Research, how we do it?
Ethos
The point of doing clinical research is to improve patient care and clinical practice – doing things better. Primary research studies are generally designed to find out whether doing something different (or stopping doing something) is better than what is being done at present (standard care), whilst secondary research summarises existing primary research to determine the balance of evidence for or against particular care options.
The Process
1. Ask the question
One of the fundamental skills required for practising EBM is the asking of well-built clinical questions. To benefit patients and clinicians, such questions need to be both directly relevant to patients' problems and phrased in ways that direct your search to relevant and precise answers. A question should have 4 components. The PICO model is a helpful tool that assists you in organizing and focusing question. Dividing into the PICO elements helps identify search terms/concepts to use in research design and literature search.
P = Patient, Problem, Population (How would you describe the target group of patients? What are the most important characteristics of the patient?)
I = Intervention, Prognostic Factor, Exposure (What main intervention are you considering? What do you want to do with this patient? What is the main alternative being considered?)
C = Comparison (What is the main alternative to compare with the intervention (Can be none or placebo)? Are you trying to decide between two treatments, or two diagnostic tests?)
O= Outcome (What are you trying to accomplish, measure, improve or affect? Outcomes may be disease-oriented or patient-oriented.)
NB: From this point on every stage should have a written protocol before you start to do anything, which needs in particular to describe the objectives and the methods to be used to achieve those objectives
2. Do we already have the answer (or part of it)?
Look for a topic-specific systematic review: Don’t forget non-indexed sources such as Cochrane or Agency for Healthcare Research and Quality (AHRQ) – check Google.
If no review – need to do it yourself. A medical librarian will provide useful help plus web Evidence Based Medicine resources like Cochrane.
3. Is it an important topic?
Need to consider local, national (NHS), patient, clinician, management perspectives. This will encompass:
· Estimating the size of the problem typically using databases such as hesonline.nhs.uk.
· Auditing current practice (don’t forget the protocol)
· Gaining consensus from clinicians/patients/managers
4. Is it possible to answer the question – feasibility?
Need to consider:
· Is it ethical?
· What is the size of the difference are you looking for?
· Are you demonstrating superiority or equivalence?
· Resources – your time, availability of research subjects and willingness to take part, infrastructure, unavoidable costs.
5. What methodology is most appropriate?
Some terms in order of EBM acceptability!
· Meta-analysis: A statistical technique that summarizes the results of several studies in a single weighted estimate, in which more weight is given to results of studies with more events and sometimes to studies of higher quality.
· Systematic Review: a review in which specified and appropriate methods have been used to identify, appraise, and summarise studies addressing a defined question. It can, but need not, involve meta-analysis). In Clinical Evidence, the term systematic review refers to a systematic review of RCTs unless specified otherwise.
· Randomized Controlled Trial: a trial in which participants are randomly assigned to two or more groups: at least one (the experimental group) receiving an intervention that is being tested and another (the comparison or control group) receiving an alternative treatment or placebo. This design allows assessment of the relative effects of interventions.
· Controlled Clinical Trial: a trial in which participants are assigned to two or more different treatment groups by a method other than random allocation.
· Cohort Study: a non-experimental study design that follows a group of people (a cohort), and then looks at how events differ among people within the group. A study that examines a cohort, which differs in respect to exposure to some suspected risk factor (e.g. smoking), is useful for trying to ascertain whether exposure is likely to cause specified events (e.g. lung cancer). Prospective cohort studies (which track participants forward in time) are more reliable than retrospective cohort studies.
· Case control study: a study design that examines a group of people who have experienced an event (usually an adverse event) and a group of people who have not experienced the same event, and looks at how exposure to suspect (usually noxious) agents differed between the two groups. This type of study design is most useful for trying to ascertain the cause of rare events, such as rare cancers.
· Case Series: analysis of series of people with the disease (there is no comparison group in case series).
There are lots of web-based resources to help you more e.g: http://researchguides.dml.georgetown.edu/content.php?pid=129563&sid=1111317
The point of doing clinical research is to improve patient care and clinical practice – doing things better. Primary research studies are generally designed to find out whether doing something different (or stopping doing something) is better than what is being done at present (standard care), whilst secondary research summarises existing primary research to determine the balance of evidence for or against particular care options.
The Process
1. Ask the question
One of the fundamental skills required for practising EBM is the asking of well-built clinical questions. To benefit patients and clinicians, such questions need to be both directly relevant to patients' problems and phrased in ways that direct your search to relevant and precise answers. A question should have 4 components. The PICO model is a helpful tool that assists you in organizing and focusing question. Dividing into the PICO elements helps identify search terms/concepts to use in research design and literature search.
P = Patient, Problem, Population (How would you describe the target group of patients? What are the most important characteristics of the patient?)
I = Intervention, Prognostic Factor, Exposure (What main intervention are you considering? What do you want to do with this patient? What is the main alternative being considered?)
C = Comparison (What is the main alternative to compare with the intervention (Can be none or placebo)? Are you trying to decide between two treatments, or two diagnostic tests?)
O= Outcome (What are you trying to accomplish, measure, improve or affect? Outcomes may be disease-oriented or patient-oriented.)
NB: From this point on every stage should have a written protocol before you start to do anything, which needs in particular to describe the objectives and the methods to be used to achieve those objectives
2. Do we already have the answer (or part of it)?
Look for a topic-specific systematic review: Don’t forget non-indexed sources such as Cochrane or Agency for Healthcare Research and Quality (AHRQ) – check Google.
If no review – need to do it yourself. A medical librarian will provide useful help plus web Evidence Based Medicine resources like Cochrane.
3. Is it an important topic?
Need to consider local, national (NHS), patient, clinician, management perspectives. This will encompass:
· Estimating the size of the problem typically using databases such as hesonline.nhs.uk.
· Auditing current practice (don’t forget the protocol)
· Gaining consensus from clinicians/patients/managers
4. Is it possible to answer the question – feasibility?
Need to consider:
· Is it ethical?
· What is the size of the difference are you looking for?
· Are you demonstrating superiority or equivalence?
· Resources – your time, availability of research subjects and willingness to take part, infrastructure, unavoidable costs.
5. What methodology is most appropriate?
Some terms in order of EBM acceptability!
· Meta-analysis: A statistical technique that summarizes the results of several studies in a single weighted estimate, in which more weight is given to results of studies with more events and sometimes to studies of higher quality.
· Systematic Review: a review in which specified and appropriate methods have been used to identify, appraise, and summarise studies addressing a defined question. It can, but need not, involve meta-analysis). In Clinical Evidence, the term systematic review refers to a systematic review of RCTs unless specified otherwise.
· Randomized Controlled Trial: a trial in which participants are randomly assigned to two or more groups: at least one (the experimental group) receiving an intervention that is being tested and another (the comparison or control group) receiving an alternative treatment or placebo. This design allows assessment of the relative effects of interventions.
· Controlled Clinical Trial: a trial in which participants are assigned to two or more different treatment groups by a method other than random allocation.
· Cohort Study: a non-experimental study design that follows a group of people (a cohort), and then looks at how events differ among people within the group. A study that examines a cohort, which differs in respect to exposure to some suspected risk factor (e.g. smoking), is useful for trying to ascertain whether exposure is likely to cause specified events (e.g. lung cancer). Prospective cohort studies (which track participants forward in time) are more reliable than retrospective cohort studies.
· Case control study: a study design that examines a group of people who have experienced an event (usually an adverse event) and a group of people who have not experienced the same event, and looks at how exposure to suspect (usually noxious) agents differed between the two groups. This type of study design is most useful for trying to ascertain the cause of rare events, such as rare cancers.
· Case Series: analysis of series of people with the disease (there is no comparison group in case series).
There are lots of web-based resources to help you more e.g: http://researchguides.dml.georgetown.edu/content.php?pid=129563&sid=1111317