Best Evidence Topics

Randomised control trial

Vaiva, G; Ducrocq, F; Meyer, P; et al
Effect of telephone contact on further suicide attempts in patients discharged from an emergency department: randomised controlled study
  • Submitted by:Craig Ferguson - SPR
  • Institution:Salford Royal Foundation Trust
  • Date submitted:2nd June 2006
Before CA, i rated this paper: 6/10
1 Objectives and hypotheses
1.1 Are the objectives of the study clearly stated?
  Not mentioned in introduction but in abstract states that the objective was to determine the effects of phoning patients 1 month or 3 months after attendance for deliberate self poisoning compared to no contact after discharge over the period of one year.
2 Design
2.1 Is the study design suitable for the objectives
  Yes, although it excludes a lot of patients who may be at higher risk.
2.2 Who / what was studied?
  Adult patients who attended one of 13 emergency departments following a deliberate drug overdose. Excluded homeless patients, patients without GPs, patients without telephones, patients who discharged themselves. Schizophrenia also appears to have been an exclusion criteria. Patients only recruited day-time and weekdays.
2.3 Was this the right sample to answer the objectives?
  Should be reproducible selected group.
2.4 Is the study large enough to achieve its objectives? Have sample size estimates been performed?
  Not clear how they decided that 400 patients would provide significant results. Do not clarify how much of a difference in outcome was expected and what the primary outcomes of the study were to be.
2.5 Were all subjects accounted for?
  I think so. Do provide data on drop-out rate and analyse on intention-to-treat basis.
2.6 Were all appropriate outcomes considered?
  Consider suicide, attempted suicide and lost to follow up as adverse events.
2.7 Has ethical approval been obtained if appropriate?
2.8 Were the patients randomised between treatments?
2.9 How was randomisation carried out?
  Number in opaque envelope. Randomised in blocks of 8 in a 2:2:4 basis.
2.10 Are the outcomes clinically relevant?
3 Measurement and observation
3.1 Is it clear what was measured, how it was measured and what the outcomes were?
  States that follow up was by telephone by a blinded psychologist. Also states that if unable to obtain telephone contact then contacted GP, checked ED attendance records and checked for death at the registrar generals office. Not clear how many patients were contacted by phone and how many through records. Appear to have only contacted intervention group patients by phone if successfully contacted initially. Not clear then what is meant by lost to follow up.
3.2 Are the measurements valid?
3.3 Are the measurements reliable?
  Likely to get under-reporting of suicide attempts by checking with GPs or ED attendances compared with talking to patients.
3.4 Are the measurements reproducible?
3.5 Were the patients and the investigators blinded?
  Patients and investigators not blinded. Assessor was blind but if the assessor could not contact the patient then the records were searched by non-blinded investigator.
4 Presentation of results
4.1 Are the basic data adequately described?
  Yes. Good progress chart and good Table 1.
4.2 Were groups comparable at baseline?
4.3 Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
4.4 Are the results internally consistent, i.e. do the numbers add up properly?
  3 errors spotted. In text adverse outcomes in group contacted at 3 months given as 5% rather than 25%. In table same group described as 28% rather than 25%. Difference in suicide attempts with contact at three months compared to standard treatment given as 5% (95% CI -2 to 1).
In the text mentions that in the group successfully contacted at one month there was a lower rate of attempted suicide but states that this difference was seen over 6 months after telephone contact although the follow up was for 1 year.
4.5 Were side effects reported?
  Possibility of any adverse effect of intervention not discussed.
5 Analysis
5.1 Are the data suitable for analysis?
5.2 Are the methods appropriate to the data?
  Yes, I think.
5.3 Are any statistics correctly performed and interpreted?
  Errors mentioned. Did not check chi squares.
6 Discussion
6.1 Are the results discussed in relation to existing knowledge on the subject and study objectives?
  Yes but rather limited.Despite a selected group of patients suicide attempts overall occured at a similar rate to data from the literature.
6.2 Is the discussion biased?
  Limited discussion of drawbacks of this paper.
7 Interpretation
7.1 Are the authors' conclusions justified by the data?
  Authors conclusion suggests that telephone intervention may help but suggests that in order to help people would need to be phoned earlier and an unlimited number of times.
7.2 What level of evidence has this paper presented? (using CEBM levels)
7.3 Does this paper help me answer my problem?
  Not really. Suggests possible need for further research in this area to see if telephone contact provides a cheap and effective way of helping people at risk of further suicide attempts.
After CA, i rated this paper: 5/10
8 Implementation
8.1 Can any necessary change be implemented in practice?
8.2 What aids to implementation exist?
8.3 What barriers to implementation exist?