Virginia A. Moyer, MD, MPH Professor of Pediatrics Baylor College of Medicine

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1 Virginia A. Moyer, MD, MPH Professor of Pediatrics Baylor College of Medicine

2 I have no conflicts to declare related to this presentation With great appreciation to Alan Schroeder, MD, Director, PICU, Santa Clara Valley Medical Center

3 The problem is: Which half?

4 Always use (100%) oxygen for resuscitation Every child should have a voiding cystourethrogram (VCUG) after the first urinary tract infection Intubate and suction every meconium-stained baby to prevent meconium aspiration Treat osteomyelitis with at least 6 weeks of intravenous antibiotics Screen all adolescents for scoliosis

5 What we used to know: Hypoxia is always bad for you, therefore you should administer 100% oxygen any time a baby requires resuscitation oxygen should be used, it is not toxic and there is no reason to be concerned International Liaison Committee on Resuscitation guidelines for newborn resuscitation Don t lose any Apgar points for blue color!

6 Meta-analysis of 10 studies, 2134 term or preterm infants in need of resuscitation Mortality: 12.8% in infants resuscitated with 100% 8.2% in infants resuscitated with 21% oxygen NNT = 25 Subgroup analysis of the highest quality studies: 3.9% vs. 1.2% mortality O.D. Saugstad, S. Ramji and M. Vento, Biol Neonate, 87 (2005), pp

7 resuscitation with ambient air reduces time to first breath to 30 s, and increases heart rate at 90 s of age and 5 min Apgar score. Normal infants are born with O2 saturation of <60%, and can take up to 10 minutes to reach >90% Hyperoxia is toxic

8 it is best to begin resuscitation with air rather than 100% oxygen. Administration of supplementary oxygen should be guided by oximetry monitored from the right upper extremity.

9 Reflux of infected urine is the primary cause of End Stage Renal Disease, so we must aggressively evaluate for reflux and provide prophylaxis if reflux is found to children after a single uncomplicated lower urinary tract infection. Maybe we should image their siblings as well.

10 The incidence of childhood UTI is about 5% (50,000 per million), the incidence of ESRD due to reflux nephropathy is 5 per million thus at most, only 1 in 10,000 children with UTI develops ESRD. Meta-analyses of RCTs show no benefit to prophylaxis no difference in recurrence rate, no difference in renal scarring. VCUG is invasive, time consuming and expensive

11 New AAP and NICE guidelines do not recommend VCUG after the first febrile UTI, and do not recommend prophylactic antibiotics Ultrasound imaging remains controversial

12 We prevent meconium aspiration by tracheal suctioning of the meconium-stained infant before the first breath, even if the baby is vigorous Based on physiological reasoning and conflicting studies of low methodological quality Tube to mouth suctioning has been recommended and used

13 RCT of antepartum suctioning of the mouth and oropharynx 2514 infants >37wks randomized to naso- and oropharyngeal suctioning before delivery No difference in any outcome (MAS 4% vs 4%) RCT of postpartum endotracheal suctioning 2094 infants >37wks randomized to intubation and suctioning or to expectant management No difference in outcome (MAS 3.2% vs. 2.7%), 3.8% of intubated infants had mild complications of intubation

14 Vigorous babies do not benefit from intubation and suctioning to prevent meconium aspiration Unfortunately, we still do it 30-50% in several surveys sometimes or always suction meconium stained infants.

15 Osteomyelitis must be treated with long term intravenous antibiotics

16 1969 patients at 29 children s hospitals, no Pediatrics 2009 difference in recurrence rates in long (defined by placement of a PICC) vs short IV course 3.4% of PICC line group got readmitted for complication

17 Short term IV therapy followed by oral therapy is just as effective and results in fewer complications. But we are still using long term IV therapy

20 Arch Int Med, May 2010

21 The greatest threat to America s fiscal health is not Social Security. It s not the investments that we ve made to rescue our economy during this crisis. By a wide margin, the biggest threat to our nation s balance sheet is the skyrocketing cost of health care. It s not even close. Barack Obama, March 2009

22 Total per person spent on health care Copyright 2008 by Project HOPE, all rights reserved. Gerard F. Anderson and Bianca K. Frogner, Health Spending In OECD Countries: Obtaining Value Per Dollar, Health Affairs, Vol 27, Issue 6,

23 7 6 US Rank: 29/ CzechRep US England Singapore Cuba

25 No. of MRI Units/Million Persons United States Switzerland Germany OECD Netherlands Canada Median United Kingdom France Australia Data are from the organization for Economic Cooperation and Development (OECD) Health Data NEJM 360:10 3/5/2009

26 Decades of observational studies supporting the use of estrogen or estrogen/progester one in postmenopausal women to prevent CAD. In 1990 s, ~15 million users/year

27 Women s Health Initiative: RCT of ~17,000 women Treatment increased hazard ratio of (all significant): CHD: 1.3 CVA: 1.4 PE: 2.1 Breast CA: 1.3 Colon CA 0.6 Hip Fx 0.6 No change in total mortality But, absolute increase in risk of any negative event = 19 events per 10,000 person-years Rossouw, JAMA 2002

28 Lessons: Spending billions but net harm Residual confounding and the limitations of observational studies Implications for pediatrics, where RCTs are rare

29 Why? Screening tests for pre- symptomatic disease, though they may save lives, generally take well people and make them unwell Biases of screening tests RCT example: PSA

30 Lead time bias Length time bias Stage migration bias Healthy volunteer bias Overdiagnosis

31 A screening test can pick up a disease earlier and therefore appear to improve survival Survival after diagnosis Biologic Onset Detectable by screening Diagnosed from symptoms Death Lead time Survival after diagnosis Biologic Onset Detectable by screening Diagnosed By screening Death

32 Screening tends to pick up disease that is more slowly progressive. acponline.com, 199

33 Newer, more sensitive tests lead to less severe disease and a better prognosis at each stage The Will Rogers Phenomenon: When the Okies left Oklahoma and moved to California, it raised the I.Q. of both states.

34 Randomized trial, with overall mortality as primary outcome

35 PSA testing supported by many population-based studies 30 million men get tested each year = $3B Prostate CA found in autopsy of 30% of men in their 50 s, 80% of men in their 70 s (Breslow, -- Int J Cancer, 2006)

36 77,000 men aged Annual PSA/rectal vs control Screening group: 2820 cancers, 2 deaths/10,000 person yea Control group: 2322 cancers, 1.7 deaths/10,000 person ye

37 182,000 men aged PSA once every 4 years vs control 8.2% vs 4.8% incidence of cancer Absolute risk difference for death =.71 death per 1000 men Screen 1410 men and treat 48 cases of cancer to prevent one death

38 Meta-analysis (Djubelgovic et al, BMJ 2010): 6 RCTs RR of prostate CA = 1.46 ( ) Overall RR of mortality 0.99 ( )

39 I never dreamed that my discovery four decades ago would Lead to such a profit-driven public health disaster.

40 When used appropriately can and do save lives But: Costly and subject to multiple biases May make well people unwell Harmful interventions for diseases that never would have caused a problem Pediatrics?

43 In general Medicare costs by state inversely proportional to outcomes

44 Instead of: Don t just stand there, do something! Don t just do something, stand there!

45 Pressure from families Pressure from colleagues Eminence- based medicine Sins of omission vs sins of commission May be misconstrued as rationing More often feels safer and alleviates uncertainty Hard to sit and do nothing Worse with inexperience Worse when stakes are high

46 Time Medical Education Publication bias Malpractice concerns Perverse incentives

47 How? RCTs are costly and time consuming but are the gold standard Practice variability is a natural experiment and may be a key to progress

48 12,333 infants < 6 months at 24 children s hospital. Treatment failure in 1.6% of short course ( 3 days) and 2.2% of long course ( 4 days) 1000 kids (~30%) < 1 month got short course!

50 21 days of IV Abx for E Coli meningitis if baby looks great at day 2? 9 months of INH prophylaxis for TB? 48 hours of IV Abx for febrile neonate?

51 Instead of If we re drawing blood, might as well throw in a blood culture A blood Cx costs $xx, and because the probability of a bacterial bloodstream infection is so low, the risk of harm from yielding a contaminant far outweighs the risk of benefit from yielding a true pathogen.

52 To be safe, let s just watch him another night. To be safe, let s take out his IV and send him home.

53 Well, it s a pretty benign test. No test is benign.

54 We need a diagnosis. In this case, arriving at a diagnosis will not improve this patient s life, but will worsen pain and suffering

55 Connect physicians with the cost of healthcare Disconnect reimbursement from utilization Compensate MDs for how they do, not what they do Introduce safely doing less into the patient safety dialogue Remind our patients and our trainees: unanticipated harms constantly reevaluate what we accept as standard of care Primum no nocere

Urinary Tract Infections in Infants & Toddlers: An Evidence-based Approach. No disclosures. Importance of Topic 5/14/11. Biases

Urinary Tract Infections in Infants & Toddlers: An Evidence-based Approach Thomas B. Newman, MD, MPH Professor of Epidemiology & Biostatistics and Pediatrics University of California, San Francisco May