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Reporting guidelines

Iveta Simera

The EQUATOR NetworkCentre for Statistics in Medicine, Oxford, UK

November 2014

• This is where you are when you finish your research project

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How do you turn all

this into a well

reported paper?

What to include?

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Trying to submit to a journal

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If you are a diligent author – I to A

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Reporting guidelines

• Focus on scientific content of the article

– Complement journals’ instructions to authors

• Definition:

– Specify a minimum set of items required for a clear and transparent account of what was done and what was found in a research study, reflecting in particular issues that might introduce bias into the research

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Good (clear) reporting

Sequence generation:

• “Independent pharmacists dispensed either active or placebo inhalers according to a computer generated randomization list.”

• ... The randomization code was developed using a computer random number generator to select random permuted blocks. The block lengths were 4, 8, and 10 varied randomly ...”

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Unclear reporting

“Patients were assigned to either the intervention or control group, by selection of a card from a pile of equal numbers of cards for each group.”

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Clear reporting but poor methodology

“Randomization was alternated every 10 patients, such that the first 10 patients were assigned to early atropine and the next 10 to the regular protocol, etc. To avoid possible bias, the last 10 were also assigned to early atropine.”

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Example: bad

• Nowhere in the paper any mention of the review methodology!

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Example: better

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Example: good

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Reporting guidelines

• ‘Reminders’ of scientific content

– Methodology

– Clinical / Research related focus

• Form:

– structured advice, often as a checklist

perhaps also a flow diagram

• Most internationally accepted RGs

– Based on evidence

– Consensus of relevant stakeholders (multidisciplinary group)

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Typical research (study designs)

• Randomised trials

• Cohort studies

• Cross-sectional studies

• Case-control studies

• Case reports

• Qualitative research

• Research synthesis

(systematic reviews)

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Typical research (study designs)

• Randomised trials CONSORT

• Cohort studies

• Cross-sectional studies STROBE

• Case-control studies

• Case reports CARE

• Qualitative research COREQ

• Research synthesis PRISMA (systematic reviews) ENTREQ

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Types of studies by research questions / focus

• Treatment evaluations - RCTs

• Disease aetiology, harms, .. - Observational studies

• Prognostic studies

• Diagnostic studies

• Experiences, views, .. – Qualitative studies

• Quality improvement studies

• Economic evaluations

• Patients’ involvement in research

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Types of studies by research questions / focus

Generic guideline for each of these types of studies:

• Treatment evaluations – RCTs CONSORT

• Disease aetiology, harms, .. - Observational studies

STROBE

• Prognostic studies [TRIPOD]

• Diagnostic studies STARD

• Experiences, .. – Qualitative studies COREQ

• Quality improvement studies SQUIRE

• Economic evaluations CHEERS

• Patients’ involvement in research GRIPP

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Best place to find reporting guidelines

• Lot of help for writing up your research available here: www.equator-network.org

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A

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Lot of acronyms to remember

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CONSORT

GRIPP

STROBE

CARETRIPOD

CHEERS

PRISMA

Use the best possible tools

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Reporting observational studies- STROBE Statement

• Checklist with 22 items

– Recommendation, divided into: cohort, case-control, cross-sectional study - where different

Reporting RCTs - CONSORT

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Reporting systematic reviews -PRISMA 2009

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Preferred Reporting Items for Systematic Reviews and Meta-Analyses (2009)

27-item checklist, flow diagram

Learn about reporting requirements early

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Design Conduct Publication

They help here

.. But you have to know them here

So how well do other people write?

Acupressure paper

• Look at CONSORT

• Read the paper

(focus on methods)

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