Elizabeth Wager

Reducing waste from incomplete or unusable reports of biomedical research

Research publication can both communicate and miscommunicate. Unless research is adequately reported, the time and resources invested in the conduct of research is wasted. Reporting guidelines such as CONSORT, STARD, PRISMA, and ARRIVE aim to improve the quality of research reports, but all are much less adopted and adhered to than they should be. Adequate reports of research should clearly describe which questions were addressed and why, what was done, what was shown, and what the findings mean. However, substantial failures occur in each of these elements. For example, studies of published trial reports showed that the poor description of interventions meant that 40-89% were non-replicable; comparisons of protocols with publications showed that most studies had at least one primary outcome changed, introduced, or omitted; and investigators of new trials rarely set their findings in the context of a systematic review, and cited a very small and biased selection of previous relevant trials. Although best documented in reports of controlled trials, inadequate reporting occurs in all types of studies-animal and other preclinical studies, diagnostic studies, epidemiological studies, clinical prediction research, surveys, and qualitative studies. In this report, and in the Series more generally, we point to a waste at all stages in medical research. Although a more nuanced understanding of the complex systems involved in the conduct, writing, and publication of research is desirable, some immediate action can be taken to improve the reporting of research. Evidence for some recommendations is clear: change the current system of research rewards and regulations to encourage better and more complete reporting, and fund the development and maintenance of infrastructure to support better reporting, linkage, and archiving of all elements of research. However, the high amount of waste also warrants future investment in the monitoring of and research into reporting of research, and active implementation of the findings to ensure that research reports better address the needs of the range of research users.

[CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration].

Background Clear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract. Methods and Findings We generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design (e.g., method of allocation, blinding/masking); trial participants (i.e., description, numbers randomized, and number analyzed); interventions intended for each randomized group and their impact on primary efficacy outcomes and harms; trial conclusions; trial registration name and number; and source of funding. We recommend the checklist be used in conjunction with this explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for the inclusion of each item. Conclusions CONSORT for Abstracts aims to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. It will help authors of abstracts of these trials provide the detail and clarity needed by readers wishing to assess a trials validity and the applicability of its results.

CONSORT for reporting randomised trials in journal and conference abstracts

www.thelancet.com Vol 371 January 26, 2008 281 To facilitate understanding of mechanisms that mediate the association between parental education and physical growth of children, two crucial issues need to be addressed. First, Semba and colleagues’ results highlight the importance of identifying factors that mediate the infl uence of paternal education, and we cannot assume that the same mediators will hold for mothers and fathers. Second, there is evidence that mediators of the association between parental education and children’s growth do not function in isolation from each other, but are interlinked. For example, women who have some degree of control over family-resource allocation, or women living in families with more economic resources are at lower risk for depression than women without control over resource allocation or women living in poorer families. Even more crucially, the eff ect of a given mediator may vary as a function of the operation of other mediators. For example, the relation between maternal education and the mother’s decision-making power on household expenditures will vary as a function of the overall level of family resources, while the risk of growth failure for children of depressed mothers varies as a function of level of maternal intelligence. These fi ndings mean that we should study what infl uences a child’s physical growth within a multidimensional systems framework, where the eff ect of one mediator depends on those of other mediators. This complexity is needed because, in the real world, mediators rarely act alone.

Science journal editors’ views on publication ethics: results of an international survey

Background: Breaches of publication ethics such as plagiarism, data fabrication and redundant publication are recognised as forms of research misconduct that can undermine the scientific literature. We surveyed journal editors to determine their views about a range of publication ethics issues. Methods: Questionnaire sent to 524 editors-in-chief of Wiley-Blackwell science journals asking about the severity and frequency of 16 ethical issues at their journals, their confidence in handling such issues, and their awareness and use of guidelines. Results: Responses were obtained from 231 editors (44%), of whom 48% edited healthcare journals. The general level of concern about the 16 issues was low, with mean severity scores of <1 (on a scale of 0–3) for all but one. The issue of greatest concern (mean score 1.19) was redundant publication. Most editors felt confident in handling the issues, with <15% feeling “not at all confident” for all but one of the issues (gift authorship, 22% not confident). Most editors believed such problems occurred less than once a year and >20% of the editors stated that 12 of the 16 items never occurred at their journal. However, 13%–47% did not know the frequency of the problems. Awareness and use of guidelines was generally low. Most editors were unaware of all except other journals’ instructions. Conclusions: Most editors of science journals seem not very concerned about publication ethics and believe that misconduct occurs only rarely in their journals. Many editors are unfamiliar with available guidelines but would welcome more guidance or training.

European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications

ABSTRACT Background: Many papers in biomedical journals are drafted not by the named authors, but by professional medical writers working under the direction of those authors, usually funded by pharmaceutical companies. Although this practice can improve both the quality and speed of publications, it has attracted controversy as a result of concerns about the inappropriate influence of pharmaceutical companies. Objectives: To define ethical standards for professional medical writers who prepare papers for publication in medical journals. Consensus methods: Guidelines were drafted after a 4-round Delphi consultation among a group of experienced medical writers. The guidelines were then further refined by seeking comments on the draft from a range of interested parties. Findings and conclusions: The guidelines stress the importance of respecting widely recognised authorship criteria, and in particular of ensuring that those listed as named authors have full control of the content of papers. The role of medical writers must be transparent, which normally means a mention in the acknowledgements section, together with a statement about funding. Writers and authors must have access to relevant data while writing papers. Medical writers have professional responsibilities to ensure that the papers they write are scientifically valid and are written in accordance with generally accepted ethical standards.

Hardly worth the effort? Medical journals' policies and their editors' and publishers' views on trial registration and publication bias: quantitative and qualitative study.

Objectives To determine the proportion of medical journals requiring trial registration and to understand their reasons for adopting (or not adopting) such policies and other measures designed to reduce publication bias. Design Quantitative study of journals’ instructions to authors (in June 2012) and qualitative study of editors’ and publishers’ views on trial registration and publication bias (carried out in Autumn 2012). Setting Random selection of 200 medical journals publishing clinical trials identified from the Cochrane CENTRAL database. Participants Editors (n=13) and publishers (n=3) of journals with different policies on trial registration (and with recently changed policies) identified from the survey of their instructions to authors. Results Only 55/200 journals (28%) required trial registration according to their instructions and a further three (2%) encouraged it. The editors and publishers interviewed explained their journals’ reluctance to require registration in terms of not wanting to lose out to rival journals, not wanting to reject otherwise sound articles or submissions from developing countries, and perceptions that such policies were not relevant to all journals. Some interviewees considered that registration was unnecessary for small or exploratory studies. Conclusions Although many major medical journals state that they will only publish clinical trials that have been prospectively registered, and such policies have been associated with a dramatic increase in the number of trials being registered, most smaller journals have not adopted such policies. Editors and publishers may be reluctant to require registration because they do not understand its benefits or because they fear that adopting such a policy would put their journal at a disadvantage to competitors.

Recognition, reward and responsibility: Why the authorship of scientific papers matters

Author lists should inform readers about who did a piece of research. If authorship attribution is incorrect, the wrong people may take the credit or the blame. Correct authorship of medical papers is also important because the research and publication process relies on trust. If scientists or clinicians are prepared to lie about who was involved with a research project why should we believe their findings? Groups of journal editors, notably the International Committee of Medical Journal Editors, have tried to establish criteria for authorship but these are not universally accepted. Despite the lack of agreement, authorship of journal articles continues to be the basis for academic appointments and is used to measure the research output of departments and therefore determine future funding. Some journals have started to use contributor lists, indicating the role of each individual, in place of, or in addition to, traditional lists of authors. However, problems about the threshold of involvement that merits authorship, and the order of listing remain unresolved. Journal editors are usually unable to adjudicate on authorship disputes since detailed, local knowledge is required. Institutions might therefore play a greater role in setting and enforcing authorship policies. Disputes could be reduced if authorship criteria were agreed, in writing, among all contributors at the start of a research project.

Survey of British Women's Views on the Menopause and HRT:

Objective To examine British womens views on the menopause and HRT. Study design Face-to-face interviews with 393 women aged 40–65 (randomly selected to be representative of the UK in terms of geographical region, social class and age) and with a different group of 244 women from across the UK selected according to their HRT use by means of a “snowballing” technique. Main outcome measures Descriptive statistics of womens responses to structured interview. Results Of the 393 women, 17% were currently using HRT (31% of those experiencing menopausal symptoms) and 11% were past users; 51% had discussed HRT with their doctor. Most claimed to know a little (57%) or a lot (25%) about HRT. Reasons for stopping HRT were: side-effects (35%), poor efficacy (24%) and concern about long-term risks (18%). Most current users expected to take HRT long-term: 29% for life, 18% for >5 years and 25% for 2–5 years. 67% of past users and 49% of non-users thought they would take HRT in the future. When considering statements about the menopause, 65% of women felt more would be done if men experienced it, 52% preferred to consult a woman doctor, 60% wanted to learn more about the menopause and 56% were glad that their periods had stopped. Conclusions Compared with past surveys, this suggests that British womens knowledge and use of HRT is increasing. Women may stop HRT if side-effects are troublesome or because of concern about long-term risks. However, many are prepared to use HRT for long periods.

Exploring why and how journal editors retract articles: findings from a qualitative study.

Editors have a responsibility to retract seriously flawed articles from their journals. However, there appears to be little consistency in journals’ policies or procedures for this. In a qualitative study, we therefore interviewed editors of science journals using semi-structured interviews to investigate their experience of retracting articles. We identified potential barriers to retraction, difficulties in the process and also sources of support and encouragement. Our findings have been used as the basis for guidelines developed by the Committee on Publication Ethics.

Evidence-informed recommendations to reduce dissemination bias in clinical research: conclusions from the OPEN (Overcome failure to Publish nEgative fiNdings) project based on an international consensus meeting

Background Dissemination bias in clinical research severely impedes informed decision-making not only for healthcare professionals and patients, but also for funders, research ethics committees, regulatory bodies and other stakeholder groups that make health-related decisions. Decisions based on incomplete and biased evidence cannot only harm people, but may also have huge financial implications by wasting resources on ineffective or harmful diagnostic and therapeutic measures, and unnecessary research. Owing to involvement of multiple stakeholders, it remains easy for any single group to assign responsibility for resolving the problem to others. Objective To develop evidence-informed general and targeted recommendations addressing the various stakeholders involved in knowledge generation and dissemination to help overcome the problem of dissemination bias on the basis of previously collated evidence. Methods Based on findings from systematic reviews, document analyses and surveys, we developed general and targeted draft recommendations. During a 2-day workshop in summer 2013, these draft recommendations were discussed with external experts and key stakeholders, and refined following a rigorous and transparent methodological approach. Results Four general, overarching recommendations applicable to all or most stakeholder groups were formulated, addressing (1) awareness raising, (2) implementation of targeted recommendations, (3) trial registration and results posting, and (4) systematic approaches to evidence synthesis. These general recommendations are complemented and specified by 47 targeted recommendations tailored towards funding agencies, pharmaceutical and device companies, research institutions, researchers (systematic reviewers and trialists), research ethics committees, trial registries, journal editors and publishers, regulatory agencies, benefit (health technology) assessment institutions and legislators. Conclusions Despite various recent examples of dissemination bias and several initiatives to reduce it, the problem of dissemination bias has not been resolved. Tailored recommendations based on a comprehensive approach will hopefully help increase transparency in biomedical research by overcoming the failure to disseminate negative findings.