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Background. The Ischemic Optic Neuropathy Decompression Trial compared optic nerve decompression surgery with careful follow-up for treatment of patients with nonarteritic ischemic optic neuropathy. Surgeons submitted a standardized data collection form and operative notes for 123 patients randomized to and undergoing surgery. The purpose of this study was to see whether operative notes have sufficient and reliable data to avoid development of a surgery data collection form in future trials. Methods. We abstracted data from Ischemic Optic Neuropathy Decompression Trial patient operative notes, calculated the proportion of completed responses, and compared abstracted responses with those originally recorded on corresponding case report forms. Results. Variables used to identify persons, dates, or eye (left/right) were reported 100% of the time on operative notes and with excellent agreement with those recorded on the case report form (median agreement, 100%; range, 95% to 100%). Categoric variables, used to establish the characteristics of surgical steps, were also reported reliably on operative notes (median agreement, 84%; range, 0 to 100%). Open-ended variables tended to be reported more frequently on operative notes (exact agreement, 57% and 34%, respectively, for complications and postoperative medications). Quantitative variables were infrequently reported but correlated well with values reported on the data collection forms (Pearson correlation coefficients, 0.78, 0.79, 0.94, 0.96). For many variables, disagreements were minor and often were related to interpretation of the operative notes by the abstractor. Conclusion. In our trial, operative note abstraction adequately documented surgery date and surgeon and provided more complete information than the standardized report form with respect to complications but did not provide complete information for other variables. (Surgery 2003;133:324-30.)

PURPOSE: To examine the prevalence and incidence of second eye nonarteritic anterior ischemic optic neuropathy (NAION) and associated patient characteristics in patients enrolled in the Ischemic Optic Neuropathy Decompression Trial (IONDT) Follow-up Study. DESIGN: Randomized clinical trial with observational cohort. METHODS: Patients randomized to optic nerve sheath decompression surgery or careful follow-up had a diagnosis of acute unilateral NAION, visual acuity between 20/64 and light perception, and were aged 50 years or older. Eligible patients who declined randomization or whose visual acuity was better than 20/64 were not randomized but followed as part of an observational cohort. Follow-up examinations took place at 3, 6, 12, 18, and 24 months and annually thereafter. RESULTS: Four hundred eighteen patients were enrolled; 258 randomized and 160 observed. Previous NAION or other optic neuropathy was present in the fellow eye of 21.1% (88/418) of patients at baseline. Four patients developed optic neuropathy in the fellow eye at follow up that could not be conclusively diagnosed as NAION. New NAION in the fellow eye occurred in 14.7% (48/326) of patients at risk during a median follow up of 5.1 years. Randomized patients experienced a higher incidence (35/201; 17.4%) than nonrandomized patients (13/125; 10.4%). A history of diabetes and baseline visual acuity of 20/200 or worse in the study eye, but not age, sex, aspirin use, or smoking were significantly associated with new NAION in the fellow eye. Final fellow eye visual acuity was significantly worse in those patients with new fellow eye NAION whose baseline study eye visual acuity was 20/200 or worse. CONCLUSIONS: Follow-up data from the IONDT cohort provide evidence that the incidence of fellow eye NAION is lower than expected: new NAION was diagnosed in 14.7% of IONDT patients over approximately 5 years. Increased incidence is associated with poor baseline visual acuity in the study eye and diabetes, but not age, sex, smoking history, or aspirin use.

It is not known whether articles with group authorship (ie, with a research group name listed as the author) are difficult to identify or whether use of group authorship may lead to problems with citation.To examine ways in which reports of controlled trials with group authorship are indexed and citations counted in bibliographic databases, we conducted a cross-sectional study in January 2000. We identified 47 controlled trials funded by the National Eye Institute and 285 associated articles. Between January and August 2000, we searched PubMed and Science Citation Index (SCI) and recorded the citation practices for these articles. Our main outcome measures were ways in which trial reports were listed in PubMed and SCI and number of citations to each report by type of authorship.Of the 285 published reports identified, 126 (44%) had group authorship, 109 (38%) had modified group authorship (listing individual names plus the name of the research group), and 50 (18%) had named authors only. In PubMed, no group authors were listed in the author field (per MEDLINE rules); in SCI, group-authored reports generally were incorrectly attributed (first name on investigator list [35.3%], first name on writing committee [25.5%], contact name [16.7%], anonymous [16.7%], and other [5.9%]). Using the SCI general search, we identified citations to 16.7% of group-authored reports, compared with citations to 96.9% of reports with modified group authorship and 93.9% of citations to reports with named authors only. Other systematic search methods found that more than 98% of group-authored reports actually had been cited and that group-authored reports were cited more than other reports.Indexing systems are not optimally adapted to group authorship. We recommend that indexing services change their practices to include group authors in the author field to help correct the problem.

Introduction Choice of outcomes is critical for clinical trialists and systematic reviewers. It is currently unclear how systematic reviewers choose and pre-specify outcomes for systematic reviews. Our objective was to assess the completeness of pre-specification and comparability of outcomes in all Cochrane reviews addressing four common eye conditions. Methods We examined protocols for all Cochrane reviews as of June 2013 that addressed glaucoma, cataract, age-related macular degeneration (AMD), and diabetic retinopathy (DR). We assessed completeness and comparability for each outcome that was named in ≥25% of protocols on those topics. We defined a completely-specified outcome as including information about five elements: domain, specific measurement, specific metric, method of aggregation, and time-points. For each domain, we assessed comparability in how individual elements were specified across protocols. Results We identified 57 protocols addressing glaucoma (22), cataract (16), AMD (15), and DR (4). We assessed completeness and comparability for five outcome domains: quality-of-life, visual acuity, intraocular pressure, disease progression, and contrast sensitivity. Overall, these five outcome domains appeared 145 times (instances). Only 15/145 instances (10.3%) were completely specified (all five elements) (median = three elements per outcome). Primary outcomes were more completely specified than non-primary (median = four versus two elements). Quality-of-life was least completely specified (median = one element). Due to largely incomplete outcome pre-specification, conclusive assessment of comparability in outcome usage across the various protocols per condition was not possible. Discussion Outcome pre-specification was largely incomplete; we encourage systematic reviewers to consider all five elements. This will indicate the importance of complete specification to clinical trialists, on whose work systematic reviewers depend, and will indirectly encourage comparable outcome choice to reviewers undertaking related research questions. Complete pre-specification could improve efficiency and reduce bias in data abstraction and analysis during a systematic review. Ultimately, more completely specified and comparable outcomes could make systematic reviews more useful to decision-makers.

With passage of The Patient Protection and Affordable Care Act (Public Law 111–148), the United States has taken an important step toward health care for all. But can “good” health care for all be achieved? The United States has lagged behind Canada, Europe, Australia, and now China ( 1 ) in making a national commitment to creating and utilizing research evidence on “what works” as an integral part of clinical practice and health policy ( 2 ). This approach, termed “evidence-based health care,” has been defined as “the integration of best research evidence with clinical expertise and patient values” ( 3 ). Evidence-based health care is not without its critics. Some have rejected it as “cookbook medicine” ( 4 , 5 ), apparently ignoring that evidence is not the only ingredient in the approach and that the alternative ignores the scientific underpinnings of medicine.

There is strong evidence that clinical trials with a positive outcome are more likely to be published than are trials with negative results. In this Viewpoint, Richard Johnson and Kay Dickersin explore the reasons for this phenomenon and discuss possible solutions.

Discussions about evidence-based medicine (EBM) have engendered both positive and negative reactions from clinicians, researchers, and policymakers since the term was first coined in the early 1990s.1,2 These discussions were brought to the forefront again in a recent commentary by Dr Bernadine Healy, former director of National Institutes of Health, in U.S. News & World Report .3 She raised several issues that EBM practitioners and teachers face when advocating this model of care. Firstly, she stated that EBM practitioners advocate using the “best” evidence which is mostly taken from randomised trials and cost benefit studies. Secondly, she raised the issues of the interpretation of evidence for screening mammography and prostate specific antigen as examples where EBM has failed because EBM proponents did not advocate for these tests based on the available evidence. Thirdly, she likened the practice of EBM to a “straitjacket” or a cookbook approach in which both clinician judgement and patient values and circumstances are ignored. All of these criticisms of EBM stem from misperceptions or misunderstandings and can be answered by careful consideration of the definition of EBM. EBM is defined as the integration of the best available evidence with our clinical expertise and our patients’ unique values and circumstances.4 Evidence, whether strong or weak, is never sufficient to make clinical decisions. Individual values and preferences must balance this evidence to achieve optimal shared decision making. Others besides Dr Healy have stated their concern that only randomised …

The Ischemic Optic Neuropathy Decompression Trial (IONDT) is a randomized, single masked, multicenter trial designed to assess the safety and efficacy of optic nerve decompression surgery compared with careful follow-up in patients 50 years or older with non-arteritic anterior ischemic neuropathy (NAION).To examine and evaluate the sex, race, and age distributions of the screened, and subsequently enrolled, IONDT population, especially the proportions of female, minority, and elderly patients, and demographic characteristics of clinical center investigators, the geographical location of IONDT Clinical Centers, and the referral patterns of local physicians.Twenty-five U.S. clinical centers.There were 1,681 referrals to the Clinical Centers; an Eligibility Screening Form providing demographic information was completed for 1,152.Forty-three percent (495/1,152) of screened cases were women. Seven percent (85/1,152) were minorities: 33 African-Americans, 34 Hispanics, 17 Asians, and 1 Native-American. The average age was 66 +/- 10 years with a range of 22-92 years of age. Of the 1,152 referred patients, 305 were eligible for randomization; 258 (85%) of these agreed to participate in the trial. The demographic makeup of the randomized IONDT patients was similar to that of the screened population.Women and the elderly are well represented in the IONDT. Because the number of participating minorities was low, we cannot reliably assess their level of participation. Both a low incidence of NAION in minorities and a low referral rate of minorities to clinical trials are plausible explanations for our findings.

Objective: (1) To review evaluations of Acquired Immunodeficiency Syndrome (AIDS) prevention interventions targeting adolescents to determine whether these efforts have been effective in reducing risk behaviors. (2) To examine the relation between intervention design issues and outcomes measures. Method: A systematic review of five electronic databases and hand-searches of 11 journals, were undertaken for articles published from January 1983 through November 1995 that reported evaluations of adolescent AIDS risk-reduction interventions conducted in the United States. Outcomes examined include: improved attitudes about AIDS risk and protective behaviors, increased intention to abstain from sexual intercourse or to use condoms, and reduced sexual risk behaviors. Results: Forty studies that met preestablished inclusion criteria were found. For each outcome assessed, a majority of studies found a positive intervention impact (88% of studies assessing changes in knowledge; 58% changes in attitude, 60% changes in intention to use condoms, 73% in condom use, and 64% in decreasing number of sexual partners). Interventions that demonstrated an increase in intention to use a condom were significantly more likely to be theory-based than those that did not show any significant changes in intention (100% vs. 0%, p = .048). Interventions that increased condom use and decreased the number of sexual partners were longer in duration than those that did not improve these outcomes. Conclusions: AIDS risk reduction interventions can be effective in improving knowledge, attitudes, and behavioral intentions and in reducing risk practices. The positive relationship between improved outcomes and several elements of intervention design underscores the need for increased focus on intervention design in future studies.

Evidence-Based Ophthalmology offers a unique approach to managing eye disease. From systematic reviewing of evidence, this book provides an overview of techniques for optimum management in key areas, including glaucoma, cataract and retinal disease - an invaluable reference source for practitioners worldwide representing an important contribution to the literature. Key Features International authorship by leading Cochrane participants An unbiased method for summarising and disseminating the evidence Identifies gaps in evidence, and therefore research opportunities Free-access update website giving the latest trial data and recommendations for implementation in practice Includes a free fully searchable CD-ROM

Unpublished and misreported studies make it difficult to determine the true value of a treatment. Peter Doshi and colleagues call for sponsors and investigators of abandoned studies to publish (or republish) and propose a system for independent publishing if sponsors fail to respond

Background The inclusion of randomized controlled trials (RCTs) reported in conference abstracts in systematic reviews is controversial, partly because study design information and risk of bias is often not fully reported in the abstract. The Association for Research in Vision and Ophthalmology (ARVO) requires trial registration of abstracts submitted for their annual conference as of 2007. Our goal was to assess the feasibility of obtaining study design information critical to systematic reviews, but not typically included in conference abstracts, from the trial registration record. Methods We reviewed all conference abstracts presented at the ARVO meetings from 2007 through 2009, and identified 496 RCTs; 154 had a single matching registration record in ClinicalTrials.gov. Two individuals independently extracted information from the abstract and the ClinicalTrials.gov record, including study design, sample size, inclusion criteria, masking, interventions, outcomes, funder, and investigator name and contact information. Discrepancies were resolved by consensus. We assessed the frequencies of reporting variables appearing in the abstract and the trial register and assessed agreement of information reported in both sources. Results We found a substantial amount of study design information in the ClinicalTrials.gov record that was unavailable in the corresponding conference abstract, including eligibility criteria associated with gender (83%; 128/154); masking or blinding of study participants (53%, 82/154), persons administering treatment (30%, 46/154), and persons measuring the outcomes (40%, 61/154)); and number of study centers (58%; 90/154). Only 34% (52/154) of abstracts explicitly described a primary outcome, but a primary outcome was included in the “Primary Outcome” field in the ClinicalTrials.gov record for 82% (126/154) of studies. One or more study interventions were reported in each abstract, but agreed exactly with those reported in ClinicalTrials.gov only slightly more than half the time (88/154, 56%). We found no contact information for study investigators in the abstract, but this information was available in less than one quarter of ClinicalTrial.gov records (17%; 26/154). Conclusion RCT design information not reported in conference abstracts is often available in the corresponding ClinicalTrials.gov registration record. Sometimes there is conflicting information reported in the two sources and further contact with the trial investigators may still be required.

THE ORIGINAL PURPOSE OF REGISTRIES OF CLINICAL trials was to reveal the existence of all trials, published or not, to investigators and systematic reviewers. Trials left unpublished because results were unfavorable to their sponsors, or simply because investigators never submitted them to journals for publication, could then be discovered, the trial investigators contacted, and the available trial evidence involving medical interventions could then be assessed. This would help eliminate publication bias, shown originally in the 1980s, demonstrated by Simes to affect the treatment of patients, and later revealed to be widespread by the expanding efforts of the Cochrane Collaboration. A seemingly arcane statistical point became a pressing clinical problem. Although the 1997 US Food and Drug Administration Modernization Act (FDAMA) established a US-based trial registry, ClinicalTrials.gov, the mandated content was narrowly defined by law, and trial investigators, whether funded by commercial sponsors, government agencies, or academic institutions, largely ignored any legal requirement to register. In the United States, the lines were drawn at a small invitational meeting in April 2000 that we both attended when pharmaceutical company executives stated emphatically that they would resist any effort to have a public registry of trials registered at inception. By that year, 2000, the US ClinicalTrials.gov registry was made publicly available (FIGURE), and in addition, more than 200 individual trial registries existed. Some investigators registered trials before the first patient was randomized, others when the trials were complete. The proliferation of registries by hospitals and academic centers was at least in part because their leaders could see the importance of trial enrollment as a way of attracting both grant funding and patients to their centers. Pharmaceutical companies established their own registries and contributed to existing registries as well. Many of these early trial registries were selective in the information they displayed and in their public accessibility, and they were remarkably limited on facts (eg, a drug might simply have been listed as “investigational drug”) at a time when developments in the techniques of systematic review and meta-analysis were demanding easier and fuller access to more uniform registries. Acknowledging that many others, chiefly in the United Kingdom, Europe, and elsewhere, had been pushing for trial registration, we responded with an explanatory editorial in 2003 designed to build the scientific, clinical, and ethical case for such registries and to secure support from academic leaders and journal editors, particularly in the United States. Two key events occurred in 2004. First, the New York State Attorney General Eliot Spitzer sued GlaxoSmithKline (GSK) for failing to reveal the results of trials that showed an antidepressant might be harmful. Within a matter of days, GSK and several other pharmaceutical companies announced that they would henceforth register their trials and had intended to do so all along. Shortly thereafter, the International Committee of Medical Journal Editors (ICMJE) announced that their journals, which included those regarded as among the most prestigious, would not publish reports of trials unless they had been registered, adding to their definition of trials and medical interventions the necessity of a concurrent control group and concentrating on phase 3 trials. For many, including the pharmaceutical industry and those in academia, the ICMJE decision was the most important motivator to register their trials, given the substantial gain to investigators and sponsors from positive results published in high-profile journals. The World Health Organization declared support for clinical trials registration and in 2006 launched the WHO International Clinical Trials Registry Platform (ICTRP), a portal through which more than a dozen major trial registries from around the world can now be accessed. They include ClinicalTrials.gov; ISRCTN; the Australian New Zealand

The authors developed and tested a framework for identifying evidence gaps and prioritizing comparative effectiveness research by using a combination of clinical practice guidelines and systematic reviews. In phase 1 of the project, reported elsewhere, 45 clinical questions on the management of primary open-angle glaucoma were derived from practice guidelines and prioritized by using a 2-round Delphi survey of clinicians. On the basis of the clinicians' responses, 9 questions were classified as high-priority. In phase 2, reported here, systematic reviews that addressed the 45 clinical questions were identified. The reviews were classified as at low, high, or unclear risk of bias, and evidence gaps (in which no systematic review was at low risk of bias) were identified. The following comparative effectiveness research agenda is proposed: Two of the 9 high-priority questions require new primary research (such as a randomized, controlled trial) and 4 require a new systematic review. The utility and limitations of the framework and future adaptations are discussed.

Objectives. —To estimate the rate of full publication of the results of randomized clinical trials initially presented as abstracts at national ophthalmology meetings in 1988 and 1989; and to combine data from this study with data from similar studies to determine the rate at which abstracts are subsequently published in full and the association between selected study characteristics and full publication. Data Sources. —Ophthalmology abstracts were identified by review of 1988 and 1989 meeting abstracts for the Association for Research in Vision and Ophthalmology and the American Academy of Ophthalmology. Similar studies were identified either from reports contained in our files or through a MEDLINE search, which combined the textword "abstract" with "or" statements to the Medical Subject Headings ABSTRACTING & INDEXING, CLINICAL TRIALS, PEER REVIEW, PERIODICALS, MEDICAL SOCIETIES, PUBLISHING, MEDLINE, INFORMATION SERVICES, and REGISTRIES. Study Selection. —Ophthalmolgy abstracts were selected from the meeting proceedings if they reported results from a randomized controlled trial. For the summary study, similar studies were eligible for inclusion if they described followup and subsequent full publication for a cohort of abstracts describing the results of any type of research study. All studies had to have followed up abstracts for at least 24 months to be included. Data Extraction. —Authors of ophthalmology abstracts were contacted by letter to ascertain whether there was subsequent full publication. Other information, including characteristics of the study design possibly related to publication, was taken from the abstract. For the summary study, rates of full publication were taken directly from reported results, as were associations between study factors (ie, "significant' results and sample size) and full publication. Data Synthesis. —Sixty-six percent (61/93) of ophthalmology abstracts were published in full. Combined results from 11 studies showed that 51% (1198/2391) of all abstracts were subsequently published in full. Full publication was weakly associated with "significant" results and sample size above the median. Conclusions. —Approximately one half of all studies initially presented in abstract form are subsequently published as full-length reports. Most are published in full within 2 years of appearance as abstracts. Full publication may be associated with "significant" results and sample size. (JAMA. 1994;272:158-162)

Metabias poses unique challenges for comparative effectiveness research and evidence-based healthcare. Dechartres and colleagues' study in this issue raises the specter of a new metabias that is pa...

A shortfall exists of female doctors in senior academic posts in the United Kingdom. Career progression depends on measures of esteem, including publication in prestigious journals. This study investigates gender differences in first and senior authorship in six peer-reviewed British journals and factors that are associated with publication rates.Data was collected on United Kingdom first and senior authors who had published in the British Medical Journal, Lancet, British Journal of Surgery, Gut, British Journal of Obstetrics and Gynaecology and the Archives of Diseases in Childhood. Authorship and gender were quantified for 1970, 1980, 1990, 2000 and 2004 (n=6457). In addition, selected questions from the Athena Survey of Science Engineering and Technology (ASSET2006), web-based doctor's self-report of publications were also analysed (n=1162).Female first authors increased from 10.5% in 1970 to 36.5% in 2004 (p0.001) while female senior authors only increased from 12.3% to 16.5% (p=0.046). Within individual journals, the largest rise was in British Journal of Obstetric and Gynaecology with 4.5- and 3-fold increases for first and senior authors, respectively. In contrast, female senior authors marginally declined in Gut and Lancet by 2.8% and 2.2%, respectively. ASSET2006 identified that female respondents who were parents were less likely to have publications as sole (p=0.02) and joint authors (p0.001) compared to male respondents. Female respondents with care responsibilities for parents/partner also had less publications as lead authors compared to those without carer responsibilities (p0.001).The increase in UK female first authors is encouraging. In contrast, there is considerable lag and in some specialties a decline in female senior authors. Factors that could narrow the gender gap in authorship should be sought and addressed.

Nature Reviews Cancer 7, 309–315 (2007) The author affiliations on page 314 for Pamela Klein and Frances M. Visco were missing. They are now shown below. Pamela Kline is at Genentech, Inc., 1 DNA Way, Suite MS 88, South San Francisco, California, 94080, USA. Frances M. Visco is at the National Breast Cancer Coalition Fund, 1101 17th Street, NW, Suite 1300, Washington, DC 20036, USA.

Studies with positive results are more likely to be published than studies with negative results (publication bias). One reason this occurs is that authors are less likely to submit manuscripts reporting negative results to journals. There is no evidence that publication bias occurs once manuscripts have been submitted to a medical journal. We assessed whether submitted manuscripts that report results of controlled trials are more likely to be published if they report positive results.Prospective cohort study of manuscripts submitted to JAMA from February 1996 through August 1999. We classified results as positive if there was a statistically significant difference (P.05) reported for the primary outcome. Study characteristics and indicators for quality were also appraised. We included manuscripts that reported prospective studies in which participants were assigned to an intervention or comparison group and statistical tests compared differences between groups.Among 745 manuscripts, 133 (17.9%) were published: 78 (20.4%) of 383 with positive results, 51 (15.0%) of 341 with negative results, and 4 (19.0%) of 21 with unclear results. The crude relative risk for publication of studies with positive results compared with negative results was 1.36 (95% confidence interval [CI], 0.99-1.88). After being adjusted simultaneously for study characteristics and quality indicators, the odds ratio for publishing studies with positive results was 1.30 (95% CI, 0.87-1.96).Among submitted manuscripts, we did not find a statistically significant difference in publication rates between those with positive vs negative results.

ContextStudies have shown that reports from clinical trials with statistically significant results tend to be submitted and published more rapidly than reports from studies with null or nonsignficant findings.MethodsWe wanted to determine whether manuscripts reporting positive results from controlled clinical trials are published more quickly than those reporting negative results. We tracked manuscripts from submission to JAMA until the publication decision. We classified results as positive if a statistically significant difference was reported for the primary outcome. Manuscripts were further classified according to indicators of methodologic quality and other study characteristics. We included manuscripts if they were submitted from February 1996 through August 1999, reported results of a prospective study in which participants were assigned to a treatment or comparison group, used statistical tests to compare differences between groups, and were accepted for publication.ResultsOne hundred thirty-three manuscripts met our inclusion criteria, 78 (59%) reported positive results, 51 (38%) reported negative results. We were unable to classify the direction of results for 4 articles (3%). The time interval between submission and publication was not associated with positive results: median time between submission and publication was 7.8 months for reports with positive vs 7.6 months for reports with negative results (P = .44). Time to publication also was not associated with any marker of study quality or study characteristic.ConclusionsAmong 133 published controlled trials, time to publication was not associated with statistical significance, methodologic quality, or other study characteristics.

Continuing controversy surrounds screening mammography, particularly for women 40 to 49 years of age. Newspapers are potentially important sources of information on this topic, but it is not known whether they provide well-founded and objective information and recommendations.To examine how screening mammography is reported in newspapers.Cross-sectional descriptive study.6 top-circulation U.S. newspapers, 1990 to 1997.Number of articles about screening mammography, issues covered by the articles, information sources, content and sources of quotes, recommendations cited in articles, and presentation of risks and benefits.The most common theme of newspaper articles about mammography was screening for women 40 to 49 years of age. Thirty-one percent of the articles presented information without citing a source or justification. Quotes and recommendations in the articles were approximately twice as likely to support as to express reservations about mammography for women aged 40 to 49 years. Recommendations changed little over time and rarely reflected changes in recommendations of national organizations. Of the 102 articles describing the benefits of mammography, 95% expressed them in relative terms and 11% expressed them in absolute terms.Newspapers tended to overrepresent support for screening mammography for women aged 40 to 49 years. Reports would have been improved by identification of all sources for information cited, less reliance on relatively few sources, and discussion of benefits in absolute as well as relative terms. Medical journalism may benefit from identification of standards similar to those used for reporting medical research.

Context.—Editors, authors, and reviewers are influential in shaping science. The careers of women in public health have received less scrutiny than those of women in medicine and other branches of science. The performance of women as editors, authors, and reviewers in epidemiology has not been previously studied.Objective.—To examine changes over time in the representation of women at the editorial level in US epidemiology journals compared with the proportion of women authors and reviewers.Design and Setting.—Cross-sectional study of 4 US epidemiology journals, American Journal of Epidemiology, Annals of Epidemiology, Epidemiology, and the Journal of Clinical Epidemiology (formerly the Journal of Chronic Diseases), for 1982, 1987, 1992, and 1994.Subjects.—Editors, authors, and reviewers for the selected years.Main Outcome Measures.—Sex of editors, authors, and reviewers.Results.—We identified 2415 reports associated with 8005 authors. One of 7 editors in chief was a woman, a position she shared with a man. For all journals, the proportion of editors who were women ranged from 5 (6.5%) of 77 in 1982 to 42 (16.3%) of 258 in 1994. Over all journals and all years, women comprised a higher proportion of authors (28.7% [2225/7743] ) compared with reviewers (26.7% [796/2982]) or editors (12.8% [89/696]).Conclusions.—Fewer women in public health hold editorial positions than are authors and reviewers. The reasons for this important discrepancy, including the possibility of a selection bias favoring men, should be further investigated.

Objective. —To provide physicians with a current consensus on total hip replacement. Participants. —A nonfederal, nonadvocate, 13-member consensus panel representing the fields of orthopedic surgery, rehabilitation and physical medicine, biomechanics and biomaterials, internal medicine, public health, geriatrics, biostatistics, and a public representative. In addition, 27 experts in orthopedic surgery, rehabilitation and physical medicine, biomechanics and biomaterials, rheumatology, geriatrics, and epidemiology presented data to the consensus panel and a conference audience of 425. Evidence. —The literature was searched through MEDLINE and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. Consensus. —The panel, answering predefined consensus questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. Consensus Statement. —The panel composed a draft statement that was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. Conclusions. —Total hip replacement is an option for nearly all patients with diseases of the hip that cause chronic discomfort and significant functional impairment. Most patients have an excellent prognosis for long-term improvement in symptoms and physical function. At this time, a cemented femoral component using modern cementing techniques, paired with a porous-coated acetabular component, can give excellent long-term results. Revision of a total hip replacement is indicated when mechanical failure occurs. Continued periodic follow-up is necessary to identify early evidence of impending failure so as to permit remedial action before a catastrophic event. (JAMA. 1995;273:1950-1956)

Objective. —To assess the safety and efficacy of optic nerve decompression surgery compared with careful follow-up alone in patients with nonarteritic anterior ischemic optic neuropathy (NAION). Design. —The Ischemic Optic Neuropathy Decompression Trial (IONDT) is a randomized, single-masked, multicenter trial. Setting. —Twenty-five US clinical centers. Participants. —The IONDT ceased recruitment on October 20, 1994, on the recommendation of its Data and Safety Monitoring Committee. The preliminary results presented herein are based on data as of September 8,1994, from 244 patients with NAION and visual acuity of 20/64 or worse. One hundred twenty-five patients had been randomized to careful follow-up, and 119 had been randomized to surgery, with 91 and 95, respectively, having completed 6 months of follow-up. Intervention. —Patients in the surgery group received optic nerve decompression surgery and follow-up ophthalmologic examinations; those in the careful follow-up group received ophthalmologic examinations at the same times as the surgery group. Main Outcome Measures. —Gain or loss of three or more lines of visual acuity on the New York Lighthouse chart at 6 months after randomization, as measured by a technician masked to treatment assignment. Results. —Patients assigned to surgery did no better when compared with patients assigned to careful follow-up regarding improved visual acuity of three or more lines at 6 months: 32.6% of the surgery group improved compared with 42.7% of the careful follow-up group. The odds ratio (OR) for three or more lines better, adjusted for baseline visual acuity and diabetes, was 0.74 (95% confidence interval [CI], 0.39 to 1.38). Patients receiving surgery had a significantly greater risk of losing three or more lines of vision at 6 months: 23.9% in the surgery group worsened compared with 12.4% in the careful follow-up group. The 6-month adjusted OR for three or more lines worse was 1.96 (95% CI, 0.87 to 4.41). No difference in treatment effect was observed between patients with progressive NAION and all others. Conclusion. —Results from the IONDT indicate that optic nerve decompression surgery for NAION is not effective, may be harmful, and should be abandoned. The spontaneous improvement rate is better than previously reported. ( JAMA . 1995;273:625-632)

To the Editor. —Dr Rennie 1 was right on target in his editorial comments. His Editorial on what went wrong in the NSABP misconduct case highlights numerous areas, within the scientific process in general and the NSABP specifically, in need of critical examination and revision. The process of understanding what happened in this unfortunate episode has strayed considerably from the mark, however. At a recent international professional meeting I attended, the head of the NSABP, Dr Bernard Fisher, was praised and the "bully boys" at the National Cancer Institute (NCI) were excoriated for their respective roles in spearheading important breast cancer trials and in impaling Fisher. The scientific and medical community appears all too ready to focus on the individuals involved and not the more critical issue of where the system broke down and the ways in which it should be modified so that similar problems do not occur in

In Reply. —The letter from Dr Kaufman raises questions that we cannot answer with the study we performed. Our investigation was carried out within Johns Hopkins Health Institutes and hence does not provide information on the nature of publication bias across institutions, or by such variables as size or reputation of the institution. Indeed, variables such as those

Objective. —To investigate factors associated with the publication of research findings, in particular, the association between "significant" results and publication. Design. —Follow-up study. Setting. —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. Population. —A total of 737 studies were followed up. Results. —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. Conclusion. —There is a statistically significant association between significant results and publication. (JAMA. 1992;267:374-378)