SIGN 50: A guideline developer's handbook - Annex C: Methodology Checklist 2: Randomised Controlled Trials

Methodology Checklist 2: Randomised Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)
Guideline topic:			Key Question No:
Checklist completed by:
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?
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?
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?
2.4	Are the results of this study directly applicable to the patient group targeted by this guideline?
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	Do we know who the study was funded by?		[ ] Academic Institution [ ] Healthcare Industry [ ] Government [ ] NGO [ ] Public funds [ ] Other
3.2	How many centres are patients recruited from?
3.3	From which countries are patients selected? (Select all those involved. Note additional countries after “Other”)		[ ] Scotland [ ] UK [ ] USA [ ] Canada [ ] Australia [ ] New Zealand [ ] France [ ] Germany [ ] Italy [ ] Netherlands [ ] Scandinavia [ ] Spain [ ] Other:
3.4	What is the social setting (ie type of environment in which they live) of patients in the study?		[ ] Urban [ ] Rural [ ] Mixed
3.5	What criteria are used to decide who should be INCLUDED in the study?
3.6	What criteria are used to decide who should be EXCLUDED from the study?
3.7	What intervention or risk factor is investigated in the study? (Include dosage where appropriate)
3.8	What comparisons are made in the study? (ie what alternative treatments are used to compare the intervention with?). Include dosage where appropriate.
3.9	What methods were used to randomise patients, blind patients or investigators, and to conceal the randomisation process from investigators?
3.10	How long did the active phase of the study last?
3.11	How long were patients followed-up for, during and after the study?
3.12	List the key characteristics of the patient population. Note if there are any significant differences between different arms of the trial.
3.13	Record the basic data for each arm of the study. If there are more than four arms, note data for subsequent arms at the bottom of the page
	Arm 1: Treatment: Sample size: No. analysed With outcome: Without outcome:	Arm 2: Treatment: Sample size: No. analysed With outcome: Without outcome Primary outcome?	Arm 3: Treatment: Sample size: No. analysed With outcome: Without outcome Primary outcome?	Arm 4: Treatment: Sample size: No. analysed With outcome: Without outcome Primary outcome?
3.14	Record the basic data for each IMPORTANT outcome in the study. If there are more than four, not data for additional outcomes at the bottom of the page.
	Outcome 1: Value: Measure: P value Upper CI Lower CI Primary outcome?	Outcome 2: Value: Measure: P value Upper CI Lower CI Primary outcome?	Outcome 3: Value: Measure: P value Upper CI Lower CI Primary outcome?	Outcome 4: Value: Measure: P value Upper CI Lower CI Primary outcome?
3.15	Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question. {Much of this is likely to be contributed by GDG members).

[SIGN 50 Annex C] [Notes on use of checklist]