Review Article
Publication guidelines need widespread adoption

https://doi.org/10.1016/j.jclinepi.2011.07.008Get rights and content

Abstract

Objective

During the past two decades teams of researchers and editors have developed a variety of publishing guidelines to improve the quality of published research reports. Journals and editorial groups have adopted many of these guidelines. Whereas some guidelines are widely used, others have yet to be generally applied, thwarting attainment of consistent reporting among published research reports. The aim of this study is to describe the development and adoption of general publication guidelines for various study designs, provide examples of guidelines adapted for specific topics, and recommend next steps.

Study Design and Setting

We reviewed generic guidelines for reporting research results and surveyed their use in PubMed and Science Citation Index.

Results

Existing guidelines cover a broad spectrum of research designs, but there are still gaps in topics and use. Appropriate next steps include increasing use of available guidelines and their adoption among journals, educating peer reviewers on their use, and incorporating guideline use into the curriculum of medical, nursing, and public health schools.

Conclusion

Wider adoption of existing guidelines should result in research that is increasingly reported in a standardized, consistent manner.

Introduction

What is new?

  • Multiple guidelines have been developed for publishing a variety of types of studies; this study summarizes and compares such guidelines for major study designs.

  • Appropriate next steps would be to increase use of available guidelines and incorporating their use into curricula for health care professionals.

Well-designed clinical trials and observational studies are essential to provide appropriate information needed by clinicians to adapt or change treatments. The primary mode of communication among scientists is peer-reviewed publication. Hence, it is important that the quality of such publications be maximized. Even if clinicians prefer not to modify a practice with which they are familiar, the pressure to assure evidence-based practice and minimize health care costs will necessitate that even unpopular results, if rigorously documented and confirmed, be incorporated into treatment decisions. This will require that results of clinical research be increasingly scrutinized.

The limitations of any study should be carefully summarized in research publication. Variability in the format and presentation of research studies, however, can make it difficult to discern whether the limitations of the study are inherent in the design or whether the presentation of the results in their final published form are simply not providing sufficient clarity or specificity. For example, there is considerable variation in published descriptions of recruiting participants, training data collectors, calculating sample size, monitoring the integrity of an intervention, and assessing outcome measures. Even for a concept as basic as “blinding,” differences in interpretation have been noted [1]. In one survey of randomized clinical trials, 18 different combinations of groups were blinded, despite the fact that each study reported “double blinding” [2], and in a survey of 73 trials only 19% of “double blind” trials clearly described the blinding of participants [3].

To improve the clarity and consistency of research reports, efforts beginning in the 1990s were initiated by researchers, editors, and methodologists to develop and recommend specific standards for the publication of research [4], [5]. The initial guidelines focused on randomized clinical trials, but since 1999 there has been a burgeoning of statements and checklists. The aim of this study is to describe the development and adoption of general publication guidelines for various study designs, provide examples of guidelines adapted for specific topics, and recommend next steps.

Section snippets

Review methodology

For this review, we defined “general” guidelines as those developed to serve as generic guides to the publication of studies using specific study designs. These include guidelines for studies using intervention, observational, and qualitative designs; systematic reviews and meta-analyses; and Internet surveys. To assess the extent to which guidelines are being used and cited, we searched PubMed for the years after the first publication of each guideline through December 2010 for references to

Guidelines for intervention studies (CONSORT, TREND, SQUIRE)

The first statement designed to improve reporting of research was the Consolidated Standards of Reporting Trials (CONSORT). Motivated by evidence of inadequate and inconsistent reporting of randomized clinical trials work to develop this statement began in 1993 with 30 experts, including editors, authors, publishers, and scholars in the field, who met in Canada. Their first statement was published in 1994 [4], [5]. A second group convened in California simultaneously developed and published a

Examples of additional guidelines adapted for specific topics

General guidelines are fundamental, but there is a growing number of guidelines adapting the generic guidance for a specific research area to allow better comparison across studies (e.g., added components standardizing terminology or outcomes selection and definition). In fact, more than 140 such guidelines have been identified (http://www.equator-network.org/). Below we describe just a few examples of these specific guidelines, which have been used and cited in the literature.

Discussion

Evidence of the need for publishing guidelines continues, despite the fact that many journals and editorial groups have publicly endorsed such guidelines. For example, between 2000 and 2006 only minimal improvement was found among articles listed in PubMed for such design attributes as defining a primary end point (45% in 2000 and 53% in 2006), describing how participants were assigned to a comparison group (21% in 2000 and 34% in 2006), and reporting a sample size calculation (27% in 2000 and

References (64)

  • R. Gupta et al.

    Clinical cardiac involvement in idiopathic inflammatory myopathies: a systematic review

    Int J Cardiol

    (2011)
  • E.M. Seidler et al.

    Meta-analysis comparing efficacy of benzoyl peroxide, clindamycin, benzoyl peroxide with salicylic acid, and combination benzoyl peroxide/clindamycin in acne

    J Am Acad Dermatol

    (2010)
  • E. von Elm et al.

    The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies

    Lancet

    (2007)
  • S.F. Coppus et al.

    Quality of reporting of test accuracy studies in reproductive medicine: impact of the Standards for Reporting of Diagnostic Accuracy (STARD) initiative

    Fertil Steril

    (2006)
  • E. van Trijffel et al.

    Inter-examiner reliability of passive assessment of intervertebral motion in the cervical and lumbar spine: a systematic review

    Man Ther

    (2005)
  • N. Voirin et al.

    Hospital-acquired influenza: a synthesis using the Outbreak Reports and Intervention Studies of Nosocomial Infection (ORION) statement

    J Hosp Infect

    (2009)
  • P.J. Devereaux et al.

    Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials

    JAMA

    (2001)
  • M.T. Haahr et al.

    Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors

    Clin Trials

    (2006)
  • A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group

    JAMA

    (1994)
  • Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature

    Ann Intern Med

    (1994)
  • C. Begg et al.

    Improving the quality of reporting of randomized controlled trials. The CONSORT statement

    JAMA

    (1996)
  • D. Moher et al.

    CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials

    BMJ

    (2010)
  • D.C. Des Jarlais et al.

    Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement

    Am J Public Health

    (2004)
  • A.M. Riethmuller et al.

    Efficacy of interventions to improve motor development in young children: a systematic review

    Pediatrics

    (2009)
  • F. Moss et al.

    A new structure for quality improvement reports

    Qual Health Care

    (1999)
  • R.G. Thomson et al.

    QIR and SQUIRE: continuum of reporting guidelines for scholarly reports in healthcare improvement

    Qual Saf Health Care

    (2008)
  • F. Davidoff et al.

    Publication guidelines for quality improvement studies in health care: evolution of the SQUIRE project

    BMJ

    (2009)
  • G. Ogrinc et al.

    The SQUIRE (Standards for QUality Improvement Reporting Excellence) guidelines for quality improvement reporting: explanation and elaboration

    Qual Saf Health Care

    (2008)
  • N.S. Abraham et al.

    Meta-analysis of non-randomized comparative studies of the short-term outcomes of laparoscopic resection for colorectal cancer

    ANZ J Surg

    (2007)
  • D. Singh-Grewal et al.

    Circumcision for the prevention of urinary tract infection in boys: a systematic review of randomised trials and observational studies

    Arch Dis Child

    (2005)
  • J.P. Vandenbroucke et al.

    Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration

    Epidemiology

    (2007)
  • J. Huynh et al.

    Self-collection for vaginal human papillomavirus testing: systematic review of studies asking women their perceptions

    J Low Genit Tract Dis

    (2010)
  • Cited by (27)

    • Using the STROBE statement: survey findings emphasized the role of journals in enforcing reporting guidelines

      2019, Journal of Clinical Epidemiology
      Citation Excerpt :

      Authors of biomedical manuscripts are generally unaware of the existence or utility of RGs and those responding to peer reviewers often have problems adhering to the methodological standards proposed [2–4]. Many journals do not require a relevant RG checklist to be submitted with a manuscript therefore, there is often no incentive for authors to complete one [5]. Some authors reject RGs, claiming that RGs can be condescending and rigid [6,7].

    • A reference case for economic evaluations in osteoarthritis: An expert consensus article from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO)

      2014, Seminars in Arthritis and Rheumatism
      Citation Excerpt :

      The most recent addition is the ISPOR-backed Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement [31] that proposes a checklist of 24 items, each with a corresponding recommendation. This checklist was produced using an approach consistent with that used for producing the CONSORT statement for reporting randomised controlled trials (RCTs) (www.consort-statement.org), which has achieved widespread recognition and acceptance [32,33]. The aim of this report was to enhance the interpretability of comparative effectiveness research in osteoarthritis, by proposing a reference case scenario for each of the main manifestations of the disease (the hand, knee and hip).

    • The prevalence of infections and patient risk factors in home health care: A systematic review

      2014, American Journal of Infection Control
      Citation Excerpt :

      Our systematic review was guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.17 PRISMA is a 27-item checklist that is used to improve the reporting of systematic reviews and meta-analyses and has been endorsed by major biomedical journals for publication of systematic reviews.18 A comprehensive search of the literature was conducted independently by 2 reviewers (JS and CM).

    • Reporting quality of abstracts of randomized controlled trials published in leading orthodontic journals from 2006 to 2011

      2012, American Journal of Orthodontics and Dentofacial Orthopedics
      Citation Excerpt :

      This pattern indicates a lack of awareness of the accepted guidelines for abstract reporting of RCTs. Consequently, although general adoption of these guidelines by particular journals might not occur, it would be helpful if journal editors could as a minimum raise the awareness of these guidelines,18 as has previously been undertaken for other reporting guidelines.8 The quality of reporting of abstracts of RCTs in orthodontic journals needs improvement.

    View all citing articles on Scopus
    View full text