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Ana Marusic - MedicReS World Congress 2011

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Reporting Guidelines - Good Reporting

Reporting Guidelines - Good Reporting

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  • 1. Good reporting guidelines Ana Marušić Croatian Medical Journal ana.marusic@mefst.hr
  • 2. Presenting data Example (MJA 2004;180:128-130): Four treatments were tested against placebo in clinical trials for about 5 years. In no trial were there major side effects of the treatments. The results were reported as follows: Trial A; 91.8% in the group allocated to the active treatment survived, compared with 88.5% in the placebo group. Trial B; Patients allocated to the active treatment had a 30% reduction in the risk of death. Trial C; Mortality was reduced by 3.4% in the group allocated to the active treatment. Trial D; One death was avoided for every 30 patients treated. On the basis of these reports, and assuming all treatment costs are modest, which treatments would seem reasonable to introduce into your clinical practice?
  • 3. Presenting data Clinicians’ opinions:  more than 70% considered the active treatments in Trials B and D worth using in clinical practice; Trial B: Patients allocated to the active treatment had a 30% reduction in the risk of death. (most popular format to present results) Trial D: One death was avoided for every 30 patients treated  less than 20% considered the treatments in Trials A and C worthwhile; Trial A: 91.8% in the group allocated to the active treatment survived, compared with 88.5% in the placebo group Trial C: Mortality was reduced by 3.4% in the group allocated to the active treatment
  • 4. Presenting data The same trial: Trial A; 91.8% in the group allocated to the active treatment survived, compared with 88.5% in the placebo group. EVENT RATE (EER and CER) Trial B; Patients allocated to the active treatment had a 30% reduction in the risk of death. RRR Trial C; Mortality was reduced by 3.4% in the group allocated to the active treatment. ARR Trial D; One death was avoided for every 30 patients treated. NNT
  • 5. Presenting data Control Group Experimental group Event a b No event c d ER = event rate RR = risk reduction CER = a / (a + c) EER = b / (b + d) RRR = (CER – EER) / CER ARR = CER – EER NNT = 1 / ARR
  • 6. Ideal reporting of trial results  Numbers of events (ER) observed and numbers at risk in each comparator group separately  The absolute risk reduction/difference for each event type (ARR)  Relative risk (RR) or odds ratio (OR) for treatment effect  95% confidence interval (CI) for either absolute risk reduction or relative risk (or odds ratio)  2-sided P value for determining statistical significance of either absolute risk reduction or relative risk (or odds ratio)  Number needed to treat (NNT) and 95% CI and/or number needed to harm (NNH) and 95% CI  The minimum clinically worthwhile benefit of the intervention
  • 7. Tom Lang: Common statistical errors in scientific articles (EASE: Science Editors’ Handbook, 2003): Error 1: reporting group means for paired data without reporting within-pair changes Error 2: using descriptive statistics incorrectly Error 3: using SEM as a descriptive statistics Error 4: reporting only P values for results Error 5: not confirming that the assumptions of statistical tests were met Error 6: extrapolating results from a regression line beyond the range of data Error 7: not accounting for all data or all subjects Error 8: confusing the “unit of observation” when reporting or interpreting results Error 9: not defining “normal” Error 10: interpreting non-statistically significant results as “negative” when they are, in fact, inconclusive Error 11: reporting relative differences rather than absolute differences
  • 8. Enhancing the QUAlity and Transparency Of health Research - international initiative that seeks to enhance reliability of medical research literature by promoting transparent and accurate reporting of research studies.
  • 9. What are reporting guidelines? - statements that provide advice on how to report research methods and findings - usually in the form of a checklist, flow diagram or explicit text - specify a minimum set of items required for a clear and transparent account of a research study, reflecting in particular issues that might introduce bias into the research.
  • 10. “Our readers would be amazed to learn how often we have to remind authors to simply mention where and when their study was conducted.” Alfredo Morabia, Editor, Preventive Medicine
  • 11. What guidance is available for reporting research studies? - CONSORT(reporting of randomized controlled trials) - STARD (reporting of diagnostic accuracy studies) - STROBE (reporting of observational studies in epidemiology) - QUOROM, recently renamed PRISMA (reporting of systematic reviews) - MOOSE (reporting of meta-analyses of observational studies)
  • 12. Improving the reporting of Randomized Controlled Trials (RCTs): the CONSORT statement Consolidated Standards of Reporting Trials
  • 13. CONSORT: •early 1990s •2 groups of journal editors, trialists, and methodologists •independently published recommendations on the reporting of trials: A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group. JAMA. 1994;272:1926-31. 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;121:894-5.
  • 14. CONSORT: http://www.consort-statement.org The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration Douglas G. Altman, DSc; Kenneth F. Schulz, PhD; David Moher, MSc; Matthias Egger, MD; Frank Davidoff, MD; Diana Elbourne, PhD; Peter C. Gøtzsche, MD; and Thomas Lang, MA, for the CONSORT Group Ann Intern Med. 2001;134:663-694. Medical Journal of Australia: EBM series: TRIALS ON TRIAL, 2003 and 2004
  • 15. CONSORT: Why do we need it? Survey of RCTs published in 1994: •61% did not report allocation concealment. •growth of meta-analysis revealed serious problems with the reporting and (?design) of RCTs. •publications did not provide enough details to evaluate studies.
  • 16. CONSORT: •checklist of essential items that should be included in reports of RCTs • diagram for documenting the flow of participants through a trial
  • 17. CONSORT: checklist (22 items) PAPER SECTION and topic Item Description Reported on Page # TITLE & ABSTRACT 1 How participants were allocated to interventions (e.g., "random allocation", "randomized", or "randomly assigned"). INTRODUCTION Background 2 Scientific background and explanation of rationale. METHODS Participants 3 Eligibility criteria for participants and the settings and locations where the data were collected. Interventions 4 Precise details of the interventions intended for each group and how and when they were actually administered. Objectives 5 Specific objectives and hypotheses. Outcomes 6 Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors). Sample size 7 How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules.
  • 18. CONSORT: flow diagram Assessed for eligibility (n= ) Excluded (n= ) Not meeting inclusion criteria (n= ) Refused to participate (n= ) Other reasons (n= ) Analyzed (n= ) Excluded from analysis (n= ) Give reasons Lost to follow-up (n= ) Give reasons Discontinued intervention (n= ) Give reasons Allocated to intervention (n= ) Received allocated intervention (n= ) Did not receive allocated intervention (n= ) Give reasons Lost to follow-up (n= ) Give reasons Discontinued intervention (n= ) Give reasons Allocated to intervention (n= ) Received allocated intervention (n= ) Did not receive allocated intervention (n= ) Give reasons Analyzed (n= ) Excluded from analysis (n= ) Give reasons Allocation Analysis Follow-Up Enrollment Randomized?
  • 19. Improving the reporting of observational studies: the STROBE statement STrengthening the Reporting of OBservational studies in Epidemiology
  • 20. Clear reporting is particularly important for observational studies because: - they are vulnerable to bias and confounding - reporting is often incomplete - findings are often over-interpreted - findings often generate health scares STROBE:
  • 21. STROBE: www.strobe-statement.org Check list of 22 items, published in 2007. Restricted to cohort, case-control and cross- sectional studies. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7.
  • 22. STROBE: Item No Recommendation Page No Title and abstract 1 (a) Indicate the study’s design with a commonly used term in the title or the abstract (b) Provide in the abstract an informative and balanced summary of what was done and what was found Introduction Background/rationale 2 Explain the scientific background and rationale for the investigation being reported Objectives 3 State specific objectives, including any prespecified hypotheses Methods Study design 4 Present key elements of study design early in the paper Setting 5 Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection Participants 6 Give the eligibility criteria, and the sources and methods of selection of participants Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable Data sources/ measurement 8* For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group Bias 9 Describe any efforts to address potential sources of bias Study size 10 Explain how the study size was arrived at Checklist of items that should be included in reports of cross-sectional studies
  • 23. Using the CONSORT for Abstracts checklist: examples
  • 24. Before Text highlighted in blue signifies where items are reported from the CONSORT for Abstracts checklist BMJ. 2006;333(7580):1193.
  • 25. After Text highlighted in red signifies where items have been added from the CONSORT for Abstracts checklist BMJ. 2006;333(7580):1193.
  • 26. Before Text highlighted in blue signifies where items are reported from the CONSORT for Abstracts checklist Lancet. 2006;368(9552):2053-60.
  • 27. After Text highlighted in red signifies where items have been added from the CONSORT for Abstracts checklist Lancet. 2006;368(9552):2053-60.
  • 28. Implementing reporting standards: experience from a journal
  • 29. Results: Mean global composite scores increased from 72.2 pre-Guidelines to 80.1 post-Guidelines (P<0.0001). Scores increased in each subcategory: Methods, 71.9 to 78.6 (P<0.0001) Results, 77.2 to 83.0 (P=0.002) More than one treatment group, 40.0 to 70.6 (P=0.0003) Post-Guidelines implementation scores have increased over time.
  • 30. Thank you. ana.marusic@mefst.hr

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