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Williams JW Jr, Cox CE, Hargett CW, et al. Noninvasive Positive-Pressure Ventilation (NPPV) for Acute Respiratory Failure [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Jul. (Comparative Effectiveness Reviews, No. 68.)

Appendix BEfficacy-Effectiveness Rating Form

Directions: For each article, rate the study along the seven dimensions listed. For each dimension, consider whether, on balance, the study is most consistent with the definition of efficacy or effectiveness. Make your best judgment, but if the article does not give adequate information to make a determination, choose “unclear.”

DimensionEfficacyEffectiveness
1. Setting

[ ] Unclear
Highly specialized setting for administering NPPV (e.g., specialized NPPV unit) or Tertiary care setting (referral population or Academic medical Center) or restricted to highly trained practitionersCommunity Hospitals without specialized NPPV units or specifies that practitioners do not have any special training
2. Eligibility criteria
[ ] Unclear
Convenience sample or sample selection criteria that excludes typical comorbidities (e.g., mild hemodynamic instability, chronic medical conditions, dysrhythmias, recent surgery) or those less likely to adhere to treatmentConsecutive patients; allows usual comorbidities and those less likely to be adherent
3. Health Outcomes
[ ] Unclear
Does not include mortality or health related quality of lifeIn the methods section, specifies mortality (in hospital or longer) or Health related quality of life outcomes
4. Study Duration/clinically relevant NPPV
[ ] Unclear
NPPV administration is fixed (e.g., given for pre-specified, inflexible duration), OR specific respirator settings not based on clinical response, OR outcomes are short-term only (e.g. ICU stay or shorter)Intervention given to clinical endpoints rather than pre-specified duration. NPPV administration is flexible and responds to clinical status. Outcomes are measured for full hospitalization or longer
5. Assessment of adverse events
[ ] Unclear
Report fewer than 2 of the following: discontinuation of NPPV due to intolerance, rates of infection, facial ulcerationsReports at least 2 of the following: discontinuation of NPPV due to intolerance, rates of infection, facial ulcerations
6. Adequate sample size for health outcomes
[ ] Unclear
Sample size not given for mortality or HRQOLSample size calculation given for mortality or minimum clinically important difference for HRQOL
7. ITT analysis
[ ] Unclear
Completers analysis or excludes those with protocol deviations.Follows intent-to-treat principle for analysis (includes all patients regardless of compliance, eligibility)
Cover of Noninvasive Positive-Pressure Ventilation (NPPV) for Acute Respiratory Failure
Noninvasive Positive-Pressure Ventilation (NPPV) for Acute Respiratory Failure [Internet].
Comparative Effectiveness Reviews, No. 68.
Williams JW Jr, Cox CE, Hargett CW, et al.

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