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Guideline for the Prevention and Control of Norovirus Gastroenteritis Outbreaks in Healthcare Settings, 2011

Appendix 3: Data Extraction Tool

Author, Yr (Reference)

Study Design

Study Objective

Population and Setting

Power and Sample Size

N

Results

Outcome definitions

Other comments

Relevant Questions: ( √ all that apply)

Question 1:    Question 2:    Question 3:    Question 4:    Question 5:

Quality Assessment

1. Systematic review

  • Search terms described
  • Databases searched described and two or more databases searched
  • Inclusion/exclusion criteria described
  • Number of included/excluded studies along with reasons of exclusion described
  • Studies screened by two independent reviewers for inclusion
  • Data extracted by two independent reviewers
  • Individual study quality assessed
  • Heterogeneity between study results assessed qualitatively and/or quantitatively
  • Publication bias assessed

2. Randomized controlled trial

  • Described as randomized
  • Randomization appropriately performed (e.g. random number table, computerized scheme)
  • Described as double-blind
  • Outcome assessor blinded
  • Study participant blinded (e.g. interventions identical in appearance)
  • Investigator blinded (e.g. opaque sealed envelopes)
  • Attrition described
  • Attrition smaller than 10-15% of assigned patients
  • Attrition appropriately analyzed (e.g. intention to treat analysis)

3. Prospective/retrospective controlled or pre-post studies

  • All study groups derived from similar source/reference populations
  • Attrition not significantly different across study groups
  • The measure of exposure is valid
  • The measure of outcome is valid
  • Investigators blinded to endpoint assessment
  • Potential confounders identified
  • Statistical adjustment for potential confounders done

4. Descriptive Study

  • Valid selection of study sample (consecutive or randomly selected subjects)
  • Criteria for inclusion/exclusion clearly stated
  • Outcomes measured in a valid manner
  • Effect estimates presented (e.g. proportions)

5. Diagnostic study

  • Valid selection of study sample (consecutive or randomly selected subjects)
  • Valid reference standard
  • Diagnostic test and reference standard performed independently in each subject
  • Diagnostic test and reference standard evaluated independently on each subject (blinding)

6. Economic evaluation

  • Perspective defined (e.g. societal, payer, provider)
  • Time horizon defined Decision tree(s) or rule(s) explicit
  • Sources of cost estimates presented
  • Sources of event rate estimates presented
  • Sensitivity analyses performed

7. Basic science study

  • N/A

8. Please mention any other relevant quality considerations:

 
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