The ORION statement Guidelines for transparent reporting of

Document Sample
The ORION statement Guidelines for transparent reporting of Powered By Docstoc
					Making research & reporting better using the
  ORION statement to design or evaluate
 infection control intervention studies and
             outbreak reports

  Using the short “ORION Abstract” for conference and
          journal abstract submission & review

    Dr Sheldon Stone, Royal Free Campus, University
          College London Medical School, UK
      Professor Barry Cookson, HPA and LSHTM
               On behalf of ORION group
                       Session Goals:
This interactive session will :
1. Help you write a high quality conference/journal abstract
2. Provide you with a framework to help referee a conference
 3. Help you select the best papers/conference presentations to
     inform continuing professional development..
        what article to read?
        what conference oral/poster session to go to?
4. Give us feedback on how to improve the abstract tool (short
ORION) and how to teach it

5. Encourage you to study the full ORION statement for papers and
grant applications
            Meet the Expert Outline
1) Brief summary of ORION ~10minutes

2) We provide:

  • the ORION abstract checklist,
  • four Abstracts:
     o An antibiotic stewardship intervention
     o A Hand Hygiene trial
     o Two Outbreak Reports
                      Outline (2)
•   Working alone or with neighbours:

•   5 mins to read first abstract: Stone et al Age & Aging 1998
•   5 mins to assess with the ORION abstract check-list
•   5 mins individual feed-back by show of hands

• Repeat above for second abstract: P1381 ECCMID

• Repeat above for third abstract: Lopansri et al 2010

• Repeat if time for fourth abstract: Dror Marchaim et al 2010
                 The ORION statement:
                 Guidelines for transparent reporting of
   Outbreak Reports & Intervention studies Of Nosocomial Infection

A CONSORT equivalent for Infection Control

   Funded by Health Technology Assessement Board

Stone et al Lancet Infect Dis 2007; J Antimicrob Chemother 2007
           Co-authors & Collaborating Institutions
•   Ben Cooper Stats/Modelling
•   Chris Kibbler Microbiology
•   Jenny Roberts Health Economics Royal Free&University College Medical School
•   Graham Medley Modelling        Health Protection Agency, Colindale
•   GeorgiaDuckworth Public        London School Hygiene & Tropical Medicine
                         Health       Warwick University
• Rosalind Lai Library Sciences       Frenchay Hospital, Bristol
                                      UK Cochrane Centre, Oxford ;
• Shah Ebrahim Epidemiology,
                                      University of Dundee Medical School
• Erwin Brown Microbiology
• Phil Wiffen EBM
• Peter Davey Infectious Diseases
            Evidence Base for Infection Control Interventions
                  Davey et al Cochrane 2005;Cooper et al BMJ 2004

• Cochrane review of interventions to change antibiotic prescription &
  evaluate HCAI outcomes (2005) & HTA (2003) review isolation
  practices in MRSA show limited evidence of some effect but
  inadequate reporting & major flaws in design & statistical analysis

•   Lack of details eg on interventions & timings
•   Failure to assess & adjust for confounders/biases
•   Aggregation of outcomes (misses trends)
•   Analysis fails to account for dependencies of infectious outcomes

• Quality of infection control research must improve to provide robust
  evidence for policy & practice
            To summarise the problem…..
    Cooper B et al BMJ 2004, HTA 20003, Davey et al Cochrane
                    2005;Ramsay et al JAC 2003

• Studies conclude interventions cause  MRSA
  or antibiotic use or Clostridium difficile

• Validity of conclusions threatened by
  confounders & biases, unaccounted for in
  studies, which provide plausible alternative
  explanations of outcome and by inappropriate
  statistics e.g. aggregation of data (misses time
  trends) & assumption that infection outcomes
  are independent (Chi-Sq; OR)
The sort of problems: regression to mean, statistical

                      Nosocomial MRSA (infections?). ICU & 4
                              South ward combined.
                       Non-medicated soap     Low-iodine soap
% of patients

                      Aug Oct Dec Feb Apr Jun Aug Oct Dec Feb Apr Jun
                       1983               1984                     1985
                                            Onesko KM, Infection Control 1987
Interrupted time series
            AIM OF ORION Statement
        CONSORT equivalent for infection control studies

•   Improve standards research & publication
•   Transparency of reporting
•   Readers relate studies to their situation.
•   Facilitate synthesis of evidence
•   Framework for reviewers & editors to assess papers
•   Criteria research grant assessment panels

• Designed especially for Interrupted Time Series (with
  or without controls groups) and outbreak reports.
             Key issues addressed by ORION
Transparency: Why was the study done? (hypothesis)
                  What sort of study? (design)
                  Exactly what was done, to whom, when?

Analysis:        Disaggregated data
                 Account for dependencies

Inference:       How do findings relate to hypothesis?
                 What else influenced the findings?
                 Do findings generalise ?
              Components of ORION
                 Stone et al Lancet ID 2007;JAC
• adapted CONSORT statement        • 22 item checklist
  to the wide variety settings       Title
  interventions, designs &           Abstract
  statistical issues infection       Introduction
  control studies & outbreak         Methods
  reports                            Results
• Consultation with professional
  societies                        • Summary table
                                      Clinical setting
                                      Precise nature & timing of all

• Independent academic review
  in two journals                  • Graphical summary results
ORION exemplar paper….. .Fowler S et al JAC 2007
CONSORT journal & conference abstract checklist
                  Hopewell et al PLOS Med 2008
• ORION is a CONSORT equivalent for Infection Control and
  Antimicrobial Stewardship interventions & Outbreak Reports

• CONSORT for ABSRACTS : for submission & review of
  conference & journal abstracts of RCTs (same flaws as full articles)

• Aim to improve reporting of RCTs in journal abstracts & conference
  proceedings, giving readers the detail & clarity to assess validity &
  applicability of RCT and help them decide which full articles to
  read or conference presentations to attend

• ORION followed suit

• Used for SHEA Conference 2011
Title        1.Clear statement that this is an intervention study or outbreak report.

Background   2.Rationale for study with clear hypothesis for intervention studies or
             objective for outbreak reports

             3.Clear statement of intervention study design1 or case and outbreak
             definition for outbreak report.
             4.Brief description of participants, setting and of intervention or
             outbreak control measures (with start & stop dates)
             5. Clearly defined outcomes & denominators at regular time intervals2,
             not as totals for each phase
                                 (can be put in results instead)
             6. Statistical analysis accounts for any dependencies in the data (can
             be in results instead) ( analysis may not be appropriate for OR)
                ABSTRACT CHECKLIST (cont)
Methods         7. Which potential confounders or biases were considered, recorded or
(cont)          adjusted for3 (can be in results instead)

                8. Where relevant: details of culture, typing, environmental sampling,
                & risk factors for acquisition, root cause analysis or organisational risk

Results-         9. For main outcomes: estimated effect size & its precision (usually 95%

                (A graphical summary is often appropriate eg for most time series).
Conclusions 10. For intervention studies: consider in relation to original hypothesis,
                accounting for potential confounders & biases.

                For outbreak reports: consider clinical significance of observations &
                hypothesis to explain them.
                       Stone et al abstract
•   Title- not explicit that intervention   •   Statistical analysis:
    study β                                      fail to account for dependencies β
                                                (segmental regression for AB &
•   Background- rationale but no clear          Poisson for CDI)
    hypothesis β                            •   Confounders/bias
•   Methods-                                    - no mention β
    design: not stated β                    •   Culture, typing etc
•   Brief description                           - N/R
    of intervention but not setting,
    participants or dates β                 •   Results-
                                                no estimated size effect &
                                                precision, no graphical summary β
•   Outcomes-
    (I) no regular time intervals ie not
    disaggregated β                         •   Conclusions-
    (ii) clear CDI outcomes but not AB          no original hypothesis …. β
       P1381 Feedback Intervention Trial
            (poster this afternoon)
•   Title-                                   •   Statistical analysis:
    RCT α                                        accounts for dependencies α

•   Background-                              •   Confounders/bias
    rationale but no explicit hypothesis         - mentioned & accounted for α
                                             •   Culture, typing etc- N/R
•    Methods-
     -design: clear α                        •   Results-
     -setting, participants, intervention,       estimated size effect &
     dates α                                     precision, graphical summary α
•       Outcomes-
    - clear primary & secondaryα             •   Conclusions-
     -regular time points (monthly- fig)         no explicit hypothesis but
     α                                           accounted for confounders
     - clear denominators α                      (implementation) …. +
                               Outbreak abstract 1
                         Lopansri et al HPA SHEA 2010
•    Title: outbreak report α                       • Methods (cont)-

                                                           -Risk factors analysed but are there
                                                        others that should be mentioned as not
•    Background: rationale and objectives α             having been present +
                                                        More details on micro/strain?
                                                        Information on C&S from samples from
•    Methods-                                           flash sterilised equipment?
    -case definition α
    -no outbreak definition                        • Results-
    -hospital setting & outbreak control                -OK but graph might have been helpfulα-
     measures but not ward briefly described
     but little detail on participants +

                                                    •    Conclusions-
    - start & stop dates for original index cases
      but not for whole study +                        - Clinical significance observation &
                                                         explanatory hypothesis α
    - outcomes & stat analysis : NRα
                                 Outbreak abstract 2
                          Marchaim D et al SHEA 2010
•    Title: outbreak in titleα                   • Methods (cont)-
                                                     - stats:NRα
                                                      -Confounders:NR α
•    Background: rationale and objectiveα
                                                     -Cultures etc : other risk factors (eg
                                                     patients characteristics, environmental
•     Methods-                                       contamination) not mentioned 
     -clear case definitionα
     -participants settings & outbreak control   • Results-
      measures not described  but LOS, age,         -chart would have been useful 
      mortality given                                 -colistin agrregated 
    - start & stop dates of outbreak given but
      not of study +
                                                 •    Conclusions-
    - outcomes: chart would have been useful
      especially as shared wards presented as        - Significance not stated. No hypothesis
      important                                      generated. Effect of control measures
                                                      stated with no evidence
                        Reflections 1
•    Has the session achieved its original aims?
    1. Helping you write high quality conference or journal
    2. Providing you with a framework to help referee a
    conference abstract
    3. Helping inform your CPD with a tool to help select
       -which full articles to read
       -which conference sessions to hear

• Was this appropriate for a “meet the expert” session?

• Tool and meet the expert session materials is on website
                    Reflections 2
• Did ORION for abstracts work for intervention studies?
• Did ORION for abstracts work in outbreak reports?

• Does it need an explanatory document like CONSORT
  with examples of compliant & non compliant practice

• Does it need more slightly more submission space for
  journals (2500 characters works for conferences)
• What doesn’t the checklist cover?
• What would make it better?
       Thank you

Comments & suggestions to

Shared By: