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PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this article incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Comment. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from 4 stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, according to each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Publishing↗
PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Humans↗
PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Con solidated S tandards o f R eporting T rials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Algorithms↗
PubMed2005

The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001.

To comprehend the result of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this article incorporates new evidence and addresses some criticism of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Comment. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage or participants through an RCT. The revised flow diagram depicts information from 4 stages of a trial (enrollment, intervention allocation, follow-up and analysis). The diagram explicitly includes the number of participants, according to each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting or an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Guidelines as Topic↗
PubMed2001

The revised CONSORT statement for reporting randomized trials: explanation and elaboration.

Overwhelming evidence now indicates that the quality of reporting of randomized, controlled trials (RCTs) is less than optimal. Recent methodologic analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which boast the elimination of systematic error as their primary hallmark. Systematic error in RCTs reflects poor science, and poor science threatens proper ethical standards. A group of scientists and editors developed the CONSORT (Con solidated S tandards o f R eporting T rials) statement to improve the quality of reporting of RCTs. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have adopted the CONSORT statement. The CONSORT statement facilitates critical appraisal and interpretation of RCTs by providing guidance to authors about how to improve the reporting of their trials. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the CONSORT statement. The meaning and rationale for each checklist item are presented. For most items, at least one published example of good reporting and, where possible, references to relevant empirical studies are provided. Several examples of flow diagrams are included. The CONSORT statement, this explanatory and elaboration document, and the associated Web site ( http://www.consort-statement.org ) should be helpful resources to improve reporting of randomized trials. Throughout the text, terms marked with an asterisk are defined at end of text.

Algorithms↗
PubMed1976

Isolation of Chlamydia trachomatis from women attending a clinic for sexually transmitted diseases.

Attempts were made to isolate Chlamydia trachomatis from the cervix of 300 women attending a clinic for sexually transmitted diseases in Leeds. The women were divided into four groups; (1) 130 were consorts of men suffering from non-specific urethritis; (2) 66 were suffering from gonorrhoea, or were consorts of men suffering from this disease; (3) 56 were suffering from other sexually transmitted diseases; (4) 48 had no evidence of STD. The overall isolation rate of Chlamydia trachomatis was 20%. Positive results were obtained in 30%. of Group 1, in 27-3%. of Group 2, in 3-6%. of Group 3, and in 2-1%. of Group 4. No pathogenic sign or symptom of Chlamydia trachomatis infection of the cervix was detected.

Adolescent↗
PubMed2006

Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement.

Herbal medicinal products are widely used, vary greatly in content and quality, and are actively tested in randomized, controlled trials (RCTs). The authors' objective was to develop recommendations for reporting RCTs of herbal medicine interventions, based on the need to elaborate on the 22-item CONSORT (Consolidated Standards of Reporting Trials) checklist. Telephone calls were made and a consensus meeting was held with 16 participants in Toronto, Canada, to develop these recommendations. The group agreed on context-specific elaborations of 9 CONSORT checklist items for RCTs of herbal medicines. Item 4, concerning the herbal medicine intervention, required the most extensive elaboration. These recommendations have been developed to improve the reporting of RCTs using herbal medicine interventions.

Herbal Medicine↗
PubMed2005

[Randomized clinical trials (CONSORT)].

It has been repeatedly shown that the information supplied in publications of clinical trials is frequently insufficient or inaccurate and that some methodologic problems are associated with exaggerated estimates of the effect of healthcare interventions. To improve the quality of reports of clinical trials, a group of scientists and editors developed the CONSORT statement (Consolidated Standards of Reporting Trials), a 22-item checklist (plus flow diagram), that can be used by authors, editors, reviewers, and readers. After publication in 1996, CONSORT was adopted by several journals and editorial groups. In 1999, a second version was drawn up, which was published in 2001. This article presents the Spanish translation of the two elements integrating the revised CONSORT, the flow diagram and the 22-item checklist, and provides a short comment on each of them. Previous publications of the CONSORT statement and other useful resources such as examples of what are considered good communications may be obtained from the CONSORT web site (http://www.consort-statement.org).

Authorship↗
PubMed2002

Baseline comparisons in surgical trials.

INTRODUCTION: Baseline measurements are an essential component of clinical trials. They should establish that the groups involved are clinically equivalent so that any observed differences can be attributed to the intervention under evaluation. The objective of this study was to review the use of baseline comparisons in surgical trials. METHODS: A standardized format was used to evaluate 206 surgical trials published within 10 prestigious journals between January 1997 and December 1999. RESULTS: One hundred and fifty-one (73%) of the trials used the first table in the article to record baseline data. More than one-quarter of the trials declared less than five items and one-third of the trials inappropriately used 'P-values' as a measure of baseline equivalence. Only nine of the 54 multicentre studies (17%) mentioned the individual centres as possible confounding factors. DISCUSSION: Greater attention needs to be paid to baseline comparisons in surgical trials. One way of developing this type of critical ability is to use a checklist while reading a surgical trial of interest. Good resources include the CONSORT Statement by a group of prominent international biostaticians and the CLEAR (Critical Literature Evaluation and Research) Courses run by the Royal Australasian College of Surgeons.

Clinical Trials as Topic↗
PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials.

To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can only be achieved through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement.The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results and Discussion. The revised checklist includes 22-items selected because empirical evidence indicates that not reporting the information is associated with biasedestimates of treatment effect or the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis.In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Humans↗
PubMed1993

A randomized double-blind trial of tinidazole treatment of the sexual partners of females with bacterial vaginosis.

OBJECTIVE: To determine whether a single oral 2-g dose of tinidazole for women with clinically diagnosed bacterial vaginosis and their partners increases the cure rates as compared with the same treatment for the female patients alone. METHODS: During a 15-month period, 250 women aged 17-40 years who attended a gynecologic outpatient clinic for abnormal vaginal discharge and/or pruritus vulvae were randomized into two groups. They received a single oral dose of 2 g tinidazole while their partners received either 2 g tinidazole or placebo. Symptomatic improvement and clinical cure rates were assessed at 1 and 4 weeks after treatment. RESULTS: There were no statistical differences (P > .05) in symptomatic improvement, clinical cure rates, or culture results between the groups of women whose partners were treated with either tinidazole or placebo. However, male consorts of women in the tinidazole group experienced side effects more often than those in the placebo group (P = .0006). CONCLUSION: Routine treatment is not recommended for male partners of women with bacterial vaginosis.

Adolescent↗
PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.

To comprehend the results of a randomised controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through total transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by use of a checklist and flow diagram. The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect, or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly shows the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have done an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Humans↗
PubMed2001

Value of flow diagrams in reports of randomized controlled trials.

CONTEXT: Diagrams of the flow of participants through a clinical trial are recommended in the Consolidated Standards for Reporting of Trials (CONSORT) statement, but it is unclear whether such flow diagrams improve the quality of trial reports. OBJECTIVE: To examine the information contributed by flow diagrams and the completeness of reporting overall in reports of randomized controlled trials (RCTs) published in 5 general and internal medicine journals. DESIGN AND SETTING: Analysis of 270 reports of RCTs published in 1998 in the Annals of Internal Medicine (AIM; n = 19), BMJ (n = 42), JAMA (n = 45), The Lancet (n = 81), and The New England Journal of Medicine (NEJM; n = 83). MAIN OUTCOME MEASURES: Proportion of reports that included a flow diagram, information provided in flow diagrams, and completeness of reporting about flow of participants overall in flow diagrams or text. RESULTS: A total of 139 reports (51.5%) of RCTs included a flow diagram, but this varied widely among journals (AIM, 21.0%; BMJ, 38.1%; JAMA, 80.0%; The Lancet, 93.8%; and NEJM, 8.4%). Diagrams generally provided useful information, but only 73 (52.5%) included the number of participants who received allocated interventions and only 32 (23.0%) included the number of participants included in the analysis. In logistic regression analysis, overall completeness of reporting about flow of study participants was associated with publication of a flow diagram. CONCLUSIONS: Flow diagrams are associated with improved quality of reporting of randomized controlled trials. However, the structure of current flow diagrams is less than ideal. We propose a revised flow diagram that includes all important counts through the stages of parallel group trials.

Algorithms↗
PubMed2005

[The CONSORT statement for cluster randomised trials].

With the publication of the CONSORT statement there is now increased awareness of the need to adequately report the findings of randomised controlled trials. The CONSORT statement includes a checklist of items that should be addressed in the trial report. The original CONSORT statement was developed to ensure the appropriate reporting of parallel group randomised controlled trials in which individual participants are allocated to different intervention groups. In cluster randomised trials, however, groups of participants, rather than individuals, are randomly allocated to study groups. The process of allocating groups of participants raises additional reporting considerations and led to the publication of an extension to the CONSORT statement specifically for cluster randomised trials. In this paper we review the CONSORT extension to cluster randomised trials, outlining the special features of the cluster randomised trial which must be considered.

Authorship↗
PubMed2006

Improving the quality of reporting of randomized controlled trials evaluating herbal interventions: implementing the CONSORT statement [corrected].

BACKGROUND: Given that herbal medicinal products are widely used, vary greatly in content and quality, and are actively tested in randomized controlled trials (RCTs), such RCTs must clearly report the specifics of the intervention. OBJECTIVE: Our objective was to develop recommendations for reporting RCTs of herbal medicine interventions. METHODS: We identified and invited potential participants with expertise in clinical trial methodology, clinical trial reporting, pharmacognosy, herbal medicinal products, medical statistics, and/or herbal product manufacturing to participate in phone calls and a consensus meeting. Three phases were conducted: (1) Premeeting item generation via telephone calls, (2) Consensus meeting, and (3) Postmeeting feedback. Sixteen experts participated in premeeting phone calls for item generation, and 14 participants attended a consensus meeting in Toronto, Ontario, Canada, in June of 2004. During the consensus meeting, a modified Delphi technique was used to aid discussion and debate of information required for reporting RCTs of herbal medicines. RESULTS: After extensive discussion, the group decided that context-specific elaborations of nine Consolidated Standards of Reporting Trials (CONSORT) items to RCTs of herbal medicines were necessary: Item 1 (Title and Abstract), 2 (Background), 3 (Participants), 4 (Interventions), 6 (Outcomes), 15 (Baseline data), 20 (Interpretation), 21 (Generalizability), and 22 (Overall evidence). DISCUSSION: The elaboration of item 4 of the CONSORT statement outlines specific information required for complete reporting of the herbal medicine intervention. The reporting suggestions presented will support clinical trialists, editors, and reviewers in reporting and reviewing RCTs of herbal medicines and readers in interpreting the results.

Consensus↗
PubMed1989

Should male consorts of women with bacterial vaginosis be treated?

Nitroimidazoles have been shown to be the drugs of choice to treat women with bacterial vaginosis, but the recurrence rate is high. Some workers have suggested that the recurrence of symptoms may in fact be reinfection by male consorts, but no controlled studies have been undertaken to confirm this. In an international, multicentre, randomised, double blind trial, the recurrence rate was studied in 241 women with a clinical diagnosis of bacterial vaginosis. All women were treated with 2 g metronidazole twice at an interval of two days. The patients were randomly allocated to two groups, one contained 123 women, whose consorts were given the same dose of metronidazole, the other consisted of 118 women whose consorts were given inert but identical placebo tablets. The women were evaluated at weeks 1, 4, and 12 after treatment. At week 1, the cure rate was 97% (115/119) in women whose consorts had been treated and 98% (111/113) in the others. At week 4 bacterial vaginosis had recurred in 17% (19/112) of women whose consorts had been treated and in 13% (14/106) of those whose consorts had received placebo. At week 12 the recurrence rates were 21% (20/95) in women with treated consorts, and 16% (15/95) in the others. The differences in recurrence rates between the two groups of women were not significant. In conclusion, treating the sexual partners of women with bacterial vaginosis does not seem to increase the cure rate.

Adolescent↗
PubMed2001

The success of science and social norms.

In this paper I characterize science in terms of both invisible hand social organization and selection. These two processes are responsible for different features of science. Individuals working in isolation cannot produce much in the way of the warranted knowledge. Individual biases severely limit how much secure knowledge an individual can generate on his or her own. Individuals working in consort are required, but social groups can be organized in many different ways. The key feature of the social organization in science is that only working scientists can confer the most important reward in science--use--and scientists must use each other's work in order to succeed in realizing this goal. An analysis of science as a selection process serves quite a different function. Individual scientists strive to come up with novel solutions to significant problems. The question then becomes how to be creative. From a selective perspective, science as a process involves the production of numerous alternatives and a selection among them. A single scientist solving an important problem makes science look very efficient. Treating science as a selection process casts it in a very different light. In this paper I combine an invisible hand mechanism with a selective perspective in order to explain why science is as successful as it is. I do not make recourse to evolutionary epistemology in any of its traditional senses.

Biological Evolution↗