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Biometry ~ Types of Studies. Research classifications. Observational vs. Experimental Observational – researcher collects info on attributes or measurements of interest, but does not influence results.

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research classifications
Research classifications
  • Observational vs. Experimental

Observational – researcher collects info on attributes or measurements of interest, but does not influence results.

Experimental – researcher deliberately influences events and investigates the effects of the intervention, e.g. clinical trials and laboratory experiments.

We often use these when we are interested in studying the effect of a treatment on individuals or experimental units.

experiments observational studies
Experiments & Observational Studies

We conduct an experiment when it is (ethically, physically etc) possible for the experimenter to determine which experimental units receive which treatment.

experiments observational studies4
Experiments & Observational Studies

Experiment Terminology

Experimental Unit Treatment Response

  • patient drug cholesterol
  • worm drug protein level
  • tomatoes fertilizer yield
  • mouse radiation mortality
experiments observational studies5
Experiments & Observational Studies

In an observational study, we compare the units that happen to have received each of the treatments.

experiments observational studies6

Unit

Treatment

Response

patient

smoking

lung cancer

potatoes

weather

yield

walleye

waterway

Hg level

Experiments & Observational Studies

e.g. You cannot set up a control (non-smoking) group and treatment (smoking) group.

Observational Study

experiments observational studies7
Experiments & Observational Studies

Note:

Only a well-designed and well-executedexperiment can reliably establish causation.

An observational study is useful for identifying possible causes of effects, but it cannot reliably establish causation.

1 completely randomized design
1. Completely Randomized Design

The treatments are allocated entirely by chance to the experimental units.

1 completely randomized design9
1. Completely Randomized Design

Example:

Which of two varieties of tomatoes (A & B) yield a greater quantity of market quality fruit?

Factors that may affect yield:

  • different soil fertility levels
  • exposure to wind/sun
  • soil pH levels
  • soil water content etc.
1 completely randomized design10

(B)

(B)

(B)

(B)

What if the field sloped upward from left to right?

1. Completely Randomized Design

Divide the field into plots and randomly allocate the tomato varieties (treatments) to each plot (unit).

8 plots – 4 get variety A

UPHILL

(A)

(B)

(A)

(A)

(A)

(B)

(B)

(A)

(A)

(B)

Randomly assign A & B varieties in each strip of similar elevation.

Discuss for ½ Minute

1 completely randomized design11
1. Completely Randomized Design

Note:

Randomization is an attempt to make the treatment groups as similar as possible — we can only expect to achieve this when there is a large number of plots.

2 blocking
2. Blocking

Group (block) experimental units by some known factor and then randomize within each block in an attempt to balance out the unknown factors.

Use:

  • blocking for known factors (e.g. slope of field in previous example)

and

  • randomization for unknown factors to try to “balance things out”.
2 blocking13
2. Blocking

Example continued:

It is recognized that there are two areas in the field – well drained and poorly drained.

Partition the field into two blocks and then randomly allocate the tomato varieties to plots within each block.

2 blocking14

1 (A)

2 (B)

3 (A)

4 (B)

2. Blocking

Well drained Poorly drained

How should we allocate varieties to plots?

Discuss in groups for 1/2 minute.

1 (B)

2(A)

4 (B)

3(A)

6(A)

5(A)

8 (B)

7 (B)

Randomly assign types to 4 well drained plots and then to the 8 poorly drained plots.

2 blocking15
2. Blocking

Example 2: Comparing Three Pain Relievers for Headache Sufferers

  • How could blocking be used to increase precision of a designed experiment to control to compare the pain relievers?
  • What are some other design issues?
example 3 comparing 17 different leg wraps on used on race horses
Example 3: Comparing 17 Different Leg Wraps on Used on Race Horses
  • 17 “boots” tested, each boot is tested n = 5 times. Why?
  • Because of the time constraints all boots were not tested on the same day.
  • 8 tested 1st day, 5 tested 2nd day, 4 tested 3rd day.
  • Leg was placed in freezer and thawed before the 2nd and 3rd days of testing.
horse leg wraps cont d

Forces readings obtained from cadaver leg when no boot or wrap was used.

Horse Leg Wraps (cont’d)
  • What problems do you foresee with this experimental design? Discuss
  • What actually happened?

What are the implications of these results? Discuss

horse leg wraps cont d18
Horse Leg Wraps (cont’d)

FINAL BOOT COMPARISONS

horse legs wraps cont d
Horse Legs Wraps (cont’d)
  • What should have been done?

Discuss

3 people as experimental units
3. People as Experimental Units

Example: Cholesterol Drug Study – Suppose we wish to determine whether a drug will help lower the cholesterol level of patients who take it.

How should we design our study?

Discuss for two minutes in groups.

polio vaccine example22
Polio Vaccine Example

Dr. Jonas Salk, vaccine pioneer 1914-95

Iron Lung

the salk vaccine field trial
The Salk Vaccine Field Trial
  • 1954 Public Health Service organized an experiment to test the effectiveness of Salk’s vaccine.
  • Need for experiment:
    • Polio, an epidemic disease with cases varying considerably from year to year. A drop in polio after vaccination could mean either:
      • Vaccine effective
      • No epidemic that year
the salk vaccine field trial24
The Salk Vaccine Field Trial

Subjects: 2 million, Grades 1, 2, and 3

  • 500,000 were vaccinated
    • (Treatment Group)
  • 1 million deliberately not vaccinated
    • (Control Group)
  • 500,000 not vaccinated - parental permission denied
the salk vaccine field trial25
The Salk Vaccine Field Trial

NFIP Design

  • Treatment Group: Grade 2
  • Control Group: Grades 1 and 3 + No Permission

Flaws ? Discuss for 30 seconds.

  • Polio contagious, spreading through contact. i.e. incidence could be greater in Grade 2 (bias against vaccine), or vice-versa.
  • Control group included children without parental permission (usually children from lower income families) whereas Treatment group could not (bias against the vaccine).
the salk vaccine field trial26
The Salk Vaccine Field Trial

Double-Blinded Randomized Controlled Experimental Design

  • Control group only chosen from those with parental permission for vaccination
  • Random assignment to treatment or control group
  • Use of placebo (control group given injection of salted water)
  • Diagnosticians not told which group the subject came from (polio can be difficult to diagnose)
  • i.e., a double-blind randomized controlled experiment
the salk vaccine field trial27

Size of

Rate per

(NFIP rate)

group

100,000

Treatment

200,000

28

(25) Grade 2

Control

200,000

71

(54) Grade1/3

Noconsent

350,000

46

(44) Grade 2

The Salk Vaccine Field Trial

The double-blind randomized controlled experiment (and NFIP) results

3 people as experimental units28
3. People as Experimental Units
  • control group:
    • Receive no treatment or an existing treatment
  • blinding:
    • Subjects don’t know which treatment they receive
  • double blind:
    • Subjects and administers / diagnosticians are blinded
  • placebo:
    • Inert dummy treatment
3 people as experimental units29
3. People as Experimental Units
  • placebo effect:
    • A common response in humans when they believe they have been treated.
    • Approximately 35% of people respond positively to dummy treatments - the placebo effect
observational studies
Observational Studies
  • There are two major types of observational studies:

prospective

and retrospective studies

observational studies31
Observational Studies

1. Prospective Studies

  • (looking forward)
  • Choose samples now, measure variables and follow up in the future.
  • E.g., choose a group of smokers and non-smokers now and observe their health in the future.
observational studies32
Observational Studies
  • Looks back at the past.
  • E.g., a case-control study
    • Separate samples for cases and controls (non-cases).
    • Look back into the past and compare histories.
    • E.g. choose two groups: lung cancer patients and non-lung cancer patients. Compare their smoking histories.
  • 2. Retrospective Studies
    • (looking back)
observational studies33
Observational Studies

Important Note:

1. Observational studies should use some form of random sampling to obtain representative samples.

  • Observational studies cannot reliably establish causation.
controlling for various factors
Controlling for various factors
  • A prospective study was carried out over 11 years on a group of smokers and non-smokers showed that there were 7 lung cancer deaths per 100,000 in the non-smoker sample, but 166 lung cancer deaths per 100,000 in the smoker sample.
  • This still does not show smoking causes lung cancer because it could be that smokers smoke because of stress and that this stress causes lung cancer.
controlling for various factors35
Controlling for various factors
  • To control for this factor we might divide our samples into different stress categories. We then compare smokers and non-smokers who are in the same stress category.
  • This is called controlling for a confounding factor.
example 1
Example 1
  • “Home births give babies a good chance” NZ Herald, 1990
    • An Australian report was stated to have said that babies are twice as likely to die during or soon after a hospital delivery than those from a home birth.
    • The report was based upon simple random samples of home births and hospital births.

Q: Does this mean hospitals are dangerous places to have babies in Australia? Why or why not?Discuss for 1 minute in groups.

example 2
Example 2
  • “Lead Exposure Linked to Bad Teeth in Children” ~ USA Today

The study involved 24,901 children ages 2 and older. It showed that the greater the child’s exposure to lead, the more decayed or missing teeth.

Q: Does this show lead exposure causes tooth decay in children? Why or why not?

Discuss for 1 minute.

example 2 cont d
Example 2 ~ cont’d
  • “Lead Exposure Linked to Bad Teeth in Children” ~ USA Today

Researcher:

“We controlled for income level, the proportion of diet due to carbohydrates, calcium in the diet and the number of days since the last dental visit.”

additional example 1 determine whether age at 1 st pregnancy is a risk factor for cervical cancer
Additional Example 1 – Determine Whether Age at 1st Pregnancy is a Risk Factor for Cervical Cancer

How might we proceed?

Discuss

additional example 2 determine what factors might influence the success of a duck nest
Additional Example 2 – Determine what factors might influence the “success” of a duck nest.

How might we proceed?

Discuss

additional example 3 test the toxicity of a new pesticide herbicide on aquatic organisms
Additional Example 3 – Test the toxicity of a new pesticide/herbicide on aquatic organisms.

How might we proceed?

Discuss

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