An Introduction to Sociology – and what it can do for pharmacy practice researchBissel 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 practice2) Growing role of Pharmacy in promoting health, enhancing compliance, providing medicines management services3) 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 societythere are social aspects to medication usage and beliefs about those medications

4) All healthcare practice is conducted within social relationships and social structuresex. 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 structure2) The relationship between self and society3) 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 ApproachIn Foundations of behavioural research 2 nd ed. New York: Holt, Reinhart, Winston, 1973:2-15.

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 controlledextension of common sense-both are a series of concepts satisfactory for the practical uses of mankindPROBLEM: sometimes these “concepts” Can be misleading i.e. last century it was“common sense” to use punishment for pedagogy. Now evidence to show thatrewards work better than punishment

1) Layman may use the idea of “concepts” loosely, i.e. “ a person gets sick b/c they need to be punished for committing a crime”. Scientists systematically builds theoretical structures and tests them for internal consistiency. Realizes that the concepts are “man-made” and may not represent reality

2) Scientist systematically and empirically tests his theories and hypothesis. They carefully guard against preconceptions, predilections and selective support of their hypothesis

3) Control in science-scientist tries to systematically rule out variables that he has hypothesized to be the causes. Layman don’t do that.

4) Cause and effect: Layman may see two phenomena occurring coincidently and label as cause and effect. Scientist consciously and systematically pursues relations

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 facts2) 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

lab2) scientist is a brilliant individual—thinks, spins complex theories, generally spends time in ivory

tower aloof from the world and it’s problems3) 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 knowledgeDYNAMIC 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 views1) 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 ideaThe 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 full-blown 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.

HypothesisIt 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 –DeductionThe 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 – ExperimentTest 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 situation2. formulation of problem. 3. literature search / scans own experiences4. 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 evidence7. 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 SciencesMount JK. In Foundations of behavioural research 3 rd 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 resolvedo 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 pharmacyo Conceptual and explanatory frameworkso 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 useo Pharmacy practice and serviceso 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 Example of Application

Experiment *Good internal control*Random assignment used

Situations often artificially structured

Educational interventions

Survey Research *Random sampling can be used*Good representation of population possible

Generally only cross-sectional data collected

*consumer surveys*drug epidemiology

Field Research Can study events in natural surroundings

Internal control very difficult to achieve

Observation of patient- professional interaction

Content Analysis Researcher ahs direct effect on subjects being studied

Problems with data completeness, accuracy and verification

Analysis of professional curriculum

Existing Data Research

Same as above Same as above Pharmacy records review

Historical Research Allows comparisons not possible at one point in time

Restrictions of types, amount and quality of data available

Development of professional codes of ethics

Comparative Research

Allows comparisons not possible in any single community society

Comparability of data difficult to assess (as is accuracy often times)

State of pharmacy throughout the world

Evaluation Research

Determination of effects of interventions possible

Value biases and values conflict problems often arise

Evaluation of patient counseling techniques

B: Data collection collection of social science data takes a variety of forms

i. direct observationii. 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 pharmacyb. outline new questions for the pharmacy research and education agendac. supply a set of approaches, tools and techniques for addressing these questions.

The provision of enhanced pharmacy services in OntarioDolovich 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 guideDetermine the level and frequency of provisionIdentify sources and rate of compensation

Method:Study DesignCross-sectional, survey by mail, returned by fax or mailFollow-up reminder to non-responders, second reminder by phone

Survey27 items, 3 sections with questions related to OPA fee guide, 4th section demographics800 sent out, with target response rate of 30%

Data AnalysisDescriptive statistics, (mean, median, range etc.)

Results:24% response, chain and independent, usually had more than one pharmacist/technician working

Additional dispensing servicesrate of provision and patient volume:high: compounding, DRP’s, delivery low: refill reminder, trial RxTime requirements: simple 6-10 mins, complex 11-15Compensation: most free of charge, except for compliance aid package, compounding, colostomy supply consultative services

Pharmaceutical Care ServicesRate of provision: (high to low)Med review, advanced patient education, care plan prep, patient assessment, HCP team consultationPatient volume: 1-3/weekTime: 16-30 minsCompensation: mostly fee of charge (93-100%), compensation usually from pt not TPP

Specialized Pharmacy ServicesRate of provision: (high to low)Smoking cessation, complementary care consultation vs. home care, drug abuse consultationPatient Volume: 1-3/week except complementary care (7-9)Time: most under 15 mins, some up to 30Compensation: 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 MedicationsNair 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!)

AbstractObjective: - 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 - 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.

MethodsDesign: - 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

Consequences

↓↓

StrategiesCausal condition Phenomenon

↑

Intervening factors ↑

Diagnosis and treatment prescribed

Wanting or needing info about med or treatment

Actively seek and evaluate info

Do nothing

More informed enhanced dialogue with health care provider

No change Effect unknown

CultureExpectations about their role in health care

AccessibilityExperienceCondition for which info is soughtQuality of relationship with health care provider

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 idea2. 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 answerthere 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 variablesSometimes 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 mortalityEven if the primary response variable isn’t mortality, mortality must still be noted:

1. mortality reduces the overall sample size2. if mortality is related to the intervention, excluding those who died from study

results can seriously bias the studyTo 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 CareLipowski 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 outcomeNecessary 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 IndicatorsThe 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. PracticeCould 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 levels2. 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 report3. 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, 1979:337-46.

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 experimentationo Assumes truth can only be found with empirical evidenceo 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 populationo The definition of the population to be studied will largely depend on how results of

the study are to be applied

o Most common problem is defining the population too broadlyo The population should not be defined as greater that the group from which the

researcher can randomly sampleii. 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 populationo Conclusions are then specified concerning the populationo The size of the sample depends on the anticipated degree of effect: the greater the

degree, the smaller the sample requiredo 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.iii. 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 groupo Random assignment ensures that the subjects will not differ on the average with

respect to any characteristic more than could be expected by chance aloneo 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 thing2. Precision: the extent to which an indicator is consistent for a single observer3. Objectivity: the extent to which the same instrument is consistent for 2 or more variables4. 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 health2. Observer reliability: subject factors also affect the way an observer makes their

measurements3. Situational reliability: conditions under which the measurement is made may produce

changes in results4. Instrument reliability: the factors of the instrument itself may affect is reliability, ie –

poorly worded questions in an interview5. 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 effect2. 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 test4. Instrumentation: changes in calibrations, observers or scores used may produce changes

in measurements5. Regression artifacts: pseudo-shifts occurring when persons or treatment units have been

selected upon the basis of their extreme scores6. Selection: biases resulting from differential recruitment of comparison groups7. Experimental mortality: differential loss of respondents from comparison groups8. 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 unpre-tested 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 treatmentO Process of observation or measurement

Xs & Os in a row Applied to same specific persons (in temporal order)

Xs & Os vertically SimultaneousR Random assignment to experiment & control

groupsRows separated by a

lineComparison groups not equated by random 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 (anti-

psoriatic) 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 AX-735.

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 re-administered 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 cephalothin-induces 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 Design1. Carefully define the study population2. Sample randomly from the population, if possible3. Randomly assign subjects to experimental and control groups4. Carefully define all variables and conditions5. Carefully isolate experimental and control conditions6. Carefully develop measurement instrument and pre-test it7. Carefully train observers in proper use of measurement instrument8. Observe inconspicuously, if possible9. Conduct investigation double-blindedly10. Choose an appropriate statistic for making comparisons11. Use a true design vs. a quasi design, if possible12. Be careful that conclusions are firmly supported by data

Determining the value of pharmacy services — the search for rigorous research designsMalone 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 PracticeIt 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 ResearchFarley 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

Discussion

-type of study proposed-risks, time, inconvenience involved-presence or absence of invasive procedures-potential value to themselves & others

-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)

-quality of provider/pt relationship(>85-90% of patients are willing to become involved in research inapproached by physicians)

-**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 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

-practice management -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

-patient education -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-patient participation usually is excellent when studies involve some connection with health maintenance

or disease prevention-relationship of practice to the community

-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

-previous involvement of practice in research projects

-patients who have had good research experience with a particular practice or provider usually will be more willing to participate in other projects

-role of learners in the practice -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 public-supported 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(e.g. HIV/AIDS)-public awareness of the problem-confidence in whether confidentialitybe maintained

-ethical issues are always present & must be dealt with in any research-all practice-based research MUST be done in a way that ensures continued confidentiality & minimizes the chance for any social, psychological or physical harm to the patient as a result

-retention of patients in prospectivestudies

-one reason why some pts enroll in studies is b/c they believe they will benefit from the extra attention & 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 reviewEdwards P, Roberts I, Clarke M, DiGuiseppi C, Pratap S, Wentz R, Kwan I. BMJ. 2002;324:1-9.

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.

ResultsThe 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- 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 incentiveo 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- 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 ResearchHarrison EL, DraugalisJR. J Am Pharm Assoc. 1997;NS37:662-6.

AbstractObjective: 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 researchError Source Synonym Assesment ProcedureCoverage error Sampling bias Sampling frame determinationSampling error Random error Sample size calculationsMeasurement error Response bias Validity and reliability estimatesNonresponse error Nonresponse bias 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 interviewero Mail survey research uses standardized method of collecting data → some protection against this

source of erroro Second source – when survey items are unclear or vague to the respondentso Each respondent may interpret the question differently and provide inconsistent responses that

greatly reduce reliability and validity of survey instrumento Third source – bias introduced by researcher via cover letter or sponsoring agento Respondents provide answers that they consider desirable, given the cover letter wording or

research sponsoro Fourth source – respondents’ inability or unwillingness to respond correctlyo 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 samplingo Normally associated with educational or knowledge assessment tests and surveyso 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 purposeo 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

expectedo 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 responseso Reliability estimates = crucial to controlling and estimating measurement erroro Determines degree of correlation btwn survey items measuring the same variable/concepto Involves calculation of correlation coefficients (CC)o CC = 0 if no association, CC = 1 if perfect or complete associationo High reliability assures that the data did not occur by chance but were the result of the specific

items includedo 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 QuestionsCoverage 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 studyo Must indicate whether it was conductedo Identifies and controls for possible sources of erroro Assures reader that you carefully thought through the research undertaking

Mailing procedureso Proper procedures help control for sources of error & maximizing response rate/ reliabilityo 4-step process is widely accepted1. Send an advance-notice letter2. One week later → personalized cover letter, handwritten signature, questionnaire and a self-

addressed, return-postage-stamped envelope3. One week after questionnaire → follow-up reminder postcard to the entire sample4. 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 QuestionnairesZeinio RA. In Research in pharmacy practice: princples and methods. Ed: Nelson AA. Bethesda: American Soceity of Hospital Pharmacists, 1981:70-6.

- 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

- 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 non-

respondents are different from respondents than the sample no longer represents the population

- most bias disappears when response rate is greater than 70%

- QUESTIONNAIRE CONSTRUCTION AND ADMINISTRATION

- 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

- 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- 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- 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

- 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

- 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

- 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

- 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

- 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

- “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”

- 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

- Rankings- items in list are to be ordered according to some criteria- most common mistake is the failure to rank all items

- 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

Informed Consent: What Every Pharmacist Should KnowWick JY, Zanni GR. J Amer Pharm Assoc. 2001:41(4).

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 legislationfueling 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 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 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 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 consentwhat 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

Many pharmacists struggle with what to exactly tell benefits during risk-benefits counselingo 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

Informing patients about treatment alternatives can be tricky because for the most part, this duty falls to the physician

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

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 stigmao 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

importanceo 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 foro 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

Conclusion

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