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									Evidence Based Medicine and Level 1
  Outcomes Research in Pediatric

      George W. Holcomb, III, M.D., MBA
          Children’s Mercy Hospital
            Kansas City, Missouri

   Center for Prospective Clinical Trials
The Right People

               Good to Great
  Evidence Based Medicine

• Integration of best research evidence with
 clinical expertise and patient values

• Treating patients based on data, not
 “feeling” (gestalt), or one’s own experience
             Levels of Evidence
A clinical surgeon publishes a retrospective review of 350
patients over 20 years undergoing an endorectal pull-
through (Soave procedure) for Hirschsprung’s Disease.
This is felt to be a seminal paper on this disease in infants
and children. What is the level of evidence for this

Level 1    (A)
Level 2    (B)
Level 3    (C)
Level 4    (D)
Level 5    (E)
           Levels Of Evidence
5 – Expert opinion, or applied principles from
    physiology, basic science, or other conditions
4 – Case series or poor quality case control and
    cohort studies
3 – Case control studies
2 – Review of case control or cohort studies with
    agreement or poor quality randomized trial
1 – Prospective, randomized controlled trials
                   Levels of Evidence
5.       Expert opinion, or applied principles from
         physiology, basic science, or other conditions

     •      Leave patient intubated and paralyzed for 3-5
            days following an esophageal resection to take
            tension off esophageal anastomosis
            No data – no study to show intubated/paralyzed patient has
            less esophageal tension

     •      Transverse incision is used for abdominal
            exploration in baby b/c better exposure
            No data to support this practice
            Levels of Evidence
4. Case series or poor quality case control and
   cohort studies


  1) Paper reviewing results from one approach
     to a disease
      Large retrospective review of Soave operation for
      Hirschsprung’s Disease
           Levels of Evidence
3. Case control studies


  1) Paper showing different management
     strategies/operative technique for one
     disease process
      Single center (or multicenter) retrospective review
      of Duhamel vs Soave operation for
      Hirschsprung’s Disease
               Levels of Evidence

2.    Review of case control or cohort (followed “long-
      term”) studies with agreement or a poorly performed
      prospective randomized trial

     1) Review of two or three large series describing one
        management strategy (Soave procedure)
        compared to two or three large series describing
        another management strategy (Duhamel
   Levels of Evidence

1. Prospective randomized trials
 Children’s Mercy Hospital
Focus on common conditions which are
  •   Pyloric stenosis
  •   Perforated appendicitis
  •   Pectus excavatum
  •   Fundoplication for reflux
  •   Empyema
  •   Non-palpable intra-abdominal testis
Complicated cases (relatively rare) best
suited for multi-institutional trials:

 • Choledochal cyst
 • Esophageal atresia
 • Pulmonary lobectomy
 • Pull-through for high imperforate anus

But, need good infrastructure at each

• There is a lot more to an MIS operation
  than just technique

• Postoperative care is also important and
  open for study (antibiotics?, pain
  management?, etc.)
  Open vs Lap Pyloromyotomy
• Lap vs Open – 2003 - controversial around the world
  and in our hospital
• Different feeding regimens used in our hospital (2
  hours, 4 hours, 6 hours)
• Different postoperative pain management strategies
• Differences between staff made it difficult for residents,
  NPs, floor nurses
• Benefits: single protocol for feeding, pain management,
  discharge used in study still used currently (6 years
• No level 1 data
                   OPEN (n = 100)      LAP (n = 100)     P value
                   (Mean +/- S.E.)   (Mean +/- S.E.)
OR time (mins)     19:28 +/- 0.60    19:34 +/- 0.78       0.93

Emesis (#)           2.61 +/- 0.27    1.84 +/- 0.23       0.05

Full Feeds (hrs)    21:01 +/- 2.16   19:30 +/- 1.46       0.43

LOS (hrs)           33:10 +/- 1.63   29:38 +/- 1.69       0.12

Tylenol (doses)     2.23 +/- 0.18     1.59 +/- 0.16       0.01

                                          Ann Surg 244:363-370, 2006
   Cosmetic Outcome
Open              Lap
2. Thoracoscopy vs Fibrinolysis
        for Empyema
       Treatment Of Empyema
• Fibrinolysis had been shown to be better than
  chest tube drainage alone in several retrospective

• Primary thoracoscopic debridement had been
  shown to better that tube drainage alone in
  several retrospective studies

• At the initiation of this study, there were no
  comparative data between primary
  thoracoscopic debridement and fibrinolysis as
  initial treatment for empyema in children
              Study Population
               Inclusion Criteria
• Under 18 years of age
   Septation or loculation seen on ultrasound or
    computed tomography
   Greater than 10,000 white blood cells identified on
    pleural tap

              Exclusion Criteria
 •   Immunodeficiency process
 •   Secondary condition that would limit
               Sample Size

• Using our own institution’s retrospective
  data on length of hospitalization after
  intervention between thoracoscopic
  debridement and fibrinolysis with an alpha
  0.05 and power of 0.8

• Sample size of 36 with 18 in each arm
        Empyema Study Protocol
•   12 Fr tube placed by IR or surgery in procedure
•   4mg tPA in 40ml NS given into tube on insertion
    and each day for 3 doses

•   Thoracoscopic debridement with chest tube left
    behind on – 20 cm H20 suction
                            APSA, 2008
                            J Pediatr Surg 44:106-111, 2008
     Empyema Study Protocol
      Primary Outcome Measure

• Length of hospitalization after
  intervention (tPA or thoracoscopic
  debridement) until discharge criteria met
  (chest tube removed, afebrile & oral

                      APSA, 2008
                      J Pediatr Surg 44:106-111, 2008
   Empyema Study Protocol
    Secondary Outcome Measure

• Days of Tmax > 38CDays of tube
• Doses of analgesia

• Days of oxygen requirement

• Hospital charges after intervention

• Procedure charges
                       APSA, 2008
                       J Pediatr Surg 44:106-111, 2008
                   Study Results
      Patient Variables at Consultation
                     VATS         tPA               P value
Age (Years)           4.8           5.2                0.77

Weight (kg)          24.6         20.7                 0.52

WBC                  20.8         19.7                 0.71

O2 support (L/min)    0.81          0.79               0.96

Days of Symptoms      9.0         10.6                 0.32

ER/PCP visits         2.9           2.7                0.69
                             J Pediatr Surg 44:106-111, 2008
                    Study Results
                     VATS               tPA              P value
LOS (Days)             6.89                6.83                0.96

O2 tx (Days)           2.25                2.33                0.89

PO Fever (Days)        3.1                 3.8                 0.46

Analgesic doses      22.3                 21.4                 0.90

Patient Charges    $11,660               $7,575                0.01

                  16.6% failure rate for fibrinolysis
                                      J Pediatr Surg 44:106-111, 2008
   London Prospective Trial
  VATS v Fibrinolysis w/Urokinase

• No difference in LOS (6 v 6 days)

• No difference in 6 month CXR

• VATS more expensive ($11.3K v $9.1K)

• 16 % failure rate for fibrinolysis

                 Am J Respir Crit Care Med 174:221-227, 2006

• There appears to be no therapeutic or
  recovery advantages to thoracoscopic
  debridement compared to fibrinolysis as the
  primary treatment for empyema

• Thoracoscopy results in significantly higher
  patient charges

                              J Pediatr Surg 44:106-111, 2008
3. Complete esophageal mobilization
   vs minimal mobilization during
     laparoscopic fundoplication
   Prospective Randomized Trial
        Primary Outcome Measure
• Transmigration of fundoplication wrap

      2 centers participating
      Powered at 360 patients (12%vs 5%)
      All patients get upper GI study at 1 yr
      Study closed at interim analysis (177 pts)
      Presentation at APSA, 2010
    PRCT’s Now Enrolling

• Epidural vs PCA for pain control after
 MIS pectus repair (Nuss procedure)

• Sample size of 110 Patients (now at 109)

• APSA, 2011
          PRCTs Now Enrolling
• Burn study – SSD vs collagenase
• One stage vs 2 stage laparoscopic orchiopexy for intra-
  abdominal testis
• Standardized feeding protocol vs ad lib feedings
  following laparoscopic pyloromyotomy
• Esophago-crural sutures vs no sutures at laparoscopic
  fundoplication (both groups receive minimal esophageal
• SSULS appendectomy vs 3 port lap appendectomy
• SSULS cholecystectomy vs 4 port lap cholecystectomy
• Irrigation/suction vs suction alone in patients with
  perforated appendicitis
         Why Do This?

Manage patient according to evidence:

Evidence based medicine allows us to treat
patients on objective data rather than our
own opinions which are fraught with
anecdotal experience and may not
represent the best care for the patient


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