clinical study types

7/28/2019 Clinical Study Types

1/16

Internet Medicine

Who do you trust?

Resolve Meeting

January 2, 2001

Mark Perloe, M.D.,

[email protected] www.ivf.com


2/16

Getting Online Technical stuff

Internet Service Provider Dial-up, ISDN, cable modem, DSL (ADSL-SDSL), partial T-1

Security Firewalls (ZoneAlarm, Norton Security) Dedicated IP address vs. dynamic

Be cautious when providing credit card, social security, phonenumber or real name

Mail accounts Separate personal & business

Software vs. web based access

Eudora, MS Outlook, Netscape Messenger

SmartMail.com, Mail2web.com

Filters


3/16

Internet Resources

Where to find information

National Library of Medicine

Medline, Grateful Med, PubMed

Expert Chats PCOSupport. Inciid, AllHealth

Bulletin Boards & Newsgroups

Organization Websites

Resolve, ASRM, PCOsupport, AIA,ERC, EIN,

Other Websites

OBGYN.net, About.com, IVF.com,

ihr.com, Child of My Dreams, ARC


4/16

Mail Lists & eGroups

Miscarriage [email protected]

Hannahs, Paml, eLimbo,

Overweight seeking fertility [email protected]

PCOS PCO-Georgia, PCOS Low-Carb,

PCOSPreciousDreams,

MetforminPregnancy

Endometriosis Inferendo, erc, infertility alternatives

IVF

Ivf, Onna, Surrogacy
http://www.lsoft.com/scripts/wl.exe?SL1=MAI&H=LISTSERV.ACSU.BUFFALO.EDUhttp://www.lsoft.com/scripts/wl.exe?SL1=OASIS-L&H=HOME.EASE.LSOFT.COMhttp://www.lsoft.com/scripts/wl.exe?SL1=OASIS-L&H=HOME.EASE.LSOFT.COMhttp://www.lsoft.com/scripts/wl.exe?SL1=OASIS-L&H=HOME.EASE.LSOFT.COMhttp://www.lsoft.com/scripts/wl.exe?SL1=OASIS-L&H=HOME.EASE.LSOFT.COMhttp://www.lsoft.com/scripts/wl.exe?SL1=MAI&H=LISTSERV.ACSU.BUFFALO.EDU


5/16

Caveats & Limitations

Limitations

Credentials may not evident

Financial bias Self promotion Dumbing down information provided

Is material current?

No two cases are identical

Keyboard + monitorPelvic Exam+UltrasoundEvaluating medical literature Press and public get access at before physicians!


6/16

Mass-Media Influence

Discoveries and innovationscharacterized by unjustifiable degree of certainty

Immediate promise of reducingthe burden of illness orincreasing life expectancy

Technical detail and scientificjargon are boring

Exaggerates the risks posedby putative health hazards

Pharmaceutical companyadvertising


7/16

Rationale for Evidence-based Medicine

Cost of medical care rising sharply

Wide variations in outcomes of medical care

Patients are better informed and more vocal seeking tomake informed choices

Health-care decision making should involve the patient

and be based on best evidenceStatistical tools (meta-analysis) are better understood

Evaluation of research papers for validity and relevance


8/16

Evidence-based Medicine

Incorporation of relevant scientific informationinto the clinical decision making process

Provides the impetus to gather, review andsummarize evidence on effective and cost ofhealth-care interventions (meta-analysis)

Optimizes the utilization of health-care resourcesby avoiding ineffective and medical & surgicaltherapies


9/16

Clinical Study Types

Experimental Studies

Randomized Control Trials (RCT)

Randomized Cross-Over TrialObservational Studies

Cohort (Incidence, Longitudinal)

Case-Control

Cross-Sectional (Prevalence)

Case Series

Case Report


10/16

Statistics

ANOVA, Students t-test, Chi-square

P < 0.05

Power Calculations

Clinical vs. biological significance


11/16

Evaluating Medical Studies

Validity: Truth

External Validity: Can the study be generalized to

the population of the reader Internal Validity: Study is well designed. Results not

due to chance, bias or confounding factors

Symmetry Principle: Groups are similar


12/16


13/16

Whats a Meta-analysis?

Met-analysis provides an overview of clinical

trials

Meta-analysis is a set of statistical proceduresdesigned to accumulate experimental and

correlational results across independent studies

that address a related set of research questions.


14/16

Meta-Analysis

Variability in populations

Variability in study design

Study quality Endpoint reportage

Availability of data

Variability in interventions


15/16

Limitations of EBM

Impact of prevailing political, ideological, economic and

technological forces

NIH research often politically directed (stem cell) Pharmaceutical industry financing limits comparative studies

of alternative therapies

Homogenous population required for studies

Limited evaluation of co-therapies

Lack of evidence does not equal lack of effectiveness


16/16

Clinical Decision-making

What is my RISK ?

of the event the treatment strives to prevent?

of the side-effect of treatment?

What is my chance of RESPONDING?

What is the treatments FEASIBILITY in my MDs

practice/setting?

What are my VALUES ?

clinical study types

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