Review or meta-analysis
- Submitted by:Neelima Deshpande - SPR O&G
- Institution:Birmingham Women's Hospital
- Date submitted:30th October 2002
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
yes, the review addresses the important question of how useful urodynamic testing is in clinical decision making and patient outcomes as well as cost effectiveness
2
Design
2.1
Is the study design suitable for the objectives?
Yes the study design seeks to find randomised or quasi randomised controlled trials which address the use of urodynamics as an intervention in the management of adult incontinent patients
2.2
Were the search methods used to locate relevant studies comprehensive?
Yes, the Cochrane trials group search strategy stipulated by the incontinence research group was used. Additionally a hand search of relevant articles was done and authors contacted for raw data.N
2.3
Was this the right sample to answer the objectives?
No. The studies which were chosen fulfilled the criteria originally laid down but did not answer the questions in entirety. The two papers identified were too different from each other to be able to combine them. In reality no meaningful conclusion about the use of urodynamics can be made on the basis of these studies.
2.4
Is the study large enough to achieve its objectives?
No. Both studies identified were underpowered and did not look at the objectives that the review set out to look at.
2.5
Were all the studies accounted for?
Yes there is a table accounting for the studies that were rejected from the final review and the reasons why.
2.6
Were all appropriate outcomes considered?
yes, all appropriate outcomes of using urodynamics as an intervention have been considered. The review did not attempt to test urodynamics as a test.
2.7
Has ethical approval been obtained if appropriate?
dont know
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
No there is no clarity about how decision making was meant to be measured and how it was to be compared across studies. The outcomes were defined but no definite quality of life measure was determined. A cost effectiveness analysis was not a part of either study that was included.
3.2
Were explicit methods used to determine which studies to include in the review?
yes, only randomised controlled or quasirandomised controlled trials were included in the review. Studies not looking at clinical decision making or patient outcomes were excluded. Studies comparing one type of urodynamics with another and including patient outcomes/ decision making were included.
3.3
Was the selection of primary studies re-producible and free from bias?
I think so
3.4
Was the methodologic quality of the primary studies assessed?
poor
3.5
Are the measurements valid?
dont know
3.6
Are the measurements reliable?
no
3.7
Are the measurements reproducible?
dont know
4
Presentation of results
4.1
Are the basic data adequately described?
yes
4.2
Were the differences between studies adequately described?
yes
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?
data not able to be pooled
5
Analysis
5.1
Were the results of primary studies combined appropriately?
not combined
5.2
Has a sensitivity analysis been performed?
no
5.3
Were all the important outcomes considered?
yes
5.4
Are the data suitable for analysis?
no
5.5
Are the methods appropriate to the data?
not done
5.6
Are any statistics correctly performed and interpreted?
not done
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
yes, however there is no mention of current recommendations and guidelines that are used. Urodynamics has been considered a gold standard and has never been tested as one. The reviewers recommend further larger trials comparing management based on urodynamic diagnosis and on clinical examination. The feasibility of such a trial will need in depth studying because of many predetermined notions and biases towards and against urodynamics by current users. The review fails to address the issue of quality of life in relation to the variety of diagnostic categories in male and female patients which lend themselves to a large variety of treatment options
6.2
Is the discussion biased?
yes, because it biases itself solely to the study objectives and fails to see the reasons why there are no good studies that can be included into the review. The question raised is a valid one and the discussion based on the evidence is not biased, but in the present climate the trials suggested may not be feasible or advisable.
7
Interpretation
7.1
Are the author's conclusions justified by the data?
yes, the data obtained by the author justify their conclusions
7.2
What level of evidence has this paper presented?
level 3
7.3
Does this paper help me to answer my problem?
not really
8
Implementation
8.1
Can any necessary change be implemented in practice?
no there can be no immediate changes in practice. Institution of a database of all patients attending a urodynamic clinic is essential to doing a regression analysis subsequently. It would be essential to keep data on changes in quality of life and objective measurement of cure following management of incontinence whether surgical or conservative.
8.2
What aids to implementation exist?
Forward urodynamic unit with research bent of mind. Clinicians prepared to see evidence as it is presented provided it is based on studies with good methodology. There is some element of bias depending upon who has written the paper and which unit it was published from.
8.3
What barriers to implementation exist?
Nursing staff view addtional paperwork as a burden. Objective pad testing for all patients not a viable option because of staffing and time commitments and patient load. No ready made database available to commence patient data input. Computer friendliness audit necessary before starting!