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EBM Process
• Ask a well built (focused) clinical
question
• Search for the best evidence to answer
the question
• Critically appraise the evidence
• Apply the evidence to the patient
2
Case Presentation
• 61y F w HTN, HFpEF, DM, CKD 4
presented to ED after labs in clinic
revealed acute on chronic renal failure
and hyperkalemia. Pt c/o SOB related to
recent CAP for which she had just
completed Abx. Pt treated for several
days with kayexylate, and high dose IV
lasix with minimal response and
worsening renal function 3
Search Strategy
• Why you chose your article – article
given to me by renal colleagues as
evidence our plan of ultrafiltration was a
bad idea
• Describe your search strategy –
– Cochrane for ‘heart failure ultrafiltration’
• Results of your search
– 5 studies were found which compared UF
with diuretics 4
• Bart BA, MD et al. Ultrafiltration in
Decompensated Heart Failure with
Cardiorenal Syndrome. NEJM. Nov. 6,
2012.
Reference
5
Article Conclusion
• The use of stepped pharmacologic-
therapy (diuretics) was superior to
ultrafiltration in preservation of renal
function with similar weight loss at 96
hours. Ultrafiltration was associated
with a higher rate of adverse events.
6
Critically Appraise the
Evidence
• Are the Results Valid?
• What are the results?
• Do the Results Apply to my patient and
the patients in my practice?
7
Are the results valid?
• Were the patients randomized? Yes
• Was randomization concealed? Yes
– Study design: Automated Web-based
system, patients were randomly assigned
in 1:1 ratio. Permuted block, stratification in
clinical sites.
8
Are the Results Valid?
• Were patients similar at baseline with respect
to prognostic factors? Probably
– Table 1: Some differences as expected with small
sample size of 188 pts.
– Ultrafiltration: older, lower wt, EF. More ischemia,
A-fib, on ACE, ↑ BNP, Bblockers,ACE,
– Pharm: More chf hosp in last year, DM, ↑BUN, ↑Cr
– All quartile ranges overlap
9
Are the Results Valid?
• Were all 5 groups blinded (pt, clinicians, data
collectors, outcome assessors, data
analystist)? No – this would be impossible to
do
• Discussion/limitations: Treatment
assignments not blinded, biases of
investigators may have effected treatment.
10
Are the Results Valid?
• How complete was follow-up? Fairly
complete
– 2 patients in ultrafiltration group not
included in 1°endpoint due to lack of
baseline Cr (1) and lack of all post baseline
Cr levels (1).
11
Are the Results Valid?
• Was the trial stopped early for benefit?
No.
– The study was stopped early for worse
outcomes and higher adverse event rate in
the ultrafiltration group.
– Stopped at 188 pt (planned 200 pt)
12
Are the Results Valid?
• Were patients analyzed in the groups to
which they were randomized (Intention
to treat)? Yes
• No difference in cross over
– 18% in Pharm
– 23% in UF
13
What are the Results?
1°Endpoint
Pharm Ultra-
filtration
P Value
Cr
change
↓ 0.04 ↑0.23 0.003
Wt
change
↓5.5kg
(12.1 lb)
↓ 5.7kg
(12.6 lb)
0.58
14
What are the results?
2°Endpoints • No diff in worsening condition @ 7
days: (Definition of Composite Endpoint of “Worsening Condition”: death, dialysis, adverse events, persistent CHF.
• No sig difference rehospitalizations for HR, or any.
• No sig difference in dyspnea or global well-being (96 hr, 7 d, discharge)
15
What are the Results?
Adverse Events: kidney failure, bleeding, IV catheter
complications including infection (all: HF,CV problems, anemia, lytes)
Pharm UF P value
Serious
Adverse
Events
57% 72% 0.03
Mortality
@ 60 d
13% 17% 0.47
16
What are the results?
Calculations: Adverse Events
• If you treat 7 people with ultrafiltration 1
additional person will have a serious
adverse event compared to diuretic tx.
17
ARI RRI NNH
│57%-72%│= 15%/57% = 1/.15
↑15% ↑26% 6.7
What are the results?
• How precise were the results?
– No confidence intervals
– Probably not due to small sample size
18
Applicability
• Were the study patients similar to my
patient? No.
– The study would not have included this
particular patient
– But, many of our CHF patients would be
included
19
Applicability
• Were all clinically important outcomes
considered?
• 1°outcomes: weight and serum creatinine
• 2°outcomes: – worsened condition during treatment, crossover, death,
rehospitalization, ED or acute clinic visits
– 96hr changes in: clinical decongestion, Na, Hgb, BNP, BUN,
GFR, Pt score of well-being, Pt SOB, Total net fluid loss
– Change in furosemide-equivalent dose from preadmission to
discharge
21
Applicability
• Are the benefits worth the costs and
potential risks? No.
• Study showed that the UF group had
more adverse events without
significantly better outcomes
• This was different from other 4 studies
in lit. (N = 200, 100, 30, 19)
22
GRADE: Quality of Evidence
RCTs start high • 5 limitations can lower confidence
– Biases in design and execution • Concealment, blinding, ITT, loss to follow up
– Indirectness • Surrogate or physiologic outcomes
– Inconsistency • Variability in results (heterogeneity)
– Imprecision • Small numbers, low power, wide confidence intervals
– Reporting or publication bias • Funnel plot
Grading Recommendations:
• Strong recommendations
– Strong Methods
– Large precise effect
– Few downsides of therapy
• Weak recommendations
– Weak methods
– Imprecise estimate
– Small effect
– Substantial downsides
Strength of Recommendation
• STRONG or WEAK
• STRONG:
– Benefits clearly outweigh risks/hassles/cost
– Risk/hassles/costs clearly outweigh
benefits
• WEAK
– There is a close or uncertain balance
between benefits and risks/hassles/costs
– Based on low quality evidence
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