An Introduction to Sociology – and what it can do for pharmacy practice research
Bissel P, Traulsen JM, Haugbolle LS. Int J Pharm Pract. 2001;9:289-95.
Why Sociology Important for Pharmacy Research?
1) Training of health professionals have increasing emphasis on social &interpersonal aspects
of health care practice
2) Growing role of Pharmacy in promoting health, enhancing compliance, providing medicines
management services
3) Health&illness are social (not just biological) phenomena and so are amenable to
sociological analysis
being ill affects our lives and relationships with others in society
there are social aspects to medication usage and beliefs about those medications
4) All healthcare practice is conducted within social relationships and social structures
ex. a hospital is a mini-society
What is Sociology?
Characteristics: - ongoing influence by popular culture and evolving society
- tends to focus on “problems”, especially idea of social order
- rarely provides certainty or objectivity in responses to questions
Three Major Concerns:
1) The nature of social structure
2) The relationship between self and society
3) The historical development of society
Sociological Theories:
To address these concerns sociologists develop theories. These theories often emphasize
either “agency” or “structure”, the degree to which characterizes the theory.
if focus on agency = seek to understand how individuals influence the wider society through
their thoughts, actions and behaviours
if focus on structure = seek to understand how the thoughts, actions and behaviours of
individuals are influenced by wider society
Eg. how is compliance affected by individual beliefs and behaviours? (agency) vs. how is
compliance affected by culture, family and financial resources? (structure)
What are the Goals of Sociology?
- to provide a framework within which to interpret and understand research findings
- to determine the “nature of power”
ex. the consequences of how a health professional’s use of their power and authority
affects patient health outcomes (compliance with difficult regimen, etc)
- to question current healthcare practices and policies
Engaging sociological theory can provide deeper insights into health, medicine and human
behaviour…this can add to the strength and diversity of pharmacy practice research.
Science and the Scientific Approach
In Foundations of behavioural research 2nd ed. New York: Holt, Reinhart, Winston, 1973:215.
Sept 4th Readings (i.e. the one Thorsen HINTED would be on the exam!!!)
Intro: -point of article is to explain scientific language and the scientific approach to problem solving
-this is because in order to understand ANY complex human activity, we must grasp the language
and the approach of the individuals who use it
-the scientists approach to problems IS different than layman’s, but it’s not strange or esoteric (when
understood it will seem natural)
Science and Common Sense: -“in creative thought common sense is a bad master”
-How are common sense and science alike and different?
Similar
Different in 5 ways
-science is a systematic and
1) Layman may use the idea of “concepts” loosely, i.e. “ a
controlled
person gets sick b/c they need to be punished for
extension of common sense
committing a crime”. Scientists systematically builds
-both are a series of concepts
theoretical structures and tests them for internal
satisfactory
consistiency. Realizes that the concepts are “man-made”
for the practical uses of
and may not represent reality
mankind
2) Scientist systematically and empirically tests his theories
PROBLEM: sometimes
and hypothesis. They carefully guard against
these “concepts”
preconceptions, predilections and selective support of
Can be misleading i.e. last
their hypothesis
century it was
3) Control in science-scientist tries to systematically rule out
“common sense” to use
variables that he has hypothesized to be the causes.
punishment for
Layman don’t do that.
pedagogy. Now evidence to
4) Cause and effect: Layman may see two phenomena
show that
occurring coincidently and label as cause and effect.
rewards work better than
Scientist consciously and systematically pursues relations
punishment
5) Explanations of observed phenomena: scientist carefully
rules out “metaphysical” relations: i.e people are poor b/c
God wills it, studying hard subjects improves child’s
moral character. None of these things can be tested—
metaphysical. Doesn’t mean that scientist doesn’t believe
them, he just can’t be concerned with them while in the
scientist role.
Four Methods of Knowing (or fixing belief):
1) Method of TENACITY: -men hold firmly to what they believe is true because they have always
known it to be true.
-repetitions of the truth increase its validity
-men tend to cling to their beliefs when there are conflicting facts
2) Method of AUTHORITY: -established belief (i.e. if the Bible says so, it is. If a noted physicist
says there’s a God, there is).
-superior than tenacity. Life couldn’t go on w/o this method (i.e. we all take large body of fact and
information on the basis of authority)
-human progress can still be achieved w/this method (unlike tenacity)
3) PRIORI Method (method of intuition): -priori propositions agree with “Reason”…but not
necessarily with experience
-idea seems to be that men, w/free communication can reach the truth by reasoning b/c natural
inclinations are towards the truth
-problems: what happens when 2 men reason things out differently? who is right?
4) Method of SCIENCE: - one characteristic that no other method has: self correction
-bulit-in checks along the way used to control and verify scientist’s activities and conclusions
-scientists INSIST on testing every hypothesis no matter how “promising” it looks
-scientists insist that testing procedure be open to public inspection
-OBJECTIVITY: no bias, preconceptions…etc
-most DEPENDABLE form of knowledge
Science and it’s Function:
-science is a badly misunderstood word—3 popular beliefs:
1) whitecoat, stethescope stereotype—scientist is a PECULIAR person who works with facts in the
lab
2) scientist is a brilliant individual—thinks, spins complex theories, generally spends time in ivory
tower aloof from the world and it’s problems
3) equates science with engineering and technology (i.e. building bridges, improving misiles etc)
In the scientific world there are 2 broad views of science:
STATIC VIEW: -an activity that contributes systemized information to the world, adds to the existing
body of knowledge
DYNAMIC VIEW: an activity that scientists DO. It’s a base for further scientific theory. Heuristic view:
the word heuristic means to serving to discover or reveal. May be called problem solving with an
emphasis on imaginative not routine problem-solving. Established facts are important b/c they add to
further theory, discovery etc
FUNCTION OF SCIENCE: --2 views
1) science as an activity aimed at improving things (view held by layman)
2) similiar to heuristic view, but with an added element of establishment of general laws
The Aims of Science, Scientific Explanantion, and Theory:
-basic aim of science is theory, to explain natural phenomena
-the point of THEORIES is to find general explanations that can be applied to specific behaviors
-note, the basic aim of science is NOT betterment of mankind (hard to believe for students)
Theory def’n: A theory is a set of interrelated constructs (concepts), definitions, and
propositions that present a systematic view of phenomena by specifiying relations among
variables, with the purpose of explaining and predicting the phenomena.
-think of the bolded parts as three important parts of the def’n.
-take example of failure in school as a theory: variables could be intelligence, anxiety,
motivation; the phenomena is failure in school; the scientist “understand” school failure by
relating the variables to the phenomena, and then is able to “predict” it.
-explaination and prediction are RELATED (if u can explain phenomena, u can predict it)
-by its very nature, theory PREDICTS.
Scientific Research – A definition
Scientific Research is systematic, controlled, empirical, and critical investigation of hypothetical
propositions about the presumed relations among natural phenomena.
Two points:
1. Systematic and controlled means, in effect, that scientific investigation is ordered that
investigators can have critical confidence in research outcomes. This means that the research
observations are tightly disciplined.
2. Scientific research is empirical – Subject belief must be tested against objective reality
The Scientific Approach
- it a special systematized form of all reflective thinking and inquiry.
- what follows is based on Dewey’s analysis
Problem – obstacle idea
The scientist will usually experience an obstacle to understanding. His first step is to get the idea out in
the open and express the problem in some reasonable manageable form. Problem will not spring fullblown at this stage. Then he states the problem, explicitly or implicitly and here he intellectualized what
was first an emotional quality of the whole situation.
Hypothesis
It is a conjectural statement, a tentative proposition, about the relation between two or more phenomena
or variables. (“If such and such occurs, then so and so results”)
Reasoning –Deduction
The scientist now deduces the consequences of the hypothesis he has formulated. Experience,
knowledge, and perspicuity are important.
He may arrive at a problem quite different from the one he started with, or the deductions led him to
believe that the problem can’t be solved with present technical tools. (eg. Before modern statistics were
developed, it was difficult to test more than one hypotheses at the same time, but now there’s reason to
believe that certain problems are insoluble unless they are tackled in a multivariate manner, ie teaching
methods).
Eg. investigator looks at aggressive behaviour, and notes that aggressive behaviour seems to occur when
people have experienced difficulties of some kind. He formulated hypothesis: Frustration leads to
aggression and reasons that, if frustration leads to aggression than then we should find a great deal of
aggression in children who are in schools that are restrictive. This shows that reasoning may change the
problem. The initial problem was only a special case of a broader problem. Important because of its
almost heuristic quality. Reasoning can help lead to wider, more basic, and more significant problems, as
well as provide operational (testable) implications of the original hypothesis.
Observation –Test – Experiment
Test hypothesis by testing the relation expressed by the hypothesis, (test the relation between variables)
for the purpose of putting the problem relation to empirical test. A vague and poor stated question can
lead to ignorance and misguided information.
We test the deduced implications of the hypothesis. Eg. Hypothesis may be “writing remarks on student
papers will improve future papers”, which was deduced from a broader hypothesis, “Reinforcement of
responses leads to an increment in the response rate and strength”. We are testing the relation between
writing remarks on papers and the improvement of future papers.
Temporal sequence of reflective thinking or inquiry is not fixed. (ie. the first step is not neatly completed
before the second step begins).
We may test before adequately deducing the implications of the hypothesis. The hypothesis itself may
seem to need elaboration or refinement as a result of deducing implications from it.
Feedback to the problem, hypothesis, and theory of the results of research is very important. People have
altered their theories and research because of experimental findings. Part of the essential core of
scientific research is the constant effort to replicate and check findings, to correct theory on the basis of
empirical evidence, and to find better explanations of natural phenomena. Science has a cyclic aspect.
Theory and research is challenged by other researcher.
Summary of scientific approach.
1. doubt, a barrier, and indeterminate situation
2. formulation of problem.
3. literature search / scans own experiences
4. hypothesis is constructed – then empirical implications are deduced. (original hypothesis may be
changed)
5. relation expressed by the hypothesis is tested by observation and experimentation.
6. hypothesis is accepted or rejected on the basis of research evidence
7. information is then fed back to original problem, which is kept or changed based on the evidence
Phases of the process can be expanded or skipped. What’s important is the controlled rationality of
scientific research as a process of reflective inquiry, and the interdependent nature of the parts of the
process, and the importance the problem and its statements.
Contributions of the Social Sciences
Mount JK. In Foundations of behavioural research 3rd ed., William and Wilkins, 1989. 1-16.
Preliminaries
 Growing concern among public/health care professionals that health needs are not being met by
biomedical research alone (which is considered the dominant approach to health care).
 We also have to consider the “human side” of things, or the psychosocial issues, for complete
patient care.
 George Engel proposed a biomedical model of health care that adopts the biopsycosocial idea,
and considers the social sciences (SS) as a complement to the physical and biological sciences.
 Inclusion of the social sciences offers a new approach to health care
 This is important because pharmacy practice is continually changing (ie. we need to take on new
professional roles and patient care orientations, and the social sciences can help us understand
these new roles better and focus on the human side of things).
 Social sciences (eg. anthropology, sociology, psychology, epidemiology) focus on understanding
patterns and meanings of human behaviour.
 Definition of Science – (1) it is theory based;
(2) it uses precise principles for investigation which
specify appropriate techniques for collecting and
analyzing data;
(3) knowledge base is always expanding and cumulative,
and can support or refute what is already known;
(4) identifies cause-effect relationships so we can make
predictions.
 Definition of Theory – a series of related, testable propositions that describe how a set of facts are
related to one another and under what conditions these relationships hold. Eg. the germ theroy
 The social sciences are considered a science because they are theory based, use systematic
research techniques, and are cumulative and predictive (but this is the weakest aspect for SS
because they are still at the early stages of development, unlike chemistry/biology).
 Solving DRPs have mainly focused on physical and biological sciences, but over the last ~ 20
years, pharmacists have started using the SS.
 SS deal with phenomenon that are part of our “life-world”. They are not described by common
sense.
 SS are accurately described as interpretive sciences, highlighting peoples understanding of the
social world and how it affects them.
 Social scientists must be more explicit in their recognition of their interpretations, and spend time
on validating their techniques and theories.
 Basic SS researchers seek enhanced understanding and have the primary goal of knowledge
discovery for its own sake. Eg. does patient recall of info affect their medication compliance?
 Applied social or behavioural research want to apply this knowledge about human behaviour to
address real concerns or issues. Eg. What memory enhancing techniques best improve patient
compliance?
 The weaknesses of the biomedical model:
o Once the best of the physical and biological science knowledge is applied to the treatment
of diseases a number of problems are not completely resolved
o The model has a tendency to consider patients as biologically active organisms and its
frequent failure to consider patients as socially active participants in health care
endeavors

Weaknesses are addressed in the biopsychosocial model which allows us to view pharmacy and
drugs within the human context in which they exist
o Model provides a ‘systems approach’ to understanding the world
Contributions of the social sciences

There are 3 specific areas in which the social sciences contribute to our understanding of
pharmacy and pharmacy practice. It provides with:
o Approaches to asking questions in pharmacy
o Conceptual and explanatory frameworks
o Research tools and techniques
Contribution 1: Approaches to Analyzing pharmacy
 Most important contribution of social sciences to pharmacy is their assistance in identifying
questions and subjects that need to be addressed.
 It helps to identify the central problematics of social and behavioural pharmacy
 Question of central interest can be grouped into
o Drugs and drug use
o Pharmacy practice and services
o Pharmacy as a profession
 Social sciences also help to understand the basic work of pharmacy
 2 major interrelated aspects of this work are
o at the microsocial level: describe pharmacy as the discrete activities and interactions
carried out as part of pharmacists’ day to day functioning (Eg. Discussing how belonging
to a profession affects individual members)
o at a broader level (ie macrosocial) : pharmacy services describe formally or informally
organized sets or systems of pharmacists’ work activities (Eg. Use of an international
comparative approach to assessing the status of pharmacy)
 another topic informed by the social sciences focuses on the state and status of the pharmacy
profession.
Contribution no. 2: Conceptual and Explanatory Frameworks:
The social sciences assist provide explanatory frameworks for interpreting our question and it’s answers.
Such an explanatory framework is a theory or a theoretical approach.
Several broad theoretical orientations underpin most of the theories social scientists examine.
1. Psychological
 how personality and psychological processes (learning, feeling, thinking) affect
behaviour
2. Social Psychological
 like psychological but emphasizes how individual behaviour is affected by social group
membership
3. Functional
 influences that result from existence, organization and operation of large social groups
 assumes that consensus and agreement dominate these social groups
4. Political


influences that result from existence, organization and operation of large social groups
assumes that conflict and competition dominate
5. cultural
 focus on social groups within their environmental context
 greater emphasis on social/man-made environmental influences on human behaviours
6. ecological
 focus on social groups within their environmental context
 emphasizes physical/natural environmental influences
 theoretical orientation is a basic set of assumptions regarding the factors that influence human
behaviour
Contribution no. 3: Research Techniques and Tools
A: Research Design
Research Method
Strengths
Weaknesses
Experiment
*Good internal control
*Random assignment
used
*Random sampling can
be used
*Good representation of
population possible
Can study events in
natural surroundings
Situations often
artificially structured
Content Analysis
Researcher ahs direct
effect on subjects being
studied
Existing Data
Research
Historical Research
Same as above
Problems with data
completeness,
accuracy and
verification
Same as above
Survey Research
Field Research
Comparative
Research
Evaluation
Research
Allows comparisons not
possible at one point in
time
Allows comparisons not
possible in any single
community society
Determination of effects
of interventions possible
Example of
Application
Educational
interventions
Generally only crosssectional data
collected
*consumer surveys
*drug epidemiology
Internal control very
difficult to achieve
Observation of
patient- professional
interaction
Analysis of
professional
curriculum
Restrictions of types,
amount and quality of
data available
Comparability of data
difficult to assess (as
is accuracy often
times)
Value biases and
values conflict
problems often arise
B: Data collection
 collection of social science data takes a variety of forms
i. direct observation
Pharmacy records
review
Development of
professional codes of
ethics
State of pharmacy
throughout the world
Evaluation of patient
counseling techniques
ii. review of written records
iii. personal interviews
iv. paper and pencil surveys
C: Data Analysis
 social scientists require specialized data analysis techniques because;
i. of the research methods and data collection procedures
ii. broad social science concepts have to be incorporated into an overall measure or
scale that is reliable and valid
Conclusion:
The social sciences contributions
a. provide a unique perspective for enhances understanding of contemporary pharmacy
b. outline new questions for the pharmacy research and education agenda
c. supply a set of approaches, tools and techniques for addressing these questions.
The provision of enhanced pharmacy services in Ontario
Dolovich L, Ho CS, Wichman K, Bowles-Jordan J. CPJ/RPC 2002:May;29-36.
Objective:
Proile the types of enhanced services provided based on definitions in OPA fee guide
Determine the level and frequency of provision
Identify sources and rate of compensation
Method:
Study Design
Cross-sectional, survey by mail, returned by fax or mail
Follow-up reminder to non-responders, second reminder by phone
Survey
27 items, 3 sections with questions related to OPA fee guide, 4th section demographics
800 sent out, with target response rate of 30%
Data Analysis
Descriptive statistics, (mean, median, range etc.)
Results:
24% response, chain and independent, usually had more than one pharmacist/technician working
Additional dispensing services
rate of provision and patient volume:
high: compounding, DRP’s, delivery
low: refill reminder, trial Rx
Time requirements: simple 6-10 mins, complex 11-15
Compensation: most free of charge, except for compliance aid package, compounding, colostomy supply
consultative services
Pharmaceutical Care Services
Rate of provision: (high to low)
Med review, advanced patient education, care plan prep, patient assessment, HCP team consultation
Patient volume: 1-3/week
Time: 16-30 mins
Compensation: mostly fee of charge (93-100%), compensation usually from pt not TPP
Specialized Pharmacy Services
Rate of provision: (high to low)
Smoking cessation, complementary care consultation vs. home care, drug abuse consultation
Patient Volume: 1-3/week except complementary care (7-9)
Time: most under 15 mins, some up to 30
Compensation: mostly free of charge (90-100%), compensation usually from pt not TPP
Discussion:
- as the complexity of enhanced pharmacy services increased, the # of pharmacies providing them
& the # of patients receiving them decreased.
- Few pharmacies receive compensation for providing enhanced services.
- To provide enhanced services you need: therapeutic knowledge, comprehensive advanced
service delivery techniques, time management, and supportive staff.
- Services provided the most: medication reviews & complementary med consult
- Limitations of the study: low response rate (24%), not all questions were answered, bias – those
who responded are more likely to be those who provide phm care, the questions contained terms
that could be interpreted differently by different pharmacists, study relies on self-reported data.
What Patients Want To Know About Their Medications
Nair K, Dolovich L, Cassels A, McCormack J, Levine M, Gray J, Mann K, Burns S. Canadian
Family Physician. 2002;48:104-9.
I think this article was just an example of a research article and the information in it is irrelevant,
but we summarized it anyways. (Don’t concentrate too hard on this one!)
Abstract
Objective:
- describe what patients want to know about their meds and how they access info.
- describe how MDs and pharmacists respond to patients’ info needs.
- to use patients’, MDs and pharmacists’ feedback to develop evidence-based
treatment info sheets
Conclusion: patients and clinicians appear to differ in what and how much info patients should
receive about meds.
Introduction
-
Methods
Design:
patients want and seek more info about drug and non drug treatment options,
but much of information contains conflicting, inaccurate, poorly written or
non-evidence-based information.
Need for balanced, accessible patient information
Objectives as per abstract.
- qualitative study used grounded-theory approach; focus groups held with
patients, physicians, pharmacists in 3 regions of Canada (Ont, NS, BC).
Study sample: - used combination of purposeful and convenience sample.
- purposeful sampling consciously seeks out participants who can contribute to
subject area.
- Reflected cultural and demographics of targeted cities  stratification of
potential participants  convenience sampling used to recruit patients
- 18yo or older with more than 1 med eligible in patient focus groups
- pharmacists and MDs that practiced in clinical capacity for at least 1 yr
invited to participate
- focus groups conducted until theoretical saturation (repetition of themes)
reached.
Focus group format: - patients focus groups consisted of 17 open-ended question asking
patients general med info needs and opinions about draft info sheets.
- MDs and pharmacists asked for opinions about themes emerging from patient
focus groups.
- Interview guide pilot-tested to ensure clarity, timing, and wording of
questions.
- Audiotaped, 2 research team member present in each group; one facilitated
group, other wrote notes.
- After each interview, researchers held debriefing, tapes transcribed  data
analysis.
Data analysis: - common themes defined from verbatim statements; transcripts coded
independently by at least 2 research members.
- themes continually developed and explored  further analysis conducted as
new themes emerged  summaries of each theme produced  reviewed to
elicit confirming and nonconfirming data for themes generated  3
researchers ensured consensus for report.
Results
- patients wanted general info about their condition before they made decisions
about treatment.
- patients also identified 5 specific areas for info: side effects and risks (including
drug interactions and contraindications); range of treatment options (including
nonpharms and alternative remedies); how long to take medications; cost of meds
(if covered by drug plans or more cost-effective alternatives available, ie.
Generics); and whether the meds were right for them (ie. Reflecting individual
health situation).
- overwhelmingly, patients thought pharmacists were most accessible as source
of info; other sources were tv, newspapers, librairies, internet, family and
friends.
- MDs and pharmacists generally felt that extra info on drugs should be given
only if it did not contribute to info overload, confusion or noncompliance.
- MDs and pharmacists unaware patients wanted treatment info for their own
unique health situations, why a particular med or treatment was suggested for
them.
- developed model of how and why patients seek information:
Context
Culture
Expectations about
their role in health
care
Consequences
↓
↓
Causal condition
Phenomenon
Diagnosis and
treatment
prescribed
Wanting or
needing info
about med
or treatment

Strategies
Actively seek 
and evaluate
info

Do nothing
Intervening factors
More informed
enhanced dialogue
with health care
provider

↑
↑
Accessibility
Experience
Condition for which info is sought
Quality of relationship with health care provider
No change
Effect unknown
Discussion
Strengths : - focus groups conducted with diverse patient sample which facilitated analysis
process to reach saturation.
- 2 qualitative verification procedures were carried out: negative case analysis
and investigator triangulation
- negative case analysis examined data to find contradictory evidence to
acknowledge breadth of possible responses  this ensures bias doesn’t not
unduly affect analysis
- investigator triangulation also used to diminish bias and affirm consistency of
findings by having more than one person conduct analysis.
Limitations: - study not large enough to allow saturation for identification of subtle differences
between subgroups (eg. urban vs rural).
- use of volunteer participants likely resulted in overrepresentation of those
more interested in patient info needs.
- Most participants in groups were older women.
Conclusion
-
both patients and clinicians acknowledge patients need info to make informed
decisions about treatments.
Patients want more info about side effects than clinicians think they should
provide.
Patients and clinicians support use of evidence-based treatment info sheets as
means of reinforcing oral advice.
Results of study were used to help develop patient info sheets compatible with
patients’ info needs.
Development of a successful research grant application
Woodward DK and Clifton GD. American Journal of Hospital Pharmacy. 1994;51:813-22.


Careful planning is essential
Competition is steep
Sources of Funding:
 Association and foundations
 Associations are membership organizations consisting of individuals with
common goals and interests eg. Canadian diabetes society.
 Foundations are non-profit organizations governed by a board of directors.
 Should be sure that your research is consistent with the views of such
organizations.



Government.
Industry.
Intramural. This is when institution for which you work (university) funds your
research.
Types of Funding:
 Grant.
 Contracts. Usually given out by industry. Monitored more closely.
Locating Funding Source:
 Associations publish RFA’s in journals or newsletters.
 Directories. example The foundation directory.
 Grant offices. Some institutions have departments devoted to research funding.
 Newsletter.
 Computer networks.
Drafting a grant proposal:
1. Develop the idea
2. Determine specific aims and long term goals.
3. Estimate the duration of the project.
4. Estimate the cost of the project.
5. Identify potential funding sources.
6. Obtain application forms and information packets from potential funding sources.
7. Identify colleagues who can review the proposal and request their assiatance.
8. Set deadlines for completion of the first, second and final drafts (more drafts if time
allows) and for mailing the proposal. Make sure to find out if the application deadline
is the postmark date or the date of receipt by the funding agency.



Title should be informative and as specific as possible.
Specific aims and long-term objectives.
Background and significance.






Experience and qualifications of the investigator.
Letters form collaborators and consultants.
Experimental design and methods
Budget
Abstract
Appendixes (questionnaires, photos, graphs, figures)
Revise the proposal.
Include self addressed stamped envelope for them to reply to you.
Proposal will be reviewed by institutions review group.
Response to Proposal:
 Funding-Granting agencies require strict accounting records. Once research is done
final expenditure report is expected.
 Renewal/continuance-Should you go overtime you should inform the granting
institution and find out what must be done to get more money if needed.
 Rejection-Reviewers comments and critique should be carefully analyzed.
Resubmission is possible if the problem areas can be dealt with.
What is the Question?
Friedman LM, Furberg CD, DeMets L. Fundamentals of Clinical Trials, 3rd ed. St Louis:
Mosby-Year Book, 1995.
Fundamental point: Each clinical trial must have a primary question. The primary question, as well as any
secondary or subsidiary questions, should be carefully selected, defined, and stated in advance.
Function of the questions:
primary question is the one that investigators most want to answer and CAN answer
there can also be secondary questions, related to the primary question. They come in 2 flavours:
1. response (dependent) variable differs from that in the primary question (ie. primary question
asks whether mortality from any cause is altered by the intervention; secondary question asks about
incidence of cause-specific death, or nonfatal MI, or some other dependent variable that ISN’T mortality )
2. secondary question relates to subgroup hypothesis. For example – investigator may want to
divide subjects by stage of disease at entry into the trial, and see if their outcomes differ. Subgroup
hypotheses must be specified before data collection begins, based on reasonable expectations, and
limited in number (too many = false positives). Usually the number of participants in a subgroup is too
small to prove or disprove anything.
both types of secondary questions raise methodological issues, eg. if you do a significance test for each
secondary question you have, they’ll start being significant by chance alone (5% chance). Answers
gleaned from multiple testing should be used to suggest new hypotheses, not to propose definite
answers.
Studies can be used to assess adverse effects, but what adverse effects might occur and how severe
they might be is unpredictable – you can’t always specify in advance the question you’ll answer. It’s also
pretty unethical to continue a study to the point where a drug is conclusively shown to do more harm than
good. Statistical significance and false positives aren’t as important as clinical judgment and participant
safety, so some coincidental adverse events may be labelled as adverse effects.
Studies can be used to answer questions that may not bear directly on the intervention you’re testing
but are still of interest. These are ancillary (ancillary = of secondary importance) questions. (eg. the Beta
Blocker Heart Attack Trial found that low education among survivors of MI was a marker for poor survival
risk; ancillary study found that inability to cope with stress was also associated with mortality, even though
stress wasn’t the point of the study.)
Doing a natural history study of the control group is a good use of collected data; it lets you see how
baseline factors affected specific outcomes for better understanding of disease under study. Can only
infer predictive association, not causation, from such data. Don’t collect unnecessary baseline information
thinking that it might be useful – that’s too expensive; collect only what is known to be related to prognosis.
In a large, simple clinical trial, you have a very large sample size and you do a very modest, simple
intervention. These trials are more common for serious conditions, where even modest interventions can
make a useful difference. An easily administered intervention is required, as are very brief data collection
forms, an easily ascertained outcome (eg. mortality), and a brief follow-up time.
Intervention:
investigators have a type of intervention in mind when they come up with a question; they often know
the exact drug, procedure, or lifestyle modification they’ll study.
intervention must have maximum benefit with minimum toxicity.
availability of intervention being tested (eg. if it’s an experimental drug) must be determined – if not yet
licensed, get special approval.
investigators must take into account things like time intervention is started, how long it will last, and how
to blind patients to the intervention, among other considerations.
Response variables:
response variables are outcomes measured during the course of the trial; they answer your question.
Examples: total mortality, death from specific cause, disease incidence, specific adverse effect,
symptomatic relief, lab measurement, cost of administering intervention…
Specific response variables may only partially reflect the original question (eg. using extent of mobility
as a measurement for “how severe is arthritis?”)
Pick only one response variable to answer your question, or chance of false positive increases
(checking for statistical significance more than once, with a 5% chance of false positive each time…).
Events can be combined to make up one response variable – but you can only count one event per
participant. eg. in a study of heart disease, combined events might be “death from CHD” + “nonfatal MI”.
This makes sense, since these two conditions together represent a measure of coronary heart disease. If
both events could occur in one individual, you must establish a hierarchy to decide which one counts
more – eg. if pat dies, discount nonfatal MI (obviously).
Another kind of combination response variable: multiple events of the same sort. Instead of “did it
happen?” look at “how often did it happen?” eg. frequency of TIA within a specific follow-up period.
No matter what you’re measuring, some rules apply:
1. Define and write the question in advance, being as specific as possible. “In population W, is drug A at
daily dose X more efficacious in reducing Z over a period of time T than drug B at daily dose Y?” Stating
the question this way lets you plan your study design and calculate your sample size. (Calculating sample
size requires specification of response variables and establishing what happens with a “successful”
intervention – 10% improvement? 25%?)
2. The primary response variable must be capable of being assessed in all participants. Response
variables must be measured the same way for all participants.
3. Participation ends when the primary response variable occurs, generally. (Investigator may still wish to
watch patient – eg. deaths occurring after the nonfatal primary response variable but before the study ends
can still be of interest.)
4. Response variables should be capable of unbiased assessment. Double-blinding helps, as do
independent reviewers. If a study can’t be blinded, using only “hard,” purely objective response variables
(eg. blood pressure) could ensure honest results.
5. Response variables must be able to be ascertained as completely as possible. If you lose a patient to
follow-up and the response variable depends on an interview, you’ve lost your information and could
unbalance your final results. Death is a good response variable because it is easily assessed, but it is not
always applicable.
Surrogate response variables
Sometimes we use surrogate response variables to substitute for what we actually care about, eg.
osteoporosis in bones as surrogate for bone fractures, change in tumour size as surrogate for mortality.
Changes in these variables are likely to occur before the clinical event does, shortening the time required
for the trial; also, these variables are more often continuous, allowing for smaller sample size and cheaper
studies. Surrogate variables aren’t always appropriate – eg. reducing ventricular arrhythmia does not
reduce risk of sudden cardiac death; and although use of inotropic drugs in heart failure improves
exercise tolerance and symptomatic manifestations, it also increases risk of death.
Surrogate response variables are useful in the early stages of development of a new intervention (eg.
phase I or II) because they speed things up. Before using a SRV in phase III or further on, though,
consider:
1. does the variable really reflect the clinical outcome?
2. can the surrogate be assessed accurately and reliably?
3. will the assessment be so unacceptable to the patient that study can’t be done?
4. will assessment require expensive equipment and highly trained staff ($)?
5. small sample size of SRV trials means you may not get all important data on safety. (you may
not see all adverse effects)
6. will the conclusions of the trial be accepted by the scientific and medical communities?
\
Impact of total mortality
Even if the primary response variable isn’t mortality, mortality must still be noted:
1. mortality reduces the overall sample size
2. if mortality is related to the intervention, excluding those who died from study results can
seriously bias the
study
To get around this, pick mortality as the primary response variable, or combine it with a nonfatal
response variable for a combined response variable.
If neither of those are feasible, monitor both your primary response variable and mortality and evaluate
considering those who died during the study.
Evaluating the Outcomes of Pharmaceutical Care
Lipowski EE. Journal of the American Pharmaceutical Association. 1996;12:726-35.
Measuring pharm care and relationship to patient benefit requires documentation of activity and
mechanism of evaluation.
Currently phm’s in a circular argument – phm’s will provide PC with adequate funding, funding
only after evidence of PC benefit proved.
Payors skeptical of direct link b/w PC and improved pt. outcomes, no definitive studies.
PC should be proved on key outcomes which patients value most.
Requires participation of many pharmacists – improves exposure and uniformity of care
Evaluation:
Step 1: define the desired outcomes (physiologic parameters, patient’s symptom’s or
saticfaction)
Usually focus on 5 D’s – death, disease, disability, discomfort, dissatisfaction.
May be able to measure multiple outcomes in one study.
Step 2: describe the sequence of events starting with phm intervention and ending at desired outcome.
Process may take many steps. (flow chart).
It may be hard to link cause& effect between steps, must validate assumptions used, identify
other factors that may lead to outcome
Necessary to find the most efficient way for patient & phm to reach the outcome.
Step 3: determine what evidence needs to be gathered. May need to resort to indirect
measurement of
outcome (validate relationship with indirect marker first e.g. BP and risk of MI) Used
when:

not feasible to measure outcome directly

outcome far removed from process (5 yr survival)

outcome is hard to define

too many factors contribute to outcome (can’t control everything)
Selecting Indicators
The best indicators show direct connection b/w phm activity and phm performance to
patient outcome.
Want to measure events that are monitored frequently and/or have significant health effect
(eg BP)
Also, measure should vary in intensity, frequency and duration (can see if things are
changing)
Try to eliminate outside factors, quantitative data better than qualitative.
Evaluate the ability of patients to self report measures - using patients saves effort (eg
diabetics)
Patients can fill out standardized forms to assess qualitative data (QOL, Pain inventory)
Positive results in combined qual & quant study reinforce benefit of PC
Evaluation in Prof. Practice
Could get results from one or more pharmacy, individual or groups of patients (need to be
defined)Requires documentation, possible claim made for reimbursement for services.
Make other HCP’s aware of the study- may refer patients or help monitor outcomes.
Steps in documenting pharmaceutical care:
Ask following questions in series:
1.
What are the objectives of the pharmaceutical care intervention?
e.g. improve inhaler technique, monitor theophylline serum levels
2.
How can progress toward the desired outcomes be measured?
e.g. observe the inhaler technique performed by the patient
e.g. observe theophylline level in the lab report
3.
What should we do if we are not observing progress toward the goals?
e.g. modify the process to achieve the goal
- also document the steps you took
4.
What evidence can support a claim that a program of pharmaceutical care has
accomplished its stated goals?
record therapeutic goals, actions taken, and results achieved for each
patient
compare this result with other patients with similar conditions and goals
do the recording from the beginning of the program; don’t leave it to the
end!
Using aggregate data to evaluate performance:
 aggregating and comparing the experience of multiple patients in the same practice
 routine review of success/failure of patient will help the health team appreciate variations
among patients
 also helps to set realistic goals and expectations for the pharmacist and the patient
 recording the same type of information as other practitioners helps the pharmacist to compare
his or her performance to other health practitioners and the literature.
 comparisons of data are useful in finding a better way of providing services.
Need for software:
 we need software to do this, but there is lack of good software for pharmaceutical care
 this lack of software is a barrier
 today’s pharmacy software is not equipped for doing pharmaceutical care
 software and integrated electronic medical records system will come from a growing
recognition of their importance.
 to provide PC, we need software program that allows us to gather information systematically
and make the info available to decision makers
Evaluation as research activity
 We will need two things in order to evaluate the impact of pharmaceutical care: formal
research and pharmacist evaluations.
1.
we will need more formal research on the impact of pharmaceutical care, because
there is not much evidence now.
2.
We will also need to know if the results of the research can be extended to real
life situation. So, we will need the pharmacists’ evaluation of how well certain
pharmaceutical protocol is making an impact on a particular patient.

Formal research demonstrates what is possible under specified conditions; pharmacist’s
(practitioner’s) evaluation demonstrates the achievement of expected results and how to
improve upon the results
Evaluation and pharmacy practice:
 it is important to document your interventions and outcome measures
 results of evaluations will be different from person to person.
 understand that even a small intervention will make a significant impact
 individual evaluations will help us understand how health interventions work
Philosophy of design and research
Sharpe TR. In Handbook of Institutional Pharmacy Practice. Williams & Wilkins, 1979:33746.
Evidence and Causal Analysis


Aim of research is to establish knowledge based upon reliable and valid information and
facts.
There are methods for establishing this knowledge:
- Method of tenacity – people hold firmly to the truth because they know it is the
truth. Repetition of facts makes them truth.
o Assumes all people know truth
- Method of authority – an idea is the truth if it has public sanction and tradition
behind it.
o Assumes that some people know truth
- Method of a priori (or intuition) – truth is established if the idea agrees with
reason or the way things should be.
o Assumes people can find truth without empirical evidence (observation)
- Method of science – truth is based on observation and experimentation
o Assumes truth can only be found with empirical evidence
o This is the focus of the discussion in research design
The Stimulus-Response Model




All experimental designs have some variation of the stimulus-response model
S
R
This model states that a stimulus treatment elicits a direct and measurable response when
applied to a treatment subject.
- eg- a stimulus treatment may be an intervention program to provide a patient with
information concerning the importance of finishing his/her antibiotics therapy.
The response is an increase in patient compliance
a variation of the S-R model is when an intervening mechanism takes place within an
organism prior to the response
O
S
R
according to this model a stimulus treatment elicits a measurable response which is first
mediated by some intervening mechanism
Establishing Causality

There are 3 criteria for establishing causality in the S-R model
1. Association






Includes 2 characteristics that strengthen the conclusion that one variable is the cause of
another: magnitude and consistency
The greater the magnitude of the relationship between 2 variables, the more confidence
one has that the association is truly causal
If a relationship persists under a variety of conditions, this causes consistent confidence
in the causal nature of the relationship.
o eg – the relationship between smoking and cancer has been found in
prospective and retrospective studies, animal and human studies, in different
ethnic and racial groups and in males and females.
A causal association may also exist when two variables are just barely related because
there may be several factors producing an event.
All causal relationships apply only under certain circumstances, therefore if results are
not consistent, it may be that the causal relationships apply only under certain
circumstances
Also, consistence is a necessary but not sufficient condition to establish causality.
2. Time Priority


An event in the future cannot determine an event in the past or present
Without knowledge concerning time priority, we are limited to making conclusions only with respect to
association among variables.
3. Spurious (false) Relationship


Assuming that the effects of all relevant variables have been eliminated, then we can be
more confident in interpreting the relation as being causal and not due to other factors
o eg – if it can be shown that genetic factors predispose to a smoker to getting
cancer, then it would be spurious to interpret the relation between smoking and
cancer causal.
Therefore, only when all three conditions of association, time priority and non-spurious
relationship exist can we draw conclusions concerning causal relationships
Characteristics of experimental designs
See figure 1.1 – Implementation of an experimental design

There are 3 main conditions of the experimental method : (1) Sampling equivalent
experimental and control groups; (2) isolation and control of the stimulus; (3) definition and
measurement of response
1. Sampling equivalent experimental and control groups
i.
Defining the Study population
o The definition of the population to be studied will largely depend on how results of
the study are to be applied
ii.
iii.
o Most common problem is defining the population too broadly
o The population should not be defined as greater that the group from which the
researcher can randomly sample
Sample selection
o Many populations are impossible or impractical to study directly because of lack of
accessibility
o Data is usually gathered on only a part or sample of the population
o Conclusions are then specified concerning the population
o The size of the sample depends on the anticipated degree of effect: the greater the
degree, the smaller the sample required
o Random sampling is a method of drawing a sample population such that every
member has an equal chance or being selected. (therefore the sample represents the
population from which it was drawn)
o Stratified random sampling first divides the population into strata (ie age groups, men
and women) and random samples are drawn from each of these strata in proportion to
their presence in the population. This is useful if there is some basis for expecting
that the strata are related to the phenomenon being studied.
o Non random sampling include:
 Convenience sampling – selection is based on the convenience to the
investigation
 Quota sampling – the population is divided into groups according to
selected characteristics which are considered important
 Interval sampling – individuals are selected in a periodic sequence.
 Judgement sampling – selection is based on the investigator’s
judgement that the sample is representative of the population
 Systematic sampling – choosing every nth person from a population.
Common if a list of people in population is available.
o Without some form of random sampling, no conclusions can be inferred concerning
relationships in the population.
Random assignment to experimental and control
o The essence of a true experimental design is that the available pool of subjects is
randomly sorted into the various groups
o An equal or nearly equal number of people should be placed in each group
o Random assignment ensures that the subjects will not differ on the average with
respect to any characteristic more than could be expected by chance alone
o The randomization process ensures that there are no systematic influences that tend to
make the average value of a variable higher in one group than in another.
2. Isolation and control of the stimulus



Careful formulation and definition of the stimulus (independent variable) are important to
increasing reliability of the study measurements
It is important that each member in the experimental group receive the same treatment.
This is important for the immediate study and for those who with to replicate the
investigation



Stimulus variables should be clearly defined including specific content, message, medium
and situational environment. eg- unacceptable to say “experimental group received
intensive counseling”. The intensive counseling must be more clearly defined.
Isolation of the stimulus is also important since introducing extraneous stimuli can
confound the effects resulting from the stimulus treatment.
Also important to isolate treatment from control.
3. Definition and Measurement of Response
 Defining response (dependent variables) is also important
 The dependent variable should also be defined in measurable terms
Reliability and Validity
Reliability
 Reliability is consistency
 Refers to the degree to which the measure produces consistent results upon repeated
application
 Classified into four types:
1. Congruency: the extent to which several indicators measure the same thing
2. Precision: the extent to which an indicator is consistent for a single observer
3. Objectivity: the extent to which the same instrument is consistent for 2 or more variables
4. Constancy: the extent to which the object being measured does not fluctuate

Five sources of unsystematic variables (unreliability) in experiments include:
1. Subject reliability: subjects mood may affect physical and mental health
2. Observer reliability: subject factors also affect the way an observer makes their
measurements
3. Situational reliability: conditions under which the measurement is made may produce
changes in results
4. Instrument reliability: the factors of the instrument itself may affect is reliability, ie –
poorly worded questions in an interview
5. Processing reliability: coding or mechanical errors occurring at random in an
unsystematic manner

All results contain error, therefore the researcher must reduce this error such that it does not
interfere with the valid use of the measurement instrument
Reliability is best controlled by careful attention to factors which permit large chance error to
enter the experiment.

Validity
 Validity is the degree to which a measure or procedure succeeds in doing what it claims to do
 Are we measuring what we say we are measuring?
 It reflects systematic errors that represent bias, slanting the results in a particular direction
rather than at random
 Because of this non-randomness, errors may falsely be interpreted as causes of these trends




Internal validity

Did the experimental treatments make a difference in this specific instance?

This is the basic minimum, so that without it, any experiment is uninterpretable
External validity
 To what populations, setting, treatment variables and measurement variables can this
effect be generalized?
Campbell and Stanley identified 8 classes of extraneous variables which might produce
effects confounded with the effect of the experimental stimulus if not controlled:
1. History: events that occur between pre-test and post-test that could provide an alternate
explanation of the effect
2. Maturation: processes producing changes as a function of the passage of time (eg.
growth, fatigue)
3. Testing: the effect that taking a test will have upon the scores of a second test
4. Instrumentation: changes in calibrations, observers or scores used may produce changes
in measurements
5. Regression artifacts: pseudo-shifts occurring when persons or treatment units have been
selected upon the basis of their extreme scores
6. Selection: biases resulting from differential recruitment of comparison groups
7. Experimental mortality: differential loss of respondents from comparison groups
8. Selection-maturation interaction: selection biases that result in differential rates of
maturation
They also outlined 4 factors that jeopardize external validity:
1. Interaction effect of testing: the effect of a pre-test influencing respondents sensitivity or
responsiveness to the experimental variable, making it unrepresentative of an unpretested universe
2. Interaction of selection and experimental treatment: unrepresentative responsiveness of
treated population
3. Reactive effects of experimental arrangements: conditions making the experimental
setting atypical of regular application of the treatment (“artificiality”, Hawthorne effects)
4. Multiple-treatment interference: multiple treatments are jointly applied, effects atypical
of separate applications
Classification of Research Designs
 Campbell and Stanley classified experimental designs and evaluated them according to their
typology of threats to internal and external validity
 Legend to understanding the graphical representations below:
X
Exposure of group to experimental treatment
O
Process of observation or measurement
Xs & Os in a row
Applied to same specific persons (in temporal
order)
Xs & Os vertically
Simultaneous
R
Random assignment to experiment & control
groups
Rows separated by a
Comparison groups not equated by random
line
assignment
Pre-experimental Designs
1. The One-shot Case Study:
X O
 Example: 8 cases of thrombosis (incl. 1 death) in patients treated with azarbrin (antipsoriatic) during the 1st year of marketing when 500-100 patients were being treated with it
 this lead to an FDA request to withdraw from the market
 In this design observations are made after treatment has been administered
 Simplest form of research design, the one most frequently used in pharmacy and medicine
 Weakest form of design, because no baseline measurements or control groups  no way to
evaluate if response was due to the stimulus
 Results are testimonials
 Primary sources of invalidity: history, maturation, selection, mortality
2. The One-group, Pre-test, Post-test Design:
O1 X O2
 Example: Study to determine the analgesic activity of an investigational new drug AX-735.
It involved administering a pin prick to patients right forearm to measure their pain threshold
(PT), before giving drug and 4 hours after. A lower PT was found post-medication which the
researchers attributed to the drug.
 Introduces baseline measurements before stimulus administered, followed by a measurement
after
 Researcher can objectively measure change, improvement over method #1
 It doesn’t allow researcher to attribute this change to the stimulus administered
 5 main threats to internal validity are:
 History  other events may occur simultaneously influencing effect
 Maturation  people may improve with/without exposure to stimulus
 Testing  the first measurement may constitute a stimulus itself
 Instrumentation  after measurement may be due to fatigue or instrument reliability
 Statistical regression  unreliability may produce statistical regression with shifting values
toward the mean
3. The Static Group Comparison



X O1
O2
Example: Another study to determine analgesic activity of AX-735. 25 patients on one floor
of a hospital were given a 200 mg dose and PT measurements were done 4 hours later. 25
patients on another floor were given placebo and PT measurements were taken 4 hours later.
A lower PT was found in the treatment group vs. placebo which researchers attributed to AX735.
Merely gives the appearance of providing a control group since it was not randomly assigned
2 threats to internal validity:
 Selection  differential recruitment of observation groups can lead to differences in
response regardless of stimulus
 Mortality  differential drop-out may create differences between observation groups
True Experiment Designs
 Allow researcher to objectively measure change and to attribute it to experimental stimuli
4. The Pre-test, Post-test Control Group Design





R O1 X O2
R O3
O4
Example: Pharmacists who attend weekly CE meetings were randomly assigned to treatment
and control groups. Week 1: Pharmacists were given a Diabetes Mellitus drug therapy test.
Week 5: Experimental group shown a DM drug therapy film. Week12: Both groups readministered DM test. Mean improvement score was greater for treatment group.
Investigators attributed this to the film stimulus.
Most frequently used of true experiment designs
Groups are equivalent due to randomization
Baseline is measured and compared to the “after” measurement
All threats to internal validity are controlled since extraneous variables would produce
differences in both groups since they are equivalent and mortality can be evaluated by
examining differential drop-out rates
5. The Post-test Only, Control Group Design



R X O1
R
O2
Example: Double-blind study to determine effectiveness of methods to prevent cephalothininduces phlebitis. Patients were randomly assigned to 2 treatment groups: 1. Heparin 1000
mcg + hydrocortisone 10 mg, 2. Heparin 500 mcg + hydrocortisone 1 mg. Patients were
given cephalothin and phlebitis was assessed q12h. Significant differences were found in
both groups, found attributable to the treatment.
Similar to design # 4 except without the pre-test which is not essential since randomization
can suffice without it, and this is the most adequate way to ensure equivalency of both groups
Controls all threats of validity without actually measuring them like in design #4
6. The Solomon Four-group Design


R O1 X O2 This is part of Design #4
R O3
O4
R
X O5 This is part of Design #5
R
O6
Controls and measures experimental and possible interaction effects of measuring process
Allows researcher to determine whether pre-test was a stimulus itself, this would be indicated
by significant differences between O2 and O5 and/or between O4 and O6
Quasi-Experimental Designs


Often realities prevent researcher from controlling sample selection, randomization and
scheduling stimuli, making a true design not possible
Don’t control threats of internal validity but can determine whether a rival hypothesis can be
ruled out through circumstantial evidence
7. The Time-Series Experiment
O1 O2 O3 O4 X O5 O6 O7 O8
8. The Equivalent Time-Samples Design
X1 O X0 O X1 O X0 O
9. Non-Equivalent Control Group Design
O1 X O2
O3
O4
Practical Guidelines of Effective Study Design
1. Carefully define the study population
2. Sample randomly from the population, if possible
3. Randomly assign subjects to experimental and control groups
4. Carefully define all variables and conditions
5. Carefully isolate experimental and control conditions
6. Carefully develop measurement instrument and pre-test it
7. Carefully train observers in proper use of measurement instrument
8. Observe inconspicuously, if possible
9. Conduct investigation double-blindedly
10. Choose an appropriate statistic for making comparisons
11. Use a true design vs. a quasi design, if possible
12. Be careful that conclusions are firmly supported by data
Determining the value of pharmacy services — the search for rigorous research
designs
Malone DC. Journal of Managed Care Pharmacy. 2002;8:153-5.
Basic message: Author briefly summarizes studies evaluating clinical pharmacy services with
respect to study design and results. He presents suggestions to improve the quality of research
associated with pharmacy services.
Example of a good study (conducted by the author of course)
IMROVE study to evaluate ambulatory clinical pharmacy services plus medical care (n = 523)
vs. medical care only (n = 531)
Subjects were randomized into treatment and control groups at 9 VA medical centres.
No difference in terms of SF-36 scores or overall resource utilization, but costs of pharmacy
services did not increase overall costs.
Subset of hyperlipidemic patients showed significant decrease in TC and LDL vs. control
Conducting Rigorous Research fo Pharmacy Practice
It is important not to overstate or understate the value of pharmacy services based upon studies
with poor research designs.
Common study problems are:
Lack of control group
 Control group serves to rule out alternative explanations for observations.
 Control group crucial in IMPROVE study because entire VA health care system
simultaneously initiated program to improve hyperlipidemia treatment.
Selection bias
 Especially problematic in retrospective studies because difficult to find identical treatment
and control groups; they tend to differ in disease severity.
 Disease severity measures generally not available in administrative databases.
 Alternative is to identify a surrogate e.g., clinic visits, hospitalizations, medication use..
 Often still difficult to find identical control groups so may need to normalize differences by
regression of outcomes such as post-period costs and hospitalizations.
 Be ware of self-selection bias e.g., patients who agree to be study measuring patient
satisfaction will likely report higher satisfaction anyway; sometimes difficult to avoid with
interventions that are obvious or cannot be masked.
Selecting cases based on extreme scores
 Patients selected on basis of extreme values of observed parameter tend to “regress to the
mean” of the population.
 This is because out-of-range subjects statistically will become more normal even when no
intervention is made.
 So studies that select especially poorly performing subjects at outset will observe
improvement regardless of intervention.
 Therefore especially important to have control group.
 Control group can be formed in a separate but similar setting as the one providing care.


Randomization is preferred method of forming control group to eliminate selection bias.
Pharmacist performing intervention should not participate in group assignment to avoid bias.
Poor measurement of principal outcomes
 Use previously validated measurement tools; published tool is not necessarily validated.
 Tool should correlate with an objective pathophysiological parameter (e.g., asthma QoL with
lung function).
 Should be sufficiently sensitive, but not prone to false positives (test-retest reliability).
Inadequate follow-up periods
 Many researchers conduct a study with 3- to 6-month pre- and post-intervention
measurement periods.
 Changes in chronic disease control are likely to take months to manifest e.g., hypertension,
diabetes or with rare events e.g., asthmatic attack
 Recommend collect data for 12 months retrospectively before implementing service
(baseline) and 12 months prospectively when possible.
Recruiting & Retaining Patients in Research
Farley E. In Conducting research in the practice setting, Eds: Bass MJ et al, 1993. Sage
Publications, 58-67.
Factors/Determinants of patients’
willingness to participate in research
-type of study proposed
-risks, time, inconvenience involved
-presence or absence of invasive
procedures
-potential value to themselves
& others
-quality of provider/pt relationship
(>85-90% of patients are willing to
become involved in research in
approached by physicians)
Discussion
-in any study that involve patients directly, the patients should acquire a clear understanding of the purpose,
procedures, risks, potential outcomes for the subject, and potential significance for others
-most practice-based research is associated with no risk (requires minimal to moderate input from pt)
-Characteristics of studies most accepted by pts: low risk study that offers greatest potential good to society
-most demanding & disruptive routine: clinical drug trials (esp. in Phase III)
-**provider-patient relationship can be a significant factor in patient’s acceptance
(e.g. Dr. David Hahn reported that majority of the patients who declined to participate in an asthma study
were new patients to the practice; those patients with whom he had an established relationship not only
participated willingly but at times also ask when he will be starting another study)
-patients who have limited or no ability to select their personal providers (e.g. in isolated communities with
one physician, in group practices, or restrictions of a health insurance plan) may be less likely to participate
-acceptance is also higher if the patients feel that there is a sense of personal
connection (if the practice is organized so that patients and their doctor(s) know
each other)
-nature of practice
-practice management
-patient education
-practice type, function, and structure of a practice can determine what types of research can be done and
patients’ acceptance
-traditionally, large, impersonal hospital clinics have had more difficulty with compliance than smaller, more
personal private practices. However, a review conducted by the author shows little difference between these
two types of environments. This finding reflects that patients develop great loyalty to any organization or
institution from which they receive ongoing care
-the nature and size of a practice also influence acceptance
-mixed specialty practices may be able to undertake studies different from those of single-specialty practices
-primary care practices can undertake studies on a subset of the population different from those of
subspecialty practices
-e.g. patients in a health maintenance organization (HMO) may be more amenable to studies on
prevention than patients in fee-for-service practices
-factors that affect patients’ willingness to participate in research are:
how patients are scheduled with their physicians or other providers
how available the practitioners are to the patients
the hours the practice is open
how support staff relate to the providers, the patients, and the community
how the business office handles billings and collections (particularly for those who
have difficulty paying or who receive Medicare benefits
the general ambience of the facility
-how a practice organizes the data it collects in the ongoing care of patients helps determine the type of
research that can be done
-an important starting point is the minimal basic data set (MBDS) collected on all patients
-even if the MBDS only include the usual registration data (name, date of birth, address, telephone number,
head of household, and insurance company payer), its an excellent basis on which to define research
questions and to manage the practice (by dividing the population served into cohorts)
-MBDS is expanded to include disease or problem, education, occupation, race, religion, ethnicity &
members of household
-practices that emphasize on patient education for health maintenance and disease prevention usually
attract patients who are more motivated to remain in good health
-some practices use the service of a nurse practitioner or health educator who are
usually very comfortable in communicating with patients and often can be
used to help recruit and retain patients into studies
-relationship of practice to the
community
-previous involvement of practice in
research projects
-role of learners in the practice
-patient participation usually is excellent when studies involve some connection with health maintenance
or disease prevention
-practices that use a community-oriented primary care (COPC) approach are involved fully in the community,
have an advisory committee of community members, and work closely with the community to improve the
overall health status of the population
-success of such practices depend on the strength of the advisory committee (composed of representatives
from the community, including medical personnel)
-the committee gave the physicians, nurses, health visitors, and medical anthropologists an opportunity to
work with the community on common health concerns, to explain what we could and could not do in the
way of prevention, diagnosis and treatment, and to explain what we were doing in the way of research
-examples of studies that use a COPC approach are studies on the prevalence and ambulatory treatment
of TB, streptococcal disease
-COPC practices usually have little problem enrolling and retaining patients in studies
-patients do not want to be “guinea pigs”; when a community believes the practice group has a sense of
responsibility toward its
members, individuals are usually very willing to participate in research
-patients who have had good research experience with a particular practice or
provider usually will be more willing to participate in other projects
-learners, such as residents or medical, nursing, and physician assistant students, can have a significant
impact b/c if these learners are integrated into practice setting in a manner that wins patient acceptance
and interest, they can increase the willingness of patients to participate in a specific projects
-from the author’s experience, practices that include learners have no problem with patient involvement in
research if the patients are made aware of the activities and feel included in the process and if the learners
are monitored closely and have clearly delineated roles that are consistent with their learning stage
-characteristics of population served
-it is important to understand the population served because socioeconomic and sociocultural status may
affect how an individual or group accepts involvement
-clearly defined distinguishing attributes of some groups allow the researchers to develop hypotheses of
questions that practice- or population-based research may answer
-with the diverse people who make up the North American continent, it can be expected that practice-based
research will come to focus increasingly on health and illness patterns associated with cultural and religious
diversity
-understanding sociocultural diversity within a racial or cultural group can enable us to provide care, determine
individuals’ willingness to participate in studies, to ask the right questions, and to undertake the right studies
concerning the effect of our care on individual health and function
-another population aspect that must be considered is access to medical care which is affected by
socioeconomic (e.g. people who are under- or uninsured and do not have easy access to publicsupported care) or cultural factors
-whether they get paid or not
-remuneration is very important that require considerable patient time & commitment in order to maintain
continuing
involvement in studies
-patients should also be paid for any study-related costs
-NOT usually the primary factor in determining whether patients will participate or not
-social/moral implications of the problem -ethical issues are always present & must be dealt with in any research
(e.g. HIV/AIDS)
-all practice-based research MUST be done in a way that ensures continued confidentiality & minimizes
-public awareness of the problem
the chance
-confidence in whether confidentiality
for any social, psychological or physical harm to the patient as a result
be maintained
-retention of patients in prospective
-one reason why some pts enroll in studies is b/c they believe they will benefit from the extra attention
studies
& tests,
therefore, it’s important to maintain that hope in the pts in order to get continual involvement from them
-patients seen for a scheduled study visits will continue to present other problems that must be either
attended to at
that time or followed up at a later time.
Increasing response rates to postal questionnaires: systematic review
Edwards P, Roberts I, Clarke M, DiGuiseppi C, Pratap S, Wentz R, Kwan I. BMJ. 2002;324:19.
The article describes the systematic review of 292 RCTs of any method to influence response to postal
questionnaires
Objective of the study: To identify methods to increase response to postal questionnaires.
Main outcome measure: The proportion of completed or partially completed questionnaires returned.
Postal questionnaires:
- used to collect data in health research
- the only financially viable option when collecting info from large, geographically dispersed
populations
Non-response
- reduces the effective sample size
- can introduce bias, i.e. affects the validity of epidemiological studies
There is a need to identify effective strategies to increase response to postal questionnaires to improve
the quality of health research
Methods:
The RCTs
- were found through both electronic database and manual searching (reference lists of relevant
trials and reviews)
- were not restricted to medical surveys; 1/3 medical, epidemiological, or health related; ¼
psychological, educational or sociological; 2/5 marketing, business or statistical
- included any postal questionnaire topic in any population
- included studies in languages other than English
- included strategies requiring telephone contact
- excluding (due to cost) the strategies requiring home visits.
75 different strategies for increasing response to postal questionnaires were identified
- the average # of participants per trial was 1091 (range 39-10047)
- all tests for selection bias were significant (P<0.05) in 5 strategies: monetary incentives, varying
length of questionnaire, follow up contact with non-respondents, saying that the sponsor will
benefit if participants return questionnaires, and saying that society will benefit if participants
return questionnaires.
Results
The following strategies made response more likely and can be used by health researches to improve the
quality of their research:
- short questionnaires vs. long ones
- coloured ink vs. blue or black ink
- making questionnaires and letters more personal
- recorded delivery (doubled the response), stamped return envelopes and 1st class post
- contacting participants before sending questionnaires
- follow-up contact
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providing non-respondents with a 2nd copy of the questionnaire
questionnaires designed to be of more interest to participants as opposed to those containing
questions of sensitive nature
questionnaires originating from universities rather than from commercial organizations
their model predicts that:
o the odd of response with a $1 incentive will be twice that with no incentive
o the marginal benefit will diminish, in terms of increasing the odds of response with
each additional $1 increase in the amount given (i.e. the odds of response with a $15
incentive will be only 2.5 times that with no incentive)
o odds of response with a single page will be twice that with three pages
Discussion
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selection bias may have an effect on the results obtained here, but they estimate that their search
strategy retrieved nearly all eligible trials, trials that were excluded were ones where they could
not confirm that participants had be randomly allocated to intervention or control groups
substantial heterogeneity was found in half of the strategies, and it may be inappropriate to
combined results to produce a single estimate of effect
cannot be sure about the size of the effect, but are confident that there was an effect on response
Evaluating The Results Of Mail Survey Research
Harrison EL, DraugalisJR. J Am Pharm Assoc. 1997;NS37:662-6.
Abstract
Objective: to provide guidance for critically evaluating mail questionnaire survey research considering possible
sources of error.
Conclusion: to draw valid conclusions, one must evaluate the 4 sources of error and the administration of the survey
--Failure to account for sources of error or inappropriate administration can affect the generalizability and validity of
results
Purpose of Surveys:
-to collect info from sample and generalize the findings to a larger target population
-to identify, assess, compare respondents ideas, feelings, plans, beliefs or demographics
-surveys are often seen pharm/medical literature, so pharmacists must know how to properly evaluate them
2 aspects to evaluating a mail questionnaire survey
(1)How well does the researcher evaluate the 4 sources of error?
-Are there compounding variables or other influencing effects that the researcher didn’t control for?
-If sources of error not controlled for, variables lack precision/accuracy and data is unreliable.
(2)Are the results generalizable to my practice setting/my patients?
Sources of error in survey research
Error Source
Synonym
Coverage error
Sampling bias
Sampling error
Random error
Measurement error
Response bias
Nonresponse error
Nonresponse bias
Assesment Procedure
Sampling frame determination
Sample size calculations
Validity and reliability estimates
Evaluation of nonrespondants or comparison of early
and late respondents
Coverage error (sampling bias)
-Controlled when: every member of target pop has equal chance of being selected for the study
-Occurs when: --sampling frame (list of subjects from which the sample is drawn) doesn’t include all
elements of the target population
--there is a discrepancy/difference between the sampling frame and the target population
-Affects:
--generalizability of the research
-Assessment:
--assess the sampling frame used and see if it differs from the target population and
whether this difference could affect the results (sometimes have to use intuition for this)
--the methods section should describe how sampling frame was developed
Example:
--If your target population is the entire population of pharmacists in a given state...
--Best sampling frame = roster of the state board of pharmacy
--Bad sampling frame = roster of state pharmacists association
--here you are leaving out those pharmacists who chose not to join the association and there could
be a significant difference between the pharmacists who choose to join and those who don’t
Sampling error (random error)
-Occurs when: researcher surveys only a subset of all possible subjects
-Controlled when: every member of the target pop has an equal chance of being included in the sample
-Minimized by: using RANDOM SAMPLING procedures is essential
using a sufficient sample size (the larger the better)
-Usually due to small sample size bias
-Results in : inaccurate measurement of research variable which can lead to serious flaws in conclusions
-How to choose a sufficent sample size
-Use Krejcie & Morgan’s method of estimating the required sample size
-The methods section should clearly state how sample size was determined
-Example:
-Lets say there were 2400 licensed pharmacists in the state of interest
-Using Krejcie & Morgan, one determines that the sample size required is 331 pharmacists
-Any study with less than 331 pharmacists or that doesn’t describe in the methods section how the
sample size was chosen is less credible
Management Error (Response bias)
 Minimized when survey questions are clear and unambiguous
 Occurs when:
subject’s response to a question is inaccurate, imprecise and/or cannot be usefully
compared with other subjects’ responses
 magnitude of the error = difference btwn the respondent’s answer and the true answer
 4 sources of measurement error identified:
o First source: the wrong survey method (mail, phone, interview) used to collect data
o Responses to telephone/ face-to-face interviews can be influenced by interviewer
o Mail survey research uses standardized method of collecting data → some protection against this
source of error
o Second source – when survey items are unclear or vague to the respondents
o Each respondent may interpret the question differently and provide inconsistent responses that
greatly reduce reliability and validity of survey instrument
o Third source – bias introduced by researcher via cover letter or sponsoring agent
o Respondents provide answers that they consider desirable, given the cover letter wording or
research sponsor
o Fourth source – respondents’ inability or unwillingness to respond correctly
o Respond in what they consider a desirable manner (ex Self-reported attitudes )
 Controlled through validity and reliability estimates
 very little may be safely concluded from data gathered using an invalid instrument
 Survey or survey item considered valid when it measures what it was intended to measure and can be
assessed both quantitatively and qualitatively
 Content validity
o Concerned with adequacy of item sampling
o Normally associated with educational or knowledge assessment tests and surveys
o Face validity
 Important aspect of survey instrument development
 Involves experts’ qualitative evaluation of whether the questionnaire will be useful in
gathering data for its stated purpose
o Sampling validity
 Concerned with whether the survey instrument contains a sufficient number of items to
measure the concept the survey purports to measure
 Criterion validity concerns the degree of association btwn an item or survey instrument and a criterion or
“gold standard” (gold standard usually = previously accepted survey instrument/items)
 Concept validity
o Determines whether association between specific items in the survey instrument are indeed as
expected
o Items that measure the same concept should be highly correlated, whereas those items measuring
different concepts should not
 Methods section must describe the results of attempts to assess the validity of the instrument
 3 kinds of relevant information are reported in the methods section of mail survey research reports:
1) If items were systematically pretested, method and results of pretesting should be described
2) Should present results of analyses that assess the validity of responses, especially when the criterion
or concept validity assessments are useful
3) Report efforts made to validate factual data
 Reliability is a relative consistency of item responses
o Reliability estimates = crucial to controlling and estimating measurement error
o Determines degree of correlation btwn survey items measuring the same variable/concept
o Involves calculation of correlation coefficients (CC)
o CC = 0 if no association, CC = 1 if perfect or complete association
o High reliability assures that the data did not occur by chance but were the result of the specific
items included
o Methods of estimating reliability
1) Use of parallel forms of either specific survey items or entire survey instrument
 Usually consist of alternately worded items
 Requires calculation of CC’s between the parallel items or survey instruments
 Easy to use and common
2) Assessment of instrument’s internal consistency
 Involves calculation of coefficient alpha (measures average inter-item correlation)
 Allows determination of how responses to one item co-vary or correlate with responses to
other items that supposedly measure the same concept
 Coefficient alpha = 0 means no consistency, =1 means perfect consistency
 If multiple constructs are measured using multiple subscales within the same survey, then
a measure of internal consistency is required for each construct (or subscale)
 The methods section must describe the methods used to assess the reliability of the survey instrument and
present the results of the reliability estimates
 Most researchers agree that reliability coefficient should exceed 0.80 for the study to be published
 Reliability results should be around 0.90 before the results should be acted on
Nonresponse Error (Non-response bias-may bias the results)
 Occurs when:
a significant number of subjects do not respond to the survey and when these subjects
differ from respondents in a way that could or does influences the results
 Minimized when: characteristics of interest for respondents and nonrespondents are similar
 If Response rates < 60% ; the researcher should address the potential for bias
 Methods of estimating nonresponse bias:
1) Aggressive follow-up of a representative sample of nonrespondents
 Determines whether nonrespondents differ from responders on the variables crucial to
research
 Telephone and personal interviews
 Expensive
2) Comparison of early and late respondents
 Inexpensive
 Assumption that late respondents are no different from nonrespondents
3) Comparison of known information from nonrespondents to that of respondents
 Ex. compare demographic data – age, gender, practice site
 The methods section must provide sufficient info to assure that researchers assessed and controlled
nonresponse error
 Must adequately describe the method used to assess
 When significant differences exist, must determine whether these differences could alter the results
 Assess the potential influence of nonresponse on sample size before conducting study → ex. if want
sample size of 331 and predict response rate of 60% → mail out 553 surveys
Assessing Survey Administration
 Methods section should address all aspects of survey research, including survey administration.

Evaluation Component
Assessment Questions
Coverage
Was the sample derived from the population to which the results are
generalized?
Sampling
Are the sample size calculations provided? Was the sample corrected for
nonrespondents?
Measurement error
Are validity and reliability estimates provided?
Nonresponse error
Was an attempt made to determine the impact of nonrespondents on the
results of the survey? Were early and late respondents compared? Were
nonrespondents evaluated?
Pilot study
Was one done? Is it described?
Multiple mailings used
Were multiple attempts made to reach all nonrespondents in the sample?
Are the mailing procedures described?
Statistical analysis
Are the statistical analyses adequately described with the required level for
statistical significance stated (usually p<0.05)?
 Pilot study
o Must indicate whether it was conducted
o Identifies and controls for possible sources of error
o Assures reader that you carefully thought through the research undertaking
 Mailing procedures
o Proper procedures help control for sources of error & maximizing response rate/ reliability
o 4-step process is widely accepted
1. Send an advance-notice letter
2. One week later → personalized cover letter, handwritten signature, questionnaire and a selfaddressed, return-postage-stamped envelope
3. One week after questionnaire → follow-up reminder postcard to the entire sample
4. 3 weeks after questionnaire → mirrors second mailing
Conclusion
 Practitioners must be able to critically evaluate the results of mail survey research through the assessment
of the study’s internal rigor and generalizability
 Internal rigor can be examined through identification of 4 sources of possible error:
 The ability to evaluate research results is highly dependent on the amount and quality of info presented in
the methods section
 Researcher must make the methods used in research as transparent as possible, providing sufficient info on
the sampling frame, sample size determination, instrument reliability and validity and the potential effect of
nonrespondents on the results.
 When done correctly, mail survey research can provide sound info from a small sample that may be
generalized to a larger target population
Mail Questionnaires
Zeinio RA. In Research in pharmacy practice: princples and methods. Ed: Nelson AA.
Bethesda: American Soceity of Hospital Pharmacists, 1981:70-6.
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ADVANTAGES OF MAIL QUESTIONNAIRES
Gather large amounts of information at low cost
Respondents can consult other sources of information
Can be done in private  therefore can address ‘sensitive’ issues
Can avoid the influence of interviewers
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DISADVANTAGES OF MAIL QUESTIONNAIRES
can be difficult to reach representative samples of population
hard to pose complex questions
response rate can be affected by questionnaire appearance and/or organization
lack of in depth answers since respondents can’t explain themselves
main criticism relates to the possibility of biased results owing to non-response i.e. if nonrespondents are different from respondents than the sample no longer represents the
population
most bias disappears when response rate is greater than 70%
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QUESTIONNAIRE CONSTRUCTION AND ADMINISTRATION
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Cover Letter
used to convince readers to complete and reader questionnaire
also stress that respondent is part of a carefully selected, representative sample and that there
is no one to substitute
offer a guarantee of confidentiality/anonymity
personalization  be sure to individually sign and address each letter
tell reader how results of study will be used e.g. results will be sent to an
organization/government who have the power to bring about change
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Questionnaire Construction
must decide sequence of questions, appearance, and length
some questions may convey favourable/unfavourable impression to respondent while the
response to some questions may influence the response to other questions
use the ‘funnel approach’  first few questions should be general and easy to answer while
latter questions can be more personal/sensitive
‘filter technique’  depending on answers to filter questions, respondents are directed to
omit other questions
purpose of ‘filter technique’ is twofold  1) not all questions may apply to all respondents,
2) if a respondent gets a question that does not apply than they may get frustrated and avoid
questionnaire
Administration of Mail Questionnaire
aspects of mail questionnaire administration that influence response rate include precontact,
follow-up, postage, premiums, and mailing date
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precontact  notify potential respondent that they will receive a questionnaire or asked if
they would be willing to participate
‘follow-up’  non-respondents are contacted to be persuaded to respond (can use a
reminder/thank-you card after 1 week and a replacement questionnaire after 3 weeks)
‘postage’  more expensive forms of postage yield better response
‘premiums’  give the person an incentive to respond (cash premiums yield good response
if provided in initial mailing rather than promised upon receiving questionnaire)
‘mailing date’  try to have respondent receive questionnaire on a Thursday/Friday (avoid
the month of December)
Pretesting
pretesting should duplicate all methods of sampling, data collection, and administration of
survey
with respect to the questionnaire  want to determine if research problem can be solved
without violating any assumptions
QUESTION WRITING
act of writing questions can be broken down into 3 areas: question content, wording, and
type of question
Question Content
4 content areas: attitude questions, beliefs, behavior, and attributes
Attitude Questions  how respondent feels about something, use words such as favour,
oppose, prefer, not prefer, good, bad
Beliefs  measure what the respondent thinks is true or false, use words such as correct,
incorrect, accurate, inaccurate
Behavior  determine what the respondent has done, is doing, or plans to do
source of error is the existence of practical and ethical standards
practical standards indicate what can feasibly be done
ethical standards dictate what should be done
Attributes  questions that deal with demographics, socioeconomic status, or personal
characteristics and are used to categorize respondents
Questions The Researcher Must Ask His/Herself
Is the question necessary and is it valid?
Are several questions required to adequately cover the subject?
Does the respondent have the desired information and will the respondent provide the desired
information?
Do the questions ask about general attitudes, beliefs or behaviors, or are they valid only in
specific circumstances?
Question Wording
First Criteria
must not be open to varying interpretations
excess precision in question wording contributes little because the measurements are only
valid under unrealistically specific circumstances
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good practice to use follow-up questions when there is doubt about the respondent’s ability to
understand
Second Criteria
avoid making the question objectionable
avoid emotionally laden words like freedom, justice, honesty
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Third Criteria
questions must be accurate and valid
two types of biased questions: leading questions, loaded questions
leading questions are worded to direct the respondent
loaded questions are loaded with emotionally coloured words that engender approval or
disapproval
questions that asks respondents for information that they do not have are invalid
double-barreled questions are two questions combined into one; also invalid
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Types Of Questions
Open-ended
unstructured or free response essay type questions that are easier to ask
appropriate for complex issues
allow a wide variety of responses and interpretations
difficult to interpret and subject to researcher bias
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Close-ended
provide the possible answers and ask respondent to select
easier to answer, more reliable, easier to tabulate
understanding of question facilitated by list of answers provided to select from
best used when alternative responses are well known, limited in number, and easily identified
by the researcher  omission of valid responses is a significant error
lack of an exhaustive response set is largest source of error – questions is biases toward
answers that are included
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Types Of Closed-ended Questions
Dichotomous
two answers (i.e. yes/no, agree/disagree)
reserved for issues where opinions are well formed, for factual items
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Multiple Choice
more than two answers to choose from
can draw attention to less obvious responses and may suggest answers that did not occur to
the researcher, thus challenging the validity of the reponse set
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“Cafeteria” Style
asks respondent to select the subset of answers listed that best describes their attitudes
i.e. “From the list below, select three factors that are most important to you when you
recommend that PHM 425 not be included in the pharmacy curriculum on the course
evaluation sheet”
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Checklist
composed of mutually exclusive and exhaustive items, such that the respondent chooses only
one answer
order in which items are presented must be random
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Rankings
items in list are to be ordered according to some criteria
most common mistake is the failure to rank all items
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Rating Or Assigning Numbers According To The Amount Of Some Property Possessed
sources of error:
Interrater Reliability: numbers associated with the various scale positions may not mean the
same thing to all the respondents
Halo Effect: respondent’s overall impression of an object is generalized to al individual
ratings of that object’s characteristics (i.e.) liking pharmacists in general leads to giving good
ratings in quality of service
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Informed Consent: What Every Pharmacist Should Know
Wick JY, Zanni GR. J Amer Pharm Assoc. 2001:41(4).
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pharmacist discomfort arise from uncertainty of knowing if patient understands implications of their therapy, i.e.
did patient’s health care team do their job?
professional obligation to counsel so patients are informed co-managers of their drug therapy
evolving role of health care providers and federal /state legislationfueling health care providers’ discomfort
patient’s trusting physician’s decisions gradually being replaced with skepticism
30-50% patients do not use meds as prescribed b/c lack information
question raised by state laws: “will pharmacies be prevented from using information contained in their databases
to monitor adherence and educate customers?”
some pharmacists perceive informed consent guidelines as a professional constraint
Legislation and Regulatory History
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concept of informed consent seized attention during Nazi war criminals, unethically using subjects cruelly
led to formulation of Nuremberg Code of Ethics in Medical research, which codified informed consent
in 1964, World Medical Association adopted Declaration of Helsinki...emphasized human rights protection in
medical research, and that all subjects should be informed of risks/benefits of participation in research
informed consent gained everyday medical practice momentum with thalidomide tragedy
1966, Fair Packaging & Labeling act: drugs and medical devices to be informatively labeled
1970, FDA directed managers to include package insert describing risks/benefits of OC’s
health and safety codes required practitioners to obtain patient’s informed consent to tx
established ethical guidelines: promote respect for patient’s autonomy, understandable communication, and
discretion
1990, Missouri department of Health ruled right of a competent person to refuse treatment embodied in doctrine
of informed consent, and is constitutionally protected
obligation of informed consent now extends to all clinicians involved in direct patient care...fundamental right
protected by law
autonomy: right to choose best treatment in light of information received
informed consent is written or verbal, an interactive process best measured by patients ability to reiterate
information...if can’t, cannot say informed consent took place
Components of informed consent
-patient has medical conditions for which reasonable standard of care dictates need of treatment
-known benefits/risks of treatment articulated
-alternatives to recommended treatment presented with consequences of refusing treatment
-patient has the right to refuse/accept recommended treatment
Consent to treatment: General vs. specific
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in routine medical settings, patient not fully informed of risks/benefits
e.g. patient gives informed consent to general treatment plan during surgery & post-op
practice appropriate as long as patient given information that meets standard of “reasonable care”, and
opportunity to ask questions (patient education)
pharmacist’s role promoted as public becomes aware of pharmacist’s accessibility and training
patients see pharmacist often...but there is gap in information flow
Guidelines
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different patients need different levels of informed consent
what they really want to know is what their choices are, how to manage probable and possible problems
some patients want and can handle detailed, complex info, others overwhelmed
universal concern of patient is impact of meds on sleep and activity
does it make them drowsy, gain weight, libido, anxious?
counseling sessions on what they need and what they want to know
must respect patient’s right to choose, even if it is to forgo treatment
approach to ensure informed consent:
Scope of interactive informed consent
what counseling pharmacists need to know:
 who the drug is for
 symptoms and duration
 other treatment tried
 pregnancy or breast-feeding
 concurrent meds
 allergies
what patient wants to know:
 description of drug and dosage form
 duration of treatment
 special directions
 common and severe side effects
 food and drug interactions and how to avoid these
 what to do if a dose is missed
 self-monitoring techniques
Benefits and Risks Of Treatments
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Many pharmacists struggle with what to exactly tell benefits during risk-benefits counseling
o For example: doctor prescribes a medication and the patient is under the assumption that the
medication will work, however the pharmacists may know there are grounds for uncertainty and the
therapy may not actually work
Concerns are similar when explaining potential treatment risks  common SE’s are mentioned, while the rarer
ones are not
Pharmacists dilemma is provide the patient with information that they need to optimize outcomes without
alarming the patient
Adequate benefit-risks counseling by pharmacists is measured by reasonable practitioner standards: the
information that is provided should be similar to that given by other practitioners under similar circumstances
Pharmacists who only mention the information that they percfeive the patient wants to hear invite trouble. This
approach is too subjective- the provider assumes that they know what the patient deems as important and it
violates reasonabl practioner standards
Alternatives to Treatment
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Informing patients about treatment alternatives can be tricky because for the most part, this duty falls to the
physician
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For pharmacists, the requirement to inform patients about alternatives usually applies when they present an Rx
for a costly medication that is not covered by their insurer. The patient reluctant to pay cash, may ask if there
are alternatives, opening the door for the counseling about options
Lacking the luxury of access to patients medical records, the pharmacist must usually rely on the patients recital
of health history or ask permission to contact the doctor before making a recommendation
Obstacles To Informed Consent
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Stigma: many patients guard their medical history. Fear of discovery and consequent repercussions promote
secrecy.
o 1993 study found that 11% of health care was delivered off the books because of stigma
o People with mental or sexual disorders can be especially anxious
 Pharmacists should always approach counseling with compassion and discretion
Lack of insight: many patients do not even after constant repetition medical information or recognize its
importance
o Conversely some patients act as though they understand when they really do not
 Important to simplify the message and work on conveying the most important parts first
Literacy and vision: illiteracy is high  23% of Americans read at or below a fifth grade level
o Visual impairment is common  reading labels or package inserts can be difficult, and as a result the
patient may take the wrong medication
 Patients are helped by clear verbal counseling and innovative labeling
New drugs of greater complexity: a patient can have multiple health conditions and a cabinet full of numerous
medications
 Computers strengthen the pharmacist to present information quickly and concisely
 Written instructions are a must and pharmacists need to keep abreast of current literature so
that they may address a patients concerns
Cultural issue: language, diet, health beliefs and stigma are influenced by culture
 Best way to overcome this is to hire people who represent the local community, engage
trained interpreters and learn about health beliefs of other cultures
Discomfort or fear: discomfort or fear differs from stigma in that the patient is more afraid of taking the
medication or asking questions than of someone else finding out about their condition
o People fear asking questions about sexual adverse effects, or questions that they fear that the
pharmacist or physician may view as vain
 Pharmacist must volunteer advice and/or ask questions in a gentle manner, out of hearing of
others or patients can be encouraged to telephone in later
o Some individuals fear taking medications because of information that they have heard from a
questionable and unreliable sources (i.e. friends, media, internet)
 Pharmacist should educate and if they still refuse, the doctor should be notified in order to
come up with an alternative that may be more attractive for the patient
Off-label Use: use of a medication in an area that it has not been indicated for
o In these circumstances patients need to know enough information to make a decision
Placebo: many physicians prescribe drugs with known pharmacological effects that are irrelevant to the clinical
problem. This practice is referred to as impure placebo
o I.e. antibiotic prescribed for a cold for a very demanding patient
 This places the pharmacist in a dilemma, and these situations should be handled by
contacting the physician
Expired drugs: expired drugs may be donated to a compassionate care program
o Most drugs if unopened and stored under proper conditions, retain their potency for years beyond their
potency. However, drugs that contain a preservative, like eye drops, will lose potency as the
preservative breaks down
For pharmacists the issue is: is the drug effective for the patient’s condition and what are the
risks?
Contraceptives: pharmacists should be careful when dispensing OC’s to a minor, there may be laws or
regulations that govern this
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Conclusion
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Optimal role of the pharmacist involves collaboration with other health care professional
Care should be taken during counseling not to undermine the patients confidence in their provider
If a pharmacist has concerns about a patients prescription, they should discuss this with the practitioner—do not
do so would be unprofessional
Patients expect pharmacists to make it easy for them to ask questions
Informed consent makes the patient the final decision maker
Pharmacists are legally and ethically required to counsel patients and cutting corners in counseling is a
disservice to both the profession and the patient