Randomised control trial
Thomas G. Costantino, Aman K. Parikh, Wayne A. Satz, John P. FojtikULTRASONOGRAPHY-GUIDED PERIPHERAL INTRAVENOUS ACCESS VERSUS TRADITIONAL APPROACHES IN PATIENTS WITH DIFFICULT INTRAVENOUS ACCESS
ANNALS OF EMERGENCY MEDICINE
NOVEMBER 2005; VOLUME 46, NO.5, PAGES 456
- Submitted by:Lucas Leete - physician
- Institution:Michigan State University/MERC
- Date submitted:14th March 2006
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
YES, SUCCESS OF PERIPHERAL ACCESS IN DIFFICULT-ACCESS PATIENTS, USING ULTRASOUND VS TRADITIONAL TECHNIQUES.
2
Design
2.1
Is the study design suitable for the objectives
YES
2.2
Who / what was studied?
ULTRASOUND VS BLIND (E.M. PHYSICIANS) IV PERIPHERAL ACCESS IN PATIENTS THAT HAD 3 FAILED ATTEMPTS BY NURSES.
2.3
Was this the right sample to answer the objectives?
YES
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
-NO, A LARGER NUMBER OF PARTICIPANTS WOULD IMPROVE THE STUDY
-NO
-NO
2.5
Were all subjects accounted for?
YES
2.6
Were all appropriate outcomes considered?
YES, MAY BENEFIT FROM FOLLOW UP
2.7
Has ethical approval been obtained if appropriate?
YES
2.8
Were the patients randomised between treatments?
PATIENTS ALLOCATED EVEN/ODD. POSSIBLE "DAY" SELECTION BIAS
2.9
How was randomisation carried out?
EVEN/ODD DAY ALLOCATION
EVEN DAYS=BLIND ATTEMPTS
ODD DAYS=ULTRASOUND TECHNIQUE
EVEN DAYS=BLIND ATTEMPTS
ODD DAYS=ULTRASOUND TECHNIQUE
2.10
Are the outcomes clinically relevant?
YES, ENDPOINTS WERE SUCCESSFUL, 1) CANNULATION, 2) NUMBER OF STICKS, 3) TIME 4) PATIENT SATISFACTION.
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
YES
3.2
Are the measurements valid?
YES
3.3
Are the measurements reliable?
YES
3.4
Are the measurements reproducible?
YES
3.5
Were the patients and the investigators blinded?
NO
4
Presentation of results
4.1
Are the basic data adequately described?
YES
4.2
Were groups comparable at baseline?
YES (TABLE)
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
YES
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
YES
4.5
Were side effects reported?
YES=IMMEDIATE COMPLICATIONS
5
Analysis
5.1
Are the data suitable for analysis?
YES
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
6.2
Is the discussion biased?
YES, LIKELY SELECTION BIAS OCCURRED
7
Interpretation
7.1
Are the authors' conclusions justified by the data?
YES, AS A PILOT STUDY, A FOLLOW UP STUDY SHOULD BE SOUGHT WITH LARGER NUMBERS OF PATIENTS.
7.2
What level of evidence has this paper presented? (using CEBM levels)
2B
7.3
Does this paper help me answer my problem?
YES
8
Implementation
8.1
Can any necessary change be implemented in practice?
IT PROVOKES INTEREST, LARGER STUDIES REQUIRED TO CHANGE PRACTICE ON LARGE SCALE.
8.2
What aids to implementation exist?
DECREASE PATIENT MORBIDITY
DECREASE TIME
DECREASE TIME
8.3
What barriers to implementation exist?
SMALL STUDY
LEARNING CURVE FOR ULTRASOUND
EXPENSIVE EQUIPMENT NEEDED (ULTRASOUND), NOT AVAILABLE AT MANY PROGRAMS
LEARNING CURVE FOR ULTRASOUND
EXPENSIVE EQUIPMENT NEEDED (ULTRASOUND), NOT AVAILABLE AT MANY PROGRAMS