ASPIRE CLASS 1: Conceiving the Research IdeaSarah J. Billups, PharmD, BCPS, Clinical Pharmacy Specialist Samuel Johnson, PharmD, BCPS (AQ Cardiology), Clinical Pharmacy Specialist

Learning Objectives

Class 1: Conceiving the Research Idea

ASPIRE

Write a research question that meets PICO & FINER criteria Formulate primary and secondary objectives Formulate study hypotheses and select outcome measures

for each objective Use a well-written study question to survey primary literature Identify an efficient process for reviewing articles and

managing references

Where Do Research Questions Come From?

Clinical practice Literature Institutional and clinical problems

Where Do Research Questions Come From?

Example Research Questions

How effective is a clinical pharmacy service in managing patients with diabetes?

Why do HMO patients take their prescriptions to outside (out of plan) pharmacies?

What are the benefits of Medication Management? Why don’t patients pick up their new

bisphosphonate prescriptions?

What Makes a Good Research Question?

PICO

Population

Intervention

Comparison Group

Outcome

What Makes a Good Research Question?

FINER

Feasibility

Interesting

Novel

Ethical

Relevant

Example Question

Does a home blood pressure monitoring program improve hypertension control?

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Quality/ Completeness Check: PICO

Does a home blood pressure monitoring program improve hypertension control?

Population

Intervention

Comparison

Outcome

Quality/ Completeness Check: PICO

Does a home blood pressure monitoring program improve hypertension control?

Population—adult pts with a HTN diagnosis and uncontrolled HTN

Intervention—Pharmacist-managed HBPM program

Comparison—adult pts meeting inclusion criteria but not enrolled in program

Outcome—achieving target BP

Revised Question

Does a pharmacist-managed home blood pressure monitoring program increase the proportion of

hypertensive patients with uncontrolled BP who achieve their target blood pressure compared to similar patients

receiving usual care?

Example Question #2

Why don’t patients pick up their new bisphosphonate prescriptions?

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Quality/ Completeness Check: PICO

Why don’t patients pick up their new bisphosphonate prescriptions?

Population

Intervention

Comparison

Outcome

Quality/ Completeness Check: PICO

Why don’t patients pick up their new bisphosphonate prescriptions?

Population—adult women who don’t purchase an oral bisphosphonate Rx within 90 days of its being written

Intervention— N/A

Comparison—patients who DO purchase their Rx…

Outcome—questionnaire responses

Revised Question

How do beliefs about osteoporosis and bisphosphonates differ between adult women with new prescriptions for oral bisphosphonates who do versus do not purchase their medication within 90 days of its being ordered?

Quality Check: FINER

Feasibility

Interesting

Novel

Ethical

Relevant

Knowledge Check

What does the ‘C’ stand for in PICO ?

a. Cohort

b. Context

c. Confounder

d. Comparison Group

Knowledge Check

What does the ‘C’ stand for in PICO ?

a. Cohort

b. Context

c. Confounder

d. Comparison Group

Elements of a Research Protocol

Background

Population

Design

Objectives

ProceduresAnalytical

Plan

Research Question

Objectives, Hypotheses, and Outcomes

Objective: – What you want to learn

Hypothesis– What results do you expect?

Outcome – How you plan to measure it

– Specific

Study Objectives (Study Aims)

What the study will achieve Guides thinking, study design, analysis, and reporting Serves as outline for organizing later sections– Methods section should follow parallel sequence

Can have multiple objectives; designate a primary and remainder as secondary or tertiary

Not too many!

Study Objectives: Example

Compare concerns about medication cost between patients with and without primary nonadherence (defined as those who did versus did not purchase a new bisphosphonate prescription within 90 days of its being written).

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Study Hypothesis

Definition: prediction of the relationship between one or more factors and the problem under study

More specific than objectives and are amenable to explicit statistical evaluation

Guides how to conduct the statistics as the type of data collected/analyzed should be clear

Study Hypothesis

Most appropriate for intervention/evaluative studies– Difficult for descriptive/exploratory studies

At least 1 hypothesis for each objective – can have more than 1

Simple, specific, and stated in advance Stated as null or alternative– statistical analysis based on null hypothesis

Example

Objective: Compare concerns about prescription cost between

patients with and without primary non-adherence.

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Example

Hypothesis:

Alternative: Patients with primary non-adherence will have more

concern about prescription costs than adherent patients

Null: Patients with and without primary non-adherence will

have the same level of concern about prescription costs

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Study Outcome(s)

This is the specific thing you are going to measure

Example

Outcome: The proportion of patients in each group who express

that they are “very” or “somewhat” concerned about prescription cost in response to a telephone survey

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Objective, Hypothesis, and Outcome

Objective: To identify the incidence of bisphosphonate primary

non-adherence over a 3 month period

Hypothesis:

Outcome: Among patients with a new oral bisphosphonate

prescription written between August 1 and October 31, 2012, the percent who do not purchase it within 90 days

Example 2

Knowledge Check

Knowledge Check

Classify the following statement :

High school students given two samples of cola will express a preference for Pepsi over Coke.

a. Study Objective

b. Null Hypothesis

c. Alternative Hypotheses

d. Study Outcome

Knowledge Check

Classify the following statement :

High school students given two samples of cola will express a preference for Pepsi over Coke.

a. Study Objective

b. Null Hypothesis

c. Alternative Hypotheses

d. Study Outcome

Elements of a Research Protocol

Background

Population

Design

Objectives

ProceduresAnalytical

Plan

Research Question

Researching Background: Goals

Understand what is already known about the subject and where there are holes

Learn how others have approached this problem Reveal limitations or holes in the existing literature

Broad statement of topic Review relevant published

literature Outline gaps in the literature

and why these gaps are important

End with research question/purpose statement

Building the Background

General Search Strategies

Start with your PICO question(s)

Establish preliminary search terms

Establish inclusion and exclusion criteria

Tips to insure a high-quality, systematic search:1) Use at least two databases2) Check references of studies meeting

inclusion criteria3) Check with content experts to make sure

relevant studies are not missed4) Search for ‘gray’ literature5) Avoid limiting searches by date6) Come up with a process for reference

management (manual or software assisted)

7) Record search history

Free Resources for Reference Management

1. PubMed: Register for a free NCBI Account

2. EndNote Web Version: Register for free access (1 year)

3. Manual management: Hey, whatever works!

PubMed Resources

Pros It’s free It’s easy to access Most people are familiar

with it

Cons It doesn’t include gray

literature Access to most full-texts

requires you to use a PC with a KPCO IP address

EndNote Web Resource

Pros It’s free It enables you to

maintain a comprehensive electronic reference list

It’s widely accessible

Cons It’s only free for 1 year The interface is not that

intuitive Not all functionality is

available on KP PCs

Manual Reference Management

Pros It’s free ;) Not vulnerable to IT

issues ;) It’s like retro, man

Cons

Once You Have References…

Determine which should be included (relevant) Devise a scheme for routinely updating reference list

(PubMed resources) Detail references in your protocol, posters, and

manuscript

Assessing Quality of Studies

Appropriate study design Application of appropriate statistical testing Identification of bias and conflicts of interest Meaningful synthesis of results Appropriate conclusions drawn Various published quality assessment tools are

available (email me if you are interested)

Sample Evidence Summary

Study N Design Inclusion criteria Intervention Comparator Outcomes Median

follow-up

Chacon, 2011 675 RCT

>18 yearsKP memberNormal Renal function

Bloodletting Leeches Syncope 30 days

Sample Evidence Table

More detailed than evidence summary May be used to fuel a SR and meta-analysis Screenshot example(s)

In summary…

Start with a good PICO question Record your search history, consult with content experts Devise a systematic way to review and store references (and

stick to it ;) Use free online resources to your advantage Recognize opportunities for ST and meta-analysis

– Evidence synthesis

– Development of guidelines or consensus statements

Class 1 Assignment

Begin background literature review for your study Prepare a 5-10 min presentation for your small group

session including draft versions of the following:– Your research question (use FINER and PICO criteria)

– Primary and secondary objectives

– A hypothesis and study outcome(s) for each objective

Please come prepared with the above items

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