International Journal of Nursing Studies 52 (2015) 1025–1028
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Editorial
Ensuring the reporting quality of publications in nursing journals: A shared responsibility? A R T I C L E I N F O
Keywords: Reporting Quality Nursing Journals Consort Statement Randomised Controlled Trials
In this edition of the International Journal of Nursing Studies we publish a study by Jull and Aye that explores the effect of endorsement of the CONSORT Statement on the quality of randomised trials reported in leading nursing journals (Jull and Aye (2015)). The International Journal of Nursing Studies, which has long supported a variety of reporting guidelines, is one of the journals included in the review. CONSORT stands for Consolidated Standards of Reporting Trials. The CONSORT Statement, originally published in 1996, was revised most recently in 2010 (Schulz et al., 2010). It comprises guidance for reporting randomised controlled trials and a checklist, specifying the essential content for a report of a randomised controlled trial. The original CONSORT Statement referred to individually randomised trials but subsequently other guidelines were developed covering, for example, cluster randomised studies (Campbell et al., 2012). The rationale for the development of the CONSORT Statement was that in order to practice evidence based medicine it is necessary to determine the quality of the research providing that evidence. Randomised, controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating health care interventions. However, randomised trials can yield biased results if they lack methodological rigor (1). To assess a trial accurately, readers of a published report need complete, clear, and transparent information on its methodology and findings. (Schulz et al., 2010p 726). That means that reports of research have to contain sufficient information to allow a reader to determine its http://dx.doi.org/10.1016/j.ijnurstu.2015.02.009 0020-7489/ß 2015 Elsevier Ltd. All rights reserved.
validity. However, many studies in both medical and nursing journals have shown that reports of randomised controlled trials frequently fail to include information that is essential to consider when assessing validity (Chan and Altman, 2005; Smith et al., 2008). After it was first released, the CONSORT Statement was rapidly adopted and endorsed by leading medical journals. A systematic review of comparative studies suggested that the quality of trial reports in medical journals adopting the statement did improve (Plint et al., 2006) with the reporting of some, but not all aspects of trials significantly better in journals that adopted the CONSORT Statement. In the study reported in this issue, Jull and Aye reviewed randomised controlled trials published in 2012 in the top 15 nursing journals, rated by 5 year impact factor. They conclude that many trials published in nursing journals provide insufficient information for assessment of the key quality measures advocated by the CONSORT Statement. Of the journals considered in the paper, seven (including the International Journal of Nursing Studies) were classified as CONSORT promoting journals. While journals that promoted the CONSORT statement generally had more complete reporting than those which did not, for most aspects assessed the difference was small. Reporting of allocation concealment was poor, whether journals endorsed CONSORT or not, with only 34% of papers giving adequate detail to assess validity. This is important because inadequate concealment of allocation in trials is associated with selection bias (either deliberate or inadvertent) and consequent overestimation of treatment effects (Schulz et al., 1995). The 41% increase odds ratios associated with inadequate allocation concealment found by Schultz is greater than for some of the more
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Table 1 Completeness of reporting aspects of the CONSORT reporting guidelines for randomised controlled trials published in leading nursing journals in 2012 (data from Jull and Aye (2015)). Journal group
n Trials
Sequence generation n (%)
Allocation concealment n (%)
Blinding n (%)
Completeness of follow-up n (%)
CONSORT diagram n (%)
Baseline equivalence n (%)
CONSORT endorsing journals Non-endorsing journals
58 25
45 (78%) 18 (72%)
20 (34%) 8 (32%)
41 (71%) 16 (64%)
54 (93%) 23 (92%)
48 (83%) 13 (52%)
50 (86%) 22 (88%)
widely recognised (and better reported) aspects of trial design such as blinding or the generation of the random sequence itself. These findings echo similar studies in medical journals although endorsement of CONSORT by those journals does seem to be associated with improvement in reporting allocation concealment (Plint et al., 2006). By contrast the only area that seemed to be substantially better in nursing journals endorsing CONSORT compared to those that do not was the inclusion of a diagram showing participant flow through a trial (Table 1). Thus it seems that the CONSORT Statement may not have had a major impact upon the quality of reporting nursing research, even in those journals that actively endorse it. This is unfortunate because it means that the rigour of many studies published in nursing journals cannot be assessed and so must be considered as having a risk of bias even if in reality the studies were carried out rigorously. We simply cannot know. Jull and Aye, with some justification, place the responsibility for improving the quality of reporting research studies upon the journal editors and reviewers, whom they feel should be more proactive in ensuring that the quality of reporting research meets industry standards which, for randomised controlled trials is, in effect, the CONSORT Statement. Readers might object that this discussion is of marginal relevance to nursing research because randomised controlled trials comprise only a small part of the research published. This may be true but reporting guidelines exist for many forms of research. As a journal we endorse their use. While reporting of other designs may be less rigorously researched, our experience as editors suggests that incomplete reporting is not restricted to reports of randomised controlled trials. The equator network (www equator-network.org) provides an excellent resource for reporting guidelines for many study types. Reporting guidelines endorsed by the International Journal of Nursing Studies include: Observational cohort, case control and cross sectional studies: STROBE—strengthening the reporting of observational studies in epidemiology (von Elm et al., 2008). Quasi-experimental/non-randomised evaluations: TREND— transparent reporting of evaluations with non-randomised designs, (Des Jarlais et al., 2004). Randomised (and quasi-randomised) controlled trial: CONSORT—consolidated standards of reporting trials (Schulz et al., 2010). Study of Diagnostic accuracy/assessment scale: STARD— standards for the reporting of diagnostic accuracy studies (Bossuyt et al., 2003).
Systematic Review of Controlled Trials: PRISMA—preferred reporting items for systematic reviews and metaanalyses (Moher et al., 2009). Systematic Review of Observational Studies: MOOSE— meta-analysis of observational studies in epidemiology (Stroup et al., 2000). We also ask qualitative researchers to consult COREQ (Tong et al., 2007) (consolidated criteria for reporting qualitative research) and for reviews ENTREQ (enhancing transparency in reporting the synthesis of qualitative research) (Tong et al., 2012), although we do not formally endorse them or require their use. Other guidelines are emerging all the time. We recently became the first journal to publish the SAMPL guidelines (statistical analyses and methods in the published literature) for reporting statistical methods (Lang and Altman, 2015), and have also published guidelines on reporting the development and evaluations of complex interventions in health care (Mo¨hler et al., 2012) and Guidelines for Reporting Reliability and Agreement Studies (GRRAS) (Kottner et al., 2011a,b; Kottner et al., 2011a,b). Other recent guidelines highly relevant to papers published in this journal relate to the better reporting of interventions, providing a template for intervention description to permit replication (the TIDieR checklist and guide) (Hoffmann et al., 2014). These newer guidelines may not, as yet, be supported by the same degree of consensus as the CONSORT guidance, but they provide a useful framework for determining the completeness of reporting for most types of study and we are beginning to see their influences in papers that we publish (Griffiths and Norman, 2013; Klaus et al., 2013). With all these helpful guidelines available, how can editors and reviewers improve the quality of reporting, and what responsibilities lie with the authors themselves? Journal endorsement of the CONSORT Statement and other guidelines is a start, but clearly, as we have seen, it is not enough. Loder and Penzien (2009) addressed this problem for medical journals by suggesting that editors work more closely with their reviewers to stress the importance of using endorsed guidelines as a framework for reviewing the quality of submitted papers. Peer review has an important role in determining publication quality, yet reviewers are seldom given guidance about how to review for particular journals. Both the authors of this editorial are reviewers for many journals, nursing, medical, health service research, but we rarely receive any guidance on what an editor expects in terms of a review. Like many reviewers we learned the craft by looking at the reviews of the same articles written by the other reviewers. This is an extraordinarily valuable
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process, but it happens ‘after the event’ and does not guarantee that other reviewers are applying the relevant reporting guidelines. The editors of the International Journal of Nursing Studies are actively considering what we can do to encourage (and help) reviewers to use reporting guidelines when assessing studies. We have long encouraged authors to submit a checklist. This may partly explain why the International Journal of Nursing Studies performed better that the average with compliance with the CONSORT statement in Jull and Aye’s study. But we cannot be complacent, and although the International Journal of Nursing Studies managed to get 100% compliance with some aspects of reporting, for others, in common with other journals, our performance was poor. We have recently started requiring checklists. We are also considering changes to information to reviewers and making it much clearer for reviewers what guidelines the journal endorses. However improving the reporting quality of articles is not just the job of the editors and the reviewers. Authors themselves have to take most of the responsibility—after all it is they who want to have their paper published and have a vested interested in demonstrating the quality of their science. Editors reject many articles before they even go out to review and increasingly we reject papers which demonstrate poor reporting standards without review. No research is perfect and increased transparency may reveal limitations in the research. This need not always prevent publication. Reviewers (and future readers) can make informed judgments about limitations, provided reporting is clear. Authors of research papers are themselves researchers, and as such they should be aware of the general principles of good reporting guidelines before they start their study. Consulting guidelines when preparing a paper (as opposed to at the point of submission) should become routine. While not their primary function, reporting guidelines can also be useful in developing study protocols and funding applications, by highlighting important aspects of design that need to be made explicit. Interestingly in recent years checklists and guidelines based on the same principles as reporting guidelines have been published that relate to detail that should be included in study protocols (Chan et al., 2013; Shamseer et al., 2015). In summary, if ensuring the quality of reporting in nursing journals is to be a shared responsibility then the following actions will be necessary to improve standards: Authors prepare their manuscripts in line with the reporting guidelines. Editors reject articles where the reporting quality is poor. Editors provide reviewers with explicit guidance for reviewing. Reviewers use the journal endorsed guidelines to guide their reviews. We strongly encourage our authors and our reviewers to pay close attention to reporting guidelines and to use them to help ensure that the quality of the science we publish can be properly judged and, in turn, to ensure that it is of high quality. Ultimately this is no academic matter.
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It is a matter of ensuring that nursing care delivery is based on a demonstrably sound evidence base. The sad conclusion that must be drawn from Jull and Ayes paper is that all too often it is not possible to be sure that this is the case. Conflict of interest statement: None declared. References Bossuyt, P.M., Reitsma, J.B., Bruns, D.E., Gatsonis, C.A., Glasziou, P.P., Irwig, L.M., Lijmer, J.G., Moher, D., Rennie, D., de Vet, H.C.W., 2003. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. British Medical Journal 326 (7379), 41–44. Campbell, M.K., Piaggio, G., Elbourne, D.R., Altman, D.G., 2012. Consort 2010 statement: extension to cluster randomised trials. British Medical Journal 345, e5661. Chan, A.-W., Tetzlaff, J.M., Gøtzsche, P.C., Altman, D.G., Mann, H., Berlin, J.A., Dickersin, K., Hro´bjartsson, A., Schulz, K.F., Parulekar, W.R., Krlezˇa-Jeric´, K., Laupacis, A., Moher, D., 2013. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. Annals of Internal Medicine 158 (3), 200–207. Chan, A.W., Altman, D.G., 2005. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 365 (9465), 1159–1162. Des Jarlais, D.C., Lyles, C., Crepaz, N., Group, T., 2004. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am. J. Public Health 94 (3), 361. Griffiths, P., Norman, I., 2013. Qualitative or quantitative? Developing and evaluating complex interventions: time to end the paradigm war. Int. J. Nurs. Stud. 50 (5), 583–584. Hoffmann, T.C., Glasziou, P.P., Boutron, I., Milne, R., Perera, R., Moher, D., Altman, D.G., Barbour, V., Macdonald, H., Johnston, M., Lamb, S.E., Dixon-Woods, M., McCulloch, P., Wyatt, J.C., Chan, A.-W., Michie, S., 2014. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. British Medical Journal 348, g1687. Jull, A., Aye, P.S., 2015. Endorsement of the CONSORT guidelines, trial registration, and the quality of reporting randomised controlled trials in leading nursing journals: a cross-sectional analysis. Int. J. Nurs. Stud., [in press]. Klaus, S.F., Dunton, N., Gajewski, B., Potter, C., 2013. Reliability of the nursing care hour measure: a descriptive study. Int. J. Nurs. Stud. 50 (7), 924–932. Kottner, J., Audige, L., Brorson, S., Donner, A., Gajewski, B.J., Hro´bjartsson, A., Roberts, C., Shoukri, M., Streiner, D.L., 2011a. Guidelines for reporting reliability and agreement studies (GRRAS) were proposed. Int. J. Nurs. Stud. 48 (6), 661–671. Kottner, J., Gajewski, B.J., Streiner, D.L., 2011b. Guidelines for reporting reliability and agreement studies (GRRAS). Int. J. Nurs. Stud. 48 (6), 659–660. Lang, T.A., Altman, D.G., 2015. Basic statistical reporting for articles published in Biomedical Journals: the statistical analyses and methods in the published literature or the SAMPL guidelines. Int. J. Nurs. Stud. 52 (1), 5–9. Loder, E.W., Penzien, D.B., 2009. Improving the quality of research reporting: headache steps up to the plate. Headache: J. Head Face Pain 49 (3), 335–340. Moher, D., Liberati, A., Tetzlaff, J., Altman, D.G., The, P.G., 2009. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 6 (7), e1000097. Mo¨hler, R., Bartoszek, G., Ko¨pke, S., Meyer, G., 2012. Proposed criteria for reporting the development and evaluation of complex interventions in healthcare (CReDECI): guideline development. Int. J. Nurs. Stud. 49 (1), 40–46. Plint, A.C., Moher, D., Morrison, A., Schulz, K., Altman, D.G., Hill, C., Gaboury, I., 2006. Does the CONSORT checklist improve the quality of reports of randomised controlled trials?. A systematic review. Med. J. Aust. 185 (5), 263. Schulz, K.F., Altman, D.G., Moher, D., for the, C.G., 2010. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 7 (3), e1000251. Schulz, K.F., Chalmers, I., Hayes, R.J., Altman, D.G., 1995. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 273 (5), 408–412. Shamseer, L., Moher, D., Clarke, M., Ghersi, D., Liberati, A., Petticrew, M., Shekelle, P., Stewart, L.A., 2015. Preferred reporting items for system-
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Claire Halea,* Peter Griffithsb a Emeritus Professor School of Healthcare, Baines Wing, University of Leeds, Leeds LS29UT, United Kingdom b Executive Editor International Journal of Nursing StudiesProfessor of Health Services research, University of Southampton, United Kingdom *Corresponding author. Tel.: +44(0)1133431434 E-mail addresses:
[email protected] (C. Hale), peter.griffi
[email protected] (P. Griffiths). Received 10 February 2015 Accepted 10 February 2015