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Investing in updating: how do conclusions change when Cochrane systematic reviews are updated?

BACKGROUND: Cochrane systematic reviews aim to provide readers with the most up-to-date evidence on the effects of healthcare interventions. The policy of updating Cochrane reviews every two years consumes valuable time and resources and may not be appropriate for all reviews. The objective of this study was to examine the effect of updating Cochrane systematic reviews over a four year period. METHODS: This descriptive study examined all completed systematic reviews in the Cochrane Database of Systematic Reviews (CDSR) Issue 2, 1998. The latest version of each of these reviews was then identified in CDSR Issue 2, 2002 and changes in the review were described. For reviews that were updated within this time period and had additional studies, we determined whether their conclusion had changed and if there were factors that were predictive of this change. RESULTS: A total of 377 complete reviews were published in CDSR Issue 2, 1998. In Issue 2, 2002, 14 of these reviews were withdrawn and one was split, leaving 362 reviews to examine for the purpose of this study. Of these reviews, 254 (70%) were updated. Of these updated reviews, 23 (9%) had a change in conclusion. Both an increase in precision and a change in statistical significance of the primary outcome were predictive of a change in conclusion of the review. CONCLUSION: The concerns around a lack of updating for some reviews may not be justified considering the small proportion of updated reviews that resulted in a changed conclusion. A priority-setting approach to the updating of Cochrane systematic reviews may be more appropriate than a time-based approach. Updating all reviews as frequently as every two years may not be necessary, however some reviews may need to be updated more often than every two years.

Bibliometrics↗

Clinical and cost-effectiveness of donepezil, rivastigmine and galantamine for Alzheimer's disease: a rapid and systematic review.

BACKGROUND: Alzheimer's disease is the most common cause of dementia and is characterised by an insidious onset and slow deterioration. The estimated prevalence of Alzheimer's disease for a standard health authority (500,000 people) is about 3330. Current service involves a wide range of agencies, and drug therapy for some patients. OBJECTIVES: To provide a rapid and systematic review of the clinical effectiveness and cost-effectiveness of donepezil, rivastigmine and galantamine in the symptomatic treatment of people suffering from Alzheimer's disease. METHODS: A systematic review of the literature was undertaken. METHODS - DATA SOURCES: Searches were made of electronic databases, including MEDLINE, EMBASE, The Cochrane Library, Database of Abstracts of Reviews of Effectiveness, NHS Economic Evaluation Database, National Research Register, Science Citation Index, BIOSIS, EconLit, MRC Trials database, Early Warning System, Current Controlled Trials, TOXLINE, Index of Scientific and Technical Proceedings, and Getting Easier Access to Reviews. All sources were searched over the period covered by the databases up to March/July 2000. Bibliographies of related papers were assessed for relevant studies and experts were contacted for advice and peer review, and to identify additional published and unpublished references. Manufacturer submissions to the National Institute for Clinical Excellence (NICE) were reviewed. METHODS - STUDY SELECTION: Studies were included if they fulfilled the following criteria: (1) INTERVENTION: donepezil, rivastigmine or galantamine used to treat Alzheimer's disease. (2) PARTICIPANTS: people diagnosed with Alzheimer's disease who meet the criteria for treatment with donepezil, rivastigmine and galantamine. (3) OUTCOMES: measures assessing changes in cognition, function, behaviour and mood, quality of life (including studies assessing carer well-being and carer-input), and time to institutionalisation. (4) DESIGN: systematic reviews of randomised controlled trials (RCTs) and RCTs comparing donepezil, rivastigmine or galantamine with placebo or each other or non-drug comparators were included in the review of effectiveness. Economic studies of donepezil, rivastigmine or galantamine used to treat Alzheimer's disease that included a comparator (or placebo) and both the costs and consequence (outcomes) of treatment were included in the review of cost-effectiveness. Studies in non-English language, and abstracts and conference poster presentations of systematic reviews, RCTs and economic evaluations were excluded. Two reviewers identified studies by independently screening study titles and abstracts, and then by examining the full text of selected studies to decide inclusion. METHODS - DATA EXTRACTION AND QUALITY ASSESSMENT: Data extraction and quality assessment were undertaken by one reviewer and checked by a second reviewer, with any disagreements resolved through discussion. The quality of RCTs was assessed using the Jadad scale and the quality of systematic reviews was assessed using criteria developed by the NHS Centre for Reviews and Dissemination. The quality of economic evaluation studies was assessed by their internal validity (i.e. the methods used) using a standard checklist, and external validity (i.e. the generalisability of the economic study to the population of interest) using a series of relevant questions. METHODS - DATA SYNTHESIS: The clinical effectiveness and cost-effectiveness of donepezil, rivastigmine and galantamine were synthesised through a narrative review with full tabulation of results of all included studies. In the economic evaluation, the reviewers assessed whether adjustments could be made to existing models to reflect the current situation in England and Wales. RESULTS - CLINICAL EFFECTIVENESS: (1) Donepezil--three systematic reviews and five RCTs (plus four studies from industry (unpublished data, submitted as commercial in confidence)) were found. Results suggest that donepezil is beneficial when assessed using global and cognitive outcome measures. (2) Rivastigmine--three systematic reviews and five RCTs (plus two studies from industry (unpublished data, submitted as commercial in confidence)) were found. Results suggest that rivastigmine is beneficial in terms of global outcome measures. (3) Galantamine--one systematic review and three RCTs (plus three studies from industry (unpublished data, submitted as commercial in confidence)) were found. Results suggest that galantamine is beneficial in terms of global, cognitive and functional scales. RESULTS - SUMMARY OF BENEFITS: It is difficult to quantify benefits from the evidence available in the literature. Statistically significant improvements in tests such as ADAS-cog (Alzheimer's Disease Assessment Scale cognitive subscale) may not be reflected in changes in daily life. (ABSTRACT TRUNCATED)

Alzheimer Disease↗

Reporting of ethical review of clinical research submitted to the Journal of the American Academy of Dermatology.

BACKGROUND: In recent years there has been an increasing focus on human subject protection and on documentation of ethical review in published clinical research. The JAAD clearly states in its instructions to authors, which adhere to the guidelines set forth by the International Committee of Medical Journal Editors, "studies involving live human subjects must have been approved by the author's Institutional Review Board or its equivalent." OBJECTIVE: To determine what proportion of prospective studies on human subjects submitted to the clinical trials and therapeutics section lacked mention of review by an ethics board and to determine the outcome of these manuscripts. METHODS: We reviewed 150 prospective studies submitted from July 1, 2004 to January 16, 2006 to a single associate editor, who receives the majority of reports requiring ethics board review. RESULTS: Of 150 prospective studies, 36% (n = 54) had no mention of ethics review or consent, whereas 15% (n = 22) mentioned consent but not ethics review. Forty-two papers were returned asking for ethics information, and of these, 48% were resubmitted with confirmation of ethics review, 22% were withdrawn, 12% were never resubmitted, 12% responded that ethical review was not obtained, and 7% were clarified as exempt from review. Of the 150 papers, 45% were from US authors and 55% were from international authors. Sixty-seven percent of US papers and 35% of international papers included ethics board information (P <or= .001). Of the remaining authors who did not initially provide information on ethics review, 25% of US and 53% of international authors were able to provide documentation of ethics board review when asked. Of international authors asked for ethics information, 67% of European authors provided confirmation of ethical review, as compared with 48% of non-European authors. LIMITATIONS: It is not possible to know with certainty whether each study not citing ethics review actually did not undergo review by an ethics board. Additionally, other editors may have handled some studies requiring ethics review. CONCLUSIONS: One half of authors submitting papers on prospective clinical studies to the JAAD did not provide evidence of ethical review on initial submission. The reason for omission was likely oversight in half of the cases, but in others ethics review and approval were likely not obtained. International authors were more likely to omit mention of ethics review, but, although sample size was too small for statistical analysis, international authors were more often able to provide it when asked, suggesting oversight or misunderstanding as a reason for omission. Furthermore, ethics review may be more standard in the European Union, as European authors were more likely to be able to provide the information when asked, although small sample size precluded statistical analysis.

Dermatology↗

Economics methods in Cochrane systematic reviews of health promotion and public health related interventions.

BACKGROUND: Provision of evidence on costs alongside evidence on the effects of interventions can enhance the relevance of systematic reviews to decision-making. However, patterns of use of economics methods alongside systematic review remain unclear. Reviews of evidence on the effects of interventions are published by both the Cochrane and Campbell Collaborations. Although it is not a requirement that Cochrane or Campbell Reviews should consider economic aspects of interventions, many do. This study aims to explore and describe approaches to incorporating economics methods in a selection of Cochrane systematic reviews in the area of health promotion and public health, to help inform development of methodological guidance on economics for reviewers. METHODS: The Cochrane Database of Systematic Reviews was searched using a search strategy for potential economic evaluation studies. We included current Cochrane reviews and review protocols retrieved using the search that are also identified as relevant to health promotion or public health topics. A reviewer extracted data which describe the economics components of included reviews. Extracted data were summarised in tables and analysed qualitatively. RESULTS: Twenty-one completed Cochrane reviews and seven review protocols met inclusion criteria. None incorporate formal economic evaluation methods. Ten completed reviews explicitly aim to incorporate economics studies and data. There is a lack of transparent reporting of methods underpinning the incorporation of economics studies and data. Some reviews are likely to exclude useful economics studies and data due to a failure to incorporate search strategies tailored to the retrieval of such data or use of key specialist databases, and application of inclusion criteria designed for effectiveness studies. CONCLUSION: There is a need for consistency and transparency in the reporting and conduct of the economics components of Cochrane reviews, as well as regular dialogue between Cochrane reviewers and economists to develop increased capacity for economic analyses alongside such reviews. Use of applicable economics methods in Cochrane reviews can help provide the international context within which economics data can be interpreted and assessed as a preliminary to full economic evaluation.

Clinical Protocols↗

Statistical reviewing policies in dermatology journals: results of a questionnaire survey of editors.

BACKGROUND: Problems with statistical methods and reporting have been noted in articles published in dermatology journals. Conclusions presented in published reports may be misleading if based on inappropriate or misinterpreted statistical analysis. OBJECTIVE: We sought to assess dermatology journal editors' policies and perceptions regarding statistical review of submitted manuscripts. DESIGN: We mailed and e-mailed a questionnaire survey. PARTICIPANTS: A total of 43 dermatology journal editors, representing 35 dermatology journals from the United States and abroad, participated in this study. RESULTS: In all, 32 editors (74.4%), representing 30 journals (85.7%), returned questionnaires. A total of 24 editors (75%) reported having requested statistical reviews on less than 5% of published manuscripts containing original quantitative analysis (ie, excluding reviews and case reports), whereas 3 editors (9.4%) reported having requested statistical reviews on more than 75% of such manuscripts. Most editors reported requesting statistical reviews on a case-by-case basis either after initial favorable review by subject-matter (nonstatistical) reviewers (12 editors; 37.5%) or at the same time that subject-matter review was requested (6 editors; 18.8%). A total of 4 editors (12.5%) reported requesting statistical review for all manuscripts at the same time they are sent for subject-matter review. Another 10 editors (31.3%) said their journals had no general policy on statistical reviewing, and statistical review is almost never needed. For 15 editors (46.9%), ideal statistical reviewing policy was identical to their current policy, whereas 13 (40.6%) favored a more rigorous and 3 (9.4%) a less rigorous policy. CONCLUSIONS: Dermatology journals infrequently perform statistical reviews of submitted manuscripts. Dermatology journal editors' statistical review policies range from no general policy to (most frequently) requesting reviews on a case-by-case basis to reviewing all submitted manuscripts. Many editors favor more rigorous statistical reviewing policies for their journals. Increased use of statistical reviewing may increase the reliability of conclusions published in dermatology journals.

Dermatology↗

Case record review of adverse events: a new approach.

OBJECTIVES: To redesign the existing clinical review form (RF2) used in previous retrospective case record review studies in order to clarify the review process and provide a more powerful analysis of adverse events; and then to ask clinicians to pilot and evaluate the new modular review form (MRF2). The review form is divided into five sections, each with a defined purpose, providing a modular structure. DESIGN: Design and testing of the MRF2 on a sample of medical and nursing records, and evaluation of the reviewers' responses regarding the new review form. SETTING: Hospital based teams from eight countries. RESULTS: The modular review form was reported to be comprehensive, well structured, and clear. Most of the reviewers agreed with the positive statements regarding the review form. Overall, the modular structure was thought to be helpful. Several modifications have been made to the final version to take account of criticisms and suggestions. CONCLUSIONS: The full potential of case record review has yet to be explored. The benefits of this review form include a modular format which enables reviewers or project leaders to select the focus of their review based on resources and the purpose of the review, and to identify contributory factors which indicate areas for improvement and prevention. The training of reviewers is of vital importance for record review. Record review remains one of the primary methods for assessing the incidence of adverse events and the new format is suitable for both prospective and retrospective review.

Attitude of Health Personnel↗

Effect of blinding and unmasking on the quality of peer review: a randomized trial.

CONTEXT: 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. OBJECTIVE: 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. DESIGN AND SETTING: Randomized trial of 527 consecutive manuscripts submitted to BMJ, which were randomized and each sent to 2 peer reviewers. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: Mean total quality score, time taken to carry out the review, and recommendation regarding publication. RESULTS: 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. CONCLUSIONS: 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.

Authorship↗

Does masking author identity improve peer review quality? A randomized controlled trial. PEER Investigators.

CONTEXT: 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. OBJECTIVES: 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. DESIGN AND SETTING: 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. INTERVENTIONS: 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. MAIN OUTCOME MEASURE: 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. RESULTS: 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. CONCLUSIONS: 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.

Authorship↗

Identification of randomized controlled trials in systematic reviews: accuracy and reliability of screening records.

A study was conducted to estimate the accuracy and reliability of reviewers when screening records for relevant trials for a systematic review. A sensitive search of ten electronic bibliographic databases yielded 22 571 records of potentially relevant trials. Records were allocated to four reviewers such that two reviewers examined each record and so that identification of trials by each reviewer could be compared with those identified by each of the other reviewers. Agreement between reviewers was assessed using Cohen's kappa statistic. Ascertainment intersection methods were used to estimate the likely number of trials missed by reviewers. Full copies of reports were obtained and assessed independently by two researchers for eligibility for the review. Eligible reports formed the 'gold standard' against which an assessment was made about the accuracy of screening by reviewers. After screening, 301 of 22 571 records were identified by at least one reviewer as potentially relevant. Agreement was 'almost perfect' (kappa>0.8) within two pairs, 'substantial' (kappa>0.6) within three pairs and 'moderate' (kappa>0.4) within one pair. Of the 301 records selected, 273 complete reports were available. When pairs of reviewers agreed on the potential relevance of records, 81 per cent were eligible (range 69 to 91 per cent). If reviewers disagreed, 22 per cent were eligible (range 12 to 45 per cent). Single reviewers missed on average 8 per cent of eligible reports (range 0 to 24 per cent), whereas pairs of reviewers did not miss any (range 0 to 1 per cent). The use of two reviewers to screen records increased the number of randomized trials identified by an average of 9 per cent (range 0 to 32 per cent). Reviewers can reliably identify potentially relevant records when screening thousands of records for eligibility. Two reviewers should screen records for eligibility, whenever possible, in order to maximize ascertainment of relevant trials.

Databases, Bibliographic↗

Systematic reviews: a cross-sectional study of location and citation counts.

BACKGROUND: Systematic reviews summarize all pertinent evidence on a defined health question. They help clinical scientists to direct their research and clinicians to keep updated. Our objective was to determine the extent to which systematic reviews are clustered in a large collection of clinical journals and whether review type (narrative or systematic) affects citation counts. METHODS: We used hand searches of 170 clinical journals in the fields of general internal medicine, primary medical care, nursing, and mental health to identify review articles (year 2000). We defined 'review' as any full text article that was bannered as a review, overview, or meta-analysis in the title or in a section heading, or that indicated in the text that the intention of the authors was to review or summarize the literature on a particular topic. We obtained citation counts for review articles in the five journals that published the most systematic reviews. RESULTS: 11% of the journals concentrated 80% of all systematic reviews. Impact factors were weakly correlated with the publication of systematic reviews (R2 = 0.075, P = 0.0035). There were more citations for systematic reviews (median 26.5, IQR 12 - 56.5) than for narrative reviews (8, 20, P <.0001 for the difference). Systematic reviews had twice as many citations as narrative reviews published in the same journal (95% confidence interval 1.5 - 2.7). CONCLUSIONS: A few clinical journals published most systematic reviews. Authors cited systematic reviews more often than narrative reviews, an indirect endorsement of the 'hierarchy of evidence'.

Bibliometrics↗

Changing conclusions on secondhand smoke in a sudden infant death syndrome review funded by the tobacco industry.

BACKGROUND: Prenatal and postnatal exposure to tobacco smoke adversely affects maternal and child health. Secondhand smoke (SHS) has been linked causally with sudden infant death syndrome (SIDS) in major health reports. In 1992, the US Environmental Protection Agency (EPA) first noted an association between SHS and SIDS, and both prenatal exposure and postnatal SHS exposure were listed as independent risk factors for SIDS in a 1997 California EPA report (republished in 1999 by the National Cancer Institute) and a 2004 US Surgeon General report. The tobacco industry has used scientific consultants to attack the evidence that SHS causes disease, most often lung cancer. Little is known about the industry's strategies to contest the evidence on maternal and child health. In 2001, a review was published on SIDS that acknowledged funding from the Philip Morris (PM) tobacco company. Tobacco industry documents related to this review were examined to identify the company's influence on the content and conclusions of this review. METHODS: Tobacco industry documents include 40 million pages of internal memos and reports made available to the public as a result of litigation settlements against the tobacco industry in the United States. Between November 2003 and January 2004, we searched tobacco industry document Internet sites from the University of California Legacy Tobacco Documents Library and the Tobacco Documents Online website. Key terms included "SIDS" and names of key persons. Two authors conducted independent searches with similar key terms, reviewed the documents, and agreed on relevancy through consensus. Thirty documents were identified as relevant. Two drafts (an early version and a final version) of an industry-funded review article on SIDS were identified, and 2 authors independently compared these drafts with the final publication. Formal comments by PM executives made in response to the first draft were also reviewed. We used Science Citation Index in July 2004 to determine citation patterns for the referenced SIDS reviews. RESULTS: PM executives feared that SHS and maternal and child health issues would create a powerful and emotional impetus for smoke-free areas in the home, public areas, and the workplace. In response to the 1992 US EPA report on SHS, the Science and Technology Department of PM's Switzerland subsidiary, Fabriques de Tabac Reunies, searched for "independent" consultants to publish articles addressing SHS. The first industry-funded article was a literature review focusing on smoking and SIDS, conducted by consultant Peter Lee and co-author Allison Thornton, which stated that the association between parental smoking and SIDS could have been attributable to the failure to control fully for confounders. That first review has only been cited once, in the subsequent industry-funded review. In 1997, PM commissioned a consultant, Frank Sullivan, to write a review, with coauthor Susan Barlow, of all possible risk factors for SIDS. The first draft concluded that prenatal and postnatal smoking exposures are both independent risk factors for SIDS. After receiving comments and meeting with PM scientific executives, Sullivan changed his original conclusions on smoking and SIDS. The final draft was changed to emphasize the effects of prenatal maternal smoking and to conclude that postnatal SHS effects were "less well established." Changes in the draft to support this new conclusion included descriptions of Peter Lee's industry-funded review, a 1999 negative but underpowered study of SIDS risk and urinary cotinine levels, and criticisms of the conclusions of the National Cancer Institute report that SHS was causally associated with SIDS. In April 2001, the Sullivan review was published in the United Kingdom journal Paediatric and Perinatal Epidemiology, with a disclosure statement that acknowledged financial support from PM but did not acknowledge contributions from PM executives in the preparation of the review. By 2004, the Sullivan SIDS review had been cited at least 19 times in the medical literature. CONCLUSIONS: PM executives responded to corporate concerns about the possible adverse effects of SHS on maternal and child health by commissioning consultants to write review articles for publication in the medical literature. PM executives successfully encouraged one author to change his original conclusion that SHS is an independent risk factor for SIDS to state that the role of SHS is "less well established." These statements are consistent with PM's corporate position that active smoking causes disease but only public health officials conclude the same for SHS. The author's disclosure of industry funding did not reveal the full extent of PM's involvement in shaping the content of the article. This analysis suggests that accepting tobacco industry funds can disrupt the integrity of the scientific process. The background of this SIDS review is relevant for institutions engaged in the debate about accepting or eschewing funding from the tobacco industry. Those who support acceptance of tobacco industry funds argue that academic authors retain the right to publish their work and maintain final approval of the written product, but this argument fails to recognize that the tobacco industry funds work to ensure that messages favorable to the industry are published and disseminated. Clinicians, parents, and public health officials are most vulnerable to the changed conclusions of the SIDS review. The national SIDS "Back to Sleep" campaign has been very successful in reducing SIDS rates. However, estimates of SIDS risk from SHS (odds ratios range from 1.4 to 5.1) have considerable overlap with estimates of risk from prone sleep positioning (odds ratios range from 1.7 to 12.9). With the Back to Sleep campaign well underway, efforts to address parental smoking behavior in both the prenatal and postnatal periods should be intensified. The tobacco industry's disinformation campaign on SHS and maternal and child health can be counteracted within clinicians' offices.

Causality↗

Evaluating the care of general medicine inpatients: how good is implicit review?

OBJECTIVE: Peer review often consists of implicit evaluations by physician reviewers of the quality and appropriateness of care. This study evaluated the ability of implicit review to measure reliably various aspects of care on a general medicine inpatient service. DESIGN: Retrospective review of patients' charts, using structured implicit review, of a stratified random sample of consecutive admissions to a general medicine ward. SETTING: A university teaching hospital. PATIENTS: Twelve internists were trained in structured implicit review and reviewed 675 patient admissions (with 20% duplicate reviews for a total of 846 reviews). RESULTS: Although inter-rater reliabilities for assessments of overall quality of care and preventable deaths (kappa = 0.5) were adequate for aggregate comparisons (for example, comparing mean ratings on two hospital wards), they were inadequate for reliable evaluations of single patients using one or two reviewers. Reviewers' agreement about most focused quality problems (for example, timeliness of diagnostic evaluation and clinical readiness at time of discharge) and about the appropriateness of hospital ancillary resource use was poor (kappa < or = 0.2). For most focused implicit measures, bias due to specific reviewers who were systematically more harsh or lenient (particularly for evaluation of resource-use appropriateness) accounted for much of the variation in reviewers' assessments, but this was not a substantial problem for the measure of overall quality. Reviewers rarely reported being unable to evaluate the quality of care because of deficiencies in documentation in the patient's chart. CONCLUSION: For assessment of overall quality and preventable deaths of general medicine inpatients, implicit review by peers had moderate degrees of reliability, but for most other specific aspects of care, physician reviewers could not agree. Implicit review was particularly unreliable at evaluating the appropriateness of hospital resource use and the patient's readiness for discharge, two areas where this type of review is often used.

Health Resources↗

Rational decision-making in mental health: the role of systematic reviews.

BACKGROUND: "Systematic reviews" have come to be recognized as the most rigorous method of summarizing confusing and often contradictory primary research in a transparent and reproducible manner. Their greatest impact has been in the summarization of epidemiological literature - particularly that relating to clinical effectiveness. Systematic reviews also have a potential to inform rational decision-making in healthcare policy and to form a component of economic evaluation. AIMS OF THE STUDY: This article aims to introduce the rationale behind systematic reviews and, using examples from mental health, to introduce the strengths and limitations of systematic reviews, particularly in informing mental health policy and economic evaluation. METHODS: Examples are selected from recent controversies surrounding the introduction of new psychiatric drugs (anti-depressants and anti-schizophrenia drugs) and methods of delivering psychiatric care in the community (case management and assertive community treatment). The potential for systematic reviews to (i) produce best estimates of clinical efficacy and effectiveness, (ii) aid economic evaluation and policy decision-making and (iii) highlight gaps in the primary research knowledge base are discussed. Lastly examples are selected from outside mental health to show how systematic reviews have a potential to be explicitly used in economic and health policy evaluation. RESULTS: Systematic reviews produce the best estimates of clinical efficacy, which can form an important component of economic evaluation. Importantly, serious methodological flaws and areas of uncertainty in the primary research literature are identified within an explicit framework. Summary indices of clinical effectiveness can be produced, but it is difficult to produce such summary indices of cost effectiveness by pooling economic data from primary studies. Modelling is commonly used in economic and policy evaluation. Here, systematic reviews can provide the best estimates of effectiveness and, importantly, highlight areas of uncertainty that can be used in "sensitivity analysis". DISCUSSION: Systematic reviews are an important recent methodological advance, the potential for which has only begun to be realized in mental health. This use of systematic reviews is probably most advanced in producing critical summaries of clinical effectiveness data. Systematic reviews cannot produce valid and believable conclusions when the primary research literature is of poor quality. An important function of systematic reviews will be in highlighting this poor quality research which is of little use in mental health decision making. IMPLICATIONS FOR HEALTH PROVISION: Health care provision should be both clinically and cost effective. Systematic reviews are a key component in ensuring that this goal is achieved. IMPLICATIONS FOR HEALTH POLICIES: Systematic reviews have potential to inform health policy. Examples presented show that health policy is often made without due consideration of the research evidence. Systematic reviews can provide robust and believable answers, which can help inform rational decision-making. Importantly, systematic reviews can highlight the need for important primary research and can inform the design of this research such that it provides answers that will help in forming healthcare policy. IMPLICATIONS FOR FURTHER RESEARCH: Systematic reviews should precede costly (and often unnecessary) primary research. Many areas of health policy and practice have yet to be evaluated using systematic review methodology. Methods for the summarization of economic data are methodologically complex and deserve further research

Journal Article↗

Effect of blinded peer review on abstract acceptance.

CONTEXT: Peer review should evaluate the merit and quality of abstracts but may be biased by geographic location or institutional prestige. The effectiveness of blinded peer review at reducing bias is unknown. OBJECTIVE: To evaluate the effect of blinded review on the association between abstract characteristics and likelihood of abstract acceptance at a national research meeting. DESIGN AND SETTING: All abstracts submitted to the American Heart Association's annual Scientific Sessions research meeting from 2000-2004. Abstract review included the author's name and institution (open review) from 2000-2001, and this information was concealed (blinded review) from 2002-2004. Abstracts were categorized by country, primary language, institution prestige, author sex, and government and industry status. MAIN OUTCOME MEASURE: Likelihood of abstract acceptance during open and blinded review, by abstract characteristics. RESULTS: The mean number of abstracts submitted each year for evaluation was 13,455 and 28.5% were accepted. During open review, 40.8% of US and 22.6% of non-US abstracts were accepted (relative risk [RR], 1.81; 95% confidence interval [CI], 1.75-1.88), whereas during blinded review, 33.4% of US and 23.7% of non-US abstracts were accepted (RR, 1.41; 95% CI, 1.37-1.45; P<.001 for comparison between peer review periods). Among non-US abstracts, during open review, 31.1% from English- speaking countries and 20.9% from non-English-speaking countries were accepted (RR, 1.49; 95% CI, 1.39-1.59), whereas during blinded review, 28.8% and 22.8% of abstracts were accepted, respectively (RR, 1.26; 95% CI, 1.19-1.34; P<.001). Among abstracts from US academic institutions, during open review, 51.3% from highly prestigious and 32.6% from nonprestigious institutions were accepted (RR, 1.57; 95% CI, 1.48-1.67), whereas during blinded review, 38.8% and 29.0% of abstracts were accepted, respectively (RR, 1.34; 95% CI, 1.26-1.41; P<.001). CONCLUSIONS: This study provides evidence of bias in the open review of abstracts, favoring authors from the United States, English-speaking countries outside the United States, and prestigious academic institutions. Moreover, blinded review at least partially reduced reviewer bias.

Abstracting and Indexing↗

Editors' requests of peer reviewers: a study and a proposal.

BACKGROUND: Despite the pivotal role of peer review in the scientific process, there has never been a formal study of the way in which reviewers' opinions are elicited. This article describes such a study and makes recommendations for a more standardized approach to the peer review process. We hope, through this publication and related efforts, to encourage such a process in Preventive Medicine and in other journals. METHOD: The study population included the top 100 journals (as rated by the 1989 Institute for Scientific Information citation frequency index). Only journals with primarily U.S.-based editorial offices are included (n = 73). Participants provided their reviewer forms, cover letters for reviewers, and instructions for reviewers that were used routinely. All data were collected in February 1992. RESULTS: The response rate was 97.3%. Journals varied substantially in many of their reviewer requests. While 96% of journals asked reviewers to recommend acceptance or rejection, only 72% asked reviewers to assess manuscripts' novelty, 69% requested assessments of clarity, and only 51% asked for assessments of the reasonableness of manuscripts' conclusions. Similarly, only 46% of journals reminded reviewers that manuscripts were confidential documents, 51% provided a separate cover letter, and 25% provided extensive (>1 full page) reviewer instructions. CONCLUSIONS: While review uniformity is not requisite, differences between review protocols may not be a function of specific journals' needs, but of some journals' excluding important review components from explicit mention. Based in part on the Council of Biology Editors' recommendations, standard components of reviews and of instructions for reviewers are suggested. If editors' expectations were more explicit, reviewers' comments could better serve editorial needs.

Humans↗

Effect of attendance at a training session on peer reviewer quality and performance.

STUDY OBJECTIVE: To determine whether attendance at a voluntary training workshop improves quality ratings of medical journal peer reviewers. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Case-Control Studies↗

Systematic reviews in rehabilitation for stroke: issues and approaches to addressing them.

OBJECTIVES: To describe the problems encountered when undertaking systematic reviews of rehabilitation and to give advice to reviewers about ways of addressing these issues. BACKGROUND: Evidence-based practice has become established as a way of linking clinical practice with research evidence. The most robust evidence is usually considered to be that from randomized controlled trials, and from systematic reviews of these trials. However, most reviews have focused on drug and surgical interventions, and few reviews have been produced in the field of rehabilitation. This may be due to the unique difficulties that are posed by reviews in this area. EXPERIENCE OF SYSTEMATIC REVIEWS IN APHASIA: We describe the challenges that occurred when carrying out systematic reviews of speech and language therapy for aphasia following stroke, and of ways to deliver rehabilitation services to people who have suffered a stroke. Issues arose at all stages of the reviews and included: using expertise; planning the review; defining the health care problem, patients, outcomes and interventions of interest; searching for, interpreting and synthesizing the results of the studies identified; and deriving implications from the review. Suggestions made to address these challenges include: developing a suitable team of reviewers; using inclusive and broad criteria for inclusion of trials to a review; developing appropriate search strategies; and using caution in arriving at conclusions. It is important to be explicit about decisions made during the review process concerning how to handle the challenges. Practical advice about carrying out reviews in the field of stroke rehabilitation is likely to be helpful to reviewers of other rehabilitative interventions. There are likely to be relatively few studies available for such reviews, and limitations in drawing specific practical conclusions. Such undertakings are, however, useful in setting the agenda for further research.

Humans↗

The treatment of attention-deficit hyperactivity disorder: an annotated bibliography and critical appraisal of published systematic reviews and metaanalyses.

CONTEXT: The Agency for Health Care Policy and Research charged the McMaster Evidence-based Practice Center with conducting a comprehensive systematic review of the literature on the treatment of attention-deficit hyperactivity disorder (ADHD), with input from various groups of stakeholders. One strategy used to avoid duplication of work included a critical appraisal of existing systematic reviews and metaanalyses. OBJECTIVE: To identify and appraise published metaanalyses and systematic reviews on the treatment of ADHD and to produce an annotated bibliography. DATA SOURCES: Medline, Cumulative Index in Nursing and Allied Health (CINAHL), Healthstar, Psycinfo, and Embase were searched to September 1998; the Cochrane Database (1998 issue 3), selected Internet sites, and the files of investigators were also reviewed. STUDY SELECTION: Review articles described as systematic reviews or metaanalyses or including a Methods section were identified independently by 3 reviewers. DATA EXTRACTION: Two reviewers extracted, by consensus, relevant information on the name, methodological quality, ADHD-related aspects (comorbid disorders, family characteristics) of those reviews; data on the population, study setting, interventions, and outcomes evaluated by the reviews were also retrieved. RESULTS: Thirteen reviews, published from 1982 to 1998, were included. Eight included metaanalysis and 5 a qualitative review. Nonpharmacological treatments were mentioned in 6 reviews and combination therapies in 3. One review focused on the treatment of adults. Forty-seven drugs and 20 adverse effects were mentioned. Most reviews had major methodological flaws. CONCLUSIONS: Most published systematic reviews and metaanalyses on the treatment of ADHD have limited value for guiding clinical, policy, and research decisions. A rigorous, systematic review following established methodological criteria is warranted.

Attention Deficit Disorder with Hyperactivity↗