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Good PICO Question

Good PICO Question
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100% found this document useful (1 vote)
2K views122 pages

Good PICO Question

Good PICO Question
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 122

How to Ask A Good Question

PICO

What is EBM?
How to make a clinical decision?

EBM
"the conscientious, explicit and judicious use of
current best evidence in making decisions about
the care of the individual patient. It means
integrating individual clinical expertise with the
best available external clinical evidence from
systematic research." (Sackett D, 1996)
EBM is the integration of clinical expertise,
patient values, and the best evidence into the
decision making process for patient care.

The Steps in the EBM Process


The patient

1. Start with the patient -- a clinical problem or


question arises out of the care of the patient

The question

2. Construct a well built clinical question derived from


the case

The resource

3. Select the appropriate resource(s) and conduct a


search

The evaluation

4. Appraise that evidence for its validity (closeness to


the truth) and applicability (usefulness in clinical
practice)

The patient

5. Return to the patient -- integrate that evidence with


clinical expertise, patient preferences and apply it to
practice

Self-evaluation

6. Evaluate your performance with this patient

Lifelong learning model


A process of lifelong, self-directed, problembased learning in which caring for one's own
patients creates the need for clinically important
information about diagnosis, prognosis, therapy
and other clinical and health care issues.
Target your reading to issues related to specific
patient problems. Developing clinical questions
and then searching current databases may be a
more productive way of keeping current with the
literature.

Why is EBM important?


Physicians reported that their practice generated
about 2 questions for every 3 patients
Investigators found that physicians had about 5
questions for each patient. 52% of these
question could be answered by the medical
record or hospital information system. 25% could
have been answered by published information
resources such as textbooks or MEDLINE
Studies have also shown that when clinicians
have access to information, it changes their
patient care management decisions

What is the best way to deliver


2-agonist therapy for the acute
asthma patient in the ED?
MDI with a holding chamber or Nebulizer ?

Physical Methods for Cooling

Tepid sponging
Bathing
Fanning
Cooling blankets
Rubbing alcohol on the skin
Cool enemas
Ice packs

Is the Evidence Available?


145 cases and clinical decisions analyzed:
31 could be supported by a randomized
controlled trial
65 were supported by a head-to-head trial
(not a placebo-controlled trial)
23 were supported by case-control or cohort
studies
4 were supported by case series reports
22 could not be supported with a study from
the literature

The EBM Process


Pauline is a new patient who recently moved to the area to be
closer to her son and his family. She is 67 years old and has
a history of congestive heart failure brought on by several
myocardial infarctions.
She has been hospitalized twice within the last 6 months for
worsening of heart failure. At the present time she remains in
normal sinus rhythm. She is extremely diligent about taking
her medications (enalapril, aspirin and simvastatin) and wants
desperately to stay out of the hospital. She lives alone with
several cats.
You think she should also be taking digoxin but you are not
certain if this will help keep her out of the hospital. You decide
to research this question before her next visit.

Pauline

Can you construct a well built clinical question ?

Anatomy of a good clinical question


Patient or problem

How would you describe a group of patients similar to yours? What are the
most important characteristics of the patient?

Intervention, prognostic factor, or exposure

Which main intervention, prognostic factor, or exposure are you


considering? What do you want to do for the patient? Prescribe a
drug? Order a test? Order surgery? What factor may influence the
prognosis of the patient? Age? Co-existing problems? What was
the patient exposed to? Asbestos? Cigarette smoke?

Comparison

What is the main alternative to compare with the intervention?

Outcomes

What can you hope to accomplish, measure, improve or affect?

Clinical Experience
Foreground knowledge

Background knowledge

Medical
Students

Expert
Practitioners

The structure of the question might


look like this:
Patient / Problem
Intervention
Comparison, if any
Outcome

congestive heart failure,


elderly
digoxin
none, placebo
primary: reduce need for
hospitalization; secondary:
reduce mortality

For our patient, the clinical


question might be:
In elderly patients with
congestive heart failure, is
digoxin effective in reducing
the need for rehospitalization?

Oral, rectal or tympanic


temperature?

Type of question
Diagnosis

how to select and interpret diagnostic tests

Therapy

how to select treatments to offer patients that do


more good than harm and that are worth the efforts
and costs of using them

Prognosis

how to estimate the patient's likely clinical course


over time and anticipate likely complications of
disease

Harm/ Etiology

how to identify causes for disease (including


iatrogenic forms)

Type of Study
MetaAnalysis

Systematic Review
Randomized Controlled Trial
Cohort studies
Case Control studies
Case Series/Case Reports
Animal research/Laboratory studies

The type of question is important and can


help lead you to the best study design
Type of
Question

Suggested best type of Study

Therapy

RCT>cohort > case control > case series

Diagnosis

prospective, blind comparison to a gold standard

Harm/Etiology RCT > cohort > case control > case series
Prognosis

cohort study > case control > case series

Prevention

RCT>cohort study > case control > case series

Clinical Exam

prospective, blind comparison to gold standard

Cost

economic analysis

For our patient, the clinical question is:


In elderly patients with congestive heart
failure, is digoxin effective in reducing the
need for rehospitalization
It is a therapy question and the best
evidence would be a randomized controlled
trial (RCT). If we found numerous RCTs,
then we might want to look for a systematic
review.

Clinical
question
Patient
Population
Intervention

Clinical
MEDLINE
Scenario
strategy
congestive heart heart failure,
failure, elderly
congestive
Limit to Aged
digoxin
digoxin

Comparison (if
any)
Outcome

none or placebo

rate of
hospitalization
Type of question therapy

hospitalization

Type of study

RCT

Limit to randomized
controlled trial as
publication type

Select a resource
Colleagues
Summaries of the primary evidence
ACP Journal Club | Clinical Evidence | eMedicine |
FPIN Clinical Inquiries | InfoPOEMs| UpToDate
Databases
MEDLINE | Cochrane Library
Electronic textbooks and libraries
ACP Medicine | Harrisons | MD Consult | Stat!Ref
Meta-Search Engines
SUMSearch | TRIP Plus: Turning Research into Practice

ACP Online: http://www.acpjc.org/


Clinical Evidence:
http://www.clinicalevidence.com/
eMedicine: http://www.emedicine.com
FPIN: http://www.fpin.org
InfoPOEMS: http://www.infopoems.com/
UpToDate: http://www.uptodate.com
MEDLINE Access PubMed at:
http://www.pubmed.gov

Clinical Questions

Textbook
or other
source

Map to
resource

Choose
database
within
resource

Background
Clinical
query

ForeForeground ground Map to


or
question
background
type
question?

Map to
study
designs

Design
and
execute
search

Appraise evidence and make


decision

Henry is an active 5 year old boy. His mother


brought him in for a check-up because Henry has
had a fever and a sore throat for several days.
You suspect Strep and take a throat culture. The
standard treatment for Streptococcal Pharyngitis
is oral Penicillin three times a day. However, for
Henry and his mother, you are concerned about
compliance and the expense of this medication.
You recall that a drug representative recently told
you that a daily dose of amoxicillin is just as good
as penicillin, but costs less. You want to review
the literature before you decide on amoxicillin for
Henry and possibly changing your standard
practice.

Based on this scenario, choose the best,


well-built clinical question:
A. In children with strep throat, is amoxicillin
as effective as penicillin for relief of
symptoms?
B. What is the best treatment for relieving
the symptoms of a sore throat?
C. Is amoxicillin better than penicillin for
young children?

Experience on The Application


of EMB

Evidence-Based Case
Conference
Modified PBL

History
A 68 year-old female is brought to the ED
by her husband who is concerned that she
is not acting right.
The patient has been not eating well for
several days, and has been increasingly
confused.
Intermittent stomach pains intermittently
and vomiting

Vital signs

Blood Pressure - 78/60 mmHg


Heart Rate - 120 beats/minute
Respiratory Rate - 24 breaths/minute
Temperature 38.50 C
Oxygen Saturation (SaO2): 100% on 2
liters via nasal cannula

Physical Exam
General: patient responds verbally, but is weak
appearing and somewhat confused
HEENT: possible scleral jaundice
Neck: Soft, no JVD, no meningismus
Heart: Increased rate, no murmurs or rubs.
Respiratory: Mild basilar rhonchi in both lung
fields, no retractions
Abdomen: Soft, non-distended, RUQ tenderness
with deep palpation, no rebound or guarding
Extremities: no appreciable edema, rash, or
erythema

Labs

WBC: 22,000/mm3
HCT: 30%
HCO3: 17 mEq/L
BUN: 60 mg/dL
Cr: 2.1 mg/dL
Total Bilirubin: 4.6 mg/dl
Alkaline Phosphatase: 223 U/L
Coagulation values: normal
Urinalysis: (+) urobilinogen
Blood, Urine, Sputum Cultures pending

Imaging
ECG: sinus tachycardia with an old LBBB
Head CT: no acute changes
Chest x-ray: normal

Clinical Course
Within the first 3hs: 2 liters NS, Ceftriaxone
1g IV, and 500mg metronidazole 500 mg IV
Repeat BP: 88/30 mmHg norepinephrine
at 3 mcg/kg/min, BP increased to 105/60
with HR115, and she appeared somewhat
improved
Admitted to the ICU and arrived about 3
hours later when a bed became available
She died shortly after arriving to the ICU

Mortality Conference

Patient Profile 16:27

Age: 76 years old


Sex: male
Arrival: walk by himself
Vital signs: BT 37.6
PR 118 RR16
BP 132/78
Triage III

History
A 76 y/o male suffered from progressive
abdominal pain since yesterday afternoon after
painless colonoscopy in a medical center
Nausea(+), vomiting(+), no stool passage for 1
day
Denied fever, tarry stool
PH: irritable bowel disease, constipation, GU,
appendicitis s/p op, denied hypertension and
DM

PE

Consciousness: clear E4M6V5


HEENT: no icteric, no anemic
Chest and heart: no specific findings
Abdomen: Soft, distended, mild diffuse
tenderness, no rebound pain, hypoactive
bowel sound
Extremities: no edema, warm, no rash

Management

IV fluid with NS
Morphine 5mg IV st
CBC+DC/PL, BCS
KUB, CXR (Standing)

Lab 17:57
WBC 24070 with Seg 87%, Band 2%
Hb: 16.3 Platelet: 175k

Management 18:20
Primperan 10mg IV st
Fleet enema 1 BT st: Fail
Fleet enema 1 BT st again

Lab 18:43
Na 132 K 4.5 Sugar 171 GOT 50
BUN 27 Cr 2.5
CRP 23.7

Progression (19:15)
Abdominal pain exacerbation after the 2nd
enema
Vital signs: PR 116 RR 14 BP 104/56
On Monitor, 12-lead ECG, Cardiac
enzyme and D-dimer
Plain abdomen (Left decubitous view) and
Abdomen CT

Progression (20:00)

Vital signs: PR 120, RR 36 BP 98/62


Intubation (RSI)
Fluid resuscitation and Inotropic agents
Antibiotics
Consult surgeon
No ICU bed available

Lab (20:10)
ABG 7.301/35.7/205.1/17.8 (O2 mask
6L/min)
TnT: neg, D-dimer 708

Progression 21:00
Vital signs: PR 118 RR 22 BP 85/57
Admitted to ICU
Operation was performed until 00:50 due
to
Unstable hemodynamics
No key family member could make decision

OP Findings
A huge perforation hole about 6x4cm was found
on the anterior wall of the rectosigmoid area at
the distance 18~20cm from the anal verge
A marked gangrene change with impending
perforation was seen on a segment about 50cm
of small bowel, 80cm away from the ileocecal
valve
There were multiple spots to patches of ischemic
changes spreading on the whole colon and
small bowel.
The whole colon was congested, edematous.
thick-walled and erythematous changes

What was happened?


General surgeon: Colon perforation
complicated with intestinal necrosis
( ischemic bowel disease)
Operator of colonoscopy: colon perforation
by enema, not related to colonoscopy
EP?????
!
!

Clinical Guidline

When to Perform Head CT in The


Patients with Mild Head Injury
Yi-Kung Lee MD
Department of Emergency Medicine
Buddish Tzu Chi Dalin General
Hospital

Guidelines
Clinical Policy: Neuroimaging and
Decisionmaking in Adult Mild Traumatic Brain
Injury in the Acute Setting (ACEP)
Pratice Management Guidelines For The
Management Of Mild Traumatic Brain Injury
(Eastern Association for the Surgery of Trauma)
New Orleans and Canadian Criteria
NICE Head Injury Guideline
NCWFNS Proposal
Results of The WHO Collaborating Center Task
Force on Mild Traumatic Brain

Clinical Policy: Neuroimaging and


Decisionmaking in Adult Mild
Traumatic Brain Injury in the
Acute Setting
Ann Emerg Med. August 2002;40:231-249

Inclusion Criteria
Blunt trauma to the head within 24 hours
of presentation to the ED
Any period of posttraumatic LOC or of
posttraumatic amnesia
A GCS score of 15 on initial evaluation in
the ED
Age older than 15 years

Exclusion Criteria

Presence of a bleeding disorder


Penetrating trauma
Patients with multisystem trauma
Focal neurologic findings

Core Questions
Is there a role for plain film radiographs in
the assessment of acute MTBI in the ED?
Which patients with acute MTBI should
have a noncontrast head CT scan in the
ED?
Can a patient with MTBI be safely
discharged from the ED if a noncontrast
head CT scan shows no evidence of acute
injury?

Outcome
Presence of an acute intracranial
abnormality on noncontrast head CT scan

Is there a role for plain film radiographs


in the assessment of acute MTBI in the
ED?
Recommendation B:
Skull film radiographs are not recommended
in the evaluation of MTBI.
Although the presence of a skull fracture
increases the likelihood of an intracranial
lesion, its sensitivity is not sufficient to be a
useful screening test. Indeed, negative
findings on skull films may mislead the
clinician.

Which patients with acute MTBI should have


a noncontrast head CT scan in the ED?
Recommendation A: (New Orleans low risk
criteria)
A head CT scan is not indicated in those patients with
MTBI who do not have

headache,
vomiting,
age greater than 60 years,
drug or alcohol intoxication,
deficits in short-term memory,
Physical evidence of trauma above the clavicle, or
seizure.

Can a patient with MTBI be safely


discharged from the ED if a
noncontrast head CT scan shows no
evidence of acute injury?
Recommendation C:
Patients with MTBI who present 6 hours after
sustaining the injury, have a normal clinical
examination, and who have a head CT scan
that does not demonstrate acute injury can be
safely discharged from the ED.
Patients can be discharged after a shorter
period of observation if they are under the
care of a responsible third party.

Pratice Management Guidelines


for The Management of Mild
Traumatic Brain Injury
The EAST Practice Management Guidelines Work
Group
Copyright 2001 Eastern Association for the Surgery of
Trauma

Mild Traumatic Brain Injury


An injury caused by blunt
acceleration/deceleration forces which
produce a period of unconsciousness for
20 minutes or less and/or brief retrograde
amnesia, a Glasgow Coma Scale score of
13 to 15, no focal neurological deficit, no
intracranial complications (e.g. seizure
activity), and normal computed
tomography (CT) findings.

Recommendation
CT of the brain is the gold standard
diagnostic study for MTBI patients and
should be performed on all patients
sustaining a transient neurologic deficit
secondary to trauma. A patients with a
normal hCT has a 0 to 3% probability for
neurologic deterioration, usually in patients
with a GCS 13 and 14.

(N Engl J Med 2000;343:100-5.)

Low Risk Criteria Study


Objective: To develop and validate a set of
clinical criteria that could be used to identify
patients with minor head injury who do not need
to undergo CT
Prospective cohort study (Dec 1997 ~ Jun 1999)
Two Phases study
Minor head injury, >3 y/o, <24 hours after the
injury

Definition of Minor Head Injury


Loss of consciousness
witness or
the patient reported loss of consciousness
the patient could not remember the traumatic event

Normal findings on a brief neurologic


examination
normal cranial nerves and normal strength and
sensation in the arms and legs

A score of 15 on the Glasgow Coma Scale

Phase I

6.9%

Definition of Items
Headache: any head pain, whether diffuse or local.
Vomiting: any emesis after the traumatic event.
Drug or alcohol intoxication :on the basis of the history
obtained from the patient or a witness and suggestive
findings on physical examination, such as slurred speech
or the odor of alcohol on the breath. Measurements of
blood alcohol and toxicologic tests were ordered at the
discretion of the physician.
A deficit in short-term memory : persistent
anterograde amnesia in a patient with an otherwise
normal score on the GCS

Physical evidence of trauma above the


clavicles: any external evidence of injury,
including contusions, abrasions, lacerations,
deformities, and signs of facial or skull fracture.
Seizure : a suspected or witnessed seizure after
the traumatic event.
Coagulopathy : a history of bleeding or a
clotting disorder or current treatment with
warfarin.

Phase II

Sensitivity 100%!
(95-100%)

Positive CT Findings

Conclusion

JAMA. 2005;294:1511-1518

Lancet 2001; 357: 139196

Clinical Decision Rule


To develop a highly sensitive clinical
decision rule for use of CT in patients with
minor head injuries
Prospective cohort study
Adults who presented with a GCS score of
1315 after head injury
From 1996 to 1999

Inclusion Criteria
Blunt trauma to the head resulting in
witnessed loss of consciousness, definite
amnesia, or witnessed disorientation; and
Initial emergency department GCS score
of 13 or greater as determined by the
treating physician; and
Injury within the past 24 h
3121 patients

Exclusion criteria
< 16 years old
Minimal head injury (ie, no loss of consciousness,
amnesia, or disorientation)
No clear history of trauma as the primary event (eg,
primary seizure or syncope)
Obvious penetrating skull injury or obvious depressed
fracture
Acute focal neurological deficit
Unstable vital signs associated with major trauma
A seizure before assessment in the emergency
department
Bleeding disorder or used oral anticoagulants (ie,
coumadin)
Returned for reassessment of the same head injury
Pregnancy

Outcome Measure
The primary outcome was need for neurological
intervention (3121/3121)
either death within 7 days secondary to head injury or
the need for any of the following procedures within 7
days:
craniotomy, elevation of skull fracture, intracranial pressure
monitoring, or intubation for head injury (shown on CT).

The secondary outcome was clinically important


brain injury, on CT. (2078/3121, 67%)
Any acute brain finding revealed on CT and which
would normally require admission to hospital and
neurological follow-up

Lancet 2001; 357: 139196

Lancet 2001; 357: 139196

Variables

Lancet 2001; 357: 139196

Lancet 2001; 357: 139196

Lancet 2001; 357: 139196

External Validity
External Validation of
the Canadian CT
Head Rule and the
New Orleans Criteria
for CT Scanning in
Patients With Minor
Head Injury
Dutch prospective
study
>16 y/o
JAMA. 2005;294:1519-1525

CT Findings

JAMA. 2005;294:1519-1525

Validation

JAMA. 2005;294:1519-1525

Comparison of the CCHR and NOC


Canadian prospective study
(1) blunt trauma to the head resulting in
witnessed loss of consciousness, definite
amnesia, or witnessed disorientation; (2)
initial ED GCS score of 13 or greater as
determined by the treating physician, and
(3) injury within the previous 24 hours

JAMA. 2005;294:1511-1518

Clinical Outcome

JAMA. 2005;294:1511-1518

JAMA. 2005;294:1511-1518

Sensitivity and Specificity

JAMA. 2005;294:1511-1518

Sensitivity and Specificity

JAMA. 2005;294:1511-1518

Realities

Before application
of CCHR

Emerg. Med. J. 2004;21;420-425

Realities

After application
of CCHR

Emerg. Med. J. 2004;21;420-425

Compliance

Emerg. Med. J. 2004;21;420-425

Compliance

Emerg. Med. J. 2004;21;420-425

Impaction

Emerg. Med. J. 2004;21;426-428

NICE (National Institute for


Clinical Excellence) Head
Injury Guideline
Head injury
Triage, assessment, investigation and early
management of head injury in infants,
children and adults
June 2003
Developed by the National
Collaborating Centre for Acute Care

Definitions
Infants<1 y/o, children 115 y/o and adults
>16 y/o, the infants and young children <
5y/o
Head injury: any trauma to the head,
other than superficial injuries to the face.
The primary patient outcome of concern
throughout the guideline is clinically
important brain injury.

Selection of patients for CT


imaging of the head

Patients who have sustained a head injury and present with any one
of the following risk factors should have CT scanning of the head
immediately requested.

GCS < 13 at any point since the injury.


GCS = 13 or 14 at 2 hours after the injury.
Suspected open or depressed skull fracture.
Any sign of basal skull fracture (haemotympanum, panda eyes,
cerebrospinal fluid otorrhoea, Battles sign).
Post-traumatic seizure.
Focal neurological deficit.
More than one episode of vomiting (clinical judgement should be used
regarding the cause of vomiting in those aged <12 y, and whether
imaging is necessary).
Amnesia for greater than 30 minutes of events before impact. The
assessment of amnesia will not be possible in pre-verbal children and is
unlikely to be possible in any child aged under 5 years.

Selection of patients for CT


imaging of the head
CT should also be immediately requested in
patients with any of the following risk factors,
provided they have experienced some loss of
consciousness or amnesia since the injury:

Age 65 years.
Coagulopathy (history of bleeding, clotting disorder,
current treatment with warfarin).
Dangerous mechanism of injury (a pedestrian struck
by a motor vehicle, an occupant ejected from a motor
vehicle or a fall from a height of greater than 1 metre
or five stairs). A lower threshold for height of falls
should be used when dealing with infants and young
children (that is, aged under 5 years).

Evaluate the impact of the NICE


head injury guidelines
Before/ after study
month A, six months
before the
implementation of NICE
(Nov 2002 at NTGH and
May 2003 at Hope), and
month B, one month after
the implementation of
NICE (May 2003 at
NTGH and Jan 2004 at
Hope).
Emerg. Med. J. 2005;22;845-849

Emerg. Med. J. 2005;22;845-849

Conclusion
cost
effectiveness
should not be a
barrier for the
implementation
of the NICE head
injury guidelines
in UK EDs

Clinical Performance of NICE


Recommendations versus
NCWFNS Proposal in Patients
with Mild Head Injury
JOURNAL OF NEUROTRAUMA
Volume 22, Number 12, 2005

Over a 5-year
period, the
clinical data of
7,955
adolescent and
adult patients
with mild head
injury were
prospectively
collected

Results
Three hundred fifty-four patients (6.8%)
had intracranial lesions on computed
tomography (CT) scan;
Neurosurgical intervention was needed in
108 patients (1.3%), and
An unfavorable outcome occurred in 54
patients (0.7%) at 6-month follow-up.

Favor!

Favor!

Meta-Analysis
(for Risk Factor Analysis)
Cohort or nested cohort studies
MEDLINE and EMBASE were searched from
01/1990 to 06/2002
Grey literature
The reference lists of guidelines developed by
the American Academy of Pediatrics, The
Eastern Association for the Surgery of Trauma,
The Scottish Intercollegiate Guidelines Network,
and The Royal College of Surgeons of England
JOURNAL OF NEUROTRAUMA,21(7),877-885 2004

83,636 patients from 35 papers


Present relative risk ratios for 23 clinical
variables that may predict the presence of
significant intracranial injury in adults
sustaining minor head injury

Clinical History

JOURNAL OF NEUROTRAUMA,21(7),877-885 2004

Mode of Injury

JOURNAL OF NEUROTRAUMA,21(7),877-885 2004

Clinical Exam&Imaging

JOURNAL OF NEUROTRAUMA,21(7),877-885 2004

JOURNAL OF NEUROTRAUMA,21(7),877-885 2004

DIAGNOSTIC PROCEDURES IN MILD TRAUMATIC


BRAIN INJURY: RESULTS OF THE WHO
COLLABORATING CENTRE TASK FORCE ON MILD
TRAUMATIC BRAIN INJURY

J Rehabil Med 2004; Suppl.


43: 6175

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