EVIDENCE - BASED

MEDICINE:
A CRITICAL APPRAISAL ON
THERAPY AND PREVENTION
PRESENTED BY:
Ianni Bea Calalang, M.D.
OBJECTIVES
• To outline the steps in performing EBM
• To critically appraise a sample article on Therapeutics and Prevention
DISCLAIMER
• EBM is not a perfect paradigm
• It is just one paradigm
• The challenge is to balance judicious use of evidence to our clinical
skills and humane attention to patient needs
• The slides have been replicated from the lectures done by my
mentors in Family Medicine Residency
 The EBM Triad

What is
evidenced-based
medicine?
• “EBM is the integration of best
research evidence with clinical
expertise and patient values” –
Dave Sackett
Steps in EBM
EXAMPLES OF CLINICAL
DILEMMA IN PATIENT
ENCOUNTERS
• A patient of yours asked which of the first-
line medications (Fosfomycin or
Nitrofurantoin) for acute uncomplicated
cystitis as empiric treatment is a better
choice?

• A friend of yours asked if he could use

Ivermectin as a treatment for COVID-19
 • Therapy and Prevention
ASK • Diagnostic Test
• Prognosis
• Harm

• Others: Differential diagnosis, systematic

review or meta-analysis, clinical practice
guidelines
 ASK (Clinical Question)
Patient Problem Comparison
Intervention Outcomes Methodology
(Population) Intervention
• Describe the ones • types of dressings, • Standard therapy • Make a distinction • Study designs that
that you come drug therapies, • No intervention between the best answers the
into contact with placebos or (placebo) outcome which is questions
and are relevant counselling. • Alternative relevant to your
to your practice • provision of treatment, patient or problem
differing esposure or and the outcome
environmental diagnostic test measures
factors or deal with deployed in
the way in which studies. Spend
information is some time working
given to patients out exactly what
• Diagnostic tests outcome is
important to you,
your patient, and
the time-frame
which is
appropriate
CASE SCENARIO

JAC
2YO / MALE
CHILD
ROMAN CATHOLIC
LUINAB, ILIGAN CITY
CC: VOMITING AND LBM
HISTORY OF
PRESENT ILLNESS

NIGHT PRIOR TO CONSULT

• PATIENT HAD SUDDEN ONSET OF VOMITING X 2 EPISODES, ASSOC WITH ABDOMINAL PAIN

MORNING PRIOR TO CONSULT

• HAD ANOTHER 1 EPISODE OF VOMITING OF PREVIOUSLY INGESTED MILK
• HAD 2 EPISODES OF WATERY STOOL, BROWNISH IN COLOR, NON-MUCOID, NON-BLOODY
MINUTES PRIOR TO CONSULT
• HAD ANOTHER EPISODE OF WATERY STOOL AND 2 EPISODES OF VOMITING OF
PREVIOUSLY INGESTED FOOD, HENCE SOUGHT CONSULT
 BIRTH/FEEDING/IMMUNIZATIO
N/DEVELOPMENTAL HISTORY
• BIRTH:
• delivered via NSD at 38 weeks AOG
• BIRTH WEIGHT: 3.46kg
• Nutrition: Mixed breastfeeding for only 1 month;
• Formula Milk: Nido Junior 1-3; able to eat table food
• Immunization: completed EPI at Brgy. Health Center
• Dev’t milestones: social smile at 2months, able to support head at 3months, able to sit
without support at 6months, able to crawl at 7months, able to walk alone at 1yo, able to talk
in 1-2 words at 1 8/12months, run at almost 2yo
PAST HISTORY

• Patient had Acute Gastroenteritis when

he was still 2 months old after shifting his
milk to Nan. LBM resolved after shifting
the formula milk to Similac.
• Had ~1cm laceration – sutured at nasal
bridge when he was 1 8/12 yo after he
fell and hit his nasal bridge on the table
edge
 FAMILY HISTORY

• Father: JJC, 36yo, engineer

• Mother: YC, 35yo, teacher
• Siblings:
• JEC, 12yo, grade 7 student
• SJC, 1yo
 ENVIRONMENTAL HISTORY
• Since both parents are at work, patient is left to the care of his
grandmother.
• water source: mineral water bought from a refilling station.
REVIEW OF SYSTEMS
GENERAL (-) weight loss, (+) weakness
SKIN (-) rashes, itchiness
HEENT (-) headache, (-) colds, nose bleeding, gum
bleeding/swelling
NECK (-) stiffness, lumps
RESPIRATORY (-) cough, SOB, tachypnea
CARDIOVASCULAR (-)chest pain
GASTROINTESTINAL (+)abdominal pain, nausea, vomiting, LBM
ENDOCRINE (-)heat and cold intolerance, excessive sweating
G.U.T. (-)oliguria, hematuria
NEURO (+)irritable
MUSCULOSKELETAL (-) myalgia, (-) joint pains
PHYSICAL
EXAMINATION
• GENERAL SURVEY
• Well developed, well nourished
• Conscious, crying, not in mild respiratory
distress

• VITAL SIGNS Anthropometric measurements:

• Wt: 14kg
• BP: not taken • Ht: 95 cm
• Middle upper arm circ:
• HR: 100 16.5cm
• RR: 30 • Head circ: 52CM
• Chest circ: 53CM
• TEMP: 37C • BMI: 15.51 (z = -0.2)
HEENT Normocephalic, anicteric sclerae, pupils equal and reactive to
light, (-) nasal discharge, (+) dry lips and tongue (-) tonsillar
enlargement
NECK (-) LAD, supple, trachea at midline

RESPIRATORY Equal chest expansion, (-) retractions, equal tactile fremitus, (-)
fine rales, (-) wheezing
CARDIOVASCULA PMI @ 5th ICS LMCL, no heaves/thrills, CAD not enlarged,
R regular rhythm, no murmurs

ABDOMEN Flat, no scars, Hyperactive bowel sounds, tympanitic, soft,

nontender
EXTREMITIES Strong, equal palpable peripheral pulses, CRT<2sec, no pitting
bipedal edema
Assessment
• Acute Gastroenteritis with some
dehydration
• Nutrition: Well nourished
PLAN
• Labs: CBC, PC, U/A, S/E
• Meds:
1. AlMgOH syrup, 5ml TID PO after meals
2. Probiotics 100M, 5 drops OD x 1 week
3. ORS for vol/vol replacement
4. Domperidone drops, 1ml TID PRN for vomiting
• Parents were advised to have the patient on NPO X
2 hours after vomiting.
 The grandmother wants to give
ginger since according to her, it can
prevent vomiting. The px's mother
then asked me if it is safe to give
DILEMMA and/or if it is effective as an
antiemetic.
 • Among pediatric patients
diagnosed to have AGE with
symptoms of vomiting(P), will
ginger concoction(I) be effective
ASK as an antiemetic (C) in the
management of vomiting in
acute gastroenteritis(O) in a
Randomized Controlled Clinical
trail (M)?
Types of Study Design according to the types
of Clinical Question

Types of Question Type of Study

Etiology Case-control or cohort study
Diagnosis Diagnostic validation study
Prognosis Inception cohort study
Therapy Randomized controlled Trial
Cost-effectiveness Economic Evaluation
Quality of life Qualitative Study
ACQUIRE: SEARCH
THE LITERATURE!
use online
databases for
applicable
research data
ACQUIRE
 • 4 COMPONENTS OF
APPRAISAL TOOLS (R-V-R-A)
Appraise: Critically • RELEVANCE
• Does this study address clearly focused question?
appraise the • Does the study answer a particular question similar to my own?
• VALIDITY
evidence gathered • Did the study use valid methods to address this question?
with regards to its • RESULTS
• What are the results?
validity and • Are the valid results of this study important?
relevance • APPLICABILITY
• Are these valid, important results applicable to my patient or
population?
• Will the results be helpful to me?
 R ELEVA NCE APPRAIS IN G DIRECTN ES S : IS THE OBJ ECTIVE OF THE
ARTICL E COMPARIN G THERAPEUTIC IN TERVEN TION S
Critical S IMIL AR TO YOUR CL IN ICAL DIL EMMA?

Appraisal on Validity Primary Validity:

• Was the assignment of patients to treatment groups
Therapeutics randomized?
and Prevention • Was follow-up rate adequate?

• Were all patients analyzed in the group to which they were

originally randomized?

Secondary Validity:
• Were Baseline Characteristics similar at the start of the trial?

• Were patients blinded to treatment assignment?

• Were clinicians “blind” to treatment?

• Was the study personnel “blind” to the treatment?

• Aside from the experimental intervention, were the groups

treated equally?

Overall, is the YES to at least

study VALID? • ONE primary validity
• TWO secondary validity
APPRAISE
RELEVANCE VALIDITY RESULTS

APPLICABILITY CONCLUSION RESOLUTION

RELEVANCE
DILEMMA ARTICLE

• Pediatric patient • Pediatric patients

P P

• Salabat/ ginger concoction • Ginger 10mg (20 drops)

I I

• Placebo • Placebo
C C

• Relief of vomiting • Reduction of vomiting

O O

• Double-blind, Randomized
• Randomized Controlled Trial M controlled trial
M
Inclusion • age between 1 and 10 years
Criteria • suspected AGE‐related symptoms lasting <12 h:
AGE‐associated vomiting (not bilious or bloody) from <4 h;
modification of stool pattern lasting <12 h;
• mild to moderate dehydration

Exclusion • concomitant presence of other diseases: neurologic and neuropsychiatric diseases; genetic and
metabolic diseases, autoimmune diseases, immunodeficiencies, celiac disease, cancer, adverse
Criteria food reactions (including ginger allergy); functional gastrointestinal disorders; inflammatory bowel
diseases; liver diseases; pancreatic diseases; malformations of the gastrointestinal tract;
• infectious diseases other than AGE;
• severe dehydration;
• malnutrition defined as weight‐for‐height <3 standard deviation scores (SDS);
• previous surgery of the respiratory, gastrointestinal or urinary tract;
• use of gastric acidity inhibitors, antibiotics, antiemetics or other drugs in the 2 weeks before the
enrollment;
• use of prebiotics, probiotics or symbiotics in the 2 weeks before the enrollment;
• participation to other studies.
RELEVANCE
Is the Objective of the article
comparing therapeutic
interventions similar to my clinical
dilemma?

• Yes
RELEVANCE

 Does this study address a clearly

focused question?
 YES
APPRAISE
RELEVANCE VALIDITY RESULTS

APPLICABILITY CONCLUSION RESOLUTION

VALIDITY
• Did the study use
valid methods to
address the question?
• YES

• Was the assignment

to the different
treatment groups
randomized?
• YES
VALIDITY
• Was the follow-up
rate adequate?
• YES
• DROP OUT RATE:
• 9/150 x 100= 6%

• Were all patients

analyzed in the
group to which they
were originally
randomized?
• YES
VALIDITY
• Were the baseline characteristic
similar at the start of the trial?
• YES
 VALIDITY
• Was the assignment • Was the clinicians • Was the study
to the different “blinded” to personnel “blind” to
treatment groups treatment? treatment?
blinded? • YES • YES
• YES
IS THE STUDY VALID?
• YES

Primary Validity
Was the assignment to the different treatment groups randomized? YES

Was the follow-up rate adequate? YES

Were all patients analyzed in the group to which they were originally YES
randomized?
Secondary Validity
Were the baseline characteristic similar at the start of the trial YES

Were the patients blinded to treatment assignment? YES

Were the clinicians “blind” to treatment? YES

Was the study personnel “blind” to treatment? YES
APPRAISE
RELEVANCE VALIDITY RESULTS

APPLICABILITY CONCLUSION RESOLUTION

 RESULTS (EVENT RATES)
Rt = number of patients who did not improve in
the treatment group/number of patients in the
group
Nt 75
Number of patients who RT= 50/75
improved 25 = 0.67
Still with vomiting 50
Rc = number of patients who did not improve in
the control group/number of patients in the
group
Nc 75
Number of patients who Rc =
improved 10 65/75=
0.87
Still with vomiting 65
RESULTS
EVENT

Risk in Treatment (Rt) (GINGER) Rt= 50/75 = 0.67

RATES

Risk in Treatment (Rc) (PLACEBO) Rc = 65/75= 0.87

MEASUREMENT

Relative Risk (RR) Rt/Rc = 0.67/0.87 = 0.77

1 - RR = 1 - 0.77 = 0.23 x 100% =
EFFECTS

Risk Reduction (RRR) 23%

Rc - Rt = 0.87 - 0.67 = 0.2 x
Absolute Risk Reduction (ARR) 100% = 20%
Number Needed to Treat (NNT) 100/ARR = 100/20 = 5

<1.0
~1.0
>1.0
• 95% Confidence Interval
• P value <0.05
 RESULTS
• How precise was the estimate of the treatment effect?
• 95% Confidence Interval
• P-value = 0.002
 APPRAISE
RELEVANCE VALIDITY RESULTS

APPLICABILITY CONCLUSION RESOLUTION

APPLY
 APPLICABILITY
Can the results be applied to YES
my patient care?
NNT 5 PATIENTS
Were all clinically important YES NNT X COST X DURATION OF TREATMENT
outcomes considered? = 5 X 620pesos X 1

Are the likely treatment YES (?) = 3,100 PESOS

worth the potential harm and
costs?
APPRAISE
RELEVANCE VALIDITY RESULTS

APPLICABILITY CONCLUSION RESOLUTION

 Ginger can decrease the frequency of
vomiting in patients with AGE.

Conclusion and Availability of the medication that also

Resolution to has 10mg ginger in 20ml syrup is hard to
find.
the problem
A home-made ginger concoction can be
done, however, having the same
concentration is not ensured, hence if
given q 8hrs, might not be as effective.
References
Remember…
Safety First!
Thank you!