Research Methods for the Frontline Clinician

10th Annual Centura Health Evidence-Based Practice, Research and Innovation Conference

November 10, 2017

Jane Braaten, PhD, RN, CPPSCarrie McDermott, PhD, RN, ACNS-BCCynthia A. Oster, PhD, RN, APRN, MBA, ACNS-BC, ANP, FAAN

Objectives

• Upon completion of the session, the participant will be able to:

– Describe how to form a clinical question.

– Compare and contrast different research methods and study designs.

– Discuss the application of ethical principles for protection of human subjects in research.

– Identify the required components in an Institutional Review Board Packet.

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Why do Bedside Research?

• Bedside RNs are closest to the problems

– They see the clinical problems every day

• They are creative problem solvers

– Bedside RNs and continually adapting and innovating to deal with the problems at hand

• To advance the Science of Nursing

– There is insufficient evidence to answer many of our current clinical problems

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The Research Question

• Practice-based research is messy

– Be systematic

• Difficult to control the research procedures

– Secure organizational approval

• Difficult data collection

– Use secondary data when possible

Houser & Bokovoy, 2006

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Good Clinical Questions for Beside Clinicians

• Stays within your area of expertise

• Able to maintain staff interest

• Is important to your practice/patient outcomes

• Includes large numbers-patients you see every day

• Does not require funding

• Data collection is part of routine daily practice

Granger & Chulay, 1999

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Brainstorming the Research Question

• What kind of patients do you see every day?

– Population and Setting

• What kinds of problems do your patients have?

– Pain, glucose control, difficulty breathing, mobility

• What nursing interventions or technologies are you using?

– Symptom relief, patient education, multidisciplinary rounding

– EHR, IV pumps, MyChartBedside

• What patient outcomes are you interested in?

– Length of stay/readmissions, satisfaction, functional abilityGranger & Chulay, 1999

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Brainstorming the Research Question

General Terms

• Research Focus– General topic

• Research Problem– hat is the problem, how many people are

affected?

• Purpose Statement– The purpose of this study is to (test an

intervention, identify a relationship, explore a phenomena)

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The Research Question

• Research Question– Does ___ intervention decrease _____ symptoms in

_____ patients

• Hypothesis– ____ intervention may decrease ____ symptoms in

_____ patients

• Study AimsDescribes mores specific relationships between population and primary or secondary outcome measures

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Creating an Answerable Question

Type of Question Description Example

Background A broad knowledge based question-can be answered with common knowledge from a text

What is the best method to prevent HAPI?What are the risk factorsfor cardiac disease ?

ForegroundA specific question that provides evidence for clinical decision making

PICO(P)In mechanically ventilated patients in a small ICU, (I)does CHG bathing compared to (C) standard care, (O)affect VAP rate?

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http://libraryguides.missouri.edu/c.php?g=28271&p=174073

Asking the Right Questions for EBP

“If you don’t ask the right question, you won’t get the right answer”

• Common Problems

– Too broad

– Too vague

– Does not include a comparison

– Outcome is not measurable

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Creating an Structured Answerable Question: PICO

P •Population or Problem

I •Intervention or approach

C •Comparison group

O •Outcomehttp://libraryguides.missouri.edu/c.php?g=28271&p=174073

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Types of QuestionsQuestion Definition Example Template

Intervention or therapy

What is most effective How does aromatherapy compare to standard treatment in PONV.

Etiology Risk factors for a condition

What are the characteristics of those who develop rhabdomyolysis after intense exercise?

Diagnosis or test Which is more accurate in identifying or diagnosing

Is the Heinrich II better at identifying fall risk than ____?

Prognosis or prediction

Predicting clinical complications or clinical status over time

How does patient history of marijuana use affect pain control in the hospital?

Meaning What is the experience of a group or individual.

How do patient with intractable chest pain experience multiple ED visits?

http://libraryguides.missouri.edu/c.php?g=28271&p=174073 13

Population or Problem

• Age, gender

• Those at risk for a disease process or complication

• Who specifically does this effect?

• Our surgical patients keep getting pressure injuries…. Which surgical patients?

• Our post op patients keep throwing up…What type of post op patients?

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Intervention

• Treatment

• Solution applied

• What do we think could improve the problem?

• What are the best EB intervention?

• What would work for us?

• What treatments are available that might help prevent HAPI in surgery?

• What are alternative therapies to PONV?

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Comparison

• Reference group to compare

• How will we know our intervention is better than nothing at all or another intervention?

• Padding compared to no padding?

• Aromatherapy compared to no aromatherapy?

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Outcome

• Our desired state

• What are we trying to “win” at??

• Decrease in HAPI during surgery

• Decrease in PONV and length of stay in PACU

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PICO(TS)

• Time - in what time frame?

• Study design - what type of design is appropriate?

• During the hospital stay

• RCT; Comparative study

• Case control

• Longitudinal- over time

• Does it include perception –Qualitative?

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Now you do it….

Our surgical patients keep getting pressure ulcers that begin to develop in surgery…

P- What type of patients

I- What might help?

C- Compared to what?

O- What are we trying to achieve

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A good question can be turned into a study title…

• PICO-In (P)_______patients,(I)does _______compared to (C)______ decrease the rate of pressure ulcers?

• Study title: The effect of _______compared to ______on rate of pressure injuries in _________patients.

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Quantitative Research

• Exploratory vs Experimental

• Retrospective vs prospective

• Longitudinal vs Cross-Sectional

• Randomized-controlled

• Case-controlled

• Cohort studies

• Survey research

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Quantitative Analysis

• Levels of Measurement

– Nominal

– Ordinal

– Interval

– Ratio

• Statistics

– Descriptive

– Inferential

• Variables

– Independent

– Dependent

• Sampling

– Convenience

– Randomized

• Power and Effect Size

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Inferential Statistics

• Parametric Statistics

– T-tests

– ANOVA

– Correlations• Pearson (r)

• Multivariate

– ANCOVA/MANCOVA

– Multiple Regression• Linear, logistic

– Factor analysis

• Non-parametric Tests

– Chi Square

– Fishers exacts test

– Mann-Whitney U-test

– Spearman’s Rank order

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Quantitative Research Design • Experimental Design

– Causality

– Placebo controlled

– Randomization

• Temel, JS, et. al. (2010). Early Palliative Care for Patients with Metastatic Non–Small-Cell Lung Cancer. N Engl J Med. 363:733-42.– Randomized Palliative care with usual care in patients

diagnosed with NSCLC

– Primary outcome QOL

– Linear regression, fishers exact, chi square, Kaplan-Meier

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Quantitative Research Design

• Quasi-Experimental– Non-equivalent control group

– Prospective cohort study

• Pasion, E., et. al., (2010). Evaluation of the Monitor Cursor-line Method for Measurement of Pulmonary Artery and Central Venous Pressure. American Journal of Critical Care, 19(6), 511.– Patients served as their own control

– Compare 3 methods of hemodynamic measurement

– ANOVA

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Quantitative Research Design

• Non-Experimental

– Exploratory

– Observational

• Altice, N. F., & Madigan, E. A. (2012). Factors associated with delayed care-seeking in hospitalized patients with heart failure. Heart & Lung. 41(3): 244-254.

– Descriptive cohort study

– Correlations

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Research Continuum

• The continuum of research design reflects the different purposes of research

• Each type of research design fulfills a particular purpose and brings strength to the research process

• The appropriate research design and methods of analysis are based in the type of research question and the data available

Portney and Watkins, 2009

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What is qualitative research?

• How is qualitative knowledge relevant to nursing knowledge?

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Quantitative Research

• Characteristics– Objective, Numbers

– One truth

– Controlled

– Researcher is outside process

– Tests theory ( Deductive-broad to specific)

• Answers the Questions– How many? Is there a relationship? Cause and

effect-Does doing this cause that?Creswell, 2014

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Qualitative Research

• Characteristics– Subjective

– Multiple realities

– Based in real life setting: little control

– Researcher is part of the process

– Builds theory (Inductive)

• Answers the questions:– Why does this happen? What do the numbers

mean? De Chesnay, 2015

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CONTEXT - Qualitative Research takes place within the context of real life

• Context-everything that is not a part of the project/research itself

Overeit, 2011

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What questions are appropriate for qualitative research?

• Why do nurses hesitate to call an RRT?– Focus groups

• What factors lead to better adherence to discharge instructions?– Interviews/document review/action research

• What is the experience of ED nurses exposed to assault during their workday?– Interview

• How do nurses view professional practice ?– Appreciative inquiry

• How do patients define “feeling safe”?– Interviews

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Emergency Nurses’ Experience of Crisis: A Qualitative Study

• Aim: A crisis is an environment created in a rapidly changing and chaotic work setting which is found in a busy emergency department of a hospital with higher intensity. The objective of this study was to define and explore emergency room nurses' description of crisis in critical situations and to identify barriers and mitigating factors that affect how nurses handle crises.

• Methods : This study is a qualitative research with a content analysis approach. Eighteen emergency nurses were purposefully selected to take part in this study. Data collection was through face-to-face semistructured interviews until data saturation was finalized. Data analysis was conducted using content analysis.

• Results: The data analysis consisted of four main categories: (i) loss of balance; (ii) crisis control (anticipation–preparation, resource control, control skills, and supporting nurses); (iii) human factors related to staff (sufficient staff, competent staff, individual characteristics, ability to communicate); and (iv) teamwork (cooperation and reciprocal trust).

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Vasli, P. and Dehghan-Nayeri, N. (2016), Emergency nurses' experience of

crisis: A qualitative study. Japan Journal of Nursing Science, 13: 55–64.

doi:10.1111/jjns.12086

Identifying Barriers to Disclosure of Errors as Experienced by Nurses

• Results: Nurses generally thought that patients should be informed about every error, but only a very few nurses actually reported disclosing errors in practice. Indeed, many nurses reported that most errors are not disclosed to the patient. Nurses identified a number of barriers to error disclosure that have already been reported in the literature among all clinicians, such as legal consequences and the fear of losing patients’ trust. However, nurses in this study more frequently reported personal characteristics and a lack of guidance from the organisation as barriers to disclosure. Both issues suggest the need for a systematic institutional approach to error disclosure in which the decision to inform the patient stems from within the organisation and is not shouldered by individual nurses alone.

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McLennan, Stuart R. et al (2016) Nurses’ perspectives regarding the disclosure of errors to patients: A qualitative study. International Journal of Nursing Studies, 54: 16 – 22.

Common Qualitative Designs for Nurses

• Narrative inquiry

• Qualitative descriptive

• Grounded theory

• Action research

• Ethnography

• Appreciative Inquiry

36Creswell, 2014

Data Collection Approaches

• Interviews

• Focus groups

• Surveys

• Observation

• Photovoice

37Creswell, 2014

Analysis: Deductive versus Induction

Testing theory

Creating theory

Ded

uct

ive

Ind

uctive

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De Chesnay, 2015

Common Analysis Method for Qualitative Data

• Getting familiar with the data (reading and re-reading).

• Coding (labeling) the whole text

• Searching for themes with broader patterns of meaning

• Reviewing themes to make sure they fit the data

• Defining and naming themes

• The write-up (creating a coherent narrative that includes quotes from the interviewees)

39De Chesnay, 2015

Myths about Qualitative Research

• It is not rigorous

• It doesn’t need to go the IRB because it is not risky

• It is not generalizable knowledge

• It is not research

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Taylor, 2017

Is it real research?

• Does it create new knowledge?

• Did it include a research design for data collection and analysis?

• Did it include research questions?

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Protection of Research Participants

• Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

• Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains– Data through intervention or interaction with the individual, or

– Identifiable private information.

Human Subjects Research (45 CFR 46)

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Institutional Review Board

• “An IRB is defined as an “administrative body” composed of scientists and nonscientists established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.” (Bankert & Amdur, 2006, p. 16)

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Responsibilities• Conducts a prospective review of proposed

research.

• Monitors continuing research.

• Safeguards the rights and welfare of the participants.

• Ethics is the critical component of the review and approval of research protocols.

Bankert & Amdur, 2006

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Brief History• The history of human research is marked with

terrible examples of how basic ethical principles were ignored.– Nazi Medical Experiments (1935 - 1945)

– Tuskegee Syphilis Study (1932 - 1972)

– Willowbrook Study (late 1950’s - early 1970’s)

– Jewish Chronic Disease Hospital Study (1960’s)

– The Thalidomide Experience (1962)

– Contraception Study (early 1970’s)

– Tearoom Trade Study (early 1970’s)

Amdur & Bankert, 2011

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Guiding Principles

• The Code of Federal Regulations Title 45 Part 46: Protection of Human Subjects (CFR)

– Contains bureaucratic rules

• The Belmont Report

– Details ethical principles and applications

Amdur & Bankert, 2011

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The Belmont Report• Principle 1: Respect for

Persons

– Treat individuals as autonomous agents.

– Protect persons with diminished autonomy.

• IRB Requirements

– Voluntary consent

– Informed consent

– Protection of privacy and confidentiality

– Right to withdraw without penalty

Amdur & Bankert, 2011

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Informed Consent• Elements

– Title of study and names of investigators

– Introduction and invitation to participate

– Basis for selection

– Duration of participation

– Reasonably foreseeable risks/unforeseen risks

– Benefits of participation/cost of participation

– Appropriate alternatives to participation

• Elements– Voluntary withdrawal from study

– Payments/compensation

– Confidentiality of records

– Contact person

– Funding statement/conflict of interest statement

– Statement of voluntary participation

– Signature lines

Bankert & Amdur, 2006

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Informed Consent

• Comprehension

– Understand the intent of the study

– Write at 7th or 8th grade level

– Use simple language

– Avoid technical terms

– Avoid healthcare jargonBankert & Amdur, 2006

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The Belmont Report

• Principle 2: Beneficence

– Do unto others as you

would have them do

unto you.

• IRB Requirements

– Risks are justified by potential benefits.

– Study is designed so risks are minimized.

– Conflicts of interest are managed adequately.

Amdur & Bankert, 2011

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The Belmont Report• Principle 3: Justice

– Distribute the risks and potential benefits of research equally among those who may benefit from the research.

• IRB Requirements

– Vulnerable subjects are not targeted for convenience.

– People who are likely to benefit from research participation are not systematically excluded.

Amdur & Bankert, 2011

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TRUST

Investigator

Public/Subject

Federal Government

Institution/SponsorIRB

The Belmont Circle

Bankert & Amdur, 2006

“Human-subjects research is a privilege and not a right.”

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Accountability for Human Research

• Levels of Accountability

– Institutional

– IRB

– Investigator

• Common Goal

– The safe and ethical conduct of research.

Bankert & Amdur, 2006

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Accountability for Human Research

• Institutional Accountability

– “Institutional Official” assumes overall responsibility for regulatory compliance.

• IRB Accountability

– Ensure all appropriate review procedures are followed.

Bankert & Amdur, 2006

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Institutional Review Board

• Membership

– Physicians

– Nurses

– Pharmacists

– Chaplains

– Lawyers

– Community Representatives

– IRB Staff

http://www.hhs.gov/ohrp/assurances/assurances/filasurt.htmlhttp://www.chiresearch.org/

The 100+ strong CHI hospital network is the foundation for CHI Institute of Research and Innovation or CIRI.

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Institutional Review Board

http://www.chiresearch.org/CIRI/Human-Research-Protection-Program-IRB56

Institutional Review Board

https://www.irbnet.org/release/index.html; http://www.chiresearch.org/Content/Documents/CHI-CIRI-CHIRB-Instructions.pdf 57

Accountability for Human Research

• Investigator Accountability– Required to submit research for

prospective IRB approval.– Comply with:

• All IRB conditions of approval

• Institutional policy

• Federal regulations and laws

• State regulations and laws

Bankert & Amdur, 2006

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Navigating the Institutional Review Board

• Protection of Human Research Subjects Education

• “The Package”

• Fees and Deadlines

• IRB Response

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Protection of Human Research Subjects Education

• Complete prior to submission

• Know the course and modules required

– NIH Office of Extramural Research – Protecting Human Research Participants

• http://phrp.nihtraining.com/users/login.php

– Collaborative Institutional Training Initiative (CITI)

• https://www.citiprogram.org/default.asp?language=english

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Tips for Success• Know the IRB manager/coordinator

• Do human subject education beforehand

• Use the CHIRB Submission Guide

• Write a detailed cover letter

• Version dates on all materials

• Study number on all correspondence

• Meet deadlines

• Sign and date the application

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Why do we need to do nursing research???

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Questions

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References• Amdur, R.J. & Bankert, E.A. (2011). Institutional Review Board Member Handbook. 3rd ed. Jones and Bartlett Publishers:

Sudbury MA.

• Bankert, E.A & Amdur, R.J. (2006). Institutional Review Board Management and Function. Jones and Bartlett Publishers: Sudbury, MA.

• Burns, N. & Grove, N. (2007). Understanding Nursing Research: Building an Evidence Based Practice. Elsevier: St. Louis.

• Collaborative Institutional Training Initiative (CITI) at https://www.citiprogram.org/default.asp?language=english

• Creswell, J. W. (2014). Research design: qualitative, quantitative, and mixed methods approaches. 4th ed. Thousand Oaks, California: SAGE Publications

• De Chesnay, M. (Ed.)(2015). Nursing research using data analysis: Qualitative designs and methods in nursing. Springer: New York, NY.

• Evidence Based Nursing Practice at http://libraryguides.missouri.edu/c.php?g=28271&p=174073

• Granger, B & Chulay, M.(1999). Research Strategies for Clinicians. Appleton & Lang: Samford CT

• Houser, J & Bokivoy, J. (2006). Clinical Research in Practice: A Guide for the Bedside Scientist. Jones and Bartlett: Studbury, MA

• Human Subjects Research (45 CFR 46) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html retrieved 10/17/12.NIH Office of Extramural Research – Protecting Human Research Participants at http://phrp.nihtraining.com/users/login.php

• Office for Human Research Protections (OHRP) at http://www.hhs.gov/ohrp/

• Overeit, J. (2011). Understanding the conditions for improvement: research to discover which context affect improvement success. BMJ Quality and Safety, 20(supp. 1) 18-23.

• Portney, L G, & Watkins, M P., (2009). Foundations of Clinical Research: Applications to Practice (3rd Ed). Pearson Education: Upper Saddle River, NJ

• Polit, D. & Hungler, B. (1995). Nursing Research: Principles and Methods (6th ed). Lippincott: Philadelphia.

• Taylor, J. (2017). Deconstructing myths in qualitative research. International Forum, 20(1),18-30.

1.Øvretveit J. Understanding the conditions for improvement: research to discover which context influences affect improvement success. BMJ Qual Saf 2011;20(Suppl 1):i181.Øvretveit J

. Understanding the conditions for improvement: research to discover which context influences affect improvement success. BMJ Qual Saf 2011;20(Suppl 1):i18Understanding the conditions for improvement: research to discover which context influences affect improvement success. BMJ Qual Saf 2011;20(Suppl 1):i18

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Contact Information

• Jane Braaten, PhD, RN, CPPSNurse ScientistCastle Rock Adventist Hospitaljanebraaten@centura.org720-455-2533

• Carrie McDermott, PhD, RN, APRN, ACNS-BCProgram CoordinatorCentura Health Palliative Carecarriemcdermott@centura.org303-561-5069 Office

• Cynthia A. Oster, PhD, RN, APRN, MBA, ACNS-BC, ANP, FAANNurse ScientistClinical Nurse Specialist - Critical Care and Cardiovascular ServicesPorter Adventist Hospitalcynthiaoster@centura.org303-778-5266

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