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Consolidated Standards (consolidate + standards)
Selected AbstractsAssessment of the quality of reporting of randomized clinical trials in paediatric dentistry journalsINTERNATIONAL JOURNAL OF PAEDIATRIC DENTISTRY, Issue 5 2009ABEER A. AL-NAMANKANY Introduction., 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. Objective., 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. Methods., 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. Results., 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. Conclusion., 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. [source] Improving the quality of reporting acupuncture interventions: describing the collaboration between STRICTA, CONSORT and the Chinese Cochrane CentreJOURNAL OF EVIDENCE BASED MEDICINE, Issue 1 2009Hugh MacPherson Background First published in 2001, STRICTA (STandards for Reporting Interventions in Controlled Trials of Acupuncture) was designed to expand on the reporting of one item within the CONSORT (Consolidated Standards of Reporting Trials) Statement checklist, the item relating to the intervention. Two recent reviews had found that STRICTA was highly regarded in the field and that there was a need for minor revisions. Objective To revise STRICTA within the CONSORT family of reporting guidelines. Design A collaborative effort involving the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was agreed. A consultation process with 47 international experts provided detailed feedback on an initial draft of a revised checklist. These data, along with the two review studies, comprised the documentation for a consensus meeting in Freiburg, Germany in October 2008. A total of 21 participants attended the meeting, bringing their expertise as research methodologists, reporting guideline developers, acupuncturists, physicians and journal editors. Results At the workshop, a revised draft checklist was agreed. There was general consensus that STRICTA should continue to function as a stand-alone guideline as well as an extension to CONSORT. It was agreed that STRICTA should be sufficiently broad to cover all type of clinical studies, from case reports through uncontrolled studies to randomised controlled trials. It was also decided that explanations and examples, as with other CONSORT reporting guidelines, would provide a useful way of supporting the uptake to the new recommendations when published. Discussion The checklist will be subjected to further revision processes in order to further its impact and support wider dissemination. Journals that regularly publish acupuncture trials will be encouraged to adopt the revised STRICTA, include it in their guidelines for authors, and promote the adoption of its recommendations for clinical studies of acupuncture. [source] Quality of Reporting of Clinical Trials of Dogs and Cats and Associations with Treatment EffectsJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 1 2010J.M. Sargeant Background: To address concerns about the quality of reporting of randomized controlled trials, and the potential for biased treatment effects in poorly reported trials, medical journals have adopted a common set of reporting guidelines, the Consolidated Standards of Reporting Trials (CONSORT) statement, to improve the reporting of randomized controlled trials. Hypothesis: The reporting of clinical trials involving dogs and cats might not be ideal, and this might be associated with biased treatment effects. Animals: Dogs and cats used in 100 randomly selected reports of clinical trials. Methods: Data related to methodological quality and completeness of reporting were extracted from each trial. Associations between reporting of trial features and the proportion of positive treatment effects within trials were evaluated by generalized linear models. Results: There were substantive deficiencies in reporting of key trial features. An increased proportion of positive treatment effects within a trial was associated with not reporting: the method used to generate the random allocation sequence (P < .001), the use of double blinding (P < .001), the inclusion criteria for study subjects (P= .003), baseline differences between treatment groups (P= .006), the measurement used for all outcomes (P= .002), and possible study limitations (P= .03). Conclusions and Clinical Importance: Many clinical trials involving dogs and cats in the literature do not report details related to methodological quality and aspects necessary to evaluate external validity. There is some evidence that these deficiencies are associated with treatment effects. There is a need to improve reporting of clinical trials, and guidelines, such as the CONSORT statement, can provide a valuable tool for meeting this need. [source] The REFLECT Statement: Methods and Processes of Creating Reporting Guidelines for Randomized Controlled Trials for Livestock and Food SafetyJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 1 2010A.M. O'Connor The conduct of randomized controlled trials in livestock with production, health, and food-safety outcomes presents unique challenges that might not be adequately reported in trial reports. The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting these livestock trials. A 2-day consensus meeting was held on November 18,19, 2008 in Chicago, IL, to achieve the objective. Before the meeting, a Web-based survey was conducted to identify issues for discussion. The 24 attendees were biostatisticians, epidemiologists, food-safety researchers, livestock production specialists, journal editors, assistant editors, and associate editors. Before the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items would need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT (Reporting Guidelines for Randomized Control Trials) statement for livestock and food safety and 22-item checklist. Fourteen items were modified from the CONSORT checklist, and an additional subitem was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health, and food-safety outcomes. [source] The CONSORT statement checklist in allergen-specific immunotherapy: a GA2LEN paperALLERGY, Issue 12 2009P. J. Bousquet The methodology of randomized clinical trials is essential for the critical assessment and registration of therapeutic interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement was developed to alleviate the problems arising from the inadequate reporting of randomized controlled trials. The present article reflects on the items that we believe should be included in the CONSORT checklist in the context of conducting and reporting trials in allergen-specific immunotherapy. Only randomized, blinded (in particular blinding of patients, health care providers, and outcome assessors), placebo-controlled Phase III studies in this article. Our analysis focuses on the definition of patients' inclusion and exclusion criteria, allergen standardization, primary, secondary and exploratory outcomes, reporting of adverse events and analysis. [source] Replacement versus repair of defective restorations in adults: resin compositeAUSTRALIAN DENTAL JOURNAL, Issue 3 2010MO Sharif Background:, Composite filling materials have been increasingly used for the restoration of posterior teeth in recent years as a tooth coloured alternative to amalgam. As with any filling material composites have a finite life-span. Traditionally, replacement was the ideal approach to treat defective composite restorations, however, repairing composites offers an alternative more conservative approach where restorations are partly still serviceable. Repairing the restoration has the potential of taking less time and may sometimes be performed without the use of local anaesthesia hence it may be less distressing for a patient when compared with replacement. Objectives:, To evaluate the effectiveness of replacement (with resin composite) versus repair (with resin composite) in the management of defective resin composite dental restorations in permanent molar and premolar teeth. Search strategy:, For the identification of studies relevant to this review we searched the Cochrane Oral Health Group Trials Register (to 23rd September 2009); CENTRAL (The Cochrane Library 2009, Issue 4); MEDLINE (1950 to 23rd September 2009); EMBASE (1980 to 23rd September 2009); ISI Web of Science (SCIE, SSCI) (1981 to 22nd December 2009); ISI Web of Science Conference Proceedings (1990 to 22nd December 2009); BIOSIS (1985 to 22nd December 2009); and OpenSIGLE (1980 to 2005). Researchers, experts and organizations known to be involved in this field were contacted in order to trace unpublished or ongoing studies. There were no language limitations. Selection criteria:, Trials were selected if they met the following criteria: randomized or quasi-randomized controlled trial, involving replacement and repair of resin composite restorations. Data collection and analysis:, Two review authors independently assessed titles and abstracts for each article identified by the searches in order to decide whether the article was likely to be relevant. Full papers were obtained for relevant articles and both review authors studied these. The Cochrane Collaboration statistical guidelines were to be followed for data synthesis. Main results:, The search strategy retrieved 279 potentially eligible studies, after de-duplication and examination of the titles and abstracts all but four studies were deemed irrelevant. After further analysis of the full texts of the four studies identified, none of the retrieved studies met the inclusion criteria and all were excluded from this review. Authors' conclusions:, There are no published randomised controlled clinical trials relevant to this review question. There is therefore a need for methodologically sound randomised controlled clinical trials that are reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement (http://www.consort-statement.org/). Further research also needs to explore qualitatively the views of patients on repairing versus replacement and investigate themes around pain, anxiety and distress, time and costs. [source] Midazolam Versus Diazepam for the Treatment of Status Epilepticus in Children and Young Adults: A Meta-analysisACADEMIC EMERGENCY MEDICINE, Issue 6 2010Jason McMullan MD Abstract Background:, Rapid treatment of status epilepticus (SE) is associated with better outcomes. Diazepam and midazolam are commonly used, but the optimal agent and administration route is unclear. Objectives:, The objective was to determine by systematic review if nonintravenous (non-IV) midazolam is as effective as diazepam, by any route, in terminating SE seizures in children and adults. Time to seizure cessation and respiratory complications was examined. Methods:, We performed a search of PubMed, Web of Knowledge, Embase, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, American College of Physicians Journal Club, Cochrane Central Register of Controlled Trials, the Cumulative Index to Nursing and Allied Health Literature, and International Pharmaceutical Abstracts for studies published January 1, 1950, through July 4, 2009. English language quasi-experimental or randomized controlled trials comparing midazolam and diazepam as first-line treatment for SE, and meeting the Consolidated Standards of Reporting Trials (CONSORT)-based quality measures, were eligible. Two reviewers independently screened studies for inclusion and extracted outcomes data. Administration routes were stratified as non-IV (buccal, intranasal, intramuscular, rectal) or IV. Fixed-effects models generated pooled statistics. Results:, Six studies with 774 subjects were included. For seizure cessation, midazolam, by any route, was superior to diazepam, by any route (relative risk [RR] = 1.52; 95% confidence interval [CI] = 1.27 to 1.82). Non-IV midazolam is as effective as IV diazepam (RR = 0.79; 95% CI = 0.19 to 3.36), and buccal midazolam is superior to rectal diazepam in achieving seizure control (RR = 1.54; 95% CI = 1.29 to 1.85). Midazolam was administered faster than diazepam (mean difference = 2.46 minutes; 95% CI = 1.52 to 3.39 minutes) and had similar times between drug administration and seizure cessation. Respiratory complications requiring intervention were similar, regardless of administration route (RR = 1.49; 95% CI = 0.25 to 8.72). Conclusions:, Non-IV midazolam, compared to non-IV or IV diazepam, is safe and effective in treating SE. Comparison to lorazepam, evaluation in adults, and prospective confirmation of safety and efficacy is needed. ACADEMIC EMERGENCY MEDICINE 2010; 17:575,582 © 2010 by the Society for Academic Emergency Medicine [source] Use of intravenous steroids at induction of anaesthesia for adult tonsillectomy to reduce post-operative nausea and vomiting and pain: a double-blind randomized controlled trialCLINICAL OTOLARYNGOLOGY, Issue 1 2006S. McKean Objective:, To assess the effectiveness of intravenous steroids at induction of anaesthetic to reduce post-operative nausea and vomiting and pain after adult tonsillectomy. Design:, Prospective, double-blind, randomized, placebo controlled trial, with ethical approval, following Consolidated Standards of Reporting Trials guidelines. Setting:, District General Hospital in Scotland, UK. Participants:, Seventy-two adults between 16 and 70 years, American Association of Anaethetists (ASA) 1, listed for elective tonsillectomy. Intervention:, Single dose of either 10 mg of dexamethasone or 2 mL of saline after induction with a consistent anaesthetic technique. Main outcome measures:, Patients filled in a visual analogue scale relating to pain and post-operative nausea and vomiting for the day of operation and 7 days after operation. The time to first ingestion of food and drink after operation was also noted. Results:, Data completion rate of 64% (46 of 72 patients enrolled). Statistically significant relative decrease (62%P = 0.001) in the incidence of post-operative nausea and vomiting was seen in those treated with dexamethasone. Statistically significant relative decrease (23%P = 0.016) in post-operative pain scores for the day of operation was seen in those treated with dexamethasone. Significant decrease (17.5%, P < 0.001) in mean pain score for seven post-operative days was seen in those treated with dexamethasone. No adverse effects were seen. Conclusions:, Dexamethasone given as a single dose of 10 mg at induction of anaesthesia for adult tonsillectomy is an effective, safe and inexpensive method for reducing morbidity in adult tonsillectomy. [source] | ||||||||||