Effect on the quality of peer review of blinding reviewers and asking them to sign their reports: a randomized controlled trial. Effects of training on quality of peer review: randomised controlled trial. Comparison of review articles published in peer-reviewed and throwaway journals. Readers' evaluation of effect of peer review and editing on quality of articles in the Nederlands Tijdschrift voor Geneeskunde. The Medical Journal of Australia Internet peer-review study. Effect of open peer review on quality of reviews and on reviewers' recommendations: a randomised trial. Open peer review: a randomised controlled trial. Publication bias and meta-analyses: a practical example. Does masking author identity improve peer review quality? A randomized controlled trial. PEER Investigators. Manuscript quality before and after peer review and editing at Annals of Internal Medicine. How does the peer review process influence AANA journal article readability? Commercially funded and United States-based research is more likely to be published; good-quality studies with negative outcomes are not. Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards. Effect of written feedback by editors on quality of reviews: two randomized trials. The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist. Publication bias: evidence of delayed publication in a cohort study of clinical research projects. Effects of peer review and editing on the readability of articles published in Annals of Internal Medicine. Effect of attendance at a training session on peer reviewer quality and performance. A randomized controlled trial evaluating the impact of knowledge translation and exchange strategies. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. Cumulative meta-analysis of clinical trials builds evidence for exemplary medical care. Impact of random assignment on study outcome: an empirical examination. Factors associated with failure to publish large randomized trials presented at an oncology meeting. Examination of the analytic quality of behavioral health randomized clinical trials. Effect of blinding and unmasking on the quality of peer review: a randomized trial. Assessing the quality of reports of randomized clinical trials: is blinding necessary?
Anxiety about bias, lack of accountability, and poor quality of peer review has led to questions about the imbalance in anonymity between reviewers and authors.
                To evaluate the effect on the quality of peer review of blinding reviewers to the authors' identities and requiring reviewers to sign their reports.
                Randomized controlled trial.
                A general medical journal.
                A total of 420 reviewers from the journal's database.
                We modified a paper accepted for publication introducing 8 areas of weakness. Reviewers were randomly allocated to 5 groups. Groups 1 and 2 received manuscripts from which the authors' names and affiliations had been removed, while groups 3 and 4 were aware of the authors' identities. Groups 1 and 3 were asked to sign their reports, while groups 2 and 4 were asked to return their reports unsigned. The fifth group was sent the paper in the usual manner of the journal, with authors' identities revealed and a request to comment anonymously. Group 5 differed from group 4 only in that its members were unaware that they were taking part in a study.
                The number of weaknesses in the paper that were commented on by the reviewers.
                Reports were received from 221 reviewers (53%). The mean number of weaknesses commented on was 2 (1.7, 2.1, 1.8, and 1.9 for groups 1, 2, 3, and 4 and 5 combined, respectively). There were no statistically significant differences between groups in their performance. Reviewers who were blinded to authors' dentities were less likely to recommend rejection than those who were aware of the authors' identities (odds ratio, 0.5; 95% confidence interval, 0.3-1.0).
                Neither blinding reviewers to the authors and origin of the paper nor requiring them to sign their reports had any effect on rate of detection of errors. Such measures are unlikely to improve the quality of peer review reports. To determine the effects of training on the quality of peer review.
                Single blind randomised controlled trial with two intervention groups receiving different types of training plus a control group.
                Reviewers at a general medical journal. Interventions Attendance at a training workshop or reception of a self taught training package focusing on what editors want from reviewers and how to critically appraise randomised controlled trials.
                Quality of reviews of three manuscripts sent to reviewers at four to six monthly intervals, evaluated using the validated review quality instrument; number of deliberate major errors identified; time taken to review the manuscripts; proportion recommending rejection of the manuscripts.
                Reviewers in the self taught group scored higher in review quality after training than did the control group (score 2.85 v 2.56; difference 0.29, 95% confidence interval 0.14 to 0.44; P = 0.001), but the difference was not of editorial significance and was not maintained in the long term. Both intervention groups identified significantly more major errors after training than did the control group (3.14 and 2.96 v 2.13; P < 0.001), and this remained significant after the reviewers' performance at baseline assessment was taken into account. The evidence for benefit of training was no longer apparent on further testing six months after the interventions. Training had no impact on the time taken to review the papers but was associated with an increased likelihood of recommending rejection (92% and 84% v 76%; P = 0.002).
                Short training packages have only a slight impact on the quality of peer review. The value of longer interventions needs to be assessed. To compare the quality, presentation, readability, and clinical relevance of review articles published in peer-reviewed and "throwaway" journals.
                We reviewed articles that focused on the diagnosis or treatment of a medical condition published between January 1 and December 31, 1998, in the 5 leading peer-reviewed general medical journals and high-circulation throwaway journals. Reviewers independently assessed the methodologic and reporting quality, and evaluated each article's presentation and readability. Clinical relevance was evaluated independently by 6 physicians.
                Of the 394 articles in our sample, 16 (4.1%) were peer-reviewed systematic reviews, 135 (34.3%) were peer-reviewed nonsystematic reviews, and 243 (61.7%) were nonsystematic reviews published in throwaway journals. The mean (SD) quality scores were highest for peer-reviewed articles (0.94 [0.09] for systematic reviews and 0.30 [0.19] for nonsystematic reviews) compared with throwaway journal articles (0.23 [0.03], F(2,391) = 280.8, P<.001). Throwaway journal articles used more tables (P =.02), figures (P =.01), photographs (P<.001), color (P<.001), and larger font sizes (P<.001) compared with peer-reviewed articles. Readability scores were more often in the college or higher range for peer-reviewed journals compared with the throwaway journal articles (104 [77.0%] vs 156 [64.2%]; P =.01). Peer-reviewed article titles were judged less relevant to clinical practice than throwaway journal article titles (P<.001).
                Although lower in methodologic and reporting quality, review articles published in throwaway journals have characteristics that appeal to physician readers. Academic biomedical journals use peer review and editing to help to select and improve the quality of articles. We have investigated whether articles accepted by the Nederlands Tijdschrift voor Geneeskunde, the Dutch Journal of Medicine, were improved after peer review and editing (post-acceptance scientific and copy editing).
                400 readers of the journal (100 each of medical students, recent medical graduates, general practitioners, and specialists) were invited to participate in a questionnaire survey. The first 25 from each group who agreed to participate were included. We posted a pack containing a set of identically appearing typescripts (ie, blinding) of the submitted, accepted, and published versions of 50 articles that had been published in Ned Tijdschr Geneeskd. Each evaluator received two of the sets of versions, and each set was evaluated by one person from each group. The package also included two questionnaires: the first was used to compare the submitted with the accepted version (25 questions), the second compared the accepted with the published version (17 questions). The questions were answered on five-point scales, and were about the quality of the articles or were general/overall scores. We analysed the data as scores of 3-5 (ie, improvement) versus 1-2.
                After peer review, the quality in 14 of 23 questions (61%) was significantly improved (p = 0.03 or smaller). In particular, the overall score and general medical value were significantly improved (p = 0.00001 for each). Editing led to significant improvement in 11 of 16 questions (69%, p = 0.017 or smaller), and especially in style and readability (p = 0.001 and p = 0.004). Generally, we found no differences between the scores of the four categories of evaluators. 72% of the evaluators correctly identified which version was which.
                Evaluations by readers of the Ned Tijdschr Geneeskd indicated significant improvement of published articles after both peer review and editing. We think that peer review and editing are worthwhile tasks. We also think that possible biases would have had a negligible effect on our results (including the fact that we selected the first 25 evaluators who responded, that some evaluators may have read the published version, and that one questionnaire may have looked more scientific than the other, more editorial one). Peer review of medical papers is a confidential consultancy between the reviewer and the journal editor, and has been criticised for its potential bias and inadequacy. We explored the potential of the internet for open peer review to see whether this approach improved the quality and outcome of peer review.
                Research and review articles that had been accepted for publication in The Medical Journal of Australia (MJA) were published together with the reviewers' reports on the worldwide web, with the consent of authors and referees. Selected readers' e-mailed comments were electronically published as additional commentary; authors could reply or revise their paper in response to readers' comments. Articles were edited and published in print after this open review.
                60 (81%) of 74 authors agreed to take part in the study, together with 150 (92%) of 162 reviewers. There was no significant difference in the performance of commissioned reviewers before and during the study. Four articles were not included because of insufficient time before print publication. Of the remaining 56 papers, 28 received 52 comments from 42 readers (2% of readers submitted comments). Most readers' comments were short and specific, and seven articles were changed by the authors in response.
                Open peer review is acceptable to most authors and reviewers. Postpublication review by readers on the internet is no substitute for commissioned prepublication review, but can provide editors with valuable input from individuals who would not otherwise be consulted. Readers also gain insight into the processes of peer review and publication. To examine the effect on peer review of asking reviewers to have their identity revealed to the authors of the paper.
                Randomised trial. Consecutive eligible papers were sent to two reviewers who were randomised to have their identity revealed to the authors or to remain anonymous. Editors and authors were blind to the intervention.
                The quality of the reviews was independently rated by two editors and the corresponding author using a validated instrument. Additional outcomes were the time taken to complete the review and the recommendation regarding publication. A questionnaire survey was undertaken of the authors of a cohort of manuscripts submitted for publication to find out their views on open peer review.
                Two editors' assessments were obtained for 113 out of 125 manuscripts, and the corresponding author's assessment was obtained for 105. Reviewers randomised to be asked to be identified were 12% (95% confidence interval 0.2% to 24%) more likely to decline to review than reviewers randomised to remain anonymous (35% v 23%). There was no significant difference in quality (scored on a scale of 1 to 5) between anonymous reviewers (3.06 (SD 0.72)) and identified reviewers (3.09 (0.68)) (P=0.68, 95% confidence interval for difference - 0.19 to 0.12), and no significant difference in the recommendation regarding publication or time taken to review the paper. The editors' quality score for reviews (3.05 (SD 0.70)) was significantly higher than that of authors (2.90 (0.87)) (P<0.005, 95%confidence interval for difference - 0.26 to - 0.03). Most authors were in favour of open peer review.
                Asking reviewers to consent to being identified to the author had no important effect on the quality of the review, the recommendation regarding publication, or the time taken to review, but it significantly increased the likelihood of reviewers declining to review. Most scientific journals practise anonymous peer review. There is no evidence, however, that this is any better than an open system.
                To evaluate the feasibility of an open peer review system.
                Reviewers for the British Journal of Psychiatry were asked whether they would agree to have their name revealed to the authors whose papers they review; 408 manuscripts assigned to reviewers who agreed were randomised to signed or unsigned groups. We measured review quality, tone, recommendation for publication and time taken to complete each review.
                A total of 245 reviewers (76%) agreed to sign. Signed reviews were of higher quality, were more courteous and took longer to complete than unsigned reviews. Reviewers who signed were more likely to recommend publication.
                This study supports the feasibility of an open peer review system and identifies such a system's potential drawbacks. Publication bias is widely appreciated, but considerable time and effort are needed to locate and obtain data from unpublished randomized controlled trials (RCTs), those published in non-English language journals or those reported in the gray literature; for this publication, we will call this collection of trials the "gray+literature." However, excluding such trials from systematic reviews could introduce bias and give rise to misleading conclusions.
                We aimed to explore and quantify the impact of inclusion of gray+ literature on the results of all completed individual patient data (IPD) reviews coordinated by our group (13 meta-analyses). For each IPD review, results were calculated for RCTs fully published in English language journals and RCTs fully published in English language journals and the gray+literature.
                The IPD meta-analyses based only on RCTs that were fully published in English language journals tended to give more favorable results than those that included RCTs from the gray+literature. Although in most cases the addition of gray+data gave less encouraging results, moving the estimated treatment effect toward a null result, the direction of effect was not always predictable.
                We recommend that all systematic reviews should at least attempt to identify trials reported in the gray+literature and, where possible, obtain data from them. All authors may not be equal in the eyes of reviewers. Specifically, well-known authors may receive less objective (poorer quality) reviews. One study at a single journal found a small improvement in review quality when reviewers were masked to author identity.
                To determine whether masking reviewers to author identity is generally associated with higher quality of review at biomedical journals, and to determine the success of routine masking techniques.
                A randomized controlled trial performed on external reviews of manuscripts submitted to Annals of Emergency Medicine, Annals of Internal Medicine, JAMA, Obstetrics & Gynecology, and Ophthalmology.
                Two peers reviewed each manuscript. In one study arm, both peer reviewers received the manuscript according to usual masking practice. In the other arm, one reviewer was randomized to receive a manuscript with author identity masked, and the other reviewer received an unmasked manuscript.
                Review quality on a 5-point Likert scale as judged by manuscript author and editor. A difference of 0.5 or greater was considered important.
                A total of 118 manuscripts were randomized, 26 to usual practice and 92 to intervention. In the intervention arm, editor quality assessment was complete for 77 (84%) of 92 manuscripts. Author quality assessment was complete on 40 (54%) of 74 manuscripts. Authors and editors perceived no significant difference in quality between masked (mean difference, 0.1; 95% confidence interval [CI], -0.2 to 0.4) and unmasked (mean difference, -0.1; 95% CI, -0.5 to 0.4) reviews. We also found no difference in the degree to which the review influenced the editorial decision (mean difference, -0.1; 95% CI,-0.3 to 0.3). Masking was often unsuccessful (overall, 68% successfully masked; 95% CI, 58%-77%), although 1 journal had significantly better masking success than others (90% successfully masked; 95% CI, 73%-98%). Manuscripts by generally known authors were less likely to be successfully masked (odds ratio, 0.3; 95% CI, 0.1-0.8). When analysis was restricted to manuscripts that were successfully masked, review quality as assessed by editors and authors still did not differ.
                Masking reviewers to author identity as commonly practiced does not improve quality of reviews. Since manuscripts of well-known authors are more difficult to mask, and those manuscripts may be more likely to benefit from masking, the inability to mask reviewers to the identity of well-known authors may have contributed to the lack of effect. To evaluate the effects of peer review and editing on manuscript quality.
                Editorial offices of Annals of Internal Medicine.
                Masked before-after study. MANUSCRIPTS: 111 consecutive original research manuscripts accepted for publication at Annals between March 1992 and March 1993.
                We used a manuscript quality assessment tool of 34 items to evaluate the quality of the research report, not the quality of the research itself. Each item was scored on a 1 to 5 scale. Forty-four expert assessors unaware of the design or aims of the study evaluated the manuscripts, with different persons evaluating the two versions of each manuscript (before and after the editorial process).
                33 of the 34 items changed in the direction of improvement, with the largest improvements seen in the discussion of study limitations, generalizations, use of confidence intervals, and the tone of conclusions. Overall, the percentage of items scored three or more increased by an absolute 7.3% (95% CI, 3.3% to 11.3%) from a baseline of 75%. The average item score improved by 0.23 points (CI, 0.07 to 0.39) from a baseline mean of 3.5. Manuscripts rated in the bottom 50% showed two- to threefold larger improvements than those in the top 50%, after correction for regression to the mean.
                Peer review and editing improve the quality of medical research reporting, particularly in those areas that readers rely on most heavily to decide on the importance and generalizability of the findings. This study examined the readability of the AANA Journal, quantifying the effect of peer review on case and research reports published from 1992 to 1994. Gunning and Flesch index-based computer analysis, as well as human comparative analysis, was undertaken. Computer and human assessment of readability revealed improvement as papers evolved from submitted to published versions; however, at publication the manuscripts remained in the "difficult" readability range. Although this study provides evidence that peer review improves readability, it may be that, due to a professed need for scientific purity and an imposed sense of scholarship, nursing and other biomedical journals may overemphasize a style and approach that paradoxically make transfer of information unreasonably difficult. Prior studies implying associations between receipt of commercial funding and positive (significant and/or pro-industry) research outcomes have analyzed only published papers, which is an insufficiently robust approach for assessing publication bias. In this study, we tested the following hypotheses regarding orthopaedic manuscripts submitted for review: (1) nonscientific variables, including receipt of commercial funding, affect the likelihood that a peer-reviewed submission will conclude with a report of a positive study outcome, and (2) positive outcomes and other, nonscientific variables are associated with acceptance for publication.
                All manuscripts about hip or knee arthroplasty that were submitted to The Journal of Bone and Joint Surgery, American Volume, over seventeen months were evaluated to determine the study design, quality, and outcome. Analyses were carried out to identify associations between scientific factors (sample size, study quality, and level of evidence) and study outcome as well as between non-scientific factors (funding source and country of origin) and study outcome. Analyses were also performed to determine whether outcome, scientific factors, or nonscientific variables were associated with acceptance for publication.
                Two hundred and nine manuscripts were reviewed. Commercial funding was not found to be associated with a positive study outcome (p = 0.668). Studies with a positive outcome were no more likely to be published than were those with a negative outcome (p = 0.410). Studies with a negative outcome were of higher quality (p = 0.003) and included larger sample sizes (p = 0.05). Commercially funded (p = 0.027) and United States-based (p = 0.020) studies were more likely to be published, even though those studies were not associated with higher quality, larger sample sizes, or lower levels of evidence (p = 0.24 to 0.79).
                Commercially funded studies submitted for review were not more likely to conclude with a positive outcome than were nonfunded studies, and studies with a positive outcome were no more likely to be published than were studies with a negative outcome. These findings contradict those of most previous analyses of published (rather than submitted) research. Commercial funding and the country of origin predict publication following peer review beyond what would be expected on the basis of study quality. Studies with a negative outcome, although seemingly superior in quality, fared no better than studies with a positive outcome in the peer-review process; this may result in inflation of apparent treatment effects when the published literature is subjected to meta-analysis. --To investigate factors associated with the publication of research findings, in particular, the association between "significant" results and publication.
                --Follow-up study.
                --Studies approved in 1980 or prior to 1980 by the two institutional review boards that serve The Johns Hopkins Health Institutions--one that serves the School of Medicine and Hospital and the other that serves the School of Hygiene and Public Health.
                --A total of 737 studies were followed up.
                --Of the studies for which analyses had been reported as having been performed at the time of interview, 81% from the School of Medicine and Hospital and 66% from the School of Hygiene and Public Health had been published. Publication was not associated with sample size, presence of a comparison group, or type of study (eg, observational study vs clinical trial). External funding and multiple data collection sites were positively associated with publication. There was evidence of publication bias in that for both institutional review boards there was an association between results reported to be significant and publication (adjusted odds ratio, 2.54; 95% confidence interval, 1.63 to 3.94). Contrary to popular opinion, publication bias originates primarily with investigators, not journal editors: only six of the 124 studies not published were reported to have been rejected for publication.
                --There is a statistically significant association between significant results and publication. Better peer review is needed, but proven methods to improve quality are unknown. Our objective was to determine whether written feedback to reviewers improves subsequent reviews.
                Eligible reviewers were randomized to intervention or control (receiving other reviewers' unscored reviews and the editor's decision letter). Study 1 (September 1998-September 2000) included reviewers with a median quality score of 3 or lower; study 2 (April 2000-January 2002), reviewers with median score of 4 or lower. Study 1 was designed with a power of 0.80 to detect a difference in score of 1; study 2, with a power of 0.80 to detect a difference of 0.5. All reviewers were at a peer-reviewed journal (Annals of Emergency Medicine). The main outcome measure was the editor's routine quality rating (1-5) of all reviews (blinded to study enrollment).
                For study 1, 51 reviewers were eligible and randomized and 35 had sufficient data (182 reviews) for analysis. The mean individual reviewer rating change was 0.16 (95% confidence interval [CI], -0.26 to 0.58) for control and -0.13 (-0.49 to 0.23) for intervention. For study 2, 127 reviewers were eligible and randomized, and 95 had sufficient data (324 reviews). Controls had a mean individual rating change of 0.12 (95% CI, -0.20 to 0.26) and intervention reviewers, 0.06 (-0.19 to 0.31).
                In study 1, minimal feedback from editors on review quality had no effect on subsequent performance of poor-quality reviewers, and the trend was toward a negative effect. In study 2, feedback to average reviewers was more extensive and supportive but produced no improvement in reviewer performance. Simple written feedback to reviewers seems to be an ineffective educational tool. The "Consolidated Standards of Reporting Trials" (CONSORT) was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). However, little is known about the quality of reporting since this publication. We undertook an observational study to determine the quality of reporting key methodological factors in RCTs since the publication of the CONSORT statement and if a journal policy to promote adherence to the CONSORT checklist was associated with superior reporting. We recorded the reporting of 11 key methodological factors in 105 RCTs from 29 medical journals published subsequent to the CONSORT statement. We examined the quality of reporting in relation to whether a journal was a "CONSORT promoter" as defined by inclusion of the CONSORT checklist in a journal's "information to authors" section or a requirement that authors, manuscript reviewers, or copy editors complete the CONSORT checklist. Multivariate analysis controlled for journal impact factor, study outcome, and time of publication. Six of the 11 methodological factors were reported <50% of the time. The number of methodological factors reported was greater in CONSORT promoters than in journals not promoting CONSORT in both unadjusted (6.0 and 5.1, respectively, p-value = 0.03) and adjusted (6.4 and 4.8 of the 11 methodological factors, respectively, p-value = 0.0001) analyses. While journals that promote CONSORT demonstrate superior reporting of RCTs, persistent inadequacies in reporting remain. Until these inadequacies are resolved health-care providers will remain limited in their ability to make informed inferences about the validity of the studies upon which they base their clinical practice. To determine the extent to which publication is influenced by study outcome.
                A cohort of studies submitted to a hospital ethics committee over 10 years were examined retrospectively by reviewing the protocols and by questionnaire. The primary method of analysis was Cox's proportional hazards model.
                University hospital, Sydney, Australia.
                748 eligible studies submitted to Royal Prince Alfred Hospital Ethics Committee between 1979 and 1988.
                Time to publication.
                Response to the questionnaire was received for 520 (70%) of the eligible studies. Of the 218 studies analysed with tests of significance, those with positive results (P < 0.05) were much more likely to be published than those with negative results (P > or = 0.10) (hazard ratio 2.32 (95% confidence interval 1.47 to 3.66), P = 0.0003), with a significantly shorter time to publication (median 4.8 v 8.0 years). This finding was even stronger for the group of 130 clinical trials (hazard ratio 3.13 (1.76 to 5.58). P = 0.0001), with median times to publication of 4.7 and 8.0 years respectively. These results were not materially changed after adjusting for other significant predictors of publication. Studies with indefinite conclusions (0.05 < or = P < 0.10) tended to have an even lower publication rate and longer time to publication than studies with negative results (hazard ratio 0.39 (0.13 to 1.12), P = 0.08). For the 103 studies in which outcome was rated qualitatively, there was no clear cut evidence of publication bias, although the number of studies in this group was not large.
                This study confirms the evidence of publication bias found in other studies and identifies delay in publication as an additional important factor. The study results support the need for prospective registration of trials to avoid publication bias and also support restricting the selection of trials to those started before a common date in undertaking systematic reviews. To measure the effect of the peer review and editorial processes on the readability of original articles.
                Comparison of manuscripts before and after the peer review and editorial processes.
                Annals of Internal Medicine between March 1 and November 30, 1992. MANUSCRIPTS: One hundred one consecutive manuscripts reporting original research.
                Assessment of readability by means of two previously validated indexes: the Gunning fog index (units of readability in the fog index roughly correlate to years of education) and the Flesch reading ease score. Each manuscript was analyzed for readability and length on receipt and after it had passed through the peer review and editorial processes. Text and abstracts were analyzed similarly but separately. Mean readability scores were compared by two-tailed t tests for paired observations.
                Mean (+/- SD) initial readability scores of manuscripts and abstracts by the Gunning fog index were 17.16 +/- 1.55 and 16.65 +/- 2.80, respectively. At publication, scores were 16.85 +/- 1.42 and 15.64 +/- 2.42 (P = .0005 and P < .0001 for before-after differences, respectively). By comparison, studies of other print media showed scores of about 11 for the New York Times editorial page and about 18 for a typical legal contract. Similar changes were found for the Flesch scores. The median length of the manuscripts increased by 2.6% and that of the abstracts by 4.2% during the processes.
                The peer review and editorial processes slightly improved the readability of original articles and their abstracts, but both remained difficult to read at publication. Better readability scores may improve readership. To determine whether attendance at a voluntary training workshop improves quality ratings of medical journal peer reviewers.
                Peer reviewers for Annals of Emergency Medicine who completed two or more reviews during the 20 months before or the 20 months after October 1995 were eligible. Reviews were routinely rated by editors on a subjective 5-point quality scale. Comparisons were made between reviewers who chose to attend a 4-hour workshop on peer review sponsored by the journal in 1995 (attendees) and 2 groups of reviewers who did not attend: controls matched for review quality and number of reviews completed before the workshop, and unmatched controls. Guest reviewers were excluded.
                A total of 298 reviewers completed 1906 reviews before the workshop and 2,194 after the workshop; 2,117 of these reviews were rated by editors. Forty-five attendees participated in the workshop, 39 of whom had sufficient ratings for analysis. Matched controls were almost identical in performance to attendees, but unmatched controls had performed fewer reviews and had lower average ratings before the workshop. There was no significant change in any performance measurement after the workshop, including average quality rating, percent change in quality rating, odds ratio for recommending acceptance, and odds ratio for congruence with editor's decision.
                In a self-selected group of experienced reviewers who attended a 4-hour workshop on peer review, no effect could be identified in subsequent performance as measured by editors' quality ratings or reviewer performance statistics. Significant resources and time are invested in the production of research knowledge. The primary objective of this randomized controlled trial was to evaluate the effectiveness of three knowledge translation and exchange strategies in the incorporation of research evidence into public health policies and programs.
                This trial was conducted with a national sample of public health departments in Canada from 2004 to 2006. The three interventions, implemented over one year in 2005, included access to an online registry of research evidence; tailored messaging; and a knowledge broker. The primary outcome assessed the extent to which research evidence was used in a recent program decision, and the secondary outcome measured the change in the sum of evidence-informed healthy body weight promotion policies or programs being delivered at health departments. Mixed-effects models were used to test the hypotheses.
                One hundred and eight of 141 (77%) health departments participated in this study. No significant effect of the intervention was observed for primary outcome (p < 0.45). However, for public health policies and programs (HPPs), a significant effect of the intervention was observed only for tailored, targeted messages (p < 0.01). The treatment effect was moderated by organizational research culture (e.g., value placed on research evidence in decision making).
                The results of this study suggest that under certain conditions tailored, targeted messages are more effective than knowledge brokering and access to an online registry of research evidence. Greater emphasis on the identification of organizational factors is needed in order to implement strategies that best meet the needs of individual organizations.
                The trial registration number and title are as follows: ISRCTN35240937 -- Is a knowledge broker more effective than other strategies in promoting evidence-based physical activity and healthy body weight programming? Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected, but direct evidence of such bias is currently limited to case reports.
                To study empirically the extent and nature of outcome reporting bias in a cohort of randomized trials.
                Cohort study using protocols and published reports of randomized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg, Denmark, in 1994-1995. The number and characteristics of reported and unreported trial outcomes were recorded from protocols, journal articles, and a survey of trialists. An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta-analysis. Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias. Protocols and published articles were also compared to identify discrepancies in primary outcomes.
                Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes; consistency between primary outcomes defined in the most recent protocols and those defined in published articles.
                One hundred two trials with 122 published journal articles and 3736 outcomes were identified. Overall, 50% of efficacy and 65% of harm outcomes per trial were incompletely reported. Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy (pooled odds ratio, 2.4; 95% confidence interval [CI], 1.4-4.0) and harm (pooled odds ratio, 4.7; 95% CI, 1.8-12.0) data. In comparing published articles with protocols, 62% of trials had at least 1 primary outcome that was changed, introduced, or omitted. Eighty-six percent of survey responders (42/49) denied the existence of unreported outcomes despite clear evidence to the contrary.
                The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols. Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention. To ensure transparency, planned trials should be registered and protocols should be made publicly available prior to trial completion. Cumulative meta-analysis of clinical trials (a Bayesian interpretation for accumulating evidence) will profoundly affect medical care by summarizing evidence in the assessment of technology innovations. Application of the technique to the randomized control trials (RCTs) of streptokinase treatment of acute myocardial infarction, reduction of peri-operative mortality by antibiotic prophylaxis, and prevention of death from bleeding peptic ulcers has revealed efficacy years before it was suspected by any other means. Arrangement of the trials according to event rate in the controls, effect sizes, quality of the trials or according to covariables of interest has supplied unique information. If carried out prospectively the technique supplies invaluable information regarding indications for another trial, the number of patients necessary to determine the validity of past trends, and the type of patients who might be benefitted. Careful examination in a cumulative manner of the prior trials can reduce the need for future large trials. Sixty research investigations published in the biomedical literature were analyzed to examine the effect of design attributes on outcome. All 60 studies included a controlled trial involving a pretest, a therapeutic intervention, and a posttest across at least two groups. Thirty of the trials used random assignment of participants to treatment or control conditions and 30 trials employed some nonrandom method of subject assignment. Trial results were aggregated and evaluated by comparing effect sizes for the primary statistical test of the hypothesis. Data analysis revealed that the trial results, as measured by effect size, did not vary across therapeutic trials using random assignment versus those using nonrandom allocation of subjects. The impact of design attributes in the interpretation of multiple clinical trials addressing a similar research question is examined. The argument is made that various design attributes frequently associated with methodological quality should be considered as important moderator variables and their influence on trial outcome should not be assumed a priori but rather examined empirically. Large clinical trials are the criterion standard for making treatment decisions, and nonpublication of the results of such trials can lead to bias in the literature and contribute to inappropriate medical decisions.
                To determine the rate of full publication of large randomized trials presented at annual meetings of the American Society of Clinical Oncology (ASCO), quantify bias against publishing nonsignificant results, and identify factors associated with time to publication.
                Survey of 510 abstracts from large (sample size, > or =200), phase 3, randomized controlled trials presented at ASCO meetings between 1989 and 1998. Trial results were classified as significant (P< or =.05 for the primary outcome measure) or nonsignificant (P>.05 or not reported), and the type of presentation and sponsorship were identified. Subsequent full publication was identified using a search of MEDLINE and EMBASE, completed November 1, 2001; the search was updated in November 2002, using the Cochrane Register of Controlled Trials. Authors were contacted if the searches did not find evidence of publication.
                Publication rate at 5 years; time from presentation to full publication.
                Of 510 randomized trials, 26% were not published in full within 5 years after presentation at the meeting. Eighty-one percent of the studies with significant results had been published by this time compared with 68% of the studies with nonsignificant results (P<.001). Studies with oral or plenary presentation were published sooner than those not presented (P =.002), and studies with pharmaceutical sponsorship were published sooner than studies with cooperative group sponsorship or studies for which sponsorship was not specified (P =.02). These factors remained significant in a multivariable model. The most frequent reason cited by authors for not publishing was lack of time, funds, or other resources.
                A substantial number of large phase 3 trials presented at an international oncology meeting remain unpublished 5 years after presentation. Bias against publishing nonsignificant results is a problem even for large randomized trials. Nonpublication breaks the contract that investigators make with trial participants, funding agencies, and ethics boards. Adoption of evidence-based practice (EBP) policy has implications for clinicians and researchers alike. In fields that have already adopted EBP, evidence-based practice guidelines derive from systematic reviews of research evidence. Ultimately, such guidelines serve as tools used by practitioners. Systematic reviews of treatment efficacy and effectiveness reserve their strongest endorsements for treatments that are supported by high-quality randomized clinical trials (RCTs). It is unknown how well RCTs reported in behavioral science journals fare compared to quality standards set forth in fields that pioneered the evidence-based movement. We compared analytic quality features of all behavioral health RCTs (n = 73) published in three leading behavioral journals and two leading medical journals between January 2000 and July 2003. A behavioral health trial was operationalized as one employing a behavioral treatment modality to prevent or treat an acute or chronic physical disease or condition. Findings revealed areas of weakness in analytic aspects of the behavioral health RCTs reported in both sets of journals. Weaknesses were more pronounced in behavioral journals. The authors offer recommendations for improving the analytic quality of behavioral health RCTs to ensure that evidence about behavioral treatments is highly weighted in systematic reviews.
                (c) 2006 Wiley Periodicals, Inc. Little research has been conducted into the quality of peer review and, in particular, the effects of blinding peer reviewers to authors' identities or masking peer reviewers' identities.
                To determine whether concealing authors' identities from reviewers (blinding) and/or revealing the reviewer's identity to a coreviewer (unmasking) affects the quality of reviews, the time taken to carry out reviews, and the recommendation regarding publication.
                Randomized trial of 527 consecutive manuscripts submitted to BMJ, which were randomized and each sent to 2 peer reviewers.
                Manuscripts were randomized as to whether the reviewers were unmasked, masked, or uninformed that a study was taking place. Two reviewers for each manuscript were randomized to receive either a blinded or an unblinded version.
                Mean total quality score, time taken to carry out the review, and recommendation regarding publication.
                Of the 527 manuscripts entered into the study, 467 (89%) were successfully randomized and followed up. The mean total quality score was 2.87. There was little or no difference in review quality between the masked and unmasked groups (scores of 2.82 and 2.96, respectively) and between the blinded and unblinded groups (scores of 2.87 and 2.90, respectively). There was no apparent Hawthorne effect. There was also no significant difference between groups in the recommendations regarding publication or time taken to review.
                Blinding and unmasking made no editorially significant difference to review quality, reviewers' recommendations, or time taken to review. Other considerations should guide decisions as to the form of peer review adopted by a journal, and improvements in the quality of peer review should be sought via other means. It has been suggested that the quality of clinical trials should be assessed by blinded raters to limit the risk of introducing bias into meta-analyses and systematic reviews, and into the peer-review process. There is very little evidence in the literature to substantiate this. This study describes the development of an instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research and its use to determine the effect of rater blinding on the assessments of quality. A multidisciplinary panel of six judges produced an initial version of the instrument. Fourteen raters from three different backgrounds assessed the quality of 36 research reports in pain research, selected from three different samples. Seven were allocated randomly to perform the assessments under blind conditions. The final version of the instrument included three items. These items were scored consistently by all the raters regardless of background and could discriminate between reports from the different samples. Blind assessments produced significantly lower and more consistent scores than open assessments. The implications of this finding for systematic reviews, meta-analytic research and the peer-review process are discussed.
At present, little empirical evidence is available to support the use of editorial peer review as a mechanism to ensure quality of biomedical research. However, the methodological problems in studying peer review are many and complex. At present, the absence of evidence on efficacy and effectiveness cannot be interpreted as evidence of their absence. A large, well-funded programme of research on the effects of editorial peer review should be urgently launched.