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PubMedDate not supplied

[Improving the quality of reports on randomized controlled trials. Recommendations of the CONSORT Study Group].

This summary corresponds to the translation into Spanish of the Special Communication published in the Journal of the American Medical Association in August 1996, along with the editorial published in the same issue "How to report Randomized Controlled Trials. The Consort Statement". It describes the Consolidated Standards for Preparation of Controlled Clinical Trials, prepared by a work group made up of members of the SORT Group and of the Asilomar Work Group, along with the director of a magazine and the author of the report on a clinical trial. The work was carried out by means of a Delphi process and the result was a check list and a process diagram. The check list is made up of 21 items that mainly refer to methods, results and discussions on the report of a controlled clinical trial, identifying the necessary information in order to be able to evaluate the internal and external value of the report, judging the improvement to be positive for the patient, the editors and the reviewers of the magazines.

Delphi Technique↗
PubMed1976

Effects of vaccination with a Moraxella bovis bacterin on the subsequent development of signs of corneal disease and infection with M bovis in calves under natural environmental conditions.

A vaccination study was conducted for infectious bovine keratoconjunctivitis (IBK) in 440 purebred Hereford cattle (cows and their newborn calves) of the USDA Meat Animal Research Center cattle herd at Clay Center, Ne. The cattle were allotted to 4 groups: 60 calves were vaccinated with an autogenous Moraxella bovis bacterin (group 1); 60 calves that were matched with group 1 calves were designated nonvaccinated matched controls (group 2); 99 calves were peer group nonvaccinated controls (group 3); and 219 cows, the dams of the calves, were nonvaccinated consorts (group 4). The infection rates in cattle groups 1, 2, 3, and 4 during the summer were 96.6, 98.3, 100, and 79.1%, respectively, and the disease rates were 90, 93, 85, and 20%. The infection and the disease rates were significantly (P less than 0.01) different between claves and cows. The disease rate was also significantly different between older and younger cows. A larger percentage of the affected calves and cows had mild or moderate (61%) signs of IBK rather than severe (39%) signs. The rate of body weight gain was reduced in calves with severe signs of IBK. The results seemed to indicate that little would be gained by vaccinating cattle against IBK under the conditions of study.

Animals↗
PubMed1975

Changes in social organization during the breeding season of wild talapoin monkeys.

Two adjacent troops of talapoin monkeys were studied near Mbalmayo, Cameroon, during a predicted 3-month breeding season. Mating continued for just over 2 months. One troop began to mate at least 2 weeks before the other, suggesting that, though climatic changes were probably important, precise timing was mediated through some intra-troop social facilitation effect. Before the breeding season, adult males and females lived in separate sub-groups. Males began to move into female sub-groups before there was any sign of the perineal swellings characteristic of receptive talapoin females. Copulation occurred only with females with medium or large swellings, except towards the end of the season. It is probable that the majority of females were monoestrous. At the height of the mating period, females joined mainly male sub-groups, leaving their infants with the mainly female groups which also included a few males. Copulations were observed in both these types of sub-groups. Consort behaviour was not observed, males frequently returning to all-male sub-groups immediately after ejaculation. Intersexual grooming was not characteristic of sexual interactions. At the end of the season, adults were seen more frequently in groups of their own sex or with juveniles only, and there was some indication that increased aggressiveness by newly pregnant females might be partly responsible for this separation.

Age Factors↗
PubMed2004

Hidden evidence to the West: multicentre, randomised, controlled trials in sepsis and systemic inflammatory response syndrome in Japanese journals.

OBJECTIVE: To assess multicentre, randomised, controlled trials (MC-RCTs) of systemic inflammatory response syndrome (SIRS) and sepsis conducted in Japan, published in Japanese and not available to English-language medical databases. DESIGN: Methodological review. SUBJECTS: All Japanese RCTs relevant to SIRS and sepsis. INTERVENTION: Identification of manuscripts using a Japanese electronic library. Critical analysis of methodology and reporting quality using a modified Methodological Quality Assessment Score and the CONSORT group check list. MEASUREMENTS AND RESULTS: Three MC-RCTs were identified. In the first, 147 patients with septic shock were randomised to methylprednisolone (1000 mg i.v.) or placebo. In the second, 221 patients were randomised to 0.20 mg/kg per h or 0.004 mg/kg per h of sivelestat for acute lung injury with SIRS. In the third, 504 patients were randomised to immunoglobulin (5 g for 3 days) or to a control group. The average methodological quality score was higher than that of equivalent Western trials. The reporting quality (CONSORT checklist) was comparable to Western studies published during the same period. CONCLUSIONS: Despite sound methodology and quality, the information obtained from relatively large Japanese critical care trials is not widely available to English-speaking investigators and therefore might be ignored in meta-analyses.

Anti-Inflammatory Agents↗
PubMedDate not supplied

[Course of the EDEN study by using participants' flow sheets].

UNLABELLED: The development of science allows us to take up new investigative challenges. Interpretations of results can be difficult if there is no adequate and complete information about investigative methods applied, course of trial and statistical analyses. The CONSORT group proposed a standardized diagram facilitating an accurate presentation of the randomised trial. The EDEN study is an example of the application of this method, where the studied groups, number of participants, and all procedures can be presented. It is helpful to prepare reports and find necessary data. The first part of the diagram describes the course of recruitment, the second part presents data necessary to estimate the course of the study and data about numbers of patients in each timepoint whilst the third part shows the assessment of caregivers. CONCLUSIONS: The analysis of the course and correctness of the study is legible if the flow diagram is used. It is useful to find the necessary data for statistical analyses at every stage of study. Permanent control of the study allow to avoid bias upsetting the course of the study and influencing its quality. It introduces comprehensible and straight forward presentation of the results.

Clinical Trials Data Monitoring Committees↗
PubMed1983

Structural variations in pili expressed during gonococcal infection.

Gonococci were cultured from the urethra of male patients and from the cervix and urethra of their female partners. SDS-PAGE of cell lysates from within each group of consorts showed that outer membrane protein I remained constant but considerable variations were seen in the apparent molecular weight of protein II. Pili were purified from the isolates of some groups of consorts. In each case the pili expressed by the isolates from the female cervix and urethra differed in subunit molecular weight and were usually also distinct from the pili expressed by the isolate from the male partner.

Bacterial Outer Membrane Proteins↗
PubMed2004

Better reporting of harms in randomized trials: an extension of the CONSORT statement.

In response to overwhelming evidence and the consequences of poor-quality reporting of randomized, controlled trials (RCTs), many medical journals and editorial groups have now endorsed the CONSORT (Consolidated Standards of Reporting Trials) statement, a 22-item checklist and flow diagram. Because CONSORT primarily aimed at improving the quality of reporting of efficacy, only 1 checklist item specifically addressed the reporting of safety. Considerable evidence suggests that reporting of harms-related data from RCTs also needs improvement. Members of the CONSORT Group, including journal editors and scientists, met in Montebello, Quebec, Canada, in May 2003 to address this problem. The result is the following document: the standard CONSORT checklist with 10 new recommendations about reporting harms-related issues, accompanying explanation, and examples to highlight specific aspects of proper reporting. We hope that this document, in conjunction with other CONSORT-related materials (http://www.consort-statement.org), will help authors improve their reporting of harms-related data from RCTs. Better reporting will help readers critically appraise and interpret trial results. Journals can support this goal by revising Instructions to Authors so that they refer authors to this document.

Evidence-Based Medicine↗
PubMed2001

Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation.

CONTEXT: 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. OBJECTIVE: To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs. DESIGN AND SETTING: 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). MAIN OUTCOME MEASURES: 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. RESULTS: 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). CONCLUSION: Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs.

Publishing↗
PubMed2006

Recommendations for reporting randomized controlled trials of herbal interventions: Explanation and elaboration.

Controlled trials that use randomized allocation are the best tool to control for bias and confounding in trials testing clinical interventions. Investigators must be sure to include information that is required by the reader to judge the validity and implications of the findings in the reports of these trials. In part, complete reporting of trials will allow clinicians to modify their clinical practice to reflect current evidence toward the improvement of clinical outcomes. The consolidated standards of reporting trials (CONSORT) statement was developed to assist investigators, authors, reviewers, and editors on the necessary information to be included in reports of controlled clinical trials. The CONSORT statement is applicable to any intervention, including herbal medicinal products. Controlled trials of herbal interventions do not adequately report the information suggested in CONSORT. Recently, reporting recommendations were developed in which several CONSORT items were elaborated to become relevant and complete for randomized controlled trials of herbal medicines. We expect that these recommendations will lead to more complete and accurate reporting of herbal trials. We wrote this explanatory document to outline the rationale for each recommendation and to assist authors in using them by providing the CONSORT items and the associated elaboration, together with examples of good reporting and empirical evidence, where available, for each. These recommendations for the reporting of herbal medicinal products presented here are open to revision as more evidence accumulates and critical comments are collected.

Complementary Therapies↗
PubMed2006

Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT*.

When homeopathy is tested in clinical trials, understanding and appraisal are likely to be improved if published reports contain details of prescribing strategies and treatments. An international Delphi panel was convened to develop consensus guidelines for reporting homeopathic methods and treatments. The panel agreed 28 treatment- and provider-specific items that supplement the CONSORT (Consolidated Standards of Reporting Trials) Statement items 2, 3, 4 and 19. The authors recommend these for adoption by authors and journals when reporting trials of homeopathy.

Delphi Technique↗
PubMedDate not supplied

The risk of transmission of genital Chlamydia trachomatis infection is less than that of genital Neisseria gonorrhoeae infection.

A total of 211 men with 237 female sexual partners and a total of 155 women with 156 male consorts were examined for genital infection with Chlamydia trachomatis and Neisseria gonorrhoeae. The index patients had either single chlamydial or gonococcal infections or dual infections with both microorganisms. Analysis of recovery rates for groups of sexual consorts indicated that gonorrhea was contracted more frequently than chlamydial infection. Thus, when index patients had dual infections, 45% and 28% of their female and male consorts, respectively, had chlamydial infection, but 64% and 77%, respectively, had gonorrhea. When index patients had single infections with C. trachomatis or N. gonorrhoeae, chlamydial infections were observed in consorts of 45% (women) and 28% (men), but gonococcal infections were observed in 80% (women) and 81% (men). Moreover, a significantly larger proportion of consorts of patients with chlamydial infection eluded infection than did partners of patients with gonorrhea. Women who used an intrauterine contraceptive device had chlamydial and gonococcal infections more often than those who used other forms of contraception, or no contraceptive.

Adolescent↗
PubMed1999

Behavioural aspects of the raccoon mating system: determinants of consortship success.

We monitored raccoons Procyon lotor, in southern Texas during the 1990-1992 mating seasons to describe mating behaviour and identify factors affecting consortship success. During most of this study, raccoons were spatially aggregated, with female home ranges congregated around permanent water sources and larger home ranges of male groups encompassing each female group. Consortship success varied among males and ranged from zero to six females per male within a mating season. Individual females consorted with one to four different males during an oestrous period; however, most (62%) females consorted with only one male during their oestrus. Dominance through overt conflict appeared to influence male consortship success. During two mating seasons, one male from each group consorted with females on more days than all other males combined. Body weight of males was positively correlated with number of consortship days. As synchrony of oestrus increased, variance in number of consortship days among males decreased, and access to oestrous females increased for subordinate males. Wounding among males increased during the mating season, and was more frequent for males than for females. The mating system, as determined by consortship behaviour, appeared to shift between polygyny and promiscuity, and possibly varied annually as a result of the timing of oestrous cycles. Copyright 1999 The Association for the Study of Animal Behaviour.

Journal Article↗
PubMedDate not supplied

Nonspecific aerobic vaginitis and pregnancy.

During the period 1996-1998, cervical swabs of 50 pregnant women with subacute amniotic infection syndrome (AIS) and the semen of their consorts were bacteriologically analyzed. In the control group were 50 healthy pregnant women and their consorts too. Pathogenic bacteria (the most common were Escherichia coli, Staphylococcus haemolyticus, Chlamydia trachomatis and Ureaplasma urealyticum) were isolated from the cervical swab of 50 pregnant patients with AIS in 86.0% of them, while in the control group of healthy pregnant women in 28.0%. Pathogenic bacteria were present in 70.0% of semen of consorts pregnant women with AIS and only in 30.0% of semen of the control group. The congruity of pathogenic bacteria in the cervical swab and semen in the investigated group was 69.2%, while only 35.7% in the control group. Following erythromycin, cefuroxime and local tetracyclin treatment, the negativization of the cervical swab resulted in 30 pregnant patients with AIS, while the colonization persisted in 20 of them. The outcome of pregnancy was significantly better in cases with negativization of the cervical swab: perinatal loss was 6.7%, while in cases with persistent infection it was 55.0%. The authors presume the amniotic infection syndrome should be ascending manifestation of nonspecific vaginitis, which is maintained by the consort's urogenital infection. AIS should be classified as a 'sexually-transmitted disease'.

Bacteria, Aerobic↗
PubMed2003

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↗