Survey (including pre-test probabilities)
Vanek T, Straka Z, Hrabak J, Jares M, Brucek PJ, Votava J.Use of recombinant activated factor VII in cardiac surgery for an effective treatment of severe intractable bleeding.
Jpn Heart J
2004; 45:855–860.
- Submitted by:Jenifer Barrie - Student
- Institution:University of Manchester
- Date submitted:17th July 2005
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes, in the abstract.
2
Design
2.1
Is the study design suitable for the objectives
Yes, retrospective review of presumed opiate overdoses by ambulance staff.
2.2
Who / what was studied?
726 patients with presumed opiate overdoses. All patients administered naloxone were reviewed.
2.3
Was this the right sample to answer the objectives?
yes, however there was no toxicological diagnosis of opiate overdose.
2.4
Did the subject represent the full spectrum of the population of interest?
yes
2.5
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
No mention of sample size estimates.
2.6
Were all subjects accounted for?
Yes.
2.7
Were all appropriate outcomes considered?
Yes, hospital admission and death were considered however there was no mention of follow up or adverse effects of naloxone.
2.8
Has ethical approval been obtained if appropriate?
No mention of consent for using patients records.
2.9
What measures were made to contact non-responders?
No non responders as notes were reviewed.
2.10
What was the response rate?
see above
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
Yes all variables measured listed in the measurements section.
3.2
Are the measurements valid?
yes
3.3
Are the measurements reliable?
yes as long as paramedics wrote notes out accurately.
3.4
Are the measurements reproducible?
yes
4
Presentation of results
4.1
Are the basic data adequately described?
Yes demographics were described as basic numbers and percentages.
4.2
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
Yes tables one shows outcomes for all patients, table two describes characteristics of the sample, three other tables show clinical characteristics and treatment.
4.3
Are the results internally consistent, i.e. do the numbers add up properly?
Yes all numbers in tables add up.
5
Analysis
5.1
Are the data suitable for analysis?
yes chi squared test was performed to compare IV vs IM naloxone.
5.2
Are the methods appropriate to the data?
yes
5.3
Are any statistics correctly performed and interpreted?
YES
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
Yes the study is compared to other studies.
6.2
Is the discussion biased?
no
6.3
Can the results be generalised?
yes
7
Interpretation
7.1
Are the authors' conclusions justified by the data?
Yes, it was found that the majority of patients with opiod overdoses who have pulses and BPs are easily resuscitated.
7.2
What level of evidence has this paper presented? (using CEBM levels)
Level 3
7.3
Does this paper help me answer my problem?
Not directly however it does demonstrate that patients can respond to naloxone when they haven't had an opiate overdose. The circumstances or diagnoses are not stated.
8
Implementation
8.1
Can any necessary change be implemented in practice?
No but more study is recommended to investigate clinical outcomes in opiate overdose.
8.2
What aids to implementation exist?
Doing a study with a prospective rather than a retrospective design would be more accurate.
8.3
What barriers to implementation exist?