A history of the evolution of guidelines for reporting medical research: the long road to the EQUATOR Network

Testing medical treatments and other interventions aimed at improving people’s health is incredibly important. However, comparative studies need to be well designed, well conducted, appropriately analysed and responsibly interpreted. Sadly, not all available findings and ‘discoveries’ are based on reliable research. Our beliefs about best practices for medical research developed massively over the 20th century and ideas and methods continue to evolve. Much, perhaps most, medical research is done by individuals for whom it is not their main sphere of activity; notably, clinicians are expected to conduct some research early in their careers. As such, it is perhaps not surprising that there have been consistent comments on the poor quality of research and also recurrent attempts to raise understanding of how to do research well. More recently, and increasingly over the last 20 years, concerns about poor methodology1 have been augmented by growing concerns about the inadequacy of reporting in published journal articles.2

[1]  David Moher,et al.  CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. , 2016, Journal of clinical epidemiology.

[2]  Douglas G Altman,et al.  Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial , 2015, BMC Medicine.

[3]  K. Dickersin,et al.  Thomas C Chalmers (1917–1995): a pioneer of randomised clinical trials and systematic reviews , 2015, Journal of the Royal Society of Medicine.

[4]  Lotty Hooft,et al.  Reporting diagnostic accuracy studies: some improvements after 10 years of STARD. , 2015, Radiology.

[5]  D. Moher,et al.  Side effects are incompletely reported among systematic reviews in gastroenterology. , 2015, Journal of clinical epidemiology.

[6]  Gary S Collins,et al.  Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD): Explanation and Elaboration , 2015, Annals of Internal Medicine.

[7]  James Hartley,et al.  Current findings from research on structured abstracts: an update. , 2014, Journal of the Medical Library Association : JMLA.

[8]  Gary S Collins,et al.  Impact of peer review on reports of randomised trials published in open peer review journals: retrospective before and after study , 2014, BMJ : British Medical Journal.

[9]  David Moher,et al.  Relation of completeness of reporting of health research to journals’ endorsement of reporting guidelines: systematic review , 2014, BMJ : British Medical Journal.

[10]  M. Clarke,et al.  Many reports of randomised trials still don’t begin or end with a systematic review of the relevant evidence , 2013 .

[11]  R. Prescott,et al.  Lies, damn lies and statistics: errors and omission in papers submitted to INJURY 2010-2012. , 2013, Injury.

[12]  David Moher,et al.  Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane reviewa , 2012, Systematic Reviews.

[13]  J. Achten,et al.  An evaluation of the quality of statistical design and analysis of published medical research: results from a systematic survey of general orthopaedic journals , 2012, BMC Medical Research Methodology.

[14]  S. Pocock,et al.  Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. , 2006, JAMA.

[15]  G. Piaggio,et al.  Consort 2010 statement: extension to cluster randomised trials , 2012, BMJ : British Medical Journal.

[16]  Gary S Collins,et al.  Reporting of participant flow diagrams in published reports of randomized trials , 2011, Trials.

[17]  E. Wagenmakers,et al.  Erroneous analyses of interactions in neuroscience: a problem of significance , 2011, Nature Neuroscience.

[18]  Iveta Simera,et al.  Describing reporting guidelines for health research: a systematic review. , 2011, Journal of clinical epidemiology.

[19]  Sally Hopewell,et al.  Reviews assessing the quality or the reporting of randomized controlled trials are increasing over time but raised questions about how quality is assessed. , 2011, Journal of clinical epidemiology.

[20]  I. Cuthill,et al.  Reporting : The ARRIVE Guidelines for Reporting Animal Research , 2010 .

[21]  D. Moher,et al.  CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials , 2011, BMJ : British Medical Journal.

[22]  J. Sargeant,et al.  The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration † , 2010, Journal of food protection.

[23]  D. Moher,et al.  CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials , 2010, Journal of pharmacology & pharmacotherapeutics.

[24]  D. Moher,et al.  Guidance for Developers of Health Research Reporting Guidelines , 2010, PLoS medicine.

[25]  D. Altman,et al.  ACP Journal Club. Editorial: Writing a research article that is "fit for purpose": EQUATOR Network and reporting guidelines. , 2009, Annals of internal medicine.

[26]  J. Ioannidis,et al.  The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration , 2009, BMJ : British Medical Journal.

[27]  Carl Heneghan,et al.  What is missing from descriptions of treatment in trials and reviews? , 2008, BMJ : British Medical Journal.

[28]  D. Moher,et al.  Guidelines for Reporting Health Research: The EQUATOR Network's Survey of Guideline Authors , 2008, PLoS medicine.

[29]  D. Moher,et al.  CONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration , 2008, PLoS medicine.

[30]  T. Wachs,et al.  CONSORT for reporting randomised trials in journal and conference abstracts , 2008 .

[31]  S. Pocock,et al.  Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration , 2007, PLoS medicine.

[32]  D. Moher,et al.  Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review , 2006, The Medical journal of Australia.

[33]  W. Sauerbrei,et al.  REporting recommendations for tumor MARKer prognostic studies (REMARK) , 2006, Breast Cancer Research and Treatment.

[34]  Dietmar Pfahl,et al.  Reporting guidelines for controlled experiments in software engineering , 2005, 2005 International Symposium on Empirical Software Engineering, 2005..

[35]  B. Glick Inadequacies in the reporting of clinical drug research , 1963, Psychiatric Quarterly.

[36]  J. Ioannidis,et al.  Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement , 2004, Annals of Internal Medicine.

[37]  V. McCormack,et al.  Issues in the reporting of epidemiological studies: a survey of recent practice , 2004, BMJ : British Medical Journal.

[38]  A. Walker,et al.  Improving the quality of reporting in randomised controlled trials. , 2004, Journal of wound care.

[39]  Douglas G. Altman,et al.  The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials , 2001, The Lancet.

[40]  David Moher,et al.  The STARD Statement for Reporting Studies of Diagnostic Accuracy: Explanation and Elaboration , 2003, Annals of Internal Medicine [serial online].

[41]  Douglas G Altman,et al.  Systematic reviews in health care: Assessing the quality of controlled clinical trials. , 2001, BMJ.

[42]  D. Moher,et al.  The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration , 2001, Annals of Internal Medicine.

[43]  I. Olkin,et al.  Improving the Quality of Reports of Meta-Analyses of Randomised Controlled Trials: The QUOROM Statement , 2000, Oncology Research and Treatment.

[44]  I. Olkin,et al.  Meta-analysis of observational studies in epidemiology - A proposal for reporting , 2000 .

[45]  I. Olkin,et al.  Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement , 1999, The Lancet.

[46]  I Chalmers,et al.  Discussion sections in reports of controlled trials published in general medical journals: islands in search of continents? , 1998, JAMA.

[47]  S Dunn,et al.  Cargo cult science. , 1996, Oral surgery, oral medicine, oral pathology, oral radiology, and endodontics.

[48]  I. Olkin,et al.  Improving the quality of reporting of randomized controlled trials. The CONSORT statement. , 1996, JAMA.

[49]  M. Gardner,et al.  More informative abstracts revisited. , 1990, The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association.

[50]  D. Rennie Reporting randomized controlled trials. An experiment and a call for responses from readers. , 1995, JAMA.

[51]  Curtis L. Meinert,et al.  A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group. , 1994, JAMA.

[52]  D G Altman,et al.  The scandal of poor medical research , 1994, BMJ.

[53]  L. Israels,et al.  Combined modality therapy of Hodgkin's disease: 10-year results of National Cancer Institute of Canada Clinical Trials Group multicenter clinical trial. , 1991, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[54]  B. Squires,et al.  Reports of randomized controlled trials: what editors want from authors and peer reviewers. , 1990, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[55]  D. G. Altman,et al.  Randomisation and baseline comparisons in clinical trials , 1990, The Lancet.

[56]  J. Ellenberg Biostatistical collaboration in medical research. , 1990, Biometrics.

[57]  M. Zelen The reporting of clinical trials: counting is not easy. , 1989, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[58]  A. Grant,et al.  Reporting controlled trials , 1989, British journal of obstetrics and gynaecology.

[59]  P. Gøtzsche Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. , 1989, Controlled clinical trials.

[60]  S. Pocock,et al.  Statistical problems in the reporting of clinical trials. A survey of three medical journals. , 1987, The New England journal of medicine.

[61]  F. Gutzwiller,et al.  A proposal for more informative abstracts of clinical articles. Ad Hoc Working Group for Critical Appraisal of the Medical Literature. , 1987, Annals of internal medicine.

[62]  A Liberati,et al.  A quality assessment of randomized control trials of primary treatment of breast cancer. , 1986, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[63]  C. Meinert,et al.  Content of reports on clinical trials: a critical review. , 1984, Controlled clinical trials.

[64]  S G Mize,et al.  An Evaluation of the Quality of Therapeutic Studies in Perinatal Medicine , 1983, The Journal of pediatrics.

[65]  Frederick Mosteller,et al.  Reporting on methods in clinical trials. , 1982, The New England journal of medicine.

[66]  T. Colton,et al.  Should there be statistical guidelines for medical research papers? , 1978, Biometrics.

[67]  D. Laskin The problems of publication. , 1977, Journal of oral surgery.

[68]  A R Feinstein,et al.  XXV. A survey of the statistical procedures in general medical journals , 1974, Clinical pharmacology and therapeutics.

[69]  D. Mainland Some research terms for beginners: definitions, comments, and examples. I. , 1969, Clinical pharmacology and therapeutics.

[70]  S. Schor,et al.  Statistical evaluation of medical journal manuscripts. , 1966, JAMA.

[71]  A. P. Shapiro,et al.  The clinical evaluation of new drugs , 1960 .

[72]  H. L. Dunn What high-level wellness means. , 1959, Canadian journal of public health = Revue canadienne de sante publique.

[73]  S. Ross,et al.  RECOMMENDATIONS for reporting studies of psychiatric drugs. , 1957, Public health reports.

[74]  D. Mainland,et al.  Elementary Medical Statistics. The Principles of Quantitative Medicine. , 1952 .

[75]  O B ROSS,et al.  Use of controls in medical research. , 1951, Journal of the American Medical Association.

[76]  L. Hogben,et al.  Chance and choice by cardpack and chessboard , 1950 .

[77]  M. Daniels Scientific appraisement of new drugs in tuberculosis. , 1950, American review of tuberculosis.

[78]  J. Berkson The Treatment of Clinical and Laboratory Data , 1939 .

[79]  D. Mainland CHANCE AND THE BLOOD COUNT. , 1934, Canadian Medical Association journal.

[80]  B. Hart WHAT IS WRONG WITH THE MEDICAL CURRICULUM , 1932 .

[81]  H. L. Dunn,et al.  APPLICATION OF STATISTICAL METHODS IN PHYSIOLOGY , 1929 .

[82]  R. Pearl A STATISTICAL DISCUSSION OF THE RELATIVE EFFICACY OF DIFFERENT METHODS OF TREATING PNEUMONIA , 1919 .

[83]  T. Sollmann THE CRUCIAL TEST OF THERAPEUTIC EVIDENCE , 1917 .