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DON’T BELIEVE EVERYTHING YOU READ: AN EDITOR’S VIEW
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DON’T BELIEVE EVERYTHING YOU READ: AN EDITOR’S VIEW
JAMES R. SCOTT, MD
I have no conflict of interest to disclose.
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OBJECTIVES
• TO CLEARLY UNDERSTAND EVIDENCE BASED MEDICINE
• TO BE ABLE TO ASSESS VALIDITY OF NEW TREATMENTS
• TO APPLY BEST-EVIDENCE IN YOUR CLINICAL PRACTICE
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JOHN IOANNIDIS
• WHY MOST PUBLISHED RESEARCH FINDINGS ARE FALSE. PloS Med 2005;2(8):124
• “The most downloaded document of all time on PubMed”
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SCOTT’S RULE
IT WILL NEVER WORK AS WELL IN YOUR PRACTICE AS REPORTED IN THE LITERATURE
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"BELIEVE NOTHING THAT YOU SEE IN THE NEWSPAPERS [TV, INTERNET].... IF YOU SEE ANYTHING IN THEM THAT YOU KNOW IS TRUE, BEGIN TO DOUBT IT AT ONCE."
Sir William Osler
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EVIDENCE BASED MEDICINE: A RECENT PHENOMENON
RCTs
0
200
400
600
800
1000
1200
1400
1973 1983 1993 2003
Meta-Analyses
02000400060008000
10000120001400016000
1973 1983 1993 2003
2012 – 426,853 RCTs 2012 – 53,042 Meta-Analyses
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NUMBER OF PUBLISHED PAPERS WITH “EVIDENCE BASED” MEDICINE IN TITLE
0
2000
4000
6000
8000
10000
12000
14000
1992 1996 2002 2004 2007 2009
2013 – NOW > 100,000
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EVIDENCE-BASED MEDICINE
DE-EMPHASIZES• INTUITION• EXPERIENCE• PATHOPHYSIOLOGYEMPHASIZES• PROOF• OUTCOMES
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PRINCIPLES OF EVIDENCE-BASED MEDICINE
• FIRST DO NO HARM• WHAT ARE THE RESULTS? • ARE THE RESULTS VALID?• HOW DO I APPLY THEM TO MY PATIENTS?
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LEVEL OF EVIDENCE
I RANDOMIZED CONTROLLED TRIAL – The “Gold Standard”II-2 COHORT OR CASE CONTROL STUDYII-3 LARGE CASE SERIES III CASE REPORT, EXPERT COMMITTEE,
RESPECTED AUTHORITY, CLINICALEXPERIENCE
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RULES TO IMPROVE PUBLISHED PAPERS
• LEVELS OF EVIDENCE• GUIDELINES – CONSORT, PRISMA, STROBE• TRIAL REGISTRATION• CROSSCHECK FOR PLAGIARISM• DECLARE ALL CONFLICT OF INTERESTS• DETECT FRAUD
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PREFERRED STUDIES - RANDOMIZED CONTROLLED TRIALS (RCT) BEST
• MOST RELIABLE EVIDENCE • CONSORT GUIDELINES• DESIGNED FOR EFFICACY ONLY • MY RULE - INCLUDE ABSOLUTE RISK
– ACTUAL NUMBERS, PERCENTAGES– NUMBER NEEDED TO TREAT (NNT)
• NOTE – 25% LATER REFUTED
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PROBLEMS TRANSLATING RCTs INTO PRACTICE
• DIFFERENT PATIENTS• COSTS MORE• INSURANCE WON’T COVER• PATIENT DOESN’T WANT IT • YOU ARE BETTER AT SOMETHING ELSE• UNANTICIPATED COMPLICATIONS OR
SIDE EFFECTS
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CHALLENGES WITH NEW SURGICAL AND OBSTETRIC PROCEDURES
• RCTs DIFFICULT TO DO • BLINDING NOT POSSIBLE• COHORT/CASE SERIES NEXT BEST• UNETHICAL NOT TO COMPARE WITH CURRENTLY ACCEPTED METHODCAUTION: IN YOUR OWN PRACTICE
USE IRB & INFORMED CONSENT
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CLINICAL JUDGEMENT STILL IMPORTANT
• WOMEN UNDERGOING ABDOMINAL SACROCOLPOPEXY RANDOMIZED TO BURCH OR NO BURCH (Brubaker et al. N Engl J Med 2006;354:1557)
• BURCH LOWERED INCIDENCE OF SUI FROM 44% TO 24% (20%)
• REAL WORLD – PT WITH VARICOSITIES BLEEDING, HEMATOMA & 8 UNITS OF BLOOD
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IMPORTANT TO REMEMBER
EFFICACY – UNDER IDEAL CONDITIONSEFFECTIVENESS – IN REAL CLINICAL SETTING
(YOUR PRACTICE)
• NO RCT FITS EVERY PATIENT• ALMOST NO RCT FITS ANY PATIENT PERFECTLY• NOT GOOD AT DETECTING COMPLICATIONS
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META-ANALYSIS: STATE-OF-THE-ART REVIEW
ADVANTAGES• STANDARD RULES • STATISTICAL POWERDISADVANTAGES• SUBJECTIVE ASSUMPTIONS• COMPLICATED, ARTIFICIAL• ONLY AS GOOD AS THE TRIALS USED • ODDS RATIOS & CONFIDENCE INTERVALS • TAKEN AS GOSPEL
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COCHRANE REVIEWS
• MOST WELL DONE• PUBLICATION BIAS• LONG & BORING• SOME OUTDATED• LIMITED ACCESS• ODDS RATIOS ONLY
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STATISTICS
A FELLOW WITH ONE LEG FROZEN IN ICE AND THE OTHER LEG IN BOILING WATER IS COMFORTABLE – ON AVERAGE.
J. M. Yancey
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REALITY
NO RANDOMIZED TRIALS OR META-ANALYSES FOR ABOUT > 50-60% OF WHAT WE DO
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NO RANDOMIZED CONTROLLED TRIALS
• VBAC• CESAREAN ON REQUEST• SOME GYN SURGICAL PROCEDURES• MANY NEW MATERIALS & DEVICES
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EXAMPLE: THERE ARE NO RANDOMIZED TRIALS TO PROVE THAT PARACHUTES WORK
RECOMMENDATION:
EVIDENCE-BASED GURUSSHOULD PARTICIPATE IN A DOUBLE- BLIND RCT
Parachute Use to Prevent Death and Major Trauma. Smith GCS et al. BMJ 2003;327:149
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COHORT STUDIES & CASE SERIES STILL USEFUL
• MORE CHANCE OF BIAS • STROBE GUIDELINES• HOW IT WORKS IN THE TRENCHES• LONG-TERM FOLLOWUP• FIRST REPORTS OF ADVERSE
EVENTS OR RARE COMPLICATIONS
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LANDMARK OBSERVATIONAL STUDY
• FIRST DESCRIPTION OF AIDS BASED ON CLINICAL FINDINGS IN FIVE PATIENTS
• GOTTLIEB – 33 YR OLD ASSISTANT PROF.• SCHROFF – RESIDENT IN INTERNAL MED.
Gottlieb MS, Schroff et al. N Engl J Med 1981;305:1425
CITED 2,532 TIMES
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SMALL CASE SERIES: OBSTETRIC COMPLICATIONS ASSOCIATED WITH THE LUPUS ANTICOAGULANT
D. WARE BRANCH MD JAMES R. SCOTT MD NEIL K. KOCHENOUR MD ED HERSHGOLD MD
N ENGL J MED 1985;313:1322
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SIGNIFICANCE: Based on 8 Patients
• NEWLY RECOGNIZED SYNDROME• TREATABLE CAUSE OF FETAL DEATH• MAJOR ANTIPHOSPHOLIPID ANTIBODY
RESEARCH EFFORT NEXT DECADE
• CITED 583 TIMES
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GOOD CASE REPORT
• FIRST SUCCESSFUL EMBOLIZATION FOR SEVERE POSTPARTUM BLEEDING*
* BY CHIEF RESIDENT @ U OF UTAH
BROWN BJ et al. Uncontrollable Postpartum Bleeding: A New Approach to Hemostasis Through Angiographic Embolization. Obstet Gynecol 1979;54:371.
• CITED 132 TIMES
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WORTHY OF HEALTHY SKEPTICISM
• GUEST SPEAKERS • DATABASE STUDIES – Inaccurate• LARGE EPIDEMIOLOGIC STUDIES – Clinically
Irrelevant• DECISION ANALYSES – Soft data, assumptions• DRUG COMPANY SPONSORED – Ghostwriters
Bias, Overstated conclusions• ADVERTISEMENTS - Embarrassing
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ALL TOO COMMON:
• WIDELY QUOTED IN MEDIA• SAME DATABASE AS WITH
MAGNETIC FIELDS• ? BIOLOGIC PLAUSIBILITY
NO INCREASED RISK IN EPIDEMIOL. SAME MO. (no publicity)
86 Papers – Conflicting Results
MY TAKE: ALL NONSENSECONCLUSION – COFFEE ASSOCIATED WITH MISCARRIAGE
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WAKEFIELD 1998 PAPER IN LANCET RELATED MMR VACCINATIONS IN CHILDREN TO AUTISM
• DECLARED FRAUDULANT AND RETRACTED IN 2010.
• DID TREMENDOUS HARM • “SHOULD NEVER HAVE BEEN PUBLISHED”
Richard Smith, Former Editor of BMJ• SAME PATTERN OCCURING AGAIN MULTIPLE
WEAK ASSOCIATIONS --- PUBLICIZED BY MEDIA
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• LARGE DATABASE• LOGESTIC REGRESSION
“MODELING”• Odds Ratios (95% CI) =
1.21 (1.01-1.46)• WIDELY PUBLICIZED BY
THE MEDIA
CONCLUSION: INDUCTION OF LABOR AND AUGMENTATION ASSOCIATED WITH AUTISM
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INTERPRETIVE BIAS AND OVERSTATED CONCLUSIONS
• MISLEADING RESULTS - “3-FOLD INCREASED RISK …” REALLY 1/MILLION VS 3/MILLION - STATISTICALLY SIGNIFICANT BUT CLINICALLY IRRELEVANT
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OTHER BORDERLINE “ASSOCIATIONS” WITH AUTISM DURING PAST YEAR
• Flu & Fever During Pregnancy• Obese Mothers, Weight gain • Short Pregnancy Interval• Maternal Thyroid Dysfunction• ICSI (IVF)• Older Fathers• Antidepressants, Gluten Sensitivity• F.H. of Autoimmune Disease• Lyme Disease• Air Pollution, Pesticides
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TRUTH
ALL OF THESE EPIDEMIOLOGIC STUDIES WITH SMALL ODDS RATIOS SHOULD END WITH THE STATEMENT: “WE FOUND A WEAK ASSOCIATION AND WE HAVE NO CLUE WHAT IT MEANS”
David Grimes
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CAUTION
• 75% CLINICAL TRIALS INDUSTRY FUNDED• PURPOSE - MAXIMIZE FINANCIAL RETURN• ONLY 1/3 NOW DONE IN UNIVERSITIES• WHO CONTROLLED DATA & WROTE PAPER• TIES WITH COMPANIES - MANY AUTHORS &
59% OF EXPERTS WRITING GUIDELINES • 5X > CHANCE OF FAVORABLE OUTCOME
WHEN COMMERCIALLY SPONSORED
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PREDATORY OPEN ACCESS JOURNALS
• 8250 JOURNALS – 438 PUBLISHERS, 1/3rd IN INDIA
• ADVERTISE FOR PAPERS• CHARGE AUTHOR FEE TO PUBLISH• 304 VERSIONS OF FLAWED AND
FICTITIOUS WONDER DRUG PAPER SUBMITTED ACCEPTED BY 157 (>50%) SCIENCE 2013;342:60-65.
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SUBTLE PROBLEMS DESPITE THE RULES AS INDUCTION AND MAINTENANCE THERAPY FOR ULCERATIVE COLITIS. NEJM 2013;369;699
BOTTOM LINE: MODERATE EFFECT AT 6 & 52 WEEKS
• Complicated RCT – 211 centers in 34 countries
• Compared drug vs placebo• 16 Authors – 10 with multiple ties to
industry – 7 Company Employees• Company held & analyzed data• No mention of probable cost
($100,000 per year)
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• Company sponsored RCTs• Marketing in the guise of
research – to publicize expensive drugs
• Open Label, No Control Group, Short-term, Physician payment Example: VIOXX
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WHAT NEEDS TO HAPPEN:
• INDEPENDENT INVESTIGATORS • COMPARE TO PRESENT DRUG/Rx• INCLUDE COST COMPARISON• REJECT EPIDEMIOLOGY STUDIES
WITH ODDS RATIOS < 3-4• REQUIRE ABSOLUTE NUMBERS OR NNT• TRANSPARENCY – DISCLOSE ALL
CONFLICTS INCLUDING EDITORS
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• CLINICALLY RELEVANT
• VALID STUDY DESIGN
• STRINGENT REVIEW PROCESS
• RESULTS PHYSICIANS CAN TRUST
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DON’T WASTE YOUR TIME - OTHER RELIABLE AND USEFUL SOURCES
• COCHRANE LIBRARYwww.cochrane.co.uk
• ACOG PRACTICE BULLETINSwww.greenjournal.org
• UP TO DATE www.uptodate.com• MEDICAL LETTER www.medicalletter.com
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CHALLENGE
TO TRANSLATE IMPERSONAL & DOGMATIC STATISTICS INTO PERSONALIZED CARE OF REAL FLESH & BLOOD PEOPLE.
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STILL IMPORTANT
• COMPASSION• EMPATHY• COMMUNICATIO
N• CLINICAL
JUDGEMENT• COMMON SENSE• ACCESS
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REFERENCES
1. Scott JR. Show me the evidence. Obstet Gynecol 2002;100(3):403-4.2. Ioannidis JPA. Why most published research findings are false. PLoS
Med 2005;2(8)e124 3. Scott JR. Improving systematic reviews for clinicians: a journal
editor’s view. Paediat Perinat Epidemiol 2008;22(1):38-41.4. Scott JR. Evidence-based medicine under attack. Obstet Gynecol
2009;113(6):1202-3.5. Grimes DA, Schulz KF. False alarms and pseudo-epidemics. The
limitations of obsevational epidemiology. Obstet Gynecol 2012;120(4):920-7.
6. Smith R. The Trouble With Medical Journals. The Royal Society of Medicine Press Ltd. Edward Arnold Publishers. 2011, London, UK
7. Bohannon J. Who’s afraid of peer review? Science 2013;342:60-7.