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Reporting Guidelines - Good Reporting
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Presenting dataExample (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?
Presenting dataClinicians’ 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
Presenting dataThe same trial:
Trial A; 91.8% in the group allocated to the active treatmentsurvived, 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
Presenting data
Control Group
Experimental group
Event a b
No event
c dER = event rateRR = risk reduction
CER = a / (a + c)
EER = b / (b + d)
RRR = (CER – EER) / CER
ARR = CER – EER
NNT = 1 / ARR
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
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 changesError 2: using descriptive statistics incorrectlyError 3: using SEM as a descriptive statisticsError 4: reporting only P values for resultsError 5: not confirming that the assumptions of statistical tests were metError 6: extrapolating results from a regression line beyond the range of dataError 7: not accounting for all data or all subjectsError 8: confusing the “unit of observation” when reporting or interpreting resultsError 9: not defining “normal”Error 10: interpreting non-statistically significant results as “negative” when they are, in fact, inconclusiveError 11: reporting relative differences rather than absolute differences
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.
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.
“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
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)
Improving the reporting of Randomized Controlled Trials
(RCTs):the CONSORT statement
Consolidated Standards of Reporting Trials
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.
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
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.
CONSORT:•checklist of essential items that should be included in reports of RCTs
• diagram for documenting the flow of participants through a trial
CONSORT: checklist (22 items)PAPER SECTION
and topicItem Description Reported
onPage #
TITLE & ABSTRACT 1 How participants were allocated to interventions (e.g., "random allocation", "randomized", or "randomly assigned").
INTRODUCTIONBackground
2 Scientific background and explanation of rationale.
METHODSParticipants
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.
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?
Improving the reporting of observational studies:
the STROBE statement
STrengthening the Reporting of OBservational studies in
Epidemiology
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:
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.
STROBE:
Item No Recommendation Page NoTitle 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
IntroductionBackground/rationale 2 Explain the scientific background and rationale for the investigation
being reportedObjectives 3 State specific objectives, including any prespecified hypotheses
MethodsStudy 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
Using the CONSORT forAbstracts checklist: examples
Before
Text highlighted in blue signifies where items are reported from the CONSORT for Abstracts checklist
BMJ. 2006;333(7580):1193.
After
Text highlighted in red signifies where items have been added from the CONSORT for Abstracts checklist
BMJ. 2006;333(7580):1193.
Before
Text highlighted in blue signifies where items are reported from the CONSORT for Abstracts checklist
Lancet. 2006;368(9552):2053-60.
After
Text highlighted in red signifies where items have been added from the CONSORT for Abstracts checklist
Lancet. 2006;368(9552):2053-60.
Implementing reporting standards: experience from a journal
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.
Thank [email protected]
