Standards of reporting of randomized controlled trials in general surgery: can we do better? Reporting of randomized controlled trials in Hodgkin lymphoma in biomedical journals. Improving the quality of reporting alcohol outcome studies: effects of the CONSORT statement. Gynaecologic surgery from uncertainty to science: evolution of randomized control trials. Compliance with the CONSORT checklist in obstetric anaesthesia randomised controlled trials. Quality of reporting of randomized, controlled trials in cerebral palsy. Editorial policy and the reporting of randomized controlled trials: a survey of instructions for authors and assessment of trial reports in Indian medical journals (2004-05). What is the quality of reporting in weight loss intervention studies? A systematic review of randomized controlled trials. CONSORT adoption and quality of reporting of randomized controlled trials: a systematic analysis in two dermatology journals. The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist. Quality of controlled clinical trials on glaucoma and intraocular high pressure. Improving the quality of randomized controlled trials in Chinese herbal medicine, part IV: applying a revised CONSORT checklist to measure reporting quality. Of consents and CONSORTs: reporting ethics, law, and human rights in RCTs involving monitored overdose of healthy volunteers pre and post the "CONSORT" guidelines. Are leading medical journals following their own policies on CONSORT reporting? A critical assessment of the quality of reporting of randomized, controlled trials in the urology literature. Systematic review of symptom control and quality of life in studies on chemotherapy for advanced non-small cell lung cancer: how CONSORTed are the data? In the dark: the reporting of blinding status in randomized controlled trials. Examination of the analytic quality of behavioral health randomized clinical trials. Quality of reporting internal and external validity data from randomized controlled trials evaluating stents for percutaneous coronary intervention. Quality of randomised trials in COPD. Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors. Reporting on covariate adjustment in randomised controlled trials before and after revision of the 2001 CONSORT statement: a literature review. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. Reporting in randomized clinical trials improved after adoption of the CONSORT statement. The quality of reporting of randomized clinical trials published in Ophthalmology. Secular changes in the quality of published randomized clinical trials in rheumatology. Evidence of improving quality of reporting of randomized controlled trials in subfertility. Quality of reporting of randomized controlled trials in polycystic ovary syndrome. The quality of randomized controlled trials in major anesthesiology journals. Improving the quality of reporting randomized controlled trials in cardiothoracic surgery: the way forward. Trends in acute ischemic stroke trials through the 20th century. Randomized clinical trials behind level A recommendations in obstetric practice bulletins: compliance with CONSORT statement. Quality of reporting in randomized trials published in high-quality surgical journals. A systematic evaluation of the impact of STRICTA and CONSORT recommendations on quality of reporting for acupuncture trials. Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals. Application of the CONSORT statement to randomized controlled trials comparing endoscopic and open carpal tunnel release. The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry. Intention-to-treat analyses in behavioral medicine randomized clinical trials. Quality reporting of endoscopic diagnostic studies in gastrointestinal journals: where do we stand on the use of the STARD and CONSORT statements? Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China. Quality of reports on randomized controlled trials conducted in Japan: evaluation of adherence to the CONSORT statement. Quality of reporting of key methodological items of randomized controlled trials in clinical ophthalmic journals. Quality of randomized controlled trials reporting in the primary treatment of brain tumors. Fecal incontinence: the quality of reported randomized, controlled trials in the last ten years. Reporting randomised clinical trials of analgesics after traumatic or orthopaedic surgery is inadequate: a systematic review. The reporting quality of randomised controlled trials in surgery: a systematic review. Assessment of the quality of reporting of randomized clinical trials in paediatric dentistry journals. Analysis of the quality of reporting of randomized controlled trials in acute and chronic myeloid leukemia, and myelodysplastic syndromes as governed by the CONSORT statement.
To evaluate the quality of reporting of surgical randomized controlled trials published in surgical and general medical journals using Jadad score, allocation concealment, and adherence to CONSORT guidelines and to identify factors associated with good quality.
                Randomized controlled trials (RCTs) provide the best evidence about the relative effectiveness of different interventions. Improper methodology and reporting of RCTs can lead to erroneous conclusions about treatment effects, which may mislead decision-making in health care at all levels.
                Information was obtained on RCTs published in 6 general surgical and 4 general medical journals in the year 2003. The quality of reporting of RCTs was assessed under masked conditions using allocation concealment, Jadad score, and a CONSORT checklist devised for the purpose.
                Of the 69 RCTs analyzed, only 37.7% had a Jadad score of > or =3, and only 13% of the trials clearly explained allocation concealment. The modified CONSORT score of surgical trials reported in medical journals was significantly higher than those reported in surgical journals (Mann-Whitney U test, P < 0.001). Overall, the modified CONSORT score was higher in studies with higher author numbers (P = 0.03), multicenter studies (P = 0.002), and studies with a declared funding source (P = 0.022).
                The overall quality of reporting of surgical RCTs was suboptimal. There is a need for improving awareness of the CONSORT statement among authors, reviewers, and editors of surgical journals and better quality control measures for trial reporting and methodology. Randomized controlled trials (RCTs) are the best tool to evaluate the effectiveness of clinical interventions. The Consolidated Standards for Reporting Trials (CONSORT) statement was introduced in 1996 to improve reporting of RCTs. We aimed to determine the extent of ambiguity and reporting quality as assessed by adherence to the CONSORT statement in published reports of RCTs involving patients with Hodgkin lymphoma from 1966 through 2002.
                We analyzed 242 published full-text reports of RCTs in patients with Hodgkin lymphoma. Quality of reporting was assessed using a 14-item questionnaire based on the CONSORT checklist. Reporting was studied in two pre-CONSORT periods (1966-1988 and 1989-1995) and one post-CONSORT period (1996-2002).
                Only six of the 14 items were addressed in 75% or more of the studies in all three time periods. Most items that are necessary to assess the methodologic quality of a study were reported by fewer than 20% of the studies. Improvements over time were seen for some items, including the description of statistics methods used, reporting of primary research outcomes, performance of power calculations, method of randomization and concealment allocation, and having performed intention-to-treat analysis.
                Despite recent improvements, reporting levels of CONSORT items in RCTs involving patients with Hodgkin lymphoma remain unsatisfactory. Further concerted action by journal editors, learned societies, and medical schools is necessary to make authors even more aware of the need to improve the reporting RCTs in medical journals to allow assessment of validity of published clinical research. It is critical that the reporting of randomized controlled trials (RCTs) be transparent and comprehensive. The aim of this study was to examine if adopting standards of reporting, the Consolidated Standards of Reporting Trials (CONSORT), improved the quality of reporting of alcohol treatment outcome studies. RCTs were identified from eight journals publishing a substantial number of alcohol treatment outcome studies (n=127 RCTs) and coded for the quality of reporting according to the CONSORT guidelines. Both CONSORT adopter and non-adopter journals showed significant improvements in the quality of reporting of alcohol treatment outcome studies over time. While overall results suggested a non-significant trend for more improvement over time in the quality of reporting for adopter compared to non-adopter journals, comparison of effects sizes suggested that specific areas of reporting did significantly improve for the adopter journals. Results suggest that efforts to improve reporting such as the CONSORT guidelines can be useful and influential.
                2010 Elsevier Ltd. All rights reserved. It is now accepted that both medical and surgical practice should be based on reliable and sound clinical evidence. However, randomized control trials comparing surgical interventions have been associated with many problems. The aim of this review is to assess if there has been progress made in establishing the evidence base for surgical interventions in gynaecology.
                Relevant reviews were identified from Cochrane Database of Systematic Reviews (Issue , 2006) and data from individual randomized control trials extracted. Chi-squared test was used to compare quality pre- and post-Consolidated Standards of Reporting Trials (CONSORT) statement. Meta-regression analyses were performed to test the hypothesis that effect size decreased over time. Further multiple linear regression analyses were used to test the hypothesis that precision increased over time and finally a logistic regression model was used to estimate whether treatment effects differed between trials with and without allocation concealment.
                Twenty-three relevant reviews were identified, including 94 trials. The proportion of studies reporting allocation concealment significantly increased after the introduction of the CONSORT statement (P = 0.002). There was a trend towards improvement in precision over time. Similarly, there was a reduction in size of treatment effect over time (log of the ratio of odds ratios per year 0.96; 95% confidence interval 0.93-0.99, P = 0.04).
                Gynaecologic surgical practice appears to be benefiting from improvement in its research base in a subject where practitioners do not participate readily in randomized evaluation. The Consolidated Standards for Reporting of Trials (CONSORT) checklist is an evidence-based approach to help improve the quality of reporting randomised controlled trials. The purpose of this study was to determine how closely randomised controlled trials in obstetric anaesthesia adhere to the CONSORT checklist. We retrieved all randomised controlled trials pertaining to the practice of obstetric anaesthesia and summarised in Obstetric Anesthesia Digest between March 2001 and December 2002 and compared the quality of reporting to the CONSORT checklist. The median number of correctly described CONSORT items was 65% (range 36% to 100%). Information pertaining to randomisation, blinding of the assessors, sample size calculation, reliability of measurements and reporting of the analysis were often omitted. It is difficult to determine the value and quality of many obstetric anaesthesia clinical trials because journal editors do not insist that this important information is made available to readers. Both clinicians and clinical researchers would benefit from uniform reporting of randomised trials in a manner that allows rapid data retrieval and easy assessment for relevance and quality. In conducting reviews on the effectiveness of physiotherapy interventions on children with cerebral palsy, the assessment of trials can be hampered by problems in reporting. Therefore, we set out to evaluate trial reporting by using the Consolidated Standards of Reporting Trials (CONSORT) statement recommendations.
                Randomized, controlled trials published in 1990 or later were identified in literature searches for reviews on the effectiveness of physiotherapy interventions on children with cerebral palsy. Two independent reviewers evaluated the trial reporting by using a modified 33-item Consolidated Standards of Reporting Trials checklist.
                We identified 15 randomized, controlled trials. Almost half (48%) of the applicable items were reported adequately. Inadequate reporting was found in the following items: outcome measures, sample-size determination, details of the sequence generation, allocation concealment and implementation of the randomization, success of assessor blinding, recruitment and follow-up dates, intention-to-treat analysis, precision of the effect size, co-interventions, and adverse events.
                Only a small number of sufficiently reported trials were found. Because nearly all items had been described in at least 1 article, high-quality reporting seems feasible. Assessment of trials depends on appropriate reporting, and poor reporting jeopardizes judgments on the clinical implications. Authors of randomized, controlled trials are encouraged to follow the Consolidated Standards of Reporting Trials criteria. There is a clear need to improve the quality of reporting of trials in this field. Many international journals require authors of randomized controlled trials to adhere to standards of reporting described in the statement of the Consolidated Standards of Reporting Trials (CONSORT) and the requirements issued by the International Committee of Medical Journal Editors (ICMJE). We examined the extent to which these international standards have been adopted by Indian medical journals.
                To identify Indian medical journals that publish randomized controlled trials, we did electronic searches of the websites of the National Informatics Centre (Indian Medlars Centre), Database of Open Access Journals, National Library of Medicine, WHO's Index Medicus for the South-East Asian region and Google. We analysed their instructions to authors for endorsement of the CONSORT statement and the ICMJE requirements for reporting of randomized controlled trials. We then identified all randomized controlled trials published in these journals during 2004 and 2005 and assessed them against selected CONSORT items and ICMJE requirements, and scored them on the Jadad scale.
                Of the 65 journals selected, 38 (58.5%) mentioned the ICMJE requirements in their instructions for authors but only 20 (31%) specifically required authors to submit manuscripts in accordance with the CONSORT statement. Of 151 randomized controlled trials published during 2004-05, only 4 of 13 (30.8%) selected CONSORT items were reported in > 50% of trial reports. Items reflecting internal validity were poorly reported. Jadad scores were significantly higher for general medical journals compared with specialty journals (mean difference 0.46; 95% CI: 0.15-0.78; p = 0.005) and in trials published in 2005 over those published in 2004 (mean difference 0.48; 95% CI: 0.18-0.79; p = 0.002). Ethical issues were poorly reported in one-third of reports, and sources of funding and conflicts of interest were not declared in over three-fourths. Adequacy of reporting was not related to endorsing either the CONSORT statement or the ICMJE requirements.
                Medical journals published in India should adopt internationally recognized norms for reporting clinical trials and work with authors, reviewers and institutional review boards to improve the standards of conduct, reporting and validity of inferences of trials. Despite the large number of randomized controlled trials (RCTs) assessing weight loss interventions, no study has assessed the quality of reporting in these trials.
                To assess the quality of reporting of RCTs of weight loss interventions and to identify predictors of reporting quality.
                The RCTs assessed were derived from a published systematic review of trials investigating the efficacy of weight loss interventions. For our study, two reviewers independently rated the quality of reporting in these trials, based on the Consolidated Standards for Reporting of Trials (CONSORT) Statement. We describe the quality of reporting using number (percent) of studies satisfying each of the 44 CONSORT criteria. We use generalized estimating equations (GEE) to fit a multivariable regression model to determine factors that are associated with the overall quality reporting score.
                We assessed 63 RCTs, of which 25 were dietary-lifestyle trials, 22 were pharmacological trials and 16 were behavior-cognitive, exercise-lifestyle, or surgical trials. Less than half (46%) of the trials defined the primary outcome of the study; about 10% provided the description of the method of allocation concealment. Multivariable GEE results showed that the sample size, type of intervention (non-pharmacologic trials having lower scores than pharmacologic trials), and publication time relative to the CONSORT Statement publication in 1996 (publications after 1996 having higher scores) were strong predictors of the quality reporting score. Reporting a statistically significant result on the primary outcome was not significantly associated with the quality score.
                While the overall quality in reporting seemed to have improved since the publication of the revised CONSORT Statement in 1996, the reporting of some key methodologic aspects, such as clear description of primary outcome and method of allocation concealment, still requires improvements. Factors that are significantly associated with the overall quality reporting score can be used as surrogates in the review of protocols to enhance the quality of the final reports. CONSORT (Consolidated Standards for Reporting Trials) guidelines were constructed to ensure optimal reporting quality of randomized controlled trials (RCTs).
                To determine the effect of the adoption of CONSORT on the reporting quality of RCTs, we performed a systematic evaluation of RCTs published in two dermatology journals pre- and post-CONSORT adoption.
                The journals selected for the study were the Journal of the American Academy of Dermatology and the British Journal of Dermatology. We selected RCTs published in 1997 and 2006 using both Medline and hand searching. The following critical CONSORT criteria were recorded: sample size, type of disease studied, type of control, single-centre or multicentre study, type of funding, blinding, methods and type of randomization, definition of a primary endpoint, justification for sample size selection and power calculation, population for analysis, and adequacy of group comparison. A multivariable analysis was conducted to determine factors associated with optimal reporting quality.
                In total, 98 studies were included. Improvement in reporting quality was evident for the specification of the randomization method (20% in 1997 vs. 45% in 2006, P < 0.01) and for the justification of sample size (22% in 1997 vs. 43% in 2006, P = 0.027). The percentage of studies with optimal reporting quality increased from 11% in 1997 to 28% in 2006 (P = 0.03). Factors significantly associated with a good methodological quality were pharmaceutical industry funding and publication in 2006 vs. 1997.
                There is a need to improve the reporting quality of RCTs published in dermatology journals. The "Consolidated Standards of Reporting Trials" (CONSORT) was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). However, little is known about the quality of reporting since this publication. We undertook an observational study to determine the quality of reporting key methodological factors in RCTs since the publication of the CONSORT statement and if a journal policy to promote adherence to the CONSORT checklist was associated with superior reporting. We recorded the reporting of 11 key methodological factors in 105 RCTs from 29 medical journals published subsequent to the CONSORT statement. We examined the quality of reporting in relation to whether a journal was a "CONSORT promoter" as defined by inclusion of the CONSORT checklist in a journal's "information to authors" section or a requirement that authors, manuscript reviewers, or copy editors complete the CONSORT checklist. Multivariate analysis controlled for journal impact factor, study outcome, and time of publication. Six of the 11 methodological factors were reported <50% of the time. The number of methodological factors reported was greater in CONSORT promoters than in journals not promoting CONSORT in both unadjusted (6.0 and 5.1, respectively, p-value = 0.03) and adjusted (6.4 and 4.8 of the 11 methodological factors, respectively, p-value = 0.0001) analyses. While journals that promote CONSORT demonstrate superior reporting of RCTs, persistent inadequacies in reporting remain. Until these inadequacies are resolved health-care providers will remain limited in their ability to make informed inferences about the validity of the studies upon which they base their clinical practice. To study the quality of controlled clinical trials on glaucoma.
                Two hundred and twenty-six clinical trials published between 1980 and 1999 were selected from seven international ophthalmological journals. Their quality was assessed by four researchers with epidemiological skills using a structured questionnaire.
                Sample size was pre-estimated in 34 (15.0%) papers, which were of greater size (P = 0.05). Randomization was performed in 98.2% of the trials, although the procedure of randomization was scarcely reported. Masking was reported in 56.6% of the papers, and was more frequent in medical treatments (P < 0.001). The basal characteristics of the groups were compared in 139 papers (61.5%). Patient losses during the follow-up period were fully described in only 27 trials. Intention-to-treat analysis was used in 17 (7.7%) papers. Most trials reported P values, but a measure of effect (mean, proportion, or relative risk) appeared in only 16 trials (7.7%). Trials performed in the US more frequently compared baseline characteristics of the groups (P = 0.03), described the patient flow (P = 0.04), and used adequate statistical procedures (P = 0.03). Those trials that included a statistician or an epidemiologist among the authors were more commonly blinded (P = 0.06) and they always avoided the analyses of subgroups (P = 0.006). Several methodological issues have improved throughout the studied period.
                Several methodological characteristics should be improved when reporting a clinical trial on glaucoma. Using a checklist like that suggested by the CONSORT can help to achieve this. To discuss the quality of reporting in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the reporting of future clinical studies in this therapeutic area.
                A search of the Cochrane Library was conducted to identify RCTs of CHM. A revised CONSORT checklist designed for CHM clinical studies was implemented. The revised CONSORT checklist contained 63 items, including the following new items added specifically for CHM: (1) "syndrome of disease" based on Chinese medicine theories; (2) rationale of CHM formula; (3) formula composition; (4) preparation form of CHM; (5) quality control of CHM.
                The overall reporting quality of the RCTs as assessed with the revised CONSORT checklist varied between 19% and 44%, with a median score of 32% (standard deviation 8%).
                The overall quality of reporting of RCTs of CHM evaluated with a revised CONSORT checklist was poor, reflecting the need for improvements in reporting future clinical trials in this area.
                To improve the quality of reporting of RCTs of CHM, we recommend adopting a revised CONSORT checklist that includes items specific to CHM. We also recommend that editors of CHM journals require authors to use a structured approach to presenting their trials as a condition of publication. Randomized controlled trials (RCTs) of therapeutic interventions in acute drug overdose present a significant challenge for ethical, legal, and human rights protections of research subjects, particularly when healthy volunteers are involved. The CONSORT statement on the uniform reporting of clinical trials was published in 1996 with the overall aim of improving the reporting of RCTs, both individually and to facilitate their inclusion into systematic reviews. In CONSORT, reporting of ethical, legal, and human rights protections, including prior evaluation of the study by an ethics committee and provision of informed consent, was largely an implicit requirement. Those drafting CONSORT may have assumed such protections and the rights of study subjects were secured by existing doctor-patient relationships. Alternatively, CONSORT may have been viewed as likely to indirectly enhance such protections, as a flow-on effect of improved RCT design and reporting. We wished to examine whether such assumptions were justified by examining the reporting of RCTs of simulated overdose in healthy volunteers. We reviewed all reported RCTs involving activated charcoal in healthy human volunteersfor three years before the CONSORT statement (1989, 1990, and 1991) and three years afterwards (1999, 2000, 2001). Presence of documentation of inclusion and exclusion criteria, stopping rules, protocol deviations, information sheets, consent documentation, ethical approvals, conflicts of interest, understanding, refusal, inducements and coercion were recorded. We found a very poor level of reporting of some key ethical, legal, and human rights protections for healthy volunteers in toxicological RCTs. Reporting did not improve with the publication of CONSORT even in relation to requirements specifically included in the guidelines. The revised Consolidated Standards of Reporting Trials (CONSORT) statement recognizes the importance of including data so that readers are able to judge the reliability or relevance of randomized controlled trial (RCT) findings. However, it is unclear whether journals consistently report the pre-randomization information necessary to assess the general applicability of trial results. The objective of this study was to assess the extent of adherence to pre-randomization data reporting in 4 leading general medicine journals, as recommended by the revised CONSORT statement over a specific time frame. A total of 480 RCTs met the eligibility criteria for review. In 2004, 138 of 246 (56%) articles reported the full CONSORT pre-randomization information, of which 121 (88%) presented this information in diagram form. In 2006, 136 of 234 (58%) reported the full information, of which 127 (93%) presented the information in a diagram. These numbers indicate no improvement in the reporting of pre-randomization information. In conclusion, reporting of the full CONSORT data remains inconsistent. We recommend that journals continue to support the CONSORT statement and ensure that adequate information is provided upon submission before commencing the peer review process. The presentation of clear, precise data will ensure that readers are able to better interpret the applicability of findings. Randomized, controlled trials are the gold standard for evidence based assessment of therapeutic interventions. In 1996 the Consolidated Standards of Reporting Trials statement was published in an effort to standardize the reporting of clinical trials. To our knowledge we report the first systematic assessment of randomized, controlled trial quality in the urology literature by Consolidated Standards of Reporting Trials standards.
                All human subject randomized, controlled trials published in 4 leading urology journals in 1996 and 2004 were identified for formal review. A standardized evaluation form was developed based on the Consolidated Standards of Reporting Trials statement. Each article was evaluated by 2 independent reviewers and discrepancies were settled by consensus. A Consolidated Standards of Reporting Trials criteria summary score was calculated on a scale of 0 to 22.
                A total of 152 randomized, controlled trials met inclusion criteria. The mean+/-SEM Consolidated Standards of Reporting Trials summary score was 10.2+/-0.3 (median 10.3) and 12.0+/-0.3 (median 12.2) in 1996 and 2004, respectively, with a mean difference of 1.8 (95% CI 1.0, 2.6; p=0.001). Reporting of important methodological criteria, eg sample size justification and randomization implementation, improved from 1996 to 2004. Improvement notwithstanding, reporting of key methodological criteria remained consistently below 50% in 2004.
                This formal review suggests that randomized, controlled trial reporting in the urology literature has improved since the publication of the Consolidated Standards of Reporting Trials statement in 1996. Certain areas, such as reporting of trial methods, continue to meet Consolidated Standards of Reporting Trials criteria in fewer than half of publications. Ongoing graduate and postgraduate education in trial design and evidence based practice may result in further improvement in randomized, controlled trial reporting. The effect of chemotherapy on survival of patients with advanced NSCLC is modest, therefore patient reported outcomes (PRO's) are of high interest in randomized controlled trials (RCTs). CONSORT (CONsolidated Standards On Reporting Trials) is a quality checklist of 22 items for the conduct and reporting of RCTs. The aim of this report was to analyse to what extent the different RCTs with information on PRO's adhere to the CONSORT statement.
                Systematic review of RCTs using PRO's either as primary or secondary endpoint. Compliance with the (revised) CONSORT statement was checked by 2 independent reviewers by making for each study the simple sum of the 22 CONSORT items, or a weighted score with a maximum rating of 31 points.
                The median weighted CONSORT score of the different RCTs was 25, with a remarkable difference from 12 till 30. There was no significant change over time, nor difference between academic and commercial studies, but a significant correlation between CONSORT agreement and journal type (P<0.0001). Adherence to CONSORT was similar for studies comparing chemotherapy with best supportive care alone, comparing different first-line chemotherapies with PRO either as primary or secondary endpoint, or studies looking at second-line chemotherapy. Benefit in PRO's was reported in all of these settings.
                The overall adherence of peer-reviewed RCTs to CONSORT is reasonable, with nonetheless major differences between journals, and with no clear sign of change over time. Apart from modest survival differences, benefits in PRO endpoints are present in all categories of studies we analysed. To determine the quality of reporting of blinding in randomized controlled trials (RCTs), we evaluated 40 consecutive RCTs published in each of five leading journals. We noted whether authors reported the blinding status of participants, health care providers, data collectors, judicial assessors of outcomes, data analysts, and manuscript writers. Explicit reporting of blinding status occurred in <25% of RCTs for all groups. Eighty-three RCTs, reported as double-blind, provided eight combinations of blinded groups. In conclusion, prestigious journals do not currently report blinding status optimally. To do so, journals should abandon the term "double blind" and explicitly report the blinding status of the groups involved in RCTs. Until such reporting occurs, clinicians will be left with uncertainty about the validity of RCTs that guide their clinical practice. Adoption of evidence-based practice (EBP) policy has implications for clinicians and researchers alike. In fields that have already adopted EBP, evidence-based practice guidelines derive from systematic reviews of research evidence. Ultimately, such guidelines serve as tools used by practitioners. Systematic reviews of treatment efficacy and effectiveness reserve their strongest endorsements for treatments that are supported by high-quality randomized clinical trials (RCTs). It is unknown how well RCTs reported in behavioral science journals fare compared to quality standards set forth in fields that pioneered the evidence-based movement. We compared analytic quality features of all behavioral health RCTs (n = 73) published in three leading behavioral journals and two leading medical journals between January 2000 and July 2003. A behavioral health trial was operationalized as one employing a behavioral treatment modality to prevent or treat an acute or chronic physical disease or condition. Findings revealed areas of weakness in analytic aspects of the behavioral health RCTs reported in both sets of journals. Weaknesses were more pronounced in behavioral journals. The authors offer recommendations for improving the analytic quality of behavioral health RCTs to ensure that evidence about behavioral treatments is highly weighted in systematic reviews.
                (c) 2006 Wiley Periodicals, Inc. Stents are commonly used to treat patients with coronary artery disease. However, the quality of reporting internal and external validity data in published reports of randomised controlled trials (RCTs) of stents has never been assessed.The objective of our study was to evaluate the quality of reporting internal and external validity data in published reports of RCTs assessing the stents for percutaneous coronary interventions.
                A systematic literature review was conducted. Reports of RCTs assessing stents for percutaneous coronary interventions indexed in MEDLINE and the Cochrane Central Register of Controlled Trials and published between January 2003 and September 2008 were selected. A standardized abstraction form was used to extract data. All analyses were adjusted for the effect of clustering articles by journal.
                132 articles were analyzed. The generation of the allocation sequence was adequate in 58.3% of the reports; treatment allocation was concealed in 34.8%. Adequate blinding was reported in one-fifth of the reports. An intention-to-treat analysis was described in 79.5%. The main outcome was a surrogate angiographic endpoint in 47.0%. The volume of interventions per center was described in two reports. Operator expertise was described in five (3.8%) reports. The quality of reporting was better in journals with high impact factors and in journals endorsing the CONSORT statement.
                The current reporting of results of RCTs testing stents needs to be improved to allow readers to appraise the risk of bias and the applicability of the results. Randomised trials can provide high-level evidence to inform treatment decisions. Since their quality in respiratory medicine is largely unknown, we assessed the quality of a large set of chronic obstructive pulmonary disease (COPD) trials. As a marker of trial quality, we assessed the procedure and concealment of random allocation, and the conduct of an intention-to-treat-analysis in 344 randomised trials published between 1957 and 2006. We used ordered logistic regression to assess the association between trial quality and type of intervention, type of journal, journal impact factor and year of publication. 257 (75%) trials assessed pharmacological and 87 (25%) assessed nonpharmacological interventions. The generation of appropriate randomisation was reported in 27.0% of the trials, concealment of random allocation in 11.6% and an intention-to-treat analysis in 21.8% of trials. Significantly higher quality was found in trials on nonpharmacological interventions (OR 2.49, 95% CI 1.56-3.99), and in trials published in general medical journals (versus specialised journals; OR 2.25, 95% CI 1.30-3.90) and after 2000 (versus 1957-2000; OR 2.28, 95% CI 1.45-3.58). The association of quality with a high impact factor was of borderline significance (p = 0.06). The quality of many COPD trials is low but tends to become better since the adoption of the CONSORT (Consolidated Standards of Reporting Trials) statement. Insufficient blinding of persons involved in randomized clinical trials is associated with bias. The appraisal of the risk of bias is difficult without adequate information in trial reports.
                We wanted to study how blinding is reported in clinical trials and how lack of reporting relate to lack of blinding.
                A cohort study of 200 blinded randomized clinical trials published in 2001 randomly sampled from the Cochrane Central Register of Controlled Trials, and a questionnaire survey of the trial authors.
                One-hundred and fifty-six (78%) articles described trials as 'double blind'. In three (2%) of such articles the blinding status of patients, health care providers and data collectors was explicitly described. Eighty-eight (56%) articles did not describe the blinding status of any trial person, and 41 articles (26%) reported no blinding relevant information at all beyond the trial being 'double blind'. One-hundred and thirty (65%) surveyed authors responded. Patients were blinded in 101 (97%) 'double blind' trials, and health care providers in 93 (89%). Twenty (19%) 'double blind' trials had not blinded either patients, health care providers or data collectors. Survey responders provided 15 different operational meanings of the term 'double blind', and typically felt that their preferred definition was the most widely used.
                The proportions in the author survey may be too optimistic due to reporting bias. It is not known how the increased use of the CONSORT guidelines may have affected reporting in years after 2001.
                The blinding status of key trial persons was incompletely reported in most randomized clinical trials. Unreported blinding may be frequent, but one of five 'double blind' trials did not blind either patients, treatment providers or data collectors. Authors, referees, and journal editors could improve the completeness of reporting of blinding, eg, by adhering to the CONSORT statement. It is inappropriate to presume blinding of key trial persons based only on the ambiguous term 'double blind'. To evaluate the use and reporting of adjusted analysis in randomised controlled trials (RCTs) and compare the quality of reporting before and after the revision of the CONSORT Statement in 2001.
                Comparison of two cross sectional samples of published articles.
                Journal articles indexed on PubMed in December 2000 and December 2006.
                Parallel group RCTs with a full publication carried out in humans and published in English
                Proportion of articles reported adjusted analysis; use of adjusted analysis; the reason for adjustment; the method of adjustment and the reporting of adjusted analysis results in the main text and abstract.
                In both cohorts, 25% of studies reported adjusted analysis (84/355 in 2000 vs 113/422 in 2006). Compared with articles reporting only unadjusted analyses, articles that reported adjusted analyses were more likely to specify primary outcomes, involve multiple centers, perform stratified randomization, be published in general medical journals, and recruit larger sample sizes. In both years a minority of articles explained why and how covariates were selected for adjustment (20% to 30%). Almost all articles specified the statistical methods used for adjustment (99% in 2000 vs 100% in 2006) but only 5% and 10%, respectively, reported both adjusted and unadjusted results as recommended in the CONSORT guidelines.
                There was no evidence of change in the reporting of adjusted analysis results five years after the revision of the CONSORT Statement and only a few articles adhered fully to the CONSORT recommendations. To examine the reporting characteristics and methodological details of randomised trials indexed in PubMed in 2000 and 2006 and assess whether the quality of reporting has improved after publication of the Consolidated Standards of Reporting Trials (CONSORT) Statement in 2001.
                Comparison of two cross sectional investigations. Study sample All primary reports of randomised trials indexed in PubMed in December 2000 (n=519) and December 2006 (n=616), including parallel group, crossover, cluster, factorial, and split body study designs.
                The proportion of general and methodological items reported, stratified by year and study design. Risk ratios with 95% confidence intervals were calculated to represent changes in reporting between 2000 and 2006.
                The majority of trials were two arm (379/519 (73%) in 2000 v 468/616 (76%) in 2006) parallel group studies (383/519 (74%) v 477/616 (78%)) published in specialty journals (482/519 (93%) v 555/616 (90%)). In both 2000 and 2006, a median of 80 participants were recruited per trial for parallel group trials. The proportion of articles that reported drug trials decreased between 2000 and 2006 (from 393/519 (76%) to 356/616 (58%)), whereas the proportion of surgery trials increased (51/519 (10%) v 128/616 (21%)). There was an increase between 2000 and 2006 in the proportion of trial reports that included details of the primary outcome (risk ratio (RR) 1.18, 95% CI 1.04 to 1.33), sample size calculation (RR 1.66, 95% CI 1.40 to 1.95), and the methods of random sequence generation (RR 1.62, 95% CI 1.32 to 1.97) and allocation concealment (RR 1.40, 95% CI 1.11 to 1.76). There was no difference in the proportion of trials that provided specific details on who was blinded (RR 0.91, 95% CI 0.75 to 1.10).
                Reporting of several important aspects of trial methods improved between 2000 and 2006; however, the quality of reporting remains well below an acceptable level. Without complete and transparent reporting of how a trial was designed and conducted, it is difficult for readers to assess its conduct and validity. To examine the extent to which the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines improved clinical trials reporting and subject attrition, which may undermine the credibility of published randomized clinical trials (RCTs).
                Published RCTs reported in two major medical journals before and after the CONSORT guidelines were systematically reviewed; one used the CONSORT statement (JAMA) and one did not (NEJM).
                The quality of RCT reporting improved for both journals, but JAMA showed more significant and consistent improvements in all aspects of RCT reporting. Subject attrition was better accounted for after the publication of CONSORT, although the attrition rates for various reasons actually increased. Attrition due to unknown reasons, as a percentage of total attrition, declined dramatically, from 68.7% pre-CONSORT to 13.0% post-CONSORT.
                Attrition of study subjects remains a serious problem in RCTs. Bias from selective attrition can undermine the presumptive scientific advantage of RCTs. The CONSORT guidelines improved RCT reporting when they were implemented but did not substantially improve reported attrition rates. To evaluate the quality of reporting of all the new randomized clinical trials published during 1999 in OPHTHALMOLOGY: using the CONSORT statement parameters.
                Descriptive series of published studies. STUDIES INCLUDED: Randomized clinical trials.
                Eligible studies were all randomized clinical trials published in Volume 106 (1999) of OPHTHALMOLOGY: that reported the results of prospectively conducted studies in humans comparing two or more therapeutic options with regard to their effect on one or various outcomes, in which the authors stated that a process of randomization or quasi-randomization was performed before the interventions. Each study was evaluated by two independent observers establishing the specific report in the published manuscript of 57 CONSORT statement descriptors, and consensus was obtained between evaluators.
                Overall presence of CONSORT statement descriptors in published reports.
                The mean number of positive CONSORT descriptors for the 24 eligible randomized clinical trials was 33.42 (standard error of the mean [SEM] 1.57) of 57 possible. This score was significantly different (P: < 0.001) from the score of 16.6 (standard error of the mean 0.6) reported for OPHTHALMOLOGY: in the 1991 to 1994 study by Scherer and Crawley. Of the nine descriptors measuring the quality of abstract reporting, a mean of 6.25 (SEM 0.3) was included in the 24 study abstracts evaluated, significantly different from the Scherer and Crawley score (5.2, SEM 0.2. P: < 0.001). Four and six descriptors increased and decreased, respectively, their reporting in more than 20%. Key descriptors such as hypothesis postulation, primary outcome determination, sample size calculations, and a discussion of the limitations of the study such as bias, imprecision, and internal validity are still reported in less than 42% of clinical trials.
                This study describes for the first time after the adoption of the CONSORT statement recommendations the status on the quality of reporting of recently published randomized clinical trials in OPHTHALMOLOGY: Although not a direct measure of the intrinsic quality of a study, reporting quality provides the reader with useful tools for the evaluation of its validity. The quality of reporting of randomized clinical trials shows an overall improvement when compared with the period between 1991 and 1994. However, there is still significant room for improvement, especially in descriptors essential for the validation of clinical trial results that are still widely underreported. To assess the quality of published randomized clinical trials (RCTs) in rheumatology and to determine whether there has been improvement in quality between 2 time periods, 1987-1988 and 1997-1998.
                Using MEDLINE and a hand search of selected rheumatology journals, we identified RCTs of adult rheumatic diseases published in English in 1987-1988 or 1997-1998. We examined trial quality with an expanded version of the Jadad scale, which assesses the adequacy of reported random sequence generation, allocation concealment, blinding, and analysis. All trials were read by 1 reviewer, with prior standardization using a random sample read by 2 reviewers. We also evaluated "high"- versus "low"-impact journals based on citation index.
                Two hundred forty RCTs (1987-1988 119 RCTs, 1997-1998 121 RCTs) were assessed. Results showed improvement in the quality of the trials, but the rates of reported random sequence generation, allocation concealment, power, and intent-to-treat analyses were persistently low. Low rates of reports of random sequence generation, allocation concealment, and intent-to-treat analyses were present even in the high-impact journals.
                There has been improvement in the quality of reporting of RCTs in rheumatology between 1987-1988 and 1997-1998. However, methodologic problems such as lack of allocation concealment, inadequate random sequence generation, lack of reporting of power, and lack of intent-to-treat analyses remain common. Many of these problems are established sources of bias in RCTs and are easily rectifiable. The quality of randomized controlled trials (RCTs) in subfertility and their suitability for inclusion in meta-analyses have been assessed in the past and found to be insufficient. Our aim was to assess whether this quality has improved over time, particularly since the publication of the Consolidated Standards of Reporting Trials (CONSORT) statement, and to assess what proportion of trials could be included in the meta-analyses of pregnancy outcomes such as those included in Cochrane Reviews.
                A selection of subfertility trials published in 1990, 1996 and 2002 was collected from the Cochrane Menstrual Disorder and Subfertility Group (MDSG) database. Only trials published in English as full journal articles, claiming to be randomized and reporting on pregnancy outcomes, were included.
                One hundred and sixty-four trials met our inclusion criteria. Twenty-four (15%) were found not to be randomized, despite claims, and only 10 trials (6%) provided adequate details on the methods of randomization and allocation concealment. Of these, only three had sufficient details extractable to allow for an intention-to-treat analysis of the outcome 'live birth'.
                Although an improvement in some subfertility-specific issues was observed, the quality of reporting of RCTs still needs to improve to make them suitable for inclusion in meta-analyses such as those in the Cochrane Library. Inadequate reporting of randomized controlled trials (RCTs) is associated with biased estimates of treatment effects. The reporting quality of RCTs involving patients with polycystic ovary syndrome (PCOS) is unknown. The purpose of this study was to assess the reporting quality of RCTs involving patients with PCOS using a standardized tool based on the Consolidated Standards of Reporting Trials (CONSORT) statement.
                We searched PubMed database for English-language RCTs involving patients with PCOS. Quality of reporting was assessed using a 24-item questionnaire based on the revised CONSORT checklist. Reporting was evaluated overall, and for pre- and post-CONSORT periods. RCTs on PCOS associated with fertility and non-fertility disturbances were also evaluated separately.
                Nine of the 24 items were reported in less than 50% of the studies, while a significant improvement (P < 0.05) was detected in 12 of 24 items (50%) over the two CONSORT periods. The RCTs on PCOS with reference to fertility seem to have adhered better to CONSORT statement than RCTs not associated to fertility.
                There is empirical evidence of suboptimal reporting quality of RCTs in PCOS. Endorsement of the CONSORT statement may optimize the reporting quality and enhance the validity of research. Increased attention has been directed at the quality of randomized controlled trials (RCTs) and how they are being reported. We examined leading anesthesiology journals to identify if there were specific areas for improvement in the design and analysis of published clinical studies. All RCTs that appeared between January 2000 and December 2000 in leading anesthesiology journals (Anesthesiology,Anesthesia & Analgesia,Anaesthesia, and Canadian Journal of Anaesthesia) were retrieved by a MEDLINE search. We used a previously validated assessment tool, including 14 items associated with study quality, to determine a quality score for each article. The overall mean weighted quality score was 44% +/- 16%. Overall average scores were relatively high for appropriate controls (77% +/- 7%) and discussions of side effects (67% +/- 6%). Scores were very low for randomization blinding (5% +/- 2%), blinding observers to results (1% +/- 1%), and post-beta estimates (16% +/- 13%). Important pretreatment clinical predictors were absent in 32% of all studies. Significant improvement in the reporting and conduct of RCTs is required and should focus on randomization methodology, the blinding of investigators, and sample size estimates. Repeat assessments of the literature may improve the adoption of guidelines for the improvement of the quality of randomized controlled trials. To evaluate the quality of reporting of randomized controlled trials in cardiothoracic surgery, to identify factors associated with good reporting quality, and to assess the awareness of the Consolidated Standards for Reporting of Trials statement and ascertain the views of authors reporting randomized controlled trials on the difficulties in conducting randomized controlled trials and the possible ways to further improve the reporting quality of randomized controlled trials in cardiothoracic surgery.
                Randomized controlled trials of cardiothoracic surgery published in principal cardiothoracic and 4 general medical journals in 2003 were included. The quality of reporting of randomized controlled trials was assessed by using allocation concealment, the Jadad score, and a Consolidated Standards for Reporting of Trials checklist devised for the purpose. A questionnaire survey of authors reporting randomized controlled trials in principal cardiothoracic journals in 2003 was conducted.
                The overall reporting quality of the 64 randomized controlled trials included in the analysis was suboptimal as assessed by the 3 methods adopted. Most of the authors (63.5%) were not aware of the Consolidated Standards for Reporting of Trials statement; however, awareness was not associated with reporting quality. More than 65% of the authors responded that conducting randomized controlled trials in surgical specialties was difficult, and the main difficulties were blinding and obtaining a large-enough sample size to detect statistically significant differences. Fifty-four percent of the authors responded that endorsement of the Consolidated Standards for Reporting of Trials statement by the cardiothoracic journals may improve the reporting quality.
                The quality of reporting randomized controlled trials in cardiothoracic surgery is suboptimal. Endorsement of the Consolidated Standards for Reporting of Trials statement by the cardiothoracic journals may improve the quality of reporting. The advent of controlled clinical trials revolutionized clinical medicine over the course of the 20th century. The objective of this study was to quantitatively characterize developments in clinical trial methodology over time in the field of acute ischemic stroke.
                All controlled trials targeting acute ischemic stroke with a final report in English were identified through MEDLINE and international trial registries. Data regarding trial design, implementation, and results were extracted. A formal 100-point scale was used to rate trial quality.
                A total of 178 controlled acute stroke trials were identified, encompassing 73 949 patients. Eighty-eight trials involved neuroprotective agents, 59 rheological/antithrombotic agents, 26 agents with both neuroprotective and rheological/antithrombotic effects, and 5 a nonpharmacological intervention. Only 3 trials met conventional criteria for a positive outcome. Between the 1950s and 1990s, the number of trials per decade increased from 3 to 99, and mean trial sample size increased from 38 (median, 26) to 661 (median, 113). During 1980-1999, median time window allowed for enrollment decreased per half decade from 48 to 12 hours. Reported pharmaceutical sponsorship increased substantially over time, from 38% before 1970 to 68% in the 1990s. Trial quality improved substantially from a median score of 12 in the 1950s to 72 in the 1990s.
                Accelerating trends in acute stroke controlled trials include growth in number, sample size, and quality, and reduction in entry time window. These changes reflect an increased understanding of the pathophysiology of acute stroke, the imperative for treatment initiation within a critical time window, and more sophisticated trial design. We appraised the compliance of randomized clinical trials (RCTs) cited for level A recommendations in obstetric practice bulletins (OPBs) and published after the CONSORT (Consolidated Standards of Reporting Trials, published 1996) statement. From the CONSORT checklist, we identified 50 separate items the RCTs should describe in the article and assigned 1 point if present; 0, if absent. The CONSORT score was the total points, expressed as a percentage. From 1998 to 2006, American College of Obstetricians and Gynecologists published 68 level A obstetric recommendations, and 20 (29%) are supported by > or = 1 RCT published after 1997. The median CONSORT score for the 32 RCTs published after the statement was 73% (range 30 to 100%). Only four RCTs complied with 90% of the CONSORT statement. RCTs supporting level A recommendations in OPB have variable compliance with CONSORT. Recommendations that lack quality RCTs should prompt further studies into the topic. Randomized controlled trials (RCTs) in surgery can provide valuable evidence of the efficacy of interventions if they are well-designed, appropriately executed, and adequately reported. Adequate reporting of methodology in surgical RCTs is known to be poor, and adverse-event reporting in surgical research is inconsistent. The Consolidated Standards of Reporting Trials (CONSORT) statement is a framework to help authors report their findings in a transparent manner. Extensions to the CONSORT statement have been published recently to address deficiencies in adverse-event reporting and in reporting of specific criteria related to nonpharmacologic treatments. The aim of this study was to assess the quality of reporting of trial methodology and adverse events in a sample of general surgical RCTs published in high-quality surgical journals using the criteria specified in the CONSORT statements.
                We used impact factor to identify the top three ranked surgical journals in 2004. We then obtained information on all RCTs published in these journals in the 2005 calendar year. We assessed quality of reporting using Jadad score, compared the quality of RCTs from CONSORT-endorsing journals with nonendorsers, and assessed the number of RCTs adequately reporting key generic methodologic, adverse-event-related, and specific nonpharmacologic criteria.
                Of 42 RCTs analyzed, only 40% (17 of 42) had a Jadad score > or = 3. There was no significant difference in the number of high-quality RCTs published in CONSORT-endorsing journals compared with nonendorsers (p = 0.3). The median percentage of RCTs adequately reporting generic methodologic, adverse-event-related, and specific nonpharmacologic criteria was 32.5%, 17%, and 36.5%, respectively.
                Quality of reporting of generic methodologic, adverse-event-related, and specific nonpharmacologic criteria in surgical RCTs is poor. Increased attention to quality of reporting of surgical RCTs is required if studies are to meet published criteria. We investigated whether there had been an improvement in quality of reporting for randomised controlled trials of acupuncture since the publication of the STRICTA and CONSORT statements. We conducted a before-and-after study, comparing ratings for quality of reporting following the publication of both STRICTA and CONSORT recommendations.
                Ninety peer reviewed journal articles reporting the results of acupuncture trials were selected at random from a wider sample frame of 266 papers. Papers published in three distinct time periods (1994-1995, 1999-2000 and 2004-2005) were compared. Assessment criteria were developed directly from CONSORT and STRICTA checklists. Papers were independently assessed for quality of reporting by two assessors, one of whom was blind to information which could have introduced systematic bias (e.g. date of publication). We detected a statistically significant increase in the reporting of CONSORT items for papers published in each time period measured. We did not, however, find a difference between the number of STRICTA items reported in journal articles published before and 3 to 4 years following the introduction of STRICTA recommendations.
                The results of this study suggest that general standards of reporting for acupuncture trials have significantly improved since the introduction of the CONSORT statement in 1996, but that quality in reporting details specific to acupuncture interventions has yet to change following the more recent introduction of STRICTA recommendations. Wider targeting and revision of the guidelines is recommended. nan The CONSORT (Consolidated Standards of Reporting Trials) statement was developed by a group of clinical trialists, biostatisticians, epidemiologists and biomedical editors as a means to improve the quality of reports of randomized controlled trials (RCTs). The purpose of the present study is to assess the reporting quality of published RCTs that compare endoscopic carpal tunnel release (ECTR) with open carpal tunnel release (OCTR) using the CONSORT statement.
                A computerized literature search was conducted to identify all RCTs published from January 1989 to November 2004 that compared ECTR with OCTR. Foreign language studies were also included, and translated versions of these studies were obtained. Two investigators independently reviewed each eligible article and determined whether the authors reported on each of the 22 items of the CONSORT statement. Disagreements were resolved by consensus. The mean scores for studies published before the introduction of the CONSORT statement and those published afterward were compared. Similarly, a comparison was made between foreign language studies and those published in English.
                Eighteen RCTs comparing ECTR with OCTR met the inclusion criteria. The total scores on the CONSORT checklist ranged from 3 to 20, with a mean score of 9.83+/-3.79 (the maximum possible score was 22). The six studies published in foreign language journals had a statistically significantly lower mean score than the studies published in English language journals (7.00+/-2.76 versus 11.25+/-3.49, respectively; P<0.05). The mean score was higher for studies published after 1996 than for those published in 1996 or earlier (12.14+/-3.80 versus 8.36+/-3.11, respectively; P<0.05).
                The quality of reporting improved over time, but no study met all 22 criteria of the CONSORT statement. The CONSORT scores were higher for studies published after 1996 and for studies published in English language journals. Despite the improvement after 1996, most of these RCTs only reported one-half of the items listed on the CONSORT statement. Future investigators of surgical RCTs should make an effort to comply with the CONSORT checklist. To determine whether the CONSORT recommendations influenced the quality of reporting of randomized controlled trials (RCTs) in the field of psychiatry, we evaluated the quality of clinical trial reports before and after the introduction of CONSORT statement. We selected seven high impact journals and retrieved the randomized, clinical trials in the field of psychiatry during the period of 1992-1996 (pre-CONSORT) and 2002-2007 (post-CONSORT). Among the total 5201 articles screened, 736 were identified and entered in our database. After critical review of the publications, 442 articles met the inclusion and exclusion criteria. The CONSORT Index (sum of 22 items of the checklist) during the post-CONSORT period was significantly higher than that during the pre-CONSORT period. However, over 40% of post-CONSORT studies did not adhere to CONSORT statement for reporting the process of randomization, and details of the process for obtaining informed consent were still insufficient. Furthermore, adherence to the CONSORT guidelines of reporting how blinding was accomplished and evaluated actually decreased after publication of the CONSORT statement. Although the overall quality of reporting on psychiatric RCTs generally improved after publication of the CONSORT statement, reporting the details of randomization, blinding, and obtaining informed consent remain insufficient. Intention-to-treat (ITT) is an analytic approach where all randomized participants are included in analyses and in their originally assigned condition, regardless of adherence or protocol deviation.
                The present study aimed to determine whether reporting and correct use of ITT in behavioral medicine randomized clinical trials (RCTs) published in behavioral journals has improved in recent years.
                ITT and related analytic conventions were examined in behavioral medicine RCTs (N = 87) published in Annals of Behavioral Medicine, Health Psychology, and the Journal of Consulting and Clinical Psychology in the years 2000-2003 and then again in 2006-2007. Logistic regression analyses tested whether ten indicators associated with ITT were being used increasingly over time. Also tested was whether reporting and correct use of ITT improved following the adoption of Consolidated Standards of Reporting Clinical Trials (CONSORT) statement.
                Results revealed that less than half of RCTs (42%) used ITT analyses correctly. Over time, reporting of sample size estimation and primary outcome as well as use of the term "ITT" to describe analyses improved; however, correct implementation of ITT did not. Improvement was not specifically attributable to CONSORT adoption.
                Investigators' claims of using ITT analyses have increased over time, but correct use of ITT has not. 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.
                (c) Georg Thieme Verlag KG Stuttgart . New York. The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to help improve the quality of reports of randomized controlled trials (RCTs). To date, a paucity of data exists regarding whether it has achieved this goal.
                To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs.
                Comparative before-and-after evaluation in which reports of RCTs published in 1994 (pre-CONSORT) were compared with RCT reports from the same journals published in 1998 (post-CONSORT). We included 211 reports from BMJ, JAMA, and The Lancet (journals that adopted CONSORT) as well as The New England Journal of Medicine (a journal that did not adopt CONSORT and was used as a comparator).
                Number of CONSORT items included in a report, frequency of unclear reporting of allocation concealment, and overall trial quality score based on the Jadad scale, a 5-point quality assessment instrument.
                Compared with 1994, the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998, and this increase was statistically significant for the 3 adopter journals (pre-CONSORT, 23.4; mean change, 3.7; 95% confidence interval [CI], 2.1-5.3). The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals, and this change was statistically significant for adopters (pre-CONSORT, 61%; mean change, -22%; 95% CI, -38% to -6%). Similarly, 3 of the 4 journals showed an improvement in the quality score for reports of RCTs, and this increase was statistically significant for adopter journals overall (pre-CONSORT, 2.7; mean change, 0.4; 95% CI, 0.1-0.8).
                Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs. The number of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) is increasing. However, there have been few systematic assessments of the quality of reporting of these trials. Objective: This study was undertaken to evaluate the quality of reporting of RCTs in TCM journals published in mainland China from 1999 to 2004.
                Thirteen TCM journals were randomly selected by stratified sampling of the approximately 100 TCM journals published in mainland China. All issues of the selected journals published from 1999 to 2004 were hand-searched according to guidelines from the Cochrane Centre. All reviewers underwent training in the evaluation of RCTs at the Chinese Centre of Evidence-based Medicine. A comprehensive quality assessment of each RCT was completed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist (total of 30 items) and the Jadad scale. Disagreements were resolved by consensus.
                Seven thousand four hundred twenty-two RCTs were identified. The proportion of published RCTs relative to all types of published clinical trials increased significantly over the period studied, from 18.6% in 1999 to 35.9% in 2004 (P < 0.001). The mean (SD) Jadad score was 1.03 (0.61) overall. One RCT had a Jadad score of 5 points; 14 had a score of 4 points; and 102 had a score of 3 points. The mean (SD) Jadad score was 0.85 (0.53) in 1999 (746 RCTs) and 1.20 (0.62) in 2004 (1634 RCTs). Across all trials, 39.4% of the items on the modified CONSORT checklist were reported, which was equivalent to 11.82 (5.78) of the 30 items. Some important methodologic components of RCTs were incompletely reported, such as sample-size calculation (reported in 1.1% of RCTs), randomization sequence (7.9%), allocation concealment (0.3 %), implementation of the random-allocation sequence (0%), and analysis of intention to treat (0%).
                The findings of this study indicate that the quality of reporting of RCTs of TCM has improved, but remains poor. The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to improve the quality of randomized controlled trial (RCT) reports. We assessed the quality of current Japanese RCT reports by conducting a cross-sectional study to examine the extent to which they adhere to the CONSORT statement.
                Reports of RCTs conducted in Japan that were published in medical journals between January and March 2004 were sampled from MEDLINE. The proportion of adherence to each item in the CONSORT checklist was evaluated for each report. Additionally, information on ethics reporting and funding sources was collected.
                A total of 98 RCT reports from Japan were evaluated, and adherence to the CONSORT statement was found to be suboptimal. Only 6 of 29 items in the checklist were described in more than 80% of reports. Adherence to key methodological items of the CONSORT statement was as follows: 23% for sample size determination, 39% for random sequence generation, 17% for allocation concealment, 29% for blinding, 53% for numbers analyzed, and 6% for inclusion of a flow diagram. Adherence to additional items was 82% for ethics committee approval, 92% for receiving informed consent, and 20% for disclosing funding sources.
                Our study on adherence of recent RCT reports from Japan to the CONSORT statement reveals that there is a significant need for improvement. Further investigation on the quality of RCT reports and ways to improve reporting quality is required. To evaluate the reporting quality of key methodological items in randomized controlled trials (RCTs) in four general clinical ophthalmology journals.
                The reporting of 11 key methodological items in RCTs published in American Journal of Ophthalmology, Archives of Ophthalmology, British Journal of Ophthalmology and Ophthalmology in the year 2005 was assessed.
                Sixty-seven eligible RCTs were assessed and the mean number of items reported was 6.3 per RCT. No significant difference in the mean number of items reported was found between the four journals (P=0.20). The most frequently reported item was ethics approval and informed consent (97.0%), followed by masking status (85.1%), description of withdrawals (76.1%), adverse events (73.1%), and intention-to-treat analysis (71.6%). Details on sequence generation, randomization restriction, allocation concealment, allocation implementation, patient flow diagrams, and sample size calculation were reported in <50% of the RCTs assessed. Both sample size and page length of the RCTs correlated with the number of methodological items reported (P=0.024 and P=0.008, respectively).
                Similar to other specialties, rooms for improvement exist in the reporting of key methodological items of RCTs in clinical ophthalmic journals. Stricter adoption of the CONSORT statement might enhance the reporting quality of RCTs in ophthalmic journals. To assess the reporting quality of randomized controlled trials (RCTs) in the primary treatment of brain tumors and to identify significant predictors of quality.
                Two investigators searched MEDLINE, EMBASE, and bibliographies of retrieved articles for RCTs in the primary treatment of brain tumors published between January 1990 and December 2004. We assessed the quality of overall reporting and key methodologic factors reporting (allocation concealment, blinding, and intention to treat [ITT]). Two investigators also rated articles independently using items from the revised Consolidated Standards of Reporting Trials statement. A generalized estimated equation was used to generate regression models that identified significant factors associated with quality of reporting.
                We retrieved 74 relevant RCTs that randomly assigned 14,498 brain tumor patients. The quality of overall reporting has improved during the last 15 years, but eight of the 15 methodologic items were reported in less than 50% of trials. In the appraisal of the reporting quality of key methodologies, allocation concealment, blinding, and adherence to the ITT principle were reported in less than 30% of articles. Multivariable regression models revealed that an impact factor more than 1.66, publication after 1995, and sample size more than 280 were significant factors associated with better overall reporting, whereas complete industrial funding, impact factors more than 2.64, and positive primary outcomes were predictors of higher ratings of the three most important methodologic qualities.
                Despite improvement in general reporting quality, key methodologies that safeguard against biases may still benefit from better description. Significant factors associated with better reporting may act as surrogates for other characteristics. This study was designed to analyze the characteristics and the quality of reporting of randomized, controlled trials published during the last ten years on fecal incontinence.
                An electronic search for all randomized, controlled trials on fecal incontinence was undertaken by using the MEDLINE database via PubMed. The data collected were divided into general data, characteristics of reporting, methodology quality assessment using the Jadad scale and a validated methodology quality score (MINCIR score), evaluation of the items published in the CONSORT statement, and the journal impact factor. Reports were divided into two groups: published articles from 1996 to 2000 (Group 1), and from 2001 to 2005 (Group 2).
                Forty-two trials fulfilled the inclusion criteria of the study (Group 1, n = 15; and Group 2, n = 27). There were no significant differences in general characteristics of randomized, controlled trials between the two groups. In Group 2, there were a statistically significant higher number of studies that reported a flow chart (P < 0.001), written informed consent (P = 0.008), sample size calculation (P = 0.023), and withdrawals and dropouts (P < 0.001). We found a statistically significant higher score in Jadad scale (P = 0.046) and MINCIR score (P = 0.016) in the published studies in Group 2. Also we found higher journal impact factor of journals that published these randomized, controlled trials during the most recent years (P = 0.04).
                There is a lack of high-quality reported randomized, controlled trials on fecal incontinence during the last ten years. Reports of randomized, controlled trials involving patients with fecal incontinence published after 2001 were better reported than in the previous five years. Several randomised clinical trials (RCTs) of analgesics in postoperative pain after traumatic or orthopaedic surgery (TOS) have been published, but no studies have assessed the quality of these reports. We aimed to examine the quality of reporting RCTs on analgesics for postoperative pain after TOS.
                Reports of RCTs assessing analgesics in postoperative pain after TOS were systematically searched from electronic databases. The quality of reports was assessed using the CONSORT checklist (scoring range from 0 to 22). The quality was considered poor when scoring was 12 or lesser. The publication year and the impact factor of journals were recorded.
                A total of 92 reports of RCTs were identified and 69 (75%) scored 12 or lesser in CONSORT checklist (range 5-17). The mean (SD) CONSORT score of all reports was 10.6 (2.7). Missing CONSORT items included primary and secondary outcome measures (11%), the specific objectives and hypothesis definition (12%), the sample size calculation (12%), the dates defining the periods of recruitment (12%), the discussion of external validity of findings (14%), the allocation sequence generation (24%), and the interpretation of potential bias or imprecision of results (25%). There was a little improvement in CONSORT scores over time (r = 0.62; p < 0.001) and with impact factor of journals (r = 0.30; p < 0.001).
                Quality of reporting RCTs on analgesics after TOS is poor. Reporting of those RCTs should be improved according to methodological standard checklists in the next years. In order to examine the reporting quality of urological RCTs, the initial objectives of this study were to evaluate the degree to which RCTs involving urological surgical techniques (as the intervention) published in the years 2000-2003 complied with the CONSORT statement, and to assess trends and patterns of compliance. Following our initial findings in urology, we extended the methodology to a number of other specialties to assess whether our findings in urology could be generalised to other surgical disciplines.
                The Royal Society of Medicine (RSM) Library was commissioned to search the Medline and Cochrane databases for RCTs in compliance with the study inclusion criteria below. Additional analyses of five other specialties (non-urological trials: cardiovascular, gastrointestinal, hepatic, orthopaedic and vascular) were also made. For the non-urological trials, 15 English language trials (from each specialty) were randomly picked from a blast search conducted by the RSM for the year 2003. The RCTs were given a score out of 22, reflecting how many of the 22 CONSORT items were complied with (with each item being given equal weighting), this score was termed the "CONSORT score".
                Urology trials: In total 122 RCT abstracts were identified which met the inclusion criteria for this study. From these, 32 were excluded as they were follow-up studies, involved a virtual procedure or were a cost analysis, leaving 90 RCTs published across 35 different journals which were analysed (68.2%, 90/122). The average score of 11.1 for urological trials indicates that RCTs in our sample do not comply with the CONSORT statement. No trials reported how they implemented their randomisation process. Only 46% of RCTs stated that they had permission from an ethics review board, 20% had declared their sources of funding, 14% stated whether there were any conflicts of interest and only 1.1% stated their trial registry number. For non-urological studies, an average CONSORT score of 11.2 was obtained.
                Clinical research teams conducting RCTs in urology and other surgical disciplines demonstrate poor compliance with the CONSORT statement. We would recommend that trials should be registered at their outset and that urological and other surgical journals to consider supporting the CONSORT statement and to have compliance 'hard-wired' into their submission, editorial and peer-review processes. Since it seems the best researchers are unable to produce an RCT results which enable surgical techniques to be critically assessed, there is a need for education about the CONSORT statement and its importance at all levels of surgical training. We believe that an open debate is needed on the possible role of other research designs, such as tracker studies. Whether this study actually raises the question of how appropriate RCTs are to surgical techniques, we leave to the reader. Reporting of randomized controlled trials (RCTs) should be of high quality to support the conclusions reached by the authors. Poor-quality reporting has been associated with an overestimation in intervention efficacy. Within the field of paediatric dentistry, no study has assessed the quality of reporting.
                The aim of this study was to assess published RCTs in paediatric dental journals between 1985 and 2006 for: (i) whether quality of reporting allows readers to assess the validity of trials; and (ii) whether quality of reporting has improved since the introduction of the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
                Hand search of the main paediatric dentistry journals; inclusion criteria were: the trial was performed on children, and RCT. CONSORT guidelines were made into an operational checklist. Trials published between 1985 and 1997, and between 1998 and 2006 were compared to determine any improvement since the publication of the CONSORT guidelines.
                One hundred and seventy-three of 5635 articles met the inclusion criteria. Reporting quality was poor overall and showed heterogeneity. It had improved slightly since the publication of CONSORT. Few trials were reported adequately.
                The quality of reporting of clinical trials is poor, and often not adequate to allow readers to assess trial validity. Overall quality of reporting has not substantially improved since the publication of CONSORT. Randomized controlled trials (RCTs) are the best tool to evaluate the effectiveness of clinical interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement is an evidence-based approach to improve the quality of RCTs. The aim of this study was to evaluate the reporting quality of published RCTs concerning myeloid hematologic malignancies according to the CONSORT statement.
                PubMed was searched for English-language RCTs involving patients with acute myeloid leukemia (AML), chronic myeloid leukemia (CML) and myelodysplastic syndromes (MDS). Trials were considered eligible when participants were randomly assigned to at least two treatment arms and included patients with AML, CML or MDS. Quality of reporting was assessed using a 24-item questionnaire based on the CONSORT checklist. Reporting was assessed in one pre-CONSORT (1988-1995) and one post-CONSORT (1996-2008) period. The effect of CONSORT statement in high- and low-ranked journals, according to their impact factor, has also been evaluated.
                The search identified 261 eligible articles for analysis. Only 13 of the 24 items of CONSORT statement were addressed in 75% or more of the studies. Most items concerning the methodological issues were reported by fewer than 50% of the studies. Significant improvements over time were seen for items that assessed the methodological quality, while RCTs published in high-ranked journals showed better quality of reporting.
                Quality of reporting in RCTs focusing on myeloid malignancies remains unsatisfactory. Further improvement of reporting is necessary to assess the validity of clinical research.
Evidence has accumulated to suggest that the reporting of RCTs remains sub-optimal. This review updates a previous systematic review of eight evaluations. The findings of this review are similar to those from the original review and demonstrate that, despite the general inadequacies of reporting of RCTs, journal endorsement of the CONSORT Statement may beneficially influence the completeness of reporting of trials published in medical journals. Future prospective studies are needed to explore the influence of the CONSORT Statement dependent on the extent of editorial policies to ensure adherence to CONSORT guidance.