SIGN 50: A guideline developer's handbook - Annex D: Completed checklist

Annex D: Completed Checklist

Methodology Checklist 2: Randomised Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages) 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
Guideline topic: Stroke Rehabilitation		Key Question No: 12
Checklist completed by: C Mackenzie
Section 1: Internal validity
In a well conducted RCT study...		In this study this criterion is:
1.1	The study addresses an appropriate and clearly focused question.	Well covered Adequately addressed Poorly addressed	Not addressed Not reported Not applicable
1.2	The assignment of subjects to treatment groups is randomised	Well covered Adequately addressed Poorly addressed	Not addressed Not reported Not applicable
1.3	An adequate concealment method is used	Well covered Adequately addressed Poorly addressed	Not addressed Not reported Not applicable
1.4	Subjects and investigators are kept ‘blind’ about treatment allocation	Well covered Adequately addressed Poorly addressed	Not addressed Not reported Not applicable
1.5	The treatment and control groups are similar at the start of the trial	Well covered Adequately addressed Poorly addressed	Not addressed Not reported Not applicable
1.6	The only difference between groups is the treatment under investigation	Well covered Adequately addressed Poorly addressed	Not addressed Not reported Not applicable
1.7	All relevant outcomes are measured in a standard, valid and reliable way	Well covered Adequately addressed Poorly addressed	Not addressed Not reported Not applicable
1.8	What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?	>80%
1.9	All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)	Well covered Adequately addressed Poorly addressed	Not addressed Not reported Not applicable
1.10	Where the study is carried out at more than one site, results are comparable for all sites	Well covered Adequately addressed Poorly addressed	Not addressed Not reported Not applicable
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?	Overestimate of effect.
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
Section 3: Description of the study (the following information is required to complete evidence tables facilitating cross-study comparisons. Please complete all sections for which information is available). Please print clearly
3.1	How many patients are included in this study? Please indicate number in each arm of the study, at the time the study began.	24: 12 immediate treatment and 12 deferred.
3.2	What are the main characteristics of the patient population?	Single left stroke. Minimum 6 months post onset Age 38 - 79. Mixed aphasia types and severity
3.3	What intervention (treatment, procedure) is being investigated in this study? List all interventions covered by the study.	Group communication intervention in aphasia - 5 hours per week for 4 months
3.4	What comparisons are made in the study? Are comparisons made between treatments, or between treatment and placebo / no treatment?	Treatment v social contact programme (3 hours per week)
3.5	How long are patients followed-up in the study? Length of time patients are followed from beginning participation in the study. Note specified end points used to decide end of follow-up (e.g. death, complete cure). Note if follow-up period is shorter than originally planned.	4 months
3.6	What outcome measure(s) are used in the study? List all outcomes that are used to assess effectiveness of the interventions used.	Linguistic and communicative measures
3.7	What size of effect is identified in the study? List all measures of effect in the units used in the study – e.g. absolute or relative risk, NNT, etc. Include p values and any confidence intervals that are provided.	Advantage for treated group, with greater changes for more severely affected subjects
3.8	How was this study funded? List all sources of funding quoted in the article, whether Government, voluntary sector, or industry.	Not stated.
3.9	Does this study help to answer your key question? Summarise the main conclusions of the study and indicate how it relates to the key question.	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.

[Annex D]