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Chou R, Carson S. Drug Class Review: Long-Acting Opioid Analgesics: Final Report Update 5 [Internet]. Portland (OR): Oregon Health & Science University; 2008 Apr.

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Drug Class Review: Long-Acting Opioid Analgesics

Drug Class Review: Long-Acting Opioid Analgesics: Final Report Update 5 [Internet].

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Appendix CQuality abstraction tool for adverse events of opioids

AuthorStudy_____
Year published
Citation
Setting (country, single or multicenter, specialty or primary care clinic)
INTERNAL VALIDITY
Selection: 1: Study states “all patients” or “consecutive series” during specified time period (observational study) or describes and accounts for all patients deemed eligible (clinical trial) and has explicit inclusion and exclusion criteria applied to all eligible patients (all study types)
0: Selection not clear, biased selection, inclusion and exclusion criteria not specified, or unable to determine proportion of patients eligible for trial who withdrew or were not entered
Loss to follow-up: 1: Low overall and differential loss to follow-up (<15% of study population or <25% difference between groups), able to compute adverse effects according to intention-to-treat if low loss to followup
0: High overall or differential loss to follow-up (>15% overall or >25% difference between groups), or unable to calculate intention-to-treat if low loss to follow-up
Adverse events pre-specified and pre-defined: 1: Study reports definitions used for assessed adverse events in an explicit, reproducible fashion
0: Study does not meet above criteria
Ascertainment techniques adequately described: 1: Study reports methods used to ascertain complications, including who ascertained, timing, and methods used
0: Study does not meet above criteria
Non-biased and accurate ascertainment of adverse events: 1: Patients and assessors blinded to intervention and ascertainment techniques go beyond patient self-report alone
0: Study does not meet above criteria
Statistical analysis of potential confounders: 1: Study examines more than 2 relevant confounders/risk factors using standard acceptable statistical techniques
0: Study does not meet above criteria
Adequate duration of follow-up: 1: Study reports duration of follow-up and duration at least 7 days
0: Study does not meet above criteria
Internal validity score (0–7)
EXTERNAL VALIDITY
Adequate description of study population: 1: Study reports 2 or more demographic characteristics and both basic clinical characteristics of pain syndrome and average duration of pain
0: Study does not meet above criteria
Does study report numbers screened and eligible (trial) or inception cohort (observational study)?
Are exclusion criteria specified and numbers excluded for each criteria reported?
Who is the funding source?
Are authors employed by the funding source?
Are data held by the funding source?
Are patients in the study on opioids prior to study entry?
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.
Bookshelf ID: NBK10651
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