thinktwice! thinktwice! ? ? d’scerner: critical appraisal...

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1Teacher Enrichment Initiatives/CAINE2009©The University of Texas Health Science Center at San Antonio

Twice!ThinkTwice!Think

D’Scerner: Critical Appraisal of Topiramate Study (Treating Alcohol Dependence)

TEACHER SECTION

OBJECTIVES:Using instructional materials in the activity, students will be able to:

Module 1 Thinking About the Studyn Find sources of potential bias in the study and describe how they might

affect the results n Identify the type of study design n Identify independent, dependent, and controlled variables in the study

Module 2 The Resultsn Find summative data in the study n Create data tables and graphs from the study data n Determine which type of graph is most appropriate for the type of data

collected in the study

Module 3 Analyzing the Resultsn Analyze the observed results in the study in a systematic manner to

determine the meaning of the data

Module 4 Comparing and Contrastingn Compare and contrast the journal and media reports to determine

accuracy of the media report n Complete a Venn Diagram that compares the journal and media reports

ACTIVITY DESCRIPTION:How often do we hear “Research Says”…? To develop science literacy skills, students need to ask “Does it Really….”. Using a peer-reviewed journal articlethat has been transformed for age level, students will analyze a peer-reviewedreport of a scientific study. They will compare the results reported in the journalarticle to a media article that reported the results of the same study. Studentanalysis is directed in a systematic way through the use of four student modules.The modules created for each critical appraisal lesson are very similar in struc-ture to help students develop scientific “habits of mind” as they work throughthe lessons.

This lesson is based on a study done to test the effectiveness of a drug calledTopiramate in treating alcohol dependence. The study was funded by theNational Institutes of Health and was conducted in San Antonio at TheUniversity of Texas Health Science Center.



MATERIALS:n 1 class set of the Journal Article Treating Alcohol Dependence

with Topiramaten 1 class set of the Media Article Headache Drug May Aid Alcoholicsn 1 copy of the Student Modules per student

(Note: if copy numbers are limited, you can make a class set of the modules andhave students record their answers in a journal or on their own paper)

MANAGEMENT SUGGESTIONS:The lesson is divided up into separate modules; they can be completed sequentially or each can be done at different times of the year to align with the scope and sequence.

SUGGESTED MODIFICATIONS:Allow students to work in pairs and provide modules with some informationprefilled for students in need of such assistance.

SUGGESTED EXTENSIONS:Students can research the “off-label use of topiramate” controversy that eruptedover this study.

REFERENCES USED:Finley, D. (2007). Study finds combining it with counseling cuts the number of‘heavy drinking days’; migraine drug may aid alcoholics. The San Antonio Express News, Section a, p. 01.

Hill, AB. (1965). The environment and disease: Association or causation?Proceedings of the Royal Society of Medicine, 58, 295-300.

Johnson, BA; Rosenthal, N; Capece, JA; Wiegand, F; Mao, L; Beyers, K.; McKay,A; Ait-Daoud, N; Anton, RF; Ciraulo, DA; Kranzler, HR; Mann, K; O’Malley, SS;and Swift, RM. (2007). Topiramate for treating alcohol dependence: A random-ized controlled trial. Journal of the American Medical Association (JAMA), 289, 1641-1651.

Last, JM. (2000). A Dictionary of Epidemiology. USA: Oxford University Press.



Intended Grade Level: 6–12

Activity “Administrivia”

KEY CONCEPTS:

Critical appraisal skills, compare/contrast,

analyzing results of a study, study design, variables,

controlled variables

PROCESS SKILLS

UTILIZED IN LESSON:

Communication, inference, prediction,

analysis of data, graphing

Key Words for Web Page: Critical appraisal skills, compare/contrast, analyzing results of a study,study design, variables, controlled variables, graphing

6, 7, and 8 Grade Science6, 7, 8.2 Scientific investigation and reasoning.The student uses scientific inquiry methodsduring laboratory and field investigations. Thestudent is expected to: (D) construct tables and graphs, using repeatedtrials and means, to organize data and identifypatterns; (E) analyze data to formulate reasonable explanations, communicate valid conclusionssupported by the data, and predict trends. 6, 7, 8.3 Scientific investigation and reasoning.The student uses critical thinking, scientific reasoning, and problem solving to makeinformed decisions and knows the contribu-tions of relevant scientists. The student isexpected to: (A) in all fields of science, analyze, evaluate, and critique scientific explanations by usingempirical evidence, logical reasoning, andexperimental and observational testing, includ-ing examining all sides of scientific evidence ofthose scientific explanations, so as to encouragecritical thinking by the student;

6, 7, and 8 Grade Health6.4 Health information. The student compre-hends ways of researching, accessing, and analyzing health information. The student isexpected to: (A) list ways to evaluate health products, practices, and services such as sunblocks,dietary aides, and over-the-counter medica-tions; and(B) use critical thinking to research and evaluatehealth information.6.5 Health behaviors. The student engages inbehaviors that reduce health risks throughoutthe life span. The student is expected to: (C) describe chemical dependency and addic-tion to tobacco, alcohol, and other drugs andsubstances;7-8.4 Health information. The student knowshow to research, access, analyze, and use health information. The student is expected to:(A) use critical thinking to analyze and usehealth information such as interpreting mediamessages;(B) develop evaluation criteria for health information;

PREVIOUS LEARNING

ASSUMED:

Basic scientific process skills, Venn diagrams,

sources of bias

Relevant TEKS

caused 34 of the 183 in druggroup to drop out of the study. 6 from the group that did nottake the real drug dropped out.

Dr. Johnson said the drugworks by changing amounts ofchemicals in the brain.

The drug company whichmakes the drug paid for thestudy. The drug is currentlyapproved for the treatingheadaches and seizures. It is notapproved for alcoholism. Dr.Johnson said he does not adviseusing this drug to treat alcoholism until it is tested andapproved for this use.

Dr. Mark Willenbring is fromthe National Institute onAlcohol Abuse and Alcoholism.He noted that this drug “produced important results.After the 14-week study, thedrug continued to work. Thismay mean that taking it longercan produce even better resultsfor patients.”

STUDY FINDS:

Headache drug may aid alcoholics_________________________________________________________________

Teacher Enrichment Initiatives

A study done in San Antoniofound that a headache drughelped heavy drinkers lowertheir drinking.

The drug is called topiramate.It was given to patients for 14weeks. Patients were also coun-seled for 15 minutes each week.The drug along with counselinghelped patients reduce thenumber of “heavy drinkingdays”. Heavy drinking days arethose with five or more drinksfor men and four or more drinksfor women.

Patients who got only coun-seling (no drug) had moreheavy drinking days than thosewho got the drug and counsel-ing. Dr. Bankole Johnson, said“patients taking counseling andthe drug lowered heavy drink-ing from about a bottle and a half of wine each day to about31/2 glasses each day. The groupwith counseling and no drughad about six glasses of wine a day.”

The study began at TheUniversity of Texas HealthScience Center in San Antonio.It is reported in today’s Journalof the American MedicalAssociation. This drug is differ-ent from others used to treat

alcoholism because it is safe forpatients who are still drinking.

This study was conducted at 17 sites across the US. 371 maleand female alcoholics ages 18 to 65 participated. 30 were fromSan Antonio.

One group was selected bychance (randomly). This grouptook up to 300 mg per day of thedrug along with support from anurse to stick with treatment.The other group was given a pillthat looked identical to thestudy drug but did nothing.This group got matching ses-sions with trained nurses.

After 14 weeks, the group taking the drug had fewerheavy drinking days. The heavydrinking days in this groupdropped from 82% to 44%. The group that did not take thereal drug dropped 52%. Somestopped drinking completely for28 days. Those able to stopdrinking were 27 from the druggroup compared with 6 in thegroup that did not take the real drug.

Some patients in the studyhad side effects. These weredizziness, numbness, feelingtired, not sleeping, nervousness,and diarrhea. These side effects

Transformed from the original article published in the EXPRESS-NEWS on 10/10/2007, written by Don Finley, Medical Writer San Antonio EXPRESS-NEWS. Used with permission from Don Finley. Note: This transformed article has a Flesch-Kincaid Reading level of 6.7 - the original article was 13.9.

Teacher Enrichment Initiatives/CAINE2009©The University of Texas Health Science Center at San Antonio

TEI News A PLAIN LANGUAGEANTHOLOGYReviews

JOURNAL ARTICLETransformed into part of a plain language anthology

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Treating Alcohol Dependence with Topiramate: A Critical Appraisal Learning ActivityAbstract: This study set out to test a drug, topiramate, to see if it reduced theamount of alcohol people drank. The study was designed as a randomized controlledtrial. One group (183 men and women addicted to alcohol) was given the drug (topiramate). Another group (188 men and women addicted to alcohol) was given apill that looked exactly like the one taken by the first group. This pill, however, didnot contain the medicine (placebo). Neither the researchers nor the men and womenin the study knew which group patients were in (double-blinded study). This meansthey did not know who was taking topiramate or who was taking the placebo. Bothgroups received 15 minute counseling sessions each week. Some people droppedout of the study before it was finished. Dropouts affected the results. Therefore,researchers calculated results two ways. They compare the number of heavy drink-ing days in each study group. Including dropouts, the number of heavy drinkingdays was 8.44% less in the topiramate group. Not including dropouts, the number of drinking days was 16.19% less in the topiramate group. Side effects, such as lackof appetite, lack of concentration, and burning/tickling feelings were more commonin the topiramate group. Researchers said that topiramate may be a promising treat-ment for people addicted to alcohol

Background: Alcohol addiction, or alcoholism, is a complex disease. The NationalInstitute on Alcohol Abuse and Alcoholism describes four main features. These features are:

1) strong need to drink (craving)2) not being able to stop drinking once started 3) withdrawal symptoms (upset stomach, sweating, or shakiness) after

not drinking 4) need to drink more and more alcohol in order to feel it’s effects

(tolerance)

Alcoholism affects about 18 million Americans. It is serious and dangerous. It canincrease risk of certain types of cancer. It damages the brain, liver, and other organs.Alcohol can cause birth defects. It also increases the chance of dying in a car crash orfrom murder or suicide.

How does addiction happen? We feel pleasure (rewards) from eating food anddrinking fluids. These things activate our brain reward system. Feeling pleasure makesus want to repeat the behavior that caused it. This is good in the case of food andwater, which we need to survive. However, the same feeling of pleasure can becaused by some drugs. Examples include cocaine, marijuana, and alcohol. Thesedrugs activate certain networks of nerves in our brains (circuits). The brain circuitsrelease a chemical (dopamine) that makes us feel good. The brain “remembers” whatcaused the pleasure and “wants” it repeated. The need to take drugs becomes more


This article was transformed for age level from the originalarticle, which appeared in the Journal of the AmericanMedical Association (JAMA),vol. 298, October 10, 2007, pp 1641-1651. Authors: BA Johnson, N Rosenthal, JA Capece, F Wiegand, L Mao, K Beyers, A McKay, N Ait-Daoud, RF Anton, DA Ciraulo, HR Kranzler, K Mann, SS O’Malley, and RM Swift for the Topiramatefor Alcoholism Advisory Boardand the Topiramate forAlcoholism Study Group.Thisarticle is for K–12 educationaluse only. This transformationfollows peer-reviewed format.

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TEI PLAIN LANGUAGEANTHOLOGY

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important than anything else. A person addicted to alcohol no longer drinks forpleasure – they are physically dependent on it. The need for alcohol becomes all that matters. Addiction is caused by changes in the brain that may be lasting. Thesechanges make it hard to stop taking drugs.

The medicine used in this study is called topiramate. Its approved use is to preventseizures and headaches. Topiramate may do its job by changing brain chemicals.This study tested the drug, topiramate, to see if it also might be used to treat alcohol addiction.

Methods: The study design was a randomized, double blind, placebo controlled-trialthat took place in 17 study sites across the United States. The study was donebetween January 27, 2004 and August 4, 2007. 371 men and women were included inthe study. They were 18 to 65 years of age. All men in the study drank more than 35drinks per week (average of 5 drinks/day). All women in the study drank more than28 drinks per week (average of 4 drinks/day). For the study, a drink was 0.5 oz ofalcohol (this is the amount of alcohol in a 4 ounce glass of wine or a 10 ounce beer).All had to have a urine test that showed no illegal drugs in their bodies, like cocaineor marijuana. All had to want to stop or lower their drinking. People who applied to the study were not accepted if they had circumstances that could affect the studyor cause harm to the person. Some of these situations included serious withdrawalsymptoms, more than 4 unsuccessful hospital stays, or receiving psychiatric help.Other factors included taking anti-seizure medicine, being pregnant, or having kidney disease or depression. Institutional Review Boards at all 17 study locationsapproved the study design. All people in the study signed written informed consentforms. Before they could sign, they had to have breath alcohol levels less than 0.02%.

707 men and women volunteered to take part in the study. 336 did not meet studyrequirements. 31 decided not to join after learning details of the plan. 40 never followed through on the application process. 371 men and women were placed intotwo groups by chance (randomized). 183 received the medicine topiramate. 188received pills that looked identical, but had no active ingredient (placebo). Bothgroups received 15 minute counseling sessions each week (Figure 1).


2



Participants were given a card for recording the amount of alcohol they drank. Themain result (dependent variable) was percentage of heavy drinking days. A heavydrinking day for men was 5 drinks/day or more. For women it was 4 drinks/day ormore. Another result was the number of days with no drinking.

A blood test measuring alcohol intake was required in addition to the informationthe people reported. To ensure the drug was safe, vital signs, physical exams, andblood tests were watched carefully. This was done to see if the study drug causedany harmful side effects. While the study was taking place, a separate group, completely independent from the research, looked at the emerging data from timeto time. This was done to be sure every person in the study was safe.

When some patients dropped out of the study, data about them were missing. Aswith any study, it would have been better to have no missing data. The amount andpattern of missing data can affect results. Therefore, the researchers had to decidehow to handle missing data in their study. To see how missing data affected theirresults, calculations were done in two ways. The first was to analyze the study withevery subject in it, which made the most of all the available information. Thisapproach preserved the effects of patient assignment into groups at the start of the

336 not eligible in study

707 Men and Women Screened

Figure 1 Study Profile

371 randomized

112 finished study 144 finished study

188 included in main analysis

188 included in safety analysis

183 included in main analysis

183 included in safety analysis

4 dropped after enrollment

67 dropped out during study

(34 side effects)

3 dropped after enrollment

41 dropped out during study

(6 side effects)

183 assigned to take Topiramate and counseling

188 assigned to take placebo

and counseling


3



study. It was the tougher test of the drug’s affect. The second analysis was to focusonly on subjects who went all the way through the study and had complete data.This approach gave a “best case” result. These two approaches were compared to see how much dropouts affected the final results. An expert, who was not involvedin the study, checked the calculation of results.

The information on number of drinking days was reported by people in the study(self-reported). These people may have been affected by the alcohol they consumed.Therefore, their information was compared to the required blood alcohol test data.

Results: The two groups of study participants were similar at the start of the study(Table 1).

Table 1. Study Group Characteristics at Start of Study

By the end of the 14-week study, 67 people in the topiramate group dropped out(36.6%) – in contrast, 41 people dropped out of the placebo group (21.8%). In thegroup that took the medicine, the percentage of heavy drinking days dropped from 81.91% to 43.81%. In the group that took the pills without medicine in them(placebo), the percentage of heavy drinking days dropped from 81.97% to 51.76%(See Figure 2). The percent of days without drinking any alcohol increased from9.64% to 37.56% in the topiramate group; it also increased from 9.64% to 29.06% in the placebo group. The blood tests verified lower alcohol intake in the group taking the topiramate. The number of side effects was higher in the group takingtopiramate (Table 2).

Sex MaleFemale

Race WhiteBlackAsian Other

Self-Reported Drinking Days Heavy Drinking (%)Days Without Drinking (%)

Breath Alcohol (%)

13346

15212114

82.3510.91

0.002

13352

15716210

83.829.71

0.002

Topiramate Group (n=179)

Placebo Group (n=185)

46.7 47.8Average Age (years)


4



Study Week

Hea

vy D

rink

ing

Day

s (%

)

PlaceboTopiramate

B


Figure 2 Continued Percentage of Heavy Drinking Days (Dropouts Not Included)

Figure 2 Percentage of Heavy Drinking Days (Dropouts Included)

Study Week

Hea

vy D

rink

ing

Day

s (%

)

Placebo (n=188)Topiramate (n=183)

A

5



Discussion ofResults: In this 14-week study, topiramate appearedto reduce the percentage of heavy drinking days andincrease the numberof days with nodrinking (absti-nence). Because

people in the study had to meet certain requirements, they may have been healthierthan most people addicted to alcohol. Therefore, the results may not apply to allpeople with alcohol addiction. The study also did not have a long follow-up time tosee if people in the study started drinking heavily again. Our conclusion, however, is that topiramate is safe and effective for treating alcoholism. This is importantbecause alcoholism is a serious health problem in the United States.

References:

National Institute on Alcohol Abuse and Alcoholism, retrieved on May 8, 2009 from http://www.nlm.nih.gov/medlineplus/alcoholism.html.

National Institute of Drug Abuse, retrieved on April 13, 2009 fromhttp://www.nida.nih.gov/pubs/teaching/teaching2/Teaching3.html.

Johnson, BA, et al. Topiramate for treating alcohol dependence: A randomized controlled trial. JAMA, 298, 1641-1651.

Study Disclosure:Dr. Johnson reported being a consultant for Ortho-McNeil Janssen Scientific Affairs,LLC., as did 6 other researchers on the study. This company makes Topiramate, themedicine used in the study.

Funding Support for the study: Ortho-McNeil Janssen Scientific Affairs, LLC. provided the medication and funding for this study.

Role of Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC was involved in allphases of the study, from its design through analyzing the results and review of thepaper to be published. A separate analysis of the results was done by Daniel O.Scharfstein, who was not employed by Ortho-McNeil Janssen Scientific Affairs, LLC or Dr. Johnson.


Measures of Readability for this transformed article (text only):Flesch-Kincaid Grade Level 8.7Flesch Reading Ease 55.9

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Table 2 Side Effects

Side Effect Topiramate Group Placebo Group(n=183) (n=188)

Tingling of skin 95 20Headache 44 60Tired 41 33Could not concentrate 27 6Memory problems 23 13Sleepiness 22 19Nausea 19 31



1

General Information:Name of Study ___________________________________________________________

________________________________________________________________________

First Author_____________________________________________________________

________________________________________________________________________

Funders ________________________________________________________________

________________________________________________________________________

Institution(s) _____________________________________________________________

________________________________________________________________________

Disclaimers/Disclosures ____________________________________________________

________________________________________________________________________

Health Science Content ___________________________________________________

________________________________________________________________________

Describe the test subjects of the study _______________________________________

__________________________________________________________________________

Purpose of study _________________________________________________________

________________________________________________________________________

Design of Article

q Newspaper q Magazine

q Peer-Reviewed Journal q Web Article/Blog

q Kinds of figures, tables, and graphs

Words to Define __________________________________________________________

________________________________________________________________________

________________________________________________________________________

D’SCERNER, THE LIFE-LONG LEARNER:

STUDENT GRAPHICORGANIZER


Treating Alcohol Dependence with Topiramate

TOPIRAMATE FOR ALCOHOL DEPENDENCE

MODULE 1–THINKING ABOUT THE STUDY

D’Scernerand her L’ete

group must deal

with this preliminary

information to help

clearly discern the

facts of this case.L33

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2

STUDY DESIGN

ETHICAL TREATMENT OF TEST SUBJECTS

p Observational-Explain Your Choice

________________________________________

_______________________________________

_______________________________________

Why is this important to know?

_______________________________________

_______________________________________

_______________________________________

p Experimental-Explain Your Choice

_______________________________________

_______________________________________

_______________________________________

Why is this important to know?

_______________________________________

_______________________________________

_______________________________________

OBSERVATIONAL

CHECK LIST

p Case Report

p Case Series

p Cross Sectional

p Case-Control Study

p Cohort Study


EXPERIMENTALCHECK LIST

p Intervention Studyp Randomized

Controlled Trial

Why was it important for researchers to explain the study to participants and obtain written consent

from them?____________________________________________________________________________

Why was it important for the blood alcohol level of study participants be <0.02%?___________________

_____________________________________________________________________________________

Why did Institutional Review Boards of all 17 study locations have to approve the study design?_______

____________________________________________________________________________________



After reading your article, determine if the study was an observational or experimental study.

Then decide which study design was used and check the appropriate box. Explain your choice in the

space provided.

D’Ziner is a

master at identifying

the basic design in

any study. He hones

in on clues and puts

them together to

reveal the true

design of any study.

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STUDY DESIGN

Identify Variables in the Study

Identify Controlled

Variables of study

_____________________

_____________________

_____________________

_____________________

_____________________

_____________________

_____________________

Identify Independent Variable of study ___________________________________________________________________________________________________________________________________________________

Identify Dependent

Variable of study

_____________________

_____________________

_____________________

_____________________

_____________________

_____________________

_____________________

D’Isabler uses

her well-honed

super sleuthing

skills to detect and

disable any sources

of bias that might

affect the results of

this study.

STUDY DESIGN

Sources of Bias

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D’Riddlertakes the lead in

identifying the study

variables, bringing

the group one step

closer to the heart

of this study.

Sponsors, Funders, Target Audience, Predetermined study goals –

How might each of these affect the results of the study? __________________________________________________________________________________________________________________________________________

How did the research team handle any possible impact on the study from factors such as conflict of interest?

__________________________________________________________________________________________________________________________________________

?? ?

?? ?

1


MODULE 2–THE RESULTS


Nature of Data Collection p Self Reported p Clinical Setting p Interview in Person p Phone Interview p Questionnaires Check all that apply and explain how each might affect the results?____________________________________________________________________________________________________________________________________________

D’Cypheris the real masterwhen it comes tothe data. There’s noone better to have

on the team whenit comes to sorting

out the numbers.

Graphs On the graph paper that follows, use

Table 1 in the Journal Article to create a graph that compares the age, sex, race, and % Heavy Drinking Days between the two groups. Is a line graph or bar

graph better to show this data? Explain.

____________________________________________________________________________________________________________________________________________________________________________________________________________

FROM TABLE 1 STUDY GROUP

Why are the days of heavy

drinking reported as percentages?

______________________________

______________________________

______________________________

How do gender and age compare

between the two groups?

______________________________

______________________________

______________________________

Why is it important to know the

breath alcohol % of the people in the study?

______________________________

______________________________

______________________________

______________________________

How might large differences in age affect the results?

______________________________

______________________________

______________________________

Were the data reported correctly in

the news? If not, how was the

reporting incorrect or incomplete?

______________________________

______________________________

______________________________

Determine:

Average Age

# of Males

# of Females

% Heavy Drinking Days

Topiramate Group

Placebo Group ?

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2


MODULE 2–THE RESULTS

______________________________ (Axis label)

Title ______________________________

____

____

____

____

____

____

____

__

(Axi

s la

bel)


Using the data from Table 1 Study Group Characteristics in the Journal Article, make agraph of age, sex,race, and % Heavy Drinking Days between the two groups. Be sure toinclude a complete title, axis labels, and units of measurement.

3

Using the information from Table 2 (below) make a graph of the % Heavy Drinking Days(Without Dropouts) during the 14 weeks of the study. Which type of graph is better? Explain.

Table 2 Percentage Heavy Drinking DaysWeek Topiramate Group Placebo Group

With Dropouts Without Dropouts With Dropouts Without Dropouts

0 81.91 82.09 81.97 81.82

1 73 73 74 74

2 68 65 74 68

3 58 55 63 67

4 53 45 64 63

5 52 42 60 55

6 46 38 62 53

7 45 35 61 51

8 44.5 30 60.5 50

9 44 25 59.5 49.5

10 43.5 22 61 49.5

11 43.3 21.5 59 45

12 44.5 22 58.5 43

13 44 19.8 52 42

14 81.91 82.09 51.76 81.82

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

______________________________ (Axis label)

Title ______________________________

____

____

____

____

____

____

____

__

(Axi

s la

bel)




MODULE 3–ANALYZING RESULTS

1. Strength of Relationship:Study bias or factors negatively affecting theexperiment make the results less reliable. List factors that affected the study results.

2. Consistency:Were the results similar in repeated trials or in different studies? Explain. If so, the results are more reliable.

3. Compare Test Group to Control:How did the test and control groups compare? This helps establish the cause of any observed change.

4. Strength of Effect:An increase in the treatment that results in an increase in observed change helps verify that the independent variable caused the results. Was this true in this study? Explain.

5. Plausibility:Is there a reasonable way to explain how the treatment might cause the observedchanges? Explain.

6. Study Design:What kind of study design was used?

7. Analogy:How could you find out if the results of thisstudy are similar to those of other studies?

What Caused the Results? Describe the results of the study in terms of each item listed below. Write your answers in the space provided.*Modified from Bradford-Hill considerations on causality

_________________________________________________________________________________________________________________________________________________________________________________________

_________________________________________________________________________________________________________________________________________________________________________________________

_________________________________________________________________________________________________________________________________________________________________________________________

___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

_________________________________________________________________________________________________________________________________________________________________________________________

__________________________________________________________________________

____________________________________________________________________________________________________________________________________________________

Answers Here:

D’Finertakes the lead when

it’s time to analyze

the results and

define the cause of

the results and the

degree of certainty

about the cause.

Think about your answers so far. What probably caused the results found in this study?_____________________________________________________________

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

How was effectiveness of the medicine different when all test subjects were analyzed? (See Table 2 in previous module.)_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Was this difference in effectiveness of the medicine reported in the news article?_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

How might having people in the study report their own drinking affect the results?_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



MODULE 3–ANALYZING RESULTS

???

Peer-Reviewed Media ArticleResearch Report

StyleTitle written to catch readers’ attention

Results reported with little information about methods

Length of article

Length of paragraphs

Number of details about the study

Tables, Charts and Graphs included

Describe use of pictures and color

Describe writing style and use

of references



MODULE 4–COMPARING AND CONTRASTING

PLANNING PAGE

__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

_____________________________________________________________________________________________________________________________________________________________________________________________________________

_____________________________________________________________________________________________________________________________________________________________________________________________________________å


Study DescriptionResearchers, Organizations and Universities described

Details about funders and researchers included

Conflict of interest statement included

Sources of possible bias reported

Type of study design reported

Study sample described

Detailed description of procedures used in the study

Effectiveness of medicine reported




__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

_____________________________________________________________________________________________________________________________________________________________________________________________________________

__________________________________________________________________________________

What issue(s) is/are included in the media report but not the research article?__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________





DataAnalysis of data described

Use of statistics described

Information about cost of vaccine

Formulae included

__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________


Overall ComparisonConclusions of the researchers described

Describe which is more reliable and why

Describe which is more interesting and why

Overall Accuracy

____________________________________________________________________________________________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

____________________________________________________________________________________________________________________________________________________________________

å

4




D’VennderD’Vennder takes

the lead in putting

it all together and

comparing and

contrasting the

articles.

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

__________________________________________________________________________________________________________________________________________________________________________________________________________________

__________________________________________________________________________________________________________________________________________________________________________________________________________________

__________________________________________________________________________________________________________________________________________________________________________________________________________________

__________________________________________________________________________________________________________________________________________________________________________________________________________________

R E S EARCH RE POR T

MED

I AAR T I C

L E

VENN DIAGRAM

Compare and contrast the peer-reviewed article and the media literature article. Consider

factors from your completed planning page.

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All information ispresent and clearlydescribed.

Study design is correctly identifiedand well described.

Study variables arecorrectly identifiedand fully described.

Sources of biasand/or experimentalerror are correctlyidentified and welldescribed. Possibleeffects on the resultsof the study andways to reduce themare well described.

Method for collectionof data clearly described and possi-ble effects on theresults of the studydefined.

Data are correctlyorganized into tables.Tables have completetitles and headerlabels.

Most information ispresent and fairlywell described.

Study design is cor-rectly identified butnot well described.

Study variables arecorrectly identifiedbut not welldescribed.

Most sources of biasand/or experimentalerror are correctlyidentified and welldescribed. Possibleeffects on the resultsof the study andways to reduce them are not welldescribed.

Method for collectionof data clearlydescribed but possi-ble effects on theresults of the studyare not defined.

Data are somewhatorganized into tables.Tables have incom-plete titles and header labels.

Some information is present and descriptions need tobe clearer.

Study design isincorrectly identified.

Study variables arenot correctly identified.

Sources of biasand/or experimentalerror are not correct-ly identified. Possibleeffects on the resultsof the study andways to reduce themare not welldescribed.

Method for collection of data not described.

Data are not organ-ized into tables ORare inaccurate.

All information ispresent and fairlywell described.

Study design is cor-rectly identified andfairly well described.

Study variables arecorrectly identifiedand fairly welldescribed.

Sources of biasand/or experimentalerror are correctlyidentified and welldescribed. Possibleeffects on the resultsof the study andways to reduce themfairly well described.

Method for collectionof data describedand some possibleeffects on the resultsof the study defined.

Data are correctlyorganized into tables.Tables have incom-plete titles and header labels.

GeneralInformation from Articles

Study DesignIdentified

VariablesIdentified

Sources of Bias

Nature of Data Collection

Data Tables

Category Level 1 Level 2 Level 3 Level 4

1

D’SCERNER the Life-Long Learner Rubric


Type of graph isappropriate for data.Data are clearly rep-resented in graphswith complete titles,axis labels, units, and legends.

The cause and effectrelationship betweenthe variables is dis-cussed and trends/patterns logicallyanalyzed. Strengthsand weaknesses inthe study are discussed to givereaders an idea ofthe strength of therelationship between variables.

Compare/Contrastinformation welldescribed. Excellentanalysis of articles.

Type of graph isappropriate for data.Most titles, axislabels, units, and leg-ends are clear anddata are understand-able from graphs.

The cause and effectrelationship betweenthe variables is dis-cussed and trends/patterns logicallyanalyzed. Strengthsand weaknesses inthe study are weakly discussed.

Compare/Contrastinformation welldescribed. Goodanalysis of articles.

Type of graph isappropriate for data.Data are fairly wellrepresented ingraphs, but sometitles, axis labels, leg-ends, and units aremissing or confusing.

The cause and effectrelationship betweenthe variables is dis-cussed, but notrends/ patterns arelogically analyzed.Strengths and weaknesses in thestudy are weakly discussed.

Compare/Contrastinformation fairlywell described.Adequate analysis of articles.

Graphs are present,but have incompleteor missing titles, axislabels, units, and legends. Data are notrepresented clearly.

The cause and effectrelationship betweenthe variables is notdiscussed.

Compare/Contrastinformation not welldescribed. Weakanalysis of articles.

Graphs

Cause andAnalysis of Results

Compare andContrast Articles

Category Level 1 Level 2 Level 3 Level 4

D’SCERNER the Life-Long Learner Rubric, continued

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thinktwice! thinktwice! ? ? d’scerner: critical appraisal...

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