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.     

Composite outcomes in randomized trials: greater precision but with greater uncertainty?

Composite outcomes, in which multiple end points are combined, are frequently used as primary outcome measures in randomized trials and are often associated with increased statistical efficiency. However, such measures may prove challenging for the interpretation of results. In this article, we examine the use of composite outcomes in major clinical trials, assess the arguments for and against them, and provide guidance on their application and reporting. To assess incidence and quality of reporting, we systematically reviewed the use of composite end points in clinical trials in Annals of Internal Medicine, BMJ, Circulation, Clinical Infectious Diseases, Journal of the American College of Cardiology, JAMA, Lancet, New England Journal of Medicine, and Stroke from 1997 through 2001 using a sensitive search strategy. We selected for review 167 original reports of randomized trials (with a total of 300 276 patients) that included a composite primary outcome that incorporated all-cause mortality. Sixty-three trials (38%) were neutral both for the primary end point and the mortality component. Sixty trials (36%) reported significant results for the primary outcome measure but not for the mortality component. Only 6 trials (4%) were significant for the mortality component but not for the primary composite outcome, whereas 19 trials (11%) were significant for both. Twenty-two trials (13%) were inadequately reported. Our review suggests that reporting of composite outcomes is generally inadequate, implying that the results apply to the individual components of the composite outcome rather than only to the overall composite. Current guidelines for the undertaking and reporting of clinical trials could be revised to reflect the common use of composite outcomes in clinical trials.     

CONSORT 2010说明与详述：报告平行对照随机临床试验指南的更新

大量证据显示随机对照临床试验（randomised controlled trial,RCT）的报告质量不理想。报告不透明,则读者既不能评判试验结果是否真实可靠,也不能从中提取可用于系统综述的信息。最近的方法学分析表明,报告不充分和设计不合理与对治疗效果产生评价偏倚有关。这种系统误差对RCT损害严重,而RCT正是以其能减少或避免偏倚而被视为评价干预措施的金标准。为了提高RCT的报告质量,一个由专家和编辑组成的工作组制定了临床试验报告的统一标准（Consolidated Standards of Reporting Trials,CONSORT）声明。CONSORT声明于1996年首次发表,并于2001年更新。声明由对照检查清单和流程图组成,供作者在报告RCT时使用。许多核心医学期刊和主要国际性编辑组织都已认可CONSORT声明。该声明促进了对RCT的严格评价和解释。2001年,在对CONSORT进行修订时,人们就已经清楚地认识到,解释和说明制定CONSORT声明的原理,有助于研究人员等撰写或评价临床试验报告。一篇CONSORT说明与详述文章于2001年同2001版CONSORT声明一起发表。2007年1月的专家会议之后,对CONSORT声明作了进一步修订并已发表,即＂CONSORT2010声明＂。这次更新对原版对照检查清单作了文字上的修改,使其更为明晰,并收入了与一些新近才认识到的主题相关的建议,如选择性报告结局产生的偏倚。说明与详述文件旨在加强人们对CONSORT声明的理解、应用和传播,这次也作了大量修订,对每一项新增或更新的清单条目的含义和增改理由进行了解释,提供了优秀的报告实例,还尽可能地提供了相关的经验性研究的参考文献。文中收入了若干流程图实例。＂CONSORT2010声明＂、其说明与详述文件,以及相关网站（www.consort-statement.org）,对于改进随机临床试验报告必将有所裨益。     

Reporting of informed consent and ethics committee approval in clinical trials

Context  To determine whether journals have improved their disclosure of ethical protections in clinical trials. Methods  Comparison of clinical trials published before and after 1997 (July 1995 to December 1996 and January 1998 to June 1999) in Annals of Internal Medicine, BMJ, JAMA, The Lancet, and The New England Journal of Medicine. Sixty articles per journal per period were randomly selected and assessed for rate of reporting on informed consent and on ethics committee approval. Results  Informed consent was not described in 79 articles (26%) published before 1997 vs 53 (18%) published after 1997 (P = .01), and ethics committee approval was not mentioned in 93 (31%) before 1997 vs 54 (18%) after 1997 (P<.001). Neither protection was described in 48 articles (16%) published before 1997 vs 28 (9%) after 1997 (P = .01). In subgroup analyses, those journals with the worst initial rates generally improved the most. BMJ did not describe informed consent in 25 articles (42%) before 1997 vs 15 (25%) after 1997 (P = .05), and JAMA did not describe ethics committee approval in 25 (42%) before 1997 vs 13 (22%) after 1997 (P = .02). BMJ, JAMA, and Annals had the lowest initial rates of reporting on both protections in the same article, with 25 (42%), 32 (53%), and 34 (57%), respectively, but improved markedly to 38 (63%), 43 (72%), and 45 (75%) (P = .02, .04, and .03, respectively). Conclusions  Major medical journals have improved their reporting on informed consent and ethics committee approval; however, 9% of studies still report neither.      

国际著名医学期刊论文题目结构特征分析

目的分析Medline中收录的5种国际著名医学期刊论文题目结构特征,旨在对国内医学论文作者提供借鉴。方法检索与分析Medline中收录的国际5种著名医学期刊论文题目。结果"研究对象、研究方法、研究目的"三要素仍是构成期刊题目重要元素;名词短语是5大期刊论文题目的主要构成成分;句子是NatMed题目的鲜明特征,使用频率近半;大量使用副标题的期刊依次是BMJ、Lancet、JAMA;NEnglJMed的题目平均长度最短,9.92个单词。结论简短、信息量充足又符合各刊写作风格的文题拟定对稿件的投稿、同行评议、检索和被阅读次数具有影响。     

Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas

CONTEXT: Randomized trials with adequate sample size offer an opportunity to assess the safety of new medications in a controlled setting; however, generalizable data on drug safety reporting are sparse. OBJECTIVE: To scrutinize the completeness of safety reporting in randomized trials. DESIGN, SETTING, AND PATIENTS: Survey of safety reporting in 192 randomized drug trials 7 diverse topics with sample sizes of at least 100 patients and at least 50 patients in a study arm (N = 130074 patients). Trial reports were identified from comprehensive meta-analyses in 7 medical areas. MAIN OUTCOME MEASURES: Adequate reporting of specific adverse effects and frequency and reasons for withdrawals due to toxic effects; article space allocated to safety reporting and predictors of such reporting. RESULTS: Severity of clinical adverse effects and laboratory-determined toxicity was adequately defined in only 39% and 29% of trial reports, respectively. Only 46% of trials stated the frequency of specific reasons for discontinuation of study treatment due to toxicity. For these 3 parameters, there was significant heterogeneity in rates of adequate reporting across topics (P =.003, P<.001, and P =.02, respectively). Overall, the median space allocated to safety results was 0.3 page. A similar amount of space was devoted to contributor names and affiliations (P =.16). On average, the percentage of space devoted to safety in the results section was 9.3% larger in trials involving dose comparisons than in those that did not (P<.001) and 3.8% smaller in trials reporting statistically significant results for efficacy outcomes (P =.047). CONCLUSIONS: The quality and quantity of safety reporting vary across medical areas, study designs, and settings but they are largely inadequate. Current standards for safety reporting in randomized trials should be revised to address this inadequacy.     

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.     

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.     

Methodological quality and reporting of ethical requirements in phase III cancer trials

BACKGROUND: The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. METHOD: Methodological quality (Jadad score) and ethical quality (Berdeu score) were assessed for all randomised controlled trials (RCTs) published in 10 international journals between 1999 and 2001 (n = 231). RESULTS: The mean Jadad score was 9.86 +/- 1.117. The methodological quality was poor in 75 RCTs (Jadad score <9). The mean Berdeu score was 0.42 +/- 0.133. The mean ethical quality score for poor methodological quality RCTs (n = 75) was 0.39 +/- 0.133; it was 0.43 +/- 0.133 for good (n = 156) methodological quality RCTs (p = 0.07). There was improvement in ethical quality according to the year of commencement of the trials (p < 0.001). There was no correlation between methodological quality and the number of participating patients (R2 = 0.003, p = 0.78), between ethical quality and the number of participating patients (R2 = 0.003, p = 0.76 ), or between ethical quality and methodological quality (R2 = 0.012, p = 0.1). ICP and REC approval were not obtained for 21 and 77 trials respectively. CONCLUSION: The association between methodological quality and the reporting of ethical requirements probably reflects the respect shown for patients during the whole research process. These results suggest that closer attention to the conduct of clinical research, as well as the reporting of its ethical aspects, is needed.     

采用CONSORT和STRICTA评价针刺治疗糖尿病胃轻瘫随机对照试验报告质量

[目的] 采用试验报告统一标准(CONSORT)和报告针刺临床试验中干预措施(STRICTA)标准评价针刺治疗糖尿病胃轻瘫随机对照试验的报告质量。 [方法] 计算机检索Cochrane 图书馆临床对照试验数据库、PubMed、中国知识基础设施工程、维普等数据库。文种限制为中英文。纳入针刺治疗糖尿病胃轻瘫的随机对照试验, 并采用CONSORT声明和STRICTA标准进行报告质量评价。[结果] 共纳入针刺治疗糖尿病胃轻瘫随机对照研究28篇文献。根据CONSORT声明和STRICTA标准对纳入文献进行分析, 无文献提及随机分配方案的隐藏、样本量的计算方法和治疗师资历。大部分研究对随机方法描述不清、盲法使用率低、未使用流程图、不良反应报道少、针刺细节报道不充分等问题。[结论] 目前针刺治疗糖尿病胃轻瘫的研究报告质量普遍较低。今后应采用国际公认的CONSORT声明和STRICTA标准对针刺疗法进行规范报告。     

Current situation on the reporting quality of randomized controlled trials in 5 leading Chinese medical journals

Objective： The Consolidated Standards for Reporting of Trials （CONSORT） statement has already proved to be an efficient standard for reporting quality of randomized controlled trials （RCTs）. However, most of the Chinese medical journals have not endorsed the CONSORT statement. The current situation about the reporting quality of RCTs in Chinese medical journals is still unclear. The purpose of the study was to evaluate the reporting quality of RCTs on papers published in 5 leading Chinese medical journals. Methods： We evaluated 232 original RCT papers using a reporting quality scale based on CONSORT statement from 2001 to 2006 in 5 Chinese medical journals （Journal type 1） without adoption of CONSORT and Chinese Journal of Evidence-based Medicine （Journal type 2） which adopted CONSORT in 2004. We measured the inclusion of 26 items for the reporting quality scale and 6 core items of each RCT report, gave score to each item and calculated the total score obtained in each report and the proportion of reports including individual items. The reporting quality of RCT trials from 2001 to 2003 （pre-adoption period） was compared with that from 2004 to 2006 （post-adoption period）. Results： The average reporting quality of RCTs was moderate （mean score, 15.18）, and the mean score of the 6 core items was low （mean score, 1.09） in 5 leading journals. The difference in the total score and the score of the 6 core items between pre-adoption period （2001-2003） and post-adoption period （2004-2006） was statistically significant （P=0.003; P=0.000）. Interaction between journal type and period was not significant （F=0.76; P=0.383）. We concluded that the change tendency of reporting quality between Journal type 1 and 2 was not different. But as to the core items of sequence concealment and intention-to-treat analysis, the increases were greater for Journal type 2 when evaluated against Journal type 1 （P=0.038; P=0.016）. Conclusion： The reporting quality of RCT trials in 5 leading Chinese medical journals is improving. However, the lack of important items in RCT trials remains a serious problem. We recommend the endorsement of the Consolidated Standards for Reporting of Trials statement in Chinese medical journals and the continuing education on evidence-based medicine in China.     

Reporting of gender-related information in clinical trials of drug therapy for myocardial infarction

BACKGROUND: Concern has been expressed that women are not adequately represented in clinical trials evaluating treatments for medical conditions they commonly experience. This study was designed to assess the reporting of data on women in recently published trials of drug therapy for myocardial infarction, including those funded by an agency with a gender-related policy. METHODS: All randomized controlled trials and meta-analyses of drug therapies for myocardial infarction published in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, the Annals of Internal Medicine and the British Medical Journal from January 1992 to December 1996 were evaluated. On preliminary review 102 articles met the inclusion criteria; these were reviewed in detail, and 59 were excluded. Two reviewers independently extracted gender-related information from the 43 articles; discrepancies were resolved by consensus. RESULTS: Women presented up to 48% of the trial participants (mean 24.1%). In the trials funded by an agency with a gender-related policy, only 16.8% of participants, on average, were women. Of the 43 articles in the sample, only 14 (32%) provided gender-related results. Funding from an agency with gender-related policy did not affect the reporting of gender-related information. Subgroup analyses were provided for 14 (32%) of the 43 trials, including 2 (29%) of 7 trials funded by an agency with a gender-related policy. Of the 12 trials that included interaction analyses (excluding the 2 trials in which secondary analyses were conducted specifically to identify differences between women and men), 7 (58%) conducted an interaction analysis to determine if women responded differently than men; for one of these the interaction analysis was for a secondary outcome measure (drug safety). Only 5 (12%) of the 43 articles mentioned the differences between men and women in the Discussion section; 2 of these were studies that used secondary analyses to examine sex differences. Of the 5, only 1 was funded by an agency with a gender-related policy. INTERPRETATION: Women were poorly represented in the randomized controlled trials in this sample, regardless of whether the trials were funded by an agency with a gender-related policy. Structured reporting of gender-related information for clinical trials may improve the quality of information available about women and therefore facilitate the application of research findings to the care of women.     

提高中草药随机对照试验的质量Ⅳ:采用修改后的CONSORT条目评价临床随机对照试验报告的质量

目的:以Cochrane图书馆中有关中草药治疗2型糖尿病系统评价中的66个临床随机对照试验为基础,分析在中草药临床随机对照试验研究报告中存在的问题,以及如何提高临床随机对照试验报告的质量。方法:文献检索2005年7月前发表于Cochrane图书馆的纳入随机对照试验最多的系统评价—中草药治疗2型糖尿病系统评价,共包含66个临床随机对照试验。以原有的CONSORT条目为基础,增加有关中医药方面的5项内容,即中医证型、组方依据、复方组成、制剂类型及质量控制。修订后的CONSORT评估表共包含63项条目,并以此为标准评估66篇临床随机对照试验报告的质量。结果:按修改后的CONSORT条目,66篇临床随机对照试验的总体报告率为19%~44%,中位数32%(标准差8%)。结论:中草药临床随机对照试验报告的总体质量较低。建议:以CONSORT条目为基础,进行中草药临床随机对照试验报告规范化的研究。同时建议中医药类杂志的编辑要求作者按照规范格式发表临床研究报告。     

Statewide system of electronic notifiable disease reporting from clinical laboratories: comparing automated reporting with conventional methods

CONTEXT: Notifiable disease surveillance is essential to rapidly identify and respond to outbreaks so that further illness can be prevented. Automating reports from clinical laboratories has been proposed to reduce underreporting and delays. OBJECTIVE: To compare the timeliness and completeness of a prototypal electronic reporting system with that of conventional laboratory reporting. DESIGN: Laboratory-based reports for 5 conditions received at a state health department between July 1 and December 31, 1998, were reviewed. Completeness of coverage for each reporting system was estimated using capture-recapture methods. SETTING: Three statewide private clinical laboratories in Hawaii. MAIN OUTCOME MEASURES: The number and date of reports received, by reporting system, laboratory, and pathogen; completeness of data fields. RESULTS: A total of 357 unique reports of illness were identified; 201 (56%) were received solely through the automated electronic system, 32 (9%) through the conventional system only, and 124 (35%) through both. Thus, electronic reporting resulted in a 2.3-fold (95% confidence interval [CI], 2.0-2.6) increase in reports. Electronic reports arrived an average of 3.8 (95% CI, 2.6-5.0) days earlier than conventional reports. Of 21 data fields common to paper and electronic formats, electronic reports were significantly more likely to be complete for 12 and for 1 field with the conventional system. The estimated completeness of coverage for electronic reporting was 80% (95% CI, 75%-85%) [corrected] compared with 38% (95% CI, 36%-41%) [corrected] for the conventional system. CONCLUSIONS: In this evaluation, electronic reporting more than doubled the total number of laboratory-based reports received. On average, the electronic reports were more timely and more complete, suggesting that electronic reporting may ultimately facilitate more rapid and comprehensive institution of disease control measures.     

提高中草药随机对照试验的质量Ⅰ:临床试验设计和方法学

目的:通过对中草药临床随机对照试验的设计及方法学进行质量评价,探讨如何提高中草药临床试验的质量。方法:文献检索2005年7月前发表于Cochrane图书馆的中草药系统评价共11篇,包含167个中草药临床随机对照试验。质量评价方法采用修订版CONSORT声明9项指标以及中草药剂型及质量控制标准指标。结果:所有167个临床试验都含有试验目的、方法、第1结局指标、统计学方法及中药剂型;其中163(97.6%)个临床试验说明了研究对象的纳入标准,只有26(15.6%)个临床试验说明了研究对象的排除标准;只有14(8.4%)个临床试验详细说明了随机序列的产生方法;4(2.4%)个临床试验提及了随机分配隐藏;绝大部分的临床试验(86.8%)属于开放性的,只有13.2%的临床试验采用了盲法设计;只有1个临床试验在试验前进行了样本含量的计算;在中草药剂型方面,45.5%的临床试验使用的是汤剂或中药茶包,只有1个临床试验提及了制剂的质量控制。在167个临床试验中,所有质量评价指标的涉及率只有36.0%。结论:现阶段中草药临床随机对照试验的质量还很低。建议:(1)试验设计者及实施者必须接受正规的临床试验基础知识的培训;(2)推荐采用临床试验设计流程图,逐一解决临床试验过程中的关键问题;(3)在方案正式实施前进行预试验,并根据预试验的结果对临床试验设计方案进行调整;(4)对临床试验设计的最终方案进行注册登记,并预先发表(最好是网上发表)临床试验设计方案;(5)广泛开展国际合作,特别是与对中医药研究感兴趣的国际知名学术研究机构进行合作,以提高中草药临床研究的质量。     

Systematic Review on Randomized Controlled Trials of Coronary Heart Disease Complicated with Depression Treated with Chinese Herbal Medicines

Objectives: This systemic review evaluated the efficacy and safety of Chinese herbal medicines (CHMs) in patients with coronary heart disease (CHD) complicated with depression. Methods: All databases were retrieved till September 30, 2014. Randomized controlled trials (RCTs) comparing CHMs with placebo or conventional Western medicine were retrieved. Data extraction, analyses and quality assessment were performed according to the Cochrane standards. RevMan 5.3 was used to synthesize the results. Results: Thirteen RCTs enrolling 1,095 patients were included. Subgroup analysis was used to assess data. In reducing the degree of depression, CHMs showed no statistic difference in the 4th week [mean difference (MD)=–1.06; 95% confidence interval (CI) –2.38 to 0.26; n=501; I2=73%], but it was associated with a statistically significant difference in the 8th week (MD=–1.00; 95% CI –1.64 to –0.36; n=436; I2=48%). Meanwhile, the combination therapy (CHMs together with antidepressants) showed significant statistic differences both in the 4th week (MD=–1.99; 95% CI –3.80 to –0.18; n=90) and in the 8th week (MD=–5.61; 95% CI –6.26 to –4.97; n=242; I2=87%). In CHD-related clinical evaluation, 3 trials reported the intervention group was superior to the control group. Four trials showed adverse events in the intervention group was less than that in the control group. Conclusions: CHMs showed potentially benefits on patients with CHD complicated with depression. Moreover, the effect of CHMs may be similar to or better than antidepressant in certain fields but with less side effects. However, because of small sample size and potential bias of most trials, this result should be interpreted with caution. More rigorous trials with larger sample size and higher quality are warranted to give high quality of evidence to support the use of CHMs for CHD complicated with depression.     

Standards for reporting randomized controlled trials in medical informatics: a systematic review of CONSORT adherence in RCTs on clinical decision support

Introduction

The Consolidated Standards for Reporting Trials (CONSORT) were published to standardize reporting and improve the quality of clinical trials. The objective of this study is to assess CONSORT adherence in randomized clinical trials (RCT) of disease specific clinical decision support (CDS).

Methods

A systematic search was conducted of the Medline, EMBASE, and Cochrane databases. RCTs on CDS were assessed against CONSORT guidelines and the Jadad score.

Result

32 of 3784 papers identified in the primary search were included in the final review. 181 702 patients and 7315 physicians participated in the selected trials. Most trials were performed in primary care (22), including 897 general practitioner offices. RCTs assessing CDS for asthma (4), diabetes (4), and hyperlipidemia (3) were the most common. Thirteen CDS systems (40%) were implemented in electronic medical records, and 14 (43%) provided automatic alerts. CONSORT and Jadad scores were generally low; the mean CONSORT score was 30.75 (95% CI 27.0 to 34.5), median score 32, range 21–38. Fourteen trials (43%) did not clearly define the study objective, and 11 studies (34%) did not include a sample size calculation. Outcome measures were adequately identified and defined in 23 (71%) trials; adverse events or side effects were not reported in 20 trials (62%). Thirteen trials (40%) were of superior quality according to the Jadad score (≥3 points). Six trials (18%) reported on long-term implementation of CDS.

Conclusion

The overall quality of reporting RCTs was low. There is a need to develop standards for reporting RCTs in medical informatics.