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Can We Simplify the Management of Complicated Pneumonia in Children?. Samir S. Shah, MD, MSCE. Divisions of Infectious Diseases and General Pediatrics The Children’s Hospital of Philadelphia Departments of Pediatrics and Biostatistics and Epidemiology

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Can we simplify the management of complicated pneumonia in children
Can We Simplify the Management of Complicated Pneumonia in Children?

Samir S. Shah, MD, MSCE

Divisions of Infectious Diseases and General Pediatrics

The Children’s Hospital of Philadelphia

Departments of Pediatrics and Biostatistics and Epidemiology

University of Pennsylvania School of Medicine


Objectives
Objectives Children?

  • Explore the use of administrative data to clarify the

    • changing epidemiology of pneumonia and complicated pneumonia

    • role of operative vs. non-operative interventions in the management of children with complicated pneumonia


Background pneumonia
Background: Pneumonia Children?

  • Community-acquired pneumonia (CAP) is a common serious bacterial infection in children

    • >600,000 hospitalizations in the U.S. each year

  • Up to one-third of children hospitalized with CAP have a pleural effusion (complicated pneumonia)



Case Children?

  • 3-year-old boy with cough and fever

  • Evaluated 2 weeks ago

    • Diagnosed with asthma and clinical pneumonia

    • Treated with albuterol and amoxicillin

  • Returns with continued cough and fevers to 39.2°C



Case chest ct
Case: Chest CT Children?


Changing epidemiology of invasive pneumococcal disease
Changing Epidemiology of Invasive Pneumococcal Disease Children?

  • Licensure of a 7-valent pneumococcal conjugate vaccine in 2000

    • Decrease in invasive pneumococcal infections

    • Subsequent increase in the rate of infections caused by

      • penicillin-resistant S. pneumoniae

      • serotypes not included in the current vaccine

  • Increasing prevalence of infections caused by methicillin-resistant S. aureus


National hospital discharges all ages
National Hospital Discharges Children?(all ages)

■= Bacteremia of any etiology

▲= Pneumococcal bacteremia

Shah SS, et al. Clin Infect Dis 2006;42:e1-5


Pneumococcal bacteremia by serotype category
Pneumococcal Bacteremia By Serotype Category Children?

♦=vaccine serotype

■=vaccine-related serotype

○=non-vaccine serotype

Steenhoff A, Shah SS, et al. Clin Infect Dis 2006;42:907-914


Invasive disease caused by penicillin susceptible and non susceptible pneumococci ages 2
Invasive Disease Caused by Penicillin-Susceptible and Non-susceptible Pneumococci (ages <2)

Kyaw MH, et al N Engl J Med 2006;354:1455-1463


What does this have to do with pneumonia? Non-susceptible Pneumococci (ages



Datasource national hospital discharge survey nhds
Datasource: National Hospital Discharge Survey (NHDS) over time?

  • Created by the National Center for Health Statistics

  • Includes only non-federal US hospitals

    • All hospitals with >1,000 beds

    • Representative sample of others based on location, size & specialty

    • Includes ~500 hospitals & 250,000 discharges each year

  • Weighting of records by hospital size/region allows for calculation of nationally representative estimates


Eligibility
Eligibility over time?

  • Inclusion

    • Ages 1-18 years

    • Discharged 1993-2006

    • Diagnosis of community-acquired pneumonia

  • Exclusion

    • Age <1 to eliminate bronchiolitis

    • Known underlying predisposition to pneumonia (e.g., malignancy, HIV, cystic fibrosis)


Definitions of pneumonia
Definitions of Pneumonia over time?

  • Community-acquired pneumonia (CAP)

    • Pneumonia as 1°diagnosis OR

    • Pneumonia-related symptom as 1° diagnosis (e.g., cough) & pneumonia as 2° diagnosis OR

    • Empyema or pleurisy as 1° diagnosis and pneumonia as 2° diagnosis

  • Sensitivity of 89% and specificity of 80% compared with medical record review

Whittle J, et al. Am J Med Qual 1997;12:187-193


Definitions of complications
Definitions of Complications over time?

Abbreviations: HUS, hemolytic-uremic syndrome; SIRS, systemic inflammatory response syndrome


Challenges
Challenges over time?

  • Accuracy of ICD-9 codes to identify conditions of interest

    • Does our definition exclude the sickest patients?

  • Change in ICD-9 codes over time (e.g., addition of 4th or 5th digits)

    • Review annual ICD-9 addendum

  • Complex survey statistics (i.e., sample weights) to calculate national estimates

    • May limit accuracy of data for subpopulations

  • Insufficient data in publicly available dataset to calculate standard errors for some subpopulations


Regional variation in pediatric cap hospitalizations pennsylvania
Regional Variation in Pediatric CAP Hospitalizations over time?(Pennsylvania)

Gorton CP, et al. Pediatrics 2006;117:176-180



Evolution of empyema
Evolution of Empyema complex and changing

  • Exudative

    • Neutrophil migration into pleural space

  • Fibrinopurulent

    • Fibrin deposition

    • Loculations impair lung expansion

  • Organizing

    • Fibroblast formation produces an inelastic membrane or “fibrinous peel”


Management of empyema
Management of Empyema complex and changing

  • Radiologic assessment

    • CXR (upright & decubitus)

    • Ultrasound

    • CT scan


Management of empyema1
Management of Empyema complex and changing

  • Surgical options

    • Thoracentesis (needle aspiration)

    • Tube thoracostomy (+ fibrinolysis)

    • Video-assisted thoracoscopy*

    • Thoracotomy*

*Require post-procedure thoracostomy tube


Management of empyema2
Management of Empyema complex and changing

  • No consensus on optimal initial drainage strategy

    • Technique?

    • Timing?


Why use administrative data to study complicated pneumonia
Why use administrative data to study complicated pneumonia? complex and changing

  • Sonnappa et al.

  • Kurt et al.

  • Avansino et al.

  • Li et al.

  • Shah et al.


Sonnappa et al
Sonnappa et al. complex and changing

  • 1st randomized study of VATS vs. thoracostomy tube drainage

  • 60 patients enrolled from January 2002 to February 2005

  • Groups similar in

    • Age & Sex

    • Preadmission symptoms

    • Effusion stage

    • Causative bacteria (mostly S. pneumoniae)

Sonnappa S. Am J Respir Crit Care Med 20006;174:221-227


Sonnappa et al1
Sonnappa et al. complex and changing

Kurt BA, et al. Pediatrics 2006;118:e547-e553


Kurt et al
Kurt et al. complex and changing

  • 1st randomized study of VATS vs. thoracostomy tube drainage in U.S.

  • 18 patients enrolled from November 2003-May 2005

  • Groups similar in

    • Age & sex

    • Preadmission symptoms & antibiotics

    • Effusion size

    • Presence of loculation

Kurt BA, et al. Pediatrics 2006;118:e547-e553


Kurt et al1
Kurt et al. complex and changing

Kurt BA, et al. Pediatrics 2006;118:e547-e553


Key differences
Key Differences complex and changing

  • Differences

    • Kurt et al. used substantially larger chest tubes (16-24 Fr vs. 8-10 Fr)

    • Sonnappa et al. used more aggressive fibrinolysis

    • LOS presented as mean (Kurt) or median (Sonnappa)

  • Limitations

    • Single centers

    • Few patients



Avansino et al
Avansino et al. definitively?

  • Systematic review of therapy for empyema (outcome data from 3781 children)

Avansino JR. Pediatrics 2005;115:1652-1659


Avansino et al1
Avansino et al. definitively?

  • In the pooled analysis, primary operative therapy reduced

    • LOS by 45% (199 patients, 4 studies)

    • Repeat procedures by 90% (492 patients, 9 studies)

    • Results biased towards favoring operative therapy

      • Non-operative group= needle thoracentesis or chest tube drainage

Avansino JR, et al. Pediatrics 2005;115:1652-9


Avansino et al limitations
Avansino et al. - Limitations definitively?

  • Poor study quality

    • No randomized studies performed at time of review

    • Inclusion only of small (all <70 patients) observational studies with heterogeneous study designs

  • Primary outcome of interest “therapeutic failure” not chosen a priori

  • Failure to adjust for confounding variables

    • Timing of intervention

    • Chemical fibrinolysis

    • Empiric antibiotic therapy


Where do things stand
Where do things stand? definitively?

  • Randomized studies

    • Small & single center

    • Multicenter studies difficult to conduct because prevailing personal & institutional dogmas

  • Pooled analyses

    • Few high quality studies

  • Administrative data

    • Seriously?


Li et al
Li et al. definitively?

  • 2003 Kids’ Inpatient Database

  • Inclusions

    • Age 0-18 years

    • ICD-9 codes for “empyema” (510.0 & 510.9)

  • Exclusions

    • Co-morbid illness

    • Transfer from another hospital

Li ST. Arch Pediatr Adolesc Med 2008;162:44-48


Li et al1
Li et al. definitively?

  • 1173 patients

  • Primary operative management (POM) vs. Non-operative management (NM)

    • POM= decortication within 2 days of admission

    • NM= everything else, including decortication 3 or more days after admission

Li ST. Arch Pediatr Adolesc Med 2008;162:44-48


Li et al2
Li et al. definitively?

Li ST. Arch Pediatr Adolesc Med 2008;162:44-48


Li et al limitations
Li et al. - Limitations definitively?

  • ICD-9 codes incomplete

    • Other codes that suggest effusion were not included

      • 511.1 – effusion, with mention of bacterial cause other than tuberculosis

      • 513.0 – abscess of lung

    • Diagnosis of pneumonia not required

      • Potential for inclusion of effusions not related to pneumonia (e.g., post-op)

  • NM group heterogeneous

    • For example, those drained early by chest tube may be different than those drained late by VATS and those never drained


Shah et al
Shah et al. definitively?

  • Pediatric Health Information System (PHIS)

    • Inpatient data from 27 not-for-profit, tertiary care, U.S. children’s hospitals

  • Inclusions

    • Age 12 months to 18 years of age

    • Discharged between 2001-2005

    • ICD-9 codes 510.0, 510,9, 511.1, or 513.0 as primary diagnosis plus pneumonia (480-486)

    • Pleural fluid drainage within 48 h of hospitalization

  • Exclusion

    • Co-morbid illness

Shah SS. Arch Pediatr Adolesc Med 2008;162:675-681


Shah et al phis study population
Shah et al. - PHIS Study Population definitively?

Shah SS. Arch Pediatr Adolesc Med 2008;162:675-681


Shah et al initial procedure
Shah et al. - Initial Procedure definitively?

Shah SS. Arch Pediatr Adolesc Med 2008;162:675-681


Shah et al procedure variation by hospital

Thoracotomy definitively?

%

OF

P

R

O

C

E

D

U

R

E

S

VATS

Chest

Tube

Hospital

Shah et al. - Procedure Variation by Hospital


Shah et al variation in los by hospital

MEDIAN definitively?

LOS

Hospital

Shah et al. - Variation in LOS by Hospital*

*7% of patients had a LOS >28 days


Shah et al change in los
Shah et al. - Change in LOS definitively?

Shah SS. Arch Pediatr Adolesc Med 2008;162:675-681


Shah et al repeat procedure
Shah et al. - Repeat Procedure definitively?

  • Repeat procedure

    • 298 (31%) overall required a repeat procedure

    • Percent requiring repeat procedure

      • 34% with primary chest tube

      • 8% with primary VATS

      • 24% with primary thoracotomy

Shah SS. Arch Pediatr Adolesc Med 2008;162:675-681


Shah et al variation in repeat procedures by hospital
Shah et al. - Variation in Repeat Procedures by Hospital definitively?

R

E

P

E

A

T

P

R

O

C

E

D

U

R

E

Hospital

Shah SS. Arch Pediatr Adolesc Med 2008;162:675-681


Shah et al repeat procedure1
Shah et al. - Repeat Procedure definitively?

Shah SS. Arch Pediatr Adolesc Med 2008;162:675-681


Shah et al summary
Shah et al. - Summary definitively?

  • Among the subset of children with complicated pneumonia who undergo early pleural drainage, VATS is associated with

    • 20% shorter LOS

    • Fewer repeat procedural interventions

Shah SS. Arch Pediatr Adolesc Med 2008;162:675-681



Background
Background definitively?

  • VATS is more expensive than primary chest tube placement in terms of physician and procedural costs

  • Are these additional costs are offset by associated reductions in length of stay and repeat procedures?

  • A recent decision analysis concluded that chest tube with fibrinolysis was the preferred strategy


Shah et al1
Shah et al. definitively?

  • Pediatric Health Information System (PHIS)

    • Inpatient data from 27 not-for-profit, tertiary care, U.S. children’s hospitals

  • Inclusions

    • Age 12 months to 18 years of age

    • Discharged between 2001-2005

    • ICD-9 codes 510.0, 510,9, 511.1, or 513.0 as primary diagnosis plus pneumonia (480-486)

    • Pleural fluid drainage within 48 h of hospitalization

  • Exclusion

    • Co-morbid illness

Shah SS. Arch Pediatr Adolesc Med 2008;162:675-681



Analytic approaches
Analytic approaches definitively?

  • Children undergoing VATS vs. chest tube likely differ in many respects

  • How can one handle confounding in an observational study?

    • Restriction

    • Matching

    • Adjustment in a regression model

    • Propensity scores


Propensity score
Propensity Score definitively?

  • Represents the probability of treatment

  • Estimated using logistic regression

    • Outcome = Treatment (i.e., VATS vs. chest tube)

    • Exposures = Measured characteristics of the study patients

  • In theory, patients with similar propensity scores should have a similar distribution of measured covariates


1 indications for propensity scores
1.) Indications for Propensity Scores definitively?

  • Theoretical advantages

    • Confounding by indication may cause treatment groups to differ dramatically

    • Comparison of propensity scores in exposed and unexposed subjects can identify these areas of non-overlap


2 indications for propensity scores
2.) Indications for Propensity Scores definitively?

  • Useful for matching subjects

    • Matching on propensity score outperforms other matching strategies with many covariates

    • Balance achieved will mimic randomization (for measured variables)


3 indications for propensity scores
3.) Indications for Propensity Scores definitively?

  • Improved estimation with few outcomes

    • Reliable estimates not possible with multivariable modeling when there are many covariates and few outcomes


4 indications for propensity scores
4.) Indications for Propensity Scores definitively?

  • Propensity score by treatment interactions

    • Can address possibility that the effectiveness of a drug may vary according to the strength of the indication for its use


5 indications for propensity scores
5.) Indications for Propensity Scores definitively?

  • Propensity score calibration to correct for measurement errors

    • A specific (and complicated) method that allows one to account for multiple unobserved confounders

      • Propensity score 1st created in a subgroup of patients that have detailed information available

      • This gold-standard propensity score is used to correct the main study effect of the drug on outcome


Rationale for analytic approach
Rationale for Analytic Approach definitively?

  • #1 Theoretical advantages

    • Confounding by indication may cause treatment groups to differ dramatically

    • Comparison of propensity scores in exposed and unexposed subjects can identify these areas of non-overlap

  • #2 Useful for matching subjects

    • Matching on propensity score outperforms other matching strategies with many covariates

    • Balance achieved will mimic randomization (for measured variables)


Approaches to propensity score analysis
Approaches to Propensity Score Analysis definitively?

  • Restriction

    • Restrict analysis to participants with sufficient overlap in scores

  • Matching

    • A science unto itself

  • Stratified analysis

    • Stratify analysis by score categories (e.g., quintiles)

  • Weighting

    • Case weight=score; control weight=inverse of 1 minus their score then apply sample weights in regression model

  • Regression

    • Treat propensity score as model covariate with treatment


Approaches to propensity score analysis1
Approaches to Propensity Score Analysis definitively?

  • All methods should produce similar results

  • What if there are differences?

    • Figure out why

    • Present the best analysis (i.e., the one perceived to be most accurate)


Practical considerations
Practical Considerations definitively?

  • Determine area under the ROC curve for propensity score

    • Rough rule of thumb, perhaps 0.7-0.9 is ok

    • Very high values suggest non-overlap of distribution of propensity scores between subjects

  • Visually compare propensity score distributions


Distribution of propensity scores
Distribution of Propensity Scores definitively?

  • AUC = 0.70


Distribution of propensity scores1
Distribution of Propensity Scores definitively?

  • Poor overlap of propensity scores between the 2 groups at the extreme quintiles

    • Restriction

    • Matching

    • Stratified analysis

    • Weighting

    • Regression



Total hospital charges vats vs chest tube
Total Hospital Charges: VATS vs. Chest Tube definitively?

*Multivariable model included age, race, sex, season, asthma, steroids, fibrinolysis, and empiric vancomycin receipt. Propensity score created using all of these variables.

**48 VATS patients matched with 7 patients, 1 matched with 5, 1 matched with 4


Propensity analysis
Propensity Analysis definitively?

  • Bottom line: VATS does not cost more than chest tube placement despite higher physician charges and additional operating room charges



What we think we know
What we think we know Children?

  • Early intervention reduces duration of hospitalization

  • Compared with chest tube placement, VATS

    • Modestly decreases LOS

    • Substantially decreases repeat procedures

    • Does not cost more

  • Chemical fibrinolysis does not affect key outcomes


What we don t know
What we don’t know Children?

  • Short-term outcomes

    • Affect of various procedures on frequency of local, systemic and metastatic complications

  • Long-term outcomes

    • Correlation with short-term outcomes

    • Impact of Impact of early vs. late intervention

    • Impact of early VATS vs. tube thoracostomy

  • Impact of changing epidemiology on short- and long-term outcomes


Thank You Children?


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