Consolidated Standards Of Reporting Trials Criteria Research Articles

Reporting quality of heart failure randomized controlled trials 2000-2020: Temporal trends in adherence to CONSORT criteria.

Heart failure (HF) is a major cause of morbidity and mortality in older adults. Randomized controlled trials (RCTs) inform HF policy and practice, but the accurate interpretation of results is contingent on clear and transparent reporting. The CONsolidated Standards Of Reporting Trials (CONSORT) statement serves as a guide to RCT reporting. We evaluated the quality of reporting in HF RCTs in high-impact journals by assessing their adherence to CONSORT. We searched MEDLINE, EMBASE and CINAHL for HF RCTs published in high-impact journals 2000-2020. We assessed the proportion of CONSORT criteria that individual HF RCTs adhered to, and used the Jonckheere-Terpstra test to examine temporal trends in adherence. Multivariable linear regression explored the association between trial characteristics and adherence to CONSORT. Primary analysis assessed adherence to CONSORT 2010 update. A sensitivity analysis assessed adherence to the original (1996) CONSORT criteria. Among 221 RCTs analysed, the mean (standard deviation [SD]) adherence was suboptimal overall (mean [SD] adherence 69.7 [11.5]%) (5513/7913 criteria), with a temporal increase in adherence over the 20-year period (p < 0.001). Factors associated with adherence included publication after versus during/before 2010 (β = 10.17, 95% confidence interval [CI] 7.64-12.70; p < 0.001); two-group parallel individual-level randomization versus other (including multi-group or cluster randomization) (β = 5.81, 95% CI 2.88-8.73; p < 0.001); and multicentre versus single-centre trials (β = 7.26, 95% CI 3.25-11.27; p < 0.001). There was no difference in trial adherence to the updated CONSORT (2010) versus the original (1996) CONSORT criteria, and temporal trends in adherence to both sets of criteria were similar, likely due to overlap between the two sets of criteria. Trials with greater adherence to CONSORT were published in higher impact factor journals, with a positive correlation (r = 0.312; p < 0.001). The quality of reporting in HF RCTs, as measured by CONSORT adherence, has improved over time but remains suboptimal.

What is the quality of reporting in randomized controlled trials in spinal conditions.

Substandard quality across published randomized controlled trials (RCTs) is a major concern. Imperfect reporting has the potential to distort the evidence landscape and waste valuable health-care resources. In this study, we aim to assess the current quality of reporting in the field of spine using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist. A list of published RCTs in the field of spine disease from January 1, 2013, to December 31, 2020, was built. Two reviewers scored the published RCTs against a modified CONSORT checklist. The mean adjusted CONSORT scores for each study, reporting category, and checklist item were calculated. The mean and median scores across all of the RCTs were 0.72 and 0.74 out of 1.00, respectively. The spectrum of scores was wide, ranging from 0.45 to 0.94. The reporting categories with the lowest score included randomization, blinding, and abstract. The items which were most under-reported included allocation sequence generation, type of randomization used, full trial protocol details, and abstract methodology. The inter-rater reliability between our reviewers was substantial (κ = 0.7, κ = 0.71). Our findings correlate with only a moderate level of compliance to the CONSORT criteria on the quality of reporting for RCTs in spinal conditions. This is in line with previous reports on compliance, both within and outside the field of spinal conditions. Further continued and sustained efforts are still required to enhance the quality and consistency of RCT reporting, ultimately reducing health-care resource wastage and improving patient safety.

Adverse Events Reporting Quality of Randomized Controlled Trials of COVID-19 Vaccine Using the CONSORT Criteria for Reporting Harms: A Systematic Review.

Background: Assessing the quality of evidence from vaccine clinical trials is essential to ensure the safety and efficacy of the vaccine and further enhance public acceptance. This study aims to summarize and critically evaluate the quality of harm reporting on randomized controlled trials for the COVID-19 vaccine and determine the factors associated with reporting quality. Methods: We systematically searched the literature using PRISMA guidelines for randomized controlled trials (RCT) on COVID-19 Vaccine until 30 December 2021. Published articles were searched from electronic databases such as PubMed, Science Direct, Google Scholar, and Bibliovid. Bias analysis was performed using RoB-2 tools. The quality of reporting was assessed by the Consolidated Standards of Reporting Trials (CONSORT) harm extension modified into 21 items. Results: A total of 61 RCT studies (402,014 patients) were analyzed. Over half the studies demonstrated adequate reporting (59.02%), and 21 studies (34.4%) reported a low risk of bias. All studies reported death and serious adverse events (AEs), but only six studies mentioned how to handle the recurrent AEs. Reporting of AEs in subgroup analysis was also poor (25%). Conclusion: The RCTs on the COVID-19 vaccine were less biased with good quality on reporting harm based on the modified CONSORT harm extension. However, study quality must be considered, especially for a balance of information between effectivity and safety.

Examining trends in the evidence base for the treatment of burns and a quality assessment of randomised controlled trials over an 11-year period

BackgroundPrevious articles assessed the evidence-base for the treatment of burns, but the latest was published in 2010, examining data up to and inclusive of 2008. The aim of this article is to examine the trend in the number of high-evidence publications over the subsequent 11-year period and quality-assess RCTs within this timeframe. Materials and methodsAll articles published in Burns and Journal of Burn Care and Research (JBCR) were identified using PubMed Search Tools and its Single Citation Matcher function. These journals were manually screened from 01/01/2009–01/06/2020 inclusive. Additionally, a PubMed search was conducted searching for RCTs and meta-analyses in English with the MESH term burns to identify meta-analyses and RCTs in all other journals. The reporting of RCTs was assessed using a modified CONsolidated Standards of Reporting Trials (CONSORT) checklist. ResultsA total of 5145 articles were evaluated from Burns and JBCR, with 3230 (62.78%) from Burns and 1915 (37.22%) from JBCR. 0.012% were meta-analyses of RCTs, 0.30% were other meta-analyses, and 2.52% were initially identified as RCTs. Whilst a significant increase in the number of high-evidence publications is observed, these represent 2.83% (n = 237) of the total. An additional 95 RCTs were identified in other journals, 58 being included in quality-analysis. A total 128 RCTs were thus eligible for quality-assessment, the most popular individual topic being wound healing (n = 28; 21.88%). The most highly reported criterion was listed inclusion and exclusion criteria (n = 111; 86.72%) and the least reported criterion was allocation concealment (n = 22; 13.92%). ConclusionsThis study observes a positive trend in high-evidence publications. The reporting of several CONSORT criteria in RCTs remains poor. Observation to standard reporting guidelines is advocated to improve the quality of reporting.

Assessment of reporting quality in randomised controlled clinical trial abstracts of dental implantology published from 2014 to 2016

ObjectivesAccess to full texts of randomised controlled clinical trials (RCTs) is often limited, so brief summaries of studies play a pivotal role. In 2008, a checklist was provided to ensure...

Evidence-based Plastic Surgery: Assessing Progress over Two 5-year Periods from 2009 to 2019.

All articles were identified using PubMed Search Tools and Single Citation Matcher. Three journals were manually screened from May 15, 2009, to May 15, 2014, and from May 16, 2014, to May 16, 2019. The reporting of RCTs was assessed using a modified Consolidated Standards of Reporting Trials (CONSORT) checklist. Of a total of 17,334 publications, 6 were meta-analyses of RCTs, 120 were other meta-analyses, and 247 were initially identified as RCTs. Although a significant increase in the number of higher-evidence publications is observed, these represent 2.09% (n = 363) of the total. An estimated 86 RCTs were eligible for quality-assessment, with the most popular sub-specialty being breast surgery (n = 30). The most highly reported criteria were inclusion/exclusion criteria and blinding (both n = 67; 77.91%), and the least reported criterion was allocation concealment (n = 21; 24.42%). This study observes a positive trend in high-evidence publications. The number of RCTs published has increased significantly over a breadth of sub-specialties. The reporting of several CONSORT criteria in RCTs remains poor. Observation to standard reporting guidelines is advocated to improve the quality of reporting.

Reporting of Randomized Controlled Trials Investigating an Enteral or Parenteral Nutrition Intervention in Critical Illness According to the CONSORT Statement: A Systematic Review and Recommendation of Minimum Standard Reporting Criteria

Lack of reporting consistency is common in randomized controlled trials (RCTs) in critical care nutrition. This impacts synthesis and interpretation and may misinform clinical practice. The objective was to evaluate reporting of parallel-group RCTs of enteral or parenteral nutrition interventions in critically ill adults against the recommendations in the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines and a priori-defined nutrition criteria. A systematic search of CENTRAL, MEDLINE, EMBASE, and CINAHL was conducted to identify RCTs published from January 2011 to February 14, 2020. The primary outcome was the percentage of CONSORT criteria "completely met" (a score of 1) from all included studies (out of a total possible score of 37). Secondary outcomes included the percentage of CONSORT criteria that were "partially" or "not met" and the percentage of a priori-defined nutrition criteria that were "completely," "partially," or "not met" (adjusted to reflect criteria applicable to the paper). Data are presented as mean (standard deviation). Comparisons of normally distributed continuous data were made using a t-test (P < .05). Of 18,969 articles identified, 56 studies met inclusion criteria. Of these, 60% (19%) of the eligible CONSORT criteria were "completely met," 20% (9%) "partially met," and 20% (15%) "not met." For the nutrition criteria, 41% (20%) of the eligible criteria were "completely met," 25% (14%) "partially met," and 34% (17%) "not met." Reporting against CONSORT guidelines was variable and often incomplete in relation to important a priori-defined nutrition variables.

Quality of clinical trials for the prevention of keratinocyte cancer.

Keratinocyte cancer (KC) is the most common form of cancer in humans. To our knowledge, no previous publications assessing the methodological quality of clinical trials for the prevention of KC have been recently published. We aim to assess the methodological quality of clinical trials focused on the prevention of KC in high-risk groups not receiving immunosuppressive therapy (NRIT) and propose solutions to improve the design of future trials. We searched clinical trials in which the main outcome was the prevention of KC in high-risk NRIT groups using the strategy published in the International Prospective Register of Systematic Reviews (PROSPERO registry), CRD42016045981. Consolidated Standards of Reporting Trials (CONSORT)criteria and the Cochrane Collaboration risk of bias tool were used to assess methodological quality. We analyzed 23 clinical trials. We found a high risk of attrition and reporting bias in 86.9% and 60.9% of the trials, respectively. Regarding the CONSORT criteria, in at least 40% of the trials, the authors omitted the following information: a description of the trial design, the number of losses and exclusions after randomization, the results of subgroup and adjusted analysis, the estimated effect size and the precision of primary and secondary outcomes. Methodological quality was improved in the recently published clinical trials compared to those published before the CONSORT criteria development. All clinical trials should report in detail the information used to assess potential risks of bias.

Quality assessment of randomized controlled trial abstracts on drug therapy of periodontal disease from the abstracts published in dental Science Citation Indexed journals in the last ten years.

Background Randomized controlled trials (RCTs) provide the highest level of evidence and are likely to influence clinical decision-making. This study evaluated the reporting quality of RCT abstracts on drug therapy of periodontal disease and assessed the associated factors. Material and Methods The Pubmed database was searched for periodontal RCTs published in Science Citation Indexed (SCI) dental journals from 2010/01/01 to 2019/07/17. Information was extracted from the abstracts according to a modified Consolidated Standards of Reporting Trials (CONSORT) guideline checklist. The data was analyzed using descriptive statistical analysis and the statistical associations were examined using the linear regression analysis (P <0.05). Results This study retrieved 1715 articles and 249 of them were finally included. The average overall CONSORT score was 15.6 ± 3.4, which represented 40.9% (±0.6) of CONSORT criteria filling. The reporting rate of some items (trial design, numbers analyzed, confidence intervals, intention-to-treat analysis or per-protocol analysis, harms, registration) was less than 30%. The adequate reporting rate of some items (participants, randomization, numbers analyzed, confidence intervals, intention-to-treat analysis or per protocol analysis) was no more than 4%. None of the abstracts reported funding. According to the multivariable linear regression results, number of authors (P=0.030), word count (P <0.001), continent (P=0.003), structured format (P <0.001), type of periodontal disease (P <0.001) and international collaboration (P=0.023) have a significant association with reporting quality. Conclusions The quality of RCT abstracts on drug therapy of periodontal disease in SCI dental journals remained suboptimal. More efforts should be made to improve RCT abstracts reporting quality. Key words:s, RCT, drug therapy, periodontal disease, CONSORT, reporting quality assessment.

Use of the hCONSORT criteria as a reporting standard for herbal interventions for common dermatoses: a systematic review.

The use of complementary and alternative medicine (CAM) is increasing in Western countries, including in the area of dermatology. However, Western healthcare providers have not integrated CAM into regular practice owing to a lack of reliable data supporting its use. To encourage high-quality research related to the use of CAM and specifically herbal interventions, the CONsolidated Standards Of Reporting Trials (CONSORT) extension criteria on reporting herbal interventions (hCONSORT) were published in 2006. To evaluate the adherence of randomized controlled trials (RCTs) investigating herbal interventions for acne, atopic dermatitis (AD) and psoriasis to the hCONSORT criteria. A comprehensive search of the PubMed, Embase and Cochrane Library databases was conducted. RCTs published between 2009 and 2014 assessing therapeutic outcomes of plant-based interventions for acne, AD or psoriasis were included. Investigators determined the number of unique hCONSORT criteria satisfied per report. anova was used to examine differences in scores by disease entity. The vast majority of reviewed studies reported < 50% of information recommended in the hCONSORT criteria. Limitations include the small number of dermatological conditions examined, exclusion of reports based on language and lack of assessment of overall adherence to CONSORT criteria. Our data indicate lack of adherence to hCONSORT extension criteria. Adherence to hCONSORT guidelines should be encouraged in order to provide high-quality reporting of research on herbal interventions in dermatology. Doing so may ease the integration of CAM into conventional medical practice and provide actionable data to providers.

Quality of reporting for randomized controlled trials in the hypospadias literature: Where do we stand?

To assess the quality of reporting of randomized controlled trials (RCTs) in the hypospadias literature using the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. It was hypothesized that hypospadias RCTs that contained clear descriptions of key methodological items, allocation concealment, blinding, and sample size justification would have higher overall quality of reporting scores (OQS). A comprehensive search was conducted through MEDLINE to identify RCTs in hypospadias surgical techniques and postoperative management during the period 1990-2014. Two reviewers independently selected articles, which were evaluated using the CONSORT checklist. An overall quality score (%) was calculated to assess the quality of reporting. In addition, a methodological index score out of 4 was calculated based on the following items: use of intention to treat/sample size justification, allocation concealment, specification of randomization type, and blinding of outcome assessors. Of the 76 initial results, 39 (51%) were excluded due to their predominant focus on anesthesia. After full-text screening, 10 (13%) citations were further excluded because they were case control studies or did not focus on hypospadias techniques, resulting in 27 (36%) studies included for analysis. The mean overall quality score was 37±12% and a median of 36% (range: 14-61%). Fifteen (56%) studies were identified as low quality (score <40%) and 12 (44%) as moderate quality (40-70%). No studies were classified as high quality (>70%). Hypospadias RCTs published between 2007 and 2014 versus those reported before 2007 (44±9% vs 33±11%, P=0.01), RCTs with a sample size >100 patients versus those <100 (47±8% vs 36±11%, P=0.01), RCTs that disclosed having received funding versus those that did not (56±4% vs 38±10%, P<0.01) and RCTs that had proof of biostatistician/epidemiologist support versus those that did not (58±5% vs 36±11%, P=0.01) had a higher mean OQS. The number of articles that met specific 2010 CONSORT criteria is illustrated in Summary Fig. It was found that the contemporary hypospadias literature continues to suffer from suboptimal reporting standards. There seems to be an improvement in the OQS for studies published after 2007 and those with larger sample sizes, usually >100 patients. Nevertheless, none of the studies obtained high quality of reporting (OQS >70%) as per the CONSORT statement checklist. The inadequacies in reporting were related to sample size justifications, randomization method, allocation concealment strategy, blinding, description of subjects lost to follow-up and Intention To Treat (ITT) analysis. These findings were consistent with the poor quality of reporting observed in other surgical fields. The current overall quality score in hypospadias literature is suboptimal and efforts must be made to improve quality.

An assessment of the compliance of Randomised controlled trials published in craniofacial surgery journals with the CONSORT statement: A systematic review protocol

IntroductionThe role of clinical trials in medicine is expanding, particularly in surgery. Randomised controlled trials (RCTs) represent the gold standard evidence for high-quality assessment of healthcare interventions. The Consolidated Standards of Reporting Trials (CONSORT) guidance has been published to maximise RCT reporting transparency. This paper outlines the study protocol for a systematic review that will assess the current compliance of RCTs published within craniofacial surgery with the CONSORT criteria. The aims are to identify areas where reporting can be improved to ensure craniofacial surgery is guided by high-quality evidence. Methods and analysisThis protocol is compliant with the Preferred Reporting Items for Systematic Review and meta-Analysis protocols (PRISMA-P) guidelines. Craniofacial surgery RCTs will be identified by searching within craniofacial surgery journals. Five journals from the Thomson Reuters Impact Factor Report 2016 included ‘cranio’ in their title and were included. MEDLINE PubMed will be used to search all RCTs published in these journals. The search strategy is described within this protocol. It will be limited to articles written in English, conducted on humans, and published in the last five years. Two independent researchers will assess each study for inclusion and will perform the data extraction. The researchers will assess compliance of each RCT with the 25-item CONSORT Statement checklist as the primary outcome. Discrepancies will be resolved through consensus or third author arbitration. Secondary outcomes to be extracted include the pathology and interventions examined, and indices of RCT quality. The systematic review will be compliant with PRISMA guidelines. The review has been registered a priori with the Registry of Systematic Reviews/meta-analyses (UIN: reviewregistry219). Ethics and disseminationThis systematic review will be conducted in line with the Cochrane Handbook for Systematic Reviews and Interventions. The intent is to publish in a peer-reviewed journal and present the data at relevant conferences.

Quality of clinical trials for selected priority mental and neurological disorders in sub-Saharan Africa: a systematic review

Quality of clinical trials for selected priority mental and neurological disorders in sub-Saharan Africa: a systematic review Anwar Mulugeta Gebremichael,1 Girmay Medhin,2 Getnet Yimer,1 Rahimush Jemal,3 Abebaw Fekadu,4,5 1Department of Pharmacology, School of Medicine, College of Health Sciences, Addis Ababa University, 2Aklilu Lemma Institute of Pathobiology, Addis Ababa University, 3Department of Pharmacy, Tikur Anbesa Hospital, 4Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; 5Department of Psychological Medicine, Centre for Affective Disorders, Institute of Psychiatry, King’s College London, London, UK Background: There is a developing consensus on the effectiveness of various interventions for mental disorders in low- and middle-income countries, and it has been proposed that the main task is to scale up these interventions. In this context, we aimed to review the quality and extent of intervention trials for selected priority mental and neurological disorders in sub-Saharan Africa.Methods: Medline and African Journals Online databases were used for searching relevant articles. Both randomized and nonrandomized clinical trials for the treatment of schizophrenia, depression, maternal depression, bipolar disorder, and epilepsy/seizure disorders that involve pharmacotherapy, psychotherapy, and physical therapy were included. An extensive list of search terms that identified locations, disorders, interventions, and study types were employed. The qualities of the trials were appraised using the single-component quality assessment of the consolidated standards of reporting trials (CONSORT) statement and the Jadad scale.Results: From 1,136 studies identified, only 34 trials that fulfilled inclusion criteria were used for quality analysis. Most studies were clinical trials of treatments for epilepsy and were conducted after 2006. In terms of region, the majority of studies were conducted in South Africa (22 of the 34 studies). Approximately half of the trials (53%) were conducted in single center and the majority of the trials (71%) were pharmacotherapeutics-based intervention. In terms of methodological quality in relation to the Jadad scale, 82% fulfilled the criteria for good methodological quality with a score of 3−5. However, the methodological quality according to the CONSORT criteria was more mixed.Conclusion: The overall quality of clinical trials conducted in sub-Saharan Africa is encouraging despite the limited number of studies. However, important quality limitations remain and have not improved over time. Hence, establishing clinical trial centers in these countries may be one approach to improving quality and quantity of trials. Keywords: randomized controlled trial, schizophrenia, depression, epilepsy, drug therapy, psychotherapy, Africa

Improved Reporting of Randomized Controlled Trials in the Urologic Literature

BackgroundWell-designed randomized controlled trials (RCTs) have the potential to provide high-quality evidence to inform questions of therapy and prevention, but this potential is contingent on the use of appropriate methods and transparent reporting. ObjectiveTo systematically assess the quality of urology RCT reporting and identify trends over time. Design, setting, and participantsAll RCTs published in four leading urology journals in 2013 were identified and compared to a prior analysis of studies from 1996 and 2004. Two reviewers abstracted data based on the Consolidated Standards of Reporting Trials (CONSORT) checklist. Outcome measurements and statistical analysisA summary reporting score (range: 0–22) for each study was determined. Mean overall scores for 1996, 2004, and 2013 were compared using analysis of variance. We used χ2 to compare the reporting frequency of individual criteria. Results and limitationsMean CONSORT scores for RCTs were 15.6±2.0 in 2013 (n=82), 12.0±0.3 in 2004 (n=87), and 10.2±0.3 in 1996 (n=65); p<0.01. Key deficiencies remain in reporting methods of allocation concealment and group assignment (selection bias), and blinding of participants, personnel, and outcome assessors (performance and detection bias). Study limitations are potential reviewer bias resulting from lack of journal deidentification and the relatively low number of studies reviewed. ConclusionsThere has been a substantial improvement in reporting quality of RCTs in urology since CONSORT. Some methodological criteria remain underreported, and increased efforts are necessary to further this improvement. Patient summaryTreatment decisions are often based on data from randomized controlled trials. We looked at whether these trials in urology are transparent in reporting their design and conduct using a framework known as the CONSORT criteria and found significant improvements over time. Some areas of deficiency remain, and our paper aimed to highlight these drawbacks to promote continued high-quality research.

Reporting trends of randomised controlled trials in heart failure with preserved ejection fraction: a systematic review

BackgroundHeart failure with preserved ejection fraction (HFpEF) causes significant cardiovascular morbidity and mortality. Current consensus guidelines reflect the neutral results from randomised controlled trials (RCTs). Adequate trial reporting is a...

Intervenciones cognitivo conductuales para diabéticos en México

Resumen Antecedentes. La diabetes mellitus (DM) tiene una alta prevalencia en México. Se estima que sólo una cuarta parte de los casos está metabólicamente controlada. Se requiere de intervenciones eficaces que coadyuven a controlarla, como las cognitivo conductuales. Objetivo. Realizar una revisión por temas de las intervenciones cognitivo conductuales utilizadas en México para mejorar el control de la DM. Método. Las intervenciones cognitivo conductuales para la revisión se obtuvieron de bases de datos (Redalyc, Dialnet, SciELO), el Catálogo TESIUNAM, centros de documentación especializados, libros, referencias de los estudios analizados y consulta a expertos. Se incluyeron trabajos realizados entre 1990 y 2014. Se analizaron variables relacionadas con la intervención y para evaluar las características metodológicas se utilizaron los criterios del CONSORT (Consolidated Standards of Reporting Trials / Estándares Consolidados de Reporte de Ensayos). Resultados. Fueron incluidos diecinueve estudios que cumplían con los criterios necesarios. 11 intervenciones buscaban mejorar la adherencia al tratamiento y/o al autocuidado; 11 mejorar el estado de ánimo y 10 buscaban aumentar la calidad de vida y/o bienestar psicológico. De los 19 estudios, 18 reportaron resultados favorables para el control de la DM. Sólo dos estudios cumplieron con más del 50% de los criterios sugeridos por el CONSORT. Discusión y conclusión. Los alcances de las intervenciones son cortos, ya que las muestras de los estudios apenas promedian 26.21 participantes y los periodos de seguimiento promedian 2.15 meses. La mayoría de los estudios no cumple (o solo parcialmente) con los criterios del CONSORT, lo cual pone en discusión los efectos alcanzados en las intervenciones.

Adherence to Consort Patient-Reported Outcomes Reporting Guidelines in Randomized Clinical Trials Evaluating Systemic Cancer Therapy: a Systematic Review

ABSTRACT Aim: The Consolidated Standards of Reporting Trials (CONSORT) guidance was extended in 2013 to provide a set of specific recommendations regarding patient-reported outcomes (PRO) reporting in randomized clinical trials (RCTs). There is limited data regarding how well current publications of oncology RCTs report PRO if assessed using these guidelines. Methods: The reporting of PRO was reviewed using an established database of phase III RCTs published between 2007 and 2011. Manuscripts were reviewed using a 8-point PRO reporting quality score (PRORQS) based on the 2013 CONSORT criteria. Multivariable linear regression was used to identify features associated with improved reporting quality. Results: PRO was most frequently a measurement of the patients quality of life (n = 88, 71%), a measurement of the patients symptoms (n = 22, 18%) or both (n = 11, 9%). Unfortunately, the majority of trials did not report on PRO at all (201 of 325; 62%). Of the remaining 124 trials, the mean PRORQS score was 5.0 on an 11 points scale. Among the 11 items included in the PRORQS, none was correctly reported in more than 70% of RCTs. The only factor significantly associated with improved PRO reporting was where PRO reporting was the subject of a dedicated secondary manuscript, as was the case in 36 of the 124 (29%) of RCTs. Compared to PRO reported only in the primary manuscript (mean score 3.5, 95% confidence interval (CI): 3.1 to 3.9), a secondary PRO–specific article had a mean score of 9.0 (95%CI : 8.5 to 9.6) out of 11.0, a nearly 2.5 fold improvement (P Conclusions: Despite their clinical relevance, our findings show that PRO are currently omitted completely or else poorly reported. The exceptions were where PRO were described in PRO-specific secondary publication and arguably this should be norm for all pivotal oncology RCTs. Use of the 2013 PRO CONSORT extensions should be encouraged and their effects on PRO reporting subsequently reassessed. Disclosure: All authors have declared no conflicts of interest.

Low Methodological and Reporting Quality of Randomized, Controlled Trials of Devices to Treat Urolithiasis

We assessed the methodological and reporting quality of randomized, controlled trials of stone disease management and determined whether the reporting quality of randomized, controlled trials improved with time. We systematically searched the literature for randomized, controlled trials of urolithiasis treatment. We developed and pilot tested a data extraction checklist based on CONSORT (Consolidated Standards of Reporting Trials) criteria as well as a clinical checklist relevant to urolithiasis, each scored as 0 to 25. Our primary outcome measures were the mean differences in CONSORT and clinical summary scores with time. We performed statistical hypothesis testing using the Student t-test with 2-sided α = 0.05 to compare scores between 2002 to 2006 and 2007 to 2011. A total of 104 randomized, controlled trials met study inclusion criteria. The most common procedure types studied were percutaneous nephrolithotomy (41.3%), ureteral stenting (28.8%) and shock wave lithotripsy (25.0%). Mean ± SE CONSORT summary scores were 11.4 ± 0.4 and 12.1 ± 0.3 in 2002 to 2006 and 2007 to 2011, respectively, with a mean difference of 0.7 (95% CI -0.3-1.6, p = 0.167). Mean clinical summary scores were 7.4 ± 0.5 and 9.3 ± 0.4 in 2002 to 2006 and 2007 to 2011, respectively, with a mean difference of 1.8 (95% CI 0.6-3.1, p = 0.004). While the number of randomized, controlled trials of urological devices used to treat stone disease substantially increased with time, methodological and clinical reporting quality remains suboptimal. This compromises their credibility and warrants efforts to promote appropriate performance of future endourological studies.

Compliance of randomized controlled trials in trauma surgery with the CONSORT statement

Randomized controlled trials (RCTs) are the criterion standard for assessing new interventions. However, bias can result from poor reporting, which also makes critical appraisal and systematic review challenging. The Consolidated Standards of Reporting Trials (CONSORT) criteria for nonpharmacological trials published in 2008 provided a set of 23 mandatory items that should be reported in an RCT. This is the first study to assess the compliance of RCTs in trauma with the CONSORT criteria for nonpharmacological trials. The MEDLINE database was searched using the MeSH term wounds and injuries for English-language articles published between January 2009 and December 2011. Relevant articles were scored by two reviewers and compared against surrogate markers of article quality (such as journal impact factor). Eighty-three articles were deemed suitable for inclusion. The mean CONSORT score was 11.2 of 23 items (49%; range, 3.38-18.17). Compliance was poorest for items relating to the adherence of care providers (0%), abstract (5%), and implementation of randomization (6%). Only 40% declared conflicts of interest, 73% declared permission from an ethics review committee, 43% declared sources of funding, and 10% stated a trial registry number. There was a significant correlation between the CONSORT score and the impact factor of the publishing journal (ρ = 0.37, p = 0.0006) but not for the number of patients or authors or single versus multicentre trials The reporting quality of RCTs in trauma surgery needs improvement. We suggest ways by which this could be improved including the following: better education, awareness, and a cohesive strategy among all stakeholders and the hard wiring of compliance through electronic journal submission systems.

Adherence of Randomized Trials Within Children's Surgical Specialties Published During 2000 to 2009 to Standard Reporting Guidelines

Randomized clinical trials (RCTs) are uncommon in pediatric surgical specialties and the quality of reporting is unknown. Our primary purpose was to analyze published surgical RCTs involving children to measure adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Published RCTs from January 1, 2000 through December 31, 2009 were reviewed. The trials were evaluated for the presence of 7 CONSORT guidelines and also graded according to the Jadad scale. Two hundred and twenty-eight trials were included. Five trials metall 7 CONSORT criteria (2%) and 53 had a Jadad score of ≥3 (23%). Slightly more than 50% of all trials specified primary outcomes and <25% described power calculations according to CONSORT. Adherence to CONSORT guidelines for allocation concealment, randomization description, and attrition details was even lower. There were significant differences between surgical specialties with regard to CONSORT adherence to the majority of the guidelines. Pediatric general surgery had the largest number of published RCTs. Pediatric orthopaedic surgery had the highest proportion of trials with a Jadad score ≥3 (40%). Adherence to CONSORT guidelines is low across the spectrum of children's surgical specialties, although significant differences do exist. Future RCTs in children's surgical specialties should specifically focus on areas of low adherence to reporting guidelines.