Research
Question
Check List
The aim of a pragmatic randomized controlled trial is to evaluate
whether and to what degree one (or more) interventions achieve
different outcomes (e.g. health, health care processes, economic,
patient satisfaction) in
comparison with one (or more) other interventions, used in the same
setting.
The aim should describe in one or two sentences the general purposes,
for
which the trial is being proposed.
When stating the aim of a trial, the author should consider using the
PICOT method.
|
P |
Patient population – for which group do you need information? e.g. Peri- menopausal women |
|
I |
Intervention – What treatment do you need to trial the effect
of? e.g. Hormone replacement therapy (HRT) |
|
C |
Comparison – What treatment are you comparing against (could be alternative treatment or no treatment)? e.g. No HRT |
|
O |
Outcomes – How is the effect of the intervention measured? e.g. Effect on bone mineral density |
|
T |
Target – What is the target of the trial? ie. are you asking whether the experimental intervention is 'superior' to the control intervention, or 'non-inferior' to it but preferable for some other reason such as safety or cost? e.g. Effect on bone mineral density |
The advantages of using the PICOT method are:
Illustrative example - Perinatal care trial
|
|
‘The main specific aim of this project is to perform a randomized controlled trial of a behavioural intervention intended to increase the use of two evidence-based birth practices, the selective use of episiotomies and active management of the third stage of labor (injection 10 IU of oxytocin). We will randomize 24 hospitals in Department of Montevideo, Uruguay, the Province of Buenos Aires, Argentina, and the City of Rosario, Argentina.’ (Perinatal care trial - go to protocol) |
Illustrative example - SYTRUST trial
|
|
‘To determine the feasibility, accuracy, cost-effectiveness and impact on pregnancy outcome of on-site syphilis testing and related health promotion strategies in the community antenatal clinics of a rural South African health district. (SYTRUST Trial - go to protocol) |
Illustrative example - WELLINGTON trial
|
|
‘To assess the effectiveness of a community health workers programme, designed to focus on primary health care, in improving the case detection, case-holding and cure rates of tuberculosis in an agricultural setting. ( WELLINGTON trial - go to protocol) |
Illustrative example - Magpie trial
|
|
‘The aim is to find out if, overall women and/or their children do better if they get magnesium sulphate rather than placebo, regardless of whether treatment is started before or after delivery and irrespective of any previous anticonvulsant therapy. (Magpie Trial - go to protocol) |
Illustrative example - ISAT trial
|
|
‘To compare the safety and efficacy of an endovascular treatment policy of ruptured intracranial aneurysms with a conventional neurosurgical treatment policy in an eligible population. (ISAT Trial - go to protocol) |
Research
Question
Check List This checklist was developed by Dave Sackett, who prepared it for the forthcoming 3rd edition of Clinical Epidemiology; A Basic Science for Answering Questions about Health Care, to be published by Lippincott, Williams & Wilkins in 2004.
The research question
text from
3rd edition of Clinical Epidemiology
This text has been contributed by Dave Sackett, who prepared it
for
the forthcoming 3rd edition of Clinical Epidemiology; A Basic Science
for
Answering Questions about Health Care, to be published by Lippincott,
Williams
& Wilkins in 2005.
Asking a clinical question This site provides useful advice on how to ask a research question by using the PICOT method.