Transcript document

CASE MANAGEMENT,
PRESENTATION, DISCUSSION AND
SHARING OF INFORMATION ON
EXTREMITY SARCOMAS
by
Michael Angelo L. Suñaz, M.D.
Department of Surgery
Ospital ng Maynila Medical Center
CASE MANAGEMENT,
PRESENTATION, DISCUSSION
E.A., 63/M
BINAN, LAGUNA

CHIEF COMPLAINT: NON-HEALING
WOUND ON THE RIGHT GLUTEAL
AREA
HISTORY OF PRESENT ILLNESS:

4 months PTA, the patient noted a
pimple-like lesion on his right gluteal
area. No other associated signs and
symptoms were noted.
HISTORY OF PRESENT ILLNESS:

3 ½ months PTA, the mass was noted
to
have
increased
in
size.
Consultation of a private physician
was done and he was prescribed
with unrecalled medications which
afforded no relief.
HISTORY OF PRESENT ILLNESS:

2 weeks PTA, the mass persisted and
was now associated with occasional
pain and undocumented fever.
HISTORY OF PRESENT ILLNESS:

Persistence
of
his
condition
prompted
consultation
and
subsequent admission.

PAST MEDICAL Hx:
unremarkable

FAMILY Hx:
HPN - paternal side

PERSONAL/SOCIAL Hx:
- no history of smoking or alcoholic
beverage intake
PHYSICAL EXAMINATION:
G/S: conscious, coherent, not in
cardiorespiratory distress
BP= 120/70 CR=83 RR= 19
T=38.20C
SHEENT: no jaundice; pink palpebral
cojunctiva,anicteric sclera, No NAD,
No CLAD, No TPC
PHYSICAL EXAMINATION:
C/L: SCE, no retractions, clear BS
CVS: adynamic precordium, NRRR, no
murmur
Abdomen: flat; soft; no palpable
masses
PHYSICAL EXAMINATION:
Extremities: 10 x 13 cm firm, slightly
movable, ulcerating mass, tender only
upon deep palpation towards the right
gluteal area
SALIENT FEATURES:
 63 y/o, M
 10x13 cm firm, slightly movable,
rapidly growing ulcerating mass
tender only upon deep palpation
towards the right gluteal area
 Occasional pain on the affected area
 Fever (38.20C)
10x13 cm firm, nontender, slightly
movable, rapidly growing ulcerating
mass on the right gluteal area
10x13 cm firm, nontender, slightly
movable, rapidly growing ulcerating
mass on the right gluteal area
•Rapidly growing
•With associated
fever
•Tenderness only
upon deep
palpation in the
direction of the
gluteal area
10x13 cm firm, nontender, slightly
movable, rapidly growing ulcerating
mass on the right gluteal area
Infectious
•Rapidly growing
•With associated fever
•Tenderness only upon
deep palpation in the
direction of the gluteal
area
Neoplastic
Clinical Diagnosis:
Diagnosis
Certainty
Treatment
Neoplastic
Disease
75%
Surgical
Infectious
Disease
25%
Surgical/
Medical
BASES:
63 y/o, M
 10x13 cm firm, slightly movable,
rapidly growing ulcerating mass
tender only upon deep palpation
towards the right gluteal area
 Occasional pain on the affected area
 Fever (38.20C)

Do I need a para-clinical diagnostic
procedure?
YES
Paraclinical Diagnostic Procedures
Benefit
Risk
Cost
Availability
Biopsy
Can provide a histopathologic
diagnosis to determine the
primary treatment of the
lesion.
Bleeding
Pain
+
Readily
available
MRI
Accurately delineates muscle
groups and distinguishes
between bone, vascular
structures, and tumor. Sagittal
and coronal views allow 3D
evaluation of anatomical
compartments.1
none
++++
Not readily
available
CT SCAN
Provide detailed survey of the
abdomen and pelvis and
delineate adjacent organs and
vascular structures.1
Radiation
Exposure
+++
Not readily
available
Paraclinical Diagnostic Procedures

CT Scan of the Pelvis (9/29/08)
– A mixed density mass with areas of
necrosis is seen arising from the right
gluteus maximus muscle infiltrating into
the subcutaneous fat measuring about
14 x 12.25 x 9.26 (CC x W x AP). The
mass displaces the anal opening to the
left.
Paraclinical Diagnostic Procedures

CT Scan of the Pelvis (9/29/08)
– There are no enlarged lymph nodes.
– No osteolytic nor blastic changes seen.
Osteophytes are noted along the iliac
margins and vertebral endplates.
– The included bowel loops, prostate and
urinary bladder are unremarkable.
Paraclinical Diagnostic Procedures

CT Scan of the Pelvis (9/29/08)
IMPRESSION:
– Right
gluteal mass, consider
sarcoma.
– Tissue correlation suggested.
– Degenerative osseous changes,
pelvis.
10x13 cm firm, nontender, slightly
movable, rapidly growing ulcerating
mass on the right gluteal area
Infectious
•Rapidly growing
•With associated fever
•Tenderness only upon
deep palpation in the
direction of the gluteal
area
Neoplastic
Sarcoma
Paraclinical Diagnostic Procedures

CXR (9/3/08)
Both lungs are clear.
The aorta is sclerotic.
The heart is not enlarged.
Diaphragm and sulci are intact.
IMPRESSION: Atheromatous Aorta .
Paraclinical Diagnostic Procedures

Liver Ultrasound (9/3/08)
The liver is not enlarged. The ducts
are not dilated. The echo pattern is
homogenous. No focal mass lesion
is seen.
IMPRESSION: Negative study.
Paraclinical Diagnostic Procedures

Histopathology result (8/15/08)
Gross

The specimen consists of several
dark brown irregular soft and friable
tissues, 4.0 cm in agrregate. The
entire specimen is taken for study
Paraclinical Diagnostic Procedures

Histopathology result (8/15/08)
Microscopic

Microsections disclose loose aggregates of
malignant round cells exhibiting marked
hyperchromasia, anisoneuclosis and
prominent nucleoli. These have marked
eosinophilia and moderate polymorphism.
Some tumor giant cells are seen. These are
admixed with necrotic and inflammatory
material.
Paraclinical Diagnostic Procedures

Histopathology result (8/15/08)
MALIGNANT ROUND CELL TUMOR,
fragments of, admixed with
abscess material.
10x13 cm firm, nontender, slightly
movable, rapidly growing ulcerating
mass on the right gluteal area
Infectious
•Rapidly growing
•With associated fever
•Tenderness only upon
deep palpation in the
direction of the gluteal
area
Neoplastic
Sarcoma
Malignant Round Cell
Liposarcoma
Pretreatment Diagnosis:
Diagnosis
Certainty
Treatment
Malignant Round
Cell
Liposarcoma
95%
Surgical/
Neoadjuvant,
Adjuvant
Therapy
Gluteal Abscess
5%
Surgical/
Medical
TREATMENT

PRETREATMENT DIAGNOSIS:
MALIGNANT ROUND CELL
LIPOSARCOMA, RIGHT GLUTEAL
AREA
TREATMENT

GOALS OF TREATMENT:
– Curative extirpation of the tumor
TREATMENT OPTIONS
TREATMENT
BENEFIT
RISK
COST
AVAIL
En bloc Surgical
Resection
Removal of the
gross tumor.
Primary treatment
modality.2
Local recurrence if
done with
inadequate
margins.
Bleeding.
May require
contiguous organ
resection.2
++
Available
Pre-operative
Radiation Therapy
Allows early
multidisciplinary planning
while the tumor is
in place.1
Allows lower
doses to be
delivered to an
undisturbed
tissue bed that is
better
oxygenated.1
Difficulty with
pathological
assessment of
margins and
increased
incidence of
wound
complications.1
++++
Not readily
available
TREATMENT OPTIONS
TREATMENT
BENEFIT
Pre-operative
Size of the preRadiation Therapy operative
radiation fields
and the number
of joints
included in the
field are
significantly
smaller which
may result in an
improved
functional
outcome.1
RISK
COST
AVAIL
TREATMENT OPTIONS
TREATMENT
BENEFIT
Post-operative
Lower wound
Radiation Therapy complication
rate.
RISK
Larger radiation
field.
COST
++++
AVAIL
Not
readily
avalable
TREATMENT OPTIONS
TREATMENT
Brachytherapy
BENEFIT
RISK
Less radiation
scatter and
much shorter
duration of
therapy.2
Indicated only in
the setting of
high-grade
lesions.2
Rates of wound
complications
similar to those
of postoperative
external beam
radiotherapy.2
COST
++++
AVAIL
Not
readily
avalable
TREATMENT OPTIONS
TREATMENT
Adjuvant
systemic
chemotherapy
BENEFIT
Statistically
significant
improvements
in local
recurrence,
distal
recurrence,and
disease-free
survival rates
ranging from
6%-10%. 4%
improvement in
overall
survival.2
RISK
Potential
toxicity.2
COST
++++
AVAIL
Available
TREATMENT OPTIONS
TREATMENT
Neoadjuvant
systemic
chemotherapy
BENEFIT
RISK
Ability to assess Potential toxicity
tumor
responsiveness
to the give
chemotherapeutic
agents, early
treatment of
metastatic
disease, and
downstaging of
primary tumor.2
COST
++++
AVAIL
Available
TREATMENT OF CHOICE
WIDE RESECTION AND POSTOPERATIVE RADIATION THERAPY
PREOPERATIVE PREPARATION
Informed consent
 Psychosocial support
 Optimize patient’s health
 Screen for any condition that will
interfere with treatment
 Prepare materials

OPERATIVE TECHNIQUE

Patient supine under CLEA
 Asepsis/Antisepsis
 Sterile drapes placed
 Intraoperative findings noted: Mass noted
to have extended partially to the serosal
layer of the rectum and outermost layer of
the sphincter muscle. Gluteus maximus
muscle mass and sciatic nerve intact.
OPERATIVE TECHNIQUE
Wide excision with 1 cm margin; flap
created.
 Hemostasis
 Placement of drain
 Correct sponge and instrument
count
 Apposition of flap with silk 2-0
 Dry sterile dressing

OPERATION DONE:
WIDE RESECTION OF RIGHT GLUTEAL MASS
POST OPERATIVE DIAGNOSIS
Malignant round cell tumor
(liposarcoma), right gluteal area
*Final histopathology report still
pending
SHARING OF INFORMATION
SARCOMAS



Refer to tumors that show evidence
of mesenchymal differentiation.
1% of adult malignancies
15% of pediatric malignancies
•
Singer S, Canter RJ: Soft-tissue sarcoma, in Cameron JL (ed):
Current Surgical Therapy 9th Ed. Philadelphia, Mosby, 2008, pp
1101-1105
EXTREMITY SARCOMAS

Account for nearly 50% of adult
sarcomas.
•
Singer S, Canter RJ: Soft-tissue sarcoma, in Cameron JL (ed):
Current Surgical Therapy 9th Ed. Philadelphia, Mosby, 2008, pp
1101-1105
EXTREMITY SARCOMAS

Most common types :
–
–
Liposarcoma
Malignant Fibrous Histiocytoma (MFH)
•
Singer S, Canter RJ: Soft-tissue sarcoma, in Cameron JL (ed):
Current Surgical Therapy 9th Ed. Philadelphia, Mosby, 2008, pp
1101-1105
EXTREMITY SARCOMAS

Liposarcomas:
–
–
–
Well-differntiated
Myxoid/ round-cell
Pleomorphic
•
Singer S, Canter RJ: Soft-tissue sarcoma, in Cameron JL (ed):
Current Surgical Therapy 9th Ed. Philadelphia, Mosby, 2008, pp
1101-1105
EXTREMITY SARCOMAS

Diagnosis
–
–
–
Comprehensive history and PE
Mass is the most common presenting
complaint
Frequently, a trivial traumatic event draws
attention to the area (although there is
probably no causal relation between a
history of trauma and the development of a
sarcoma).
•
Singer S, Canter RJ: Soft-tissue sarcoma, in Cameron JL (ed): Current
Surgical Therapy 9th Ed. Philadelphia, Mosby, 2008, pp 1101-1105
EXTREMITY SARCOMAS

Diagnosis
–
Core needle biopsy

Typically performed as the first step

Can diagnose the presence of a sarcoma
and grade it in 80% of the cases.

For histologic type, it has an accuracy of
75%.
•
Singer S, Canter RJ: Soft-tissue sarcoma, in Cameron JL (ed): Current
Surgical Therapy 9th Ed. Philadelphia, Mosby, 2008, pp 1101-1105
EXTREMITY SARCOMAS

Staging
– Primary Tumor (T)



Tx – primary tumor cannot be assessed
T0 – no evidence of primary tumor
T1 – tumor is < or equal to 5 cm in its
greatest dimension
•
•
T1a – tumor is above the superficial fascia
T1b – tumor invading or deep to the
superficial fascia
•
Delamn KA, Cormier JN: Soft-tissue and bone sarcoma, in Feig BW,
Berger DH, Fuhrman GM (ed): The M.D. Anderson Surgical Oncology
Handbook 4th ed . Philadelphia, Lippincott Williams and Wilkins, 2006, pp
125
EXTREMITY SARCOMAS

Staging
– Primary Tumor (T)

T1 – tumor is > 5 cm in its greatest
dimension
•
•
T2a – tumor is above the superficial fascia
T2b – tumor invading or deep to the
superficial fascia
•
Delamn KA, Cormier JN: Soft-tissue and bone sarcoma, in Feig BW,
Berger DH, Fuhrman GM (ed): The M.D. Anderson Surgical Oncology
Handbook 4th ed . Philadelphia, Lippincott Williams and Wilkins, 2006, pp
125
EXTREMITY SARCOMAS

Regional Lymph Nodes (N)
– Nx – regional lymph nodes cannot be
assessed
– N0 – no regional lymph node
metastasis
– N1 – Regional lymph node metastasis
•
Delamn KA, Cormier JN: Soft-tissue and bone sarcoma, in Feig BW,
Berger DH, Fuhrman GM (ed): The M.D. Anderson Surgical Oncology
Handbook 4th ed . Philadelphia, Lippincott Williams and Wilkins, 2006, pp
125
EXTREMITY SARCOMAS

Distant Metastasis (M)
– Mx – distant metastasis cannot be
assessed
– M0 – no distant mmetastasis
– M1 – distant metastasis
•
Delamn KA, Cormier JN: Soft-tissue and bone sarcoma, in Feig
BW, Berger DH, Fuhrman GM (ed): The M.D. Anderson Surgical
Oncology Handbook 4th ed . Philadelphia, Lippincott Williams
and Wilkins, 2006, pp 125
EXTREMITY SARCOMAS

Histopahological Grade (G)
– Gx – Grade cannot be assessed
– G1 – well-differentiated
– G2 – Moderately differentiated
– G3 – poorly differentiated
– G4 - undifferentiated
•
Delamn KA, Cormier JN: Soft-tissue and bone sarcoma, in Feig BW,
Berger DH, Fuhrman GM (ed): The M.D. Anderson Surgical Oncology
Handbook 4th ed . Philadelphia, Lippincott Williams and Wilkins, 2006, pp
125
EXTREMITY SARCOMAS

Stage Grouping
– Stage 1


A – G1-2, T1a-1b, N0, M0
B – G1-2, T2a, N0,M0
•
Delamn KA, Cormier JN: Soft-tissue and bone sarcoma, in Feig
BW, Berger DH, Fuhrman GM (ed): The M.D. Anderson Surgical
Oncology Handbook 4th ed . Philadelphia, Lippincott Williams
and Wilkins, 2006, pp 125
EXTREMITY SARCOMAS

Stage Grouping
– Stage II



A – G1-2, T2b, N0, M0
B – G3-4, T1a-1b, N0,M0
C – G3-4, T2a, N0,M0
•
Delamn KA, Cormier JN: Soft-tissue and bone sarcoma, in Feig
BW, Berger DH, Fuhrman GM (ed): The M.D. Anderson Surgical
Oncology Handbook 4th ed . Philadelphia, Lippincott Williams
and Wilkins, 2006, pp 125
EXTREMITY SARCOMAS

Stage Grouping
– Stage III

G3-4, T2b, N0,M0
•
Delamn KA, Cormier JN: Soft-tissue and bone sarcoma, in Feig
BW, Berger DH, Fuhrman GM (ed): The M.D. Anderson Surgical
Oncology Handbook 4th ed . Philadelphia, Lippincott Williams
and Wilkins, 2006, pp 125
EXTREMITY SARCOMAS

Stage Grouping
– Stage IV


Any G, Any T, N1, M0
Any G, Any T, N0, M1
•
Delamn KA, Cormier JN: Soft-tissue and bone sarcoma, in Feig
BW, Berger DH, Fuhrman GM (ed): The M.D. Anderson Surgical
Oncology Handbook 4th ed . Philadelphia, Lippincott Williams
and Wilkins, 2006, pp 125
TREATMENT OPTIONS
TREATMENT
BENEFIT
RISK
COST
AVAIL
En bloc Surgical
Resection
Removal of the
gross tumor.
Primary treatment
modality.2
Local recurrence if
done with
inadequate
margins.
Bleeding.
May require
contiguous organ
resection.2
++
Available
Pre-operative
Radiation Therapy
Allows early
multidisciplinary planning
while the tumor is
in place.1
Allows lower
doses to be
delivered to an
undisturbed
tissue bed that is
better
oxygenated.1
Difficulty with
pathological
assessment of
margins and
increased
incidence of
wound
complications.1
++++
Not readily
available
TREATMENT OPTIONS
TREATMENT
BENEFIT
Pre-operative
Size of the preRadiation Therapy operative
radiation fields
and the number
of joints
included in the
field are
significantly
smaller which
may result in an
improved
functional
outcome.1
RISK
COST
AVAIL
TREATMENT OPTIONS
TREATMENT
BENEFIT
Post-operative
Lower wound
Radiation Therapy complication
rate.
RISK
Larger radiation
field.
COST
++++
AVAIL
Not
readily
avalable
TREATMENT OPTIONS
TREATMENT
Brachytherapy
BENEFIT
RISK
Less radiation
scatter and
much shorter
duration of
therapy.2
Indicated only in
the setting of
high-grade
lesions.2
Rates of wound
complications
similar to those
of postoperative
external beam
radiotherapy.2
COST
++++
AVAIL
Not
readily
avalable
TREATMENT OPTIONS
TREATMENT
Adjuvant
systemic
chemotherapy
BENEFIT
Statistically
significant
improvements
in local
recurrence,
distal
recurrence,and
disease-free
survival rates
ranging from
6%-10%. 4%
improvement in
overall
survival.2
RISK
Potential
toxicity.2
COST
++++
AVAIL
Available
TREATMENT OPTIONS
TREATMENT
Neoadjuvant
systemic
chemotherapy
BENEFIT
RISK
Ability to assess Potential toxicity
tumor
responsiveness
to the give
chemotherapeutic
agents, early
treatment of
metastatic
disease, and
downstaging of
primary tumor.2
COST
++++
AVAIL
Available
MCQ
1. Sarcomas comprise how much of
adult malignancies?
a. 1%
b. 3%
c. 15%
d. 20%
MCQ
1. Sarcomas comprise how much of
adult malignancies?
a. 1%
b. 3%
c. 15%
d. 20%
MCQ
2. Sarcomas comprise how much of
pediatric malignancies?
a. 1%
b. 3%
c. 15%
d. 20%
MCQ
2. Sarcomas comprise how much of
pediatric malignancies?
a. 1%
b. 3%
c. 15%
d. 20%
MCQ
3. Extremity sarcomas comprise how
much of adult sarcomas?
a. 10%
b. 30%
c. 50%
d. 20%
MCQ
3. Extremity sarcomas comprise how
much of adult sarcomas?
a. 10%
b. 30%
c. 50%
d. 20%
MCR
A – 1, 2, and 3 are correct
B – 1 and 3 are correct
C – 2 and 4 are correct
D – only 4 is correct
E – none are correct
MCR
I. Which of the following represents
stage I soft-tissue sarcoma?
1. G1-2, T1a-T1b, N0,M0
2. G1-2, T2b, N0, M0
3. G1-2, T2a, N0,M0
4. Any G, Any T, N1, M0
MCR
I. Which of the following represents
stage I soft-tissue sarcoma?
1. G1-2, T1a-T1b, N0,M0
2. G1-2, T2b, N0, M0
3. G1-2, T2a, N0,M0
4. Any G, Any T, N1, M0
MCR
I. Which of the following represents
stage III soft-tissue sarcoma?
1. G1-2, T1a-T1b, N0,M0
2. G1-2, T2b, N0, M0
3. G3-4, T2a, N0,M0
4. G3-4, T2b, N0, M0
MCR
I. Which of the following represents
stage III soft-tissue sarcoma?
1. G1-2, T1a-T1b, N0,M0
2. G1-2, T2b, N0, M0
3. G3-4, T2a, N0,M0
4. G3-4, T2b, N0, M0
THANK YOU!!!
REFERENCES


Delman KA, Cormier JN: Soft-tissue and bone sarcoma, in
Feig BW, Berger DH, Fuhrman GM (ed): The M.D. Anderson
Surgical Oncology Handbook 4th ed . Philadelphia,
Lippincott Williams and Wilkins, 2006, pp 125
Singer S, Canter RJ: Soft-tissue sarcoma, in Cameron JL
(ed): Current Surgical Therapy 9th Ed. Philadelphia, Mosby,
2008, pp 1101-1105
JOURNAL CRITICAL APPRAISAL
Spinal metastases from myxoid
liposarcoma warrant screening with
magnetic resonance imaging
Joseph H. Schwab, MD 1, Patrick J. Boland, MD 1, Cristina Antonescu,
MD 2, Mark H. Bilsky, MD 3, John H. Healey, MD 1 *
1Department of Surgery, Orthopedic Service, Memorial SloanKettering Cancer Center, New York, New York
2Department of Pathology, Memorial Sloan- Kettering Cancer Center,
New York, New York
3Department of Surgery, Orthopedic and Neurosurgery Services,
Memorial Sloan-Kettering Cancer Center and Medical College of
Cornell University, New York, New York
email: John H. Healey ([email protected])
*Correspondence to John H. Healey, Department of Surgery,
Orthopedic Service, Memorial Sloan-Kettering Cancer Center, 1275
York Avenue, Suite A342, New York, NY 10021
ABSTRACT

Background:
– Myxoid liposarcoma (MLS) has an
unusual tendency for extrapulmonary
metastasis, particularly to the spine and
soft tissues. The objective of this study
was to determine the prevalence of
spinal metastasis, treatment outcomes,
and optimal screening method for
spinal metastasis in patients with MLS.
ABSTRACT

Methods:
– Data from patients with had spinal metastases
were obtained from the authors' institutional
soft tissue sarcoma database. The accuracy
with which positron emission tomography
(PET) scans and bone scans identified
metastatic lesions was compared with the
accuracy of magnetic resonance imaging
(MRI). Clinical response to treatment was
based on pain, neurologic scores, and
survivorship analysis.
ABSTRACT

Results:
– There were 33 patients who developed
spinal metastasis after a median 36
months of follow-up (range, from 7.5
months to 33 years). Known spinal
metastases were detected by bone
scans in 16% of patients and by PET
scans in 14% of patients.
ABSTRACT

Results:
– Patients who underwent surgery had high-
grade spinal cord compression more often
than patients who did not undergo surgery
(72% vs 19%, respectively; P = .002). Pain and
neurologic function were improved or
maintained in all patients who received
radiation alone (n = 8 patients) and in all but 1
patient who underwent surgery (n = 18
patients). The median overall survival was 51.4
months from the time of primary diagnosis and
21.9 months from the time of first metastasis.
ABSTRACT

Conclusions:
– Bone scans and PET scan lack sufficient
sensitivity to detect spinal metastasis from
MLS. Treatment of metastasis is palliative, but
local treatment can yield long-term disease
control in select patients. Screening with
whole-spine MRI may lead to the earlier
detection of spinal metastasis. Cancer 2007. ©
2007 American Cancer Society.
Appraisal Guide:
THERAPY OR PREVENTION
Are the results of the study valid?
Primary Guides:
Was the assignment of patients to treatments randomized?
– NO. Data from patients with had spinal
metastases were obtained from the authors'
institutional soft tissue sarcoma database.
Appraisal Guide:
THERAPY OR PREVENTION
Are the results of the study valid?
Primary Guides:
Were all patients who entered the trial properly accounted
for and attributed at its conclusion?
YES. All 33 MLS patients with spinal metastasis were
accounted for.
Appraisal Guide:
THERAPY OR PREVENTION
Are the results of the study valid?
Primary Guides:
Was followup complete?
YES.
Appraisal Guide:
THERAPY OR PREVENTION
Are the results of the study valid?
Primary Guides:
Were patients analyzed in the groups to which
they were randomized?
YES.
Appraisal Guide:
THERAPY OR PREVENTION
Are the results of the study valid?
Secondary Guides:
Were patients, health workers, and study personnel
"blind" to treatment?
NO.
Appraisal Guide:
THERAPY OR PREVENTION
Are the results of the study valid?
Secondary Guides:
Were the groups similar at the start of the trial?
YES.
Appraisal Guide:
THERAPY OR PREVENTION
Are the results of the study valid?
Secondary Guides:
Aside from the experimental intervention, were the groups
treated equally?
YES.