Methodology Checklist 2: Randomised Controlled Trials

Study identification Include author, title, reference, year of publication

Elman, RJ and Bernstein-Ellis, E 1999 The efficacy of group communication treatment in adults with chronic aphasia. Journal of Speech, Language and Hearing Research 42, 411 - 419

Checklist completed by:

Section 1: Internal validity

Evaluation criterion

How well is this criterion addressed?

1.1

Does the study address an appropriate and clearly focused question?  

Clear objectives, related to effects of intervention as measured by language impairment testing and more general functional communication assessment

1.2

Was the assignment of subjects to treatment groups randomised?  

Yes, but method of randomisation is not stated

1.3

Were the treatment and control groups similar at the start of the trial?  

Yes – no significant differences in age, education, time post onset or general language severity

1.4

Was an adequate concealment method used?    

No information included on this

1.5

Were subjects and investigators kept ‘blind’ about treatment allocation?  

Not applicable to subjects Testers appear to have been blind to group allocation

1.6

Are all relevant outcomes measured in a standard, valid and reliable way?  

Respected assessments used

1.7

Apart from the treatment under investigation, were the groups treated equally?  

Social activities for control group to prevent isolation (this group were subsequently treated)

1.8

What percentage of the individuals or clusters recruited into the study are included in the analysis?  

>80%

1.9

Were all the subjects analysed in the groups to which they were randomly allocated?

Apparently yes

1.10

Are the results homogeneous between sites?

Single site

Section 2: OVERALL ASSESSMENT OF THE STUDY

2.1

How well was the study done to minimise bias? Code ++, +, or -

+

2.2

If coded as +, or - what is the likely direction in which bias might affect the study results?

Randomisation process is not detailed

2.3

Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?

Reasonably so, though with caution given the small subject number

2.4

Are the results of this study directly applicable to the patient group targeted by this guideline?

Yes – if same amount and form of treatment used

If the study reports an evaluation or comparison of diagnostic tests, please complete a diagnostic studies checklist before completing the next section.

Section 3: description OF THE STUDY

3.1

What interventions are evaluated in this study?  

Group communication intervention in aphasia – 5 hours per week for 4 months; Social contact programme – 3 hours per week

3.2

What outcome measures are used? i.e. benefits and harms

General aphasia tests and functional communication assessment

3.3

How many patients participated in the study? Overall number, and in each arm of the study.

24: 12 immediate treatment and 12 deferred. Deferred group had socialisation programme then treatment programme

3.4

What was the scale and direction of the measured effect?

Advantage for treated group, with greater changes for more severely affected subjects

3.5

Is any statistical measure of uncertainty given? e.g. confidence intervals; p values

0.05

3.4

What are the characteristics of the study population? e.g. age, sex, disease characteristics of the population, disease prevalence.

Single left stroke Minimum 6 months post onset Age 38 – 79 Mixed aphasia types and severity

3.5

What are the characteristics of the study setting? e.g. rural, urban, hospital inpatient or outpatient, general practice, community.

Not specified

3.6

How many groups/sites are there in the study? If the study is carried out on more than one group of patients, or at more than one site, indicate how many are involved.

n/a  

3.7

Are there any specific issues raised by this study? Make any general comments on the study results and their implications      

Treatment programme effective after 2 months with additional gains after further 2 months. Gains maintained after 4 – 6 week no treatment period. No change during general socialisation period for control group Encouraging result as regards language impairment and functional communication measures. Further data in relation to broader disability/handicap issues is in progress. Conclusions must be cautious given small scale of study.