study on the Proposals for Clinical Research in Korean Medicine Worldwide - Future Clinical Research Strategy Ⅱ -

The purpose of this paper is to explore the strategy of future Korean medicine(KM) clinical research through the study on the proposals for KM clinical research worldwide. In this study, the papers published in English through Pubmed were investigated mainly. Among them, we analyzed the methodological proposals from the clinical research papers that were published in the KM related fields. Various proposals for improving the problems in KM clinical studies are as follows. First, KM clinical research should be designed based on understanding for the theory, backgrounds, paradigms and worldviews of KM. In addition, considering the model validity, KM clinical research model should include the diagnosis, interventions and outcomes measurement methods reflecting the characteristics and real practice in KM. The internal validity and external validity should be also taken into account. One of the most important thing is to identify the contents about various and complex 'real practice' in KM. A prospective observational study was suitable for the purpose of this study. Finally, we suggested a few improvement directions for RCTs studies in KM. First, we would be able to improve the quality and the internal validity in KM clinical research using the checklists of CONSORT(Consolidated Standards for Reporting Trials) Statement and STRICTA(Standards for Reporting Interventions in Clinical Trials of Acupuncture). Second, we could use various clinical research methods and the modified research of RCTs such as PCT(pragmatic clinical trial) to reflect the characteristics of actual KM practice. Consequently, we would be able to improve the external validity. Third, the KM diagnosis and outcomes measurement methods should be developed based on an actual KM practice and it should reflect a real practice. The 'pattern identification( )' is the core to KM diagnosis. But in order to be applied to the clinical research, the 辨證 pattern identification( ) should be objectified and standardized. Future KM clinical research model should reflect the 辨證

The quality of reports of randomized clinical trials on traditional Chinese medicine treatments: a systematic review of articles indexed in the China National Knowledge Infrastructure database from 2005 to 2012.

BackgroundThe Consolidated Standards for Reporting Trials (CONSORT) are aimed to standardize clinical trial reporting. Our objective is to compare the quality of randomized clinical trials (RCTs) of traditional Chinese medicine (TCM) published in 2005–2009 and 2011–2012 according to the current CONSORT statements and Jadad scale.MethodsData Sources: Reports on RCTs of TCM in the China National Knowledge Infrastructure database (CNKI database) for manuscripts published from 2005 to 2009 and 2011–2012. Search terms included TCM and clinical trial. Study Selection: Manuscripts that reported RCTs of TCM were included. Data Extraction: Independent extraction of articles was done by 3 authors. Disagreement was discussed until agreement was reached. According to the CONSORT checklist, an item was scored as 1 when the item was described in the paper. Otherwise the item was scored as 0.ResultsA total of 4133 trials in 2005–2009 and 2861 trials in 2011–2012 were identified respectively. There was a significant increase in proportion of reports that included details of background (24.71% vs 35.20%, P < 0.001), participants (49.79% vs 65.26%, P < 0.001), the methods of random sequence generation (13.77% vs 19.85%, P < 0.001), statistical methods (63.00% vs 72.77%, P < 0.001) and recruitment date (70.14% vs 80.36%, P < 0.001) in 2011–2012 compared to 2005–2009. However, the percentage of reports with trial design decreased from 4.45% to 3.25% (P = 0.011). Few reports described the blinding methods, and there was a decreasing tendency (4.77% vs 2.48%, P < 0.001). There was a similar decreasing tendency on the reporting of funding (6.53% vs 5.00%, P = 0.007). There were no significant differences in the other CONSORT items. In terms of Jadad Score, the proportion of reports with a score of 2 was markedly increased (15.15% vs 19.71%, P < 0.001).ConclusionsAlthough the quality of reporting RCTs of TCM was improved in 2011–2012 compared to 2005–2009, the percentages of high-quality reports are both very low in terms of Jadad score. There is a need for improving standards for reporting RCTs in China.

Meta-epidemiology.

The concept of meta-epidemiology has been introduced with considering the methodological limitations of systematic review for intervention trials. The paradigm of meta-epidemiology has shifted from a statistical method into a new methodology to close gaps between evidence and practice. Main interest of meta-epidemiology is to control potential biases in previous quantitative systematic reviews and draw appropriate evidences for establishing evidence-base guidelines. Nowadays, the network meta-epidemiology was suggested in order to overcome some limitations of meta-epidemiology. To activate meta-epidemiologic studies, implementation of tools for risk of bias and reporting guidelines such as the Consolidated Standards for Reporting Trials (CONSORT) should be done.

A look at the potential association between PICOT framing of a research question and the quality of reporting of analgesia RCTs.

BackgroundMethodologists have proposed the formation of a good research question to initiate the process of developing a research protocol that will guide the design, conduct and analysis of randomized controlled trials (RCTs), and help improve the quality of reporting such studies. Five constituents of a good research question based on the PICOT framing include: Population, Intervention, Comparator, Outcome, and Time-frame of outcome assessment. The aim of this study was to analyze if the presence a structured research question, in PICOT format, in RCTs used within a 2010 meta-analysis investigating the effectiveness of femoral nerve blocks after total knee arthroplasty, is independently associated with improved quality of reporting.MethodsTwenty-three RCT reports were assessed for the quality of reporting and then examined for the presence of the five constituents of a structured research question based on PICOT framing. We created a PICOT score (predictor variable), with a possible score between 0 and 5; one point for every constituent that was included. Our outcome variable was a 14 point overall reporting quality score (OQRS) and a 3 point key methodological items score (KMIS) based on the proper reporting of allocation concealment, blinding and numbers analysed using the intention-to-treat principle. Both scores, OQRS and KMIS, are based on the Consolidated Standards for Reporting Trials (CONSORT) statement. A multivariable regression analysis was conducted to determine if PICOT score was independently associated with OQRS and KMIS.ResultsA completely structured PICOT score question was found in 2 of the 23 RCTs evaluated. Although not statistically significant, higher PICOT was associated with higher OQRS [IRR: 1.267; 95% confidence interval (CI): 0.984, 1.630; p = 0.066] but not KMIS (1.061 (0.515, 2.188); 0.872). These results are comparable to those from a similar study in terms of the direction and range of IRRs estimates. The results need to be interpreted cautiously due to the small sample size.ConclusionsThis study showed that PICOT framing of a research question in anesthesia-related RCTs is not often followed. Even though a statistically significant association with higher OQRS was not found, PICOT framing of a research question is still an important attribute within all RCTs.

Respiratory Muscle Training for Respiratory Deficits in Neurodegenerative Disorders: A Systematic Review

Studies of the impact of respiratory muscle training (RMT) on central neurodegenerative pathologies have been aimed at improving pulmonary function. However, there is no certainty about the effectiveness of RMT in patients affected by these groups of disorders. The purpose of this review was to assess the evidence regarding the efficacy of inspiratory muscle training (IMT) and expiratory muscle training (EMT) on respiratory function in patients with neurodegenerative disorders of the CNS. A comprehensive search from 1990 to September 2012 on MEDLINE, Physiotherapy Evidence Database (PEDro), PubMed, Cochrane Library, and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases was made. Studies reporting on IMT and EMT in patients with neurodegenerative diseases were included. The selected studies were abstracted using a standardized data collection instrument and were assessed by a quality checklist created and adapted from CONSORT (Consolidated Standards for Reporting Trials) and TREND (Transparent Reporting of Evaluation with Nonrandomized Designs). Twenty-four studies were identified by the search strategy. Only 19 studies met the criteria for full review. Ten studies met all the inclusion criteria and were included in the final analysis. Of the 16 parameters present in the quality assessment checklist, only six were achieved for the studies analyzed. There is some evidence that RMT improves a number of respiratory function parameters in patients with Parkinson disease and multiple sclerosis; however, the number of studies and their quality are not sufficient to conclude whether IMT or EMT is effective in improving respiratory function in patients with neurodegenerative disorders of the CNS.

A CONSORT Clinical Trial Reporting Compliance Audit of the Oncology Randomized Controlled Trial Literature

Introduction: The Consolidated Standards for Reporting Trials (CONSORT) checklist has been formulated to improve the reporting of randomized controlled trials (RCTs). This investigation aims to determine predictors of CONSORT checklist compliance in the oncology literature. Methods: Eight-hundred and fifty articles assessing interventions in adult breast, prostate, colorectal, and lung cancer between 1992-2010 were identified by a systematic search. Exclusion criteria included investigations reporting interim/secondary/long-term update analyses, pilot/phase 2/non-parallel design studies. After full article review, 408 RCTs were eligible for inclusion. RCT descriptive variables including number of authors/study patients, 2009 journal impact factor/journal classification, type of cancer and therapeutic intervention, publication year, primary study country, and cooperative group involvement were captured for all trials. Two qualified auditors assessed all manuscripts in order to generate average and difference CONSORT checklist scores related to the observers. Results: Mean average CONSORT score was 16.6 (SD 3, max 25) and median difference score was two (interquartile range one to three). Kappa agreement for each checklist item ranged from (0.02-0.92) with an overall two-way intra-class correlation coefficient of 0.71 (95% Cl: 0.61-0.78) for comparison of overall CONSORT score between raters. Recent year of publication, increasing author number, and higher impact factor were associated with higher average CONSORT scores (p&lt;0.0001). Conclusions: Improvements in RCT reporting have been observed over time. Further work in the assessment of the inter-observer reliability of individual CONSORT items is warranted.

Clinical trials in Brazilian journals of ophthalmology: where we are

To compare clinical trials published in Brazilian journals of ophthalmology and in foreign journals of ophthalmology with respect to the number of citations and the quality of reporting [by applying the Consolidated Standards for Reporting Trials (CONSORT) statement writing standards]. The sample of this systematic review comprised the two Brazilian journals of ophthalmology indexed at Science Citation Index Expanded and six of the foreign journals of ophthalmology with highest Impact Factor® according ISI. All clinical trials (CTs) published from January 2009 to December 2010 at the Brazilians journals and a 1:1 randomized sample of the foreign journals were included. The primary outcome was the number of citations through the end of 2011. Subgroup analysis included language. The secondary outcome included likelihood of citation (cited at least once versus no citation), and presence or absence of CONSORT statement indicators. The citation counts were statistically significantly higher (P<0.001) in the Foreign Group (10.50) compared with the Brazilian Group (0.45). The likelihood citation was statistically significantly higher (P<0.001) in the Foreign Group (20/20 - 100%) compared with the Brazilian Group (8/20 - 40%). The subgroup analysis of the language influence in Brazilian articles showed that the citation counts were statistically significantly higher in the papers published in English (P<0.04). Of 37 possible CONSORT items, the mean for the Foreign Group was 20.55 and for the Brazilian Group was 13.65 (P<0.003). The number of citations and the quality of reporting of clinical trials in Brazilian journals of ophthalmology still are low when compared with the foreign journals of ophthalmology with highest Impact Factor®.

The quality of reporting of RCTs used within a postoperative pain management meta-analysis, using the CONSORT statement

BackgroundRandomized controlled trials (RCTs) are routinely used in systematic reviews and meta-analyses that help inform healthcare and policy decision making. The proper reporting of RCTs is important because it acts as a proxy for health care providers and researchers to appraise the quality of the methodology, conduct and analysis of an RCT. The aims of this study are to analyse the overall quality of reporting in 23 RCTs that were used in a meta-analysis by assessing 3 key methodological items, and to determine factors associated with high quality of reporting. It is hypothesized that studies with larger sample sizes, that have funding reported, that are published in journals with a higher impact factor and that are in journals that have adopted or endorsed the CONSORT statement will be associated with better overall quality of reporting and reporting of key methodological items.MethodsWe systematically reviewed RCTs used within an anesthesiology related post-operative pain management meta-analysis. We included all of the 23 RCTs used, all of which were parallel design that addressed the use of femoral nerve block in improving outcomes after total knee arthroplasty. Data abstraction was done independently by two reviewers. The two main outcomes were: 1) 15 point overall quality of reporting score (OQRS) based on the Consolidated Standards for Reporting Trials (CONSORT) and 2) 3 point key methodological item score (KMIS) based on allocation concealment, blinding and intention-to-treat analysis.ResultsTwenty-three RCTs were included. The median OQRS was 9.0 (Interquartile Range = 3). A multivariable regression analysis did not show any significant association between OQRS or KMIS and our four predictor variables hypothesized to improve reporting. The direction and magnitude of our results when compared to similar studies suggest that the sample size and impact factor are associated with improved key methodological item reporting.ConclusionsThe quality of reporting of RCTs used within an anesthesia related meta-analysis is poor to moderate. The information gained from this study should be used by journals to register the urgency for RCTs to be clear and transparent in reporting to help make literature accessible and comparable.

Standards for reporting randomized controlled trials in medical informatics: a systematic review of CONSORT adherence in RCTs on clinical decision support.

IntroductionThe Consolidated Standards for Reporting Trials (CONSORT) were published to standardize reporting and improve the quality of clinical trials. The objective of this study is to assess CONSORT adherence in randomized clinical trials (RCT) of disease specific clinical decision support (CDS).MethodsA systematic search was conducted of the Medline, EMBASE, and Cochrane databases. RCTs on CDS were assessed against CONSORT guidelines and the Jadad score.Result32 of 3784 papers identified in the primary search were included in the final review. 181 702 patients and 7315 physicians participated in the selected trials. Most trials were performed in primary care (22), including 897 general practitioner offices. RCTs assessing CDS for asthma (4), diabetes (4), and hyperlipidemia (3) were the most common. Thirteen CDS systems (40%) were implemented in electronic medical records, and 14 (43%) provided automatic alerts. CONSORT and Jadad scores were generally low; the mean CONSORT score was 30.75 (95% CI 27.0 to 34.5), median score 32, range 21–38. Fourteen trials (43%) did not clearly define the study objective, and 11 studies (34%) did not include a sample size calculation. Outcome measures were adequately identified and defined in 23 (71%) trials; adverse events or side effects were not reported in 20 trials (62%). Thirteen trials (40%) were of superior quality according to the Jadad score (≥3 points). Six trials (18%) reported on long-term implementation of CDS.ConclusionThe overall quality of reporting RCTs was low. There is a need to develop standards for reporting RCTs in medical informatics.