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The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.

To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.

The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience

Just like you would not buy a car without key information such as service history, you would not "buy" a clinical trial report without key information such as concealment of allocation. Implementation of the updated CONSORT 2010 statement enables the reader to see exactly what was done in a trial, to whom and when. A fully "CONSORTed" trial report does not necessarily mean the trial is a good one, but at least the reader can make a judgement. Clear reporting is a pre-requisite for judgement of study quality. The CONSORT statement evolves as empirical research moves on. CONSORT 2010 is even clearer than before and includes some new items with a particular emphasis on selective reporting of outcomes. The challenge is for everyone to use it.

Kenneth Schulz and colleagues describe the 2010 version of the CONSORT Statement, which updates the previous reporting guideline based on new methodological evidence and accumulated experience.

A CONSORT statement on the content of abstracts of randomised, controlled trials (RCTs) was published in 2008. I therefore reviewed the abstracts from 2009 to 2010 published on RCTs in Cephalalgia, Headache and other (non-headache) journals. The following items were reviewed: number of patients, reporting of response either in percentages or absolute values, the use of p values, and effect size with its precision. The latter was recommended in the CONSORT statement. A total of 46 abstracts were reviewed and effect size with 95% confidence intervals was only reported in seven abstracts. The influence of the CONSORT statement on reporting in abstracts has so far only had a limited influence on the headache literature.

A CONSORT statement on the content of abstracts of randomised, controlled trials (RCTs) was published in 2008. I therefore reviewed the abstracts from 2009 to 2010 published on RCTs in Cephalalgia, Headache and other (non-headache) journals. The following items were reviewed: number of patients, reporting of response either in percentages or absolute values, the use of p values, and effect size with its precision. The latter was recommended in the CONSORT statement. A total of 46 abstracts were reviewed and effect size with 95% confidence intervals was only reported in seven abstracts. The influence of the CONSORT statement on reporting in abstracts has so far only had a limited influence on the headache literature.

Background The CONSORT statement is intended to improve reporting of randomised controlled trials and focuses on minimising the risk of bias (internal validity). The applicability of a trial’s results (generalisability or external validity) is also important, particularly for pragmatic trials. A pragmatic trial (a term first used in 1967 by Schwartz and Lellouch) can be broadly defined as a randomised controlled trial whose purpose is to inform decisions about practice. This extension of the CONSORT statement is intended to improve the reporting of such trials and focuses on applicability.

Methods At two, two-day meetings held in Toronto in 2005 and 2008, we reviewed the CONSORT statement and its extensions, the literature on pragmatic trials and applicability, and our experiences in conducting pragmatic trials.

Recommendations We recommend extending eight CONSORT checklist items for reporting of pragmatic trials: the background, participants, interventions, outcomes, sample size, blinding, participant flow, and generalisability of the findings. These extensions are presented, along with illustrative examples of reporting, and an explanation of each extension. Adherence to these reporting criteria will make it easier for decision makers to judge how applicable the results of randomised controlled trials are to their own conditions. Empirical studies are needed to ascertain the usefulness and comprehensiveness of these CONSORT checklist item extensions. In the meantime we recommend that those who support, conduct, and report pragmatic trials should use this extension of the CONSORT statement to facilitate the use of trial results in decisions about health care.

Pragmatic trials are designed to inform decisions about practice, but poor reporting can reduce their usefulness. The CONSORT and Practihc groups describe modifications to the CONSORT guidelines to help readers assess the applicability of the results

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 5,201 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.

Background

The extended Consolidated Standards of Reporting Trials (CONSORT) Statement for Abstracts was developed to improve the quality of reports of randomized controlled trials (RCTs) because readers often base their assessment of a trial solely on the abstract. To date, few data exist regarding whether it has achieved this goal. We evaluated the extent of adherence to the CONSORT for Abstract statement for quality of reports on RCT abstracts by four high-impact general medical journals.

Methods

A descriptive analysis of published RCT abstracts in The New England Journal of Medicine (NEJM), The Lancet, The Journal of American Medical Association (JAMA), and the British Medical Journal (BMJ) in the year 2010 was conducted by two reviewers, independently extracting data from a MEDLINE/PubMed search.

Results

We identified 271 potential RCT abstracts meeting our inclusion criteria. More than half of the abstracts identified the study as randomized in the title (58.7%; 159/271), reported the specific objective/hypothesis (72.7%; 197/271), described participant eligibility criteria with settings for data collection (60.9%; 165/271), detailed the interventions for both groups (90.8%; 246/271), and clearly defined the primary outcome (94.8%; 257/271). However, the methodological quality domains were inadequately reported: allocation concealment (11.8%; 32/271) and details of blinding (21.0%; 57/271). Reporting the primary outcome results for each group was done in 84.1% (228/271). Almost all of the abstracts reported trial registration (99.3%; 269/271), whereas reports of funding and of harm or side effects from the interventions were found in only 47.6% (129/271) and 42.8% (116/271) of the abstracts, respectively.

Conclusions

These findings show inconsistencies and non-adherence to the CONSORT for abstract guidelines, especially in the methodological quality domains. Improvements in the quality of RCT reports can be expected by adhering to existing standards and guidelines as expressed by the CONSORT group.

Hypotension is a frequent complication of spinal anaesthesia for caesarean section and can threaten the well-being of the unborn child. Numerous randomised controlled trials (RCTs) dealt with measures to prevent hypotension. The aim of this study was to determine the reporting quality of RCTs using the Consolidated Standards of Reporting Trials (CONSORT) statement since low quality can lend false credibility to a study and overestimate the effect of an intervention. We performed a systematic literature search in PubMed to identify relevant RCTs in a pre-CONSORT period (1990–1994) and a post-CONSORT period (2004–2008). A comparative evaluation was done between the two periods, and the trials were assessed for compliance with each of the 22 CONSORT items. A total of 37 RCTs was identified. The CONSORT score increased significantly (p < 0.05) from 66.7% (±12.5%) in the pre-CONSORT period to 87.4% (±6.9%) in the post-CONSORT period. A statistically significant improvement was found for eight items, including randomization, blinding and intention-to-treat analysis. The CONSORT score in the post-CONSORT era was fairly good, also in comparison to other medical fields. In the post-CONSORT era, reporting of important items improved, in particular in the domains that are crucial to avoid bias and to improve internal validity. Use of CONSORT should be encouraged in order to keep or even improve the reporting quality.

Background

The CONSORT Statement is a reporting guideline for authors when reporting randomized controlled trials (RCTs). It offers a standard way for authors to prepare RCT reports. It has been endorsed by many high-impact medical journals and by international editorial groups. This study was conducted to assess the endorsement of the CONSORT Statement by high-impact medical journals in China by reviewing their instructions for authors.

Methodology/Principal Findings

A total of 200 medical journals were selected according to the Chinese Science and Technology Journal Citation Reports, 195 of which publish clinical research papers. Their instructions for authors were reviewed and all texts mentioning the CONSORT Statement or CONSORT extension papers were extracted. Any mention of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (URM) developed by the International Committee of Medical Journal Editors (ICMJE) or ‘clinical trial registration’ was also extracted. For journals endorsing the CONSORT Statement, their most recently published RCT reports were retrieved and evaluated to assess whether the journals have followed what the CONSORT Statement required. Out of the 195 medical journals publishing clinical research papers, only six (6/195, 3.08%) mentioned ‘CONSORT’ in their instructions for authors; out of the 200 medical journals surveyed, only 14 (14/200, 7.00%) mentioned ‘ICMJE’ or ‘URM’ in their instructions for authors, and another five journals stated in their instructions for authors that clinical trials should have trial registration numbers and that priority would be given to clinical trials which had been registered. Among the 62 RCT reports published in the six journals endorsing the CONSORT Statement, 20 (20/62, 32.26%) contained flow diagrams and only three (3/62, 4.84%) provided trial registration information.

Conclusions/Significance

Medical journals in China endorsing either the CONSORT Statement or the ICMJE's URM constituted a small percentage of the total; all of these journals used ambiguous language regarding what was expected of authors.

Background

The Consolidated Standards of Reporting Trials (CONSORT) Statement is intended to facilitate better reporting of randomised clinical trials (RCTs). A systematic review recently published in the Cochrane Library assesses whether journal endorsement of CONSORT impacts the completeness of reporting of RCTs; those findings are summarised here.

Methods

Evaluations assessing the completeness of reporting of RCTs based on any of 27 outcomes formulated based on the 1996 or 2001 CONSORT checklists were included; two primary comparisons were evaluated. The 27 outcomes were: the 22 items of the 2001 CONSORT checklist, four sub-items describing blinding and a ‘total summary score’ of aggregate items, as reported. Relative risks (RR) and 99% confidence intervals were calculated to determine effect estimates for each outcome across evaluations.

Results

Fifty-three reports describing 50 evaluations of 16,604 RCTs were assessed for adherence to at least one of 27 outcomes. Sixty-nine of 81 meta-analyses show relative benefit from CONSORT endorsement on completeness of reporting. Between endorsing and non-endorsing journals, 25 outcomes are improved with CONSORT endorsement, five of these significantly (α = 0.01). The number of evaluations per meta-analysis was often low with substantial heterogeneity; validity was assessed as low or unclear for many evaluations.

Conclusions

The results of this review suggest that journal endorsement of CONSORT may benefit the completeness of reporting of RCTs they publish. No evidence suggests that endorsement hinders the completeness of RCT reporting. However, despite relative improvements when CONSORT is endorsed by journals, the completeness of reporting of trials remains sub-optimal. Journals are not sending a clear message about endorsement to authors submitting manuscripts for publication. As such, fidelity of endorsement as an ‘intervention’ has been weak to date. Journals need to take further action regarding their endorsement and implementation of CONSORT to facilitate accurate, transparent and complete reporting of trials.

Background

The clinical effectiveness of complementary and alternative medicines (CAMs) is widely debated because of a lack of clinical trials. The internet may provide an effective and economical approach for undertaking randomised controlled trials (RCTs) of low-risk interventions. We investigated whether the internet could be used to perform an internet-based RCT of a CAM fulfilling the revised CONSORT (Consolidated Standards of Reporting Trials) statement quality checklist for reporting of RCTs. A secondary aim was to examine the effect of probiotics compared to placebo in terms of well-being over 12 weeks.

Methods

People aged ≥18 years with confirmed spondyloarthropathy living in the United Kingdom with internet access were invited to participate in an internet-based RCT of probiotic compared to placebo for improving well-being and bowel symptoms. The intervention was a probiotic containing 4 strains of live bacteria or identical placebo taken by mouth daily for 3 months. The primary outcome measure was the performance of the trial according to the revised CONSORT statement.

Results

147 people were randomised into the trial. The internet-based trial of the CAM fulfilled the revised CONSORT statement such as efficient blinding, allocation concealment, intention to treat analysis and flow of participants through the trial. Recruitment of the required number of participants was completed in 19 months. Sixty-five percent (96/147) completed the entire 3 months of the trial. The trial was low cost and demonstrated that in an intention to treat analysis, probiotics did not improve well-being or bowel symptoms.

Conclusion

The internet-based RCT proved to be a successful and economical method for examining this CAM intervention. Recruitment, adherence and completion rate were all similar to those reported with conventional RCTs but at a fraction of the cost. Internet-based RCTs can fulfil all the criteria of the revised CONSORT statement and are an appropriate method for studying low-risk interventions.

Trial registration

ISRCTN36133252

Background

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.

Methodology and Principal Findings

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.

Conclusions and Significance

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.

Objective To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials.

Design Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting.

Data sources A validated Medline search strategy.

Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, 2000-8.

Results There were significant improvements in five of 14 reporting criteria: identification as cluster randomised; justification for cluster randomisation; reporting whether outcome assessments were blind; reporting the number of clusters randomised; and reporting the number of clusters lost to follow-up. No significant improvements were found in adherence to methodological criteria. Trials conducted in clinical rather than non-clinical settings and studies published in medical journals with higher impact factor or general medical journals were more likely to adhere to recommended reporting and methodological criteria overall, but there was no evidence that improvements after publication of the CONSORT extension for cluster trials were more likely in trials conducted in clinical settings nor in trials published in either general medical journals or in higher impact factor journals.

Conclusion The quality of reporting of cluster randomised trials improved in only a few aspects since the publication of the extension of CONSORT for cluster randomised trials, and no improvements at all were observed in essential methodological features. Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are needed to improve both reporting and methodology.

Background

The CONSORT Statement provides recommendations for reporting randomized controlled trials. We assessed the extent to which leading medical journals that publish reports of randomized trials incorporate the CONSORT recommendations into their journal and editorial processes.

Methods

This article reports on two observational studies. Study 1: We examined the online version of 'Instructions to Authors' for 165 high impact factor medical journals and extracted all text mentioning the CONSORT Statement or CONSORT extension papers. Any mention of the International Committee of Medical Journal Editors (ICMJE) or clinical trial registration were also sought and extracted. Study 2: We surveyed the editor-in-chief, or editorial office, for each of the 165 journals about their journal's endorsement of CONSORT recommendations and its incorporation into their editorial and peer-review processes.

Results

Study 1: Thirty-eight percent (62/165) of journals mentioned the CONSORT Statement in their online 'Instructions to Authors'; of these 37% (23/62) stated this was a requirement, 63% (39/62) were less clear in their recommendations. Very few journals mentioned the CONSORT extension papers. Journals that referred to CONSORT were more likely to refer to ICMJE guidelines (RR 2.16; 95% CI 1.51 to 3.08) and clinical trial registration (RR 3.67; 95% CI 2.36 to 5.71) than those journals which did not.

Study 2: Thirty-nine percent (64/165) of journals responded to the on-line survey, the majority were journal editors. Eighty-eight percent (50/57) of journals recommended authors comply with the CONSORT Statement; 62% (35/56) said they would require this. Forty-one percent (22/53) reported incorporating CONSORT into their peer-review process and 47% (25/53) into their editorial process. Eighty-one percent (47/58) reported including CONSORT in their 'Instructions to Authors' although there was some inconsistency when cross checking information on the journal's website. Sixty-nine percent (31/45) of journals recommended authors comply with the CONSORT extension for cluster trials, 60% (27/45) for harms and 42% (19/45) for non-inferiority and equivalence trials. Few journals mentioned these extensions in their 'Instructions to Authors'.

Conclusion

Journals should be more explicit in their recommendations and expectations of authors regarding the CONSORT Statement and related CONSORT extensions papers.

The IJTMB recommends the use of the CONSORT Statement (Consolidated Standards of Reporting Trials) guidelines for the reporting of randomized, controlled clinical trials (RCTs). A careful review of the guidelines shows important applications of these guidelines to all types of research reporting and design, not just RCTs. There is an Extension to these guidelines specific to nonpharmacologic interventions, including manually applied therapies and complementary medicine, and thus therapeutic massage and bodywork (TMB). Components of the Extension are thus relevant to publication in the IJTMB and should be considered part of standard reporting. As well, while the goals of the CONSORT Statement guidelines are to improve reporting of RCTs, the issues raised in the guidelines and explanatory document are relevant to all forms of TMB research and should be considered in all TMB research manuscripts. Finally, while not their purpose, the guidelines could also be used as an informal checklist when developing robust TMB research.

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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).

CONCLUSIONS:

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.

Background

Poor recruitment and retention of participants in randomised controlled trials (RCTs) is problematic but common. Clear and detailed reporting of participant flow is essential to assess the generalisability and comparability of RCTs. Despite improved reporting since the implementation of the CONSORT statement, important problems remain. This paper aims: (i) to update and extend previous reviews evaluating reporting of participant recruitment and retention in RCTs; (ii) to quantify the level of participation throughout RCTs.

Methods

We reviewed all reports of RCTs of health care interventions and/or processes with individual randomisation, published July–December 2004 in six major journals. Short, secondary or interim reports, and Phase I/II trials were excluded. Data recorded were: general RCT details; inclusion of flow diagram; participant flow throughout trial; reasons for non-participation/withdrawal; target sample sizes.

Results

133 reports were reviewed. Overall, 79% included a flow diagram, but over a third were incomplete. The majority reported the flow of participants at each stage of the trial after randomisation. However, 40% failed to report the numbers assessed for eligibility. Percentages of participants retained at each stage were high: for example, 90% of eligible individuals were randomised, and 93% of those randomised were outcome assessed. On average, trials met their sample size targets. However, there were some substantial shortfalls: for example 21% of trials reporting a sample size calculation failed to achieve adequate numbers at randomisation, and 48% at outcome assessment. Reporting of losses to follow up was variable and difficult to interpret.

Conclusion

The majority of RCTs reported the flow of participants well after randomisation, although only two-thirds included a complete flow chart and there was great variability over the definition of "lost to follow up". Reporting of participant eligibility was poor, making assessments of recruitment practice and external validity difficult. Reporting of participant flow throughout RCTs could be improved by small changes to the CONSORT chart.

Background

Web-based and mobile health interventions (also called “Internet interventions” or "eHealth/mHealth interventions") are tools or treatments, typically behaviorally based, that are operationalized and transformed for delivery via the Internet or mobile platforms. These include electronic tools for patients, informal caregivers, healthy consumers, and health care providers. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). While the CONSORT statement can be applied to provide broad guidance on how eHealth and mHealth trials should be reported, RCTs of web-based interventions pose very specific issues and challenges, in particular related to reporting sufficient details of the intervention to allow replication and theory-building.

Objective

To develop a checklist, dubbed CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth), as an extension of the CONSORT statement that provides guidance for authors of eHealth and mHealth interventions.

Methods

A literature review was conducted, followed by a survey among eHealth experts and a workshop.

Results

A checklist instrument was constructed as an extension of the CONSORT statement. The instrument has been adopted by the Journal of Medical Internet Research (JMIR) and authors of eHealth RCTs are required to submit an electronic checklist explaining how they addressed each subitem.

Conclusions

CONSORT-EHEALTH has the potential to improve reporting and provides a basis for evaluating the validity and applicability of eHealth trials. Subitems describing how the intervention should be reported can also be used for non-RCT evaluation reports. As part of the development process, an evaluation component is essential; therefore, feedback from authors will be solicited, and a before-after study will evaluate whether reporting has been improved.

Background

It is generally believed that exhaustive searches of bibliographic databases are needed for systematic reviews of health care interventions. The CENTRAL database of controlled trials (RCTs) has been built up by exhaustive searching. The CONSORT statement aims to encourage better reporting, and hence indexing, of RCTs. Our aim was to assess whether developments in the CENTRAL database, and the CONSORT statement, mean that a simplified RCT search strategy for identifying RCTs now suffices for systematic reviews of health care interventions.

Methods

RCTs used in the Cochrane reviews were identified. A brief RCT search strategy (BRSS), consisting of a search of CENTRAL, and then for variants of the word random across all fields (random$.af.) in MEDLINE and EMBASE, was devised and run. Any trials included in the meta-analyses, but missed by the BRSS, were identified. The meta-analyses were then re-run, with and without the missed RCTs, and the differences quantified. The proportion of trials with variants of the word random in the title or abstract was calculated for each year. The number of RCTs retrieved by searching with "random$.af." was compared to the highly sensitive search strategy (HSSS).

Results

The BRSS had a sensitivity of 94%. It found all journal RCTs in 47 of the 57 reviews. The missing RCTs made some significant differences to a small proportion of the total outcomes in only five reviews, but no important differences in conclusions resulted. In the post-CONSORT years, 1997–2003, the percentage of RCTs with random in the title or abstract was 85%, a mean increase of 17% compared to the seven years pre-CONSORT (95% CI, 8.3% to 25.9%). The search using random$.af. reduced the MEDLINE retrieval by 84%, compared to the HSSS, thereby reducing the workload of checking retrievals.

Conclusion

A brief RCT search strategy is now sufficient to locate RCTs for systematic reviews in most cases. Exhaustive searching is no longer cost-effective, because in effect it has already been done for CENTRAL.

Objective

To evaluate the reports' qualities which are about randomized controlled trials (RCTs) of acupuncture treatment on Mild Cognitive Impairment (MIC).

Methods

Nine databases including the Cochrane Central Register of Controlled Trials (CENTRAL,2010), PUBMED (1984-5/2010), EMbase (1984-5/2010), MEDLINE (1984-5/2010), CINAL (1984-5/2010), China National Knowledge Infrastructure (CNKI, 1980-5/2010), China Biomedicine Database disc (CBMdisc, 1980-5/2010), VIP (a full text issues database of China, 1989-5/2010) were searched systematically. Hand search for further references was conducted. Language was limited to Chinese and English. We identified 14 RCTs that used acupuncture as an intervention and assessed the quality of these reports against the Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA).

Results

In regard to the items in the CONSORT statement, 13(92.86%) RCTs described baseline demographic and clinical characteristics in each group. 7 (50.0%) mentioned the method of generating the random sequence, only 2 (14.3%) RCTs had adequate allocation concealment. No RCTs used blinding. RCTs reported the sample size calculation. In regard to the items in STRICTA, 10 (71.43%) mentioned the depths of insertion, 6 (42.86%) reported acupuncture response, 11 (78.57%) mentioned the technique of acupuncture, 12 (85.71%) recorded the time, and only 3 (21.43%) RCTs reported the numbers of needles inserted. No RCTs reported the background of the acupuncture practitioners and professional title of practitioners.

Conclusion

The reporting quality of RCTs of acupuncture for mild cognitive impairment was moderate to low. The CONSORT statement and STRICTA should be used to standardize the reporting of RCTs of acupuncture in future.

The CONSORT Statement was developed to help authors improve the quality of reporting randomized trials. To augment the statement we published the CONSORT explanation and elaboration paper which included at least one example of good reporting for each CONSORT checklist item. We are developing a comprehensive database of examples of good reporting for each checklist item to take advantage of the breadth and variety of trials familiar to authors and readers globally. We invite authors, editors, and readers worldwide to nominate examples of well reported items for the database.

Objective

In 1996, 2001, and 2010, the Consolidated Standards of Reporting Trials (CONSORT) group released criteria for reporting critical information about randomized clinical trials (1, 2). These criteria were intended to improve the quality and completeness of reporting of RCTs in health care research. This paper discusses the relevance of the CONSORT recommendations for the reporting and design of eHealth research.

Methods

We reviewed the CONSORT recommendations and discussed their particular relevance to eHealth (electronic information, support and/or communication resources designed to promote health) research. This review focuses on such issues as recruitment and screening of participants, description of treatment elements, and reporting of outcome data and adverse events.

Results

eHealth research presents special challenges regarding the comprehensive and effective reporting of research information. However, the strategic application of CONSORT recommendations holds great promise for improving the quality and informativeness of eHealth research.

Conclusion

Investigators need to consider CONSORT recommendations at all stages of the research enterprise, including planning, execution and reporting in order to increase the informativeness of their research efforts.

Practice Implications

The recommendations contained in this paper have the potential to enhance the public health and scientific value of eHealth research.

Background

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.

Methods

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.

Results

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.

Conclusion

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.